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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 ...
Lineage Cell Therapeutics (LCTX ) Presents At H.C. Wainwright 21st Annual Global Investment Conference - Slideshow
2019-09-10 19:11
== LINEAGE www.lineagecell.com H.C. Wainwright & Co. 21st Annual Global Investment Conference September 9, 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 veri ...
Lineage Cell Therapeutics(LCTX) - 2019 Q2 - Earnings Call Transcript
2019-08-09 03:14
BioTime, Inc (BTX) Q2 2019 Earnings Conference Call August 8, 2019 4:30 PM ET Company Participants Ioana Hone - Director, Investor Relations Brian Culley - Chief Executive Officer Brandi Roberts - Chief Financial Officer Ed Wirth - Chief Medical Officer Gary Hogge - Senior Vice President, Clinical and Medical Affairs Conference Call Participants Kevin DeGeeter - Oppenheimer Jason McCarthy - Maxim Group Joseph Pantginis - H.C. Wainwright Operator Welcome to the BioTime, Inc. Second Quarter 2019 Conference Ca ...
Lineage Cell Therapeutics(LCTX) - 2019 Q2 - Quarterly Report
2019-08-08 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, 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 1-12830 BioTime, Inc. (Exact name of registrant as specified in its charter) California 94-3127919 (State or other jurisdicti ...
Lineage Cell Therapeutics(LCTX) - 2019 Q1 - Quarterly Report
2019-05-09 20:16
PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited statements reflect the Asterias acquisition and significant unrealized gains from equity investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Total Current Assets** | $30,656 | $36,358 | | **Total Assets** | **$183,715** | **$101,660** | | **Total Current Liabilities** | $8,723 | $6,812 | | **Total Liabilities** | **$22,479** | **$9,414** | | **Total Shareholders' Equity** | **$161,236** | **$92,246** | Condensed Consolidated Statement of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--- | :--- | :--- | | **Total Revenues** | $928 | $701 | | **Loss from Operations** | $(12,761) | $(12,187) | | **Total Other Income (Expense), Net** | $47,673 | $(51,511) | | **Net Income/(Loss)** | **$39,296** | **$(63,698)** | | **Net Income/(Loss) Attributable to BioTime, Inc.** | $39,310 | $(63,548) | | **Diluted EPS** | **$0.30** | **$(0.50)** | [Note 1: Organization and Business Overview](index=9&type=section&id=1.%20Organization%20and%20Business%20Overview) The company is a clinical-stage biotech focusing on cellular therapies, recently expanding via the Asterias acquisition - The company's three primary clinical-stage cell therapy programs are **OpRegen** (dry-AMD), **OPC1** (spinal cord injury), and **VAC2** (cancer immunotherapy)[25](index=25&type=chunk)[31](index=31&type=chunk) - On March 8, 2019, BioTime completed the **acquisition of Asterias Biotherapeutics, Inc.**, which is now a wholly-owned subsidiary[27](index=27&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) - BioTime holds a significant equity stake in OncoCyte Corporation, owning **28% of its outstanding shares** as of March 31, 2019[32](index=32&type=chunk) [Note 2: Basis of Presentation, Liquidity and Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Basis%20of%20Presentation%2C%20Liquidity%20and%20Summary%20of%20Significant%20Accounting%20Policies) The company adopted the new lease standard (ASC 842) and confirms sufficient liquidity for the next twelve months - The company believes its **$27.1 million** in cash and marketable securities, plus its **$58.0 million** OncoCyte investment, provide sufficient liquidity for at least 12 months[39](index=39&type=chunk) - On January 1, 2019, the company adopted the new lease accounting standard, **ASC 842**, recognizing right-of-use (ROU) assets and lease liabilities[57](index=57&type=chunk)[62](index=62&type=chunk) - The investment in OncoCyte is accounted for using the **equity method at fair value**, with changes reported in the consolidated statements of operations[47](index=47&type=chunk) [Note 3: Asterias Merger](index=17&type=section&id=3.%20Asterias%20Merger) The acquisition of Asterias for $52.6 million resulted in $13.0 million in goodwill and $46.5 million in IPR&D assets Preliminary Purchase Price Allocation (in thousands) | Item | Value | | :--- | :--- | | Total Purchase Price | $52,580 | | Net Assets Acquired (excluding goodwill) | $36,168 | | Fair value of BioTime common stock held by Asterias | $3,435 | | **Estimated Goodwill** | **$12,977** | Acquired Intangible Assets (in thousands) | Asset | Estimated Fair Value | | :--- | :--- | | In process research and development (IPR&D) | $46,540 | | Royalty contracts | $650 | | **Total** | **$47,190** | - BioTime incurred **$3.5 million in acquisition-related costs** during the three months ended March 31, 2019, recorded in G&A expenses[94](index=94&type=chunk) [Note 4: Equity Method Accounting for OncoCyte](index=23&type=section&id=4.%20Equity%20Method%20Accounting%20for%20Common%20Stock%20of%20OncoCyte%2C%20at%20Fair%20Value) The company recognized a $37.7 million unrealized gain on its OncoCyte investment due to a stock price increase OncoCyte Investment Fair Value and Gain/(Loss) (in millions) | Date | Fair Value | Unrealized Gain/(Loss) for Quarter | | :--- | :--- | :--- | | Dec 31, 2018 | $20.3 | N/A | | Mar 31, 2019 | $58.0 | $37.7 | [Note 15: Commitments and Contingencies](index=34&type=section&id=15.%20Commitments%20and%20Contingencies) The company discloses lease commitments, a research agreement, and a shareholder lawsuit related to the Asterias Merger - A putative shareholder class action lawsuit was filed challenging the Asterias Merger, which **BioTime believes lacks merit**[176](index=176&type=chunk)[177](index=177&type=chunk) - The company entered into a Research and Option Agreement with Orbit Biomedical for its subretinal injection device, with access fees totaling **$2.5 million**[174](index=174&type=chunk) Future Minimum Lease Commitments (in thousands) | Lease Type | Total Lease Payments | Less Imputed Interest | Total Liability | | :--- | :--- | :--- | :--- | | Operating Leases | $6,237 | $(1,298) | $4,939 | | Finance Leases | $163 | $(29) | $134 | [Management's Discussion and Analysis (MD&A)](index=38&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The Asterias Merger increased operating expenses, while net income was driven by non-cash unrealized investment gains [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Q1 2019 net income of $39.3 million was driven by investment gains, despite a wider loss from operations Revenue by Source (in thousands) | Revenue Source | Q1 2019 | Q1 2018 | $ Change | | :--- | :--- | :--- | :--- | | Grant revenue | $749 | $326 | $423 | | Royalties and license fees | $86 | $136 | $(50) | | Subscription and advertisement | $- | $239 | $(239) | | Sale of research products | $93 | $- | $93 | | **Total Revenues** | **$928** | **$701** | **$227** | Operating Expenses (in thousands) | Expense Category | Q1 2019 | Q1 2018 | $ Change | | :--- | :--- | :--- | :--- | | Research and development | $4,961 | $5,935 | $(974) | | General and administrative | $8,660 | $6,044 | $2,616 | | **Total Operating Expenses** | **$13,621** | **$12,779** | **$842** | - The **$2.6 million increase in G&A expenses** was primarily due to $3.5 million in costs related to the Asterias Merger[211](index=211&type=chunk) - The swing to net income was driven by a **$37.7 million unrealized gain** on the OncoCyte investment and a **$6.7 million unrealized gain** on the Asterias investment[213](index=213&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) The company has sufficient liquidity for the next year with $27.1 million in cash and a $58.0 million OncoCyte investment - The company holds **$27.1 million in cash**, cash equivalents, and marketable securities, and a **$58.0 million stake in OncoCyte** as of March 31, 2019[234](index=234&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2019 | | :--- | :--- | | Net Cash Used in Operating Activities | $(9,314) | | Net Cash Provided by Investing Activities | $2,946 | | Net Cash Provided by Financing Activities | $606 | | **Net Decrease in Cash** | **$(5,709)** | - Cash from investing activities was primarily driven by **$3.1 million in cash acquired** in the Asterias Merger[240](index=240&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes in internal controls - Management concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2019[244](index=244&type=chunk) - **No material changes** occurred during the quarter that affected the company's internal control over financial reporting[245](index=245&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a class action lawsuit from former Asterias shareholders challenging the recent merger - A putative class action lawsuit was filed by former Asterias shareholders challenging the merger, alleging **unfair consideration and an unfair process**[248](index=248&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) No material changes were reported to the risk factors disclosed in the 2018 Annual Report on Form 10-K - **No material changes** have been made to the risk factors disclosed in the 2018 Form 10-K[249](index=249&type=chunk)
Lineage Cell Therapeutics(LCTX) - 2018 Q4 - Annual Report
2019-03-14 20:16
Part I [Business](index=5&type=section&id=Item%201.%20Business) BioTime, Inc. is a clinical-stage biotechnology company developing cellular therapies for degenerative diseases and cancer, advancing its clinical pipeline and leveraging equity stakes for funding Clinical Development Programs | Product Candidate | Indication | Clinical Phase | Funder/Collaborator | |---|---|---|---| | **OpRegen®** | Advanced dry Age-Related Macular Degeneration (dry-AMD) | Phase I/IIa | BioTime | | **OPC1** | Acute Spinal Cord Injuries | Phase I/IIa | Partially funded by CIRM | | **VAC2** | Non-Small Cell Lung Cancer | Phase I | Funded by Cancer Research UK | - In March 2019, BioTime completed its acquisition of Asterias Biotherapeutics, Inc., thereby incorporating the OPC1 and VAC2 clinical programs into its portfolio[23](index=23&type=chunk)[39](index=39&type=chunk) Key Equity Holdings (as of March 13, 2019) | Company | Ownership | Value | Note | |---|---|---|---| | OncoCyte Corporation (OCX) | ~28% | Based on closing stock price | Focused on cancer diagnostics | | AgeX Therapeutics, Inc. (AGE) | ~4.8% | Based on closing stock price | Focused on regenerative biology and aging | | Juvenescence Limited | N/A | $21.6M + interest | Value from a convertible promissory note | - The combined value of BioTime's holdings in OncoCyte, AgeX, and the Juvenescence note was approximately **$85.5 million** as of March 13, 2019, representing a significant potential source of capital[21](index=21&type=chunk) - BioTime's business strategy includes completing the integration of Asterias, advancing its three clinical programs, and monetizing its equity assets in OncoCyte, AgeX, and Juvenescence to fund operations[40](index=40&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including historical operating losses, dependence on external funding, clinical trial uncertainties, and challenges integrating acquired operations Operating Losses and Accumulated Deficit | Metric | 2018 | 2017 | |---|---|---| | **Operating Loss** | $41.8 million | $38.9 million | | **Accumulated Deficit (as of Dec 31, 2018)** | $262 million | N/A | - The company has a history of **operating losses** and will need to issue additional equity or debt to fund operations, which could result in **shareholder dilution** or restrictive covenants[170](index=170&type=chunk)[173](index=173&type=chunk) - The **successful integration of Asterias** is critical and presents challenges in consolidating functions, technologies, and cultures, which could divert management attention and resources[175](index=175&type=chunk)[176](index=176&type=chunk) - The value of investments in publicly-listed companies like OncoCyte and AgeX is subject to **stock price fluctuations** and could be negatively impacted by their business performance[191](index=191&type=chunk) - Clinical studies are **costly, time-consuming**, and subject to **risks of delay or failure**. The company relies on third parties like Contract Research Organizations (CROs) to conduct these trials[214](index=214&type=chunk)[262](index=262&type=chunk) - The company's Israeli subsidiary, Cell Cure, has received government grants that impose **conditions on manufacturing and technology transfer** outside of Israel, which could restrict future business agreements[235](index=235&type=chunk)[236](index=236&type=chunk) [Unresolved Staff Comments](index=60&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[280](index=280&type=chunk) [Properties](index=60&type=section&id=Item%202.%20Properties) BioTime's principal offices and labs are located in Alameda, California, occupying 30,795 square feet, which it shares with affiliates AgeX and OncoCyte, while its subsidiary Cell Cure leases approximately 17,896 square feet in Jerusalem, Israel - The main facility in Alameda, CA comprises **30,795 sq. ft.** and is shared with affiliates OncoCyte and AgeX[281](index=281&type=chunk) - Subsidiary Cell Cure leases a total of 1,662.5 square meters (~**17,896 sq. ft.**) of office and laboratory space in Jerusalem, Israel, including a new facility to support cGMP manufacturing[282](index=282&type=chunk)[283](index=283&type=chunk) [Legal Proceedings](index=60&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in a putative class action lawsuit filed in February 2019 on behalf of Asterias shareholders, challenging the fairness of the merger consideration and alleging material omissions - A **putative class action lawsuit** was filed on February 19, 2019, by Asterias shareholders challenging the recent merger with BioTime[285](index=285&type=chunk) - The lawsuit alleges **breach of fiduciary duty**, claiming the merger consideration was unfair and the joint proxy statement omitted material information, with plaintiffs seeking **injunctive relief or rescissory damages**[285](index=285&type=chunk) [Mine Safety Disclosures](index=60&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[286](index=286&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=61&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) BioTime's common stock is traded on the NYSE American and the Tel Aviv Stock Exchange, with 16,538 shareholders as of February 2019, and the company does not anticipate paying cash dividends - The company's common stock trades on the **NYSE American** and **Tel Aviv Stock Exchange** under the ticker BTX[288](index=288&type=chunk) - As of February 15, 2019, there were **16,538** common shareholders[289](index=289&type=chunk) - The company has **not paid dividends** and does not plan to in the foreseeable future, retaining earnings for operations[290](index=290&type=chunk) [Selected Financial Data](index=61&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, BioTime is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide selected financial data[292](index=292&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=62&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenues increased in 2018 driven by grant revenue, while operating expenses rose due to G&A increases, and net loss was significantly impacted by non-cash gains and losses on equity investments Revenues Comparison (in thousands) | Revenue Source | 2018 | 2017 | Change ($) | Change (%) | |---|---|---|---|---| | Grant revenue | $3,572 | $1,666 | $1,906 | 114.4% | | Subscription and advertising | $691 | $1,395 | ($704) | (50.5%) | | Other | $725 | $397 | $328 | 82.6% | | **Total revenues** | **$4,988** | **$3,458** | **$1,530** | **44.2%** | Operating Expenses Comparison (in thousands) | Expense Category | 2018 | 2017 | Change ($) | Change (%) | |---|---|---|---|---| | Research and development | $21,755 | $24,024 | ($2,269) | (9.4%) | | General and administrative | $24,726 | $19,922 | $4,804 | 24.1% | Key Other Income/(Expenses), Net (in thousands) | Item | 2018 | 2017 | |---|---|---| | Gain on sale/deconsolidation of AgeX | $78,511 | - | | Gain on deconsolidation of OncoCyte | - | $71,697 | | Loss on equity method investment in OncoCyte | ($47,985) | ($2,935) | | Loss on equity method investment in Asterias | ($35,449) | ($51,107) | - As of December 31, 2018, the company had **$23.6 million** in cash and cash equivalents and held OncoCyte shares valued at **$20.3 million**. Management believes these resources are sufficient to fund operations for at least the next 12 months[373](index=373&type=chunk)[374](index=374&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=76&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, BioTime is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide disclosures about market risk[381](index=381&type=chunk) [Financial Statements and Supplementary Data](index=77&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2018 and 2017, including balance sheets, statements of operations, and cash flows - This section includes the index to and the full consolidated financial statements and supplementary data for BioTime, Inc. and its subsidiaries[383](index=383&type=chunk) Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2018 | Dec 31, 2017 | |---|---|---| | **Total Assets** | **$101,660** | **$173,241** | | Cash and cash equivalents | $23,587 | $36,838 | | Equity method investments (OncoCyte & Asterias) | $33,733 | $117,167 | | **Total Liabilities** | **$9,414** | **$8,978** | | **Total Shareholders' Equity** | **$92,246** | **$164,263** | Consolidated Statement of Operations Highlights (in thousands) | Account | Year Ended Dec 31, 2018 | Year Ended Dec 31, 2017 | |---|---|---| | Total revenues | $4,988 | $3,458 | | Loss from operations | ($41,795) | ($38,902) | | Total other income (expenses), net | ($5,335) | $15,613 | | **Net Loss** | **($46,784)** | **($23,289)** | | **Net Loss Attributable to BioTime, Inc.** | **($45,990)** | **($19,976)** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=127&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable to the company - Not applicable[650](index=650&type=chunk) [Controls and Procedures](index=127&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal controls over financial reporting were effective as of December 31, 2018, with no material changes during the fourth quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[651](index=651&type=chunk) - Management's report on internal control over financial reporting concluded that these controls were effective as of December 31, 2018[655](index=655&type=chunk) - No material changes were made to the company's internal control over financial reporting during the fourth quarter[652](index=652&type=chunk) [Other Information](index=128&type=section&id=Item%209B.%20Other%20Information) This item is not applicable to the company - Not applicable[657](index=657&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=128&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's 2019 Proxy Statement - Information for this section is incorporated by reference from the registrant's Proxy Statement for the 2019 Annual Meeting of Shareholders[658](index=658&type=chunk) [Executive Compensation](index=128&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's 2019 Proxy Statement - Information for this section is incorporated by reference from the registrant's Proxy Statement for the 2019 Annual Meeting of Shareholders[661](index=661&type=chunk) [Security Ownership of Certain Beneficial Owners and Management, and Related Stockholder Matters](index=128&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%2C%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of beneficial owners and management is incorporated by reference from the company's 2019 Proxy Statement - Information for this section is incorporated by reference from the registrant's Proxy Statement for the 2019 Annual Meeting of Shareholders[662](index=662&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=128&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's 2019 Proxy Statement - Information for this section is incorporated by reference from the registrant's Proxy Statement for the 2019 Annual Meeting of Shareholders[663](index=663&type=chunk) [Principal Accounting Fees and Services](index=128&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's 2019 Proxy Statement - Information for this section is incorporated by reference from the registrant's Proxy Statement for the 2019 Annual Meeting of Shareholders[664](index=664&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=129&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Form 10-K report, including consolidated financial statements and notes on Asterias and OncoCyte - This section lists all financial statements and exhibits filed with the report[665](index=665&type=chunk) - Audited financial statements of Asterias are filed as Exhibit 99.1. The company will amend the report to include audited financial statements of OncoCyte[665](index=665&type=chunk) [Form 10-K Summary](index=132&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company provides no summary for this item - None[674](index=674&type=chunk)