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Lineage Cell Therapeutics(LCTX) - 2021 Q1 - Quarterly Report
2021-05-13 20:21
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, 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) California 94-3127919 (Stat ...
Lineage Cell Therapeutics(LCTX) - 2020 Q4 - Earnings Call Transcript
2021-03-12 01:27
Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q4 2020 Earnings Conference Call March 11, 2021 4:30 PM ET Company Participants Ioana Hone – Director-Investor Relations Brian Culley – Chief Executive Officer Brandi Roberts – Chief Financial Officer Conference Call Participants Joe Pantginis – H.C. Wainwright Jason McCarthy – Maxim Group Keay Nakae – Chardan Operator Ladies and gentlemen welcome to the Lineage Cell Therapeutics' Fourth Quarter and Year End 2020 Conference Call. At this time, all participants are ...
Lineage Cell Therapeutics(LCTX) - 2020 Q4 - Annual Report
2021-03-11 21:21
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, 2020 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) Investor Presentation - Slideshow
2021-01-20 21:12
The future of cell therapy. Corporate Overview January 6, 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 accurac ...
Lineage Cell Therapeutics(LCTX) - 2020 Q3 - Earnings Call Transcript
2020-11-05 04:08
Financial Data and Key Metrics Changes - Total revenues for Q3 2020 were $600,000, consistent with the same period last year, with an increase of $200,000 in royalties offset by decreases in grant revenues and research product sales [64][65] - Total operating expenses decreased to approximately $7.2 million from $8.9 million in Q3 2019, with R&D expenses down to $3.6 million from $4.3 million [66][67] - Net loss attributable to Lineage for Q3 2020 was $7.8 million or $0.05 per share, compared to a net loss of $16.5 million or $0.11 per share in the same period in 2019 [73] Business Line Data and Key Metrics Changes - R&D expenses for OpRegen decreased by $1.5 million due to reduced manufacturing activity, while VAC program expenses increased by $1.8 million due to a signature fee related to Cancer Research UK [66][67] - G&A expenses decreased to $3.6 million from $4.6 million, primarily due to reductions in compensation and merger-related expenses [69] Market Data and Key Metrics Changes - The company estimates nearly 2 million people in the US suffer from advanced dry AMD, representing a substantial market opportunity for OpRegen, projected to be several billion dollars [17][18] - The VAC2 program is positioned to address non-small cell lung cancer, with potential market opportunities exceeding $1 billion [83] Company Strategy and Development Direction - The company aims to grow into a leading allogeneic cell therapy company, focusing on generating compelling clinical data and developing pre-commercial manufacturing capabilities [8][11] - Lineage is modernizing its manufacturing processes to enhance the commercial viability of its products and facilitate partnerships with larger corporations [56][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming milestones, including data releases for OpRegen and updates on the OPC1 program, which are expected to create significant shareholder value [11][60] - The company is well-capitalized with $38 million in cash and marketable securities, allowing it to fund operations into 2022 [74][75] Other Important Information - The company has not conducted traditional equity financing in over three years, relying instead on cost reductions and timely sales of marketable securities [80] - Lineage is exploring potential grant support from California's Proposition 14, which could provide non-dilutive capital for its programs [92] Q&A Session Summary Question: Can you provide clarity on the OPC1 program and its manufacturing improvements? - Management plans to share specific data on manufacturing improvements in early December, highlighting advancements in scale and purity [93][94] Question: How does the recent AbbVie fast track for spinal cord injury impact Lineage? - Management views AbbVie's involvement as validation of the commercial opportunity in spinal cord injury, but emphasizes the unique advantages of their oligodendrocyte therapy [95][99] Question: Will there be updates on the OpRegen data and patient outcomes? - A comprehensive update on OpRegen data will be provided, focusing on patients that represent future customers for the therapy [108] Question: Are there plans to explore other cancer types for the VAC2 program? - Management is considering other tumor types for the VAC2 program, as the current focus on non-small cell lung cancer may not be the most effective application for their antigen [111]
Lineage Cell Therapeutics(LCTX) - 2020 Q3 - Quarterly Report
2020-11-04 21:15
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 September 30, 2020 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. 2173 Salk Avenue, Suite 200 Carlsbad, California 92008 (Address of principal e ...
Lineage Cell Therapeutics (LCTX) Investor Presentation - Slideshow
2020-09-17 18:30
The future of cell therapy. Corporate Overview Brian M. Culley, Chief Executive Officer September 14, 2020 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 ...
Lineage Cell Therapeutics (LCTX) Presents At LD Micro 500 Virtual Investor Conference - Slideshow
2020-09-01 21:24
The future of cell therapy. LD Micro 500 Virtual Investor Conference Brian M. Culley, Chief Executive Officer September 1, 2020 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 ...
Lineage Cell Therapeutics(LCTX) - 2020 Q2 - Earnings Call Transcript
2020-08-07 02:38
Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q2 2020 Earnings Conference Call August 6, 2020 5:30 PM ET Corporate Participants Ioana Hone - Director, Investor Relations Brian Culley - Chief Executive Officer Brandi Roberts - Chief Financial Officer Gary Hogge - Senior Vice President, Clinical and Medical Affairs Conference Call participants Joe Pantginis - H.C. Wainwright Dane Leone - Raymond James Operator Welcome to the Lineage Cell Therapeutics Second Quarter 2020 Conference Call. At this time, all partic ...
Lineage Cell Therapeutics(LCTX) - 2020 Q2 - Quarterly Report
2020-08-06 20:16
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides an overview of the company's financial statements and management's analysis of its performance [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents Lineage Cell Therapeutics' unaudited condensed consolidated financial statements as of June 30, 2020 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,676 | $9,497 | | Marketable equity securities | $7,575 | $21,219 | | Total current assets | $46,200 | $57,519 | | Total Assets | $112,080 | $125,478 | | **Liabilities & Equity** | | | | Total current liabilities | $7,519 | $6,494 | | Total Liabilities | $14,387 | $14,231 | | Total shareholders' equity | $97,693 | $111,247 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $386 | $779 | $900 | $1,707 | | Loss from operations | $(6,402) | $(10,821) | $(13,840) | $(23,582) | | Net (Loss)/Income | $(6,530) | $(30,052) | $(14,958) | $9,244 | | Net (Loss)/Income per Share (Basic) | $(0.04) | $(0.20) | $(0.10) | $0.07 | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,265) | $(18,981) | | Net cash provided by investing activities | $11,958 | $2,752 | | Net cash provided by financing activities | $493 | $543 | | Net increase (decrease) in cash | $3,148 | $(15,603) | [Note 1: Organization and Business Overview](index=9&type=section&id=Note%201%3A%20Organization%20and%20Business%20Overview) This note describes Lineage's focus on developing novel cell therapies for degenerative retinal diseases, neurological conditions, and cancer - Lineage is a clinical-stage biotechnology company focused on developing novel cell therapies for degenerative retinal diseases, neurological conditions, and cancer[21](index=21&type=chunk) - The company has three allogeneic cell therapy programs in clinical development: OpRegen for dry AMD, OPC1 for spinal cord injuries, and VAC2 for non-small cell lung cancer[22](index=22&type=chunk)[27](index=27&type=chunk) - As of June 30, 2020, Lineage held a **5.4% ownership stake** in OncoCyte Corporation, representing approximately **3.6 million shares**[28](index=28&type=chunk) [Note 2: Basis of Presentation, Liquidity and Summary of Significant Accounting Policies](index=10&type=section&id=Note%202%3A%20Basis%20of%20Presentation%2C%20Liquidity%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note details Lineage's financial position, liquidity, and accounting policies as of June 30, 2020 - As of June 30, 2020, Lineage had **working capital of $38.7 million** and an **accumulated deficit of $288.3 million**[36](index=36&type=chunk) - Management believes its cash, cash equivalents, marketable securities, and access to capital are sufficient to fund planned operations for at least the next twelve months[36](index=36&type=chunk) - The company entered into a Controlled Equity Offering Sales Agreement in May 2020, allowing it to raise up to **$25.0 million** in at-the-market transactions, with no sales made as of June 30, 2020[35](index=35&type=chunk) - A promissory note from Juvenescence, valued at **$24.4 million** as of June 30, 2020, was due on August 30, 2020, providing a potential source of liquidity[37](index=37&type=chunk) [Note 3: Asterias Merger](index=15&type=section&id=Note%203%3A%20Asterias%20Merger) This note outlines the acquisition of Asterias Biotherapeutics, Inc. and the allocation of its purchase price - On March 8, 2019, Lineage acquired Asterias Biotherapeutics, Inc. in a stock-for-stock transaction with a total purchase price valued at **$52.6 million**[63](index=63&type=chunk)[66](index=66&type=chunk) Purchase Price Allocation (in thousands) | Item | Fair Value | | :--- | :--- | | Acquired in-process research and development (IPR&D) | $46,540 | | Goodwill | $10,672 | | Net assets acquired (excluding goodwill) | $38,473 | | Total purchase price | $52,580 | - The acquired IPR&D assets consist of the OPC1 program for spinal cord injury (**$31.7 million**) and the VAC2 program for cancer immunotherapy (**$14.8 million**)[72](index=72&type=chunk) [Note 8: Accounts Payable and Accrued Liabilities](index=22&type=section&id=Note%208%3A%20Accounts%20Payable%20and%20Accrued%20Liabilities) This note details Lineage's accounts payable and accrued liabilities, including a PPP loan - In April 2020, Lineage received a **$523,000 loan** under the Paycheck Protection Program (PPP), with a substantial portion believed to be eligible for forgiveness[106](index=106&type=chunk) [Note 15: Commitments and Contingencies](index=30&type=section&id=Note%2015%3A%20Commitments%20and%20Contingencies) This note discusses Lineage's legal proceedings, licensing agreements, and future payment obligations - A putative class action lawsuit challenging the Asterias Merger was filed in October 2019, which Lineage intends to vigorously defend[171](index=171&type=chunk)[172](index=172&type=chunk) - In May 2020, Lineage exercised its option to acquire VAC2 Phase 1 clinical trial data from Cancer Research UK, involving a signature fee of **£1.25 million** and future milestone and royalty payments[175](index=175&type=chunk)[177](index=177&type=chunk) - Cell Cure's license agreement for OpRegen technology includes potential future milestone payments up to **$3.5 million** and mid-single-digit royalties on net sales[179](index=179&type=chunk)[181](index=181&type=chunk) [Note 16: Subsequent Events](index=37&type=section&id=Note%2016%3A%20Subsequent%20Events) This note reports significant events occurring after the reporting period, including a services agreement termination - On August 4, 2020, Lineage terminated a services agreement, resulting in the return of approximately **$0.8 million** in unspent project funds, to be offset against R&D expenses in Q3 2020[186](index=186&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes Lineage's financial performance, liquidity, and capital resources for the three and six months ended June 30, 2020 [Results of Operations](index=41&type=section&id=Results%20of%20Operations) This section compares Lineage's revenues and operating expenses for the three and six months ended June 30, 2020 Comparison of Revenues (in thousands) | Revenue Source | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | $386 | $779 | (50)% | | **Revenue Source** | **Six Months Ended June 30, 2020** | **Six Months Ended June 30, 2019** | **Change (%)** | | Total Revenues | $900 | $1,707 | (47)% | - The decrease in revenue was primarily due to reduced grant-related activities and the cessation of sales of research products and services[205](index=205&type=chunk)[206](index=206&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $2,805 | $5,235 | (46)% | | General and administrative | $3,908 | $6,258 | (38)% | | **Expense Category** | **Six Months Ended June 30, 2020** | **Six Months Ended June 30, 2019** | **Change (%)** | | Research and development | $6,144 | $10,196 | (40)% | | General and administrative | $8,427 | $14,918 | (44)% | - R&D expenses decreased significantly due to reduced manufacturing activities for the OpRegen program and lower development activities for the OPC1 program post-merger[214](index=214&type=chunk)[219](index=219&type=chunk) - G&A expenses decreased primarily due to a reduction in Asterias Merger-related expenses, lower compensation costs, and reduced accounting and investor relations expenses[216](index=216&type=chunk)[217](index=217&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses Lineage's cash position, funding sufficiency, and the impact of the COVID-19 pandemic - As of June 30, 2020, the company had **$20.3 million** in cash, cash equivalents, and marketable equity securities[239](index=239&type=chunk) - Management believes current cash, marketable securities, and access to capital are sufficient to fund planned operations for at least the next twelve months[240](index=240&type=chunk) - The COVID-19 pandemic has impacted patient enrollment in the OpRegen and VAC2 clinical trials, potentially causing delays or adverse effects[244](index=244&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2020, was **$9.3 million**, a significant reduction from **$19.0 million** in the same period of 2019[247](index=247&type=chunk)[248](index=248&type=chunk) [PART II - OTHER INFORMATION](index=48&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers non-financial information, primarily focusing on risk factors affecting the company [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section identifies significant risks to Lineage's business, including operational, regulatory, and financial challenges - The company has a history of significant operating losses, with an **accumulated deficit of $288.3 million** as of June 30, 2020, and expects substantial losses for the foreseeable future[262](index=262&type=chunk) - The ongoing COVID-19 pandemic may adversely affect operations by delaying patient enrollment in clinical trials for OpRegen and VAC2 and disrupting the supply chain[348](index=348&type=chunk)[352](index=352&type=chunk)[354](index=354&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards of approximately **$164.0 million** (federal) and **$121.1 million** (state) may be limited due to ownership changes, including the Asterias merger[271](index=271&type=chunk)[272](index=272&type=chunk) - Risks related to international operations, particularly through its subsidiary Cell Cure in Israel, include Israeli government grant regulations that may restrict technology transfer and manufacturing outside of Israel[365](index=365&type=chunk)[369](index=369&type=chunk)[374](index=374&type=chunk)