APP

IRVINE, Calif., May 5, 2025 /PRNewswire/ -- Nuravax Inc., a biotechnology company pioneering immunotherapy for neurodegenerative disorders, has been awarded a $3 million grant from the National Institutes of Health (NIH) to support Duvax, the first dual-target Alzheimer's vaccine, in its entry into human clinical trials. Nuravax, in partnership with the non-profit Institute for Molecular Medicine (IMM), secured the award on its very first NIH grant submission, earning top-tier scores. This rare distinction highlights the scientific strength and strategic importance of the Duvax vaccine. The grant, awarded through NIH's highly competitive SBIR Fast-Track program, will fund a critical milestone in the clinical validation of Duvax. An initial portion of the $3 million grant has been allocated to initiate the Phase 1 clinical trial evaluating the safety and immunogenicity of Duvax as a secondary prevention therapy, with the remaining funds expected later in 2025. "This SBIR grant is a powerful endorsement of our mission to clinically validate and advance Duvax as a first-in-class vaccine for Alzheimer's prevention," said Roman Kniazev, CEO of Nuravax. "While IMM laid the scientific foundation, our focus at Nuravax is on translating that innovation into real-world impact. This funding enables us to move Duvax into clinical trials in the U.S. and brings us one step closer to delivering it as preventive therapy for individuals at risk – before symptoms begin." Duvax is a first-in-class vaccine that targets both amyloid-beta and tau proteins, the two hallmark drivers of Alzheimer's disease, positioning it at the forefront of Alzheimer's research. Unlike conventional treatments, Duvax is designed for use during the preclinical stage, when the disease is silently progressing but before cognitive symptoms appear. "The Phase 1 trial, supported by this SBIR grant awarded to our development and commercialization partner, Nuravax, marks a critical step in translating years of foundational research at IMM into a potential clinical breakthrough," said Dr. Michael Agadjanyan, VP of IMM and Head of Immunology. "Based on strong preclinical data, we at IMM expect Duvax to elicit a robust immune response against both Aβ and tau pathologies, an approach that could fundamentally shift the paradigm of Alzheimer's treatment from symptomatic and disease-modifying treatment (DMT) to secondary preventive therapy for cognitively unimpaired people at risk of disease." The vaccine's use is guided by highly precise and specific blood tests that detect early pathological changes, enabling timely intervention. By clearing toxic forms of amyloid-beta and tau before irreversible damage occurs, Duvax aims to shift the treatment paradigm from symptom management to secondary preventive therapy. About Nuravax Nuravax is a clinical-stage biotech company developing and advancing immunotherapeutic vaccines for neurodegenerative diseases, including Alzheimer's, Parkinson's, TBI, and CTE. Focused on early intervention, Nuravax aims to alter disease progression before irreversible damage occurs. The company leads the clinical development, regulatory strategy, and manufacturing of Duvax, a dual-target vaccine licensed from the Institute for Molecular Medicine (IMM), a nonprofit dedicated to neurodegenerative disease research. About IMM The Institute for Molecular Medicine (IMM) is a non-profit research organization dedicated to understanding, preventing, and curing chronic human diseases, with a focus on neurodegeneration. IMM is advancing MultiTEP — a universal vaccine platform technology that enables the development of diverse vaccine formats, including DNA, RNA, and recombinant protein-based designs. Disclaimer: Research reported in this publication was supported by the National Institute On Aging of the NIH under Award Number R44AG091903. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. SOURCE Nuravax Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AC Immune Reports First Quarter 2025 Financial Results and Provides a Corporate Update Continuing to advance clinical active immunotherapy portfolio for precision prevention of neurodegenerative diseasesPositive immunogenicity and good safety in interim results for wholly owned anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 in Phase 2 trial in Parkinson’s disease (PD)Additional ACI-7104.056 Phase 2 interim results (pharmacodynamics and biomarkers) expected in Q2 2025Presentations at International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD™ 2025) highlight leadership in active immunotherapy and promising data on early-stage assetsCash resources of CHF 145.7 million as of March 31, 2025 provide funding into Q1 2027 before any potential milestones Lausanne, Switzerland, April 30, 2025 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended March 31, 2025, and provided a corporate update. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune’s portfolio of active immunotherapies for precision prevention of neurodegeneration continues to advance in clinical development. Our interim Phase 2 data on ACI-7104.056, our wholly owned a-syn active immunotherapy, demonstrated strong immunogenicity and a favorable safety profile in early Parkinson’s disease patients, further supporting its best-in-class characteristics. Our two partnered active immunotherapy programs, ACI-24.060 and ACI-35.030, also advanced well in their respective ongoing Phase 2 trials. Furthermore, we highlighted progress with our promising early-stage assets in presentations of preclinical data at AD/PD™ 2025, including Morphomer® small molecule drugs targeting a-syn and Tau, and Morphomer®-antibody drug conjugates (morADC) our new class of drug candidates for neurodegenerative diseases.” “AC Immune is well financed into Q1 2027, without including significant potential milestones. We are moving towards several value-inflection points throughout 2025, including pharmacodynamic and biomarker data on ACI-7104.056 and potential initiation of Part 2 of the Phase 2 VacSYn trial, reaching the 12-month treatment timepoint for all the Alzheimer’s disease (AD) cohorts (including AD3 where enrollment was completed in December 2024) of the Phase 2 ABATE trial of ACI-24.060, and further developments across our early-stage pipeline.” Q1 2025 and Subsequent Highlights: Additional interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, AC Immune’s wholly-owned anti-a-syn active immunotherapy candidate, for the treatment of patients with early PD. Antibody responses were rapidly induced against the target antigen after 2 immunizations and were further boosted by each subsequent immunization.Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average more than 20-fold higher than the placebo background level after four immunizations.Based on further interim results to be reported later in 2025, including pharmacodynamic and biomarker data, AC Immune may decide to initiate Part 2 of VacSYn, with the aim of establishing early proof-of-concept and identification of disease-specific biomarkers for rapid transition into a pivotal study. In vivo proof-of-concept study of proprietary morADC platform was completed in Q1.AC Immune’s therapeutic and diagnostic programs were featured in multiple presentations at AD/PD™ 2025.AC Immune hosted an industry symposium highlighting the company’s industry-leading pipeline of active immunotherapies for precision prevention of neurodegenerative diseases. Anticipated 2025 Milestones ProgramMilestoneExpected inACI-24.060anti-Abeta active immunotherapyABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort (with interim results reported shortly thereafter)H2 2025ACI-7104.056anti-a-syn active immunotherapyFurther interim results from Part 1 of Phase 2 VacSYn trial in PD, including pharmacodynamics and biomarkersQ2 2025Initiation of Part 2 of VacSYn trialH2 2025ACI-19764Small molecule NLRP3 inhibitorLead declaration and initiation of IND-enabling studiesQ2 2025IND/CTA filingH2 2025TDP-43monoclonal antibodyValidated pharmacodynamic assay for clinical readoutH2 2025Morphomer-Tau aggregation inhibitorsLead declaration and initiation of IND-enabling studiesH2 2025Morphomer a-syn aggregation inhibitorLead declarationH2 2025TDP-43-PET tracerInitial Phase 1 readout in genetic frontotemporal dementia (FTD)H2 2025ACI-15916a-syn-PET tracerPhase 1 readout in Parkinson’s disease (PD)H2 2025 Analysis of Financial Statements for the Quarter Ended March 31, 2025 Cash position: The Company had total cash resources of CHF 145.7 million (CHF 165.5 million as of December 31, 2024), composed of CHF 20.0 million in cash and cash equivalents and CHF 125.7 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources into Q1 2027, without including potential milestones. R&D expenditures: R&D expenses in the period were CHF 15.9 million, compared with CHF 15.2 million for the comparable period in 2024. The expenses for the period were comprised mostly of ongoing clinical trial costs as well as personnel costs (including share-based payments), and regulatory, quality assurance, and intellectual property costs.G&A expenditures: G&A expenses in the period were CHF 4.4 million, compared with CHF 5.0 million for the comparable period in 2024.IFRS loss for the period: The Company reported a net loss after taxes of CHF 19.0 million for the three months ended March 31, 2025, compared with a net loss of CHF 17.9 million for the comparable period in 2024. About AC Immune SA AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties. SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, EU, GB, JP, KR, NO, RU and SG. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release. For further information, please contact: SVP, Investor Relations & Corporate CommunicationsGary Waanders, Ph.D., MBAAC ImmunePhone: +41 21 345 91 91Email: gary.waanders@acimmune.com International MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email: chris.maggos@cohesionbureau.com Forward looking statements This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. Condensed Consolidated Balance Sheets (Unaudited)(In CHF thousands) As of March 31, December 31, 2025 2024Assets Non-current assets Property, plant and equipment 2,761 2,651Right-of-use assets 5,186 5,437Intangible asset 50,416 50,416Long-term financial assets 585 415Total non-current assets 58,948 58,919 Current assets Prepaid expenses 3,607 4,302Accrued income 925 1,099Other current receivables 1,988 1,104Short-term financial assets 125,654 129,214Cash and cash equivalents 19,960 36,275Total current assets 152,134 171,994Total assets 211,082 230,913 Shareholders' equity and liabilities Shareholders’ equity Share capital 2,230 2,226Share premium 478,999 478,506Treasury shares (218) (218)Currency translation differences (1) (5)Accumulated losses (386,212) (368,239)Total shareholders’ equity 94,798 112,270 Non-current liabilities Long-term deferred contract revenue 3,956 4,560Long-term lease liabilities 4,142 4,401Net employee defined benefit liabilities 8,940 8,844Total non-current liabilities 17,038 17,805 Current liabilities Trade and other payables 2,391 2,658Accrued expenses 11146 12098Short-term deferred contract revenue 84,676 85,056Short-term lease liabilities 1,033 1,026Total current liabilities 99,246 100,838Total liabilities 116,284 118,643Total shareholders’ equity and liabilities 211,082 230,913 Condensed Consolidated Statements of Income/(Loss) (Unaudited)(In CHF thousands, except for per-share data) For the Three Months Ended March 31, 2025 2024Revenue Contract revenue 990 —Total revenue 990 — Operating expenses Research & development expenses (15,916) (15,165)General & administrative expenses (4,443) (4,971)Other operating income/(expense), net (1) 68Total operating expenses (20,360) (20,068)Operating loss (19,370) (20,068) Financial income 687 629Financial expense (54) (36)Exchange differences (292) 1,613Finance result, net 341 2,206 Loss before tax (19,029) (17,862)Income tax expense — —Loss for the period (19,029) (17,862)Loss per share: (0.19) (0.18) Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)(In CHF thousands) For the Three Months Ended March 31, 2025 2024Loss for the period (19,029) (17,862)Items that will be reclassified to income or loss in subsequent periods (net of tax): Currency translation differences: 4 16Items that will not to be reclassified to income or loss in subsequent periods (net of tax): Remeasurement gains on defined-benefit plans (net of tax) — —Total comprehensive loss, net of tax (19,025) (17,846) Attachment 20250430__ACIU 1Q25 Earnings PR_final

BEDFORD, Mass., April 30, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that its clinical-stage F18-labeled tau Positron Emission Tomography (PET) radiodiagnostic, MK-6240 (F18-florquinitau), successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. This achievement reinforces the potential of MK-6240 as a valuable diagnostic tool. The data from these two studies will support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) expected to be filed in the third quarter of 2025. “As a clinician, the ability to visualize tau pathology represents the opportunity for a seismic shift in how we diagnose and manage Alzheimer’s disease,” said Luca Passamonti, MD, PhD, Neuroscience Medical Director, Lantheus. “Tools like MK-6240 offer more than just clarity — they provide precision. By identifying tau accumulation early and accurately, we have the potential to improve diagnostic confidence, tailor patient care, and, through monitoring, ultimately change what we know about the trajectory of disease progression. This level of insight has long been missing in the field, and MK-6240, a next-generation imaging agent, has the potential to fill that critical gap.” “The clinical results of MK-6240 underscore our commitment to providing cutting-edge imaging solutions for Alzheimer’s disease that align with the latest scientific advancements,” said Brian Markison, CEO, Lantheus. “With MK-6240 successfully meeting its primary endpoints in both pivotal studies, we are moving closer to delivering this innovative radiodiagnostic to potentially support precise diagnoses and improve disease management.” MK-6240 is designed to target aggregated tau protein in the form of neurofibrillary tangles (NFTs), a key hallmark of several neurodegenerative diseases, including Alzheimer’s disease. The successful completion of these studies represents the next step in advancing MK-6240 as a potential tool to aid in the diagnosis, staging, and monitoring of Alzheimer’s disease. The development of MK-6240 complements Lantheus’ ß amyloid PET imaging agent, NAV-4694 (F18-flutafuranol), which is currently in Phase 3 development and is actively utilized in both academic and industry-led investigational therapeutic trials for Alzheimer’s disease. Together, these imaging agents, if approved, will further position Lantheus as the leader in radiopharmaceutical innovation, supporting the evolving diagnostic landscape for neurodegenerative conditions. Driven by rising prevalence, more treatment options, and expanded PET imaging guidelines, the U.S. Alzheimer’s Disease radiodiagnostic market has the potential to reach over 400,000 scans and $1.5 billion by 2030.1 It is estimated that there are over 100 therapies in clinical development targeting either beta amyloid or tau. About Alzheimer’s Disease Alzheimer’s disease is a degenerative neurological disorder that causes a decline in cognition and function. In the U.S., there are nearly 12 million people living with mild cognitive impairment or Alzheimer’s disease. As the population ages, it is likely that the prevalence of this disease will continue to rise and, by 2050, the number of people aged 65 and older with mild cognitive impairment and Alzheimer’s disease may grow to more than 20 million.2 About MK-6240 MK-6240 is designed to target aggregated tau protein in the form of neurofibrillary tangles (NFTs), a key hallmark of several neurodegenerative diseases, including Alzheimer’s disease. MK-6240 has demonstrated a high affinity for tau and limited off-target binding in both preclinical and clinical studies.3,4 Acquired by Lantheus in 2023, MK-6240 has received Fast Track designation and is currently being used in over 100 active clinical trials. We anticipate that MK-6240 will support earlier disease detection, patient staging, therapy selection, and monitoring, and may help enable tau to serve as a surrogate endpoint for treatment efficacy. Lantheus expects to file an NDA with the FDA in the third quarter of 2025. About Lantheus Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com. Safe Harbor for Forward-Looking and Cautionary Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "continue,” “expects,” “may,” “moving closer,” “plans,” “poised,” “position,”“potential,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA for MK-6240; (ii) our ability to launch MK-6240 as a commercial product; (iii) the market receptivity to MK-6240 as a radiopharmaceutical diagnostic; (iv) the existence, availability and profile of competing products; (v) our ability to obtain and maintain adequate coding, coverage and payment for MK-6240; (vi) the safety and efficacy of MK-6240; (vii) the intellectual property protection of MK-6240; (viii) our ability to successfully develop and scale the manufacturing capabilities to support the launch of MK-6240; and (ix) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the RiskFactors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q). 1Addressable market based on current management estimates, internal data, and current WAC / 340B pricing. 2Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5). 3Krishnadas N, Doré V, Robertson JS, Ward L, Fowler C, Masters CL, Bourgeat P, Fripp J, Villemagne VL, Rowe CC. Rates of regional tau accumulation in ageing and across the Alzheimer’s disease continuum: an AIBL 18F-MK-6240 PET study. EBioMedicine. 2023 Feb;88:104450. doi: 10.1016/j.ebiom.2023.104450. Epub 2023 Jan 27. PMID: 36709581; PMCID: PMC9900352. 4Lohith TG, Bennacef I, Vandenberghe R, Vandenbulcke M, Salinas CA, Declercq R, Reynders T, Telan-Choing NF, Riffel K, Celen S, Serdons K, Bormans G, Tsai K, Walji A, Hostetler ED, Evelhoch JL, Van Laere K, Forman M, Stoch A, Sur C, Struyk A. Brain imaging of Alzheimer dementia patients and elderly controls with 18F-MK-6240, a PET tracer targeting neurofibrillary tangles. J Nucl Med. 2019 Jan;60(1):107-114. doi: 10.2967/jnumed.118.208215. Epub 2018 Jun 7. PMID: 29880509. Contacts: Lantheus Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus.com Melissa Downs Executive Director, External Communications 646-975-2533 media@lantheus.com Source: Lantheus Holdings, Inc.