Core Insights - Nxera Pharma will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals due to the initiation of clinical development of ORX142, a novel orexin receptor 2 (OX2R) agonist [1][2] - The milestone payments include US$1.8 million recognized as revenue in Q2 2025 and US$3.0 million in Q3 2025 [2] Company Overview - Nxera Pharma is a technology-driven biopharma company focused on developing specialty medicines for unmet medical needs in Japan and globally [3] - The company has established a commercial business in Japan to develop and market innovative medicines, addressing a growing market in the APAC region [3] Pipeline and Development - Nxera Pharma has an extensive pipeline of over 30 active programs, utilizing its NxWave™ discovery platform, targeting major unmet needs in neurology, metabolic diseases, and immunology [4] - The pipeline includes potentially first- and best-in-class candidates, advancing from discovery to late clinical stages in collaboration with leading pharmaceutical and biotech companies [4] Workforce and Locations - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [5]

NEW YORK, June 30, 2025 /PRNewswire/ -- Klotho Neurosciences, Inc. (NASDAQ: KLTO) today announced that it is moving forward with manufacturing and process development work in preparation for clinical trials of KLTO-202, its investigational gene therapy for amyotrophic lateral sclerosis (ALS).A unique RNA splice variant of the human gene called alpha-Klotho has been licensed by the Company from the Autonomous University of Barcelona ("UAB") including patents, patent applications, research, knowhow and other ...

Financial Data and Key Metrics Changes - The company is focused on executing the clinical development plan for NurOwn and has received FDA clearance to initiate a pivotal Phase 3b trial for ALS [6][10] - Financial constraints have been acknowledged, but the company has made significant strides in trial preparations despite limited resources [13][25] Business Line Data and Key Metrics Changes - The NurOwn technology platform is central to the company's strategy, with ongoing clinical trials aimed at demonstrating its therapeutic benefits [6][12] - The company is actively negotiating clinical trial agreements with approximately 15 leading clinical centers across the U.S. for the Phase 3b trial [10][25] Market Data and Key Metrics Changes - The ALS community's strong interest in NurOwn is highlighted by the engagement of renowned ALS clinicians and researchers [10] - The company participated in the annual ALF Drug Development Summit, indicating its active involvement in the ALS therapeutic development landscape [12] Company Strategy and Development Direction - The company aims to secure strategic funding to support the trial, with a focus on partnerships and non-dilutive grants [14][26] - Expansion of manufacturing capabilities in the U.S. is a key strategic objective, with plans to announce a letter of intent with a U.S.-based facility [30] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgency for innovative therapeutic options in ALS and the commitment to executing the trial with scientific rigor [11][12] - The company is optimistic about the potential of NurOwn and is preparing for various funding opportunities to ensure timely trial commencement [14][26] Other Important Information - The trial, named "Endurance," is designed to resonate with the ALS community, reflecting the strength and resilience of ALS patients [27] - The company is encouraged by progress in its exosome program, which shows potential in treating respiratory and inflammatory diseases [34] Q&A Session Summary Question: Can you start the trial without proper funding? - Management stated that while significant progress has been made, proper funding is essential to commence the trial [25][26] Question: What is the meaning of the trial name "Endurance"? - The name was chosen to resonate with the ALS community and reflects the company's commitment to delivering a therapeutic option for ALS [27] Question: Will the company also be producing in the U.S.? - The company confirmed plans to expand its manufacturing footprint in the U.S. and will announce a letter of intent with a U.S.-based facility [30] Question: Can you update on any advances in the exosome program? - Management expressed encouragement regarding the exosome program's progress and is preparing to advance it towards clinical development [34] Question: Have you had any communications with FDA regarding stratification by UNC13A? - Management indicated that while the FDA has not approved any biomarker as a surrogate, they are excited about the genetic discoveries and will explore them further [39][40] Question: Can the mechanism of action be used as part of the data package for the next BLA? - Management confirmed that the protective effect observed in cell cultures could support the data package for future filings [43] Question: How many clinical trial sites are you looking to open? - Management confirmed plans to open approximately 15 clinical trial sites and is finalizing agreements to begin patient enrollment [48][50]

PURCHASE, N.Y., May 09, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported preclinical data this week at the Association for Research in Vision and Ophthalmology (ARVO) showing the potential for zervimesine (CT1812) to protect retinal pigment epithelial (RPE) cells from damage in dry age-related macular degeneration (dry AMD). "Dry AMD is driven by a number of factors that contribute to the death of ...

Zervimesine treatment slowed the rate of GA lesion growth by 28.6% compared to placebo Observed GA lesion area was reduced by 28.2% at 18 months compared to placebo Dry AMD results validate zervimesine’s potential across degenerative disease indications PURCHASE, N.Y., May 08, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported topline results today from the Phase 2 COG2201 ‘MAGNIFY’ trial of zervime ...

- End-of-Phase 2 meeting with FDA requested for Alzheimer’s disease - - Phase 2 results in dementia with Lewy bodies accepted for oral presentation at AAIC - - Two posters at ARVO describe zervimesine's role supporting retinal cell health - PURCHASE, N.Y., May 07, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today reported financial results for the first quarter ended Ma ...

NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman ...

PURCHASE, N.Y., April 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria. Details of Cognition's presentation are as follows: | Posi ...

PURCHASE, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria. Mary Hamby, Ph.D., Cognition Therapeutics' VP of ...

Additional Analyses to be Presented at AD/PD Include Correlation of CSF Biomarkers with Cognitive Outcomes, and Pharmacodynamic Biomarkers of Target EngagementPURCHASE, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at ...