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 ...

Financial Data and Key Metrics Changes - The company reported cash, cash equivalents, and marketable securities of $35.5 million as of December 31, 2023, which, along with $13.8 million in net proceeds from a registered direct offering, is expected to support operations into Q3 2025 [68] - R&D expenses were $3.9 million for Q4 2023, a decrease of $0.2 million compared to $4.1 million for the same period in 2022, primarily driven by reductions in OpRegen program expenses [69] - The net loss for Q4 2023 was $4.8 million or $0.03 per share, compared to a net loss of $6.4 million or $0.03 per share for the same period in 2022, indicating an improvement in financial performance [70] Business Line Data and Key Metrics Changes - Total revenues for the full year 2023 were approximately $8.9 million, a decrease of $5.8 million compared to $14.7 million for 2022, primarily due to lower collaboration revenue recognized from the Roche agreement [101] - G&A expenses for the full year were $17.3 million, a decrease of approximately $5.2 million compared to $22.5 million for 2022, mainly due to lower litigation and legal expenses [102] Market Data and Key Metrics Changes - The company highlighted the ongoing collaboration with Roche and Genentech, which is expected to enhance awareness and support for the OpRegen program, indicating a strong market position [67] Company Strategy and Development Direction - The company aims to advance its pipeline of differentiated cell transplants while focusing on the OpRegen program, which is partnered with Roche and Genentech, reflecting a strategic emphasis on collaboration with well-resourced partners [31][67] - The company is also looking to expand its second cell transplant program into active enrollment in a disease with significant unmet needs and limited competition [67] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, noting that the recent data from the OpRegen program shows significant clinical benefits, which could lead to a shift in treatment paradigms for dry AMD [52][67] - The company is preparing for the upcoming Phase 2a data from Roche, which is anticipated to provide further insights into the program's efficacy [80] Other Important Information - The company announced the FDA clearance of the IND amendment for the OPC1 program, allowing for the initiation of clinical testing with a new delivery device [39] - The company is actively engaging with the spinal cord injury community to enhance awareness and inform development strategies [42] Q&A Session Summary Question: What is the clinical significance of the 24-month visual acuity data for OpRegen? - Management stated that maintaining an increase in visual acuity at 24 months is clinically meaningful, especially compared to untreated cases, highlighting the durability of the treatment [78][79] Question: When can we expect data from the Phase 2a study conducted by Roche? - Management indicated that while they cannot provide specific timelines, the ongoing Phase 1/2a study continues to generate valuable information that will inform future clinical work [112] Question: How do the preclinical studies inform the clinical outcomes for OpRegen? - Management emphasized that the preclinical studies are designed to guide clinical methodologies, suggesting that better delivery methods could lead to improved patient outcomes [113]

Clinical Trials and Pipeline Development - OpRegen (RG6501) is currently in a Phase 2a multicenter clinical trial for the treatment of geographic atrophy secondary to age-related macular degeneration[400] - OPC1, an allogeneic oligodendrocyte progenitor cell therapy, has been tested in two clinical trials and received a $14.3 million grant from CIRM[401] - The company expects to open the first clinical site for the DOSED study evaluating OPC1 in the second quarter of 2024[402] - The company's neuroscience pipeline includes RG6501, OPC1, ANP1, PNC1, and RND1, with RND1 being developed in collaboration with Eterna Therapeutics[407] - The FDA granted orphan drug designation to OPC1 for the treatment of acute spinal cord injuries, but there is no guarantee the company will maintain or obtain the benefits associated with such designation[22] Financial Performance and Revenue - Total revenues for 2023 were $8.9 million, a decrease of $5.8 million (39%) compared to $14.7 million in 2022[424] - Collaboration revenues decreased by $5.8 million (43%) to $7.6 million in 2023, primarily due to lower revenues under the Roche Agreement[424][425] - Royalties, license, and other revenues increased slightly by $21,000 (2%) to $1.4 million in 2023[424] - Gross profit decreased by $5.7 million (41%) to $8.3 million in 2023, driven by the decline in collaboration revenues[424] - Total revenues for 2023 decreased by 39% to $8.9 million compared to $14.7 million in 2022, primarily due to a $5.8 million decrease in collaboration revenues under the Roche Agreement[424][425] - Collaboration revenues for 2023 were $7.6 million, a 43% decrease from $13.4 million in 2022[424] Research and Development Expenses - Research and development expenses are expected to fluctuate based on the stage of development for each cell therapy program, resource availability, and timing of contractual obligations[415] - Total research and development expenses increased by $1.7 million (12%) year-over-year to $15.7 million in 2023, driven by increases in OpRegen ($0.4 million), OPC1 ($1.2 million), and preclinical programs ($2.0 million)[430][432] - OpRegen and OPC1 programs accounted for 35% ($5.5 million) and 39% ($6.2 million) of total R&D expenses in 2023, respectively[432] - Research and development expenses increased by 12% to $15.7 million in 2023, driven by a $1.2 million increase in the OPC1 program and a $2.0 million increase in preclinical programs[430][432] General and Administrative Expenses - General and administrative expenses decreased by $5.2 million (23%) year-over-year to $17.3 million in 2023, primarily due to a $4.2 million reduction in legal and litigation expenses[430][433] - General and administrative expenses decreased by 23% to $17.3 million in 2023, primarily due to a $4.2 million reduction in legal and litigation expenses[430][433] Cash Flow and Financial Position - Net loss from operations was $24.7 million in 2023, with negative cash flow from operations of $28.6 million[442] - As of December 31, 2023, the company had $35.5 million in cash, cash equivalents, and marketable securities, and raised an additional $13.8 million in net proceeds through a registered direct offering in February 2024[442] - Accumulated deficit reached $384.9 million as of December 31, 2023, with expectations of continued significant operating losses in the foreseeable future[442] - As of December 31, 2023, the company had an accumulated deficit of $384.9 million and $35.5 million in cash, cash equivalents, and marketable securities[442] - In February 2024, the company raised approximately $13.8 million in net proceeds through a registered direct offering of common shares[442] - The company issued and sold 4,774,603 common shares under its at-the-market offering program in 2023, generating gross proceeds of $6.6 million[443] Interest and Investment Income - Interest income increased by $0.8 million (97%) year-over-year to $1.6 million in 2023 due to investments in short-term U.S. Treasury securities and rising interest rates[434] - Net loss on marketable equity securities decreased by $2.0 million (92%) year-over-year to $0.2 million in 2023, primarily due to changes in the fair market value of securities[435][436] - Interest income increased by 97% to $1.6 million in 2023, driven by investments in short-term U.S. Treasury securities and rising interest rates[434] - Net loss on marketable equity securities was $0.2 million in 2023, compared to $2.2 million in 2022, primarily due to changes in the fair market value of securities[434][436] Tax and Deferred Tax Assets - The company recorded a $1.8 million deferred tax benefit in 2023 due to the ability to offset certain deferred tax assets against the deferred tax liability associated with in-process research and development[440] - The company accounts for income taxes using the asset and liability method, with valuation allowances established when necessary to reduce deferred tax assets[418] - The company recorded a $1.8 million deferred tax benefit in 2023 due to the release of a valuation allowance related to deferred tax assets[440] Risks and Challenges - The company's operations in Israel may be materially impacted by the ongoing Israel-Hamas war, with potential adverse effects on financial condition and operating results[409] - The company's manufacturing facility in Jerusalem, Israel, is exposed to risks from political and economic instability, which could disrupt operations[409] - The ongoing Israel-Hamas war could materially adversely impact the company's business, operations, and ability to raise capital[409] - The company's manufacturing operations are conducted in Jerusalem, Israel, making it vulnerable to political and economic instability in the region[409] - The company has incurred operating losses since inception and cannot predict if or when it will achieve profitability[20] - The company's investigational allogeneic cell therapies face significant challenges due to their novel approach, with clinical development being lengthy, expensive, and uncertain in timing and outcome[20] - The company relies heavily on its collaboration with Roche for the development and commercialization of RG6501 (OpRegen®), and failure or termination of this collaboration could significantly delay regulatory approval and revenue potential[20] - Manufacturing operations are concentrated in Jerusalem, Israel, exposing the company to risks from political, economic, and conflict-related disruptions in the region[20] - The company has received Israeli government grants for R&D activities, which impose conditions and potential penalties for manufacturing or transferring technologies outside Israel[20] - The company depends on CIRM grant funding for clinical development of OPC1, and failure to secure additional funding could delay or halt the DOSED clinical study[20] - The company has limited experience in manufacturing product candidates at a clinical scale and no experience at a commercial scale, which could lead to delays or failures in development and commercialization[22] - The company faces significant competition, with the risk that competitors may develop more effective, safer, or less expensive therapies[22] - The company currently lacks a marketing and sales force or distribution capabilities, which could hinder commercialization efforts[22] - The company's intellectual property may be insufficient to protect its products, and it could face infringement claims from third parties[22] - The company faces potential product liability claims, which could result in substantial liability and costs if successful claims are brought against it[22] - The company currently has no marketing and sales force or distribution capabilities[22] - The company relies on third parties for the development of its product candidates, which may lead to increased costs and delays in clinical trials[22] Collaboration and Licensing Agreements - The company received a $50.0 million upfront payment from Roche in January 2022 and is eligible for up to an additional $620.0 million in milestone payments related to the OpRegen program[400] - The company is eligible to receive tiered double-digit percentage royalties on net sales of OpRegen in the U.S. and other major markets[400] - The company's revenue recognition under collaborative agreements involves significant judgment, particularly in estimating collaboration costs and allocating transaction prices[412][413] - The company's revenue recognition under collaborative agreements requires significant judgment, particularly in estimating collaboration costs and allocating transaction prices[413] Accounting and Financial Reporting - The company relies on critical accounting estimates, including revenue recognition, R&D costs, and impairment of long-lived intangible assets, which could materially affect financial results[410][412][416] - The company reviews long-lived intangible assets for impairment and recognizes impairment if the carrying amount exceeds the estimated fair value[416] - Goodwill and acquired in-process research and development (IPR&D) assets are tested for impairment annually or when events indicate potential impairment[417] - The company's stock-based compensation expense is determined using the Black-Scholes model, with assumptions that could materially affect financial statements[420][422] - The company's deferred tax assets and liabilities are subject to changes in market conditions, tax laws, and planning strategies, which could impact future financial statements[418][419] Foreign Currency and Other Financial Items - Foreign currency transaction losses decreased by $1.5 million year-over-year to $0.5 million in 2023, offset by a $0.5 million employee retention credit under the CARES Act[437][438]

LINEAGE CELL THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE o Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). o Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen: ▪ Positive clinical data presented at 2023 Eyecelerator, 23 ...

Financial Data and Key Metrics Changes - The company reported cash, cash equivalents, and marketable securities totaling $41.3 million as of September 30, 2023, which is expected to support operations into the first quarter of 2025, one quarter longer than previously anticipated [34] - Total revenues for the third quarter were $1.2 million, a decrease of $1.8 million compared to approximately $3 million for the same period in 2022, primarily due to lower collaboration and licensing revenue from the Roche agreement [35] - Total operating expenses were $7.8 million, a slight decrease from $8 million in the same period in 2022, with R&D expenses increasing to $3.7 million from $3.6 million [36] - The net loss was $7.1 million or $0.04 per share, compared to a net loss of $6.1 million or $0.04 per share for the same period in 2022 [38] Business Line Data and Key Metrics Changes - The ANP1 program for hearing loss has advanced to the next phase of preclinical development, with positive initial proof of concept results [22][24] - The VAC platform is being treated as a business development project rather than an internal clinical development program due to the current biotech environment [18] Market Data and Key Metrics Changes - The global spinal cord therapy market is referenced upwards of $7 billion to $10 billion, indicating significant market potential for the company's spinal cord injury program [62] Company Strategy and Development Direction - The company is focusing on maintaining financial discipline to navigate the challenging biotech environment while continuing to advance its key programs [29] - The collaboration with Eterna Therapeutics aims to leverage proprietary process development capabilities combined with external cell engineering technologies to create novel product candidates [27][28] Management's Comments on Operating Environment and Future Outlook - Management noted that the ongoing conflict in Israel has not materially impacted operations, and the company remains committed to advancing its business [32] - The company is optimistic about the potential of its lead asset, OpRegen, and is eager to complete the final steps for the OPC1 IND amendment [32][58] Other Important Information - The company has patented new process development methods to support long-term exclusivity for its pipeline, including a patent for large-scale production of retinal pigment epithelial cells [57] Q&A Session Summary Question: Inquiry about OpRegen Phase 2a and its impact on study conduct - Management indicated that the initial clinical outcomes could ease conversations between investigative sites and patients, potentially facilitating quicker enrollment [14] Question: Timeline for preclinical data on ANP1 and interest in the VAC platform - Management stated that functional preclinical data for ANP1 is expected in 2024, and the VAC platform is being pursued through partnerships rather than internal development [16][18] Question: Status of tech transfer at Roche - Management confirmed that tech transfer is on target, but specific details could not be disclosed [71]