Nkarta (NasdaqGS:NKTX) Conference November 13, 2025 05:00 PM ET Speaker2Good afternoon, everybody, and thank you once again for joining us for the second day of the first annual iAI Summit at TD Cowen. I'm Yaron Warburg from the Biotech team, and it's a great pleasure to have with us today Paul Hastings, CEO, and Nadir Mahmood, President of Nkarta. Gentlemen, thanks so much for joining us. We appreciate it.Speaker1You bet.Speaker2It's good to see you. Maybe there's a lot of updates from the ongoing studies ...

Tenax Therapeutics (NasdaqCM:TENX) Update / Briefing November 13, 2025 04:30 PM ET Speaker1Good afternoon, and welcome to the Tenax Therapeutics virtual KOL call. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. A question-and-answer session will follow the KOL panel discussion. To ask a question, you may press star, then one on your touch-tone phone. To withdraw your question, please press ...

Biogen Conference Call Summary Company Overview - **Company**: Biogen (NasdaqGS:BIIB) - **Date**: November 13, 2025 - **Event**: TD Cowen's 2025 I&I Summit Key Industry and Company Insights Immunology and Kidney Strategy - Biogen has reinvigorated its immunology and kidney efforts, leveraging its expertise in neuroimmunology from its historical focus on neuroscience [2][3] - The strategy aims to support a diverse product portfolio by targeting immunological pathways applicable to multiple disease indications [2][3] R&D Pipeline Structure - The ideal R&D pipeline in immunology is driven by scientific understanding, allowing for efficient early development trials and multi-indication strategies [4][5] - Biogen's approach includes starting with multiple indications simultaneously to build confidence for further expansion [5] Investor Perception - Investors currently undervalue Biogen's immunology and kidney pipeline, potentially missing the strategic rationale behind the development of drugs like felzartamab [6] - Felzartamab is positioned to address antibody-mediated rejection in kidney transplants, supported by robust clinical data [6][7] Lupus Pipeline Confidence - Biogen has two late-stage candidates for lupus: dapirolizumab pegol and litifilimab, with confidence stemming from data-driven insights and successful proof of concept studies [9][10] - The company emphasizes the importance of clinical trial execution and understanding disease management in lupus, which has historically been challenging [10][11] Ongoing Trials - The Topaz 1 and 2 trials for systemic lupus erythematosus (SLE) have completed enrollment, with data expected by the end of 2026 [14][15] - These trials are designed to test different dosing paradigms and measure various endpoints related to disease control [15][16] Key Risks and Considerations - Risks to trial success include the complexity of lupus management and the need for precise clinical trial execution [17][18] - Biogen aims to meet statistical significance and meaningful patient outcomes in its trials, focusing on reducing flares and steroid use [19][20] New Programs and Future Directions - Biogen recently introduced BIIB142, an IRAK4 degrader, which is an oral molecule with potential applications across various autoimmune diseases [32][33] - The company is exploring multi-indication strategies for this new asset and continues to build its early-stage pipeline through collaborations and acquisitions [36] Additional Insights - Biogen is committed to reducing steroid dependency in lupus patients, aligning with evolving treatment guidelines [20] - The company is optimistic about the potential of its lupus candidates to provide meaningful improvements in patient quality of life [10][11] This summary encapsulates the key points discussed during the conference call, highlighting Biogen's strategic focus on immunology and kidney disease, ongoing clinical trials, and future directions in research and development.

Summary of Fidelity National Information Services (FIS) 2025 Conference Call Company Overview - **Company**: Fidelity National Information Services (NYSE: FIS) - **Industry**: FinTech, Financial Services Key Points and Arguments Current Business State and Strategy - CEO Stephanie Ferris expressed excitement about the company's position and the work done over the past three years, focusing on infrastructure and future technologies like AI and tokenized deposits [4][5] - The "future forward strategy" emphasizes three core areas: client-centricity, innovation, and simplicity, aiming to enhance client service and product delivery [5][6] - The company aims for durable revenue growth and profitable margins, focusing on return on invested capital [6][7] Competitive Landscape - The banking segment is experiencing positive trends, including reduced regulatory pressures, increased M&A activity, and significant investments in digital products and services [9][10] - FIS has repositioned itself to serve financial institutions, moving away from its payments business [9][10] - The fintech industry remains competitive but rational, with FIS focusing on high-margin, recurring revenue products [12][14] Pricing Environment - The pricing environment for new business remains competitive, but FIS has seen net pricing as a tailwind due to effective client retention and cross-selling strategies [13][14] - FIS's banking clients typically utilize an average of 26 products, highlighting opportunities for cross-selling [13][14] Banking Segment Performance - FIS reported strong growth in its banking business, driven by net new sales and increased account activity [16][17] - Consumer spending and digital account growth are also strong, contributing to positive performance [17] Digital Capabilities and Acquisitions - FIS has invested in digital capabilities, including the acquisition of Dragonfly to enhance commercial banking services [20][21] - The recent acquisition of Amount is expected to improve digital account opening capabilities, addressing significant fraud concerns [23][24] Office of the CFO as a Growth Vector - FIS is focusing on providing integrated treasury management solutions for CFOs, leveraging AI to enhance cash flow management [26][27] M&A Strategy - The company is pursuing an opportunistic M&A strategy, focusing on digital payments and lending capabilities as key areas for growth [45][48] - The upcoming TSYS issuer transaction is expected to enhance FIS's credit card processing capabilities and generate significant cash flow [32][33][35] AI and Technology Adoption - FIS views AI as an opportunity, with banks adopting technology faster than ever, particularly in areas like underwriting and KYC [51][52] - The company is integrating AI into its products to enhance client service and operational efficiency [53][54] Stablecoins and Digital Currency - FIS is not planning to issue a stablecoin but aims to enable financial institutions to offer digital currency capabilities through its Money Movement Hub [56][57] Investor Sentiment - Despite positive developments, the stock performance does not reflect the company's momentum, with the CEO suggesting that investors may be missing the underlying growth algorithm [60][61] Additional Important Insights - The company emphasizes cultural integration post-M&A as a critical success factor, focusing on aligning values and client-centric approaches [40][41] - FIS is committed to transforming its operations and positioning itself as a leading player in the fintech industry, aiming for double-digit earnings growth [62][63]

Summary of MacroGenics Conference Call Company Overview - **Company**: MacroGenics (NasdaqGS: MGNX) - **New CEO**: Eric Risser, appointed in August 2025, has been with the company for over 16 years, previously serving as Chief Operating Officer and leading business development [2][4] Strategic Imperatives - **Key Focus Areas**: 1. Clarifying the lower durable development strategy 2. Advancing two ADC (Antibody-Drug Conjugate) programs in the clinic targeting B7H3 and ADAM9 3. Advancing another IND (Investigational New Drug) for an undisclosed target (MGC030) 4. Advancing two additional product candidates from early-stage discovery 5. Strengthening corporate partnerships 6. Solidifying the financial position of the company [2][3] Product Development Updates - **Lorigerlimab**: - A CTLA-4 PD-1 bispecific antibody being studied in prostate cancer and gynecological malignancies - The LOWERKEY trial for prostate cancer was discontinued due to efficacy issues, but the Linet trial for gynecological malignancies remains active [5][6][10] - Early Phase I data showed a 26% response rate in prostate cancer, indicating potential despite challenges [9] - **ADC Programs**: - **B7H3 ADC**: Competitive landscape is intensifying, with multiple agents in development. MacroGenics believes in the strong expression profile of B7H3 across various solid tumors [18][19] - **ADAM9 ADC**: The program is in dose escalation, with a focus on GI-related cancers. MacroGenics aims to leverage learnings from previous partnerships to enhance this program [28][29][31] - **MGC030**: Expected to submit an IND next year, utilizing the Synaffix platform with an exatecan-based payload [32][36] Financial Position - **Cash Position**: As of September, cash and cash equivalents stood at $146 million, with an additional $75 million expected from partnerships in Q4 2025. This extends the cash runway into late 2027 [50][48] Collaborations and Partnerships - **Gilead Collaboration**: Expanded to include three programs, focusing on T-cell engagers and leveraging MacroGenics' proprietary platforms [44][46] - **Sanofi Collaboration**: Recent milestones triggered $50 million, adding to the $25 million from Gilead, contributing to a total of over $600 million in non-dilutive capital over the last three years [48][49] Market Dynamics - **Competitive Landscape**: The oncology sector is seeing increased competition, particularly in ADCs and checkpoint inhibitors. MacroGenics is positioning itself to explore combination therapies and capitalize on its diverse portfolio [41][40] Future Outlook - **Clinical Updates**: Expect updates on the Linet trial in mid-2026, with ongoing evaluations of ADC programs and potential for accelerated development paths in certain indications [15][12] This summary encapsulates the key points discussed during the MacroGenics conference call, highlighting the company's strategic direction, product development, financial health, and market positioning.

Summary of Travere Therapeutics Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Event**: Conference at TD Cowen's I&I Summit on November 13, 2025 Key Industry and Company Insights Focus on FSGS (Focal Segmental Glomerulosclerosis) - Upcoming PDUFA date is January 13, 2026, for sparsentan in treating FSGS [7] - Recent data presented at ASN Kidney Week showed significant continuity in achieving the 0.7 gram per gram UPCR target across DUPLEX and RADAR studies [3][4] - Achieving the 0.7 proteinuria reduction correlates with a lower rate of kidney failure, with an 85% reduction in risk for patients reaching this target [5][6] - Sparsentan demonstrated a 26% difference in treatment effect compared to irbesartan over two years [6] Regulatory Engagement - Consistent engagement with the FDA, with no unusual issues noted during the SNDA review process [7][14] - Anticipation of a draft label approximately one month before the PDUFA date [7] Pediatric Indication - Requested indication for patients aged eight years and older, with ongoing studies to support safety and efficacy in pediatric patients [21][22] - Potential for expanding the age range through the EPIC study, which includes patients under eight [22] Market Dynamics and Launch Strategy - The addressable patient community for FSGS is about half that of IgAN, but there is greater urgency for treatment [24] - The launch of sparsentan is expected to be faster due to existing payer coverage policies from the IgAN launch and the availability of two-year data [26][27] - Anticipated pricing dynamics suggest a higher cost due to a double dose for adult patients [28][29] Competitive Landscape - Travere Therapeutics is positioned as a first mover in the FSGS space, with expectations that other companies will follow with their own treatments [31] - The company is optimistic about the need for multiple treatment options, particularly for combination therapies [31] Financial Position - As of the third quarter, the company reported $255 million in cash, with pro forma cash of approximately $300 million after a recent milestone [39] - No immediate need for capital, but continued investments are planned for FILSPARI and the FSGS launch [39][40] Future Outlook - Continued growth in revenue is expected, driven by high patient adherence and a stable base of continuing patients [36] - The company is optimistic about the upcoming FSGS approval and the potential for rapid uptake in the market [27][37] Additional Important Points - The company is preparing for a quiet period leading up to the PDUFA date [19] - Discussions regarding the potential full REMS removal are planned post-FSGS approval [37] - The competitive landscape in IgAN is evolving, with a focus on combination therapies to enhance treatment efficacy [34][35]

Summary of PepGen Conference Call Company Overview - **Company**: PepGen (NasdaqGS:PEPG) - **Focus**: Development of EDO platform technology for treating myotonic dystrophy type 1 (DM1) Key Points Clinical Study Updates - **FREEDOM-DM1 Clinical Study**: - Early data showed significant splicing improvements: - 5 mg/kg: 12% improvement - 10 mg/kg: 29% improvement - 15 mg/kg: over 50% improvement, a first in DM1 [2][3] - Upcoming data from multiple ascending dose (MAD) study expected in Q1 next year, with a focus on 5 mg/kg and 10 mg/kg doses [3][22] Efficacy and Mechanism - **EDO Technology**: - Engineered to enhance nuclear delivery of therapeutic agents, achieving nearly 100-fold higher delivery compared to traditional methods [5][6] - Targets pathogenic RNA specifically, reducing off-target effects [6] - **Expectations for Splicing Improvement**: - Anticipated that multiple doses will yield greater splicing improvements than single doses, with functional benefits expected to translate from splicing improvements [7][10] Patient Selection and Functional Measures - **Patient Selection for MAD**: - Adjustments made to baseline myotonia requirements to minimize variability in results [9] - **Functional Measures**: - Focus on hand strength and ankle dorsiflexion as key indicators of disease progression [10] - VHOT (Voluntary Hand Opening Test) is a primary endpoint, but the company is exploring other functional measures for potential registration [11][12] Safety Profile - **Safety Data**: - No treatment-emergent adverse events related to kidney observed at 5 and 10 mg/kg doses in DM1 patients [17] - Previous DMD program showed mild to moderate renal biomarker changes, but these were transient and reversible [15][21] - **Dosing Strategy**: - 10 mg/kg is expected to be safe and well-tolerated, with potential for further exploration of higher doses [18] Regulatory Considerations - **FDA Perspective**: - Emphasis on benefit-risk assessment, particularly regarding transient and reversible side effects [20] - The company aims to establish reliable and predictable efficacy endpoints for potential registration [11] Future Plans - **Geographic Expansion**: - Plans to expand clinical studies into multiple geographies to facilitate timely data collection [27] - **Upcoming Data Releases**: - Full data from the 5 mg/kg cohort expected in Q1 next year [25][26] Additional Insights - **Natural History of Disease**: - Limited understanding of how splicing levels correlate with functional outcomes, but improvements in splicing are anticipated to enhance functional benefits [10][12] - **Patient-Centric Focus**: - The company aims to address broader patient needs beyond VHOT, including improvements in mobility, digestion, and overall quality of life [13] This summary encapsulates the key discussions and insights from the PepGen conference call, highlighting the company's advancements in clinical studies, safety profiles, and future directions in the treatment of DM1.

Xenon Pharmaceuticals Conference Call Summary Company Overview - **Company**: Xenon Pharmaceuticals (NasdaqGM:XENE) - **Focus**: Development of innovative therapies for epilepsy, psychiatry, and pain management Key Themes Discussed 1. **Lead Program - Azetukalner in Epilepsy** - Near-term phase 3 data expected in early 2026 from the fully enrolled EXTOL-two program [2][4] - Positive phase 2b data showing best efficacy in focal onset seizure studies with a severe patient population [6][7] - High confidence in phase 3 readout due to consistent inclusion-exclusion criteria and experienced clinical sites [10][11] 2. **Expansion into Psychiatry** - Ongoing phase 3 trials for major depressive disorder (MDD) and recently initiated trials for bipolar depression [2][3] - Phase 2 proof of concept study (ExNOVA) showed clear separation between active and placebo with a three-point difference on clinical scales [25][26] 3. **Emerging Early-Stage Portfolio in Pain** - Two phase 1 assets targeting NaV1.7 and Kv7, with plans to advance to phase 2 proof of concept studies in 2026 [3][50] - NaV1.7 target based on genetic studies showing patients with loss of function do not feel pain [36][37] Important Data and Insights - **Azetukalner Efficacy**: Placebo-adjusted efficacy in phase 2b ranged from teens to low 30s in monthly seizure reduction [9] - **Commercial Strategy**: Engaging with the epilepsy community and preparing for a successful launch with a Chief Commercial Officer and medical science liaisons in place [14][16] - **Market Opportunity**: Approximately 1 million patients in the U.S. with focal onset seizures are not achieving good seizure control [18] Competitive Landscape - **Market Dynamics**: Acknowledgment of multiple existing drugs in the focal onset seizure market, but belief in the unique profile of Azetukalner to differentiate from competitors [34][35] - **Regulatory Path**: Plans to file NDA next year, with Exfil and Exfil II studies included in the filing package [12][13] Pipeline Developments 1. **NaV1.7 and Kv7 Programs** - NaV1.7 in phase I study with a focus on achieving high receptor occupancy and safety [39][40] - Kv7 program showing potential analgesic effects similar to opioids [50] 2. **NaV1.1 for Dravet Syndrome** - Development of an oral small molecule to potentiate NaV1.1 channels, aiming to protect against seizures and improve survival in animal models [51][53] - Plans to initiate human clinical trials next year [54] Financial Position - **Cash Reserves**: Over $500 million in cash at the end of the last quarter, expected to sustain operations into 2027 [55]

Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM:JBIO) - **Founded**: Last year as the fourth spin-out of Paragon Therapeutics - **Lead Asset**: Jade 101, an anti-APRIL monoclonal antibody targeting IgA nephropathy [4][5] Key Points on Jade 101 - **Unmet Need**: High unmet need in IgA nephropathy with no approved disease-modifying therapies [5] - **Market Opportunity**: Significant market potential due to the lack of effective treatments [5] - **Mechanism of Action**: Targets APRIL, a cytokine implicated in IgA nephropathy, with a focus on potency and extended half-life [5][12] - **Half-Life**: Non-human primate (NHP) half-life of 27 days, with expectations for human half-life to be two to four times longer [7][9] - **Dosing Interval**: Targeting a dosing interval of at least every eight weeks, potentially extending beyond that [10][15] Financial Background - **Recent Financing**: Completed a reverse merger in April with a $200 million PIPE and a $95 million convertible note, followed by a $135 million financing [6] Clinical Development - **Phase I Data**: Expected in the first half of 2026, focusing on biomarkers such as APRIL and IgA levels [14][15] - **Biomarker Predictiveness**: Healthy volunteer data is expected to correlate strongly with patient outcomes in IgA nephropathy [20] - **Safety Profile**: Historical data shows a favorable safety profile for APRIL inhibitors, with no increased risk of infections [22][23] Competitive Landscape - **Comparison with Competitors**: Other anti-APRIL therapies have shown varying efficacy and safety profiles, with Jade 101 aiming for superior APRIL suppression [16][17] - **Regulatory Environment**: The FDA is exploring innovative trial designs for IgA nephropathy therapies, which may benefit Jade 101's development path [32][33] Jade 201 Overview - **Mechanism**: Jade 201 is a half-life extended anti-BAFFR monoclonal antibody designed to enhance B cell depletion while avoiding depletion of immature B cells [35][36] - **Indication**: Targeting rheumatoid arthritis (RA) as the first indication, with a focus on safety and biomarker responses [41] - **Market Potential**: The potential market opportunity for Jade 201 is estimated at $80 billion across various indications [45] Conclusion - **Future Outlook**: Jade Biosciences is positioned to capitalize on the growing interest in IgA nephropathy therapies and has a robust pipeline with Jade 101 and Jade 201, aiming for efficient development paths and favorable safety profiles [25][32][45]

Rollins (NYSE:ROL) FY Conference November 13, 2025 02:45 PM ET Speaker0I'm Andy Whitman. I'm the Senior Research Analyst that covers facility services here at Baird. Really happy to have the Rollins team back with us this year. Kenneth Krause is the company CFO, and Lindsey Burton's in IR. I just met Brady. Brady is the Treasurer, and we're really happy to have him. We're going to do this one as kind of a hybrid fireside chat and formal presentation. Ken's going to get us going with the presentation and goi ...