Financial Data and Key Metrics Changes - The reported net loss for the full year 2025 was approximately $63.5 million, an increase of $45 million compared to 2024, primarily due to non-cash charges linked to rising stock prices and an asset impairment charge [31][39] - Total revenues for Q4 2025 were approximately $6.6 million, a net increase of $3.7 million compared to Q4 2024, driven by higher collaboration revenue from Roche and a new research collaboration with WDI [33] - Total operating expenses for the full year were $51.2 million, an increase of $20.2 million compared to 2024, mainly due to expenses related to the impairment of an intangible asset [37] Business Line Data and Key Metrics Changes - R&D expenses for Q4 2025 were $8.2 million, an increase of $4.8 million compared to Q4 2024, driven by costs associated with the OpRegen program and other preclinical programs [34] - G&A expenses for Q4 2025 were approximately $4.8 million, an increase of $0.4 million compared to the same period in 2024, primarily due to personnel costs [34] Market Data and Key Metrics Changes - The company has a cash position of $55.8 million as of December 31, 2025, which, along with proceeds from warrant exercises, is expected to support operations into Q2 2028 [32] - The company has approximately $32 million remaining in underlying warrants priced at $0.91 per share, which could be accelerated if Roche or Genentech advance OpRegen into clinical trials [33] Company Strategy and Development Direction - The company is focused on leveraging its AlloSCOPE platform to develop scalable, allogeneic cell therapies, aiming to address significant unmet medical needs in various conditions [10][21] - The company is expanding its pipeline to include new cell types, with a recent initiative in islet cell research aimed at addressing challenges in type 1 diabetes treatment [23][24] - The company emphasizes a development philosophy of "better from the beginning," ensuring that all programs have a clear path to commercial viability [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the OpRegen program to drive positive clinical outcomes in dry AMD, supported by the commitment of their partner Roche [41] - The company is optimistic about the advancements in its manufacturing capabilities and the potential for new partnerships to fund further development [41] Other Important Information - The company achieved its first milestone under the Roche collaboration, receiving a $5 million payment, which highlights its contributions to the program [15] - The company has successfully established a GMP master cell bank, demonstrating its capability for large-scale production of cell therapies [10][22] Q&A Session Summary Question: What is the long-term business development strategy regarding various cell types? - The company aims to generate a basket of assets using the AlloSCOPE platform, focusing on partnerships that can provide funding while retaining significant ownership of programs [44][46] Question: What are the rate-limiting steps for scaling the islet cell component? - The transition from half-liter to larger scales is uncertain, but the company believes that achieving control at smaller scales will facilitate scaling to larger bioreactors [47][49] Question: Can you provide updates on the OPC1 program and its first participant? - The OPC1 study is primarily a safety and performance study, with functional assessments occurring at 1-year intervals, and anecdotal reports suggest some improvement in the first chronic patient [61][62] Question: What are the plans for future data releases regarding OpRegen? - The company is excited about the continued benefits observed in patients and will defer to Roche regarding the release of four-year data [59][60]

Financial Data and Key Metrics Changes - The reported net loss for the full year 2025 is approximately $63.5 million, which is $45 million higher than in 2024, primarily due to non-cash charges linked to rising stock prices and an asset impairment charge [31][39] - Total revenues for the fourth quarter were approximately $6.6 million, a net increase of $3.7 million compared to the same period in 2024, driven by higher collaboration revenue from Roche [33] - Total operating expenses for the fourth quarter were $13.2 million, an increase of $5.2 million compared to the same period in 2024 [34] Business Line Data and Key Metrics Changes - R&D expenses for the fourth quarter were $8.2 million, an increase of $4.8 million compared to the same period in 2024, driven by costs associated with the OpRegen program and other preclinical programs [34][38] - G&A expenses for the fourth quarter were approximately $4.8 million, an increase of $0.4 million compared to the same period in 2024, primarily due to personnel costs [34] Market Data and Key Metrics Changes - The company has achieved a significant milestone under its Roche Genentech alliance, which has led to the opening of 10 new clinical sites for the GALE study in the past nine months, indicating positive forward progress [8][14] Company Strategy and Development Direction - The company is focused on delivering the next wave of innovation in cell therapy, particularly in areas outside of oncology, with a strong emphasis on the OpRegen program for dry AMD [5][7] - The AlloSCOPE platform is being utilized to scale pluripotent cells for various applications, aiming to address challenges in manufacturing and supply for cell therapies [10][22] - A new research initiative in type one diabetes has been announced, with the company achieving its initial go/no-go development milestone, indicating a commitment to solving supply issues in islet cell transplants [23][24] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the potential for OpRegen to drive positive clinical outcomes and is encouraged by the commitment from partners [41] - The company is optimistic about the scalability of its manufacturing processes and the potential to develop additional cell-based products [12][29] Other Important Information - The company has a cash position of $55.8 million as of December 31, 2025, which, along with recent warrant exercises, is expected to support operations into Q2 of 2028 [32] - The company has identified a significant opportunity in the islet cell transplant space, focusing on overcoming supply challenges to create a commercially viable product [24][28] Q&A Session Summary Question: Strategic business development with various cell types and AlloSCOPE - The company is leveraging its AlloSCOPE platform to generate a basket of assets and is mindful of cost of capital and risk in its business development strategy [44][46] Question: Rate-limiting steps for islet cell component scale-up - The transition from half-liter to larger scales presents challenges, but the company is optimistic about achieving control in lower mid-liter scales [47][49] Question: Timing of functional measures in OPC1 program - The OPC1 study is primarily a safety and performance study, with functional assessments occurring at one year rather than earlier [61][62] Question: Potential for four-year data on OpRegen - The company is excited about the durability of benefits seen in OpRegen but does not have information on the plans for four-year data from its partner [59] Question: Learnings from islet cell research and Roche partnership - The inverted risk approach is being applied to the islet cell initiative, with insights gained from various programs contributing to the development strategy [73][74]

Financial Data and Key Metrics Changes - The reported net loss for the full year 2025 is approximately $63.5 million, which is $45 million higher than in 2024, primarily due to non-cash charges linked to rising stock prices and an asset impairment charge [31][38]. - Total revenues for the fourth quarter were approximately $6.6 million, a net increase of $3.7 million compared to the same period in 2024, driven by higher collaboration revenue from Roche [33]. - Total operating expenses for the fourth quarter were $13.2 million, an increase of $5.2 million compared to the same period in 2024 [34]. Business Line Data and Key Metrics Changes - R&D expenses for the fourth quarter were $8.2 million, an increase of $4.8 million compared to the same period in 2024, primarily driven by costs associated with the OpRegen program [34]. - G&A expenses for the fourth quarter were approximately $4.8 million, an increase of $0.4 million compared to the same period in 2024, mainly due to personnel costs [34]. Market Data and Key Metrics Changes - The company has a cash position of $55.8 million as of December 31, 2025, which, along with proceeds from warrant exercises, is expected to support operations into Q2 of 2028 [32]. - The company has approximately $32 million remaining in underlying warrants priced at $0.91 per share, which could be accelerated if Roche or Genentech advance OpRegen into clinical trials [32]. Company Strategy and Development Direction - The company is focused on leveraging its AlloSCOPE platform to develop scalable, cost-effective cell therapies, with a particular emphasis on addressing the challenges of islet cell transplants for diabetes [24][25]. - The company aims to create a pipeline of differentiated cell-based products, applying lessons learned from existing programs to new initiatives [12][24]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the OpRegen program to drive positive clinical outcomes in dry AMD, supported by the commitment from Roche [40]. - The company is optimistic about the advancements in its manufacturing capabilities and the potential for new partnerships to fund ongoing development [40]. Other Important Information - The company achieved its first milestone under the Roche collaboration, receiving a $5 million payment, which highlights its contributions to the program [16]. - The company is expanding its research initiatives, including a new focus on type one diabetes, which addresses significant challenges in islet cell transplantation [24][25]. Q&A Session Summary Question: Strategic development of various cell types and AlloSCOPE - Management highlighted the importance of generating new assets that can be partnered early to optimize returns on invested capital [44][46]. Question: Rate-limiting steps in islet cell component scaling - Management noted that transitioning from half-liter to larger scales presents challenges, but they are optimistic about the control achieved at smaller scales [47][49]. Question: Visibility on Roche's GALE study delivery methods - Management provided insights into different delivery methods being tested by Roche, emphasizing the surgical optimization nature of the study [50][52]. Question: Timing of functional measures in the OPC1 program - Management clarified that the OPC1 study is primarily a safety and performance study, with functional assessments occurring at specific intervals [60][61]. Question: Capacity for OpRegen in potential phase 3 trials - Management did not provide specific capacity details but indicated that they are prepared for large-scale trials if necessary [78].

Financial Data and Key Metrics Changes - As of September 30, 2025, the overall cash position was $40.5 million, expected to support operations into Q2 2027, one quarter longer than previously guided [25] - Total revenues for Q3 2025 were $3.7 million, a decrease of approximately $0.1 million compared to $3.8 million for the same period in 2024, primarily driven by lower royalty revenue [26] - Operating expenses for Q3 2025 were $7.5 million, a decrease of $0.1 million compared to $7.6 million for the same period in 2024 [27] - The net loss was $29.8 million, or $0.13 per share, compared to a net loss of $3 million, or $0.02 per share, for the same period in 2024, primarily driven by non-cash fair value remeasurement of warrant liabilities [28] Business Line Data and Key Metrics Changes - The R&D expenses for Q3 2025 were $3.3 million, an increase of $0.1 million compared to $3.2 million for the same period in 2024, driven by costs associated with the OPC1 program and preclinical programs [27] - G&A expenses were $4.2 million, a decrease of $0.2 million compared to $4.4 million for the same period in 2024, primarily due to stock-based compensation expenses [27] Market Data and Key Metrics Changes - The company reported a significant potential cash source of approximately $37 million from warrant capital if Roche and Genentech advance OpRegen into a clinical trial [26] Company Strategy and Development Direction - The company aims to create a basket of cell therapy assets, some developed internally and others partnered, focusing on generating multiple product candidates from its platform [18] - The strategic goals include entering into deals to fund existing product candidates, creating new assets to attract external funding, and capitalizing on unique manufacturing capabilities [10][12][13] - The company is optimistic about the OpRegen program's potential to drive positive clinical outcomes and is encouraged by partner commitments [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for OpRegen to advance into a controlled clinical trial, supported by positive indicators from clinical site expansions and independent validations of clinical findings [10][30] - The company anticipates that the favorable biotech market will improve the cost of capital, allowing for judicious expansion [17] Other Important Information - The company has preserved the right to enter into future clinical or commercial deals with pharmaceutical partners, demonstrating flexibility in its strategic approach [11] - The company is awaiting a decision on a CIRM CLIN2 grant, which could provide up to approximately $7 million in non-dilutive funding [15] Q&A Session Summary Question: Considerations for the iLET Cell program and internal decision-making - Management indicated that the biological ceiling in differentiation protocols limits the opportunity for significant process changes, focusing on maximizing early steps to achieve necessary outputs [32][33] Question: Future partnerships and collaborations - Management highlighted the importance of finding suitable partners, emphasizing that partnerships should align with the company's capabilities and strategic goals [35][36] Question: Updates on the OPC-1 program and patient dosing - Management confirmed that multiple doses could be administered at different sites, and the safety profile for OPC1 remains strong [39][40] Question: Impact of potential CIRM grant funding - Management stated that while the grant would provide significant support, the program would continue regardless of the outcome [59] Question: Future business model considerations - Management expressed a preference to avoid becoming a fee-for-service company, focusing instead on partnerships that allow for significant ownership in the upside [46][47]