Denali Therapeutics (DNLI) 2025 Conference September 03, 2025 02:45 PM ET Company ParticipantsJosh Schimmer - Managing DirectorRyan Watts - Co-Founder, President, CEO & DirectorJosh SchimmerI think we're ready to get started. Welcome, everyone. I'm Josh Schimmer from the Cantor Biotech Equity Research team. Very pleased to introduce Ryan Watts, Chief Executive Officer of Denali Therapeutics. Ryan, welcome.Ryan WattsGreat to be here.Josh SchimmerYou've got a lot going on, but I think the most pressing update ...

Tango Therapeutics (TNGX) 2025 Conference September 03, 2025 02:45 PM ET Speaker0Okay. Good afternoon, everyone, and welcome back to the Cantor conference. We're on time here, so we're going to get started. My name is Eric Schmidt. I'm one of the analysts at the firm, and it is my pleasure to welcome Tango Therapeutics today.And Barbara Weber, the company's Chief Executive Officer, will be sharing this fireside chat with me. We also have in the audience Adam Christel, the company's President and Head of R a ...

Question-and-Answer SessionBut a lot going on at Neurocrine, Matt, can you give us a quick snapshot of the highlights of 2025 that we've passed or are yet to come.Matthew AbernethyChief Financial Officer Well, thanks, Josh, and we will be making forward-looking statements, so I'll get that out there. Yes, happy to be here. A lot going on for Neurocrine. And hopefully, this is Eric. We have an open chair here. A lot going on for Neurocrine. INGREZZA is going quite well, $2.5 billion in sales is what we expec ...

Financial Data and Key Metrics Changes - The company expects revenues for the product Almighta to be between $94 million and $98 million for the year, indicating year-over-year growth [62] - The peak potential for the XaStorY opportunity is projected to exceed $1 billion, suggesting a clear path to profitability over the next five years [63] Business Line Data and Key Metrics Changes - The total addressable market (TAM) for low-grade intermediate risk non-muscle invasive bladder cancer is over $5 billion, significantly larger than the $700 million TAM for low-grade upper tract urothelial carcinoma [14] - The company reported that 80% of patients achieved a complete response without undergoing TURBT, with 72% remaining recurrence-free at 24 months [23] Market Data and Key Metrics Changes - The company has expanded its sales force to cover 8,500 physicians, targeting 85% to 90% of the market opportunity, with an initial focus on 2,000 physicians more inclined to adopt new products [36][38] - The company anticipates that 70% of utilization will eventually occur in community settings, despite initial usage being more concentrated in hospital settings [36] Company Strategy and Development Direction - The company is focused on lifecycle management, with plans to transition to UGN-one 103, which has a patent extension until December 2041, and aims to target high-grade disease [71][72] - The company is also exploring collaborations to enhance the efficacy of other drugs using its gel technology, indicating a strategy for broader market penetration [88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming permanent J code expected in January, which is anticipated to accelerate adoption and utilization of their products [44][56] - The management team noted that logistical and reimbursement barriers, rather than clinical concerns, are the primary challenges facing adoption in the urology market [46] Other Important Information - The company is conducting a study on UGN-one 103, with expectations for similar efficacy data to the existing product, and plans to file for approval in 2026 [70][81] - The company is also developing UGN-five 01, an oncolytic virus, with plans to expand its application beyond bladder cancer in the future [89] Q&A Session Summary Question: What is the importance of the J code? - The J code is crucial for urologists as it allows for electronic reimbursement processes, reducing administrative burdens and increasing confidence in product adoption [39][42] Question: How does the company plan to reach community practices? - The company has expanded its sales force and is focusing on a subset of physicians more likely to adopt new products, with a strategy to increase community practice engagement over time [36][38] Question: What is the expectation for breaking even based on the story? - The company has not provided specific guidance on the timeline to breakeven but believes its current cash runway supports a path to profitability given the size of the XaStorY opportunity [62][63]

Financial Data and Key Metrics Changes - The company reported a median overall survival of over 21 months in head and neck cancer, showing a significant improvement over the current standard of care, which is approximately 12.3 months with pembro monotherapy [5][13]. - The confirmed response rate for the company's treatment was reported at 54%, indicating a tripling of the responder population compared to pembro monotherapy [12]. Business Line Data and Key Metrics Changes - The lead asset is an EGFR TGF beta bifunctional molecule, which has been in clinical development since 2020 across various tumor types [3]. - The company is currently enrolling patients in the FORTIFY HN-one trial, which is a pivotal trial for the treatment in head and neck cancer [6]. Market Data and Key Metrics Changes - HPV negative patients account for about 85% of overall head and neck cancer cases in the recurrent and metastatic setting, indicating a substantial target market for the company's treatment [35]. - The total annual incidence of head and neck cancer in the U.S. is around 57,000, with recurrent metastatic cases accounting for approximately 23,000 patients [42]. Company Strategy and Development Direction - The company aims to optimize dosing in its pivotal trial by evaluating two different doses (750 mg and 1500 mg) in combination with pembro, with plans to select the most effective dose based on initial patient data [17][34]. - There are ongoing plans to expand into the locally advanced setting, where the company believes its treatment could show differential effects due to the TGF beta component [40][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the treatment's ability to mitigate acquired resistance pathways associated with EGFR monoclonal antibodies by combining it with TGF beta [10]. - The company has sufficient cash reserves, with $437 million on hand, providing a runway to fund operations through 2029, allowing it to complete its pivotal trial [61]. Other Important Information - The company is developing a PCR HPV test as a companion diagnostic to improve sensitivity over traditional testing methods [38]. - The company is exploring the potential of its treatment in colorectal cancer, particularly in heavily pretreated populations, with preliminary data expected in 2026 [56]. Q&A Session Summary Question: What is the relative contribution of the two different targets in the mechanism? - The combination of EGFR and TGF beta is designed to mitigate acquired resistance and enhance efficacy in head and neck cancer treatment [10]. Question: What safety events are being observed? - The most common adverse events include acneiform rash and anemia, with manageable side effects and no treatment discontinuations reported [14][15]. Question: How is the pivotal study designed? - The pivotal study includes a dose optimization portion, where initial data from 10 to 20 patients per group will inform the selection of the most effective dose [17]. Question: What is the expected market opportunity for the treatment? - The recurrent metastatic head and neck cancer market is significant, with a large percentage of patients being HPV negative, which the company is targeting [35][42]. Question: What is the company's cash position and funding for future trials? - The company has raised $362 million at its IPO and has $437 million in cash, providing a runway to fund its current pivotal trial through 2029 [61].

Financial Data and Key Metrics Changes - The company is on track with the IND filing in the second half of the year, indicating progress in its clinical pipeline [16] - The company has guided that it is fully funded for three INDs in three years, with cash expected to last into early 2027 [42][43] Business Line Data and Key Metrics Changes - Sutro Biopharma is transitioning from a phase III asset to an early-stage clinical pipeline, focusing on differentiating its early pipeline to drive shareholder value [3] - The STRO-four program has shown a 50-fold increase in exposure with a high dose of 50 mg/kg in non-human primate models, significantly higher than the approved tissue factor program [10][19] Market Data and Key Metrics Changes - The company sees significant clinical opportunities in multiple tumors expressing tissue factor, including lung, head and neck, pancreatic, and esophageal cancers [12][34] - Sutro Biopharma's STRO-six program targets integrin beta-six, a validated target in lung cancer, with competition primarily from Pfizer's program [27][28] Company Strategy and Development Direction - The company aims to redefine the tissue factor program and expand its applications beyond cervical cancer [12] - Sutro is focusing on dual payload strategies to overcome resistance in ADCs, positioning itself as a leader in this emerging area [35][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiation of their ADC platform, particularly in safety and efficacy compared to existing therapies [19][22] - The company plans to share interim top-line results as soon as possible to maintain transparency with investors [20] Other Important Information - Sutro Biopharma has a collaboration with Astellas that is expected to yield milestone payments in the next nine to twelve months [44] - An R&D day is planned for later this year to provide more specifics on the tissue factor program and its development strategy [47][48] Q&A Session Summary Question: What is the company's strategy regarding partnerships? - The company is open to discussions about partnerships but aims to retain value for its programs while being flexible in exploring opportunities [29] Question: How is the company addressing funding needs for clinical trials? - The company is fully funded for its INDs and is looking at operational efficiencies to extend its runway [43] Question: What milestones should investors expect in the near future? - Investors can expect interim results from the STRO-four program and updates on the dosing strategy during the upcoming R&D day [46][48]

Summary of Organogenesis Holdings Conference Call Company Overview - **Company**: Organogenesis Holdings (ORGO) - **Industry**: Biotechnology, specifically in wound care and surgical products - **Background**: Established in 1985 as a spin-off from MIT, with a focus on innovative wound care solutions. The company has evolved from a single product to a comprehensive portfolio addressing various wound care needs [1][2] Key Points Discussed Industry Changes and Regulatory Environment - **Physician Fee Schedule (PFS)**: A significant change in the reimbursement model is anticipated, which is viewed as a watershed moment for the industry. The proposed rule aims to standardize reimbursement across various care settings, enhancing patient access to products [4][5] - **Market Expansion**: The market volume has doubled from 2021 to 2024, indicating growth despite a tenfold increase in costs. This shift is expected to stabilize the market and reduce financial incentives based on product choice, focusing instead on clinical efficacy [6][7][8] Product Portfolio and Growth Areas - **Current Products**: The company highlighted the importance of PMA products, including the relaunch of Dermograph and the burn portfolio featuring Transite. These products are expected to gain value with the new reimbursement model [9][10] - **New Product Launches**: Two new dehydrated products were launched, which are gaining traction and are expected to contribute to stronger performance in the second half of the year [14][15] - **Surgical and Sports Medicine Growth**: The surgical segment grew by 16% in Q2 and 13% for the half-year, driven by the PuraPly brand and the introduction of Cygnus Matrix [16][17] Future Outlook and Strategic Initiatives - **Renew Product Update**: The second phase three trial has been completed, with top-line data expected soon. If successful, a BLA application will be filed by the end of the year, with commercialization anticipated in 2027 [20][21] - **Sales Strategy**: The company plans to build a direct sales force of 150 to 200 reps for the new product, focusing on the pain management market, particularly targeting the hyaluronic acid segment [22][23] Financial Health - **Balance Sheet**: The company reported a strong balance sheet with approximately $70 million in cash, positioning it well for future growth and profitability [25] Market Positioning - **Competitive Landscape**: The company aims to differentiate itself by offering a broad portfolio that addresses all stages of wound healing, utilizing both dehydrated and living technologies [26][27] Research and Development - **RCT Progress**: Ongoing research is expected to yield a publication by November 1, with plans to have PuraPly available on the LCD by January 1 [29] Additional Insights - **Hybrid Sales Model**: The introduction of hybrid representatives who can operate in both operating rooms and advanced wound care centers is seen as a valuable strategy to enhance customer relationships and sales [19] This summary encapsulates the key discussions and insights from the Organogenesis Holdings conference call, highlighting the company's strategic direction, product innovations, and market dynamics.

Invivyd (IVVD) 2025 Conference September 03, 2025 02:10 PM ET Speaker0All right, I think we're ready to get started. Welcome, everyone. I'm Josh Schumer from the Cantor Biotech Equity Research team. Very pleased to introduce from Invivid, Mark Elliott, Chairman of the Board. Mark, give us a very quick snapshot of where Invivid is in prosecuting its portfolio of COVID monoclonal antibodies.Speaker1Sure. Thanks for having us. So, Invivid is a commercial stage company right now. We have an authorized medicine ...

Compass Therapeutics (CMPX) 2025 Conference September 03, 2025 02:10 PM ET Speaker0Great. Thank you everyone for joining us this afternoon.My name is Daniel Bronder. I'm a biotech associate here at Cantor, it is our pleasure to welcome Thomas Schutz, co founder and CEO of Compass Therapeutics. For those in the audience who are less familiar with the Compass story, can you level set and highlight some recent key achievements and the milestones that we should be looking out for over the next six to twelve mon ...

Alnylam Pharmaceuticals (ALNY) Conference September 03, 2025 01:45 PM ET Company ParticipantsJeff Poulton - CFOKevin Fitzgerald - Chief Scientific OfficerConference Call ParticipantsDavid Lebowitz - Senior Research Analyst - BiotechnologyDavid LebowitzThank you all. Welcome all again to the, twenty twenty five Citi Biopharma Conference in Boston. Next on the docket, we have Alnylam. If you could, I guess, introduce us and kind of tell us a little bit about the company for no one who's for people who haven't ...