Financial Data and Key Metrics Changes - The company has streamlined its pipeline to focus on SC451 for type 1 diabetes and SG293 for in vivo CAR-T therapy, indicating a strategic shift towards high-potential products [2][6] - The company aims to initiate a clinical study for SC451 next year, with an IND submission expected soon, reflecting confidence in its development timeline [21][56] Business Line Data and Key Metrics Changes - The type 1 diabetes program is positioned as a one-time curative therapy, with the goal of eliminating the need for insulin and immunosuppression for patients [6][56] - The in vivo CAR-T platform is being developed to target various blood cancers and autoimmune disorders, with a focus on cell specificity and safety [8][46] Market Data and Key Metrics Changes - There are approximately 10 million people with type 1 diabetes in the U.S., projected to grow to 15 million in 15 years, highlighting a significant market opportunity [4][23] - The company is aware of the competitive landscape in the CAR-T space but believes its differentiated approach could lead to a best-in-class product [9][45] Company Strategy and Development Direction - The primary focus remains on advancing the type 1 diabetes program while exploring partnerships to enhance financial resilience and success probability [29][31] - The company is also considering partnerships for the in vivo CAR-T platform to accelerate development and leverage external expertise [49][50] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the high unmet need in type 1 diabetes and the urgency to deliver a safe and effective therapy [44][56] - The company is optimistic about the regulatory path and believes it can navigate the complexities of manufacturing and clinical trials effectively [15][24] Other Important Information - The company has established a master cell bank for its gene-modified pluripotent stem cells, which is crucial for consistent product manufacturing [20][19] - Safety remains a primary concern, with management focusing on mitigating risks associated with severe hypoglycemia and potential tumor formation [14][18] Q&A Session Summary Question: What is the current status of the IND preparation for type 1 diabetes? - The company is engaged in dialogues with regulators and is working on completing the non-clinical toxicology package and GMP manufacturing to move forward with human testing [11][15] Question: How does the company plan to scale manufacturing for the type 1 diabetes therapy? - The company acknowledges the challenges of scaling but believes it can solve the manufacturing issues internally while also exploring partnerships for scientific support [33][29] Question: What are the key differentiators of the in vivo CAR-T platform? - The in vivo CAR-T platform utilizes virus-like particles for targeted delivery, which allows for cell-specific treatment without the complications associated with traditional methods [46][47] Question: How does the company view potential partnerships for its programs? - The company is open to partnerships that can enhance its financial stability and improve the probability of success, particularly for the in vivo CAR-T platform [29][49] Question: What are the anticipated timelines for clinical trials? - The company aims to initiate a phase 1 trial for the type 1 diabetes therapy next year, with data expected to emerge quickly thereafter [21][56]

Sana Biotechnology (NasdaqGS:SANA) FY 2025 Conference December 02, 2025 02:30 PM ET Company ParticipantsSteve Harr - CEOConference Call ParticipantsNone - Analyst 2None - AnalystNone - Analyst 1NoneYour biotech analyst here at Citi, and today it's my pleasure to be hosting Sana Biotechnology for a fireside chat at Citi's Global Healthcare Conference. I'm joined today by CEO Steve Harr. Steve, thank you so much for being here today.Steve HarrThank you for having me, Samantha.So why don't we just start off wi ...