Company Overview - Lineage Cell Therapeutics Inc. (NYSE:LCTX) is recognized as one of the top penny stocks with potential for significant returns [1] - The company is focused on developing cell replacement therapies for critical illnesses, with a diverse portfolio of products at various stages of clinical development [4] Recent Developments - On March 24, Lineage announced the launch of COR1, a preclinical cell therapy program targeting corneal endothelial disease, utilizing its proprietary AlloSCOPE platform [2] - The management views the COR1 program as a natural extension of its platform, aimed at addressing the global shortage of donor corneal cells and expanding its presence in ophthalmology [2] - CEO Brian Culley highlighted the advancements in the AlloSCOPE "5D" manufacturing process, which could help reduce production costs through large-scale production [2] Financial Performance - For the fourth quarter, Lineage reported revenue of $6.6 million, a significant increase from $2.9 million in the previous year [3] - CEO Culley described 2025 as a productive year for the company, emphasizing its mission to pioneer allogeneic cell therapy outside oncology [3]

From promise to people. Our mission is to pioneer a new branch of medicine based on the directed differentiation and transplant of allogeneic cells to patients CORPORATE OVERVIEW MARCH 24, 2026 NYSE AMERICAN: LCTX lineagecell.com Forward-Looking Statements Cell manufacturing and transplant technology 7 Cell types in development Highly Differentiated Allogeneic product candidates 2 Active clinical trials >200 Cell types as potential targets This presentation is for informational purposes only and is not an o ...

Core Insights - Lineage Cell Therapeutics is advancing its OpRegen program for dry age-related macular degeneration (AMD) and has seen significant partner activity, including Roche and Genentech opening 10 new clinical sites for the GALE Phase 2a study, now totaling 17 sites, which is viewed as a positive indicator for future trials [1][5][6] - The company reported a cash position of $55.8 million, with expectations to fund operations into Q2 2028, bolstered by recent warrant exercises and milestone payments [5][19] - Lineage is focusing on scalable production of undifferentiated cells through its AlloSCOPE platform, which aims to address manufacturing challenges in cell therapy [4][7][17] Financial Performance - For Q4, Lineage reported total revenue of approximately $6.6 million and a net income of $0.9 million, compared to a net loss of $3.3 million in the same period last year [20] - The full-year revenue was reported at $14.6 million, with a net loss of $63.5 million, reflecting an increase in losses primarily due to non-cash charges [21][22] - The company’s cash runway has been extended due to a $21 million ATM block trade and other financial maneuvers, allowing for continued operational funding [19][22] Program Updates - The OpRegen program is highlighted as a critical case study, with analyses suggesting that a single dose could provide visual improvement for at least three years [2][5] - Lineage is also progressing with its OPC1 program for spinal cord injury, currently enrolling patients in a safety trial, and has treated its first chronic SCI patient [12][13] - The Resonance program for hearing loss has secured funding partnerships, achieving its 2025 objective and demonstrating the potential for new intellectual property [14][15] Manufacturing Strategy - The AlloSCOPE platform is central to Lineage's manufacturing strategy, focusing on scalable and consistent production of pluripotent cells [4][7] - The company has established GMP master and working cell banks, aiming to produce clinical-grade products for trials [7][8] - Lineage is addressing the supply and scale issues in islet cell transplants, with a focus on generating billions of undifferentiated pluripotent stem cells [11][17]

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].

Core Insights - Lineage Cell Therapeutics has received a novel induced pluripotent stem cell (iPSC) line with hypoimmunity edits from Factor Bioscience, marking a significant milestone in their strategic collaboration [1][2] - The new iPSC line is designed to support non-immune privileged and/or non-HLA matched indications, with specific genetic edits aimed at reducing immunogenicity and enhancing clinical differentiation [1][2] - Lineage plans to leverage this new technology to broaden its cell therapy platform and develop novel product candidates, particularly in the field of retinal cell transplantation [2] Company Overview - Lineage Cell Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic cell therapies for serious medical conditions, utilizing a proprietary cell-based technology platform [3][4] - The company's pipeline includes several therapies, such as OpRegen for age-related macular degeneration, OPC1 for spinal cord injuries, and others targeting auditory neuropathy and Type 1 Diabetes [4] Collaboration Details - The partnership with Factor Bioscience aims to combine manufacturing capabilities with advanced cell engineering technologies to create superior product candidates [2] - The agreement allows Lineage to obtain an exclusive license for the novel gene-edited cell line for preclinical, clinical, and commercial purposes, contingent on further performance criteria and testing outcomes [1][2]

Core Insights - The autologous cell therapy market has exceeded $10.1 billion in 2025, driven by advancements in biotechnology aimed at treating age-related diseases and metabolic disorders [1] - The global cell therapy market is projected to reach $60.79 billion by 2033, with a compound annual growth rate of 14.51%, fueled by applications in oncology, metabolic diseases, and regenerative medicine [2] Company Developments - Avant Technologies, Inc. has secured an exclusive worldwide license through its joint venture Klothonova, positioning itself in the anti-aging therapeutics market [3][4] - Klothonova has initiated preparations for GMP-manufacturing of encapsulated Klotho-overexpressing cell lines, with plans to advance into IND-enabling studies [5] - The scientific basis for Klotho therapies indicates that higher Klotho levels correlate with a 30% increase in lifespan, presenting significant therapeutic opportunities [6] Strategic Partnerships - Avant Technologies is collaborating with SGAustria Pte. Ltd. through Insulinova, Inc. to innovate diabetes treatment using stem cell and encapsulation technologies [7] - The partnership aims to convert stem cells into insulin-producing cells, targeting type 1 and some insulin-dependent type 2 diabetes patients globally [7][8] Market Opportunities - The global Alzheimer's market is expected to reach $32.8 billion by 2033, while the cell-based therapy market could reach $44 billion, addressing urgent health crises [9] - Diabetes affects over 500 million people worldwide, highlighting the need for innovative therapeutic solutions [9] Competitor Updates - Sana Biotechnology is refocusing on its type 1 diabetes program SC451 and next-generation in vivo CAR T candidate SG293, following positive regulatory interactions [11][12] - Lineage Cell Therapeutics has completed cGMP production runs for its therapies and is advancing a new initiative focused on islet cell transplants for type 1 diabetes [13][14] - CRISPR Therapeutics reported promising Phase 1 clinical data for CTX310, demonstrating significant reductions in triglycerides and LDL levels [15][16]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash position was $42.3 million, expected to support operations into 2027 [20] - Total revenues for Q2 2025 were $2.8 million, a net increase of $1.4 million compared to $1.4 million for the same period in 2024, primarily driven by collaboration revenue from the Roche agreement [22] - Operating expenses were $22.5 million, an increase of $5.2 million compared to $7.3 million for the same period in 2024, largely due to a non-cash impairment expense of $14.8 million related to the VAC platform [22][24] - The net loss was $30.5 million or $0.13 per share, compared to a net loss of $5.8 million or $0.03 per share for the same period in 2024 [24] Business Line Data and Key Metrics Changes - The OpRegen program showed a mean gain of vision of nine letters in treated patients over three years, contrasting with an 11-letter loss in untreated eyes, indicating a significant treatment effect [6][7] - The OPC1 program has been administered to 31 individuals with acute severe spinal cord injuries, with promising long-term safety and efficacy data [15] Market Data and Key Metrics Changes - The company noted that there are now four independent groups reporting vision gains from RPE cell transplants, validating the potential of the OpRegen program [8] - The ongoing phase 2a clinical trial run by Genentech is expected to provide insights into surgical procedures and delivery methods, enhancing the company's competitive position [9] Company Strategy and Development Direction - The company is exploring new therapeutic areas to leverage its directed differentiation expertise and recent manufacturing accomplishments, aiming to diversify its pipeline beyond OpRegen [10][11] - The strategy includes entering into deals that fund existing product candidates, creating new assets, and obtaining grants to reduce dependency on equity capital markets [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of OpRegen to drive positive clinical outcomes and highlighted the importance of independent evidence from other RPE cell transplant trials [26] - The company is focused on ensuring that OPC1 has the necessary attributes for later-stage clinical testing and is optimistic about the ongoing developments [26] Other Important Information - The company has a GMP banking and production platform capable of generating millions of doses of product candidates, which is a significant competitive advantage [8] - The company is actively pursuing non-dilutive funding sources, including milestone payments and program grants [21] Q&A Session Summary Question: Context on the dose study and patient enrollment - Management indicated that predicting enrollment is challenging due to limited experience with chronic patients, but they are optimistic about patient interest in the trial [31][32] Question: Enrollment in the Phase 2a study - Management refrained from commenting on enrollment specifics but emphasized ongoing efforts to ensure effective patient recruitment [38] Question: Manufacturing progress and potential partnerships - Management noted that manufacturing is a core focus for 2025 and they expect to see valuable outcomes from their strategies by year-end [38] Question: Preclinical data from the hearing loss program - Management confirmed that preclinical work is ongoing, but no specific timeline for reportable data was provided [51] Question: Expansion of sites for the dose study - Management stated that they are focusing on experienced sites and have already initiated the process for a second site [68] Question: Follow-up duration for patients - Management confirmed that they plan to follow patients for at least ten years, emphasizing the importance of long-term data collection [71] Question: Differences in benefit thresholds for chronic vs. subacute patients - Management acknowledged that chronic patients may have different clinical meaningfulness thresholds compared to subacute patients, which will be considered in data analysis [75]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash position was $47.9 million, expected to support operations into Q1 2027 [24] - Total revenues for Q1 2025 were $1.5 million, a net increase of $0.1 million compared to $1.4 million for the same period in 2024, primarily driven by collaboration revenue from Roche [25] - Operating expenses for Q1 2025 were $8 million, a decrease of $0.1 million compared to $8.1 million in Q1 2024 [26] - The net loss for Q1 2025 was $4.1 million or $0.02 per share, compared to a net loss of $6.5 million or $0.04 per share for the same period in 2024 [26] Business Line Data and Key Metrics Changes - OpRegen is currently in a Phase 2a study called the GALET study, which is exploring surgical delivery parameters to optimize the risk-benefit profile [8] - The OPC1 program has been tested in 30 individuals with severe spinal cord injuries, with promising long-term safety and efficacy data [18] Market Data and Key Metrics Changes - The company is encouraged by recent independent validation from competing RPE companies, indicating that RPE transplants can drive clinical outcomes beyond currently approved therapies [13] - Genentech plans to report three-year data from the Phase 1/2a trial of OpRegen, which is expected to provide additional support for the treatment's efficacy [10] Company Strategy and Development Direction - The company aims to capitalize on its investments in cell manufacturing and expand its capabilities through partnerships beyond OpRegen and OPC1 [29] - The manufacturing platform is seen as a competitive advantage, allowing for low-cost production of allogeneic therapies [15] Management's Comments on Operating Environment and Future Outlook - Management remains confident in OpRegen's potential to drive positive clinical outcomes in dry AMD and is encouraged by partners' commitment to the program [28] - The company is optimistic about the future of cell and gene therapies, especially in light of supportive regulatory comments from the new CBER director [84] Other Important Information - The company has completed GMP production runs of a product candidate from a single pluripotent cell line, marking a significant achievement in manufacturing capabilities [16] - The company is collaborating with the Christopher and Dana Reeve Foundation for the third annual SCI Investor Symposium, which will be held virtually [22] Q&A Session Summary Question: Can you compare your manufacturing capabilities to peers? - The CEO noted that direct comparisons are challenging as many peers do not disclose sufficient details about their capabilities, but emphasized that the company's manufacturing system is highly differentiated [33][36] Question: What potential tariff impacts might you expect with your manufacturing site in Israel? - The CFO indicated that they do not expect tariff impacts and have measures in place to mitigate production issues by purchasing materials in advance [38] Question: Can you elaborate on potential partnership opportunities related to your new manufacturing capabilities? - The CEO mentioned that each opportunity will be specific, and the company is not aiming to become a contract manufacturer but is open to collaborations that could involve success payments and ownership in assets [45][46] Question: When might we expect data from the OPC1 program? - The CEO stated that initial safety data from the dose study would be available within 30 days, while functional assessments would take longer, typically 6 to 12 months [54][55] Question: What does a successful delivery outcome look like for the OPC1 dose study? - The CEO explained that success will largely depend on the usability of the new delivery device and the absence of unexpected complications, with a focus on enabling a better surgical delivery method [62] Question: Can you comment on the design of the spinal cord injury trial? - The CEO provided details on the staggered enrollment process, indicating that the first three patients will be thoracic injury patients, followed by cervical patients, before moving to open enrollment [86]