Lineage Cell Therapeutics(LCTX)

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Lineage Cell Therapeutics(LCTX) - 2020 Q2 - Quarterly Report
2020-08-06 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 June 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. California 94-3127919 (State or other jurisdiction of incorporation or organization) ...
Lineage Cell Therapeutics (LCTX) Presents At 2020 Solebury Trout Virtual Investor Conference - Slideshow
2020-05-29 21:18
The future of cell therapy. 2020 Solebury Trout Virtual Investor Conference Brian M. Culley, Chief Executive Officer May 26, 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 verifi ...
Lineage Cell Therapeutics(LCTX) - 2020 Q1 - Earnings Call Transcript
2020-05-08 02:20
Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q1 2020 Earnings Conference Call May 7, 2020 4:30 PM ET Company Participants Ioana Hone - Director, IR Brian Culley - CEO Brandi Roberts - CFO Conference Call Participants Jason McCarthy - Maxim Group Joe Pantginis - H.C. Wainwright Operator Welcome to the Lineage Cell Therapeutics First Quarter 2020 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 website at w ...
Lineage Cell Therapeutics(LCTX) - 2020 Q1 - Quarterly Report
2020-05-07 20:27
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, 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) California 94-3127919 (Stat ...
Lineage Cell Therapeutics(LCTX) - 2019 Q4 - Earnings Call Transcript
2020-03-13 01:55
Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q4 2019 Earnings Conference Call March 12, 2020 4:30 PM ET Company Participants Ioana Hone - Director of 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 Keay Nakae - Chardan Capital Operator Ladies and gentlemen, welcome to the Lineage Cell Therapeutics Fourth Quarter and Full Year 2019 Fi ...
Lineage Cell Therapeutics(LCTX) - 2019 Q4 - Annual Report
2020-03-12 20:26
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, 2019 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 Therapeutic (LCTX) Investor Presentation - Slideshow
2020-01-14 15:37
Company Overview - Lineage Cell Therapeutics is a clinical-stage cell therapy company focused on manufacturing and transplanting various cell types to treat injuries and diseases[3] - The company possesses a world-class in-house GMP manufacturing capability and one of the largest patent portfolios in cell therapy[4, 9] - Lineage has a cost-efficient business model and is funded into 2021, assuming the payment of a $24.6 million note receivable from Juvenescence[4, 76] Clinical Programs - The company has three allogeneic ("off-the-shelf") treatments for three serious conditions: OpRegen for Dry AMD, OPC1 for Spinal Cord Injury, and VAC2 for Non-Small Cell Lung Cancer[4] - OpRegen has received $16 million in partnerships and external funding[6] - OPC1 has received over $14 million from CIRM[6, 52] - VAC2 has received over $10 million in-kind[6] OpRegen (Dry AMD) - OpRegen is a cell therapy product candidate for Dry Age-Related Macular Degeneration (AMD), which affects approximately 11 million people in the United States[13, 43] - In a Phase I/IIa clinical trial, some patients showed signs of structural improvement in the retina and decreases in drusen density[42] - Cohort 4 patients in the OpRegen Phase I/IIa trial showed improvements in Best Corrected Visual Acuity (BCVA), with some subjects gaining up to 25 letters[28, 31, 41] OPC1 (Spinal Cord Injury) - The OPC1 program has received >$14M from CIRM[6, 52] - In a Phase 1/2a study, 96% of subjects reported improved motor function[62] - The SCiStar study showed 96% durable engraftment through 1 year post-injection[67] Financial Status - As of September 30, 2019, Lineage had $35.7 million in cash, cash equivalents, and marketable securities[76] - On January 2, 2020, the company sold $5.0 million of OncoCyte (OCX) holdings[76] - The value of remaining equity holdings in OCX was $17.0 million as of January 7, 2020[76]
Lineage Cell Therapeutics(LCTX) - 2019 Q3 - Earnings Call Transcript
2019-11-13 02:09
Lineage Cell Therapeutics, Inc. (NYSE:LCTX) Q3 2019 Earnings Conference Call November 12, 2019 4:30 PM ET Company Participants Ioana Hone - Director of IR Brian Culley - CEO Brandi Roberts - CFO Ed Wirth - CMO Gary Hogge - SVP of Clinical and Medical Affairs Conference Call Participants Pasquale Sansone - H.C. Wainwright Keay Nakae - Chardan Capital Jason Kolbert - Dawson James Joanne Lee - Maxim Group Operator Welcome to the Lineage Cell Therapeutics Third Quarter 2019 Conference Call. At this time, all pa ...
Lineage Cell Therapeutics(LCTX) - 2019 Q3 - Quarterly Report
2019-11-12 21:51
[PART I - FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's financial statements and management's discussion and analysis [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited financial statements for the nine months ended September 30, 2019, reflect significant changes from the Asterias acquisition, impacting assets, net loss, and cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2019 (Unaudited) | Dec 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $14,366 | $23,587 | | Marketable equity securities | $21,318 | $7,154 | | Goodwill | $12,977 | $0 | | Intangible assets, net | $48,746 | $3,125 | | **Total Assets** | **$132,978** | **$101,660** | | Total Liabilities | $17,459 | $9,414 | | **Total Shareholders' Equity** | **$115,519** | **$92,246** | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $567 | $982 | $2,274 | $4,230 | | Research and development | $4,266 | $4,882 | $14,462 | $17,175 | | General and administrative | $4,609 | $6,422 | $19,527 | $17,585 | | Loss from operations | ($8,422) | ($10,357) | ($32,004) | ($31,580) | | Total other (expense) income, net | ($9,084) | $76,901 | $18,110 | $29,780 | | **Net (Loss)/Income Attributable to Lineage** | **($16,505)** | **$66,725** | **($7,227)** | **($1,038)** | | **Net (Loss)/Income Per Share (Basic & Diluted)** | **($0.11)** | **$0.53** | **($0.05)** | **($0.01)** | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($26,424) | ($25,070) | | Net cash provided by investing activities | $16,237 | $2,032 | | Net cash provided by financing activities | $622 | $5,680 | | **Net Decrease in Cash** | **($9,437)** | **($17,398)** | [Business Overview and Significant Transactions](index=11&type=section&id=Notes%20to%20Financial%20Statements%20-%20Business%20Overview%20and%20Significant%20Transactions) Lineage, a clinical-stage biotech, significantly altered its 2019 financial position through the Asterias Biotherapeutics acquisition and prior AgeX deconsolidation - The company's core focus is on three clinical-stage cell therapy programs: OpRegen for dry-AMD, OPC1 for acute spinal cord injuries, and VAC2 for non-small cell lung cancer[26](index=26&type=chunk)[33](index=33&type=chunk) - On March 8, 2019, Lineage acquired the remaining outstanding shares of Asterias Biotherapeutics, making it a wholly-owned subsidiary through a stock-for-stock transaction[10](index=10&type=chunk)[31](index=31&type=chunk) - The Asterias Merger was accounted for as a business combination with a total purchase price of **$52.6 million**, resulting in **$13.0 million** in goodwill and **$46.5 million** in acquired in-process research and development (IPR&D) assets[74](index=74&type=chunk)[79](index=79&type=chunk) - In August 2018, Lineage sold a large portion of its AgeX common stock to Juvenescence, reducing its ownership from **80.4% to 40.2%** and leading to the deconsolidation of AgeX, followed by a distribution of remaining AgeX shares to Lineage's shareholders in November 2018[12](index=12&type=chunk)[13](index=13&type=chunk)[111](index=111&type=chunk) [Significant Accounting Policies](index=12&type=section&id=Notes%20to%20Financial%20Statements%20-%20Significant%20Accounting%20Policies) Key accounting policies include the adoption of ASC 842 for leases, ASC 805 for business combinations, and fair value accounting for marketable equity securities - Adopted new lease standard ASC 842 on January 1, 2019, using the modified retrospective method, resulting in the recognition of right-of-use (ROU) assets and lease liabilities for leases with terms greater than twelve months[59](index=59&type=chunk)[60](index=60&type=chunk) - Business combinations are accounted for using the acquisition method (ASC 805), where the purchase price is allocated to the fair value of tangible and intangible assets acquired and liabilities assumed, with any excess recorded as goodwill[45](index=45&type=chunk)[207](index=207&type=chunk) - Holdings in OncoCyte, AgeX, and HBL are accounted for as marketable equity securities, measured at fair value with unrealized gains and losses reported in the consolidated statements of operations[46](index=46&type=chunk)[47](index=47&type=chunk) - Government grants are accounted for under ASC 730-20, with grant revenue recognized as related research and development expenses are incurred, as repayment is not required unless the R&D is successful[52](index=52&type=chunk) [Commitments and Contingencies](index=39&type=section&id=Notes%20to%20Financial%20Statements%20-%20Commitments%20and%20Contingencies) The company faces significant lease commitments, ongoing litigation related to the Asterias Merger, and royalty obligations on future product sales - A putative shareholder class action lawsuit challenging the Asterias Merger was filed in February 2019 and dismissed in August 2019 after a settlement of attorneys' fees, but a new, similar lawsuit was filed in Delaware Chancery Court on October 14, 2019[184](index=184&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk) - The company entered into a lease for new corporate headquarters in Carlsbad, California, commencing August 1, 2019[171](index=171&type=chunk) Future Minimum Lease Commitments (in thousands) | Year Ending Dec 31, | Operating Leases | Finance Leases | | :--- | :--- | :--- | | 2019 | $339 | $11 | | 2020 | $1,589 | $43 | | 2021 | $1,528 | $36 | | 2022 | $1,508 | $36 | | 2023 | $397 | $15 | | Thereafter | $1,015 | - | | **Total Lease Payments** | **$6,376** | **$141** | - An agreement with Orbit Biomedical for its subretinal injection device requires Lineage to pay aggregate access fees of **$2.5 million**, all of which was paid by August 2019[182](index=182&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=45&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%20(MD%26A)) MD&A details financial changes post-Asterias merger and AgeX deconsolidation, highlighting revenue decline, mixed operating expenses, and sufficient liquidity for the next twelve months [Results of Operations](index=48&type=section&id=MD%26A%20-%20Results%20of%20Operations) Results of operations show a **46%** revenue decrease, a **16%** R&D expense reduction, and an **11%** G&A expense increase, influenced by the Asterias merger and equity investment volatility Revenue Comparison (in thousands) | Revenue Source | 9M 2019 | 9M 2018 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Grant revenue | $1,628 | $2,985 | ($1,357) | (45)% | | Royalties and license fees | $390 | $312 | $78 | 25% | | Subscription and advertisement | $0 | $691 | ($691) | (100)% | | **Total Revenues** | **$2,274** | **$4,230** | **($1,956)** | **(46)%** | Operating Expense Comparison (in thousands) | Expense Category | 9M 2019 | 9M 2018 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $14,462 | $17,175 | ($2,713) | (16)% | | General and administrative | $19,527 | $17,585 | $1,942 | 11% | | **Total Operating Expenses** | **$33,989** | **$35,560** | **($1,571)** | **(4)%** | - The increase in G&A expenses for the nine-month period was primarily due to a **$6.1 million** increase in severance, legal, accounting, and other expenses related to the Asterias Merger[229](index=229&type=chunk) - Other income/expense is highly volatile, driven by unrealized gains/losses on equity method investments, including a **$6.7 million** gain on Asterias shares (pre-merger) and an **$8.0 million** gain on OncoCyte shares for the nine months ended Sep 30, 2019[231](index=231&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=MD%26A%20-%20Liquidity%20and%20Capital%20Resources) The company maintains **$35.7 million** in liquidity, deemed sufficient for twelve months, supported by cost-saving initiatives targeting **$16 million** net operational spend in 2020 - The company had **$35.7 million** in cash, cash equivalents, and marketable equity securities as of September 30, 2019[253](index=253&type=chunk) - Management believes current liquidity is sufficient to fund operations for at least twelve months from the report's issuance date[254](index=254&type=chunk) - Significant cost savings initiatives have been implemented, with a target net operational spend of **$16 million** for 2020, a substantial reduction from the combined **$43 million** spent by Lineage and Asterias in 2018[256](index=256&type=chunk) - Net cash used in operating activities was **$26.4 million** for the nine months ended September 30, 2019, while net cash provided by investing activities was **$16.2 million**, primarily from sales of marketable securities[258](index=258&type=chunk)[260](index=260&type=chunk) [Item 4. Controls and Procedures](index=59&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[264](index=264&type=chunk) - There were no material changes in the company's internal control over financial reporting during the third quarter of 2019[265](index=265&type=chunk) [PART II - OTHER INFORMATION](index=59&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, and other relevant corporate information [Item 1. Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) Legal proceedings information, incorporated from Note 15, details ongoing litigation related to the Asterias Merger - Information regarding legal proceedings is incorporated by reference from Note 15 of the financial statements, which discusses litigation challenging the Asterias Merger[267](index=267&type=chunk)[184](index=184&type=chunk)[186](index=186&type=chunk) [Item 1A. Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred in the risk factors previously disclosed in the company's 2018 Form 10-K - There have been no material changes from the risk factors disclosed in the company's 2018 Form 10-K[268](index=268&type=chunk) [Item 5. Other Information](index=60&type=section&id=Item%205.%20Other%20Information) The company announced its 2020 annual meeting of shareholders for June 9, 2020, with a March 11, 2020, deadline for shareholder proposals - The 2020 annual meeting of shareholders is scheduled for June 9, 2020[272](index=272&type=chunk) - The deadline for shareholder proposals for the 2020 Annual Meeting is March 11, 2020[272](index=272&type=chunk)
Lineage Cell Therapeutics (LCTX) Investor Presentation - Slideshow
2019-10-29 10:50
== LINEAGE www.lineagecell.com Corporate Presentation October 14, 2019 NYSE American: LCTX 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 ...