Summary of Trisalus Life Sciences Conference Call Company Overview - **Company**: Trisalus Life Sciences (NasdaqGM: TLSI) - **Focus**: Improving outcomes for patients with solid tumors in the liver, pancreas, and other areas through innovative delivery technologies [2][3] Core Technology and Market Opportunity - **Technology**: A catheter-based system that modulates pressure and flow to enhance drug delivery directly into tumors, minimizing off-target effects [3][4] - **Market Size**: The company operates in a market opportunity of approximately $500 million, with less than 10% market share currently [3][4] - **Growth Potential**: Rapid growth anticipated due to the versatility of the technology for various embolization applications [4] Innovations in Treatment - **Thyroid Artery Embolization**: A new approach developed by Dr. Juan Camacho, aimed at treating multinodular goiter as a minimally invasive alternative to surgery [10][12] - **Patient Outcomes**: The technology has shown a 50% reduction in post-procedure readmissions due to fewer complications [8][9] Multinodular Goiter Insights - **Prevalence**: Approximately 12% of the adult population worldwide has multinodular goiter, with a significant number undergoing thyroidectomies annually [17][18] - **Surgical Risks**: Many surgeries are performed by general surgeons, leading to disparities in outcomes compared to specialized surgeons [18][19] - **Symptoms and Complications**: Patients often experience significant morbidity, including hyperthyroidism and compressive symptoms [21][23] Treatment Paradigms - **Minimally Invasive Options**: Options include radioactive iodine, percutaneous ethanol injection, ablation, and thyroid artery embolization [25][31] - **Volume Considerations**: Larger nodules (>20 mL) are more effectively treated with thyroid artery embolization due to high recurrence rates with other methods [27][28] Clinical Evidence and Results - **Efficacy of Embolization**: Studies indicate that thyroid artery embolization can reduce thyroid volume by approximately 50% and improve hormone levels without causing hypothyroidism [36][37] - **Quality of Life Improvements**: Significant improvements in quality of life reported post-procedure, with a high euthyroid conversion rate in patients with hyperthyroidism [38][39] Future Directions - **Research and Guidelines**: Ongoing efforts to build robust clinical data and establish guidelines for patient selection and treatment protocols [54][56] - **Awareness and Training**: Emphasis on increasing awareness of the procedure among patients and healthcare providers, and ensuring proper training for practitioners [64][65] Conclusion - **Emerging Treatment**: Pressure-enabled thyroid artery embolization presents a promising alternative for patients with large goiters, particularly when surgery poses high risks [52][53] - **Multidisciplinary Approach**: Collaboration among various specialties is crucial for optimizing patient care and integrating this technology into standard practice [64][65]

Summary of Anixa Biosciences Conference Call Company Overview - **Company**: Anixa Biosciences (NasdaqCM: ANIX) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company with two early-stage clinical developments: a CAR T cell therapy for ovarian cancer and a breast cancer vaccine program [1][2] Key Points and Arguments Breast Cancer Vaccine Program - The breast cancer vaccine program is designed as both a treatment and prophylactic, focusing on a novel approach targeting a protein expressed only during lactation, which is produced by cancer cells in some breast cancer patients [6][7][8] - The phase one study presented at the 2025 San Antonio Breast Cancer Symposium showed promising results, with the data exceeding expectations and being superior to other cancer vaccines in phase one trials [9][10] Phase One Study Results - The phase one trial involved three cohorts of women: 1. Women with a history of triple-negative breast cancer at high risk of recurrence 2. Women with BRCA mutations who opted for prophylactic mastectomies 3. Women with residual disease post-treatment [10][12][13] - Key findings: - The vaccine was found to be safe with no significant side effects, only mild injection site irritation [11][18] - Strong immune responses were observed in 75% of participants [11][20] - No significant differences in immune response rates among the cohorts [21] Future Clinical Trials - Plans for a phase two study in a neoadjuvant setting, where newly diagnosed breast cancer patients will receive the vaccine alongside standard care (Keytruda) [24][25] - The trial is expected to enroll 80 to 100 women and take approximately two to three years to complete, with data available much sooner [29][31] - The goal is to demonstrate the vaccine's efficacy in reducing tumor burden before surgery, potentially leading to better outcomes and lower recurrence rates [25][27] Corporate Strategy and Partnerships - Anixa aims to establish pharmaceutical partnerships to fund further trials and commercialize the vaccine, reducing reliance on capital markets [28] - The IND has been transferred from Cleveland Clinic to Anixa, allowing the company to sponsor the trial [32] Broader Research Initiatives - Anixa is also advancing preclinical and R&D vaccine programs targeting other cancers, including ovarian, prostate, lung, and colon cancers, with a focus on identifying unique proteins associated with these cancers [34][35] Additional Important Insights - The approach of targeting unique proteins on cancer cells aims to avoid autoimmune responses, which is a significant advantage over traditional cancer vaccine strategies [7][35] - The company is optimistic about the potential for the breast cancer vaccine findings to be replicated in other cancer types, indicating a broader application of their research strategy [34][35]

Summary of CytoSorbents Fireside Chat - December 15, 2025 Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Biotechnology, specifically medical devices focused on blood purification - **Key Products**: - **CytoSorb**: Removes cytokines and toxic substances from blood - **DrugSorb-ATR**: Investigational product aimed at removing blood thinners Core Points and Arguments - **Product Mechanism**: CytoSorb utilizes a highly porous polymer bead technology to extract toxic materials from blood without the need for affinity agents, making it compatible with existing hospital blood pumps [6][7] - **Market Presence**: CytoSorb is EU-approved and sold in over 70 countries, with more than 300,000 human treatments conducted to date, generating approximately $37 million in trailing 12-month revenue [9][10] - **Gross Margins**: The product has a gross margin of about 71%, with potential for higher margins as the U.S. market is pursued [10] - **Regulatory Strategy**: The company is focusing on the U.S. market for DrugSorb, which has received two FDA breakthrough device designations due to the significant unmet medical need for managing perioperative bleeding in patients on blood thinners [11][22] - **Clinical Trials**: The START trial, a randomized controlled trial involving 140 patients, aimed to demonstrate the efficacy of DrugSorb in reducing perioperative bleeding but missed its primary endpoint due to trial design issues [41][51] - **Regulatory Discussions**: The FDA has acknowledged the safety of the device and is open to a new De Novo submission that includes real-world evidence to support efficacy [58][62] Financial Management - **Cash Flow Strategy**: The company aims to achieve cash flow break-even by early 2026, with a refinancing agreement providing additional cash and extending the interest-only period on debt [70][71] - **Market Opportunity**: The total addressable market for DrugSorb is estimated at $300 million, potentially growing to over $1 billion as additional blood thinners and surgeries are included [26] Pipeline and Future Prospects - **Product Pipeline**: In addition to CytoSorb and DrugSorb, the company has products like VetRescue for animals and HemoDefend-BGA for universal plasma, indicating a broadening of its product offerings [12][13] - **Launch Strategy**: Upon FDA approval, the company plans a targeted launch in the U.S., focusing on clinical sites that have shown interest in the product [73][74] - **Regulatory Outlook**: The company expects to submit a new De Novo application in early 2026, with the potential for approval within the same year [64][65] Additional Insights - **Market Challenges**: The company faces challenges typical of microcap biotech firms, including the need for substantial resources for clinical trials and regulatory approvals [51][52] - **Surgeon Interest**: There is significant interest from surgeons in the U.S. for a solution to manage bleeding risks associated with blood thinners during surgeries, which could facilitate a successful product launch [74] This summary encapsulates the key points discussed during the fireside chat, highlighting the company's current status, regulatory strategies, financial management, and future prospects in the biotechnology industry.

Summary of Westlake Corporation PEM Profitability Improvement Plan Update Conference Call Company Overview - **Company**: Westlake Corporation - **Segments**: Performance and Essential Materials (PEM), Housing and Infrastructure Products (HIP) Key Points and Arguments Profitability Challenges - PEM's earnings and margins have declined due to global overcapacity in materials, particularly in the chlorovinyl chain and styrene [5][10] - The overcapacity has led to downward pressure on sales prices, resulting in unprofitable conditions at higher-cost manufacturing sites [5][10] Actions Taken - Westlake announced the closure of several higher-cost chlorovinyl and styrene plants in North America, specifically: - VCM plant in Lake Charles North - Chlor-alkali plant in Lake Charles South - PVC facility in Aberdeen, Mississippi - Styrene plant in Lake Charles - These closures are part of the PEM Profitability Improvement Plan and are expected to reduce global chlorovinyl capacity by 11% to 15% [8][9] Financial Impacts - Expected annual EBITDA benefit of approximately $100 million starting in 2026 from these actions [6][10] - Additional cash savings of $75 million in 2026 from avoided capital spending and turnaround costs, leading to total free cash flow savings of approximately $175 million [6][10] - Total pre-tax charges related to the closures are estimated at $415 million, including non-cash charges and employee severance costs [9][10] Market Conditions - Global macroeconomic conditions remain challenging, with weak industrial and manufacturing demand impacting sales prices and margins [11] - Fourth quarter EBITDA for PEM is expected to be $125 million to $150 million lower than the third quarter of 2025 [11][43] Future Outlook - The optimization actions are expected to position Westlake as a leading global chlorovinyl producer with a better cost structure [12][60] - The company anticipates that the manufacturing footprint optimization will contribute a total of $600 million in EBITDA improvement starting in 2026 [10][12] Strategic Focus - The focus of the closures is on improving cost positions rather than directly addressing supply-side issues [25][76] - The company plans to continue servicing export markets with better-positioned assets, aiming for improved profitability [76] Additional Important Information - The decision to close plants was made after extensive analysis, emphasizing the need for a path to improve EBITDA and return on investment [12][60] - The company has not ruled out the possibility of restarting the closed plants if market conditions improve in the future [73][76] - The impact of these closures on the overall PVC, caustic, and chlorine markets is still uncertain, but the company aims to operate at a lower cost position moving forward [24][25][76]

Financial Data and Key Metrics Changes - Backlog as of October 31, 2025, was approximately $15 million, an increase of $11.2 million year-over-year, reflecting conversion of opportunities across various sectors [7] - Pipeline expanded to $137.5 million, up $53.2 million year-over-year, indicating larger and more strategic opportunities [7] - Revenue for the quarter was $0.4 million, down from $2.4 million in the prior period, primarily due to delays in deliverables [8] - Gross profit for the quarter was a loss of $1.4 million compared to a profit of $0.8 million in the prior year [8] - Operating expenses increased to $8.8 million for the quarter, up from $4.7 million in the prior year, largely due to higher non-cash stock-based compensation [9] - Net losses for the quarter were $10.8 million, compared to $3.9 million in the prior year [9] Business Line Data and Key Metrics Changes - Eight Autonomous Surface Vehicles (ASVs) were delivered during the quarter, supporting demonstrations and ongoing user trials [8] - The company maintained steady ASV deliveries and advanced PowerBuoy readiness for national security missions [5] Market Data and Key Metrics Changes - The company is seeing increased demand across defense, government security, offshore energy, and commercial applications [4] - International demonstrations in Latin America and the UAE have validated system performance and opened avenues for follow-on work [5] Company Strategy and Development Direction - The company reorganized delivery and internal R&D teams to improve coordination and scalability as opportunities grow [6] - Focus remains on execution, reliability, and supporting customer missions with systems that perform consistently in real-world environments [10] Management's Comments on Operating Environment and Future Outlook - Management noted strengthening demand signals across core markets and regained momentum in government engagement [10] - The company is optimistic about upcoming orders and has started pre-building buoy assets for anticipated orders [17] Other Important Information - The company has been recognized as a trusted operator by AUVSI, leading to the opening of a training school for USV operators [16] - The company is actively engaged in international markets, particularly in oil and gas sectors outside the U.S. [24] Q&A Session Summary Question: Can you provide details on the pipeline and customer orders? - Management indicated a balanced mix in the pipeline, with ongoing discussions particularly in homeland security and the Department of War [13] Question: How is headcount expansion supporting the pipeline? - The company has increased headcount in delivery-focused functions and marine operations to facilitate discussions with government agencies [16] Question: Will the government shutdown impact future revenues? - Management noted an uptick in pace and is optimistic about shipping efforts shortly, although it is uncertain if the impact will be additive or merely a push-out [17] Question: How has recent regulatory news affected momentum in wind energy? - The company remains engaged in offshore energy sectors outside the U.S., particularly in the UAE, and is focused on lowering operational costs for international clients [23] Question: How does the company differentiate between pipeline and backlog? - Pipeline consists of qualified opportunities under NDA, while backlog includes confirmed contracts and purchase orders [26]

Financial Data and Key Metrics Changes - Backlog as of October 31, 2025, was approximately $15 million, an increase of $11.2 million year-over-year, reflecting conversion of opportunities across various sectors [7] - Pipeline expanded to $137.5 million, up $53.2 million year-over-year, indicating larger and more strategic opportunities [7] - Revenue for the quarter was $0.4 million, down from $2.4 million in the prior period, attributed to delays in deliverables [8] - Gross profit for the quarter was a loss of $1.4 million compared to a profit of $0.8 million in the prior year [8] - Operating expenses increased to $8.8 million for the quarter, up from $4.7 million in the prior year, primarily due to higher non-cash stock-based compensation [9] - Net losses were $10.8 million for the quarter, compared to $3.9 million in the prior year [9] Business Line Data and Key Metrics Changes - The company delivered eight WAM-V vehicles during the quarter, supporting demonstrations and customer trials [8] - Operational planning reflects expectations for buoy orders, indicating a focus on long-duration power solutions and autonomous surface vehicles [5] Market Data and Key Metrics Changes - The company is seeing increased engagement in defense, government security, offshore energy, and commercial applications, with a notable uptick in U.S. government activity [4] - International demonstrations in Latin America and the U.A.E. have validated system performance and opened avenues for follow-on work [5] Company Strategy and Development Direction - The company reorganized delivery and internal R&D teams to improve coordination and scalability in response to rising demand [6] - Focus remains on execution, reliability, and supporting customer missions with systems that perform consistently in real-world environments [10] Management's Comments on Operating Environment and Future Outlook - Management noted strengthening demand signals across core markets, with backlog and pipeline at significantly higher levels than last year [10] - Government engagement has regained momentum, supported by new initiatives across multiple agencies [10] Other Important Information - The company has been granted trusted operator status by AUVSI, leading to the opening of a training school for USV operators [16] - The company is actively pursuing international opportunities, particularly in oil and gas sectors outside the U.S. [24] Q&A Session Summary Question: Can you talk about the pipeline and customer orders? - Management indicated a balanced mix in the pipeline, with ongoing discussions particularly in homeland security and the Department of War [13] Question: How is headcount growth supporting the pipeline? - Headcount has expanded in delivery-focused functions and commercial teams to facilitate discussions with government agencies [16] Question: Will the government shutdown impact revenues next quarter? - Management noted an uptick in pace recently and is optimistic about shipping efforts shortly [17] Question: How has recent regulatory news on wind permits impacted momentum? - The company remains engaged in offshore energy sectors outside the U.S., focusing on oil and gas projects [23] Question: How does the company identify and quantify pipeline versus backlog? - Pipeline consists of qualified opportunities under NDA, while backlog includes confirmed contracted purchase orders [26]

Financial Data and Key Metrics Changes - Backlog increased to approximately $15 million, up $11.2 million year-over-year, reflecting conversion of opportunities across various sectors [6][8] - Pipeline expanded to $137.5 million, an increase of $53.2 million year-over-year, indicating larger and more strategic opportunities [6][8] - Revenue for the quarter was $0.4 million, down from $2.4 million in the prior period, attributed to delays in deliverables [8] - Gross profit for the quarter was a loss of $1.4 million, compared to a profit of $0.8 million in the prior year [8] - Operating expenses rose to $8.8 million for the quarter, compared to $4.7 million in the prior year, primarily due to higher non-cash stock-based compensation [9] - Net losses were $10.8 million for the quarter, compared to $3.9 million in the prior year [9] - Cash and short-term investments totaled $11.7 million as of October 31, up from $6.7 million at the beginning of the fiscal year [9] Business Line Data and Key Metrics Changes - Eight Autonomous Surface Vehicles (ASVs) were delivered during the quarter, supporting demonstrations and customer milestones [8] - The company maintained steady ASV deliveries and advanced PowerBuoy readiness for national security missions [5][8] Market Data and Key Metrics Changes - The company is seeing increased demand across defense, government security, offshore energy, and commercial applications [4][10] - International demonstrations in Latin America and the UAE have validated system performance and opened new avenues for follow-on work [5][10] Company Strategy and Development Direction - The company reorganized delivery and internal R&D teams to improve coordination and scalability as opportunities grow [6] - Focus remains on execution, reliability, and supporting customer missions with systems that perform consistently in real-world environments [10] Management's Comments on Operating Environment and Future Outlook - Management noted strengthening demand signals across core markets and regained momentum in government engagement [10] - The company is preparing for anticipated buoy orders and has aligned teams to support upcoming opportunities [10] Other Important Information - The company has been granted trusted operator status by AUVSI, leading to the opening of a training school for USV operators [17] - The company is expanding its international footprint, particularly in the oil and gas sector outside the U.S. [24] Q&A Session Summary Question: Can you talk about the pipeline and customer orders? - Management indicated a balanced mix in the pipeline, with ongoing discussions particularly in homeland security and the Department of War [12][13] Question: How is headcount growth supporting the pipeline? - The company has expanded its delivery-focused functions and commercial team to facilitate discussions with government agencies [16][17] Question: Will the government shutdown impact revenues next quarter? - Management noted an uptick in pace and is optimistic about shipping efforts shortly, but it is uncertain if it will be additive or a push-out [18] Question: How has recent regulatory news impacted momentum in wind energy? - The company remains engaged in offshore energy sectors outside the U.S., particularly in the UAE, and is focused on lowering operational costs for customers [23][24] Question: How does the company differentiate between pipeline and backlog? - Pipeline consists of qualified opportunities under NDA, while backlog includes confirmed contracts and purchase orders [25][26]

Footprint Optimization - The company is shutting down three North American chlorovinyl plants and exiting the styrene business due to unfavorable market conditions and high costs[2, 5] - These closures are expected to improve annual EBITDA by approximately $100 million and generate free cash flow savings of around $175 million in 2026[2, 9] - The company anticipates one-time charges of about $415 million in 4Q'25, including a $357 million non-cash accelerated depreciation, amortization, and asset write-off charge[9] - The shutdown includes the following capacity reductions: 825 million lbs of Chlorine (11% of WLK global capacity), 910 million lbs of VCM (11% of WLK global capacity), 1,000 million lbs of PVC (15% of WLK global capacity), and 570 million lbs of Styrene (100% of WLK global capacity)[5] Profitability Improvement Plan - The company's Profitability Improvement Plan aims to restore PEM's Return on Investment to an appropriate level[4] - The plan is expected to generate approximately $600 million per year of EBITDA uplift starting in 2026, with each of the three pillars contributing around $200 million[9, 10, 12] - The footprint optimization efforts, including North American chlorovinyls and styrene closures, are projected to contribute $100 million to the $200 million total from Footprint Optimization[10] - The plan has an expected payback period of less than one year on the $58 million cash costs required for execution[2, 9]

Summary of Immunome's Conference Call on AL102 Phase 3 Results Company and Industry Overview - **Company**: Immunome - **Industry**: Oncology, specifically focusing on desmoid tumors Key Points and Arguments 1. **Positive Phase 3 Results**: The top-line results from the AL102 Ringside phase 3 clinical trial for desmoid tumors were reported as positive, indicating the potential for AL102 to be a best-in-class treatment [4][5][6] 2. **Primary and Secondary Endpoints**: The trial met all primary and secondary endpoints, including: - Progression-Free Survival (PFS) hazard ratio of 0.16, indicating a significant reduction in disease progression risk compared to placebo [5][10] - Confirmed Objective Response Rate (ORR) of 56%, the highest reported in randomized trials for desmoid tumors [5][11] - Median tumor volume reduction of 83%, with placebo showing an 11% increase [5][12] 3. **Safety Profile**: AL102 was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor (GSI) class. Common adverse events included diarrhea, fatigue, and rash, primarily grade one or two [5][13] 4. **Ovarian Toxicity**: Notably, 55.6% of women of childbearing potential experienced ovarian toxicity, which is a known side effect of GSIs. This rate is lower than the up to 75% reported in the GSI class [13][14] 5. **Regulatory Plans**: Immunome plans to meet with the FDA in early 2026 to review the trial results and aims to submit a New Drug Application (NDA) in the second quarter of 2026 [6][14] 6. **Commercial Strategy**: The company is focused on a three-pillar strategy (start, support, scale) to drive adoption of AL102 upon approval, targeting approximately 11,000 actively managed desmoid tumor patients in the U.S. [25][26] 7. **Market Dynamics**: There are about 85 specialty sarcoma centers in the U.S. that treat desmoid tumors, which will facilitate efficient engagement and rapid uptake of AL102 [26][27] 8. **Future Studies**: Additional studies are planned to explore AL102's efficacy in treating other tumors and to better understand its impact on patients with functional impairments [14][61] Other Important Insights 1. **Patient Impact**: Desmoid tumors significantly affect the quality of life, often leading to debilitating pain and loss of function, particularly in younger patients [17][18] 2. **Treatment Landscape Evolution**: The treatment approach for desmoid tumors has shifted from surgery to active surveillance and systemic therapy, with GSIs emerging as a viable option [19][20] 3. **Clinical Experience**: The call featured insights from Dr. Mrinal Gounder, an expert in desmoid tumors, who emphasized the potential of AL102 to become a standard of care based on its clinical profile [20][23] 4. **Payer Coverage**: The expectation is for over 90% payer coverage at launch, supported by the familiarity of key opinion leaders (KOLs) with AL102 [27][28] 5. **Pricing Strategy**: While specific pricing details were not disclosed, the company plans to engage with payers and doctors to determine an appropriate price for AL102 [72] This summary encapsulates the critical aspects of Immunome's conference call regarding the promising results of AL102 for desmoid tumors, highlighting its potential impact on patient care and the company's strategic plans moving forward.

Summary of Palvella Therapeutics Conference Call on Phase 2 TOIVA Study Results Company and Industry Overview - **Company**: Palvella Therapeutics (NasdaqCM:PVLA) - **Industry**: Biotechnology, specifically focusing on treatments for rare genetic diseases, particularly cutaneous venous malformations (CVM) Key Points and Arguments Phase 2 TOIVA Study Results - Positive top-line results were reported from the phase 2 study evaluating Qtorin rapamycin for treating cutaneous venous malformations, a serious rare genetic disease with no FDA-approved therapies currently available [4][6][30] - Qtorin rapamycin demonstrated statistically significant improvements on multiple clinician-reported and patient-reported efficacy endpoints, with a mean effect size of 1.5 on the overall CVM investigator global assessment at week 12, p-value < 0.001 [6][21] - 73% of patients (11 out of 15) showed a one-point improvement or greater at week 12, and 67% (10 out of 15) were rated as either much improved or very much improved [6][30] - Statistically significant improvements were also observed in key aspects of CVM, including height/engorgement, appearance, and bleeding [7][21] Safety Profile - Qtorin rapamycin was generally well tolerated, with the most common treatment-emergent adverse event being erythema in 25% of patients; all adverse events were moderate or mild [29] - Systemic absorption of rapamycin was very low, with levels below the lower limit of quantification in systemic circulation for all participants [29] Unmet Medical Need - Cutaneous venous malformations are chronic, progressive conditions that can cause significant pain, swelling, and functional limitations, representing a major gap in treatment options [11][12] - Current treatment options are largely procedural and do not address the underlying disease pathology, leading to a cycle of recurrence and inadequate management [12][15] Future Steps and Regulatory Strategy - Palvella plans to engage with the FDA to explore the potential for breakthrough therapy designation and align on the design of a phase 3 pivotal study [30][31] - The company aims to establish Qtorin rapamycin as a first-line therapy for the estimated 135,000 patients in the U.S. with cutaneous venous malformations [36] Mechanistic Insights - The study highlights the genetic basis of CVM, with known mutations in TEK and PIK3CA genes leading to persistent hyperactivation of mTOR in venous endothelial cells [13][14] - Qtorin rapamycin is designed to deliver high concentrations of rapamycin directly to the skin, addressing the limitations of oral rapamycin, which has limited biodistribution to the skin [18][19] Additional Important Content - The study design included a 24-week duration with each patient serving as their own control, allowing for a robust assessment of treatment effects over time [19] - The results indicate a clear time-dependent increase in clinical response, suggesting that longer treatment duration may yield greater clinical benefits [23] - The qualitative interviews conducted during the study provided insights into the profound impact of CVM on patients' daily lives, reinforcing the importance of patient-reported outcomes [28] Conclusion - The TOIVA phase 2 study results support the potential for Qtorin rapamycin to become the first FDA-approved therapy for cutaneous venous malformations, addressing a significant unmet medical need in this patient population [32][33]