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 ...

Start Time: 16:30 January 1, 0000 5:12 PM ET Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q3 2023 Earnings Conference Call November 09, 2023, 16:30 PM ET Company Participants Brian Culley - CEO Jill Howe - CFO Gary Hogge - SVP, Clinical and Medical Affairs Ioana Hone - Head, IR Conference Call Participants Joseph Pantginis - H.C. Wainwright Abigail Gray - Baird Kristen Kluska - Cantor Fitzgerald Operator Welcome to the Lineage Cell Therapeutics Third Quarter 2023 Conference Call. At this time, all participan ...

For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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 Lineage Cell Therapeutics, Inc. (Exact name of registrant as specified in its charter) California 94-3127919 (State or other jurisdiction of incorporation or organization) (IRS Employer Identifica ...

Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Ioana Hone - Head-Investor Relations Brian Culley - Chief Executive Officer Jill Howe - Chief Financial Officer Gary Hogge - Senior Vice President-Clinical & Medical Affairs Conference Call Participants Jack Allen - Baird Joe Pantginis - H. C. Wainwright Jason Bouvier - Cantor Fitzgerald Michael Okunewitch - Maxim Group Operator Welcome to the Lineage Cell Therapeutics Second Quarter ...

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 June 30, 2023 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 (State ...

Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q1 2023 Results Conference Call May 11, 2023 4:30 PM ET Company Participants Ioana Hone - Head of Investor Relations Brian Culley - Chief Executive Officer Jill Howe - Chief Financial Officer Gary Hogge - Senior Vice President of Clinical and Medical Affairs Conference Call Participants Jack Allen - Baird Joe Pantginis - H. C. Wainwright Kristen Kluska - Cantor William Wood - B. Riley Michael Okunewitch - Maxim Group Operator Welcome to the Lineage Cell Therapeuti ...

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, 2023 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, Inc. (NYSE:LCTX) Q4 2022 Earnings Conference Call March 9, 2023 4:30 PM ET Company Participants Ioana Hone - Head of IR Brian Culley - CEO Jill Howe - Chief Financial Officer Gary Hogge - SVP, Clinical and Medical Affairs Conference Call Participants Jack Allen - Baird William Wood - B. Riley Securities Kristen Kluska - Cantor Fitzgerald Joe Pantginis - HC Wainwright Joanne Lee - Maxim Group Operator Welcome to the Lineage Cell Therapeutics Fourth Quarter and Full Year 2022 Confer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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) (State or other jurisdiction ...