Lineage Cell Therapeutics (LCTX) FY 2025 Conference May 20, 2025 02:30 PM ET Speaker0 Hey. Good afternoon, everybody. I'm gonna turn this on. Good afternoon, everybody. My name is Joe Pangenis, managing director here at HC Wainwright. Welcome back to our next fireside chat. Very happy to have with us Brian Culley, chief executive officer of Lineage Cell Therapeutics. And, so thank you very much for being here. And little before this presentation, I thought of a little analogy. Think, feel like I'm in front ...

Financial Performance - Lineage Cell reported a quarterly loss of $0.02 per share, which aligns with the Zacks Consensus Estimate, an improvement from a loss of $0.04 per share a year ago [1] - The company posted revenues of $1.5 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 31.73%, but showing a slight increase from $1.44 million year-over-year [2] - Over the last four quarters, Lineage Cell has surpassed consensus EPS estimates three times and has topped consensus revenue estimates three times as well [2][1] Stock Performance - Lineage Cell shares have declined approximately 4.7% since the beginning of the year, compared to a decline of 0.6% for the S&P 500 [3] - The current Zacks Rank for Lineage Cell is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $2.25 million, and for the current fiscal year, it is -$0.07 on revenues of $16.05 million [7] - The trend of estimate revisions for Lineage Cell is mixed, which could change following the recent earnings report [6] Industry Context - Lineage Cell operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 35% of over 250 Zacks industries [8] - Research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8]

Lineage Cell Therapeutics (LCTX) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Ioana Hone - Head, IRBrian Culley - CEOJill Howe - Chief Financial Officer Conference Call Participants William Wood - Equity Research AnalystJack Allen - Senior Research AnalystMichael Okunewitch - Senior Biotechnology AnalystAlbert Lowe - Senior Research AnalystNone - Analyst Operator Welcome to the Lineage Cell Therapeutics First Quarter twenty twenty five Conference Call. At this time, all participants a ...

Lineage Cell Therapeutics (LCTX) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Welcome to the Lineage Cell Therapeutics First Quarter twenty twenty five Conference Call. At this time, all participants are in a listen only mode. An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage, and recordings, reproductions, or transmissions of this call without the express written consen ...

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, 2025 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 REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE CARLSBAD, CA – May 13, 2025 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical- stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions, today reported its first quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and ...

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were approximately $2.9 million, a net increase of $0.8 million compared to $2.1 million for the same period in 2023, primarily driven by increased collaboration revenue from Roche [43] - Total operating expenses for Q4 2024 were $7.8 million, a decrease of $0.4 million compared to $8.2 million for the same period in 2023 [44] - The net loss attributable to Lineage for Q4 2024 was $3.3 million or $0.02 per share, compared to a net loss of $4.8 million or $0.03 per share for the same period in 2023 [46] Business Line Data and Key Metrics Changes - R&D expenses for Q4 2024 were $3.4 million, a decrease of $0.5 million compared to $3.9 million for the same period in 2023, driven by a decrease in OPC1 program expenses [44] - G&A expenses for Q4 2024 were $4.4 million, consistent with expenses for the same period in 2023 [44] Market Data and Key Metrics Changes - The company reported a year-end cash position of $47.8 million as of December 31, 2024, which supports operations into Q1 2027 [40] - The November 2024 financing included a milestone warrant that could provide an additional $36 million if clinical milestones are achieved [41] Company Strategy and Development Direction - The company is focused on advancing its lead candidate OpRegen for dry AMD and is confident in its potential to drive positive clinical outcomes [52] - Investments in scalable GMP manufacturing are seen as critical for the success of allogeneic cell therapy products, with a goal to produce millions of doses [30][22] - The company is also advancing its OPC1 program for spinal cord injury, with plans for a larger clinical trial once necessary improvements are in place [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing GAlette Study for OpRegen, noting that independent evidence from other RPE transplant trials supports their belief in the treatment's efficacy [52] - The competitive landscape for RPE cell therapies is acknowledged, but management believes their partnerships with Roche and Genentech provide a significant advantage [60] Other Important Information - The company has continued to add value to its patent portfolio, with two additional OpRegen patents issued earlier in the year [38] - The company is working on a new delivery device for the OPC1 program, which is expected to enhance the administration process [34] Q&A Session Summary Question: What is the company doing to protect its market leadership in RPE cell placements? - Management emphasized the importance of having the right attributes for success, including strong manufacturing capabilities and partnerships with Genentech and Roche [60] Question: When will the updated three-year data for OpRegen be available? - Management indicated that inquiries regarding the timeline for the three-year data should be directed to Genentech, as they control the announcement schedule [64] Question: Can you describe any changes in logistics for getting patients to the surgical suite faster? - Management noted improvements in training and the development of an immediate use formulation to streamline the process [77] Question: Will the FDA require proof of device safety before fully enrolling in the DOSED study? - Management confirmed that there is a staging process for safety measures, starting with thoracic patients before moving to broader enrollment [83] Question: What are the plans for the resonance program given market uncertainty? - Management stated that while the resonance program remains important, they are being prudent with investment decisions in the current market environment [88]

Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q4 2024 Earnings Conference Call March 10, 2025 4:30 PM ET Company Participants Ioana Hone - Head of Investor Relations Brian Culley - Chief Executive Officer Jill Howe - Chief Financial Officer Conference Call Participants Jack Allen - Baird Joseph Pantginis - H.C. Wainwright Michael Okunewitch - Maxim Group Mayank Mamtani - Riley Securities Albert Lowe - Craig-Hallum Sean McCutcheon - Raymond James Operator Thank you for standing by. My name is Rochelle and I wi ...

Financial Performance and Profitability - The company has incurred operating losses since inception and is uncertain when it will attain profitability[20] - The company anticipates needing to raise substantial additional capital to fund operations and product development, which may dilute existing shareholders[20] Product Development and Regulatory Risks - The company relies on third-party collaboration with F. Hoffmann-La Roche Ltd and Genentech, Inc. for the development and commercialization of RG6501 (OpRegen), which is critical for potential revenue[20] - The FDA granted orphan drug designation to OPC1 for the treatment of acute spinal cord injuries, but maintaining this designation is not guaranteed[21] - The company has limited experience in manufacturing its product candidates on a commercial scale, which poses risks for clinical development and regulatory approval[21] Market and Competitive Landscape - The commercial success of product candidates will depend on market acceptance by physicians, patients, and third-party payors[21] - The company faces significant competition, which may impact its ability to successfully commercialize its product candidates[21] - The company has no marketing and sales force or distribution capabilities currently in place[21] Stock Market and Geopolitical Risks - The market price of the company's common shares has been and may continue to be volatile[21] - The company is exposed to geopolitical risks that could disrupt operations, particularly at its facility in Jerusalem, Israel[20]

Financial Performance - Total revenues for Q4 2024 were approximately $2.9 million, a net increase of $0.8 million compared to $2.1 million in Q4 2023, primarily driven by collaboration revenue from Roche[13] - Total revenues for the full year 2024 were $9.5 million, a net increase of $0.6 million compared to $8.9 million in 2023, driven by collaboration revenue from Roche[19] - Total revenues for the year ended December 31, 2024, increased to $9,499,000, representing a 6.2% growth from $8,945,000 in 2023[34] - Collaboration revenues rose to $8,149,000, up from $7,588,000, indicating an 7.4% increase year-over-year[34] Operating Expenses - Total operating expenses for Q4 2024 were $7.8 million, a decrease of $0.4 million compared to $8.2 million in Q4 2023[14] - Total operating expenses for the full year 2024 were $31.0 million, a decrease of $2.7 million compared to $33.7 million in 2023[20] - Total operating expenses declined to $30,977,000, down 8.0% from $33,678,000 in the previous year[34] Research and Development - R&D expenses for Q4 2024 were $3.4 million, a decrease of $0.5 million compared to $3.9 million in Q4 2023[15] - R&D expenses for the full year 2024 were $12.5 million, a decrease of $3.2 million compared to $15.7 million in 2023[21] - Research and development expenses decreased to $12,472,000 from $15,705,000, a reduction of 20.0%[34] Net Loss - Net loss attributable to Lineage for Q4 2024 was $3.3 million, or $0.02 per share, compared to a net loss of $4.8 million, or $0.03 per share, for Q4 2023[18] - Net loss attributable to Lineage for the full year 2024 was $18.6 million, or $0.09 per share, compared to a net loss of $21.5 million, or $0.12 per share, for 2023[25] - Net loss attributable to Lineage for 2024 was $18,609,000, compared to a net loss of $21,486,000 in 2023, reflecting a 13.1% improvement[34] Financial Position - Cash and cash equivalents increased to $45,789,000 as of December 31, 2024, up from $35,442,000, a growth of 29.0%[32] - Total assets grew to $113,218,000, compared to $101,019,000 in 2023, marking a 12.0% increase[32] - Total liabilities decreased to $36,206,000 from $38,996,000, a reduction of 4.6%[32] - Lineage's shareholders' equity increased to $78,381,000, up from $63,419,000, representing a 23.5% rise[32] - The company anticipates sufficient cash, cash equivalents, and marketable securities to support operations into the first quarter of 2027[29] Regulatory and Clinical Updates - OpRegen received RMAT designation from the FDA, and the ongoing GAlette Study is expanding to additional clinical sites[12] Financing Activities - Lineage completed two financings totaling $44 million in gross proceeds, with potential for an additional $36 million upon full cash exercise of clinical milestone-linked warrants[5]