Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine Foundation’s 2026 Antimicrobial Resistance Benchmark Report




Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine Foundation’s 2026 Antimicrobial Resistance Benchmark Report

Report Highlights the Company’s Collaboration with GARDP to Develop NUZOLVENCE^® (zoliflodacin) for Oral Suspension for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Pediatric Patients

WALTHAM, Mass.–(BUSINESS WIRE)–Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc., today announced that its infectious disease therapeutic portfolio earned a strong performance rating of 80% in the 2026 Antimicrobial Resistance (AMR) Benchmark Report published by the Access to Medicine Foundation. The score represents the highest rating in the small- and medium-sized enterprise (SME) category, achieved by only one other company in this year’s report. The AMR Benchmark evaluates pharmaceutical companies’ efforts to combat antimicrobial resistance and expand global access to effective treatments.

“We are honored to be recognized in this important global assessment of the antibiotic treatment landscape, particularly at a time when there is a growing need for new therapies as antibiotic resistance continues to rise across many regions, challenging our ability to treat life-threatening infections effectively,” said David Altarac, M.D., Chief Medical Officer of Innoviva Specialty Therapeutics. “Addressing this urgent public health crisis is central to our mission, and we remain committed to developing innovative therapies that target high-priority and difficult-to-treat pathogens.”

The Foundation’s recognition highlights Innoviva Specialty Therapeutics’ commitment to advancing therapies for serious and life-threatening infections, including those caused by priority pathogens, classified by the World Health Organization (WHO), as well as for its innovation and best practices in research and development. The report cites the Company’s recently U.S. FDA-approved first-in-class single-dose oral therapy, NUZOLVENCE^® (zoliflodacin) for oral suspension in adults and adolescents, which treats susceptible strains of Neisseria gonorrhoeae, including those resistant to cephalosporins, and meets three of four WHO innovation criteria. The report notes that the Company’s work in this area demonstrates Best Practice for its innovative candidate and stands out for its integration of access and stewardship considerations within its development plan, which was created in partnership with the Global Antibiotics Research and Development Partnership (GARDP).

Innoviva was evaluated in the SME category based on its performance in the R&D Technical Area. This assessment examines the strength and innovation of the Company’s pipeline, including alignment with WHO criteria, demonstrated clinical value, and relevance to critical gaps in the global antimicrobial R&D landscape. It also considers whether late-stage (Phase II/III) projects are supported by comprehensive access and stewardship plans.

The 2026 AMR Benchmark report will be formally presented at a high-level launch event in London, underscoring the growing global urgency to combat antimicrobial resistance and accelerate coordinated action across governments, industry, and healthcare systems. Co-hosted by the Access to Medicine Foundation and the Fleming Initiative, the event will convene approximately 100 global health leaders for a focused discussion on recent progress, persistent challenges, and practical steps to accelerate industry action against drug resistance.

Since its establishment in 2023, Innoviva Specialty Therapeutics has built a comprehensive portfolio of hospital-focused therapies addressing urgent, challenging, and unmet medical needs. The portfolio includes a novel vasopressor for patients with septic or other distributive shock, as well as four FDA-approved antimicrobial agents, including NUZOLVENCE^® (zoliflodacin) for oral suspension. The Company remains focused on expanding its infectious disease portfolio and collaborating with global partners to help address one of the most pressing public health challenges of our time.

About NUZOLVENCE^® (zoliflodacin) for oral suspension

NUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies.

NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae.

Important Safety Information (ISI)

Indication and Usage

Indication

NUZOLVENCE^® is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.

Usage to Reduce Development of Drug-Resistant Bacteria: To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Contraindications

• Known history of hypersensitivity to NUZOLVENCE.
• Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy.

Warnings and Precautions

• Embryo-Fetal Toxicity: Potential Risk for Pregnant Females
  • Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential.
• Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential:
  • Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration.
• Testicular Toxicity and Risks to Male Fertility:
  • Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Hypersensitivity Reactions:
  • Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures.
• Clostridioides difficile Infection (CDI):
  • CDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
• Development of Drug-Resistant Bacteria:
  • Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.

Drug Interactions

Concomitant use with moderate or strong CYP3A4 inducers is contraindicated.

Use in Specific Populations

• Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.
• Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur.
• Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE.
  • Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE.
  • Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE.
  • Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.
• Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Reporting Adverse Events

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

Innoviva Specialty Therapeutics™

1-800-651-3861

medinfo@istx.com

U.S. Food and Drug Administration

1-800-FDA-1088

www.fda.gov/medwatch

Before administering, please see the Full Prescribing Information for NUZOLVENCE.

About Innoviva Specialty Therapeutics

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA^® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA^® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter), and NUZOLVENCE^® (zoliflodacin), a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. Through a licensing agreement with Basilea Pharmaceutica, Ltd., Innoviva Specialty Therapeutics retains U.S. marketing rights for ZEVTERA^® (ceftobiprole), the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). For more information about Innoviva Specialty Therapeutics, please visit here.

Forward Looking Statements

This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR^®/BREO^® ELLIPTA^®, ANORO^® ELLIPTA^®, GIAPREZA^®, NUZOLVENCE^®, XERAVA^®, XACDURO^® and ZEVTERA, the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

Contacts

Media Contact:
David Patti

Corporate Communications

Innoviva Specialty Therapeutics

David.patti@inva.com

Investor Relations Contact:
Eleanor Barisser

Director of Investor Relations and Corporate Communications

Innoviva, Inc.

Eleanor.barisser@inva.com

Centauri Therapeutics Granted FDA QIDP Status for CTX-187 Treatment of Gram-Negative Bacterial Infections




Centauri Therapeutics Granted FDA QIDP Status for CTX-187 Treatment of Gram-Negative Bacterial Infections

• Lead clinical candidate CTX-187 is a novel antimicrobial immunotherapy developed to treat clinically-prevalent and multi-drug resistant Gram-negative bacterial infections
• Qualified Infectious Disease Product designation awarded for the development of antibacterials and antifungals intended to treat serious or life-threatening conditions in humans

ALDERLEY PARK, England–(BUSINESS WIRE)–Centauri Therapeutics Limited (‘Centauri’ or ‘the Company’), an immunotherapy company with a unique and proprietary platform technology applicable across a wide range of therapeutic indications, today announced that the Company’s lead clinical candidate in the ABX-01 programme, CTX-187, has received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA). Currently in pre-clinical development ahead of first in-human trials, CTX-187 provides a novel immunotherapeutic approach to treat Gram-negative bacterial infections and expand therapeutic options for clinically vulnerable patients.

QIDP status is awarded under the US GAIN (Generating Antibiotic Incentives Now) provisions for the development of antibacterials and antifungals intended to treat serious or life-threatening conditions in humans. Drug products receiving QIDP status gain access to several benefits to accelerate the development process, including eligibility for fast-track designation and priority review, and a five-year extension to market exclusivity.

CTX-187 is a novel antimicrobial built on Centauri’s proprietary Alphamer^® platform, featuring a dual mechanism-of-action that combines immunotherapeutic effects through complement activation and opsonophagocytosis with antibacterial activity. The molecule is currently in development, progressing to first in-human clinical trials later this year as a new treatment for clinically prevalent and multidrug-resistant Gram-negative bacteria.

Dr. Debra Barker, Chief Medical Officer, Centauri Therapeutics, said: “This designation from the FDA will be invaluable as we continue to advance toward first in-human trials for CTX-187. The recognition of the potential value of our technology further underpins our belief in its potential to transform treatment paradigms for Gram-negative bacterial infections, filling an urgently needed gap in the market for new and effective treatment options for clinically vulnerable patients.”

The Alphamer^® platform is a modularly designed immunotherapeutic that redirects the body’s natural antibody repertoire against disease. The unique design is backed by strong proof-of-concept data, demonstrating >99.9% immune-mediated bacterial clearance at sub-therapeutic doses across Gram-negative and multi-drug resistant bacterial strains in vivo¹. This novel immunotherapeutic approach enables Alphamers to be used as a viable treatment option for clinically vulnerable patient groups where current therapies are limited or ineffective, including patients that are immunosuppressed.

Daniel Hynes, VP of Development, Centauri Therapeutics, commented: “The FDA’s QIDP designation is a crucial programme designed to address the healthcare burden of serious and life-threatening infections by accelerating the development of promising therapeutics. We welcome this regulatory endorsement of CTX-187, which will enable us to streamline our route to regulatory approvals, and bring a much-needed treatment option to address serious infections in vulnerable patient groups.”

The Company has also been supported by CARB-X² (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) to undertake research and development studies since 2019, advancing the ABX-01 programme from Lead Optimization to the Preclinical phase.

1. Hairsine, B. et al. (2025) ‘Harnessing endogenous anti-glycan antibodies using a novel, bifunctional immunotherapy to treat gram-negative bacterial infections’, The Journal of Immunology, 00, pp. 1–13. doi:10.1093/jimmun/vkaf055.
2. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Research, Technology and Space (BMFTR), and the Novo Nordisk Foundation. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

Contacts

Media
Katie Odgaard

katie.odgaard@zymecommunications.com

Alzheon to Present Clinical, Imaging, and Fluid Biomarker Results from Trials with Oral Valiltramiprosate/ALZ-801 at 2026 AD/PD Conference in Copenhagen, Denmark




Alzheon to Present Clinical, Imaging, and Fluid Biomarker Results from Trials with Oral Valiltramiprosate/ALZ-801 at 2026 AD/PD Conference in Copenhagen, Denmark

Valiltramiprosate Shows Promise as an Oral Potentially Disease-Modifying Agent that can Slow Alzheimer’s Disease Based on Clinical Results, MRI Data, and Fluid Biomarkers in APOE4/4 MCI Patients

Two Oral Presentations and Six Posters Highlight Consistent Effects of Oral Valiltramiprosate on Brain Volume, Microstructural Integrity, Neurodegeneration, Systems Modeling, and Long-Term Clinical Stability

Valiltramiprosate Designed to Inhibit Amyloid Aggregation via Distinct Upstream Mode of Action, Targeting Soluble Amyloid Oligomers – A Key Driver of Alzheimer’s Disease Pathology

Precision Medicine Approach Supported by Favorable Safety Results in High-Risk APOE4/4 Patients in Phase 3 & Phase 2 Trials

FRAMINGHAM, Mass.–(BUSINESS WIRE)–#ALZ801—Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of investigational therapies and diagnostic assays for patients with Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced it will present new efficacy, imaging, safety, biomarker, and quantitative systems pharmacology findings for its lead investigational therapy, valiltramiprosate/ALZ-801 during the 2026 International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD) in Copenhagen, Denmark.

“Valiltramiprosate stands out as the only late-stage oral Alzheimer’s treatment with potential for a major near-term impact,” said Susan Abushakra, Chief Medical Officer of Alzheon. “Our results at AD/PD align with previous clinical, imaging, safety, and biomarker data. Targeting toxic amyloid oligomers continues to show promise for preserving cognition, daily function, and brain volume. As we prepare for regulatory discussions, our priority is approval of valiltramiprosate for Alzheimer’s patients with the APOE4 genotype and expanding to additional high-risk groups.”

Valiltramiprosate is an investigational oral therapeutic agent in Phase 3 development that works upstream of anti-amyloid antibodies by preventing the formation of neurotoxic soluble amyloid oligomers. As a valine-conjugated prodrug of tramiprosate with improved pharmacokinetics and brain penetration, valiltramiprosate targets early amyloid aggregation, a core driver of Alzheimer’s pathology and disease progression. Valiltramiprosate aims to preserve brain structure and cognitive function in individuals with early-stage Alzheimer’s disease, with particular emphasis on APOE4/4 homozygotes, which are the highest-risk genetic subgroup, characterized by aggressive neurodegeneration and limited treatment options.

New results to be presented at AD/PD include safety and ARIA analyses from the APOLLOE4 Phase 3 placebo-controlled trial, quantitative systems pharmacology (QSP) analyses of amyloid aggregation dynamics, diffusion MRI findings showing preserved microstructural integrity, and clinical-imaging correlations in the pre-specified Mild Cognitive Impairment (MCI) subgroup of the Phase 3 study. These results are further supported by responder analyses showing reversal of hippocampal atrophy, and long-term MMSE outcomes from a Phase 2 study which had disease stability over four years of treatment in APOE4 MCI carriers.

Details of Presentations at AD/PD Conference

Alzheon will deliver two oral presentations and showcase six posters covering clinical, MRI, microstructural, biomarker, and QSP analyses.

Symposium: Advances in AD Treatment

Saturday, March 21, 2026 – 2:10pm- 4:10pm

Podium Presentation: Clinical Efficacy and Imaging Results of Oral Valiltramiprosate in APOE4/4 Homozygotes with Early AD: Phase 3 Topline Results from 78-Week APOLLOE4 Trial

• Presenter: Dr. Aidan Power, Chief Development Officer, Alzheon, Inc.
• Lecture Time: 2:10pm – 2:25pm

Podium Presentation: Clinical Stabilization in MCI APOE4 Carriers Over 3 Years Correlates with Improved Hippocampal Volume in Valiltramiprosate Phase 2 LTE Study

• Presenter: Dr. John Hey, Chief Scientific Officer, Alzheon, Inc.
• Lecture Time: 2:25pm – 2:40pm

Tuesday, March 17 from 7:30am – Thursday, March 19^th 11:00am

Poster: Biomarker‑Positive APOE4 Carriers with MCI Show Disease Stability Over 4 Years of Valiltramiprosate/ALZ‑801 Treatment: MMSE Responder Analysis from the ALZ‑801 Phase 2 Long‑Term Extension Study

• Presenter: Patrick Kesslak, Senior Research Fellow, Alzheon, Inc.

Thursday, March 19^th from 1:50pm – Saturday, March 21^st 5:00pm

Poster: Positive Effects of Oral Valiltramiprosate on Grey and White Matter Microstructural Integrity by DTI in APOE4/4 Homozygotes with Early AD: APOLLOE4 78‑Week Phase 3 Results

• Presenter: Earvin Liang, VP of Clinical Operations, Alzheon, Inc.

Poster: Safety and ARIA Analyses of the Oral Anti‑Amyloid Oligomer Agent Valiltramiprosate in APOE4/4 Homozygotes with Early AD: Results of the 78‑Week Phase 3 APOLLOE4 Trial

• Presenter: Dr. David Watson, CEO, Alzheimer’s Research & Treatment Center

Poster: Quantitative Systems Pharmacology Analyses of Beta‑Amyloid Aggregation Dynamics: Additive/Synergistic Effects of Valiltramiprosate Used in Combination with Leqembi and Kisunla

• Presenter: Jean Schaefer, VP of CMC & Project Management, Alzheon, Inc.

Poster: Valiltramiprosate Reverses Neurodegeneration and Improves Clinical Outcomes in Subgroup of Early Symptomatic AD in Homozygotes: Results from the 78‑Week Phase 3 APOLLOE4 Trial

• Presenter: Dr. John Hey, Chief Scientific Officer, Alzheon, Inc.

Poster: Valiltramiprosate Effects in the Pre‑Specified MCI Group Show Significant Correlations Between Clinical and Brain Volume Benefits: Phase 3 APOLLOE4 Results in Early AD APOE4/4 Homozygotes

• Presenter: Dr. Aidan Power, Chief Development Officer, Alzheon, Inc.

About ALZ-801

Valiltramiprosate/ALZ-801 is an investigational oral agent currently in Phase 3 development as a potential first-in-class, disease-modifying treatment for Alzheimer’s disease.^3-7,9,12 Valiltramiprosate is designed to inhibit the formation of neurotoxic soluble beta amyloid oligomers that contribute to cognitive decline in individuals with AD.^4-8,10,15 Preclinical mechanism-of-action studies have demonstrated that ALZ-801 can completely block the formation of these neurotoxic oligomers at the dosage used in Phase 3 clinical trials.^3,9,12,14 Valiltramiprosate employs an enveloping molecular mechanism of action intended to prevent the aggregation of soluble amyloid oligomers in the human brain, ¹⁴ which are associated with the onset and progression of cognitive impairment in AD patients.^3,4,7,9,10 In recognition of its therapeutic promise, valiltramiprosate received Fast Track designation from the U.S. Food and Drug Administration in 2017 for the treatment of Alzheimer’s disease.

Clinical trial data indicate that valiltramiprosate exhibits strong clinical efficacy at the MCI stage, and a favorable safety profile, with no observed increase in the risk of brain vasogenic edema.^5-1-10,13,15 The initial Phase 3 program for valiltramiprosate targets Early AD patients who are homozygous for the apolipoprotein ε4 allele (APOE4/4), with plans to expand future research to include AD treatment and prevention in individuals carrying one copy of the APOE4 gene.^3–10

Valiltramiprosate APOLLOE4 Phase 3 Trial

An Efficacy and Safety Study of Valiltramiprosate in APOE4/4 Early Alzheimer’s Disease Subjects (NCT04770220): This trial was designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of valiltramiprosate in Early AD subjects with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who constitute approximately 15% of Alzheimer’s patients. This double-blind, randomized trial compared oral valiltramiprosate to placebo treatment over 78 weeks. The APOLLOE4 trial was supported by a grant from the National Institute on Aging to Alzheon, with Susan Abushakra as the principal investigator.

Valiltramiprosate APOLLOE4 Long Term Extension Trial (Phase 3 LTE)

An ongoing long-term extension of the trial, APOLLOE4-LTE, evaluates valiltramiprosate in subjects who complete the core APOLLOE4 study for an additional 104 weeks of treatment for a total of 182 weeks or 3.5 years over the core and LTE study. This LTE study ended in January 2026 (NCT06304883).

Valiltramiprosate Phase 2 Biomarker Trial

Biomarker Effects of Valiltramiprosate in APOE4 Carriers with Early Alzheimer’s Disease (NCT04693520): This trial was designed to evaluate the effects of 265 mg twice daily oral dose of valiltramiprosate on biomarkers of AD pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotype and constitute 65-70% of Alzheimer’s patients. The primary outcome was the change from baseline in plasma p-tau₁₈₁. The trial also included evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic profile of valiltramiprosate over 104 weeks of treatment. A completed long-term extension of the trial evaluated the same dose of valiltramiprosate for an additional 104 weeks of treatment for a total of 208 weeks.^3,7,8

About Alzheon

Alzheon, Inc. is a clinical-stage biopharmaceutical company dedicated to advancing a diverse portfolio of product candidates and diagnostic assays for individuals affected by Alzheimer’s disease and other neurodegenerative disorders. The company is focused on innovating therapeutic solutions that directly target the underlying pathology of neurodegeneration. Its lead Alzheimer’s clinical candidate, valiltramiprosate/ALZ-801, is a first-in-class oral agent currently in Phase 3 clinical development as a potentially disease-modifying treatment for Alzheimer’s disease. Valiltramiprosate is an orally administered small molecule shown in preclinical studies to completely inhibit the formation of neurotoxic soluble amyloid oligomers. Leveraging clinical expertise and a robust technology platform, Alzheon pursues drug discovery and development using a precision medicine approach that incorporates individual genetic and biomarker profiles, aiming to advance therapies with meaningful benefits for patients.

Alzheon Scientific Publications

¹Abushakra S, et al: Hippocampal Atrophy on Magnetic Resonance Imaging as a Surrogate Marker for Clinical Benefit and Neurodegeneration in Early Symptomatic Alzheimer’s Disease: Synthesis of Evidence from Observational and Interventional Trials, CNS Drugs 2025; 40, 199-214.

²Abushakra S, et al: Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEε4/ε4 Homozygotes with Early Alzheimer’s Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial, Drugs 2025; 85, 1455-1472.

³Pearson D, et al: Polymorph Analysis of ALZ-801 (Valiltramiprosate), a Valine-Conjugated Oral Prodrug of Tramiprosate in Late-Stage Clinical Development for Alzheimer’s Disease, Journal of Chemical Crystallography 2025; 55, 206-215.

⁴Hey JA, et al: Clinical Pharmacokinetics of Oral ALZ-801/Valiltramiprosate in a Two-Year Phase 2 Trial of APOE4 Carriers with Early Alzheimer’s Disease, Clinical Pharmacokinetics 2025; 64, 407-424.

⁵Aye S, et al: Point of View: Challenges in Implementation of New Immunotherapies for Alzheimer’s Disease, The Journal of Prevention of Alzheimer’s Disease 2025;12(1):100022.

⁶Abushakra S, et al: APOLLOE4 Phase 3 Study of Oral ALZ-801/Valiltramiprosate in APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease: Trial Design and Baseline Characteristics, Alzheimer’s & Dementia 2024; 10(3): e12498.

⁷Tolar M, et al: The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention, International Journal of Molecular Sciences 2024; 25(5), 2727.

⁸Hey JA, et al: Analysis of Cerebrospinal Fluid, Plasma β Amyloid Biomarkers, and Cognition from a 2-Year Phase 2 Trial Evaluating Oral ALZ-801/Valiltramiprosate in APOE4 Carriers with Early Alzheimer’s Disease Using Quantitative Systems Pharmacology Model, Drugs 2024; 84(7), 825-839.

⁹Hey JA, et al: Effects of Oral ALZ-801/Valiltramiprosate on Plasma Biomarkers, Brain Hippocampal Volume, and Cognition: Results of 2-Year Single Arm, Open Label, Phase 2 Trial in APOE4 Carriers with Early Alzheimer’s Disease, Drugs 2024; 84(7), 811-823.

¹⁰Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences 2021; 22(12), 6355.

¹¹Abushakra S, et al: APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease Show Accelerated Hippocampal Atrophy and Cortical Thinning that Correlates with Cognitive Decline, Alzheimer’s & Dementia 2020; 6(1): e12117.

¹²Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer’s Disease with Potential for Near Term Approval, Alzheimer’s Research & Therapy 2020; 12(1): 95.

¹³Tolar M, et al: The Path Forward in Alzheimer’s Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer’s & Dementia 2020; 16(11):1553-1560.

¹⁴Hey JA, et al: Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain, CNS Drugs 2018; 32(9): 849-861.

¹⁵Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease, Clinical Pharmacokinetics 2018; 57(3): 315-333.

¹⁶Abushakra S, et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease Suggest Disease Modification Potential, Journal of Prevention of Alzheimer’s Disease 2017; 4(3): 149-156.

¹⁷Kocis P, et al: Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs 2017; 31(6): 495-509.

¹⁸Abushakra S, et al: Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect,” Journal of Prevention of Alzheimer’s Disease 2016; 3(4): 219-228.

Contacts

Media Contact
Yasemin Khakian, Alzheon, Inc.

508.808.2301

yasemin.khakian@alzheon.com

Investor Contact
Erwan de Naurois, Alzheon, Inc.

802.735.8789

erwan.denaurois@alzheon.com

For the First Time, Ferring Reports Revenue of Over €2.5 Billion in 2025




For the First Time, Ferring Reports Revenue of Over €2.5 Billion in 2025

• Ferring’s total revenues for 2025 exceeded €2.5 billion, an increase of 10% from 2024, mainly driven by our flagship product Menopur^®
• Continued ramp-up in the US for Adstiladrin^®, our novel gene-based therapy for bladder cancer, confirming its position as Ferring’s second major growth driver
• Commitment to sustainability demonstrated by SBTi approval of our targets to reduce greenhouse gas emissions, and by our programme to reduce maternal deaths in low- and lower middle-income countries

SAINT-PREX, Switzerland–(BUSINESS WIRE)–Ferring today published its 2025 Annual Report and Sustainability Report. The company achieved total revenues of over €2.5 billion in 2025, an increase of 7% over the previous year at actual exchange rates (AER) and 10% at constant exchange rates (CER). These were mainly driven by our flagship product Menopur^® (menotropins for injection) in reproductive medicine, and the ramp-up in the US of our breakthrough gene-based therapy for non-muscle invasive bladder cancer, Adstiladrin^® (nadofaragene firadenovec-vncg).

Operating expenses were contained to an increase of €61 million year-on-year (i.e. +5% at AER and +7% at CER), and this includes significant non-recurring items (notably impairment charges and restructuring provisions). Underlying operating expenses remained well-controlled, with increased investments targeted to support the growth of Adstiladrin and other opportunities. Thus, operating profit for the year reached €167 million, a decrease of -€24 million (‑13%) versus the prior year at AER, while remaining flat at CER – with the difference being driven by the weaker US dollar.

Following a focus on improving cash conversion after several heavy investments, free cash flow generation approached neutral despite currency headwinds from the weaker US dollar. This represents a substantial improvement compared to the previous year, and a significant step towards sustainable cash generation.

Jean-Frédéric Paulsen, Chairman of the Board of Directors and Chief Executive Officer, said: “This was a pivotal year as we continued evolving our business to become stronger, more agile and more resilient, and importantly we got back to free cash flow neutral. Moreover, in 2025, we introduced an enterprise model designed to create greater value for patients and customers while supporting sustainable growth. This reflects our long-term commitment to serving patients’ need, and fostering an environment where people can learn, grow and perform at their best.”

Ferring has always conducted business responsibly by seeking to protect the environment, create value for society, and uphold our high standards of ethics and governance. In 2025, we passed a major milestone when our targets for reducing greenhouse gas (GHG) emissions were approved by the Science Based Targets initiative (SBTi). This globally recognised standard ensures corporate goals are aligned with international climate policy. During the year, we succeeded in reducing our Scope 1 and 2 GHG emissions by 4.3% and Scope 3 emissions by 19%.

Access to affordable healthcare is embedded in Ferring’s purpose and strategic priorities. The Project Family™: Safe Birth initiative aims to reduce maternal deaths in low- and lower middle-income countries by enabling wider access to Carbetocin Ferring (carbetocin, room-temperature stable formulation). In 2025, we worked with partners to supply around 1.7 million doses of this life-saving medicine at an affordable access price, while gaining further approvals in seven low- and lower middle-income countries.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately owned specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,500 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries.

Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram and YouTube.

Contacts

For more information, please contact

Carine Julen
Senior Manager, Corporate Communications & Public Affairs
carine.julen@ferring.com

C-Further Unveils First Therapeutic Programmes Dedicated to Paediatric Oncology




C-Further Unveils First Therapeutic Programmes Dedicated to Paediatric Oncology

C-Further to advance its first two bespoke paediatric cancer therapeutics in collaboration with leading global academic and industry investigators

Selected programmes to potentially address multiple children’s cancers including Ewing sarcoma, bone sarcoma, medulloblastoma and acute myeloid leukaemia

Additional C-Further programmes to be announced in 2026

LONDON–(BUSINESS WIRE)–C-Further, an international consortium committed to creating new therapeutics for childhood cancers, today unveils the first early-stage therapeutic programmes for its pipeline, dedicated to paediatric oncology indications. Through its collaborative model, C-Further has partnered with investigators at UVA Comprehensive Cancer Center, Dana-Farber Cancer Institute and Mass General Brigham to advance CF-012 for the potential treatment of Ewing sarcoma. In parallel, the consortium has partnered with investigators at MiNK Therapeutics (Nasdaq: INKT) to advance CF-033, leveraging MiNK’s proprietary platform with translational support by investigators at the University of Southampton, for the potential treatment of multiple children’s cancers, including bone sarcoma, medulloblastoma and acute myeloid leukaemia.

Enabled by C-Further’s core partners, Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity (GOSH Charity), the consortium will support the progression of CF-012 and CF-033 up to preclinical candidate nomination, subject to completion of scientific milestones. Together, these projects form the foundation of C-Further’s expanding pipeline which is supported by an initial $40m (£30m) budget.

Lone Friis, PhD, C-Further Programme Co-lead said: “By combining the pioneering approaches of our scientific collaborators with industry-standard drug discovery capabilities, expertise of our core partners and reach into critical paediatric-focused networks, C-Further is advancing a pipeline of potential first-in-class therapies for childhood cancers. Guided by an indication-agnostic but child-first approach, we believe the initial CF-012 and CF-033 programmes have the potential to address a profound unmet need across multiple children’s cancers.”

The selected research partners represent top academic and industry investigators from across the globe, underscoring the international reach and ambition of C-Further.

• CF-012 targets ETV6, a newly identified and critical transcriptional dependency that is essential for tumour growth and metastasis. The aim is to develop a potential first-in-class inhibitor with a precise mechanism to disrupt tumour growth and metastasis in young patients.

  John Bushweller, PhD, Professor at the University of Virginia School of Medicine and a member of UVA Comprehensive Cancer Center, investigator for CF-012, said: “We’re excited to partner with C-Further to progress CF-012. Children and young people have historically lacked effective, targeted cancer treatments and CF-012 has the potential to address an urgent unmet need in relapsed and metastatic Ewing sarcoma – a rare, aggressive bone tumour that most commonly occurs in young people. With C-Further’s collaborative, child-first drug discovery model, we believe we have the power to bring these medicines to market.”

  Other key investigators for the CF-012 therapeutic programme include Kimberly Stegmaier, MD, Chair of the Department of Pediatric Oncology at Dana-Farber Cancer Institute, and Miguel Rivera, MD, Assistant Molecular Pathologist at Massachusetts General Hospital.

• CF-033 is a potential first-in-class allogeneic iNKT cell therapy engineered with a specific T-cell receptor targeting PRAME, which bridges innate and adaptive immunity and is designed to enable both direct tumour cell killing and broader immune activation within the tumour microenvironment. As an allogeneic, off-the-shelf approach without the need for toxic lymphodepletion, CF-033 has the potential to support more timely treatment delivery and improved tolerability, which are important considerations in paediatric oncology, where new therapeutic approaches are urgently needed.

  Marco Purbhoo, PhD, Head of Translational Medicine at MiNK Therapeutics, investigator for CF-033, said: “CF-033 is a PRAME-targeted invariant NKT (iNKT) cell therapy developed to address the urgent needs of children with high-risk cancers, which are often marked by treatment resistance and a weakened immune response that cannot sustain tumour control. Unlike conventional CAR-T or TCR-T therapies, CF-033 harnesses the unique biology of iNKT cells — immune cells that can both directly kill cancer and help coordinate a broader, longer-lasting anti-tumour response. Importantly, this approach is designed to be delivered without the need for HLA matching or toxic lymphodepletion, which is particularly meaningful for this vulnerable paediatric population.”

  Ali Roghanian, PhD, Associate Professor at the University of Southampton, is the other key investigator leading the CF-033 therapeutic programme.

C‑Further welcomes expressions of interest from researchers, innovators and partners who share its mission to accelerate new tailored and well-tolerated treatments for children and young people with cancer. The deadline to be considered for the next round of submissions is 13 March 2026.

C-Further has also commenced preliminary research on a third, undisclosed project. Additional programmes are expected to be announced in 2026.

To learn more about ongoing work or to explore partnering opportunities, visit the C-Further website.

About C-Further

C-Further is an international consortium that aims to bring together drug discovery and development researchers, clinicians, partners and impact investors with a shared commitment to creating new therapeutics for childhood cancers.

Our vision is to break from the conventional approach of repurposing adult therapies causing lasting harm to developing bodies – and create a world where young patients are treated effectively with tailored, well-tolerated treatments.

Together we’re combining expertise from around the world to create an innovation ecosystem that allows us to challenge conventional approaches to developing therapies and accelerate promising ideas towards better outcomes for children living with cancer. Our operational model brings together industry-standard drug discovery and academic innovation, ensuring a clear and viable path to patients. If you share this vision and believe you can contribute, we invite you to connect with us and be part of the change: info@c-further.org. Visit www.c-further.org for more information.

About UVA Comprehensive Cancer Center and UVA Health

UVA Comprehensive Cancer Center is one of 57 National Cancer Institute (NCI) designated comprehensive cancer centers in the United States for its work in cancer research, prevention, detection and treatment. UVA Comprehensive Cancer Center provides world-class cancer treatment led by doctors who have been honored by publications such as Best Doctors in America® and America’s Top Doctors®. UVA Comprehensive Cancer Center is part of UVA Health, a leading academic health system that includes the UVA School of Medicine, UVA School of Nursing, UVA Physicians Group and the Claude Moore Health Sciences Library, as well as multiple hospitals across Virginia. In addition, UVA recently launched the Paul and Diane Manning Institute of Biotechnology to accelerate the development of new treatments and cures for cancers and other complex diseases. Visit uvahealth.com for more information, resources and social media links.

About Dana-Farber Cancer Institute

Dana-Farber Cancer Institute is one of the world’s leading centers of cancer research and treatment. Dana-Farber’s mission is to reduce the burden of cancer through scientific inquiry, clinical care, education, community engagement and advocacy. Dana-Farber is a federally designated Comprehensive Cancer Center and a teaching affiliate of Harvard Medical School.

Dana-Farber is the only hospital nationwide with a top 3 U.S. News & World Report Best Cancer Hospital ranking in both adult and pediatric care.

As a global leader in oncology, Dana-Farber is dedicated to a unique and equal balance between cancer research and care, translating the results of discovery into new treatments for patients locally and around the world, offering more than 1,200 clinical trials.

About Mass General Brigham

Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for our communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org.

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies. MiNK’s proprietary platform is designed to restore immune balance and drive cytotoxic responses across cancer, immune-mediated diseases, and pulmonary immune failure. MiNK’s lead candidate, agenT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GvHD, solid tumors, and severe pulmonary inflammation. With a scalable cryopreserved manufacturing process and differentiated biology bridging innate and adaptive immunity, MiNK is committed to developing next-generation immune reconstitution therapies. For more information, visit www.minktherapeutics.com or follow us on X @MiNK_iNKT.

About the University of Southampton

The University of Southampton drives original thinking, turns knowledge into action and impact, and creates solutions to the world’s challenges. We are among the top 100 institutions globally (QS World University Rankings 2025). Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 24,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, the University helps students on a journey of discovery to realise their potential and join our global network of over 300,000 alumni. www.southampton.ac.uk

Contacts

C-Further Press Release Contacts:

– Megan McGrath (trade outlets): megan@ctdcomms.com
– Fiona Scott (consumer and nationals): Fiona.Scott@cancer.org.uk
– Please CC Pierre Peotta pierre.peotta@cancer.org.uk

UVA Comprehensive Cancer Center and UVA Health Press Release Contact:

– Josh Barney – jdb9a@uvahealth.org

MiNK Therapeutics Press Release Contacts:

– Investor Contact: 917-362-1370 | investor@minktherapeutics.com
– Media Contact: 781-674-4428 | communications@minktherapeutics.com

MiNK Therapeutics Corporate Spokesperson: Dr. Jennifer Buell

– Media Liaison: Stefanie Perna-Nacar: Stefanie.nacar@agenusbio.com
– Please cc Dr. Buell’s assistant, Dimitra Dariotis-Diaz dimitra.dariotis-diaz@agenusbio.com on any media inquiries sent to Stefanie

The University of Southampton Press Release Contact:

– Lucy Collie, PR Manager: l.j.collie@soton.ac.uk