Axsome Therapeutics (AXSM) FY Conference June 03, 2025 11:40 AM ET Speaker0 To the the William Blair forty fifth Annual Growth Stock Conference. My name is Miles Minto. I'm a senior biotech analyst here at the firm. I cover the neurosciences and genetic medicines, and Axsome has been a day one coverage company for me. So early two thousand seventeen before before the Ascend data actually was when picked up coverage there. You know, obviously a bona fide growth story with a Vality well underway, launch of a ...

Core Insights - Bioxytran, Inc. is advancing treatments for ischemic stroke and Alzheimer's disease through its universal oxygen carrier (UOC) technology, which is detailed in a newly published book by Prof. Avraham Mayevsky [1][2][3] - The UOC is designed to replace hyperbaric oxygen treatment (HBOT) by delivering therapeutic oxygen at the cellular level, providing a significant improvement over traditional methods [2] - The Mongolian gerbil model is utilized for research due to its unique brain structure that lacks compensatory mechanisms for blood flow, making it ideal for studying stroke pathophysiology [3][4] Company Overview - Bioxytran, Inc. focuses on developing complex carbohydrate-based therapeutics to meet critical medical needs across three core platforms: virology, cancer metastasis, and oxygen transport [5] - The company is also working on programs for pulmonary fibrosis and stroke treatment, with a specific product, BXT-25, showing potential to significantly reduce the time until treatment in emergency situations [5]

Alto Neuroscience (ANRO) Update / Briefing June 03, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Alto Neuroscience Investor Conference Call to discuss the company's acquisition of a novel dopamine agonist combination product candidate. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Amit Edkin, Founder ...

Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]

Company Overview - Alector, Inc. is a late-stage clinical biotechnology company focused on developing therapies for neurodegenerative diseases [3] - The company utilizes genetics, immunology, and neuroscience to advance a portfolio of genetically validated programs aimed at treating conditions such as frontotemporal dementia, Alzheimer's disease, and Parkinson's disease [3] - Alector is developing a proprietary blood-brain barrier platform called Alector Brain Carrier (ABC) to enhance therapeutic delivery and improve patient outcomes [3] Upcoming Events - Alector management will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2024, at 8:40 am ET [1] - A live webcast of the event will be available on Alector's website, with a replay accessible for 90 days post-event [2]

Disclaimer This presentation contains "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, each as amended. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identif ...

ENLIGHTEN 2 Study Results - The ENLIGHTEN 2 study met its primary endpoint, demonstrating a statistically significant improvement over sham in 3CS at Week 24 in CRS patients without nasal polyps[42] - Key secondary endpoints of change in 3CS and SNOT-22 in the full study population were also met, showing statistically significant results at Week 24[42] - The study showed a numerical improvement in the key secondary endpoint of change in % ethmoid opacification (CT)[42] - The trial demonstrated a favorable safety profile with no product-related serious adverse events reported[42] Patient Demographics & Adverse Events - In the LYR-210 group (n=111), 60.4% of patients experienced any treatment-emergent adverse events (TEAEs), compared to 44.3% in the Sham group (n=61)[27] - Epistaxis was more frequent in the LYR-210 group (16.2%) compared to the Sham group (1.6%)[27] Market Opportunity & Product Design - Approximately 8 million people in the United States have CRS with nasal polyps, and around 4 million have CRS without nasal polyps[9] - The annual healthcare expenditure for CRS in the United States is approximately $60 billion[9] - Lyra's product is designed to deliver 6 months of continuous, local drug therapy with a single placement[13,17] Pooled Analysis - In the pooled ENLIGHTEN 1 and ENLIGHTEN 2 patients with grade 1 nasal polyps, there was a consistent, positive trend in symptomatic endpoints starting in Week 4 and throughout Week 24[42]

Core Viewpoint - Abivax SA reported its financial results for the first quarter of 2025, highlighting a decrease in total operating income and an increase in operating loss, primarily driven by rising research and development expenses [2][3][7]. Financial Highlights - Total operating income for Q1 2025 was €1.0 million, down from €1.2 million in Q1 2024, reflecting a decrease of €0.2 million [3][7]. - Total operating expenses increased, with research and development costs rising to €39.3 million from €35.7 million, an increase of €3.6 million [3][7]. - The operating loss for the quarter was €47.2 million, compared to €44.7 million in the same period last year, marking an increase of €2.5 million [3][7]. - The net loss for the period was €52.4 million, up from €42.9 million in Q1 2024, indicating a rise of €9.5 million [3][7]. Balance Sheet Overview - As of March 31, 2025, the net financial position was €18.5 million, a decrease of €34.9 million from €53.4 million at the end of 2024 [3][5]. - Cash and cash equivalents stood at €103.6 million, down from €144.2 million at the end of 2024, reflecting a decrease of €40.6 million [5][7]. - Total assets decreased to €166.9 million from €205.2 million, a reduction of €38.3 million [5]. Research and Development Focus - R&D expenses increased significantly, with a €3.0 million (736%) rise related to the Crohn's Disease clinical program, driven by the progression of Phase 2b clinical trials for obefazimod [7]. - A €2.7 million (78%) increase in transversal activities was noted, attributed to the expansion of the R&D headcount and new equity awards [7]. - There was a decrease of €1.3 million (-4%) in expenses related to the Ulcerative Colitis clinical program as Phase 3 trials reached full enrollment [7]. Operational Updates - Abivax is focused on developing therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod, currently in Phase 3 clinical trials for ulcerative colitis [2][8]. - The company anticipates being able to finance its operating cash flow requirements into the fourth quarter of 2025 based on current funds and operating assumptions [6].

Zai Lab Limited ZLAB and NovoCure Limited NVCR revealed additional data on Saturday from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer.The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting.The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclita ...

Summary of Thai Life Sciences and Beckley Cytec Conference Call Company and Industry Overview - The conference call involved **Thai Life Sciences** and **Beckley Cytec**, focusing on their business combination aimed at developing psychedelic treatments for mental health conditions [4][10]. Key Points and Arguments 1. **Business Combination Announcement**: The merger between Assata Life Sciences and Beckley Cytec is expected to create significant synergies and unlock value for patients and shareholders [4][10]. 2. **Psychedelic Research Background**: Beckley Cytec has a history of scientific research into psychedelics, aiming to develop these compounds into approved pharmaceutical medicines for mental health conditions [5][6]. 3. **Pipeline Focus**: The combined company will have a focused pipeline of differentiated psychedelic products, including BPL-three and BPL-one, targeting treatment-resistant depression and social anxiety disorder [8][13]. 4. **Upcoming Milestones**: The company anticipates several important milestones, including the results of the BPL-three Phase 2b trial, expected in the middle of the year [14][15]. 5. **Market Opportunity**: The psychedelic compounds are positioned within the interventional psychiatry paradigm, targeting treatment-resistant conditions. The success of SPRAVATO, which achieved $930 million in sales, highlights the market potential for these new treatments [16][17]. 6. **Efficacy and Administration**: The compounds BPL-three and BPL-one are designed for shorter administration times compared to existing treatments, potentially improving patient compliance and outcomes [20][25]. 7. **Intellectual Property (IP) Strategy**: The company has a strong IP position with multiple patents granted in the U.S. and Europe, ensuring protection for their proprietary formulations [50][51]. 8. **Regulatory Interactions**: The company has had positive interactions with the FDA regarding their development programs, indicating a clear path forward for Phase III trials [66][68]. Additional Important Content 1. **Safety Profile**: The Phase 1 and 2a studies indicated that BPL-three was well tolerated, with a high percentage of participants willing to take the treatment again [30][44]. 2. **Differentiation from Competitors**: The company believes that their intranasal delivery method and single administration model provide significant advantages over competitors like GH Research, which uses a more complex inhalation device [96][97]. 3. **Future Directions**: The company is open to exploring additional indications for their compounds beyond depression, including anxiety disorders and PTSD, depending on the results of ongoing studies [102][103]. 4. **Spin-off Plans**: The LE-one hundred one compound will be spun out into a separate entity, allowing the combined company to focus on its core assets while still retaining a stake in the new venture [104][105]. This summary encapsulates the key discussions and insights from the conference call, highlighting the strategic direction and potential of the combined company in the psychedelic treatment landscape.