Group 1 - Lineage Cell (LCTX) reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.04, representing an earnings surprise of 50% [1] - The company posted revenues of $3.78 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 222.99%, compared to $1.25 million in the same quarter last year [2] - Over the last four quarters, Lineage Cell has surpassed consensus EPS estimates three times and topped revenue estimates two times [2] Group 2 - The stock has underperformed, losing about 16.2% since the beginning of the year, while the S&P 500 gained 25.5% [3] - The current consensus EPS estimate for the upcoming quarter is $0.02 on revenues of $2.02 million, and for the current fiscal year, it is -$0.15 on revenues of $6.06 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 29% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

Financial Performance - Total revenues for the three months ended September 30, 2024, were $3,779,000, a 203% increase compared to $1,246,000 for the same period in 2023[13]. - Collaboration revenues increased to $3,386,000 for the three months ended September 30, 2024, compared to $957,000 in the same period of 2023, representing a 254% growth[13]. - The net loss attributable to Lineage for the three months ended September 30, 2024, was $3,034,000, an improvement from a net loss of $7,110,000 in the same period of 2023[13]. - Total operating expenses for the three months ended September 30, 2024, were $7,619,000, a slight decrease from $7,951,000 in the same period of 2023[13]. - Comprehensive loss attributable to Lineage common shareholders for the three months ended September 30, 2024, was $3,454,000, compared to $6,583,000 in the same period in 2023[14]. - The net loss for the nine months ended September 30, 2024, was $15,336,000, compared to a net loss of $16,711,000 for the same period in 2023, indicating a reduction in losses of about 8.3%[19]. - Total revenue for the nine months ended September 30, 2024, decreased by $226,000, or 3%, to $6.6 million compared to $6.9 million for the same period in 2023[141]. Cash and Liquidity - Cash and cash equivalents decreased to $27,750,000 as of September 30, 2024, down from $35,442,000 as of December 31, 2023[11]. - The total cash, cash equivalents, and restricted cash at the end of the period was $28,306,000, down from $35,992,000 at the beginning of the period, reflecting a decrease of approximately 21%[19]. - As of September 30, 2024, the company had $32.7 million in cash, cash equivalents, and marketable securities, indicating sufficient liquidity for planned operations for at least the next twelve months[34]. - The company raised approximately $13.8 million in net proceeds through a registered direct offering of common shares in February 2024[158]. - Cash provided by financing activities for the nine months ended September 30, 2024 was $14.1 million, primarily from the sale of common shares[165]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $3,171,000, compared to $3,741,000 in the same period of 2023[13]. - Total research and development expenses for the three months ended September 30, 2024, were $3.171 million, a decrease of 15% compared to $3.741 million in the same period of 2023[146]. - For the nine months ended September 30, 2024, total research and development expenses were $9.049 million, down 23% from $11.799 million in the prior year[147]. - The OpRegen program accounted for 55% of total research and development expenses for the three months ended September 30, 2024, compared to 34% in the same period of 2023[149]. Shareholder Equity - The company's shareholders' equity increased to $64,794,000 as of September 30, 2024, up from $62,023,000 as of December 31, 2023[12]. - Total shareholder equity increased to $64,794,000 as of September 30, 2024, up from $62,023,000 at the end of 2023, reflecting a growth of approximately 4.5%[17]. - The weighted-average common shares used to compute basic and diluted net loss per common share were 188,835 for the three months ended September 30, 2024, compared to 174,868 for the same period in 2023[13]. - As of September 30, 2024, Lineage had 188,837,375 common shares issued and outstanding, an increase from 174,986,671 shares as of December 31, 2023[71]. Legal and Regulatory Matters - Lineage incurred approximately $626,000 in legal expenses related to shareholder class action lawsuits from inception through July 2023[68]. - In February 2023, Lineage and certain insurers paid $10.65 million to settle a class action lawsuit related to the Asterias Merger, with Lineage contributing approximately $3.53 million[119]. - The company is subject to legal proceedings, but management believes that the outcomes will not materially harm its financial position[116]. Future Outlook and Funding - The company plans to apply for additional funding from the California Institute for Regenerative Medicine for the continued clinical development of OPC1, which has already received a $14.3 million grant[23]. - Future funding requirements indicate that the company expects to continue incurring losses for several years, necessitating significant additional capital[172]. - The company may seek additional capital through equity offerings, debt financings, or strategic alliances, but there is no assurance that adequate capital will be available on favorable terms[173]. Collaboration and Agreements - The company received a $50 million upfront payment from Roche in January 2022 and is eligible for up to $620 million in milestone payments related to the OpRegen program[22]. - Under the Roche Agreement, Lineage received a $50.0 million upfront payment and is eligible for up to $620.0 million in milestone payments, along with tiered royalties on net sales of OpRegen[102]. - Lineage has obligations under the Roche Agreement, which includes a maximum of 21.5% of milestone payments and up to 50% of royalty payments, capped at 5% of net sales of products[111]. Market and Operational Impact - The ongoing Israel-Hamas war has not materially impacted the company's operations as of the report date, although there are safety concerns and potential disruptions[136][137]. - The company has business continuity plans in place to address potential medium- or long-term disruptions due to the ongoing conflict[138].

Financial Performance - Total revenues for Q3 2024 were $3.8 million, a net increase of approximately $2.5 million compared to $1.2 million for the same period in 2023, primarily driven by collaboration revenue from Roche[6] - Total revenues for the three months ended September 30, 2024, were $3,779,000, a 203% increase compared to $1,246,000 for the same period in 2023[21] - Collaboration revenues increased to $3,386,000 for the three months ended September 30, 2024, compared to $957,000 in the same period of 2023, representing a 254% growth[21] - Net loss attributable to Lineage for Q3 2024 was $3.0 million, or $0.02 per share, compared to a net loss of $7.1 million, or $0.04 per share, for the same period in 2023[11] - Net loss attributable to Lineage for the nine months ended September 30, 2024, was $15,336,000, an improvement from a net loss of $16,711,000 for the same period in 2023[22] Operating Expenses - Total operating expenses for Q3 2024 were $7.6 million, a decrease of $0.3 million compared to $7.9 million for the same period in 2023[7] - Total operating expenses for the three months ended September 30, 2024, were $7,619,000, a decrease of 4% from $7,951,000 in the same period of 2023[21] - R&D expenses for Q3 2024 were $3.2 million, a net decrease of approximately $0.6 million compared to $3.7 million for the same period in 2023[8] - Research and development expenses for the three months ended September 30, 2024, were $3,171,000, a decrease from $3,741,000 in the same period of 2023[21] - G&A expenses for Q3 2024 were $4.4 million, a net increase of $0.4 million compared to $4.0 million for the same period in 2023[9] Cash and Equity - Cash, cash equivalents, and marketable securities totaled $32.7 million as of September 30, 2024, expected to support operations into Q1 2026[6] - The company had cash and cash equivalents of $27,750,000 at the end of the period, down from $31,474,000 at the end of the previous year[22] - Cash used in operating activities for the nine months ended September 30, 2024, was $16,746,000, a reduction from $22,547,000 in the same period of 2023[22] - The company reported a net cash provided by financing activities of $14,123,000 for the nine months ended September 30, 2024, compared to $6,436,000 in the same period of 2023[22] - As of September 30, 2024, total shareholders' equity was $64,794,000, an increase from $62,023,000 as of December 31, 2023[20] Regulatory and Market Recognition - OpRegen received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for the treatment of geographic atrophy secondary to age-related macular degeneration[3] - Lineage was added to the 2024 Russell 3000 Index, indicating positive market recognition[1] Research and Development - ReSonance (ANP1) preclinical results were presented at the 59th Annual Inner Ear Biology Workshop, showcasing its potential for treating sensorineural hearing loss[4] - Loss from operations for Q3 2024 was $3.8 million, a decrease of $2.9 million compared to $6.7 million for the same period in 2023[9] - The weighted-average common shares used to compute basic and diluted net loss per common share increased to 188,835 for the three months ended September 30, 2024, from 174,868 in the same period of 2023[21]

Lineage Cell (LCTX) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. Since a changi ...

Lineage Cell (LCTX) came out with a quarterly loss of $0.03 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to loss of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 25%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.04 per share when it actually produced a loss of $0.04, delivering no surprise. Over the last four quarters, the company has surpass ...

Financial Performance - Total revenues for Q2 2024 were $1.408 million, a decrease of 56.5% compared to $3.225 million in Q2 2023[10] - Collaboration revenues for the first half of 2024 were $2.285 million, down 54.2% from $4.992 million in the same period of 2023[10] - Net loss attributable to Lineage for Q2 2024 was $5.760 million, compared to a net loss of $5.229 million in Q2 2023, reflecting a 10.1% increase in losses[10] - The company reported a loss from operations of $5.867 million in Q2 2024, compared to a loss of $5.024 million in Q2 2023, indicating a 16.7% increase in operational losses[10] - Net loss for Q2 2024 was $5,773,000, compared to a net loss of $5,203,000 in Q2 2023, representing an increase of 10.9% year-over-year[6] - Comprehensive loss attributable to Lineage common shareholders for Q2 2024 was $5,459,000, compared to $4,733,000 in Q2 2023, indicating a 15.3% increase[6] - The total comprehensive loss for the first half of 2024 was $11,733,000, compared to $8,647,000 in the first half of 2023, reflecting a 35.5% increase[6] - Net loss attributable to Lineage for the six months ended June 30, 2024, was $12.3 million, compared to a loss of $9.6 million for the same period in 2023[9] Cash and Assets - Cash and cash equivalents decreased to $29.622 million as of June 30, 2024, from $35.442 million at the end of 2023, a decline of 16.3%[9] - Total current assets increased to $40.390 million as of June 30, 2024, compared to $38.441 million at the end of 2023, an increase of 5%[9] - Total shareholders' equity increased to $66.875 million as of June 30, 2024, from $62.023 million at the end of 2023, an increase of 7.1%[9] - The accumulated deficit increased to $397,158,000 as of June 30, 2024, compared to $372,971,000 as of June 30, 2023, reflecting a 6.5% increase[14] - The company has a total of $38.5 million in cash, cash equivalents, and marketable securities as of June 30, 2024[29] - Cash provided by financing activities was $14.13 million for the six months ended June 30, 2024, compared to $5.63 million in the same period of 2023[9] Expenses - Research and development expenses for Q2 2024 were $2.868 million, a decrease of 26% from $3.873 million in Q2 2023[10] - General and administrative expenses for the first half of 2024 were $9.360 million, an increase of 4.3% compared to $8.973 million in the same period of 2023[10] - Stock-based compensation for Q2 2024 amounted to $1,269,000, compared to $1,280,000 in Q2 2023, showing a slight decrease of 0.9%[12] - Depreciation and amortization expense for the six months ended June 30, 2024, was $295,000, compared to $276,000 for the same period in 2023[43] Liabilities - Total liabilities decreased to $35.927 million as of June 30, 2024, down 7.4% from $38.996 million at the end of 2023[9] - Accounts payable increased to $2,388,000 as of June 30, 2024, from $2,050,000 as of December 31, 2023[47] - Total liabilities decreased to $5,018,000 as of June 30, 2024, down from $6,270,000 as of December 31, 2023[47] Shareholder Information - The company reported a total of 188,824,000 common shares outstanding as of June 30, 2024, an increase from 174,439,000 shares as of June 30, 2023[14] - Shares issued through ATM financing totaled 33,000 in Q2 2024, contributing to an increase in common shares outstanding[12] - The number of common shares issued and outstanding increased to 188,823,975 as of June 30, 2024, from 174,986,671 as of December 31, 2023[55] - Lineage's 2021 Equity Incentive Plan was amended to increase the number of common shares that may be issued by 19,500,000[60] Legal and Regulatory Matters - Lineage paid $10.65 million to settle a class action lawsuit related to the Asterias Merger, with $3.53 million paid by Lineage in the first quarter of 2023[96] - Lineage has not recorded any accrual for a contingent liability associated with a legal proceeding, believing that a liability is not probable nor estimable[99] Research and Development - Lineage's lead cell therapy program, OpRegen, is currently in a Phase 2a clinical trial for the treatment of geographic atrophy secondary to age-related macular degeneration[19] - OPC1, an allogeneic oligodendrocyte progenitor cell therapy, is being developed for spinal cord injury and has received a $14.3 million grant from the California Institute for Regenerative Medicine[20] - The company plans to apply for additional funding from CIRM for continued clinical development of OPC1[20] - Lineage's pipeline includes additional programs such as ANP1 for hearing loss and PNC1 for vision loss due to photoreceptor dysfunction[21][23] Lease and Operating Commitments - The cumulative base rent for the Cell Cure lease in Jerusalem is approximately 165,000 ILS per month (approximately $44,000) as of June 30, 2024[74] - Future minimum lease commitments for operating leases total $3,130 million, with $579 million due in 2024 and $1,156 million in 2025[79] - Right-of-use assets for operating leases increased to $2,584 million as of June 30, 2024, compared to $2,522 million as of December 31, 2023, reflecting a growth of 2.5%[77] - Total operating lease liabilities rose to $2,837 million as of June 30, 2024, from $2,809 million as of December 31, 2023, indicating an increase of 1.0%[77] Tax Matters - The company established a full valuation allowance for deferred tax assets as of December 31, 2018, due to uncertainty in realizing future tax benefits[67] - Lineage did not record a deferred tax benefit or provision expense for the three or six months ended June 30, 2024[70]

Financial Data and Key Metrics Changes - The company reported that patients treated with OpRegen gained an average of 5.5 letters of visual acuity at 24 months, while comparable patients on anti-complement therapy lost 7 to 9 letters, indicating a significant improvement of 14 letters on average [97][98] - The company highlighted that some patients showed imaging evidence of retaining or gaining critical layers of their retina two years after receiving a single transplant, a phenomenon that does not occur in the natural course of the disease [100][101] Business Line Data and Key Metrics Changes - The company announced a new services agreement with Genentech to provide additional support for the ongoing development of OpRegen, which includes clinical, technical training, and manufacturing services [107][108] - The company is excited about the second cell transplant program entering active enrollment this year, targeting a disease with significant unmet needs and limited competition [2] Market Data and Key Metrics Changes - The launch of SYFOVRE, a competitor product, showed around 77,000 injections in the first quarter, indicating strong market demand for new therapies in the dry AMD space [47][48] - The company noted that the commercial market for dry AMD therapy continues to grow, creating a more informed patient population eager for new treatment options [111] Company Strategy and Development Direction - The company believes that its cell transplant approach offers advantages over small molecules and antibodies, with potential applications beyond ocular conditions [112] - The company aims to leverage its experience in cell therapy to remain a leader in this emerging field, focusing on advancing its growing pipeline of opportunities [114] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing partnership with Roche and Genentech, viewing the expanded agreement as a positive sign of commitment to the OpRegen program [24][25] - The company is encouraged by the demand for new therapies, as evidenced by the uptake of SYFOVRE, and believes that OpRegen's unique product profile positions it well in the market [49][50] Other Important Information - The company has collected and published up to 10 years of safety and efficacy data on its patients, which it believes enhances the quality profile of its spinal cord injury program [118] - The company is preparing to initiate a clinical trial for a novel delivery system for its spinal cord injury product candidate, pending FDA clearance [119][120] Q&A Session All Questions and Answers Question: Can you provide more details on the new Roche agreement? - Management described the agreement as showcasing increased commitment and expanding the scope of work related to the OpRegen program, including extending the follow-up period of ongoing trials [6][7] Question: How does the company view the competitive landscape with the new agreement? - Management sees the agreement as a positive indication of Roche's interest in maintaining a collaborative relationship, which suggests competitive barriers that others may find difficult to surpass [22][24] Question: What insights can be drawn from the SYFOVRE launch? - Management noted that the uptake of SYFOVRE indicates strong market demand for new therapies, reinforcing the potential for OpRegen to capture a significant share of the market [48][49] Question: What is the expected enrollment rate for the upcoming dose study? - Management indicated that the company plans to enroll 6 to 10 patients across a handful of sites, having initially reached out to more than 10 sites during feasibility discussions [52][53] Question: Can you comment on the variability in the coverage within the limited lab coverage subgroup? - Management explained that the two patients without 24-month data elected not to continue in the study for personal reasons, and emphasized that the observed changes in visual acuity should be interpreted cautiously due to the small patient population [73][74]

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, 2024 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 ...

Exhibit 99.1 CARLSBAD, CA – May 9, 2024 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported its first quarter 2024 financial and operating results and will host a conference call at 4:30 p.m. Eastern Time to discuss these results and to provide a business update. - OPC1 Balance Sheet Highlights "The quarter was highlighted by significant milestones and data updates on our lead pr ...

Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q4 2023 Earnings Conference Call March 7, 2024 4:30 PM ET Company Participants Ioana Hone - Head of IR Brian Culley - CEO Jill Howe - CFO Conference Call Participants Joe Pantginis - H.C Wainwright Jack Allen - Baird Kristen Kluska - Cantor Fitzgerald Mayank Mamtani - B. Riley Sean McCutcheon - Raymond James Michael Okunewitch - Maxim Group Operator Welcome to the Lineage Cell Therapeutics Fourth Quarter and Fiscal Year-End 2023 Conference Call. At this time, all ...