I'm reaching out today to share the bigger picture and highlight the exciting momentum building at Galmed. With significant recent achievements and ambitious plans ahead, this is an ideal time to connect the dots on our progress and reaffirm our vision for a transformative future. As we connect the dots on our progress, I'm excited to reaffirm the strength of Galmed and the incredible opportunities that lie ahead. Over the past year, we have successfully expanded our therapeutic focus beyond liver disease, ...

Summary of Ionis Pharmaceuticals Conference Call Company Overview - **Company**: Ionis Pharmaceuticals - **Industry**: Biotechnology, specifically focusing on genetic medicines targeting RNA for therapeutics - **Recent Achievements**: Launched two FDA-approved medicines independently in the U.S. in 2025: Tryngolza for Familial Chylomicronemia Syndrome (FCS) and Donidalorsen for hereditary angioedema [2][3] Core Points and Arguments - **Successful Product Launches**: - Tryngolza, the first FDA-approved medicine for FCS, launched successfully in 2025 [2] - Donidalorsen launched as a prophylactic treatment for hereditary angioedema [2] - **Pipeline Progress**: - Announced positive phase three data for severe hypertriglyceridemia and a neurology drug for Alexander disease [3][4] - Anticipating five phase three readouts and two to three FDA approvals in the upcoming year [4] - **Market Opportunity**: - Severe hypertriglyceridemia affects millions in the U.S., with a focus on patients at high risk for acute pancreatitis [7][9] - Plans to target both severely at-risk patients and those with mildly elevated triglycerides [10][11] - **Combination Therapy Potential**: - Exploring combination therapies for managing triglycerides and other cardiovascular risk factors [12][13] - Collaboration with AstraZeneca to combine treatments for TTR cardiomyopathy [14][17] Additional Important Insights - **Self-Administration Preference**: - Patients prefer self-administered treatments, which could enhance market penetration, especially in community settings [20][21] - **Regulatory and Market Dynamics**: - Anticipated inclusion in treatment guidelines for severe hypertriglyceridemia, with a significant patient population of over 3 million in the U.S. [40] - **Spinraza Update**: - Ionis is developing a next-generation Spinraza with once-per-year dosing, expected to re-emerge as a leading treatment for spinal muscular atrophy (SMA) [32][33] - Economic terms for the next-gen product are more favorable, with royalties in the mid-20% range compared to mid-teens for the current compound [34] Conclusion - Ionis Pharmaceuticals is positioned for significant growth with its innovative therapies targeting severe hypertriglyceridemia and SMA. The company is leveraging its unique RNA-targeting platform to address unmet medical needs and expand its market presence through strategic partnerships and a focus on patient convenience.

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $2.7 million, down from $5.4 million in Q3 2024, primarily due to restructuring efforts [15] - Gross profit for Q3 2025 was $1.3 million, or 49% of revenue, compared to $3.1 million, or 58% of revenue in Q3 2024 [15] - Operating expenses were $10.9 million, a decrease of 29% compared to the prior year, with an operating loss of $9.6 million, narrowed by 22% year-over-year [9][10] - Adjusted net operating loss was $6.9 million, a 39% improvement compared to the prior year [10][17] Business Line Data and Key Metrics Changes - The restructuring in Q3 focused on accounts and distributors promoting metabolically healthy weight loss, which is expected to lead to long-term growth [7][8] - Sales and marketing expenses decreased to $3.1 million from $5.2 million in Q3 2024, driven by increased operational efficiency [15][16] - Research and development expenses were reduced to $2.0 million from $3.2 million in Q3 2024, reflecting cost reductions related to the Audacity trial [16] Market Data and Key Metrics Changes - The company is seeing a trend where patients who discontinue GLP-1 treatments represent a significant opportunity for Allurion, as over half of these patients seek alternative therapies [9][18] - The company anticipates that the reduction in GLP-1 prices in the U.S. will drive more uptake and subsequently increase churn rates, leading to more patients looking for alternative therapies [27] Company Strategy and Development Direction - The company is advancing preparations for the U.S. launch of the Allurion Smart Capsule, with a focus on combination therapies with low-dose GLP-1s [6][11] - Allurion is exploring the development of a drug-eluting balloon in collaboration with a strategic partner, which could address adherence challenges in obesity therapy [12][19] - The company is retooling its R&D pipeline and manufacturing capabilities to enhance operational efficiency and expand capacity [11][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA approval process for the Allurion Smart Capsule, highlighting successful inspections and a positive Day 100 meeting outcome [5][6] - The company believes that the Allurion program is uniquely positioned to capitalize on the success of GLP-1s and set the stage for long-term growth in the obesity management market [18][19] Other Important Information - As of September 30, 2025, cash and cash equivalents were $6.1 million, not including a recent private placement financing of $5 million [17] - The company is on a path to being debt-free through a transaction to exchange outstanding debt for convertible preferred equity [10][11] Q&A Session Summary Question: How is the company applying learnings from international strategy to the U.S. market? - Management noted that they are learning from international experiences, particularly regarding the churn rates of GLP-1 patients, and are mapping out U.S. clinics that utilize GLP-1s [21][23] Question: What is the outlook for international revenues over the next 12 to 24 months? - Management expects continued growth in Q4 and into 2026 as clinics embrace GLP-1s and combination therapies [25][26] Question: Can you provide details on the development program for the Smart Capsule as a platform technology? - Management discussed the potential of the Smart Capsule to deliver various drugs and the initiation of a longer-term balloon project that could last beyond four months [29][32]

Core Insights - STRATA Skin Sciences, Inc. has highlighted a recent study demonstrating the efficacy of its 308nm Excimer laser combined with a JAK inhibitor for treating localized non-segmental vitiligo, showing superior results compared to monotherapy [1][2][4] Study Findings - The study involved 251 patients and revealed five key findings: 1. Mechanistic synergy between JAK inhibitors and Excimer laser therapy [7] 2. A 14.20% higher repigmentation rate with the combination therapy [7] 3. A 100% significant efficacy rate after 52 weeks of treatment [7] 4. At one-year follow-up, the combination group showed 96.5% pigmentation stability and an 8.8% relapse rate [7] 5. The treatment exhibited an excellent safety profile with no serious adverse events [7] Clinical Validation - The study adds to over 400 existing studies validating the 308nm Excimer laser as a cornerstone therapy for various inflammatory and autoimmune skin diseases [3][4] - The combination therapy is positioned as a personalized medicine approach, allowing for tailored treatment based on laser exposure duration and dosage [3] Company Strategy - The company is pursuing expanded reimbursement for its treatments, leveraging the strong clinical evidence from the recent study [3][4] - STRATA continues to work with regulators to enhance access to its treatment modalities by early 2026 [3]

Core Insights - SciSparc Ltd. has announced a collaboration with Clearmind Medicine Inc. that has resulted in the publication of an international patent application under the Patent Cooperation Treaty (PCT) [1] - The patent application covers a combination therapy of Clearmind's 5-methoxy-2-aminoindane (MEAI) and SciSparc's Palmitoylethanolamide (PEA) aimed at treating metabolic syndrome and obesity [2] - Metabolic syndrome affects up to one-third of U.S. adults, increasing the risk of serious health issues such as heart disease and type 2 diabetes [3] - The collaboration has led to the filing of 13 patent families across multiple jurisdictions, focusing on innovative therapies for mental health disorders and metabolic conditions [4] Company Overview - SciSparc Ltd. is a clinical-stage pharmaceutical company focused on developing cannabinoid-based therapies, with ongoing programs targeting Tourette Syndrome, Alzheimer's disease, autism, and status epilepticus [5] - Clearmind Medicine Inc. is a clinical-stage psychedelic pharmaceutical biotech company dedicated to developing psychedelic-derived therapeutics for health issues like alcohol use disorder, with a portfolio of 19 patent families [6]