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]

Year-over-year product revenue increased 8%, and year-over-year operating expenses decreased 5% as Vivos sets the stage for its Sleep Center of Nevada acquisition and continued advancement of its new marketing and distribution model Management to Host Conference Call today at 5:00 pm ET LITTLETON, Colo., May 15, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of ...

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...

World Order & Economic Cycles - The speaker emphasizes the importance of understanding the changing world order and its underlying mechanics [2] - The speaker highlights the cyclical nature of monetary, domestic political, and global world orders, noting their eventual breakdown [2] - The speaker suggests that understanding these cycles is crucial, especially now, given the brink of major changes [2] Author's Intent & Background - The speaker, a 75-year-old global macro investor with 50 years of experience, aims to share accumulated knowledge [1] - The speaker has authored a book and created a video, both titled "Changing World Order," to explain current events [2] - The speaker's upcoming book, releasing on June 3rd, focuses on how countries go broke [2] Communication Strategy - The speaker intends to communicate through various means, including videos and written communications, to stay connected [2]

Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial, demonstrating proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies (DLB) Plan to initiate Phase 3 trial of neflamapimod in DLB in mid-2026 following meeting with regulatory authorities Initiating separate Phase 2a trials to evaluate neflamapimod in patients with primary progressive aphasia and patients in the recovery phase after ischemic stroke BOSTON, May 12, 2025 (GLOBE NEWSWIRE ...

Core Insights - Cognition Therapeutics, Inc. reported promising preclinical data on zervimesine (CT1812) at the ARVO conference, indicating its potential to protect retinal pigment epithelial (RPE) cells from damage in dry age-related macular degeneration (dry AMD) [1][2][3] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [9] - The company is currently investigating zervimesine in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study in early Alzheimer's disease [9] Product Details - Zervimesine is an investigational oral drug candidate that has shown the ability to reach therapeutic concentrations in the eye and is being studied for its effects on retinal cell health [2][4] - The drug binds to the sigma-2 receptor (TMEM97), which is crucial for retinal cell lipid uptake, a process impaired in dry AMD [2][3] - In a Phase 2 clinical trial, zervimesine slowed the rate of geographic atrophy lesion growth by 28.6% compared to placebo, resulting in smaller lesions for treated patients [4] Disease Context - Dry AMD accounts for up to 90% of age-related macular degeneration cases and leads to irreversible vision loss due to the death of retinal cells [6] - The disease is characterized by the accumulation of oxidized lipids and drusen, which damage RPE cells and contribute to vision loss [3][6] Research Findings - Preclinical research supports zervimesine's potential to protect retinal cells from oxidized lipids and enhance cellular function in degenerative diseases [2][3][4] - The drug has also shown robust clinical results in studies involving Alzheimer's disease and dementia with Lewy bodies, indicating its broader therapeutic potential [4][7]

Core Insights - Cassava Sciences, Inc. is advancing the development of simufilam for TSC-related epilepsy, with plans to initiate clinical trials in the first half of 2026 following necessary pre-clinical studies and regulatory strategy development [3][6] - The company reported a net loss of $23.4 million for Q1 2025, a significant decrease from a net income of $25.0 million in the same period in 2024, primarily due to the change in fair value of warrant liabilities [6][10] - As of March 31, 2025, Cassava had cash and cash equivalents of $117.3 million, with no debt, indicating a favorable balance sheet for future developments [6][19] Business Update - Cassava has entered a license agreement with Yale University for intellectual property rights related to potential treatments for rare diseases, including TSC-related epilepsy [3][6] - The company has appointed Dr. Angélique Bordey as SVP of Neuroscience and Dr. Jack Moore as SVP of Clinical Development to enhance its team for the new TSC-related epilepsy program [3][6] - The Alzheimer's disease program, which did not meet its co-primary endpoints in Phase 3 studies, will be completely discontinued by the end of Q2 2025 [6][10] Financial Performance - Total operating expenses for Q1 2025 were $24.6 million, compared to $19.9 million in Q1 2024, reflecting increased general and administrative expenses primarily due to legal-related costs [10][17] - Research and development expenses decreased by 16% to $13.7 million in Q1 2025, down from $16.2 million in the same period in 2024, due to the discontinuation of Alzheimer's clinical trials [10][17] - General and administrative expenses rose to $10.9 million in Q1 2025, compared to $3.7 million in Q1 2024, largely due to legal expenses and the absence of insurance recoveries [10][17]

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 ...

Company Overview - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders [3] - The company is currently developing neflamapimod, an investigational orally administered small molecule that inhibits p38 mitogen-activated protein kinase alpha [3] - Neflamapimod has the potential to treat synaptic dysfunction associated with neurodegenerative processes in disorders such as Dementia with Lewy Bodies (DLB) [3] - The drug is currently being evaluated in a Phase 2b study in patients with DLB [3] Upcoming Events - Company management will participate in a fireside chat and one-on-one investor meetings at the H.C. Wainwright 3rd Annual BioConnect Investor Conference [1] - The fireside chat is scheduled for May 20, 2025, from 5:00 to 5:30 PM ET [2] - A webcast of the fireside chat will be accessible on the Investor section of the CervoMed website [2]

- 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 ...