Lineage Cell Therapeutics(LCTX) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were approximately $2.9 million, a net increase of$0.8 million compared to $2.1 million for the same period in 2023, primarily driven by increased collaboration revenue from Roche [43] - Total operating expenses for Q4 2024 were$7.8 million, a decrease of $0.4 million compared to$8.2 million for the same period in 2023 [44] - The net loss attributable to Lineage for Q4 2024 was $3.3 million or$0.02 per share, compared to a net loss of $4.8 million or$0.03 per share for the same period in 2023 [46] Business Line Data and Key Metrics Changes - R&D expenses for Q4 2024 were $3.4 million, a decrease of$0.5 million compared to 3.9 million for the same period in 2023, driven by a decrease in OPC1 program expenses [44] - G&A expenses for Q4 2024 were 4.4 million, consistent with expenses for the same period in 2023 [44] Market Data and Key Metrics Changes - The company reported a year-end cash position of $47.8 million as of December 31, 2024, which supports operations into Q1 2027 [40] - The November 2024 financing included a milestone warrant that could provide an additional$36 million if clinical milestones are achieved [41] Company Strategy and Development Direction - The company is focused on advancing its lead candidate OpRegen for dry AMD and is confident in its potential to drive positive clinical outcomes [52] - Investments in scalable GMP manufacturing are seen as critical for the success of allogeneic cell therapy products, with a goal to produce millions of doses [30][22] - The company is also advancing its OPC1 program for spinal cord injury, with plans for a larger clinical trial once necessary improvements are in place [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing GAlette Study for OpRegen, noting that independent evidence from other RPE transplant trials supports their belief in the treatment's efficacy [52] - The competitive landscape for RPE cell therapies is acknowledged, but management believes their partnerships with Roche and Genentech provide a significant advantage [60] Other Important Information - The company has continued to add value to its patent portfolio, with two additional OpRegen patents issued earlier in the year [38] - The company is working on a new delivery device for the OPC1 program, which is expected to enhance the administration process [34] Q&A Session Summary Question: What is the company doing to protect its market leadership in RPE cell placements? - Management emphasized the importance of having the right attributes for success, including strong manufacturing capabilities and partnerships with Genentech and Roche [60] Question: When will the updated three-year data for OpRegen be available? - Management indicated that inquiries regarding the timeline for the three-year data should be directed to Genentech, as they control the announcement schedule [64] Question: Can you describe any changes in logistics for getting patients to the surgical suite faster? - Management noted improvements in training and the development of an immediate use formulation to streamline the process [77] Question: Will the FDA require proof of device safety before fully enrolling in the DOSED study? - Management confirmed that there is a staging process for safety measures, starting with thoracic patients before moving to broader enrollment [83] Question: What are the plans for the resonance program given market uncertainty? - Management stated that while the resonance program remains important, they are being prudent with investment decisions in the current market environment [88]