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Lineage Cell Therapeutics (LCTX) Investor Presentation - Slideshow
2022-05-16 16:39
== L I N E A G E The future of cell therapy. Corporate Overview April 25, 2022 Forward-Looking Statements This presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer to buy any securities of Lineage Cell Therapeutics, Inc. ("Lineage"). This presentation includes certain information obtained from trade and statistical services, third-party publications, and other sources. Lineage has not independently verified such information and there can be no assurance a ...
Lineage Cell Therapeutics(LCTX) - 2022 Q1 - Earnings Call Transcript
2022-05-13 01:52
Financial Data and Key Metrics Changes - Total revenues for Q1 2022 were approximately $5.2 million, an increase of $4.8 million from the same period in 2021, primarily due to licensing fees from the Roche collaboration agreement [25] - Total operating expenses for the quarter were approximately $11.5 million, an increase of approximately $4.2 million compared to the same period in 2021, driven by a $3.5 million non-recurring accrual related to a potential settlement of the 2019 Asterias merger litigation [26] - The net loss attributable to Lineage for Q1 2022 was $7.1 million or $0.04 per share, with a loss from operations of approximately $6.4 million, a decrease of $0.7 million compared to the same period in 2021 [27] Business Line Data and Key Metrics Changes - The company is working on multiple clinical and regulatory milestones, including initiating a clinical safety trial of a new delivery device for OPC1 and submitting an IND for the VAC2 program [10][11] - The company reported significant progress in its clinical programs, including the presentation of 10-year safety data from the OPC1 clinical trial, indicating no medical or neurological complications [22][23] Market Data and Key Metrics Changes - The company has approximately $78 million in cash and cash equivalents as of Q1 2022, providing multiple years of cash runway to support its programs [8][28] - The company is adapting to the current biotech landscape by focusing on communication, operations, and business development, aiming to enhance its market position [14][20] Company Strategy and Development Direction - The company believes it is well-positioned to navigate the current biotech bear market due to its cash position, near-term milestones, and fundamental profile [7][12] - The company is emphasizing business development and exploring partnerships to advance its assets, particularly in the NK cell space and other therapeutic areas [18][60] Management's Comments on Operating Environment and Future Outlook - Management commented on the overreaction in the biotech sector and expressed confidence in the company's ability to outperform peers in the coming years [6][7] - The company is aware of supply chain disruptions but has not experienced significant impacts, maintaining a focus on in-house manufacturing [24] Other Important Information - The company participated in the Red Bull Wings for Life World Run to raise awareness and funds for spinal cord research, highlighting its commitment to community engagement [23] - The company plans to publish additional papers on OPC1 and other clinical studies in the coming months, further supporting its research credibility [23] Q&A Session Summary Question: Can you provide more color on the settlement of the Asterias litigation? - The company has agreed in principle to a settlement of $10.7 million, with Lineage contributing $3.5 million, which will result in the dismissal of the lawsuit without any admission of liability [35] Question: How does the company reconcile its two-year runway with the growing pipeline? - The company benefits from economies of scale in manufacturing, allowing it to expand its pipeline with only marginal increases in spending [36] Question: Is the device for the OPC1 study ready, and are the doctors trained? - Pre-clinical work has been completed, and while formal training is ongoing, the surgeons have experience with the device [40] Question: What is the strategy for the new programs OPC1 and ANP1? - The company is working on optimizing delivery and scaling up cells for commercial viability, with plans for IND submissions [47] Question: How does the company view partnership opportunities? - The company is open to various partnership strategies, balancing in-house development with external collaborations to maximize value [49] Question: Can you provide an update on the Immunomic Therapeutics collaboration? - The collaboration focuses on using the VAC platform for delivering antigens, with the potential for additional valuable partnerships in the future [63]
Lineage Cell Therapeutics(LCTX) - 2022 Q1 - Quarterly Report
2022-05-12 20:16
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, 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) California 94-3127919 (Stat ...
Lineage Cell Therapeutics(LCTX) - 2021 Q4 - Earnings Call Transcript
2022-03-11 02:11
Financial Data and Key Metrics Changes - Total revenues for Q4 2021 were approximately $1.2 million, an increase of $0.8 million from the same period in 2020, primarily due to increased royalties and licensing fees [43] - Total operating expenses for Q4 2021 were approximately $29.2 million, an increase of approximately $23.1 million compared to Q4 2020, driven by $21 million in accruals related to the Roche deal [43] - The net loss attributable to Lineage for Q4 2021 was $29 million, or $0.17 per share, compared to a net loss of $2 million, or $0.01 per share, for the same period in 2020 [44] - For the full year 2021, total revenues were approximately $4.3 million, an increase of $2.5 million compared to 2020 [45] - The net loss for 2021 was $43 million, or $0.26 per share, compared to a net loss of $20.6 million, or $0.14 per share, for 2020 [45] Business Line Data and Key Metrics Changes - The Roche collaboration is expected to provide up to $620 million in additional cash payments based on developmental, regulatory, and commercial milestones, along with tiered double-digit royalties [17] - The company anticipates moving towards additional clinical trials for its other programs in 2022, leveraging the knowledge gained from the OpRegen program [15][30] Market Data and Key Metrics Changes - The company acknowledges that the biotech sector is currently experiencing a significant bear market, impacting share prices across the industry [24] - Despite the market conditions, the company believes it is well-positioned due to its strong balance sheet and ongoing clinical progress [25] Company Strategy and Development Direction - The company aims to be a leader in cell therapy by demonstrating that off-the-shelf cells can deliver compelling safety and efficacy data [35] - Future product development is expected to be faster, cheaper, and easier due to lessons learned from the OpRegen program [28] - The company plans to broaden its regenerative medicine pipeline and is preparing to announce a new product opportunity later this month [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the Roche partnership, viewing it as a validation of their technology and a pathway to significant market opportunities [12] - The company is focused on advancing its current pipeline while exploring strategic expansions in areas where it can make a significant impact [35] - Management highlighted the importance of maintaining a disciplined approach to capital spending, with a focus on achieving value-creating milestones [48] Other Important Information - The company reported a cash balance of $83 million as of January 2022, reflecting the receipt of the Roche upfront payment [41] - The company intends to continue its efficient spending strategy while preparing for increased net spending in 2022 to advance its clinical programs [48] Q&A Session Summary Question: How will success be measured for the OPC1 trial? - The next trial for OPC1 will focus on validating a new delivery device, with an emphasis on safety and precise delivery control [57] Question: Will the outcomes differ based on the cause of cell loss? - Management confirmed that different indications will have unique characteristics, and timing of intervention is crucial for success [61][64] Question: What is the justification for delays in the OPC1 and VAC programs? - Delays were primarily due to resource allocation towards completing the Roche agreement, but development is expected to accelerate now [73][77] Question: Can Lineage commercialize OPC1 independently? - Management believes that with the right formulation and device, Lineage could handle commercialization of OPC1 [90] Question: Will future milestone payments follow a similar split as the Roche agreement? - Yes, future milestone payments are expected to follow a similar structure as the Roche agreement [94]
Lineage Cell Therapeutics(LCTX) - 2021 Q4 - Annual Report
2022-03-10 21:37
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, 2021 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 ...
Lineage Cell Therapeutics(LCTX) - 2021 Q3 - Earnings Call Transcript
2021-11-11 01:20
Financial Data and Key Metrics Changes - Total revenues for Q3 2021 were approximately $2.3 million, an increase of $1.7 million from the same period in 2020, primarily due to increased royalty revenue [25] - Total operating expenses for Q3 2021 were approximately $8.1 million, an increase of approximately $900,000 compared to the same period in 2020, mainly due to increased litigation expenses and share-based compensation [25] - The net loss attributable to the company for Q3 2021 was $7.8 million, consistent with the net loss of $7.8 million in the same period last year [25][26] Business Line Data and Key Metrics Changes - The OpRegen program showed positive clinical data, indicating potential for retinal restoration in patients with dry age-related macular degeneration [5][9] - The OPC1 program for spinal cord injury is advancing with improvements in manufacturing processes and a new delivery device [16][19] - The VAC2 cancer vaccine program is facing enrollment challenges due to COVID-19 restrictions, but efforts are being made to modernize the manufacturing process [22][23] Market Data and Key Metrics Changes - The company is positioned in the regenerative medicine market, focusing on cell therapy approaches that do not involve gene editing, which is seen as a competitive advantage [6][7] - The company anticipates significant growth in the cell therapy field, particularly with scalable allogeneic off-the-shelf approaches [29] Company Strategy and Development Direction - The company aims to become a leading cell therapy company by advancing its proprietary differentiation protocols and enhancing manufacturing capabilities [7][29] - The focus is on developing clinical programs that demonstrate meaningful clinical benefits, with an emphasis on anatomical endpoints rather than traditional metrics like visual acuity [46][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their cell therapy approaches, particularly in light of recent clinical data and upcoming FDA interactions [27][29] - The company is preparing for multiple engagements with the FDA to discuss product designations and clinical trial strategies [27][28] Other Important Information - The company ended the quarter with approximately $65 million in cash, cash equivalents, and marketable securities, providing a solid financial foundation for ongoing projects [26] - The company is actively working on improving its manufacturing processes to ensure the scalability and reproducibility of its cell therapy products [16][23] Q&A Session Summary Question: Upcoming FDA interactions for OpRegen - Management confirmed that data from the recent study will be incorporated into discussions with the FDA regarding potential designation changes and future clinical studies [31][33] Question: Improvements in OPC1 cell inject formulation - The new formulation aims to simplify the administration process, reducing handling complexity and the risk of dosing errors [36][38] Question: Impact of global supply chain issues - The company has proactively stockpiled critical materials to mitigate potential supply chain disruptions [49][50] Question: Business development discussions for additional antigens - Management refrained from providing specific details on business development activities, emphasizing a cautious approach to partnerships [52] Question: Primary endpoint for pivotal study with OpRegen - The company plans to monitor the change in geographic atrophy over time, utilizing OCT as the assessment tool [79][80]
Lineage Cell Therapeutics(LCTX) - 2021 Q3 - Quarterly Report
2021-11-10 21:16
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2021, including balance sheets, statements of operations, comprehensive loss, cash flows, and notes on key accounting policies and contingencies [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,809 | $32,585 | | Total current assets | $68,344 | $43,999 | | Total Assets | $131,212 | $107,949 | | **Liabilities & Equity** | | | | Total current liabilities | $8,791 | $7,769 | | Total Liabilities | $11,623 | $12,822 | | Total shareholders' equity | $119,589 | $95,127 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $2,270 | $571 | $3,173 | $1,471 | | Loss from operations | $(6,843) | $(6,725) | $(20,973) | $(20,565) | | Net Loss | $(7,834) | $(7,772) | $(14,080) | $(22,730) | | Net Loss Per Share (Basic & Diluted) | $(0.05) | $(0.05) | $(0.09) | $(0.15) | Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,688) | $(14,112) | | Net cash provided by investing activities | $9,891 | $12,136 | | Net cash provided by financing activities | $35,976 | $25,051 | | Net increase in cash | $28,145 | $23,039 | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) - The company is a clinical-stage biotechnology firm with three main allogeneic cell therapy programs: OpRegen for dry AMD, OPC1 for spinal cord injuries, and VAC2 for non-small cell lung cancer[21](index=21&type=chunk)[26](index=26&type=chunk) - Management has evaluated projected cash flows and believes its **$65.1 million** of cash, cash equivalents, and marketable equity securities are sufficient to fund planned operations for at least the next twelve months from the report's issuance date[36](index=36&type=chunk) - For the three and nine months ended September 30, 2021, the company recorded additional royalty revenues of approximately **$1.8 million** from a specific customer based on updated communications, which was paid in October 2021[44](index=44&type=chunk) - As of September 30, 2021, the company had issued 14,908,735 common shares for gross proceeds of **$35.9 million** under its Controlled Equity Offering Sales Agreement (ATM facility)[35](index=35&type=chunk)[95](index=95&type=chunk) - A putative class action lawsuit challenging the 2019 Asterias Merger remains pending in Delaware Chancery Court, with a five-day trial scheduled for October 2022[131](index=131&type=chunk)[132](index=132&type=chunk) The company believes the allegations lack merit[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management provides an overview of the business, critical accounting policies, and a detailed analysis of financial results for the three and nine months ended September 30, 2021, covering revenues, operating expenses, other income/expenses, and liquidity, highlighting key performance drivers and confirming sufficient liquidity [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Revenue Comparison (in thousands) | Period | 2021 | 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended Sep 30** | $2,270 | $571 | $1,699 | 298% | | **Nine Months Ended Sep 30** | $3,173 | $1,471 | $1,702 | 116% | - The significant increase in revenues for both the three and nine-month periods was primarily driven by a **$1.8 million** increase in royalties from a specific customer, based on updated communications regarding royalties due[175](index=175&type=chunk)[176](index=176&type=chunk) Operating Expense Comparison (in thousands) | Expense Category | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,811 | $3,566 | $9,136 | $9,710 | | General and administrative | $5,317 | $3,628 | $13,788 | $12,055 | - The decrease in R&D expenses for Q3 2021 was mainly due to a prior year signature fee accrual of **$1.6 million** to Cancer Research UK, partially offset by increased OPC1 program expenses[186](index=186&type=chunk) The increase in G&A expenses was primarily due to higher litigation costs related to the Asterias merger and increased share-based compensation[187](index=187&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2021, the company had **$65.1 million** in cash, cash equivalents, and marketable equity securities[205](index=205&type=chunk) - Management believes that current cash, cash equivalents, and marketable securities are sufficient to fund planned operations for at least the next twelve months[206](index=206&type=chunk) - For the nine months ended September 30, 2021, net cash used in operating activities was **$17.7 million**[209](index=209&type=chunk) Net cash provided by financing activities was **$36.0 million**, primarily from the sale of common shares (**$29.8 million** net) and proceeds from employee stock option exercises (**$6.3 million**)[213](index=213&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2021, with no material changes to internal control over financial reporting identified during the quarter - Management concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[217](index=217&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[218](index=218&type=chunk) [PART II - OTHER INFORMATION](index=45&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section details ongoing litigation, primarily a putative class action lawsuit in Delaware Chancery Court challenging the 2019 Asterias Merger, which the company believes lacks merit - The company is involved in a putative class action lawsuit filed in Delaware Chancery Court challenging the Asterias Merger, with a trial scheduled for October 2022[131](index=131&type=chunk)[132](index=132&type=chunk) - Lineage believes the allegations in the action lack merit and intends to vigorously defend the claims asserted[133](index=133&type=chunk) The company has not recorded any accrual for a contingent liability as it is not considered probable or estimable[133](index=133&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section outlines material risks and uncertainties, including those related to business operations, capital requirements, government regulation, clinical development, intellectual property, third-party dependence, and common stock [Risks Related to Business Operations and Capital Requirements](index=45&type=section&id=Risks%20Related%20to%20Business%20Operations%20and%20Capital%20Requirements) - The company has a history of significant operating losses, with a total operating loss of **$21.0 million** for the nine months ended September 30, 2021, and an accumulated deficit of **$308.1 million**[224](index=224&type=chunk) - The company will need to issue additional equity or debt to raise capital for operating expenses, and there is no assurance that such financing will be available on favorable terms, if at all[229](index=229&type=chunk) - The value of the company's investment in OncoCyte is volatile and could be negatively affected by business, regulatory, and market risks applicable to OncoCyte[242](index=242&type=chunk) [Risks Related to Government Regulation](index=50&type=section&id=Risks%20Related%20to%20Government%20Regulation) - The company's operations are subject to extensive federal and state healthcare fraud and abuse laws, and non-compliance could lead to substantial penalties[244](index=244&type=chunk) - Obtaining regulatory approvals from the FDA and foreign authorities is a lengthy, expensive, and uncertain process that is required before any products can be sold[248](index=248&type=chunk) - Commercial success is dependent on securing and maintaining reimbursement and coverage from government and private payors, which is uncertain[249](index=249&type=chunk) [Risks Related to Clinical Development and Commercial Operations](index=57&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Commercial%20Operations) - Clinical studies are costly, time-consuming, and subject to risks that could delay or prevent commercialization[269](index=269&type=chunk) Early positive results are not necessarily predictive of future success[272](index=272&type=chunk) - The COVID-19 pandemic has impacted and may continue to adversely affect clinical trial enrollment, timelines, and overall operations, including potential disruptions to the supply chain[300](index=300&type=chunk)[302](index=302&type=chunk)[304](index=304&type=chunk) - The company relies on third parties for manufacturing and conducting clinical trials[295](index=295&type=chunk) Any failure by these parties to perform their obligations could significantly delay or halt development programs[342](index=342&type=chunk) [Risks Related to our Intellectual Property](index=68&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) - The company's patent position is uncertain, and its intellectual property may be insufficient to protect its products from competition or provide meaningful commercial advantages[329](index=329&type=chunk)[330](index=330&type=chunk) - The company's success depends on its ability to obtain and enforce patents and protect trade secrets, which can be costly and time-consuming, with no guarantee of success[331](index=331&type=chunk) [Risks Pertaining to Our Common Shares](index=70&type=section&id=Risks%20Pertaining%20to%20Our%20Common%20Shares) - The market price of the company's common stock is highly volatile, which is common for biotechnology companies[348](index=348&type=chunk) - As of September 30, 2021, insiders owned approximately **24.6%** of outstanding common shares, giving them substantial influence over company matters[350](index=350&type=chunk) - Future issuance of shares, including through the ongoing at-the-market (ATM) offering, will be dilutive to existing shareholders[351](index=351&type=chunk)[354](index=354&type=chunk)
Lineage Cell Therapeutics (LCTX) Investor Presentation - Slideshow
2021-10-01 18:30
The future of cell therapy. Corporate Overview September 15, 2021 Forward-Looking Statements This presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer to buy any securities of Lineage Cell Therapeutics, Inc. ("Lineage"). This presentation includes certain information obtained from trade and statistical services, third-party publications, and other sources. Lineage has not independently verified such information and there can be no assurance as to its accu ...
Lineage Cell Therapeutics(LCTX) - 2021 Q2 - Earnings Call Transcript
2021-08-13 00:42
Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Ioana Hone – Director of Investor Relations Brian Culley – Chief Executive Officer Kevin Cook – Chief Financial Officer Conference Call Participants Kristen Kluska – Cantor Fitzgerald Joe Pantginis – H.C. Wainwright Dane Leone – RJF Operator Welcome to the Lineage Cell Therapeutics’ Second Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. An audio ...
Lineage Cell Therapeutics(LCTX) - 2021 Q2 - Quarterly Report
2021-08-12 20:21
Clinical Programs - Lineage is developing three clinical-stage allogeneic cell therapy programs: OpRegen for advanced dry age-related macular degeneration, OPC1 for subacute spinal cord injuries, and VAC2 for non-small cell lung cancer[154]. - OpRegen is currently in a Phase 1/2a clinical trial, targeting a condition that accounts for approximately 85-90% of all AMD cases, which is a leading cause of blindness in individuals over 60[154]. - OPC1's clinical trial is partially funded by the California Institute for Regenerative Medicine, focusing on spinal cord injuries[154]. - VAC2 is in a Phase 1 clinical trial funded by Cancer Research UK, targeting non-small cell lung cancer[154]. Financial Performance - Total revenues for the three months ended June 30, 2021, increased by $126,000 (33%) to $512,000 compared to $386,000 in the same period of 2020[176]. - Collaboration revenues rose by $213,000 (100%) for the three months ended June 30, 2021, primarily due to the ITI collaborative agreement[176]. - Royalties from product sales and license fees increased by $129,000 (130%) for the three months ended June 30, 2021, compared to the prior year[176]. - Grant revenues decreased by $216,000 (75%) for the three months ended June 30, 2021, due to reduced grant-related activities[176]. - Total other income for the three months ended June 30, 2021, was $2,115,000, compared to a net expense of $128,000 in the same period of 2020[192]. - The company recorded a net unrealized gain on marketable equity securities of $590,000 for the three months ended June 30, 2021, compared to an unrealized loss of $4,146,000 in the same period of 2020[194]. - For the six months ended June 30, 2021, Lineage recorded a net cash used in operating activities of $12.8 million, reflecting a loss from operations of $14.1 million[214]. - Lineage had an accumulated deficit of $300.3 million as of June 30, 2021[210]. Expenses - Research and development expenses for the three months ended June 30, 2021, were $2,931,000, an increase of $126,000 (4%) from $2,805,000 in the same period of 2020[182]. - General and administrative expenses for the three months ended June 30, 2021, increased by $628,000 (16%) to $4,536,000 compared to $3,908,000 in the same period of 2020[182]. Cash and Liquidity - As of June 30, 2021, Lineage had $68.7 million in cash, cash equivalents, and marketable equity securities, providing sufficient liquidity for planned operations for at least twelve months[210]. - Cash provided by investing activities for the six months ended June 30, 2021, was $10.0 million, primarily from sales of OncoCyte holdings[216]. - Cash provided by financing activities for the six months ended June 30, 2021, was $32.3 million, mainly from the sale of common shares[218]. Accounting and Revenue Recognition - The company recognizes revenue based on the transfer of control of products or services, following a five-step approach as per ASC 606[165]. - Revenue from government grants is recognized when related costs are incurred, as government entities do not meet the definition of a "customer" under ASC 606[166]. - Lineage assesses going concern uncertainty to ensure sufficient cash and working capital for at least one year from the issuance date of financial statements[164]. - The company has not reported significant changes to its critical accounting policies since its last annual report[157]. - Lineage's financial statements are prepared in accordance with generally accepted accounting principles in the United States, requiring management to make estimates and assumptions[156]. Taxation - Lineage recognized a deferred tax benefit of $169,000 for the six months ended June 30, 2021, primarily related to federal net operating losses[206]. - The deferred tax liability recorded in connection with the Asterias Merger amounted to $10.8 million, related to fair value adjustments for acquired assets[203]. - The company expects that deferred income tax expense or benefit will vary based on changes in the closing stock prices of OncoCyte shares[208]. - Lineage established a full valuation allowance for deferred tax assets as of December 31, 2018, due to uncertainty in realizing future tax benefits[205]. Market Impact - The COVID-19 pandemic has impacted patient enrollment in clinical trials, potentially causing delays in ongoing studies[211]. - The company expects fluctuations in other income and expenses to continue based on changes in the market price of OncoCyte shares, impacting net income or loss reported[197].