Summary of ORIC Pharmaceuticals Conference Call Company Overview - ORIC Pharmaceuticals is a clinical-stage oncology company focused on overcoming resistance in cancer, particularly in prostate, lung, and breast cancer [2][3] Key Programs - **ORIC-944**: An allosteric PRC2 inhibitor for prostate cancer, expected to start a Phase III study in the first half of 2026 [2][7] - **Enozertinib (ORIC-114)**: A selective brain-penetrant EGFR inhibitor targeting exon 20 and PACC mutations, with updates expected in the second half of 2026 [3][34] Competitive Landscape - Pfizer's **Mevrometostat** showed a PFS of 14.3 months in prostate cancer, which ORIC aims to match or exceed with their own data [5][6] - ORIC's early data showed a PSA 50 response of 40% compared to Pfizer's 34%, indicating a potentially better efficacy profile [6][10] Safety and Efficacy - ORIC believes that safety is a significant differentiator in prostate cancer treatments, with their program showing fewer adverse events compared to Pfizer's [10][13] - The company does not believe it needs to be differentiated in efficacy due to the large market and unmet needs in prostate cancer [11][12] Market Opportunity - The metastatic CRPC market is estimated to have 30,000-40,000 patients annually in the US, with a significant portion having prior exposure to AR inhibitors [25][26] - The potential market opportunity for ORIC's treatments in the post-abi setting is estimated at $3.5 billion [28] Financial Position - ORIC raised $244 million in mid-2025, providing a cash runway into the second half of 2028, which covers the costs of the first Phase III study [24][46] - The company is well-capitalized and does not require a corporate partner to initiate the first Phase III study [22][23] Future Plans - An update on dose optimization data for ORIC-944 is expected in Q1 2026, with a focus on PSA responses and safety [15][17] - ORIC plans to evaluate which AR inhibitor (apalutamide or darolutamide) to use in the Phase III study based on data from the Q1 update [19][20] Enozertinib Development - ORIC plans to continue investing in enozertinib, with a focus on CNS activity, which is a significant unmet need in lung cancer [35][36] - The company aims to differentiate itself in the EGFR market, which is competitive and requires best-in-class inhibitors [39][40] Conclusion - ORIC Pharmaceuticals is positioned to capitalize on significant market opportunities in oncology, with a strong focus on safety and efficacy in its drug development programs. The company is financially stable and prepared to advance its clinical trials without immediate need for external partnerships.

Summary of Eledon Pharmaceuticals Conference Call Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of immunosuppressive therapies for organ transplantation, particularly kidney and islet cell transplants Key Points from the Conference Call Phase 2 BESTOW Study Results - The Phase 2 BESTOW study showed promising outcomes, achieving a non-inferiority margin for a composite endpoint, which is crucial for Phase 3 approval [1] - Although the primary endpoint of kidney function was not met, the data indicated that the treatment outperformed standard care in various aspects [1][2] - Safety profile was significantly better, with a ninefold reduction in tremors and a sevenfold reduction in infection rates compared to standard care [3] Market Perception and Data Interpretation - The market may have underestimated the implications of missing the kidney function endpoint, as the approvable endpoint for kidney transplant studies is a composite endpoint unrelated to kidney function [4] - Acute rejection rates were higher in the tegoprubart arm (20%) compared to the tacrolimus arm (14%), but all rejections in the tegoprubart group occurred within the first six months [5] Phase 3 Study Planning - Eledon plans to request an end-of-phase 2 meeting with the FDA in late Q1 or early Q2 2026 to discuss the Phase 3 study design [10] - The primary endpoint for the Phase 3 study will focus on patient and graft survival, with a non-inferiority design [15][17] Long-term Data and Quality of Life Measures - Long-term follow-up data from a Phase 1b study showed no acute rejections and 100% survival, indicating potential for better long-term outcomes compared to standard care [7][8] - The Phase 3 study will include patient-reported outcomes to assess quality of life and toxicities associated with standard care [21] Commercial Opportunity - Eledon believes tegoprubart could become the new standard of care in transplantation, with potential applications in both allotransplant and xenotransplant settings [28] - The company aims to address the limitations of current therapies and believes that the infrastructure for drug administration has improved since previous launches [27] Islet Cell Program - The islet cell transplant program has shown promising results, with several patients achieving independence from insulin [31][32] - Eledon plans to transition this program into a sponsored study, with an IND filing expected by the end of 2026 [33][35] Xenotransplantation Developments - Eledon is collaborating on xenotransplantation studies, showing significant progress with genetically modified pig organs [41][42] - The company plans to supply tegoprubart as part of the immunosuppressive regimen for xenotransplantation, leveraging safety and efficacy data from ongoing studies [43] Financial Position and Future Milestones - Eledon has sufficient cash to fund operations through Q2 2027, with key milestones including the opening of INDs for kidney and islet cell transplant studies [50][51] - The company is committed to supporting ongoing research in xenotransplantation and other transplant-related studies [52] Additional Insights - The discussion highlighted the importance of managing immunosuppression protocols in clinical trials to ensure balanced treatment across study arms [23][24] - The potential for xenotransplantation to alleviate organ shortages presents a significant commercial opportunity, as many patients remain on waiting lists without receiving transplants [44]

CareDx (NasdaqGM:CDNA) Update / briefing February 12, 2026 10:00 AM ET Company ParticipantsBrandon Couillard - Managing DirectorJeffrey Teuteberg - Chief Medical OfficerJohn Hanna - President and CEOMarica Grskovic - Chief Strategy OfficerNatasha Wagner - VP of Corporate CommunicationsRan Reshef - Professor of Medicine and Director of Translational ResearchConference Call ParticipantsAndrew Brackmann - Research Analyst of HealthcareBill Bonello - Senior Research AnalystTom DeBourcy - Senior Equity Research ...

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Date**: February 12, 2026 - **Key Executives**: Marino Garcia (CEO), Ryan Savitz (CFO) Key Industry and Company Insights 1. Transformational Year - 2025 was a pivotal year for Dianthus, marked by the first patient data in myasthenia gravis (MG), which exceeded expectations [2][60] 2. Product Pipeline - **DNTH212**: In-licensed from Leads Biolabs, a bifunctional fusion protein targeting BDCA2 to reduce type I interferon and BAFF/APRIL, showing potential as a best-in-class product [2][3] - **Clasiprubart**: An active C1s inhibitor with promising phase 2 data for MG, with two major catalysts expected in 2026 [3][4] 3. Upcoming Catalysts - **CIDP Phase 3 Study**: Interim responder analysis for the first 40 patients is anticipated in Q2 2026, accelerated from H2 2026 due to strong recruitment [4][16] - **MMN Phase 2 Results**: Expected in the second half of 2026 [4] 4. Competitive Landscape - **Riliprubart**: A competitor from Sanofi, currently in phase 3 studies for CIDP. Dianthus aims to demonstrate at least equal efficacy with a more convenient dosing regimen [10][12] - **Empaciperbart**: Another competitor in MMN, with Dianthus expecting similar efficacy but with advantages in administration and safety [31][39] 5. Efficacy Expectations - For CIDP, Dianthus aims for a responder rate of 40%-50% in the interim analysis, comparable to riliprubart's phase 2 data [12][17] - The company is focusing on a dosing regimen that is more efficient, potentially reducing the number of injections required [12][15] 6. Market Potential - The U.S. market for MG is estimated at $5 billion, with potential growth to $20-$25 billion as biologics penetrate further [60] - Dianthus anticipates capturing 5%-10% of the MG market, translating to $2-$4 billion in sales [60][62] 7. Financial Health - Dianthus ended the year with $514 million in cash, sufficient to fund operations through 2028 and support upcoming milestones [64] 8. Safety and Regulatory Considerations - Concerns about drug-induced lupus (DIL) were addressed, emphasizing the reliability of data from clinical trials versus anecdotal reports [54][56] - The company is confident in the safety profile of its products, with no reported cases of DIL in clinical programs [56] 9. Commercial Strategy - Dianthus plans to leverage the convenience of its auto-injector and the absence of a box warning to differentiate its products in the market [41][44] 10. Recruitment and Trial Design - The company is focusing on efficient recruitment strategies and trial designs that allow for quicker results and better patient outcomes [16][20] Conclusion Dianthus Therapeutics is positioned for significant growth with a strong pipeline and strategic focus on efficacy, safety, and market penetration. The upcoming data releases and competitive advantages in product administration are critical to its success in the evolving biotech landscape.

Akebia Therapeutics (NasdaqCM:AKBA) 2026 Conference February 12, 2026 09:30 AM ET Company ParticipantsJohn Butler - CEOSteve Burke - CMOConference Call ParticipantsVamil Divan - Biopharm AnalystVamil DivanThanks so much, everyone, again, for joining us for the second day of our Guggenheim Emerging Outlook Biotech Summit. I'm Vamil Divan, one of the Biopharm Analyst here at Guggenheim. Next up in this room, we have the Akebia Therapeutics team. Next to me, we have John Butler, the CEO; Steve Burke, the CMO; ...

Frontier Lithium (OTCPK:LITO.F) Conference February 12, 2026 09:30 AM ET Company ParticipantsBora Ugurgel - Manager of Investor RelationsModeratorWelcome to Virtual Investor Conferences. On behalf of OTC Markets, we're very pleased you joined us for the third day of our Precious Metals and Critical Minerals Conference. The first presentation today is from Frontier Lithium. Please note, you may submit questions for the presenter in the box to the left of the slides, and you can view a company's availability ...

Cabaletta Bio (NasdaqGS:CABA) 2026 Conference February 12, 2026 09:30 AM ET Company ParticipantsDavid Chang - CMOSteve Gavel - Chief Commercial OfficerSteven Nichtberger - President, CEO and Co-FounderYatin Suneja - Senior Managing DirectorConference Call ParticipantsDalma Caiati - Biotech AnalystYatin SunejaAll right, we will go ahead and get started. Good morning, everyone. Welcome to Guggenheim Emerging Outlook Biotech Summit 2026. My name is Yatin Suneja, one of the biotech analysts here at the firm, jo ...

FedEx (NYSE:FDX) 2026 Investor Day February 12, 2026 09:00 AM ET Company ParticipantsBrie Carere - EVP and Chief Customer OfficerJason Seidl - Managing DirectorJeni Hollander - VP of Investor RelationsJohn Smith - CFOJonathan Chappell - Senior Managing DirectorJordan Alliger - Managing DirectorKami Viswanathan - President, MESAKawal Preet - EVP, Planning, Engineering, and TransformationLuiz Vasconcelos - President of Latin America and CaribbeanMike Lenz - CFORajesh Subramaniam - CEORichard Smith - COO of In ...

Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Industry**: Precision Immunology, specifically focusing on psoriasis and other autoimmune diseases Key Points and Arguments Financial and Operational Highlights - Alumis has a strong balance sheet with over **$630 million** in cash, providing runway into the **fourth quarter of 2027** [91] - The company is preparing for a potential NDA filing in the **second half of 2023** [37] Clinical Development - **Envudeucitinib**: Phase 3 results in psoriasis show: - **PASI 75** at week 24 is in the **70s%** - **PASI 90** and **PASI 100** rates are approximately **65%** and **40%**, respectively [3] - Fast onset of action with separation of PASI scores observed as early as week 4 [3] - Safety profile consistent with Phase II data, with no new safety signals [3] Market Dynamics - The oral drug market for psoriasis is expected to expand significantly, as **75%** of psoriasis patients prefer oral medications over injectables or topicals [27] - Current market dynamics indicate that the patient share of oral drugs is higher than that of injectables [25] - Alumis aims to position itself strongly in the oral psoriasis market, particularly for patients with scalp involvement and significant itch [31] Competitive Landscape - The company acknowledges competition from other TYK2 inhibitors, including **Sotyktu** and **Zasocitinib** from Takeda [22] - Alumis believes its product has a competitive edge in terms of efficacy and quality of life improvements [18] Future Indications and Research - Alumis is exploring additional indications beyond psoriasis, including **Systemic Lupus Erythematosus (SLE)** and other autoimmune diseases [46] - The company is conducting a pivotal Phase IIb trial for SLE, with results expected in the **third quarter of 2023** [52] - The potential for **20+ indications** is being considered, with a focus on optimizing the psoriasis indication and exploring rheumatology-related conditions [70] Strategic Partnerships - While Alumis has the capability to launch its products independently, the company is open to partnerships to optimize its TYK2 franchise across multiple indications [41][43] Conclusion - Alumis is positioned for significant growth in the precision immunology space, with promising clinical data and a strong financial foundation. The company is strategically preparing for market entry while exploring a broad pipeline of indications.

Neurogene (NasdaqGM:NGNE) 2026 Conference February 12, 2026 09:00 AM ET Company ParticipantsChristine Mikail - President and CFOConference Call ParticipantsDebjit - Therapeutic AnalystDebjitMorning. Thank you for joining Guggenheim's 2026 Emerging Outlook Biotech Summit. I'm Debjit, one of the therapeutic analysts, and my next presenting company is Neurogene. From Neurogene, we have Christine Mikail, President and CFO.Christine MikailGood morning.DebjitThank you for joining us.Christine MikailGood morning, ...