UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ________ Commission file number 001-12830 Lineage Cell Therapeutics, Inc. (Exact name of registrant as specified in its charter) California 94-3127919 (Stat ...

LINEAGE CELL THERAPEUTICS REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE CARLSBAD, CA – May 13, 2025 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical- stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions, today reported its first quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported year-end cash, cash equivalents, and marketable securities of $47.8 million, along with approximately $5.5 million in net proceeds from a financing event [40] - 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 [43] - The net loss attributable to the company for Q4 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, primarily driven by a decrease in OPC1 program expenses [44] - Total operating expenses for Q4 were $7.8 million, a decrease of $0.4 million compared to $8.2 million for the same period in 2023 [44] Market Data and Key Metrics Changes - The company noted an increase in OpRegen activity, with Roche and Genentech entering into an additional agreement to provide services for manufacturing and long-term follow-up of Phase 1/2a patients [11][12] - The ongoing GAlette Study has been enrolling for nearly two years, indicating a significant amount of data should be available for decision-making [10] Company Strategy and Development Direction - The company is focused on scalable GMP manufacturing, which is crucial for the success of allogeneic cell therapy products [22][30] - The company aims to establish a leading position in allogeneic process development and production, emphasizing the need for large-scale production capabilities [29][30] - The company is advancing its second clinical stage allogeneic program, OPC1, with plans for a larger clinical trial in spinal cord injury [31][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for OpRegen to drive positive clinical outcomes in dry AMD, supported by independent evidence from other RPE transplant trials [52] - The company is strategically balancing cost and investment while exploring other potential funding sources, including milestone payments and program grants [42][90] Other Important Information - The company has continued to add value to its patent portfolio, with two additional OpRegen patents issued earlier this year [38] - The company is preparing for a clinical study called the DOSED Study to test a novel delivery device for OPC1, which is expected to enhance the administration process [34][37] 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, highlighting the combination of Lineage's manufacturing, Genentech's product development, and Roche's commercialization capabilities as a competitive advantage [59][61] 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, reducing preparation time for cell administration [77][78] Question: Will the FDA require proof of device safety before fully enrolling across all planned sites for the DOSED study? - Management confirmed that there is a staging process, starting with a few 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][90]

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]

Financial Performance and Profitability - The company has incurred operating losses since inception and is uncertain when it will attain profitability[20] - The company anticipates needing to raise substantial additional capital to fund operations and product development, which may dilute existing shareholders[20] Product Development and Regulatory Risks - The company relies on third-party collaboration with F. Hoffmann-La Roche Ltd and Genentech, Inc. for the development and commercialization of RG6501 (OpRegen), which is critical for potential revenue[20] - The FDA granted orphan drug designation to OPC1 for the treatment of acute spinal cord injuries, but maintaining this designation is not guaranteed[21] - The company has limited experience in manufacturing its product candidates on a commercial scale, which poses risks for clinical development and regulatory approval[21] Market and Competitive Landscape - The commercial success of product candidates will depend on market acceptance by physicians, patients, and third-party payors[21] - The company faces significant competition, which may impact its ability to successfully commercialize its product candidates[21] - The company has no marketing and sales force or distribution capabilities currently in place[21] Stock Market and Geopolitical Risks - The market price of the company's common shares has been and may continue to be volatile[21] - The company is exposed to geopolitical risks that could disrupt operations, particularly at its facility in Jerusalem, Israel[20]

Financial Performance - Total revenues for Q4 2024 were approximately $2.9 million, a net increase of $0.8 million compared to $2.1 million in Q4 2023, primarily driven by collaboration revenue from Roche[13] - Total revenues for the full year 2024 were $9.5 million, a net increase of $0.6 million compared to $8.9 million in 2023, driven by collaboration revenue from Roche[19] - Total revenues for the year ended December 31, 2024, increased to $9,499,000, representing a 6.2% growth from $8,945,000 in 2023[34] - Collaboration revenues rose to $8,149,000, up from $7,588,000, indicating an 7.4% increase year-over-year[34] Operating Expenses - Total operating expenses for Q4 2024 were $7.8 million, a decrease of $0.4 million compared to $8.2 million in Q4 2023[14] - Total operating expenses for the full year 2024 were $31.0 million, a decrease of $2.7 million compared to $33.7 million in 2023[20] - Total operating expenses declined to $30,977,000, down 8.0% from $33,678,000 in the previous year[34] Research and Development - R&D expenses for Q4 2024 were $3.4 million, a decrease of $0.5 million compared to $3.9 million in Q4 2023[15] - R&D expenses for the full year 2024 were $12.5 million, a decrease of $3.2 million compared to $15.7 million in 2023[21] - Research and development expenses decreased to $12,472,000 from $15,705,000, a reduction of 20.0%[34] Net Loss - 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 Q4 2023[18] - Net loss attributable to Lineage for the full year 2024 was $18.6 million, or $0.09 per share, compared to a net loss of $21.5 million, or $0.12 per share, for 2023[25] - Net loss attributable to Lineage for 2024 was $18,609,000, compared to a net loss of $21,486,000 in 2023, reflecting a 13.1% improvement[34] Financial Position - Cash and cash equivalents increased to $45,789,000 as of December 31, 2024, up from $35,442,000, a growth of 29.0%[32] - Total assets grew to $113,218,000, compared to $101,019,000 in 2023, marking a 12.0% increase[32] - Total liabilities decreased to $36,206,000 from $38,996,000, a reduction of 4.6%[32] - Lineage's shareholders' equity increased to $78,381,000, up from $63,419,000, representing a 23.5% rise[32] - The company anticipates sufficient cash, cash equivalents, and marketable securities to support operations into the first quarter of 2027[29] Regulatory and Clinical Updates - OpRegen received RMAT designation from the FDA, and the ongoing GAlette Study is expanding to additional clinical sites[12] Financing Activities - Lineage completed two financings totaling $44 million in gross proceeds, with potential for an additional $36 million upon full cash exercise of clinical milestone-linked warrants[5]

Core Viewpoint - Lineage Cell (LCTX) has been upgraded to a Zacks Rank 1 (Strong Buy) due to an upward trend in earnings estimates, indicating a positive earnings outlook that may lead to increased stock price [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to significant buying or selling activity that affects stock prices [4]. Company Performance and Outlook - Rising earnings estimates for Lineage Cell suggest an improvement in the company's underlying business, which could attract investor interest and drive the stock price higher [5]. - The Zacks Consensus Estimate for Lineage Cell has increased by 15% over the past three months, with expectations of -$0.12 per share for the fiscal year ending December 2024, indicating no year-over-year change [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Lineage Cell's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Core Viewpoint - Lineage Cell (LCTX) has experienced significant selling pressure, resulting in a 43.1% decline over the past four weeks, but analysts anticipate better earnings than previously expected, indicating potential for recovery [1]. Group 1: Technical Analysis - The Relative Strength Index (RSI) for LCTX is currently at 28.88, suggesting that the stock is oversold and may be nearing a reversal point due to exhausted selling pressure [5]. - The stock's price has fluctuated, with a recent price of 0.86 as of November 15, 2024, and an RSI of 46.749, indicating a potential for price appreciation [6]. Group 2: Earnings Estimates - There has been a strong consensus among sell-side analysts to raise earnings estimates for LCTX, leading to a 28.9% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [7]. - LCTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the stock's potential for a turnaround [8].

Core Viewpoint - Lineage Cell (LCTX) has experienced a significant downtrend, with a 26.3% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to analysts' positive earnings outlook [1]. Group 1: Stock Performance - LCTX's stock has declined 26.3% in the last four weeks, indicating strong selling pressure [1]. - The Relative Strength Index (RSI) for LCTX is currently at 29.61, suggesting that the heavy selling may be exhausting itself, which could lead to a price rebound [4]. Group 2: Analyst Sentiment - There is a strong consensus among sell-side analysts regarding LCTX's ability to report better earnings than previously predicted, with a 12.8% increase in the consensus EPS estimate over the last 30 days [5]. - LCTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a favorable outlook for a potential turnaround [5].

Financial Data and Key Metrics Changes - The company reported cash, cash equivalents, and marketable securities of $32.7 million as of September 30, 2024, which is expected to support planned operations into Q1 2026, extending the runway by a quarter compared to the previous quarter [25][26] - Total revenues for Q3 2024 were $3.8 million, a net increase of $2.5 million compared to $1.2 million for the same period in 2023, primarily driven by increased collaboration revenue from Roche [27] - Operating expenses totaled $7.6 million, a decrease of $0.3 million from $7.9 million in Q3 2023, with R&D expenses at $3.2 million, down from $3.7 million, and G&A expenses at $4.4 million, up from $4 million [28][29] Business Line Data and Key Metrics Changes - The lead program, OpRegen, is currently in a Phase 2a study conducted by Genentech, with preliminary efficacy data expected to be collected [8][9] - The company is optimistic about OpRegen due to Roche's prioritization of the program and the recent RMAT designation, which may provide regulatory benefits [10][13] Market Data and Key Metrics Changes - The company highlighted the importance of commercially viable manufacturing in cell therapy, emphasizing the need for affordable and consistent production processes [15][16] - The competitive landscape for hearing loss treatments is noted, with the company positioning its ANP1 program as a potential solution that addresses a broader patient population compared to gene therapies [53] Company Strategy and Development Direction - The company aims to leverage its manufacturing expertise to establish a scalable process for allogeneic cell therapies, which is seen as a significant barrier to entry in the field [17][18] - Future plans include advancing multiple cell transplant programs in areas of high unmet need, with OpRegen data expected to validate the technology and business model [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing collaboration with Roche and Genentech, interpreting their actions as positive indicators for OpRegen's progress [31] - The company anticipates a clear path to initiating enrollment in the DOSED study for OPC1, with preliminary safety data expected to be available soon after commencement [32] Other Important Information - The company is preparing to submit a CIRM grant application for financial support of the DOSED study, with expectations that the grant portal will reopen in spring [21] - The ANP1 program has shown promising preclinical results, with successful administration and survival of cells in the inner ear [22] Q&A Session Summary Question: Timeline for OPC1 study - Management clarified that the amendment review by the FDA is expected to be completed in Q1 2025, with overlapping activities to prepare for the study while awaiting FDA feedback [35][39] Question: Coverage of cells in ANP1 program - Management noted that preclinical studies showed transplanted cells migrating within the cochlea, which may indicate effective coverage, although the exact percentage remains uncertain [41][43] Question: Activities under the services agreement with Genentech - Management indicated that continued patient follow-up for the Phase 1/2a trial for an additional five years suggests positive outcomes, reflecting supportive progress [45] Question: Future disclosures for OpRegen - Management stated that future disclosures will depend on Roche and Genentech's strategies, but they are encouraged by the regulatory precedents set for similar treatments [57][60] Question: CIRM grant and study initiation - Management confirmed that they will proceed with study preparations before the CIRM grant approval, ensuring careful cash management [69]