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Jupiter Neurosciences Amends Yorkville Installment Provisions to Align Capital With Clinical and Commercial Execution
Globenewswire· 2026-02-23 14:30
Core Economic Terms - Jupiter Neurosciences, Inc. has deferred the commencement of repayment for its financing to April 1, 2026, while the core economic terms of the $6.0 million financing remain unchanged [1][2][8] - The amendment does not introduce new pricing provisions, reset features, or additional financing commitments, focusing solely on installment timing and application mechanics [2] Strategic Alignment - The amendment reflects a strategic decision between Jupiter and Yorkville, demonstrating Yorkville's commitment to Jupiter's long-term strategy by adjusting installment timing without altering pricing or other economic terms [3] - This alignment allows the company to focus on advancing its Phase II Parkinson's program and scaling its product Nugevia™, which is generating commercial cash flow [3] Commercial Performance - Jupiter's strategy combines clinical development with active commercial revenue generation, with Nugevia™ showing repeat purchase activity of approximately 25% and product return rates of about 3% [3] - The company believes that early commercial validation, along with continued clinical progress, strengthens its capital profile and differentiates it from biotechnology peers reliant solely on capital markets funding [3] Company Overview - Jupiter Neurosciences, Inc. is a clinical-stage pharmaceutical company focused on therapies for neuroinflammation and central nervous system disorders, with its lead clinical program in a Phase IIa trial for Parkinson's disease [5] - The company is also commercializing Nugevia™, a consumer product based on its patented JOTROL™ technology platform designed to enhance resveratrol bioavailability [5]
INmune Bio to Detail XPro1595 Registrational Strategy in Upcoming Alzheimer's Webinar
Globenewswire· 2026-02-23 14:25
Core Viewpoint - INmune Bio Inc. is advancing its clinical development of XPro1595 for early Alzheimer's disease, with a webinar scheduled to discuss the registrational pathway and recent trial results [1][2]. Group 1: Clinical Development - The Phase 2 MINDFuL trial has been completed, and feedback from the FDA supports moving to a registrational study for Alzheimer's patients with inflammation biomarkers [2]. - XPro1595 is a next-generation selective soluble TNF inhibitor aimed at restoring immune homeostasis in the brain without affecting transmembrane TNF or TNF receptors [3][10]. Group 2: Webinar Details - The webinar will cover three main topics: results from the MINDFuL trial, the design of the registrational study, and the strategic roadmap to Phase 3, including global partnership opportunities [3][4][5]. - Featured speakers include Dr. Michael Woodward and Dr. Sharon Cohen, both recognized experts in Alzheimer's disease research [6]. Group 3: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms: CORDStrom™, XPro™, and INKmune® [11].
Coya Therapeutics (NasdaqCM:COYA) Update / briefing Transcript
2026-02-17 21:02
Summary of Coya Therapeutics Update - February 17, 2026 Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of targeted therapies for ALS (Amyotrophic Lateral Sclerosis) Key Industry Insights - **ALS Treatment Landscape**: The approval of tofersen for SOD1 ALS has marked a significant development, indicating that targeted therapies can have a substantial impact on the disease's biology, potentially slowing, halting, or even reversing progression for a small subset of patients [3][4] - **Current Therapies**: Existing therapies show only modest benefits due to a lack of focus and understanding of the disease's biology. The industry is shifting towards more biologically informed clinical trials [5][6] Core Scientific Insights - **Neuroinflammation**: Neuroinflammation is identified as a critical factor in ALS pathology. The understanding of its role has evolved, with a focus on specific biological processes rather than broad observations [6][12] - **Regulatory T Cells (Tregs)**: Tregs are crucial for neuroprotection but are dysfunctional in ALS patients. Enhancing Treg function is a potential therapeutic target [13][14] Combination Therapy Rationale - **Combination of Low-Dose IL-2 and CTLA-4**: The rationale for this combination therapy is based on the need to enhance Treg function while suppressing inflammatory responses from activated macrophages. This dual approach aims to prevent Treg dysfunction and improve therapeutic outcomes [16][18][19] Clinical Trial Insights - **Initial Study Results**: A small study involving four ALS patients showed promising results, with some patients experiencing slowed progression and improved biomarkers related to inflammation and oxidative stress [24][25][26] - **ALSTARS Phase 2 Trial**: The upcoming trial aims to enroll 120 patients, with a design that includes a placebo group and two different dosing regimens for the combination therapy. The trial will measure clinical outcomes and biomarkers over six months [40][41][42] Safety and Tolerability - **Safety Profile**: Previous studies indicate that both IL-2 and CTLA-4 have favorable safety profiles, with no significant increase in infection rates observed. The low-dose IL-2 specifically activates Tregs without causing pro-inflammatory responses [56][59] Future Considerations - **Potential for FDA Approval**: If the trial meets its primary efficacy endpoint, Coya plans to submit an application for FDA approval. The strength of the data will be crucial for this process [65][66] - **Long-Term Outcomes**: There is optimism that slowing disease progression could correlate with improved survival rates, although ongoing monitoring of inflammation levels will be essential [62][64] Conclusion Coya Therapeutics is at the forefront of developing targeted therapies for ALS, with a strong focus on understanding the underlying biology of the disease. The upcoming ALSTARS trial represents a significant step towards validating the efficacy of combination therapies aimed at neuroinflammation and Treg dysfunction.
BioVie Announces Abstracts Accepted for Presentation at the 2026 American College of Psychiatrists Annual Meeting
Globenewswire· 2026-02-12 13:00
Core Viewpoint - BioVie Inc. announced the acceptance of two abstracts for its lead candidate bezisterim (NE3107) at the 2026 American College of Psychiatrists annual meeting, focusing on Alzheimer's Disease and Long COVID [1][2]. Group 1: Bezisterim Overview - Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier, aiming to reduce inflammation and improve insulin sensitivity without immune suppression and with low drug-drug interaction risk [3]. - The drug targets neuroinflammation pathways (ERK, NFκB, TNF-α) and has potential applications in Parkinson's disease, Long COVID, and Alzheimer's disease [3]. Group 2: Clinical Trials and Results - In Parkinson's disease, a completed Phase 2 study indicated that patients taking bezisterim with levodopa experienced better motor control and fewer morning symptoms compared to those on levodopa alone, with minimal side effects [4]. - The SUNRISE-PD trial is currently enrolling 60 patients to assess bezisterim's efficacy in improving symptoms for untreated Parkinson's patients, with topline results expected in mid-2026 [4]. - The ADDRESS-LC trial is enrolling around 200 patients to evaluate bezisterim's ability to alleviate neurological symptoms associated with Long COVID, with topline data anticipated in mid-2026 [5]. - In Alzheimer's disease, both Phase 2 and Phase 3 trials have been conducted, showing early results that suggest cognitive improvements and biomarker support for further trials [6]. Group 3: Company Background - BioVie Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance [7]. - The company is also advancing BIV201, a treatment for liver disease that has received FDA Orphan and Fast Track designations, and plans to conduct a Phase 3 trial for its efficacy in patients with cirrhosis and ascites [8].
InMed Reports Second Quarter Fiscal 2026 Financial Results and Provides Business Update
TMX Newsfile· 2026-02-11 22:23
Core Viewpoint - InMed Pharmaceuticals reported its financial results for the second quarter of fiscal year 2026, highlighting progress in its drug development pipeline, particularly in neuroinflammation treatments for Alzheimer's disease and dry age-related macular degeneration [1][3]. Business Update - Pharmaceutical Development Programs - INM-901 is advancing as a potential treatment for Alzheimer's disease, focusing on modulating neuroinflammation. Recent pharmacokinetic studies in large animals showed robust bioavailability and no adverse effects, supporting its progression to human clinical trials [3][4]. - INM-089 is under investigation for treating dry age-related macular degeneration, with successful preclinical studies demonstrating significant improvements in disease models [5]. Financial Commentary - BayMedica's commercial business generated revenues of $0.8 million for the three months ending December 31, 2025, a 26% decrease from $1.1 million in the same period last year, primarily due to pending changes in U.S. legislation [6]. - Research and development expenses were $0.6 million for the quarter, down from $0.9 million year-over-year, attributed to reduced spending on external contractors and research supplies [7]. - General and administrative expenses were $1.6 million for the quarter, slightly down from $1.7 million in the previous year [8]. - As of December 31, 2025, the company had cash and short-term investments totaling $7.0 million, down from $11.1 million on June 30, 2025, with expectations to fund operations into the fourth quarter of calendar year 2026 [9]. Legislative Impact - The U.S. congressional legislation H.R. 5371, if enacted, could negatively impact BayMedica's commercial business by prohibiting certain aspects of its operations related to rare cannabinoids [10]. - BayMedica is exploring alternative options but has not set a timetable for decisions regarding its commercial business, which may include divesting or pivoting operations [11].
Jupiter Neurosciences Expands Nugevia™ Addressable Market with Focus on GLP-1 Users
Globenewswire· 2026-01-28 11:00
Core Insights - Jupiter Neurosciences, Inc. is launching a strategic initiative to support individuals using GLP-1-based weight loss therapies through its Nugevia™ product line, which focuses on metabolic, mitochondrial, and neuroinflammatory health [1][2] Group 1: Company Strategy - The company is pursuing a dual-engine strategy that combines a clinical-stage pharmaceutical pipeline with a direct-to-consumer longevity business, aiming to capitalize on the growing adoption of GLP-1 therapies globally [2] - Jupiter believes that the physiological demands placed on individuals undergoing GLP-1-induced weight loss represent an unmet need, as many seek solutions for long-term metabolic resilience and healthspan [3] Group 2: Product Development - The Nugevia product line is designed to address the biological stresses associated with rapid metabolic changes, particularly focusing on mitochondrial health, neuroinflammation, and cellular resilience [4] - Jupiter's proprietary formulation, JOTROL, enhances the bioavailability of resveratrol and supports mental clarity, skin health, and mitochondrial function, positioning Nugevia as a clinical-grade supplement [5] Group 3: Market Context - The rise of GLP-1 receptor agonists has significantly transformed the landscape of obesity and metabolic health, with increasing awareness of the physiological impacts of weight loss on individuals [3] - The Aesthetic Surgery Journal reported that patients with significant weight loss may appear up to 5 years older than their peers, highlighting the need for supportive solutions like Nugevia [4]
Jupiter Neurosciences Presenting at the 3rd Annual DealFlow Discovery Conference
Accessnewswire· 2026-01-27 15:45
Company Overview - Jupiter Neurosciences, Inc. is a clinical-stage pharmaceutical company focused on developing JOTROL™, a patented resveratrol-based platform aimed at addressing neuroinflammation and promoting healthy aging [3] - The company is pursuing a dual-path strategy that includes a therapeutic pipeline for central nervous system (CNS) disorders and rare diseases, as well as a consumer longevity market through its Nugevia product line [3] - JOTROL™ has shown significantly improved bioavailability, enhancing its therapeutic potential [3] Upcoming Event - Jupiter Neurosciences will participate in the DealFlow Discovery Conference on January 28-29, 2026, where the Chairman and CEO, Christer Rosén, will present the company and hold one-on-one investor meetings [1][2] - Investors can attend the conference at no cost and are encouraged to schedule meetings with the management team [2] Product Pipeline - The company's prescription pipeline is currently focused on CNS disorders, with a Phase IIa clinical trial ongoing for Parkinson's disease, and includes indications for Alzheimer's Disease, Mucopolysaccharidoses Type I, Friedreich's Ataxia, and MELAS [3] - Nugevia, the consumer product line, aims to bring clinical-grade science to the supplement market, supporting mental clarity, skin health, and mitochondrial function [3]
BioVie Completes Enrollment in Phase 2 SUNRISE-PD Trial in Early Parkinson’s Disease
Globenewswire· 2026-01-08 13:00
Core Viewpoint - BioVie Inc. has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial, which aims to evaluate the efficacy of bezisterim in delaying disease progression in early-stage Parkinson's disease patients [2][5]. Group 1: Clinical Trial Details - The SUNRISE-PD trial is designed to assess the safety and efficacy of bezisterim on both motor and non-motor symptoms in patients diagnosed with Parkinson's disease within the past four years [3][7]. - The trial employs a hybrid, decentralized design to enhance participation by addressing barriers such as delayed diagnosis and geographic constraints, allowing participants to complete visits at home or in a clinic [3][4]. - Topline results from the SUNRISE-PD trial are expected in the first half of 2026 [1][5]. Group 2: Drug Profile and Mechanism - Bezisterim (NE3107) is an oral drug that targets neuroinflammation and insulin resistance, which are believed to contribute to the progression of Parkinson's disease and other neurodegenerative conditions [6][10]. - Previous clinical trials indicated that bezisterim, when combined with levodopa/carbidopa, improved motor control and reduced symptoms in Parkinson's patients, with a favorable safety profile [4][7]. Group 3: Broader Implications and Future Trials - BioVie is also exploring bezisterim for other conditions, including Long COVID and Alzheimer's disease, with ongoing trials expected to yield results in mid-2026 [8][9]. - The company emphasizes the importance of accessible clinical trials for Parkinson's disease, reflecting strong engagement from the patient community and advocacy organizations [4][5].
Join Jupiter Neurosciences' Exclusive Live Investor Webinar and Q&A Session on January 6
Globenewswire· 2025-12-23 13:00
Core Viewpoint - Jupiter Neurosciences, Inc. is hosting a webinar to discuss its scientific platform, clinical development plans, and commercial strategy for 2026, focusing on its lead asset JOTROL™ and its dual-path approach in both pharmaceutical and consumer markets [2][4]. Group 1: Company Overview - Jupiter Neurosciences is a clinical-stage pharmaceutical company targeting neuroinflammation and healthy aging through a dual-path strategy [4]. - The company is advancing a therapeutic pipeline for central nervous system (CNS) disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia product line [4]. - JOTROL™, a proprietary enhanced resveratrol formulation, has shown significantly improved bioavailability compared to earlier resveratrol products [4][5]. Group 2: JOTROL™ and Clinical Development - JOTROL™ achieves over nine times higher bioavailability compared to previous resveratrol formulations, which is critical for its effectiveness [6]. - The company is advancing JOTROL™ toward a Phase IIa clinical trial in Parkinson's Disease, with a broader focus on CNS disorders including Alzheimer's Disease and Friedreich's Ataxia [4][6]. - The Phase I study results of JOTROL™ were published in reputable journals, indicating a strong foundation for upcoming trials [6]. Group 3: Nugevia Product Line - Nugevia™ is a premium longevity and performance supplement line that utilizes the same patented JOTROL™ technology, targeting cognitive health, skin vitality, and cellular energy [8][9]. - Nugevia products are developed under pharmaceutical standards and are based on peer-reviewed clinical data, differentiating them from conventional supplements [9]. - The product line aims to support healthy aging through formulations that enhance cognitive resilience, mitochondrial energy, and skin vitality [8].
Tiziana Life Sciences Doses First Patient in Phase 2 Alzheimer's Clinical Trial
Globenewswire· 2025-12-17 13:45
Core Viewpoint - Tiziana Life Sciences has initiated a Phase 2 clinical trial for intranasal foralumab, targeting early Alzheimer's disease, marking a significant step in exploring immunomodulatory therapies for neuroinflammation [1][3][7]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized and placebo-controlled, assessing the safety, tolerability, and potential efficacy of intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab [4]. - Primary endpoints of the trial include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers, with interim data expected in 2026 [4]. Group 2: Scientific Rationale - TSPO-PET imaging data indicates persistent microglial activation in Alzheimer's patients, even after treatment with anti-amyloid therapies, highlighting the need for therapies that address residual neuroinflammation [2]. - Intranasal foralumab is designed to modulate immune responses and reduce activated microglia, potentially slowing disease progression in early Alzheimer's disease [2][3]. Group 3: Company Insights - Gabriele Cerrone, Chairman & Founder, emphasized the importance of this trial in exploring a novel approach to Alzheimer's treatment, building on previous data showing foralumab's ability to reduce microglial activation in multiple sclerosis patients [3]. - Ivor Elrifi, CEO, expressed enthusiasm for the rapid progress from enrollment to first patient dosing, reflecting the urgent need for new treatment strategies beyond amyloid clearance [3]. Group 4: About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with previous studies showing positive outcomes in patients with non-active secondary progressive multiple sclerosis [5][6]. - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [6]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, aiming to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6][8].