Lineage's exclusive option and license agreement (the "Agreement†) with Factor was announced in 2023. The novel hypoimmune iPSC line received by Lineage contains a set of specific edits selected in a development strategy vetted with subject matter experts in the U.S. and abroad, as well as under a broader competitive landscape analysis. The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8 ...

Group 1: Snowflake Inc (NYSE:SNOW) - Snowflake reported third-quarter revenue of $1.21 billion, exceeding analyst estimates of $1.18 billion [1] - The company achieved adjusted earnings of 35 cents per share, surpassing analyst expectations of 31 cents per share [1] - In pre-market trading, Snowflake shares fell 8.6% to $241.85 [2] Group 2: Other Companies - Net Lease Office Properties (NYSE:NLOP) shares decreased by 14.7% to $25.19 in pre-market trading [4] - Symbotic Inc (NASDAQ:SYM) shares dropped 10.5% to $65.50 following a 10 million share offering announcement [4] - Capricor Therapeutics Inc (NASDAQ:CAPR) shares fell 8.4% to $27.45 after a significant increase of 371% the previous day [4] - ADC Therapeutics SA (NYSE:ADCT) shares declined 8.1% to $3.63 after reporting updated data from its LOTIS-7 trial [4] - Koninklijke Philips NV (NYSE:PHG) shares decreased by 6.8% to $26.11 in pre-market trading [4] - Omeros Corp (NASDAQ:OMER) shares fell 4.2% to $10.18 [4] - Methanex Corp (NASDAQ:MEOH) shares dropped 3.8% to $35.95 [4]

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]

Company Overview - Lineage Cell Therapeutics (LCTX) is a regenerative medicine company focused on utilizing pluripotent stem cells to create specialized human cells for organ tissue regeneration [1]. Technology and Applications - The company's platform aims to generate off-the-shelf human cells that can replace damaged tissues in various organs, including potential applications in regenerating the eyes, spinal cord, and auditory systems [1].

Financial Data and Key Metrics Changes - As of September 30, 2025, the overall cash position was $40.5 million, expected to support operations into Q2 2027, one quarter longer than previously guided [25] - Total revenues for Q3 2025 were $3.7 million, a decrease of approximately $0.1 million compared to $3.8 million for the same period in 2024, primarily driven by lower royalty revenue [26] - Operating expenses for Q3 2025 were $7.5 million, a decrease of $0.1 million compared to $7.6 million for the same period in 2024 [27] - The net loss was $29.8 million, or $0.13 per share, compared to a net loss of $3 million, or $0.02 per share, for the same period in 2024, primarily driven by non-cash fair value remeasurement of warrant liabilities [28] Business Line Data and Key Metrics Changes - The R&D expenses for Q3 2025 were $3.3 million, an increase of $0.1 million compared to $3.2 million for the same period in 2024, driven by costs associated with the OPC1 program and preclinical programs [27] - G&A expenses were $4.2 million, a decrease of $0.2 million compared to $4.4 million for the same period in 2024, primarily due to stock-based compensation expenses [27] Market Data and Key Metrics Changes - The company reported a significant potential cash source of approximately $37 million from warrant capital if Roche and Genentech advance OpRegen into a clinical trial [26] Company Strategy and Development Direction - The company aims to create a basket of cell therapy assets, some developed internally and others partnered, focusing on generating multiple product candidates from its platform [18] - The strategic goals include entering into deals to fund existing product candidates, creating new assets to attract external funding, and capitalizing on unique manufacturing capabilities [10][12][13] - The company is optimistic about the OpRegen program's potential to drive positive clinical outcomes and is encouraged by partner commitments [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for OpRegen to advance into a controlled clinical trial, supported by positive indicators from clinical site expansions and independent validations of clinical findings [10][30] - The company anticipates that the favorable biotech market will improve the cost of capital, allowing for judicious expansion [17] Other Important Information - The company has preserved the right to enter into future clinical or commercial deals with pharmaceutical partners, demonstrating flexibility in its strategic approach [11] - The company is awaiting a decision on a CIRM CLIN2 grant, which could provide up to approximately $7 million in non-dilutive funding [15] Q&A Session Summary Question: Considerations for the iLET Cell program and internal decision-making - Management indicated that the biological ceiling in differentiation protocols limits the opportunity for significant process changes, focusing on maximizing early steps to achieve necessary outputs [32][33] Question: Future partnerships and collaborations - Management highlighted the importance of finding suitable partners, emphasizing that partnerships should align with the company's capabilities and strategic goals [35][36] Question: Updates on the OPC-1 program and patient dosing - Management confirmed that multiple doses could be administered at different sites, and the safety profile for OPC1 remains strong [39][40] Question: Impact of potential CIRM grant funding - Management stated that while the grant would provide significant support, the program would continue regardless of the outcome [59] Question: Future business model considerations - Management expressed a preference to avoid becoming a fee-for-service company, focusing instead on partnerships that allow for significant ownership in the upside [46][47]

Financial Performance - Total revenues for Q3 2025 were $3,681,000, a decrease of 2.6% compared to $3,779,000 in Q3 2024[25]. - Net loss attributable to Lineage for Q3 2025 was $29,781,000, compared to a net loss of $3,034,000 in Q3 2024, representing an increase in loss of 878.5%[25]. - The company reported a comprehensive loss of $29,940,000 for Q3 2025, compared to a comprehensive loss of $3,421,000 in Q3 2024, an increase of 772.5%[27]. - For the nine months ended September 30, 2025, Lineage Cell Therapeutics reported a net loss of $64.384 million, compared to a net loss of $15.336 million for the same period in 2024, indicating a significant increase in losses[33]. - Total revenue for the three months ended September 30, 2025, was $3,681,000, a decrease of 2.6% compared to $3,779,000 for the same period in 2024[59]. - Total revenue for the nine months ended September 30, 2025, was $7,948,000, an increase of 19.9% compared to $6,631,000 for the same period in 2024[59]. Assets and Liabilities - Total assets decreased to $89,639,000 as of September 30, 2025, down from $113,218,000 as of December 31, 2024, a decline of 20.9%[23]. - Total liabilities increased significantly to $68,843,000 as of September 30, 2025, compared to $36,206,000 as of December 31, 2024, an increase of 90.2%[23]. - The company’s accumulated deficit increased to $467,849,000 as of September 30, 2025, compared to $403,465,000 as of December 31, 2024, an increase of 15.9%[23]. - The total shareholders' equity decreased to $20,796,000 as of September 30, 2025, down from $77,012,000 as of December 31, 2024, a decline of 73.0%[23]. - The total cash, cash equivalents, and restricted cash at the end of September 30, 2025, was $40.977 million, a decrease from $28.306 million at the end of September 30, 2024[33]. Research and Development - Research and development expenses for Q3 2025 were $3,271,000, slightly up from $3,171,000 in Q3 2024, an increase of 3.2%[25]. - The company is developing multiple allogeneic cell therapy programs, including OPC1 for spinal cord injuries and PNC1 for vision loss, indicating a broad pipeline of therapeutic candidates[37]. - Lineage's lead cell therapy program, OpRegen, is currently in a Phase 2a clinical trial for geographic atrophy secondary to age-related macular degeneration, with potential milestone payments of up to $620 million from Roche[36]. - The company is conducting the DOSED clinical study for OPC1, which includes participants with chronic spinal cord injuries, with the first participant dosed in August 2025[39]. - OpRegen is currently in a Phase 2a clinical trial for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), with positive 36-month visual acuity results showing a mean change in Best Corrected Visual Acuity (BCVA) of +9.0 ETDRS letters[144]. Financing and Capital - The company issued 7,895 common shares through registered direct financing, raising $3.795 million during the nine months ended September 30, 2025[31]. - The company has $40.5 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to support operations for at least the next twelve months[48]. - The company has received a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM) to support OPC1 clinical development and has applied for an additional $7.0 million[39]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $6.6 million, consisting of net proceeds from the sale of common shares and warrants[184]. - 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[193]. Operational Highlights - The company has produced scalable cGMP banking systems for three product candidates, supporting a production capability exceeding the expected patient population for OpRegen and OPC1[41]. - The company is responsible for completing activities related to its ongoing phase 1/2a clinical study for OpRegen, with enrollment now complete[113]. - The company has obligations to licensors and government entities that may result in future payments, but the timing and amounts are uncertain[51]. - The company has incurred significant operating losses since inception, primarily funded through equity securities and research grants[49]. - The company plans to leverage its scalable cGMP cell therapy production capability to produce cost-effective allogeneic cell transplant products[149]. Legal and Regulatory - The company has not recorded a deferred tax benefit or provision expense during the nine months ended September 30, 2025, or 2024[105]. - Lineage has not recorded any liabilities for indemnification agreements as of September 30, 2025, and maintains liability insurance policies to limit financial exposure[134]. - The company has not accrued for a contingent liability related to a legal proceeding involving HBL, as the likelihood of a material adverse effect is not probable nor estimable[131]. - The Israeli regional conflict has temporarily impacted operations, but as of the report date, there has been no material adverse effect on operations[154]. Stock and Equity - The company issued and sold 1.0 million common shares under its at-the-market offering program for gross proceeds of $1.3 million during the nine months ended September 30, 2025[178]. - As of September 30, 2025, the company had 230,327,537 common shares issued and outstanding, an increase from 220,416,326 shares as of December 31, 2024[80]. - The company is authorized to issue up to 450,000,000 common shares, with no preferred shares issued or outstanding as of the reporting dates[79]. - The balance of outstanding stock options increased from 16,658,000 at December 31, 2024, to 23,976,000 at September 30, 2025, with a weighted average exercise price of $1.06[98]. - Total stock-based compensation expense for the three months ended September 30, 2025, was $1.199 million, compared to $1.330 million for the same period in 2024[99].

Financial Performance - Total revenues for Q3 2025 were $3.7 million, a decrease of approximately $0.1 million compared to $3.8 million in Q3 2024[14] - Total revenues for the three months ended September 30, 2025, were $3,681,000, a decrease of 2.6% compared to $3,779,000 for the same period in 2024[30] - Net loss attributable to Lineage for Q3 2025 was $29.8 million, or $0.13 per share, compared to a net loss of $3.0 million, or $0.02 per share, in Q3 2024[20] - Net loss attributable to Lineage for the nine months ended September 30, 2025, was $64,384,000, significantly higher than the net loss of $15,336,000 for the same period in 2024[32] - Collaboration revenues for the three months ended September 30, 2025, increased to $3,544,000, up from $3,386,000 in the same period of 2024, representing a growth of 4.7%[30] Operating Expenses - Operating expenses for Q3 2025 were $7.5 million, a decrease of $0.1 million from $7.6 million in Q3 2024[16] - Total operating expenses for the nine months ended September 30, 2025, were $38,019,000, an increase of 65.5% compared to $22,999,000 for the same period in 2024[30] Cash and Liquidity - Cash, cash equivalents, and marketable securities totaled $40.5 million as of September 30, 2025, expected to support operations into Q2 2027[13] - Cash and cash equivalents decreased to $40,977,000 as of September 30, 2025, from $46,354,000 at the beginning of the period[32] - The company experienced a net cash used in operating activities of $14,041,000 for the nine months ended September 30, 2025, compared to $16,746,000 for the same period in 2024[32] Research and Development - R&D expenses increased to $3.3 million in Q3 2025, up from $3.2 million in Q3 2024, driven by $0.2 million for the OPC1 program[17] - Lineage continues to pursue grant funding from the California Institute for Regenerative Medicine (CIRM) for the OPC1 program[3] - Lineage initiated a manufacturing scale project for Type 1 Diabetes cell therapy, focusing on large-scale production of islet cells[6] Clinical Studies and Collaborations - Lineage reported positive results from the RG6501 (OpRegen) Phase 1/2a clinical study, suggesting sustained gains in visual acuity[5] - A collaboration with William Demant Invest A/S was established to develop ReSonance (ANP1) for sensorineural hearing loss, with up to $12 million in development costs covered by WDI[9] - The first chronic spinal cord injury participant was treated in the DOSED clinical study, with no significant safety events reported after sixty days[15] Liabilities and Impairments - The total liabilities increased to $68,843,000 as of September 30, 2025, compared to $36,206,000 as of December 31, 2024[28] - The company reported a loss on impairment of intangible assets of $14,840,000 for the nine months ended September 30, 2025[30] - The change in fair value of warrant liability resulted in a loss of $36,992,000 for the nine months ended September 30, 2025[30] Share Information - The weighted-average common shares used to compute basic and diluted net loss per common share for the nine months ended September 30, 2025, were 227,765, compared to 186,860 for the same period in 2024[30]

Company Overview - Lineage Cell Therapeutics is a clinical-stage biotechnology company focused on developing novel cell therapies for neurological and ophthalmic conditions [3]. Core Business Focus - The company specializes in the manufacture and delivery of specific cell types to address diseases caused by the loss of certain cell types, with a primary focus on dry age-related macular degeneration (AMD) [3]. Key Product and Application - The most significant application of the company's technology is in treating dry AMD, characterized by the loss of retinal pigment epithelium (RPE) cells, which the company manufactures and delivers to restore lost function [3].

Summary of Lineage Cell Therapeutics FY Conference Call Company Overview - **Company**: Lineage Cell Therapeutics (NYSEAM:LCTX) - **Industry**: Biotechnology, specifically focused on cell therapies for neurological and ophthalmic conditions [1][2] Core Points and Arguments - **Cell Therapy Focus**: Lineage is dedicated to manufacturing and delivering specific cell types to address diseases caused by the loss of certain cell types, with a significant focus on dry age-related macular degeneration (AMD) [2][3] - **New Initiatives**: Introduction of a new initiative called ILT1 aimed at addressing type 1 diabetes, focusing on overcoming manufacturing deficiencies to produce a large number of islet cells necessary for treatment [3][27] - **Partnerships**: Collaboration with William Demant Invest Company for the hearing loss program, which involves manufacturing auditory neurons [4][26] - **Manufacturing Capabilities**: Emphasis on the importance of scalable and affordable manufacturing processes to ensure commercial viability of cell therapies [6][8][27] - **Lead Program - OpRegen**: The lead program for dry AMD has shown promising results in improving both anatomy and function in patients, with a partnership with Roche and Genentech for a Phase 2 clinical trial [9][10][12] - **Clinical Results**: Patients receiving OpRegen have demonstrated significant anatomical improvements and clinically meaningful increases in vision, contrasting with the natural progression of the disease [13][14] Additional Important Content - **Safety Profile**: The clinical studies have shown a favorable safety profile, with only one adverse event potentially related to the therapy out of 534 reported [20][21] - **Long-term Follow-up**: The company has reported follow-up data extending up to 13 years, with no cases of tumor growth or cysts observed in patients [21][22] - **Emerging Field**: Non-oncology cell transplantation is viewed as an emerging and exciting branch of medicine, with Lineage positioned as a leader in this area [23][24] - **Future Directions**: Plans to expand successful methodologies to other areas of interest, including a photoreceptor program and potential gene editing technologies [26][27] - **Challenges in Diabetes Treatment**: Acknowledgment of the significant challenges in scaling cell production for diabetes treatment, with a need for innovative banking and differentiation modalities [27][28] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic initiatives, clinical advancements, and future directions in the biotechnology sector.

Group 1 - Lineage Cell (LCTX) reported a quarterly loss of $0.01 per share, better than the Zacks Consensus Estimate of a loss of $0.02, and improved from a loss of $0.03 per share a year ago, representing an earnings surprise of +50.00% [1] - The company posted revenues of $2.77 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 75.00%, compared to year-ago revenues of $1.41 million [2] - Lineage Cell shares have increased approximately 101% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.4% [3] Group 2 - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for Lineage Cell was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $2.52 million, and -$0.09 on revenues of $7.94 million for the current fiscal year [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Lineage Cell belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, which may impact stock performance [8] - Another company in the same industry, Biofrontera Inc. (BFRI), is expected to report a quarterly loss of $0.45 per share, reflecting a year-over-year change of +59.8%, with revenues anticipated to be $8.2 million, up 4.6% from the previous year [9]