Lineage Cell Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Lineage Cell Therapeutics, Inc. has submitted its annual 10-K filing for the fiscal year ending December 31, 2023.</b>

AI Summary

Lineage Cell Therapeutics, Inc. (LCTX) filed a Annual Report (10-K) with the SEC on March 7, 2024. Lineage Cell Therapeutics, Inc. filed its 2023 Form 10-K on March 7, 2024. The filing covers the fiscal year ending December 31, 2023. The company is incorporated in California and operates in the Biological Products sector. Key dates mentioned include fiscal year end December 31, 2023, and filing date March 7, 2024. The company's principal business address is in Carlsbad, California.

Why It Matters

For investors and stakeholders tracking Lineage Cell Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Lineage Cell Therapeutics' financial performance, business operations, and risk factors for the fiscal year 2023, crucial for investors to assess the company's current standing and future prospects. The detailed financial data and disclosures within the 10-K are essential for understanding the company's strategic direction, including its product development pipeline, collaborations, and market position within the biotechnology industry.

Risk Assessment

Risk Level: low — Lineage Cell Therapeutics, Inc. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant negative news or events, indicating a routine disclosure.

Analyst Insight

Review the full 10-K filing for detailed financial statements, management discussion and analysis, and risk factors to understand Lineage Cell Therapeutics' performance and outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-07 — Filing Date (Filed as of date)
• 0000876343 — Central Index Key (Filer's central index key)
• 2836 — Standard Industrial Classification (SIC code for Biological Products)
• 943127919 — IRS Number (Filer's IRS number)
• CA — State of Incorporation (State where the company is incorporated)
• 001-12830 — SEC File Number (SEC file number for the filing)

Key Players & Entities

• Lineage Cell Therapeutics, Inc. (company) — Filer name
• LCTX (company) — Ticker symbol
• 2024-03-07T00:00:00.000Z (date) — Filing date
• 2023-12-31 (date) — Fiscal year end
• BIOTIME INC (company) — Former company name
• 1993-03-28 (date) — Date of name change
• CARLSBAD (location) — Business address city
• CA (location) — Business address state

FAQ

Industry Context

Lineage Cell Therapeutics operates within the Biological Products industry, focusing on the development and commercialization of cell therapies.

Regulatory Implications

The company is subject to regulations governing the biotechnology and pharmaceutical sectors, including those overseen by the U.S. Securities and Exchange Commission (SEC) for financial reporting.

What Investors Should Do

1. Thoroughly review the financial statements and Management's Discussion and Analysis (MD&A) section of the 10-K for a detailed understanding of Lineage Cell Therapeutics' financial health and operational performance in FY2023.
2. Analyze the Risk Factors section to identify potential challenges and uncertainties that could impact the company's future operations and stock value.
3. Examine any disclosures related to collaborations, partnerships, or significant agreements to understand their potential impact on revenue and strategic growth.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-07: Filing Date — Date the 10-K was officially filed with the SEC.
• 1993-03-28: Name Change Date — Date the company changed its name from BIOTIME INC.

Year-Over-Year Comparison

This filing represents the annual update for the fiscal year 2023, providing a comprehensive year-end financial and operational summary compared to previous periods.

Key Financial Figures

• $50.0 million — (the "Roche Agreement"), we received a $50.0 million upfront payment in January 2022 and are
• $620.0 million — eligible to receive up to an additional $620.0 million in developmental, regulatory, and comme
• $14.3 million — lopment has been supported in part by a $14.3 million grant from the California Institute for

Filing Documents

• lctx-20231231.htm (10-K) — 2984KB
• lctx-ex10_04a.htm (EX-10.04(A)) — 80KB
• lctx-ex10_04b.htm (EX-10.04(B)) — 75KB
• lctx-ex21_1.htm (EX-21.1) — 5KB
• lctx-ex23_1.htm (EX-23.1) — 5KB
• lctx-ex31_1.htm (EX-31.1) — 14KB
• lctx-ex31_2.htm (EX-31.2) — 13KB
• lctx-ex32_1.htm (EX-32.1) — 11KB
• lctx-ex97.htm (EX-97) — 60KB
• img7151888_0.jpg (GRAPHIC) — 204KB
• img7151888_1.jpg (GRAPHIC) — 522KB
• img7151888_2.jpg (GRAPHIC) — 51KB
• img7151888_3.jpg (GRAPHIC) — 49KB
• img7151888_4.jpg (GRAPHIC) — 32KB
• img7151888_5.jpg (GRAPHIC) — 16KB
• img7151888_6.jpg (GRAPHIC) — 105KB
• img9366389_0.jpg (GRAPHIC) — 11KB
• 0000950170-24-027988.txt (&nbsp;) — 15375KB
• lctx-20231231.xsd (EX-101.SCH) — 1798KB
• lctx-20231231_htm.xml (XML) — 2267KB

Business

Business 5 Item 1A

Risk Factors

Risk Factors 33 Item 1B Unresolved Staff Comments 76 Item 1C Cybersecurity 76 Item 2

Properties

Properties 77 Item 3

Legal Proceedings

Legal Proceedings 77 Item 4 Mine Safety Disclosures 77 Part II. Item 5 Market For Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 78 Item 6 Reserved 78 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 79 Item 7A

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 89 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 90 Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 127 Item 9A

Controls and Procedures

Controls and Procedures 127 Item 9B Other Information 128 Item 9C Disclosure Regarding Foreign Jurisdictions that Present Inspections 128 Part III. Item 10 Directors, Executive Officers, and Corporate Governance 129 Item 11

Executive Compensation

Executive Compensation 129 Item 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 129 Item 13 Certain Relationships and Related Transactions, and Director Independence 129 Item 14 Principal Accountant Fees and Services 129 Part IV. Item 15 Exhibits and Financial Statements Schedules 130 Item 16 Form 10-K Summary 133

Signatures

Signatures 134 i P ART I

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. "Business," Part I, Item 1A. "Risk Factors," and Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations," but are also contained elsewhere in this report. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements in this report include, but are not limited to, statements about: the potential to receive developmental, regulatory, and commercialization milestone and royalty payments under our Collaboration and License Agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc.; our plans to research, develop and commercialize our product candidates; the initiation, progress, success, cost and timing of our clinical trials and other product development activities; the therapeutic potential of our product candidates, and the indications for which we intend to develop our product candidates; our ability to successfully manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing

BUSINESS

ITEM 1. BUSINESS Overview We are a clinical-stage biotechnology company developing novel allogeneic, or "off-the-shelf," cell therapies to address unmet medical needs. Our programs are based on our proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, we design, develop, manufacture, and test specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. The cells we manufacture are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages which are relevant to the underlying condition are transplanted into patients in an effort to (a) replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and (b) restore or augment the patient's functional activity. Our business strategy is to efficiently leverage our technology platform and our development, formulation, delivery, and manufacturing capabilities to advance our programs internally or in conjunction with strategic partners to further enhance their value and probability of success. A significant area of focus is a collaboration we entered into with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively or individually, "Roche" or "Genentech"), under which our lead cell therapy program known as OpRegen , is being developed for the treatment of ocular disorders, including geographic atrophy ("GA") secondary to age-related macular degeneration ("AMD"). OpRegen (also known as RG6501) is a suspension of human allogeneic retinal pigmented epithelial ("RPE") cells and is currently being evaluated in a Phase 2a multicenter clinical trial in patients with GA secondary to AMD.

View Full Filing

View this 10-K filing on SEC EDGAR