Lineage Cell Therapeutics(US:LCTX)2025-11-06 21:18Financial 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].