• Announced First Known Reported Finding of Retinal Tissue Restoration Following OpRegen RPE Cell Transplant
    • Exercised Option with Cancer Research UK for VAC Immuno-Oncology Cell Therapy Program and Initiated Process to Expand VAC Platform to Develop Coronavirus Vaccine
    • Provided Positive Update with OPC1 Program: Manufacturing Improvements Implemented in Production Process; Patent Position Strengthened to Protect the Processes, Product, and Methods of Use

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today reported financial and operating results for the second quarter ended June 30, 2020. Lineage management will host a conference…

    • Announced First Known Reported Finding of Retinal Tissue Restoration Following OpRegen RPE Cell Transplant
    • Exercised Option with Cancer Research UK for VAC Immuno-Oncology Cell Therapy Program and Initiated Process to Expand VAC Platform to Develop Coronavirus Vaccine
    • Provided Positive Update with OPC1 Program: Manufacturing Improvements Implemented in Production Process; Patent Position Strengthened to Protect the Processes, Product, and Methods of Use

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today reported financial and operating results for the second quarter ended June 30, 2020. Lineage management will host a conference call today at 5:30 p.m. Eastern Time/2:30 p.m. Pacific Time to discuss its second quarter 2020 financial and operating results and to provide a business update.

    "Lineage has continued to make significant progress across our entire cell therapy pipeline, with positive milestones on each of our three programs announced this quarter," stated Brian M. Culley, Lineage CEO. "Most importantly, after moving into a cohort of patients with less advanced disease, we reported the first known finding of retinal tissue restoration, which we believe could become a landmark discovery in the treatment of dry AMD. Specifically, Lineage reported evidence of substantial anatomical restoration of retinal tissue within an area of geographic atrophy, or GA. The area of GA was approximately 25% smaller when assessed at 9 months, compared to the patient's pre-treatment baseline. These findings were initially discovered by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. In light of the significance of this finding, our objective is to treat and monitor the final three patients in Cohort 4 of our dry AMD study and seek to demonstrate additional evidence of this exciting finding. These data also will direct our clinical, regulatory, and ongoing partnership discussions.

    We also recently exercised an option with Cancer Research UK, which allowed us to assume responsibility for advancing our dendritic cell vaccine program, strengthening our pipeline and moving Lineage more prominently into the field of cancer immunotherapy. The VAC platform will permit us to expand not only our oncology pipeline, but also enter infectious diseases, with steps being taken to identify external funding to develop a SARS-CoV-2 vaccine, based on VAC platform data showing strong induction of cellular immunity via T cells.

    Lastly, we have made significant progress developing and implementing manufacturing improvements for our OPC1 program to treat spinal cord injuries. We now are working to develop a "thaw-and-inject" formulation and are evaluating a superior delivery system to enable an easier and faster surgical procedure and facilitate enrollment in a late-stage clinical study.

    Our aim is to provide safe and sustained benefits of targeted cell-based therapies, alongside commercially relevant solutions with competitive advantages in areas of scale-up, production costs, and delivery techniques. We believe our holistic approach to designing new therapeutic solutions will allow us to position ourselves as the clear leader in the emerging field of cell therapy transplant medicine."

    Lineage has the following plans and objectives for the second half of 2020:

    - Meet with Biomedical Advanced Research and Development Authority (BARDA) in August to discuss our proposal for non-dilutive support for a coronavirus vaccine candidate.

    - Report initial VAC2 clinical data from patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

    - Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

    - Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the American Academy of Ophthalmology (AAO) Annual 2020 Meeting the second week of November.

    - Meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program.

    Balance Sheet and Cash Flow Highlights

    Cash, cash equivalents, and marketable securities totaled $20.3 million as of June 30, 2020. Marketable securities include our remaining ownership of unrestricted securities in OncoCyte Corporation (OncoCyte), AgeX Therapeutics, Inc. (AgeX) and Hadasit Bio-Holdings Ltd (Hadasit).

    We have continued to fund our operations primarily by selling a portion of our marketable securities. In the six months ended June 30, 2020, we sold approximately 4.8 million shares of OncoCyte common stock for net proceeds of $10.9 million. We continue to hold approximately 3.6 million shares of OncoCyte stock that are valued at $6.8 million as of August 4, 2020, based on the closing price of its common stock on that date. All of our marketable securities are now in companies in which we hold less than 10% of the outstanding shares.

    In conjunction with the sale of AgeX shares to Juvenescence Limited (Juvenescence) in 2018, we also hold a $21.6 million promissory note bearing 7% annual interest that matures later this month, on August 30, 2020. As of June 30, 2020, the outstanding principal and accrued interest on the note was $24.4 million. If, prior to August 30, 2020, Juvenescence completes an initial public offering resulting in gross proceeds of at least $50.0 million, the promissory note automatically converts into the Juvenescence securities.

    Net cash used in operating activities for the six months ended June 30, 2020 was approximately $9.3 million, a decrease of $9.7 million as compared to $19.0 million in the same period of 2019. Additionally, net cash used in the three months ended June 30, 2020 of $4.3 million is $0.7 million lower than net cash used in the three months ended March 31, 2020 of $5.0 million.

    Second Quarter Operating Results

    Revenues: Lineage's revenue is generated primarily from research grants, royalties and licensing fees. Total revenues for the three months ended June 30, 2020 were $0.4 million, a decrease of $0.4 million as compared to $0.8 million for the same period in 2019. The decrease was primarily related to a $0.2 million decrease in grant revenue due to the timing of grant related activities for OpRegen and other ophthalmic applications and a $0.1 million decrease in the sale of research products and services due to the cessation of such sales.

    Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended June 30, 2020 were approximately $6.7 million, a decrease of $4.8 million as compared to $11.5 million for the same period in 2019.

    R&D Expenses: R&D expenses for the three months ended June 30, 2020 were $2.8 million, an approximate decrease of $2.4 million as compared to $5.2 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.7 million in OpRegen and other ophthalmic application expenses, attributable primarily to a decrease in manufacturing activities in 2020 as compared to 2019, and $0.7 million in OPC1 expenses, primarily related to a decrease in development activities in 2020 as compared to 2019 when technology transfer was a focus to support OPC1 coming in-house with the acquisition of Asterias.

    G&A Expenses: G&A expenses for the three months ended June 30, 2020 were $3.9 million, a decrease of $2.4 million as compared to approximately $6.3 million for the same period in 2019. The decrease was primarily attributable to a $1.6 million reduction in expenses related to our merger with Asterias Biotherapeutics, Inc. (Asterias), a $0.2 million reduction in compensation expenses, a $0.2 million reduction in investor and public relations expenses, a $0.2 million reduction in accounting expenses, a $0.1 million reduction in travel expenses, a $0.1 million reduction in rent expenses and a $0.1 million reduction in consulting expenses, offset by a $0.2 million increase related to the cessation of shared services reimbursements.

    Loss from Operations: Loss from operations for the three months ended June 30, 2020 was $6.4 million, a decrease of $4.4 million as compared to $10.8 million for the same period in 2019.

    Other (Expense) Income, Net: Other income/(expenses), net for the three months ended June 30, 2020 reflected other expense, net of ($0.1) million, compared to other expense, net of ($20.5) million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage's international subsidiaries. The value of Lineage's OncoCyte shares decreased by $21.4 million in the three months ended June 30, 2019, which contributed greatly to the overall balance in other expense, net for that period.

    Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2020 was $6.5 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $30.0 million, or $0.20 per share (basic and diluted), for the same period in 2019.

    Conference Call and Webcast

    Lineage will host a conference call and webcast today, at 2:30 pm PT/5:30 pm ET to discuss its second quarter 2020 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through August 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6649516.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's manufacturing plans, financing plans, enrollment activities, data presentations, clinical trial advancement, proposed expansion of the VAC platform in immune-oncology and infectious diseases, expected net operational spend, planned meetings with the FDA and partnership evaluations. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (IN THOUSANDS)

     

     

    June 30, 2020

     

     

     

     

    (Unaudited)

    December 31, 2019

    ASSETS

     

     

     

     

     

     

    CURRENT ASSETS

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    12,676

     

     

    $

    9,497

     

    Marketable equity securities

     

     

    7,575

     

     

     

    21,219

     

    Promissory note from Juvenescence

     

     

    24,372

     

     

     

    23,616

     

    Trade accounts and grants receivable, net

     

     

    193

     

     

     

    317

     

    Receivables from affiliates, net

     

     

    7

     

     

     

    7

     

    Prepaid expenses and other current assets

     

     

    1,377

     

     

     

    2,863

     

    Total current assets

     

     

    46,200

     

     

     

    57,519

     

     

     

     

     

     

     

     

     

     

    NONCURRENT ASSETS

     

     

     

     

     

     

     

     

    Property and equipment, net

     

     

    7,142

     

     

     

    8,175

     

    Deposits and other long-term assets

     

     

    649

     

     

     

    864

     

    Goodwill

     

     

    10,672

     

     

     

    10,672

     

    Intangible assets, net

     

     

    47,417

     

     

     

    48,248

     

    TOTAL ASSETS

     

    $

    112,080

     

     

    $

    125,478

     

     

     

     

     

     

     

     

     

     

    LIABILITIES AND SHAREHOLDERS' EQUITY

     

     

     

     

     

     

     

     

    CURRENT LIABILITIES

     

     

     

     

     

     

     

     

    Accounts payable and accrued liabilities

     

    $

    5,948

     

     

    $

    5,226

     

    Financing lease and right of use lease liabilities, current portion

     

     

    1,241

     

     

     

    1,223

     

    Deferred revenues, current portion

     

     

    297

     

     

     

    45

     

    Liability classified warrants, current portion

     

     

    33

     

     

     

    -

     

    Total current liabilities

     

     

    7,519

     

     

     

    6,494

     

     

     

     

     

     

     

     

     

     

    LONG-TERM LIABILITIES

     

     

     

     

     

     

     

     

    Deferred tax liability

     

     

    3,315

     

     

     

    3,315

     

    Deferred revenues, net of current portion

     

     

    -

     

     

     

    200

     

    Right-of-use lease liability, net of current portion

     

     

    3,276

     

     

     

    3,868

     

    Financing lease, net of current portion

     

     

    62

     

     

     

    77

     

    Liability classified warrants, net of current portion

     

     

    215

     

     

     

    277

     

    TOTAL LIABILITIES

     

     

    14,387

     

     

     

    14,231

     

     

     

     

     

     

     

     

     

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    SHAREHOLDERS' EQUITY

     

     

     

     

     

     

     

     

    Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of June 30, 2020 and December 31, 2019

     

     

    -

     

     

     

    -

     

    Common shares, no par value, 250,000 shares authorized; 149,831 shares issued and outstanding as of June 30, 2020 and 149,804 shares issued and outstanding as of December 31, 2019

     

     

    388,271

     

     

     

    387,062

     

    Accumulated other comprehensive loss

     

     

    (486

    )

     

     

    (681)

     

    Accumulated deficit

     

     

    (288,343

    )

     

     

    (273,422)

    Lineage Cell Therapeutics, Inc. shareholders' equity

     

     

    99,442

     

     

     

    112,959

     

    Noncontrolling deficit

     

     

    (1,749

    )

     

     

    (1,712

    )

    Total shareholders' equity

     

     

    97,693

     

     

     

    111,247

     

    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

     

    $

    112,080

     

     

    $

    125,478

     

     

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (IN THOUSANDS, EXCEPT PER SHARE DATA)

    (UNAUDITED)

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    REVENUES:

     

     

     

     

     

     

     

     

     

     

     

    Grant revenue

     

    $

    287

     

    $

    529

     

    $

    635

     

    $

    1,278

     

    Royalties from product sales and license fees

     

     

    99

     

     

    140

     

     

    265

     

     

    226

     

    Sale of research products and services

     

     

    -

     

     

    110

     

     

    -

     

     

    203

     

    Total revenues

     

     

    386

     

     

    779

     

     

    900

     

     

    1,707

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of sales

     

     

    (75

    )

     

    (107

    )

     

    (169

    )

     

    (175

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Gross profit

     

     

    311

     

     

    672

     

     

    731

     

     

    1,532

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    OPERATING EXPENSES:

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    2,805

     

     

    5,235

     

     

    6,144

     

     

    10,196

     

    General and administrative

     

     

    3,908

     

     

    6,258

     

     

    8,427

     

     

    14,918

     

    Total operating expenses

     

     

    6,713

     

     

    11,493

     

     

    14,571

     

     

    25,114

     

    Loss from operations

     

     

    (6,402

    )

     

    (10,821

    )

     

    (13,840

    )

     

    (23,582

    )

    OTHER INCOME/(EXPENSES):

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income, net

     

     

    380

     

     

    437

     

     

    785

     

     

    879

     

    Gain on sale of marketable securities

     

     

    2,470

     

     

    -

     

     

    3,728

     

     

    -

     

    Unrealized (loss) gain on marketable equity securities

     

     

    (4,146

    )

     

    (607)

     

     

    (5,484

    )

     

    1,324

     

    (Loss)/gain on equity method investment in OncoCyte at fair value

    -

    (21,425

    )

    -

    16,288

     

    Gain on equity method investment in Asterias at fair value

    -

    -

     

    -

    6,744

    Unrealized (loss) gain on warrant liability

     

     

    (6

    )

     

    234

     

     

    29

     

     

    271

     

    Other income (expense), net

     

     

    1,174

     

     

    882

     

     

    (176

    )

     

    1,688

     

    Total other (expense) income, net

     

     

    (128

    )

     

    (20,479)

     

     

    (1,118

    )

     

    27,194

     

    (LOSS)/INCOME BEFORE INCOME TAXES

     

     

    (6,530

    )

     

    (31,300)

     

     

    (14,958

    )

     

    3,612

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Deferred income tax benefit

     

     

    -

     

     

    1,248

     

     

    -

     

     

    5,632

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    NET (LOSS)/INCOME

     

     

    (6,530

    )

     

    (30,052)

     

     

    (14,958

    )

     

    9,244

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss attributable to noncontrolling interest

     

     

    8

     

     

    20

     

     

    37

     

     

    34

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    NET (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.

     

    $

    (6,522

    )

    $

    (30,032)

     

    $

    (14,921

     

    )

    $

    9,278

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    NET (LOSS)/INCOME PER COMMON SHARE:

     

     

     

     

     

     

     

     

     

     

     

     

     

    BASIC

     

    $

    (0.04

    )

    $

    (0.20)

     

    $

    (0.10

    )

    $

    0.07

     

    DILUTED

     

    $

    (0.04

    )

    $

    (0.20)

     

    $

    (0.10

    )

    $

    0.07

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

     

     

     

     

     

     

     

     

     

     

     

     

     

    BASIC

     

     

    149,821

     

     

    149,582

     

     

    149,814

     

     

    141,270

     

    DILUTED

     

     

    149,821

     

     

    149,582

     

     

    149,814

     

     

    141,270

     

     

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (IN THOUSANDS)

    (UNAUDITED)

     

     

    Six Months Ended

    June 30,

     

     

    2020

     

     

    2019

    CASH FLOWS FROM OPERATING ACTIVITIES:

     

     

     

     

     

     

     

     

    Net (loss) income attributable to Lineage Cell Therapeutics, Inc.

     

    $

    (14,921

    )

     

    $

    9,278

    Net loss allocable to noncontrolling interest

     

     

    (37

    )

     

     

    (34

    )

    Adjustments to reconcile net (loss) income attributable to Lineage Cell Therapeutics, Inc. to net cash used in operating activities:

     

     

     

     

     

     

     

     

    Unrealized gain on equity method investment in OncoCyte at fair value

     

     

    -

     

     

    (16,288

    )

    Unrealized gain on equity method investment in Asterias at fair value

     

     

    -

     

     

    (6,744

    )

    Gain on sale of marketable securities

     

     

    (3,728

    )

     

     

    -

    Unrealized (gain) loss on marketable equity securities

     

     

    5,484

     

     

     

    (1,324

    )

    Deferred income tax benefit

     

     

    -

     

     

    (5,632

    )

    Depreciation expense, including amortization of leasehold improvements

     

     

    423

     

     

     

    513

     

    Amortization of right-of-use asset

     

     

    18

     

     

     

    27

     

    Amortization of intangible assets

     

     

    831

     

     

     

    992

     

    Stock-based compensation

     

     

    1,232

     

     

     

    2,202

     

    Change in unrealized loss on warrant liability

     

     

    (29

    )

     

     

    (271

    )

    Write-off of security deposit

     

     

    150

     

     

     

    -

     

    Foreign currency remeasurement and other (gain) loss

     

     

    236

     

     

    (1,461

    )

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Accounts and grants receivable, net

     

     

    125

     

     

     

    (863

    )

    Accrued interest receivable

     

     

    (756

    )

     

     

    (756

    )

    Receivables from OncoCyte and AgeX, net of payables

     

     

    -

     

     

     

    2,185

     

    Prepaid expenses and other current assets

     

     

    1,442

     

     

    (1

    )

    Accounts payable and accrued liabilities

     

     

    214

     

     

    (804

    )

    Deferred revenue and other liabilities

     

     

    51

     

     

     

    -

    Net cash used in operating activities

     

     

    (9,265

    )

     

     

    (18,981

    )

     

     

     

     

     

     

     

     

     

    CASH FLOWS FROM INVESTING ACTIVITIES:

     

     

     

     

     

     

     

     

    Proceeds from the sale of OncoCyte common shares

     

     

    10,941

     

     

     

    -

     

    Proceeds from the sale of AgeX common shares

     

     

    985

     

     

     

    -

     

    Cash and cash equivalents acquired in the Asterias Merger

     

     

    -

     

     

     

    3,117

     

    Purchase of equipment and other assets

     

     

    (16

    )

     

     

    (364

    )

    Security deposit paid and other

     

     

    48

     

     

    (1

    )

    Net cash provided by investing activities

     

     

    11,958

     

     

     

    2,752

     

     

     

     

     

     

     

     

     

     

    CASH FLOWS FROM FINANCING ACTIVITIES:

     

     

     

     

     

     

     

     

    Common shares received and retired for employee taxes paid

     

     

    (13

    )

     

     

    (77

    )

    Reimbursement from landlord on tenant improvements

     

     

    -

     

     

     

    744

     

    Repayment of financing lease liabilities

     

     

    (17

    )

     

     

    (14

    )

    Proceeds from Paycheck Protection Program ("PPP") Loan

     

     

    523

     

     

     

    -

     

    Proceeds from sale of subsidiary warrants

     

     

    -

     

     

     

    (40

    )

    Repayment of principal portion of promissory notes

     

     

    -

     

     

    (70

    )

    Net cash provided by financing activities

     

     

    493

     

     

     

    543

     

    Effect of exchange rate changes on cash, cash equivalents and restricted cash

     

     

    (38

    )

     

     

    83

    NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

     

     

    3,148

     

     

    (15,603

    )

    CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

     

     

     

     

     

     

     

     

    At beginning of the period

     

     

    10,096

     

     

     

    24,399

     

    At end of the period

     

    $

    13,244

     

     

    $

    8,796

     

     

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  1. Conference Call Scheduled for August 6, 2020 at 5:30pm Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it will report its second quarter 2020 financial and operating results on Thursday, August 6, 2020, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 6, 2020, at 5:30 p.m. Eastern Time/2:30 p.m. Pacific Time to discuss its second quarter 2020 financial and operating results and to provide a business update.

    Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and…

    Conference Call Scheduled for August 6, 2020 at 5:30pm Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it will report its second quarter 2020 financial and operating results on Thursday, August 6, 2020, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 6, 2020, at 5:30 p.m. Eastern Time/2:30 p.m. Pacific Time to discuss its second quarter 2020 financial and operating results and to provide a business update.

    Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through August 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6649516.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  2. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that as a result of continued clinical progress, the Israel Innovation Authority (IIA) has extended its previously awarded development grant in support of OpRegen®, the Company's retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD). The research & development grant of up to 9 million Israeli New Shekels (approximately $2.5 million) was awarded in 2019 by the IIA and has been extended for use through June 2021 based on promising clinical data from the ongoing Phase 1/2a clinical study of…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that as a result of continued clinical progress, the Israel Innovation Authority (IIA) has extended its previously awarded development grant in support of OpRegen®, the Company's retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD). The research & development grant of up to 9 million Israeli New Shekels (approximately $2.5 million) was awarded in 2019 by the IIA and has been extended for use through June 2021 based on promising clinical data from the ongoing Phase 1/2a clinical study of OpRegen. The IIA has provided annual grants totaling approximately $16 million for the development of the OpRegen program so far.

    "We are pleased that the IIA has elected to extend its financial support based on the positive momentum and clinical achievements we have demonstrated with our OpRegen program to date," stated Brian M. Culley, Lineage CEO. "We continue to generate promising data supporting the use of our RPE cells in dry AMD with GA. Notably, after moving into patients with less advanced disease, we announced the first known finding of retinal tissue regeneration alongside reductions in the growth of geographic atrophy, and improvements in visual acuity and reading speeds in some patients. We recently resumed patient enrollment in our OpRegen study, and our immediate efforts are focused on treating and monitoring the final three patients in Cohort 4 and utilizing these data to direct our clinical, regulatory, and partnership discussions for the program. The partnerships we have built with notable institutions like the IIA, the California Institute for Regenerative Medicine, and Cancer Research UK, provide not only capital, but also external validation of our programs, and we are working to strengthen and expand these alliances as we move forward. Concurrently, we are actively looking to identify new partnerships to help support the development of all of our programs."

    About Dry AMD

    Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

    About The Israel Innovation Authority

    The Israel Innovation Authority, an independent publicly funded agency, was created to provide a variety of practical tools and funding platforms aimed at effectively addressing the dynamic and changing needs of the local and international innovation ecosystems. This includes early-stage entrepreneurs, mature companies developing new products or manufacturing processes, academic groups seeking to transfer their ideas to the market, global corporations interested in collaborating with Israeli technology, Israeli companies seeking new markets abroad and traditional factories and plants seeking to incorporate innovative and advanced manufacturing into their businesses. More information is available at: https://innovationisrael.org.il/en/contentpage/israel-innovation-authority.

    About OpRegen

    OpRegen is currently being evaluated a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study will enroll patients into 4 cohorts, with 18 of 21 expected patients enrolled to date. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort, which is currently enrolling, will include patients with vision as high as 20/64. Cohort 4 also includes patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing the Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.

    Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. The Company also has observed evidence of benefit in other patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA, and increases in reading speed.

    OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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    • Improvements Implemented in OPC1 Production Process
    • Patent Position Strengthened to Protect the Processes, Product, and Methods of Use
    • Company is Evaluating Novel Delivery Devices to Enhance and Ease Surgical Procedure
    • FDA RMAT Meeting Planned by Year End to Discuss Manufacturing and Clinical Development

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today provided an update on OPC1, the Company's oligodendrocyte progenitor cell (OPC) therapy for the treatment of acute spinal cord injury (SCI). The OPC1 program was obtained through Lineage's acquisition of Asterias Biopharmaceuticals in March 2019, and manufacturing has…

    • Improvements Implemented in OPC1 Production Process
    • Patent Position Strengthened to Protect the Processes, Product, and Methods of Use
    • Company is Evaluating Novel Delivery Devices to Enhance and Ease Surgical Procedure
    • FDA RMAT Meeting Planned by Year End to Discuss Manufacturing and Clinical Development

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today provided an update on OPC1, the Company's oligodendrocyte progenitor cell (OPC) therapy for the treatment of acute spinal cord injury (SCI). The OPC1 program was obtained through Lineage's acquisition of Asterias Biopharmaceuticals in March 2019, and manufacturing has been completely transferred to the Company's current Good Manufacturing Practice (cGMP) facility in Israel, where key process improvements have been developed and implemented. Lineage also has strengthened its patent position in order to protect the OPC1 processes, product and composition, and methods of use. Lineage intends to meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program by the end of 2020.

    "We have worked diligently over the past year to transition all manufacturing activities for the OPC1 program to our in-house cGMP facility, where our experienced cell therapy production team could develop and deploy much-needed improvements and modernization to the production and analytical processes," stated Brian M. Culley, Lineage CEO. "This work has achieved significantly better efficiency and improved quality control, which we expect will enable a consistent supply of material to support a late-stage clinical trial of OPC1. With these necessary steps now completed, our focus turns to developing a "thaw-and-inject" formulation and superior delivery tools, to enable an easier surgical procedure and facilitate faster enrollment in the next clinical trial. We also are evaluating ways to return OPC1 to the clinic sooner than originally planned, reflecting our view of compelling clinical data which continues to read out from the 25-patient phase 1/2a SCiStar study. Our approach with OPC1 replicates our development strategy for OpRegen, our cell therapy program for dry AMD, in which we seek not only to provide cell-based regenerative benefits, but also commercially relevant solutions with competitive advantages in areas of scale-up, production costs, and delivery techniques. By analyzing every piece of the overall therapeutic landscape, we seek to position ourselves as the clear leader in the emerging field of cell therapy transplant medicine."

    Key OPC1 Program Milestones Achieved Since the Asterias Acquisition Include:

    • Technology transfer has been completed and cell production processes have been established at Lineage's cGMP cell therapy facility;
    • The production process was improved to achieve greater efficiency and higher quality control, becoming compatible with larger-scale manufacturing, and Biologics Review Application (BLA) readiness;
    • Multiple OPC1 batches have been successfully manufactured; GMP production is planned to begin in early 2021;
    • New master and working pluripotent cell banks have been produced to supply consistent clinical and commercial batches of OPC1;
    • New in-process controls and release testing have been introduced to the production and release process and have been updated to be more compatible with current and expected future FDA BLA review processes;
    • Issuance of two new patents in 2019 related to methods for utilizing pluripotent stem cell-derived OPCs for the treatment of SCI and reducing cavitation in patients with acute SCI. Additional patent applications are pending which may further protect the processes, product and composition, and methods of use of OPC1.

    Key 2020 Milestone and Development Plans for the OPC1 Program Include:

    • Meeting with the FDA to discuss manufacturing improvements and the design of a late-stage comparative clinical trial;
    • Introducing a new "thaw-and-inject" formulation to enable easier preparation and administration of cells to the spinal cord, avoiding the need for washing and other dose preparation steps one day prior to treatment and improving commercial positioning;
    • Identifying a novel delivery system, to make the surgical procedure easier, faster, and more compatible with a thaw and inject formulation of OPC1, improving overall end-user experience for the surgeon.

    About OPC1

    OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

    About the OPC1 Clinical Study

    The SCiStar Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment. Enrollment is complete in this study; patients will continue to be evaluated on a long-term basis.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's plans for OPC1 development and clinical studies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  3. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that interim results from its Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (dry AMD), will be presented at the International Society for Stem Cell Research (ISSCR) 2020 Annual Meeting, which will be held virtually June 23 to June 27, 2020. The abstract presentation, entitled, "Phase I/IIa Clinical Trial of Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that interim results from its Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (dry AMD), will be presented at the International Society for Stem Cell Research (ISSCR) 2020 Annual Meeting, which will be held virtually June 23 to June 27, 2020. The abstract presentation, entitled, "Phase I/IIa Clinical Trial of Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results", will be presented on Saturday June 27, 2020 by Benjamin E. Reubinoff, M.D., Ph.D., Chairman and Professor at Hadassah Medical Center, Jerusalem, Israel. The presentation will provide data from patient cohorts 1 through 4 of the clinical study.

    About ISSCR 2020

    The International Society for Stem Cell Research has transformed its annual scientific meeting into a virtual experience, bringing the global stem cell community together to share knowledge, collaborate, and network. The ISSCR 2020 Virtual Meeting, co-sponsored by the Harvard Stem Cell Institute (HSCI), will deliver a comprehensive scientific education program that includes plenaries featuring world-renowned scientists in the field. For more information, please visit www.isscr.org or follow the association on Twitter @ISSCR.

    About Dry AMD

    Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

    About OpRegen

    OpRegen is currently being evaluated a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study will enroll patients into 4 cohorts, with 18 of 21 expected patients enrolled to date. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort, which is currently enrolling, will include patients with vision as high as 20/64. Cohort 4 also includes patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing Gyroscope Therapeutics' Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.

    Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. The Company also has observed evidence of benefit in other patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA, and increases in reading speed.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  4. First OpRegen Patient Dosed at Cincinnati Eye Institute

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, today announced that it has restarted patient enrollment in a Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), following a temporary pause in enrollment as a result of the COVID-19 pandemic. The first patient dosed in the re-start was at Cincinnati Eye Institute (CEI) under the direction of principal investigator Christopher

    First OpRegen Patient Dosed at Cincinnati Eye Institute

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, today announced that it has restarted patient enrollment in a Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), following a temporary pause in enrollment as a result of the COVID-19 pandemic. The first patient dosed in the re-start was at Cincinnati Eye Institute (CEI) under the direction of principal investigator Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, CEI and University of Cincinnati School of Medicine. CEI is a global leader in ophthalmology research and a clinical site where local health and safety regulations recently enabled and cleared clinical study recruitment and treatment. The patient enrolled at CEI was administered Lineage's new thaw-and-inject formulation of OpRegen with Gyroscope Therapeutics' Orbit Subretinal Delivery System (SDS). The Company anticipates that it will complete enrollment of the last 3 patients in Cohort 4 of the OpRegen clinical study in the third quarter of 2020.

    "OpRegen is a promising candidate for the future treatment of dry AMD and I am excited to have dosed the first patient at our institute," stated Christopher D. Riemann, M.D. "Delivering OpRegen RPE cells to the subretinal space using the Orbit SDS was straightforward and appears to offer superior dose control and safety compared to traditional delivery methods. We have resumed our patient screening efforts and I look forward to enrolling additional patients into the study as soon as possible."

    "We are pleased to safely resume patient enrollment in our OpRegen study under the direction of Dr. Riemann at CEI," stated Brian M. Culley, Lineage CEO. "Data collected from the OpRegen program continues to support the use of our cells in dry AMD with GA, particularly after we moved into treating patients with less advanced disease. Additionally, we recently announced the first known finding of retinal tissue regeneration alongside improvements in the progression of geographic atrophy, visual acuity, and reading speeds in some patients. With enrollment once again underway, our immediate objective is to treat and monitor the final three patients in Cohort 4 of the study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market."

    Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. The loss of RPE cells over time creates progressively larger areas of geographic atrophy (GA) in the adult retina, leading to impaired vision or complete blindness. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which has led to a presumption that progression of GA may someday be slowed or halted but cannot be reversed. The unique finding from the ongoing OpRegen clinical trial supports a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Lineage has reported evidence from a patient with atrophic end-stage disease who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient's pre-treatment baseline. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.

    The Company has also observed evidence of benefit in some patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA and increases in reading speed. The addition of signs of retinal tissue regeneration provides further support that OpRegen may be a viable treatment for the millions of individuals living with dry AMD, one of the leading causes of vision loss in the world.

    About the OpRegen Phase 1/2a Clinical Study

    This is a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study will enroll patients into 4 cohorts, with 18 of 21 expected patients enrolled to date. The first 3 cohorts enrolled solely legally blind patients, with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort, which is currently enrolling, will include patients with vision ranging from 20/250 to as high as 20/64. Cohort 4 also includes patients treated with one of two formulations of OpRegen, (i) a formulation which required preparation of cells one day prior to use in a dose preparation laboratory; or (ii) a new "off-the-shelf" or "thaw-and-inject" formulation of OpRegen which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing Gyroscope Therapeutics' Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the anticipated completion of patient enrollment in Lineage's Phase 1/2a clinical study of OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  5. Presentation Begins at 9:40am Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that Brian M. Culley, Chief Executive Officer, will be presenting tomorrow morning at the 2020 Raymond James Human Health Innovation Conference at 9:40 am Eastern Time. In addition to a corporate overview, Mr. Culley will provide an update on the status of Lineage's lead program, OpRegen®, an allogeneic retinal pigment epithelium (RPE) transplant therapy for dry age-related macular degeneration (AMD). Recently, the company provided details on the first known reported finding of retinal tissue regeneration in a patient with dry AMD…

    Presentation Begins at 9:40am Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that Brian M. Culley, Chief Executive Officer, will be presenting tomorrow morning at the 2020 Raymond James Human Health Innovation Conference at 9:40 am Eastern Time. In addition to a corporate overview, Mr. Culley will provide an update on the status of Lineage's lead program, OpRegen®, an allogeneic retinal pigment epithelium (RPE) transplant therapy for dry age-related macular degeneration (AMD). Recently, the company provided details on the first known reported finding of retinal tissue regeneration in a patient with dry AMD with geographic atrophy. Interested investors can access the live presentation on the Events and Presentations section of Lineage's website.

    The archived presentation will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  6. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be presenting at the 2020 Raymond James Human Health Innovation Conference on June 18, 2020 at 9:40 am Eastern Time. Interested investors can access the live presentation on the Events and Presentations section of Lineage's website.

    The archived presentation will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About Lineage

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be presenting at the 2020 Raymond James Human Health Innovation Conference on June 18, 2020 at 9:40 am Eastern Time. Interested investors can access the live presentation on the Events and Presentations section of Lineage's website.

    The archived presentation will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, in clinical development for the treatment of non-small cell lung cancer and preclinical development for additional cancers and infectious diseases, including COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  7. Call Scheduled for Today at 4:30pm Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, will be hosting a call today with two therapeutic area experts to discuss the first known reported finding of retinal tissue regeneration in a patient receiving a retinal pigment epithelium (RPE) cell transplant for the treatment of dry age-related macular degeneration (AMD). Lineage management will be joined by therapeutic area experts Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, Barcelona Macula Foundation, and Michael S. Ip,

    Call Scheduled for Today at 4:30pm Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, will be hosting a call today with two therapeutic area experts to discuss the first known reported finding of retinal tissue regeneration in a patient receiving a retinal pigment epithelium (RPE) cell transplant for the treatment of dry age-related macular degeneration (AMD). Lineage management will be joined by therapeutic area experts Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, Barcelona Macula Foundation, and Michael S. Ip, M.D., Chief of Vitreoretinal Surgery Service, Doheny Eye Centers, UCLA, to discuss this new data from the Phase 1/2a study of OpRegen®, the company's lead product candidate. Interested parties can access the live webcast on the Events and Presentations section of Lineage's website today at 4:30pm Eastern Time / 1:30pm Pacific Time.

    "If we are able to confirm this finding in additional patients, I believe it will create a new paradigm for how we and others approach the treatment of dry AMD and will help advance the incredibly promising area of cell therapy in which we enjoy a leadership position; the directed differentiation and transplant of specific cell types to treat severe diseases and conditions," stated Brian M. Culley, Lineage CEO. "We look forward to discussing these important results with our independent experts Drs. Monés and Ip on our call later this afternoon."

    "Any therapy which can save photoreceptors and RPE cells in areas of geographic atrophy would be very important to these patients. It is hypothesized that cells in the transition areas at the boundary of the GA are dysfunctional and dying, but not completely lost," stated Jordi Monés, M.D., Ph.D. "The addition of new RPE cells may restore the microenvironment in surrounding tissue and contribute to the possibility of restoring function to existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region."

    "Our team has independently reviewed these data as part of our ongoing collaborative efforts with Lineage and I think it is evidence of a partially restorative effect in this patient. We have observed apparent RPE regeneration on detailed review of imaging and will look forward to reviewing additional patient data from the OpRegen clinical trial to determine the reproducibility and durability of this unexpected finding," added Michael Ip, M.D.

    This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. The loss of retina pigmented epithelium (RPE) cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as dry AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which has led to a presumption that progression of geographic atrophy (GA) may someday be slowed or halted but cannot be reversed. The unique finding from the ongoing OpRegen clinical trial supports a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Lineage has reported evidence from a patient with atrophic end-stage disease who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient's pre-treatment baseline. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.

    OpRegen is currently being evaluated in a Phase 1/2a clinical study in patients with dry AMD with GA. Seventeen of twenty-one expected patients have been enrolled to date. The Company has observed evidence of benefit in some patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of geographic atrophy and increases in reading speed. The addition of signs of retinal tissue regeneration provides further support that OpRegen may be a viable treatment for the millions of individuals living with dry AMD, one of the leading causes of vision loss in the world.

    OpRegen was originally developed by Drs. Benjamin Reubinoff, M.D., Ph.D. and Eyal Banin, M.D., Ph.D. of Hadassah University and licensed to Lineage's subsidiary Cell Cure Neurosciences.

    KOL Call Information and Webcast

    Lineage will host a conference call with Drs. Monés and Ip, today at 4:30 p.m. ET/1:30 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineage's website.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, in clinical development for the treatment of non-small cell lung cancer and preclinical development for additional cancers and, infectious diseases, including COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of OpRegen and Lineage's objectives. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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    • First Known Clinical Report of Retinal Tissue Regeneration Following RPE Transplant
    • Call Scheduled for June 8, 2020 with Therapeutic Area Experts to Discuss Findings

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, today announced that restoration of retinal tissue was observed in a patient enrolled in a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD). This finding supports the view that dry AMD is not an irreversible, degenerative condition…

    • First Known Clinical Report of Retinal Tissue Regeneration Following RPE Transplant
    • Call Scheduled for June 8, 2020 with Therapeutic Area Experts to Discuss Findings

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, today announced that restoration of retinal tissue was observed in a patient enrolled in a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD). This finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. Lineage plans to host a live call with two therapeutic area experts Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, Barcelona Macula Foundation: Research for Vision, and Michael S. Ip, M.D., Chief of Vitreoretinal Surgery Service, Doheny Eye Centers, UCLA, on Monday, June 8, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Drs. Monés and Ip will discuss these data and other results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineage's website.

    The loss of retina pigmented epithelium (RPE) cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as dry AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which has led to a presumption that progression of geographic atrophy (GA) may someday be slowed or halted but cannot be reversed. The unique finding from the ongoing OpRegen clinical trial supports a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. We report evidence from a patient with atrophic end-stage disease who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient's pre-treatment baseline and it grew approximately 50% slower than its historical rate during the subsequent six months. These unprecedented findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.

    "Any therapy which can save photoreceptors and RPE cells in areas of geographic atrophy would be very important to these patients. It is hypothesized that cells in the transition areas at the boundary of the GA are dysfunctional and dying, but not completely lost," stated Jordi Monés, M.D., Ph.D. "The addition of new RPE cells may restore the microenvironment in surrounding tissue and contribute to the possibility of restoring function to existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region."

    "Our team has independently reviewed these data as part of our ongoing collaborative efforts with Lineage and I think it is evidence of a partially restorative effect in this patient. We have observed apparent RPE regeneration on detailed review of imaging and will look forward to reviewing additional patient data from the OpRegen clinical trial to determine the reproducibility and durability of this unexpected finding," added Michael Ip, M.D.

    "We have evidence at multiple time points which demonstrate a thickening of the outer nuclear layer and restoration of retinal structure. These changes penetrated into the area of GA where those cells are thought to be destroyed and the improvement has persisted over time. The patient also exhibited a consistent seven to ten letter improvement in their visual acuity for the past year. These findings are extremely encouraging and it is important that we investigate why this particular individual experienced a restoration of tissue in the boundary areas of their GA," stated Gary Hogge, Senior Vice President of Clinical and Medical Affairs. "This individual had a multifocal GA and received much greater coverage of cells, either of which may be relevant to these results. Our next steps include seeking to understand the contribution from potentially critical differences in the surgical procedures or baseline characteristics so that we can reproduce this outcome in additional patients."

    "To our knowledge, this is the first time any experimental treatment for dry AMD has demonstrated a reduction, rather than expansion, of an area of atrophy over a clinically meaningful time period. If this finding is confirmed in additional patients, I believe it will create a new paradigm for how we and others approach the treatment of dry AMD and will help advance the incredibly promising area of cell therapy in which we enjoy a leadership position, the directed differentiation and transplant of specific cell types to treat severe diseases and conditions," stated Brian M. Culley, Lineage CEO.

    OpRegen is currently being evaluated in a Phase 1/2a clinical study in patients with dry AMD with GA. Seventeen of twenty-one expected patients have been enrolled to date. The Company has observed evidence of benefit in some patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of geographic atrophy and increases in reading speed. The addition of signs of retinal tissue regeneration provides further support that OpRegen may be a viable treatment for the millions of individuals living with dry AMD, one of the leading causes of vision loss in the world.

    OpRegen was originally developed by Drs. Benjamin Reubinoff, M.D., Ph.D. and Eyal Banin, M.D., Ph.D. of Hadassah University and licensed to Lineage's subsidiary Cell Cure Neurosciences.

    KOL Call Information and Webcast

    Lineage will host a conference call with Drs. Monés and Ip, on Monday, June 8, 2020 at 4:30 p.m. ET/1:30 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineage's website.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, in clinical development for the treatment of non-small cell lung cancer and preclinical development for additional cancers and COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of OpRegen and Lineage's objectives. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  8. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be participating in the Maxim Group and M-Vest COVID-19 Virtual Conference Series: The Role of Cell Therapy and Clarity on Testing on May 27, 2020 at 10:00 am Eastern Time. Interested investors can access the discussion as part of the Maxim Group and M-Vest COVID-19 Virtual Conference Series.

    The archived discussion will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be participating in the Maxim Group and M-Vest COVID-19 Virtual Conference Series: The Role of Cell Therapy and Clarity on Testing on May 27, 2020 at 10:00 am Eastern Time. Interested investors can access the discussion as part of the Maxim Group and M-Vest COVID-19 Virtual Conference Series.

    The archived discussion will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About the Maxim Group and M-Vest COVID-19 Virtual Conference Series

    The unmet need in infectious diseases cannot be overstated and COVID-19 continues to be a stark reminder of how unprepared the world is to deal with a pandemic. SARS-CoV-2, the virus that causes COVID-19, while sadly is still inducing tremendous loss of life, has brought out the very best in the biotechnology community from a drug, vaccine and testing perspective. In this iteration of our ongoing M-Vest Infectious Disease Virtual Conference Series, we focus in on two key areas related to the ongoing pandemic; cell based therapies and testing. Please join us as we break it down with two panels of companies leading efforts in cell therapies and testing for COVID-19.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, in clinical development for the treatment of non-small cell lung cancer and preclinical development for additional cancers and COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  9. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be presenting at the 2020 Solebury Trout Virtual Investor Conference on May 26, 2020 at 2:30 pm Eastern Time. Interested investors can access the live presentation as part of the Solebury Trout Virtual Conference Series.

    The archived presentation will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About Lineage Cell

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer, will be presenting at the 2020 Solebury Trout Virtual Investor Conference on May 26, 2020 at 2:30 pm Eastern Time. Interested investors can access the live presentation as part of the Solebury Trout Virtual Conference Series.

    The archived presentation will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, in clinical development for the treatment of non-small cell lung cancer and preclinical development for additional cancers and COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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    • Presented Positive New Data from Phase 1/2a Clinical Study of OpRegen in Dry AMD at 2020 ARVO Virtual Meeting
    • Announced Early Exercise of Option with Cancer Research UK for Immuno-Oncology Cell Therapy Program
    • Initiated Process to Expand VAC Cell Therapy Platform to Develop Coronavirus Vaccine
    • Maintained High Degree of Continuity of Global Operations During COVID-19 Pandemic
    • Converted Portion of OncoCyte Shares into Net Proceeds of Approximately $3.7 Million

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today reported financial and operating results for the first quarter ended March 31, 2020. Lineage management will…

    • Presented Positive New Data from Phase 1/2a Clinical Study of OpRegen in Dry AMD at 2020 ARVO Virtual Meeting
    • Announced Early Exercise of Option with Cancer Research UK for Immuno-Oncology Cell Therapy Program
    • Initiated Process to Expand VAC Cell Therapy Platform to Develop Coronavirus Vaccine
    • Maintained High Degree of Continuity of Global Operations During COVID-19 Pandemic
    • Converted Portion of OncoCyte Shares into Net Proceeds of Approximately $3.7 Million

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today reported financial and operating results for the first quarter ended March 31, 2020. Lineage management will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2020 financial and operating results and to provide a business update.

    "Lineage has adapted quickly to an unprecedented business environment. We ensured the safety of our teams while maintaining the continuity of our global operations and advancing our programs with meaningful clinical data and contractual arrangements," stated Brian M. Culley, Lineage CEO. "Looking ahead, we believe we are well positioned to achieve many of our 2020 objectives. Most notably, a clinical update recently presented at the ARVO meeting provided a more comprehensive picture of treatment with OpRegen, where certain patients were able to see better, have less growth to their area of geographic atrophy, and read faster, representing important enhancements to vision and quality of life metrics. We also are excited about exercising our option to regain control of the VAC platform for immuno-oncology and expand it to the development of a vaccine for coronaviruses such as SARS-CoV-2, the virus which causes COVID-19."

    2020 Plans and Objectives:

    - Present new OpRegen data from the ongoing Phase 1/2a clinical trial as available throughout the year.

    - Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

    - Meet with the U.S. Food and Drug Administration (FDA) to discuss the further clinical development of OpRegen.

    - Evaluate partnership opportunities for the OpRegen program and other development assets.

    - Report VAC2 clinical data from the initial patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

    - Enhance commercial utility of OPC1 program by introducing commercially enabling improvements to the manufacturing process in our GMP manufacturing facility.

    - Continue engagement with the investment and medical communities with virtual participation at medical and healthcare industry conferences, ongoing throughout 2020.

    - Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine and Cancer Research UK.

    - Seek non-dilutive support for certain programs, as may be available, including for coronavirus vaccine development.

    Balance Sheet and Cash Flow Highlights

    Cash, cash equivalents, and marketable securities totaled $25.8 million as of March 31, 2020. Marketable securities include our remaining ownership of unrestricted securities in OncoCyte Corporation (OncoCyte), AgeX Therapeutics, Inc. (AgeX) and Hadasit Bio-Holdings Ltd (Hadasit).

    We have continued to fund our operations primarily by selling a portion of our marketable securities. On January 2, 2020, we sold 2,383,090 shares of OncoCyte stock for net proceeds of approximately $5.0 million. On April 23, 2020, we sold an additional 1,672,689 shares of OncoCyte stock for net proceeds of approximately $3.7 million. We continue to hold approximately 4.3 million shares of OncoCyte stock that are valued at $11.3 million as of May 5, 2020, based on the closing price of its common stock on that date. All of our marketable securities are now in companies in which we hold less than 10% of the outstanding shares.

    In conjunction with the sale of AgeX shares to Juvenescence Limited (Juvenescence) in 2018, we also hold a $21.6 million promissory note bearing 7% annual interest that matures on August 30, 2020. As of March 31, 2020, the outstanding principal and accrued interest on the note was $24.0 million. If, prior to August 30, 2020, Juvenescence completes an initial public offering resulting in gross proceeds of at least $50.0 million, the promissory note automatically converts into the Juvenescence securities.

    Net cash used in operating activities for the three months ended March 31, 2020 was approximately $5.0 million, a decrease of $4.3 million as compared to $9.3 million in the same period of 2019. This level of quarterly activity was in line with our budgeted annual net operational spend of $16 million for 2020. As a result of incremental expenses we anticipate incurring during the remainder of the year related to the early exercise of our option with Cancer Research UK, our plans for the development of a prophylactic vaccine against SARS-CoV-2 and other coronaviruses, and delays caused by COVID-19 to our OpRegen® clinical trial, we anticipate our net operational spend for 2020 will increase modestly.

    First Quarter Operating Results

    Revenues: Lineage's revenue is generated primarily from research grants, royalties and licensing fees. Total revenues for the three months ended March 31, 2020 were $0.5 million, a decrease of $0.4 million as compared to $0.9 million for the same period in 2019. The decrease was primarily related to a $0.4 million decrease in grant revenue due to the timing of grant related activities for OpRegen and other ophthalmic applications.

    Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended March 31, 2020 were approximately $7.8 million, a decrease of $5.8 million as compared to $13.6 million for the same period in 2019.

    R&D Expenses: R&D expenses for the three months ended March 31, 2020 were $3.3 million, an approximate decrease of $1.7 million as compared to $5.0 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.8 million in OpRegen and other ophthalmic application expenses and $0.4 million in Renevia® expenses, offset by an increase of approximately $0.5 million in OPC1 expenses.

    G&A Expenses: G&A expenses for the three months ended March 31, 2020 were $4.5 million, a decrease of $4.1 million as compared to approximately $8.6 million for the same period in 2019. The decrease was primarily attributable to a $3.3 million reduction in expenses related to our merger with Asterias Biotherapeutics, Inc. (Asterias), a $0.9 million decrease in salaries, benefits and severance costs primarily related to terminated personnel, a $0.4 million reduction in accounting expenses, a $0.1 million reduction in rent expenses and a $0.1 million reduction in consulting expenses, offset by a $0.5 million increase in legal and patent expenses and a $0.2 million increase related to the cessation of shared services reimbursements.

    Loss from Operations: Loss from operations for the three months ended March 31, 2020 was $7.4 million, an approximate decrease of $5.4 million as compared to $12.8 million for the same period in 2019.

    Other (Expense) Income, Net: Other income/(expenses), net for the three months ended March 31, 2020 reflected other expense, net of ($1.0) million, compared to other income, net of $47.7 million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage's international subsidiaries. The value of Lineage's OncoCyte shares increased by $37.7 million in the three months ended March 31, 2019, which contributed greatly to the overall balance in other income, net for that period.

    Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2020 was $8.4 million, or $0.06 per share (basic and diluted), compared to a net income attributable to Lineage of $39.3 million, or $0.30 per share (basic and diluted), for the same period in 2019.

    Conference Call and Webcast

    Lineage will host a conference call and webcast today, at 1:30 pm PT/4:30 pm ET to discuss its first quarter 2020 financial results and to provide a business update. A live webcast of the conference call will be available online in the Investors section of Lineage's website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through May 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7948501.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's manufacturing plans, enrollment activities, data presentations, clinical trial advancement, proposed expansion of the VAC platform to address coronaviruses, expected net operational spend, planned meetings with the FDA and partnership evaluations. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (IN THOUSANDS)

     

     

     

    March 31, 2020

    (Unaudited)

     

    December 31, 2019

     

    ASSETS

     

     

     

     

     

     

    CURRENT ASSETS

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    9,832

     

     

    $

    9,497

     

    Marketable equity securities

     

     

    15,933

     

     

     

    21,219

     

    Promissory note from Juvenescence

     

     

    23,994

     

     

     

    23,616

     

    Trade accounts and grants receivable, net

     

     

    253

     

     

     

    317

     

    Receivables from affiliates, net

     

     

    47

     

     

     

    7

     

    Prepaid expenses and other current assets

     

     

    2,225

     

     

     

    2,863

     

    Total current assets

     

     

    52,284

     

     

     

    57,519

     

     

     

     

     

     

     

     

     

     

    NONCURRENT ASSETS

     

     

     

     

     

     

     

     

    Property and equipment, net

     

     

    7,539

     

     

     

    8,175

     

    Deposits and other long-term assets

     

     

    637

     

     

     

    864

     

    Goodwill

     

     

    10,672

     

     

     

    10,672

     

    Intangible assets, net

     

     

    47,750

     

     

     

    48,248

     

    TOTAL ASSETS

     

    $

    118,882

     

     

    $

    125,478

     

     

     

     

     

     

     

     

     

     

    LIABILITIES AND SHAREHOLDERS' EQUITY

     

     

     

     

     

     

     

     

    CURRENT LIABILITIES

     

     

     

     

     

     

     

     

    Accounts payable and accrued liabilities

     

    $

    5,321

     

     

    $

    5,226

     

    Financing lease and right of use lease liabilities, current portion

     

     

    1,240

     

     

     

    1,223

     

    Deferred revenues

     

     

    200

     

     

     

    -

     

    Deferred grant revenue

     

     

    208

     

     

     

    45

     

    Total current liabilities

     

     

    6,969

     

     

     

    6,494

     

     

     

     

     

     

     

     

     

     

    LONG-TERM LIABILITIES

     

     

     

     

     

     

     

     

    Deferred tax liability

     

     

    3,315

     

     

     

    3,315

     

    Deferred revenues

     

     

    -

     

     

     

    200

     

    Right-of-use lease liability, net of current portion

     

     

    3,527

     

     

     

    3,868

     

    Financing lease, net of current portion

     

     

    66

     

     

     

    77

     

    Liability classified warrants, net of current portion, and other long-term liabilities

     

     

    247

     

     

     

    277

     

    TOTAL LIABILITIES

     

     

    14,124

     

     

     

    14,231

     

     

     

     

     

     

     

     

     

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    SHAREHOLDERS' EQUITY

     

     

     

     

     

     

     

     

    Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of March 31, 2020 and December 31, 2019

     

     

    -

     

     

     

    -

     

    Common shares, no par value, 250,000 shares authorized; 149,818 shares issued and outstanding as of March 31, 2020 and 149,804 shares issued and outstanding as of December 31, 2019

     

     

    387,686

     

     

     

    387,062

     

    Accumulated other comprehensive income (loss)

     

     

    634

     

     

    (681)

     

    Accumulated deficit

     

     

    (281,821

    )

     

     

    (273,422)

    Lineage Cell Therapeutics, Inc. shareholders' equity

     

     

    106,499

     

     

     

    112,959

     

    Noncontrolling interest (deficit)

     

     

    (1,741

    )

     

     

    (1,712

    )

    Total shareholders' equity

     

     

    104,758

     

     

     

    111,247

     

    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

     

    $

    118,882

     

     

    $

    125,478

     

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (IN THOUSANDS, EXCEPT PER SHARE DATA)

    (UNAUDITED)

     

     

     

    Three Months Ended

    March 31,

     

     

     

    2020

     

    2019

     

    REVENUES:

     

     

     

     

     

     

    Grant revenue

     

    $

    348

     

     

    $

    749

     

    Royalties from product sales and license fees

     

     

    166

     

     

     

    86

     

    Sale of research products and services

     

     

    -

     

     

     

    93

     

    Total revenues

     

     

    514

     

     

     

    928

     

     

     

     

     

     

     

     

     

     

    Cost of sales

     

     

    (94

    )

     

     

    (68

    )

     

     

     

     

     

     

     

     

     

    Gross profit

     

     

    420

     

     

     

    860

     

     

     

     

     

     

     

     

     

     

    OPERATING EXPENSES:

     

     

     

     

     

     

     

     

    Research and development

     

     

    3,339

     

     

     

    4,961

     

    General and administrative

     

     

    4,519

     

     

     

    8,660

     

    Total operating expenses

     

     

    7,858

     

     

     

    13,621

     

    Loss from operations

     

     

    (7,438

    )

     

     

    (12,761

    )

    OTHER INCOME/(EXPENSES):

     

     

     

     

     

     

     

     

    Interest income, net

     

     

    405

     

     

     

    442

     

    Gain on sale of marketable equity securities

     

     

    1,258

     

     

     

    -

     

    Unrealized (loss) gain on marketable equity securities

     

     

    (1,338

    )

     

     

    1,931

     

    Gain on equity method investment in OncoCyte at fair value

     

     

    -

     

     

    37,713

     

    Gain on equity method investment in Asterias at fair value

     

     

    -

     

     

     

    6,744

     

    Unrealized gain on warrant liability

     

     

    35

     

     

     

    37

     

    Other (expense) income, net

     

     

    (1,350

    )

     

     

    806

    Total other (expense) income, net

     

     

    (990

    )

     

     

    47,673

     

    (LOSS)/INCOME BEFORE INCOME TAXES

     

     

    (8,428

    )

     

     

    34,912

     

     

     

     

     

     

     

     

     

     

    Deferred income tax benefit

     

     

    -

     

     

     

    4,384

     

     

     

     

     

     

     

     

     

     

    NET (LOSS)/INCOME

     

     

    (8,428

    )

     

     

    39,296

     

     

     

     

     

     

     

     

     

     

    Net loss attributable to noncontrolling interest

     

     

    29

     

     

     

    14

     

     

     

     

     

     

     

     

     

     

    NET (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.

     

    $

    (8,399

    )

     

    $

    39,310

     

     

     

     

     

     

     

     

     

     

    NET (LOSS)/INCOME PER COMMON SHARE:

     

     

     

     

     

     

     

     

    BASIC

     

    $

    (0.06

    )

     

    $

    0.30

     

    DILUTED

     

    $

    (0.06

    )

     

    $

    0.30

     

     

     

     

     

     

     

     

     

     

    WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

     

     

     

     

     

     

     

     

    BASIC

     

     

    149,807

     

     

     

    132,865

     

    DILUTED

     

     

    149,807

     

     

     

    132,869

     

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (IN THOUSANDS)

    (UNAUDITED)

     

     

     

    Three Months Ended

    March 31,

     

     

     

    2020

     

     

    2019

     

    CASH FLOWS FROM OPERATING ACTIVITIES:

     

     

     

     

     

     

     

     

    Net (loss) income attributable to Lineage Cell Therapeutics, Inc.

     

    $

    (8,399

    )

     

    $

    39,310

     

    Net loss allocable to noncontrolling interest

     

     

    (29

    )

     

     

    (14

    )

    Adjustments to reconcile net (loss) income attributable to Lineage Cell Therapeutics, Inc. to net cash used in operating activities:

     

     

     

     

     

     

     

     

    Unrealized gain on equity method investment in OncoCyte at fair value

     

     

    -

     

     

     

    (37,713

    )

    Unrealized gain on equity method investment in Asterias at fair value

     

     

    -

     

     

     

    (6,744

    )

    Gain on sale of marketable securities

     

     

    (1,258

    )

     

     

    -

     

    Unrealized loss (gain) on marketable equity securities

     

     

    1,338

     

     

     

    (1,931

    )

    Deferred income tax benefit

     

     

    -

     

     

     

    (4,384

    )

    Depreciation expense, including amortization of leasehold improvements

     

     

    212

     

     

     

    269

     

    Amortization of right-of-use asset

     

     

    9

     

     

     

    14

     

    Amortization of intangible assets

     

     

    498

     

     

     

    485

     

    Stock-based compensation

     

     

    626

     

     

     

    1,440

     

    Change in unrealized gain on warrant liability

     

     

    (35

    )

     

     

    (37

    )

    Foreign currency remeasurement and other (gain) loss

     

     

    1,424

     

     

     

    (839

    )

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Accounts and grants receivable, net

     

     

    66

     

     

     

    (614

    )

    Accrued interest receivable

     

     

    (378

    )

     

     

    (378

    )

    Receivables from OncoCyte and AgeX, net of payables

     

     

    (40

    )

     

     

    2,129

     

    Prepaid expenses and other current assets

     

     

    911

     

     

     

    (66

    )

    Accounts payable and accrued liabilities

     

     

    (138

    )

     

     

    (241

    )

    Deferred revenue and other liabilities

     

     

    167

     

     

     

    -

     

    Net cash used in operating activities

     

     

    (5,026

    )

     

     

    (9,314

    )

     

     

     

     

     

     

     

     

     

    CASH FLOWS FROM INVESTING ACTIVITIES:

     

     

     

     

     

     

     

     

    Proceeds from the sale of OncoCyte common shares

     

     

    4,963

     

     

     

    -

     

    Proceeds from the sale of AgeX common shares

     

     

    258

     

     

     

    -

     

    Cash and cash equivalents acquired in the Asterias Merger

     

     

    -

     

     

     

    3,117

     

    Purchase of equipment and other assets

     

     

    (10

    )

     

     

    (169

    )

    Security deposit paid and other

     

     

    45

     

     

     

    (2

    )

    Net cash provided by investing activities

     

     

    5,256

     

     

     

    2,946

     

     

     

     

     

     

     

     

     

     

    CASH FLOWS FROM FINANCING ACTIVITIES:

     

     

     

     

     

     

     

     

    Common shares received and retired for employee taxes paid

     

     

    (2

    )

     

     

    (74

    )

    Reimbursement from landlord on tenant improvements

     

     

    -

     

     

     

    738

     

    Repayment of financing lease liabilities

     

     

    (8

    )

     

     

    (6

    )

    Repayment of principal portion of promissory notes

     

     

    -

     

     

     

    (52

    )

    Net cash (used by) provided by financing activities

     

     

    (10

    )

     

     

    606

     

    Effect of exchange rate changes on cash, cash equivalents and restricted cash

     

     

    73

     

     

     

    53

     

    NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

     

     

    293

     

     

     

    (5,709

    )

    CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

     

     

     

     

     

     

     

     

    At beginning of the period

     

     

    10,096

     

     

     

    24,399

     

    At end of the period

     

    $

    10,389

     

     

    $

    18,690

     

     

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    • Immunogenicity Data from VAC2 Clinical Trial Supports Mechanism of Action
    • Dendritic Cell Therapy Program Will Focus on Immuno-Oncology
    • Platform Expansion to Include Coronavirus Vaccine Development; Seeking Non-Dilutive Funding

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Cancer Research UK's Commercial Partnerships has permitted Lineage to conduct an early exercise of its option to acquire data from Cancer Research UK's ongoing Phase 1 clinical trial of VAC2 in non-small cell lung cancer (NCT03371485), and develop an allogeneic dendritic cell therapy platform ("VAC"). Lineage will assume responsibility…

    • Immunogenicity Data from VAC2 Clinical Trial Supports Mechanism of Action
    • Dendritic Cell Therapy Program Will Focus on Immuno-Oncology
    • Platform Expansion to Include Coronavirus Vaccine Development; Seeking Non-Dilutive Funding

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Cancer Research UK's Commercial Partnerships has permitted Lineage to conduct an early exercise of its option to acquire data from Cancer Research UK's ongoing Phase 1 clinical trial of VAC2 in non-small cell lung cancer (NCT03371485), and develop an allogeneic dendritic cell therapy platform ("VAC"). Lineage will assume responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK concludes the ongoing trial. This decision was based on an early review of the data collected by Cancer Research UK in the VAC2 trial under a clinical trial and option agreement. In addition, Cancer Research UK will provide input on the potential use of VAC in the infectious disease space to develop a vaccine against SARS-CoV-2, the virus which causes COVID-19. Cancer Research UK is the world's largest cancer charity dedicated to saving lives through research.

    "Clinical data recently collected by Cancer Research UK in the ongoing trial of VAC2 has shown peripheral immunogenicity in patients with non-small cell lung cancer, providing validation of the underlying mechanism of using allogeneic dendritic cells to present antigens to the body's immune system. Evidence of immunogenicity was a key clinical signal which was necessary before we would consider taking over the program," stated Brian M. Culley, Lineage CEO. "This encouraging evidence builds upon earlier clinical studies of VAC which supported not only the safety of the VAC platform, but also evidence that patients developed antigen-specific T cell immune responses. We are excited to assume responsibility for advancing this promising program and move Lineage more aggressively into the field of cancer immunotherapy. Given the scientific evidence supporting our approach, the opportunity to also apply our VAC program to SARS-CoV-2 vaccine development was another positive consideration and we are pleased that Cancer Research UK facilitated this decision. Presenting a viral antigen will require transferring the program from Cancer Research UK's Centre for Drug Development to our cGMP facility, scaling the manufacturing process, and eventually submitting an IND for clinical testing. We also will be evaluating opportunities for non-dilutive funding for this new initiative."

    Dr. Nigel Blackburn, Cancer Research UK's Director of the Centre for Drug Development, said: "We are pleased that our development efforts on the VAC2 program over the past several years have generated initial evidence of an immune response in cancer patients and have resulted in an early exercise of the option by Lineage. We are excited to transfer the next phase of development to our partners and to assist the expansion of those efforts into SARS-CoV-2 vaccine development and other areas with significant unmet need."

    About VAC2

    VAC2 is an allogeneic, or non-patient specific, cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body's immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

    About Cancer Research UK's Centre for Drug Development

    Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

    About Cancer Research UK's Commercial Partnerships Team

    Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research. Cancer Research UK's specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK's commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

    About Cancer Research UK

    • Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research.
    • Cancer Research UK's pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
    • Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
    • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
    • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK's ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
    • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
    • Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

    For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's plans to develop the VAC platform and the potential of the VAC platform to address COVID-19. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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    • Better Visual Acuity, Reduced Geographic Atrophy (GA) Progression, and Improved Reading Speed Reported in First Cohort 4 and First Orbit SDS Patients
    • Additional Interim Results from Phase I/IIa Clinical Study of OpRegen Presented at Association for Research in Vision and Ophthalmology (ARVO) Meeting
    • Therapeutic Expert Call with Christopher D. Riemann, M.D. Scheduled for May 11, 2020

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment…

    • Better Visual Acuity, Reduced Geographic Atrophy (GA) Progression, and Improved Reading Speed Reported in First Cohort 4 and First Orbit SDS Patients
    • Additional Interim Results from Phase I/IIa Clinical Study of OpRegen Presented at Association for Research in Vision and Ophthalmology (ARVO) Meeting
    • Therapeutic Expert Call with Christopher D. Riemann, M.D. Scheduled for May 11, 2020

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were published online via the ARVOLearn platform as part of the 2020 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The presentation entitled, "Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results" (Abstract # 3363764), was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. Dr. Riemann's presentation is available on the Media page of the Lineage website. Lineage will also host a live call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineage's website.

    "This update is significant as it builds on our earlier reports of gains in visual acuity and provides a more comprehensive picture of treatment with OpRegen for dry AMD, with meaningful improvements in the progression of geographic atrophy, visual acuity, and reading speed observed in our first Cohort 4 patient and first Orbit SDS with thaw-and-inject formulation dosed patient," stated Brian M. Culley, Lineage CEO. "As dry AMD is a slow and progressive disease, it takes many months to observe changes to retinal anatomy or visual acuity. With the benefit of longer follow-up, we now can report that some OpRegen treated patients are able to see better, have less growth in their area of GA, and are able to read faster, all of which represent significant enhancements to vision and quality of life metrics. In addition to these individual results, the pooled data continues to suggest a treatment effect in both visual acuity and GA progression. Notably, we also are reporting additional evidence that OpRegen cells remain present for at least 4 years and hope that longer follow-up periods will reinforce a growing body of evidence that OpRegen is well-tolerated and can provide sustained and clinically meaningful benefits with a single dose of RPE cells. Our near-term objective is to treat and monitor the final four patients in Cohort 4 of the current study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market."

    "As a principal investigator on the OpRegen clinical study, I am excited to present this most recent update, where all Cohort 4 patients treated with OpRegen had improved Best Corrected Visual Acuity up to one year or at their last visit, demonstrating a substantial treatment response," stated Christopher D. Riemann, M.D. "The pooled Cohort 4 data demonstrate a significant, greater than 10-letter sustained visual acuity improvement over the entire follow‑up period. Reading center assessments of GA also suggest a reduction in GA progression in the OpRegen treated eye when compared to fellow eye in Cohort 4. I am encouraged by the results observed in patients treated to date with OpRegen and I look forward to dosing patients in this study at CEI."

    KOL Call Information and Webcast

    Lineage will host a conference call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineage's website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through May 19, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6597936.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's objectives with respect to OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  10. Grant Application Submitted to California Institute for Regenerative Medicine for Additional Funding

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it has applied for grant funding from the California Institute for Regenerative Medicine (CIRM) to support the use of VAC, Lineage's allogeneic dendritic cell therapy, toward the development of a potential vaccine against SARS-CoV-2, the virus which causes COVID-19. In response to the COVID-19 pandemic, CIRM recently approved emergency funding and the allocation of $5 million for peer-reviewed regenerative medicine and stem cell research that could quickly advance…

    Grant Application Submitted to California Institute for Regenerative Medicine for Additional Funding

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it has applied for grant funding from the California Institute for Regenerative Medicine (CIRM) to support the use of VAC, Lineage's allogeneic dendritic cell therapy, toward the development of a potential vaccine against SARS-CoV-2, the virus which causes COVID-19. In response to the COVID-19 pandemic, CIRM recently approved emergency funding and the allocation of $5 million for peer-reviewed regenerative medicine and stem cell research that could quickly advance treatments for COVID-19. The funding would be awarded as part of an expedited approval process.

    "Several lines of clinical evidence encouraged us to apply the use of the VAC technology to the development of a prophylactic vaccine against SARS-CoV-2 and other coronaviruses," stated Brian M. Culley, Lineage CEO. "Recent publications have reported that patients infected with coronaviruses can exhibit modest neutralizing antibody titers and diminished T cell responses, suggesting it may be difficult for traditional vaccine approaches to generate long-term protection via the cellular immune response. Our belief is that dendritic cells, the body's most potent antigen-presenting cell, can present viral antigens to the immune system to prime a robust immunological memory and provide durable, multi-year protection against the severe consequences of infection. This would be especially beneficial for front-line healthcare workers and others at risk of repeated exposure. Clinical data in patients with various cancers collected by Duke University Medical Center in early clinical trials of VAC1, the first product candidate from the VAC platform, showed nearly all patients developed evidence of antigen-specific T cell immune responses. This signal was confirmed in a majority of patients enrolled in a subsequent phase 2 study of VAC1 reported in 2016 by Asterias Biotherapeutics, which Lineage acquired in 2019. We believe these and additional data provide validation of the underlying mechanism of using dendritic cells to present antigens to the body's immune system. We believe we are unique among cell therapy companies that are evaluating solutions to the COVID-19 pandemic because we are not focused on late-stage critical care, but on providing long-term prophylactic protection against infection, which may help reduce the need for hospitalization and address a critical gap among the critical care and humoral immunity approaches currently in development. The ideal scenario is that protection against COVID-19 in high-risk individuals would become durable, similar to measles or pertussis, rather than influenza, which requires an annual vaccination."

    Mr. Culley continued, "Presenting a viral antigen by means of our allogeneic dendritic cell platform will require manufacturing process development and creating a new expression construct prior to submitting an Investigational New Drug (IND) application to enable clinical evaluation. This will entail a modest investment of capital, but we feel that we are able to manage this new program alongside our existing programs in dry AMD and spinal cord injury. We recently raised $3.8M of cash from the sale of OncoCyte shares and this capital, alongside the translational research grant application submitted to CIRM, should it be approved, will help support our work in this area. We also intend to seek additional opportunities to obtain non-dilutive backing for this program."

    Lineage management will host a conference call and webcast on Thursday, May 7, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2020 financial and operating results and provide a business update with additional information on the matters in this release. A live webcast of the conference call will be available online in the Investors section of Lineage's website. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through May 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7948501.

    About VAC

    VAC is an allogeneic, or non-patient specific, product candidate platform designed to stimulate patient immune responses to antigens commonly expressed in cancerous cells but not in normal adult cells. VAC product candidates are produced from a pluripotent cell line using a directed differentiation method and are comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct our body's immune system to attack and eliminate harmful pathogens and unwanted cells. Because the antigen is loaded exogenously into the dendritic cells prior to administration, VAC is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. An earlier VAC program, called VAC1, was comprised of autologous dendritic cells and provided proof-of-concept for VAC2, an allogeneic product candidate.

    About CIRM

    With $3 billion in funding and approximately 300 active stem cell programs in its portfolio, CIRM is the world's largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality. In response to the crisis caused by the COVID-19 virus, CIRM recently approved emergency funding and the allocation of $5 million for peer-reviewed regenerative medicine and stem cell research that could quickly advance treatments for COVID-19. The funding would be awarded as part of an expedited approval process. For more information go to www.cirm.ca.gov or follow CIRM on Twitter: @CIRMnews.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's development plans with respect to its VAC technology and SARS-Cov-2. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  11. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it will report its first quarter 2020 financial and operating results on Thursday, May 7, 2020, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 7, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2020 financial and operating results and to provide a business update.

    Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it will report its first quarter 2020 financial and operating results on Thursday, May 7, 2020, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 7, 2020, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2020 financial and operating results and to provide a business update.

    Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through May 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7948501.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  12. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced the pricing of the sale of 1,672,689 shares of common stock of OncoCyte Corporation at a price to buyers of $2.27 per share, representing the closing price of OncoCyte common stock on April 23, 2020. Net proceeds from the sale were approximately $3.7 million. The sale is expected to close by April 30, 2020, subject to certain closing conditions. Following the completion of the sale, Lineage will own approximately 4.3 million shares of OncoCyte. Based on the closing price of OncoCyte's common stock on April 23, 2020, the value of Lineage's remaining OncoCyte shares following…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced the pricing of the sale of 1,672,689 shares of common stock of OncoCyte Corporation at a price to buyers of $2.27 per share, representing the closing price of OncoCyte common stock on April 23, 2020. Net proceeds from the sale were approximately $3.7 million. The sale is expected to close by April 30, 2020, subject to certain closing conditions. Following the completion of the sale, Lineage will own approximately 4.3 million shares of OncoCyte. Based on the closing price of OncoCyte's common stock on April 23, 2020, the value of Lineage's remaining OncoCyte shares following the closing is approximately $9.7 million. Lineage has agreed not to sell additional shares of OncoCyte common stock prior to June 8, 2020 or unless the OncoCyte common stock price closes above $3.40.

    "In light of impacts to our industry from the COVID-19 pandemic, we have elected to make this sale to support our operations and maintain timelines," stated Brian M. Culley, Lineage CEO. "We believe this most recent transaction involving OncoCyte alongside our culture of focused and responsible spending will help us successfully navigate through this virus-related disruption. We are pleased that demand for OncoCyte shares was again available at market prices with no discount. Looking ahead, we look forward to providing our next OpRegen® update at the upcoming 2020 ARVO Meeting, which will be hosted virtually via ARVOLearn."

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's operating plans during the current COVID-19 pandemic. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  13. NEW YORK, NY / ACCESSWIRE / April 6, 2020 / Solebury Trout, a boutique investor relations and corporate communications firm, announced today that it will be hosting a fourth day of presentations as part of a Virtual Conference Series featuring leading companies from the life sciences industry. At the event, taking place on April 7, 2020, management teams will present a business overview and highlights using an online, digital meeting format.

    The April 7 schedule follows, with presentations available at https://78449.themediaframe.com/dataconf/productusers/solebury/mediaframe/36850/indexl.html:

    10:00 a.m. EST, Ascentage Pharma (6855-HK)
    10:30 a.m. EST, Maxcyte (MXCT-GB)
    11:00 a.m. EST, CASI Pharmaceuticals (CASI)
    11:30 a.m. EST, BioXcel Therapeutics…

    NEW YORK, NY / ACCESSWIRE / April 6, 2020 / Solebury Trout, a boutique investor relations and corporate communications firm, announced today that it will be hosting a fourth day of presentations as part of a Virtual Conference Series featuring leading companies from the life sciences industry. At the event, taking place on April 7, 2020, management teams will present a business overview and highlights using an online, digital meeting format.

    The April 7 schedule follows, with presentations available at https://78449.themediaframe.com/dataconf/productusers/solebury/mediaframe/36850/indexl.html:

    10:00 a.m. EST, Ascentage Pharma (6855-HK)
    10:30 a.m. EST, Maxcyte (MXCT-GB)
    11:00 a.m. EST, CASI Pharmaceuticals (CASI)
    11:30 a.m. EST, BioXcel Therapeutics (BTAI)
    12:00 p.m. EST, Pharming Group NV (PHARM-NL)
    12:30 p.m. EST, I-Mab Biopharma (IMAB)
    1:00 p.m. EST, Incysus Therapeutics (private)
    1:30 p.m. EST, Engage Therapeutics (private)
    2:00 p.m. EST, NervGen Pharma (NGEN-CA)
    2:30 p.m. EST, Camallergy (private)
    3:00 p.m. EST, Yiviva (private)

    Investors and others can register and access the conference at the Solebury Trout Virtual Global Healthcare Conference Series website: https://troutaccess.com/investor.php/c/Solebury_Trout_Virtual_Global_Healthcare_Conference.

    Companies that have presented at prior days of the conference series on March 26, March 31, and April 2, 2020, have included:

    Adrenomed (private), Affimed (NASDAQ:AFMD), AM-Pharma (private), ANTEV Limited (private), Apexigen (private), Aptorum Group (NASDAQ:APM), BerGenBio (BGBIO-NO), Catabasis Pharmaceuticals (NASDAQ:CATB), CerSci Therapeutics (private), ESSA Pharma (NASDAQ:EPIX), Evofem Biosciences (NASDAQ:EVFM), Faraday Pharma (private), Forbius (private), HaemaLogiX (private), Impact Therapeutics (private), Junshi Biosciences (1877-HK), Kineta (private), Landos Biopharma (private), Lineage Cell Therapeutics (NYSE:LCTX), NeuroRx (private), Neximmune (private), NorthSea Therapeutics (private), OnKure Therapeutics (private), Paion (PA8-DE), Paradigm Biopharma (PAR-AU), PharmaMar (PHM-SE), Pieris Pharmaceuticals (NASDAQ:PIRS). Ryvu Therapeutics (RVU-PL), Sol-Gel Technologies (NASDAQ:SLGL), Targovax (TRVX-NO), Teon Therapeutics (private), and Vaccitech Limited (private).

    More information on the event, including archived presentations when available and a list of presenters and companies potentially available for engagement with the investment community, can be found at www.troutaccess.com.

    About Solebury Trout

    Solebury Trout is a well-established Investor Relations and Corporate Communications firm. For more than 20 years, Solebury Trout has partnered with private and public companies across all sectors, offering fully outsourced investor relations, perception surveys, environmental, social and governance (ESG) evaluations, C-suite visibility programs, content development, media relations, digital and social media communications, crisis preparation and media and presentation training.

    Solebury Trout is affiliated with Solebury Capital and is a subsidiary of The PNC Financial Services Group, Inc. Solebury Capital a premier equity capital markets advisory firm providing management teams and owners with independent advice and judgment honed in decades of experience in capital markets at leading investment firms across the globe. Since its founding in 2005, Solebury Capital has advised on over 700 successful transactions representing nearly $300B in proceeds.

    Contact:

    Thomas Hoffmann
    646-378-2931

    Disclaimer

    "Solebury" is a marketing name for Solebury Trout LLC and Solebury Capital LLC. The services described herein may be performed by a combination of Solebury Trout LLC or Solebury Capital LLC. Solebury deal team members may be employees of either entity. Solebury is an affiliate of The PNC Financial Services Group, Inc., a diversified financial services company. Equity capital markets advisory and related services are provided by Solebury Capital LLC. Solebury Capital LLC, is a registered broker-dealer and member of FINRA and SIPC. This material does not constitute an offer to sell or a solicitation of an offer to buy any investment product or security.

    SOURCE: Solebury Trout



    View source version on accesswire.com:
    https://www.accesswire.com/584081/Solebury-Trout-Announces-Additional-Virtual-Conference-Presentations-from-Life-Science-Companies-on-April-7-2020

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  14. NEW YORK, NY / ACCESSWIRE / March 24, 2020 / Solebury Trout, a boutique investor relations and corporate communications firm, announced today that it will be hosting a Virtual Conference Series on March 26, March 31, and April 2, 2020, featuring leading companies from the life sciences industry. At the event, management teams will present a business overview and highlights using an online, digital meeting format.

    Investors and others can register at the Solebury Trout Virtual Global Healthcare Conference Series homepage to access the conference and presentation schedule.

    "We are pleased to introduce a virtual meeting platform to highlight the progress and potential of leading life sciences companies," commented Jonathan Fassberg, Co-CEO of Solebury…

    NEW YORK, NY / ACCESSWIRE / March 24, 2020 / Solebury Trout, a boutique investor relations and corporate communications firm, announced today that it will be hosting a Virtual Conference Series on March 26, March 31, and April 2, 2020, featuring leading companies from the life sciences industry. At the event, management teams will present a business overview and highlights using an online, digital meeting format.

    Investors and others can register at the Solebury Trout Virtual Global Healthcare Conference Series homepage to access the conference and presentation schedule.

    "We are pleased to introduce a virtual meeting platform to highlight the progress and potential of leading life sciences companies," commented Jonathan Fassberg, Co-CEO of Solebury Trout. "This platform enables investors to continue to have direct access to the many companies in our industry advancing innovative, life-saving technologies and products worldwide."

    The companies to present at the conference series include:
    Adrenomed (private), Affimed (NASDAQ:AFMD), AM-Pharma (private), ANTEV Limited (private), Apexigen (private), Aptorum Group (NASDAQ:APM), BerGenBio (BGBIO-NO), Catabasis Pharmaceuticals (NASDAQ:CATB), CerSci Therapeutics (private), ESSA Pharma (NASDAQ:EPIX), Evofem Biosciences (NASDAQ:EVFM), Faraday Pharma (private), Forbius (private), HaemaLogiX (private), Impact Therapeutics (private), Junshi Biosciences (1877-HK), Kineta (private), Landos Biopharma (private), Lineage Cell Therapeutics (NYSE:LCTX), NeuroRx (private), Neximmune (private), NorthSea Therapeutics (private), OnKure Therapeutics (private), Paion (PA8-DE), Paradigm Biopharma (PAR-AU), PharmaMar (PHM-SE), Pieris Pharmaceuticals (NASDAQ:PIRS). Ryvu Therapeutics (RVU-PL), Sol-Gel Technologies (NASDAQ:SLGL), Targovax (TRVX-NO), Teon Therapeutics (private), and Vaccitech Limited (private).

    More information on the event, including a list of presenters and companies potentially available for engagement with the investment community, can be found at www.troutaccess.com.

    About Solebury Trout

    Solebury Trout is a well-established Investor Relations and Corporate Communications firm. For more than 20 years, Solebury Trout has partnered with private and public companies across all sectors, offering fully outsourced investor relations, perception surveys, environmental, social and governance (ESG) evaluations, C-suite visibility programs, content development, media relations, digital and social media communications, crisis preparation and media and presentation training.

    Solebury Trout is affiliated with Solebury Capital and is a subsidiary of The PNC Financial Services Group, Inc. Solebury Capital a premier equity capital markets advisory firm providing management teams and owners with independent advice and judgment honed in decades of experience in capital markets at leading investment firms across the globe. Since its founding in 2005, Solebury Capital has advised on over 700 successful transactions representing nearly $300B in proceeds.

    Contact:

    Thomas Hoffmann

    Disclaimer

    "Solebury" is a marketing name for Solebury Trout LLC and Solebury Capital LLC. The services described herein may be performed by a combination of Solebury Trout LLC or Solebury Capital LLC. Solebury deal team members may be employees of either entity. Solebury is an affiliate of The PNC Financial Services Group, Inc., a diversified financial services company. Equity capital markets advisory and related services are provided by Solebury Capital LLC. Solebury Capital LLC, is a registered broker-dealer and member of FINRA and SIPC. This material does not constitute an offer to sell or a solicitation of an offer to buy any investment product or security.

    SOURCE: Solebury Trout

    View source version on accesswire.com:
    https://www.accesswire.com/582334/Solebury-Trout-Announces-Virtual-Conference-Series-with-Presentations-from-Life-Science-Companies

    View Full Article Hide Full Article
    • Reported Positive Data from Phase 1/2a Clinical Trial of OpRegen®; All Cohort 4 Patients Have Improved Visual Acuity at Twelve Months or as of Last Visit (Gained Between 8-25 Readable Letters)
    • Entered into Agreements with Three Companies for Certain IP and Assets
    • Provided Positive Clinical Update from SCiStar Trial of OPC1 for Spinal Cord Injury
    • Strengthened Extensive IP Portfolio with the Issuance of 3 New U.S. Patents
    • Awarded $3.2 Million in Grants from Israel Innovation Authority and NIH
    • Extended Anticipated Cash Runway by Implementing Cost Savings Initiatives and Converting Securities into Cash Positions

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel…

    • Reported Positive Data from Phase 1/2a Clinical Trial of OpRegen®; All Cohort 4 Patients Have Improved Visual Acuity at Twelve Months or as of Last Visit (Gained Between 8-25 Readable Letters)
    • Entered into Agreements with Three Companies for Certain IP and Assets
    • Provided Positive Clinical Update from SCiStar Trial of OPC1 for Spinal Cord Injury
    • Strengthened Extensive IP Portfolio with the Issuance of 3 New U.S. Patents
    • Awarded $3.2 Million in Grants from Israel Innovation Authority and NIH
    • Extended Anticipated Cash Runway by Implementing Cost Savings Initiatives and Converting Securities into Cash Positions

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today reported financial and operating results for the fourth quarter and full year ended December 31, 2019. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2019 financial and operating results and to provide a business update.

    "2019 was a transformative year for Lineage. We established Lineage as a leading cell therapy company with the goal to usher in a new branch of medicine based on transplanting intact cells into the body to restore activity lost to aging, injury, or disease," stated Brian M. Culley, CEO. "We expanded our clinical pipeline by combining three complementary cell therapy assets under one roof, and also significantly reduced our cash burn by eliminating non-core activities. We focused our priorities and rebranded the company with a new leadership team, name, and headquarters in San Diego County. As we enter 2020, we intend to capitalize on the changes we made in 2019 and continue our positive momentum. Our primary goal is to complete enrollment in our Phase 1/2a clinical trial of OpRegen for dry AMD and collect the data that will guide our late-stage trial design and partnership discussions. We also will continue our efforts to advance the OPC1 program into a randomized trial by introducing commercially enabling enhancements to the manufacturing process. Lastly, we are working with our development partner, Cancer Research UK, and continue to assess clinical data that is being generated from the ongoing Phase 1 trial of VAC2. We are evaluating whether to exercise our option to acquire the data generated in the trial if the data supports that decision. We are excited about the three clinical programs that we are working to advance, each of which represents a potential billion dollar market opportunity."

    Significant events and data updates from 2019 and early 2020 include:

    • Successfully dosed two patients in our OpRegen Phase 1/2a clinical trial for the treatment of dry age-related macular degeneration (AMD) with a new thaw-and-inject formulation and a new delivery device, the 510(k)-cleared Subretinal Delivery System (SDS) developed by Gyroscope Therapeutics (Gyroscope). The Gyroscope SDS is designed to precisely and consistently deliver therapeutics to the sub-retinal space via a suprachoroidal route, avoiding: (i) the need for a vitrectomy; (ii) perforation of the retina (retinotomy); and (iii) loss of cells and adverse safety events due to efflux. We have to date reported on two patients dosed with the combination of the new device and formulation. The first patient demonstrated notable improvements in vision, having gained 25 readable letters (or 5 lines) 6 months following administration, as assessed by the Early Treatment Diabetic Retinopathy Scale (ETDRS). This represented an improvement in visual acuity from a baseline of 20/250 to 20/100 in the treated eye. The second patient showed a small improvement in visual acuity in the treated eye at just 14 days following treatment. Both patients had rapid healing at the surgical site with no unexpected complications or any serious adverse events. Improvements for patients in the trial have typically become most evident approximately three to six months after treatment. Treatment for all patients in the trial continues to be well tolerated and all five patients in Cohort 4 (who have better baseline vision and less advanced disease than Cohorts 1-3 patients) registered improvement according to the ETDRS eye chart assessment. Improvements ranged from 8 to 25 additional letters correctly identified for all patients with at least 6 months of follow-up as of December 31, 2019. We expect to dose a total of six patients with the Gyroscope SDS under our current agreement with Gyroscope.
    • Acquired Asterias Biotherapeutics, Inc. in March 2019. As a result of this acquisition, we acquired two additional cell therapy product candidates, OPC1 and VAC2, along with their associated expansion opportunities and other assets. As we integrated the two companies, we reduced costs by about 50% by eliminating duplicate costs and rationalizing non-key projects.
    • Rebranded as Lineage Cell Therapeutics and relocated the corporate headquarters from the San Francisco Bay Area to Carlsbad, California. We also hired experienced biotech professionals to fill critical management positions, including the Chief Financial Officer, General Counsel and Vice President, Business Development.
    • Entered into agreements with three separate companies, with each agreement relating to different parts of Lineage's intellectual property portfolio. All three companies have ongoing commercial operations in areas related to cell therapy. The aggregate up-front cash payment from the three transactions was greater than one million dollars with additional cash and royalties due upon reaching certain development milestones or product sales.
    • Reported a positive clinical update from our ongoing Phase 1/2a clinical trial of OPC1 known as SCiStar for the treatment of acute spinal cord injury (SCI). The overall safety profile of OPC1 remained excellent with robust motor recovery in the arms/hands maintained through year 2 follow-ups to date. Gains in motor function for patients assessed to date continued, representing tremendously meaningful improvements to quality of life and independence.
    • Awarded $3.2 million in grants from the Israel Innovation Authority and the National Institutes of Health and published or presented multiple papers and abstracts describing our work.
    • Obtained patents associated with the manufacture of our unique cell types, adding additional protections to all three of our clinical programs. Also obtained patent rights describing the use of induced pluripotent stem cells, an alternate option for generating differentiated cells for transplant and treatment of diseases, further broadening the potential application of our work.
    • Granted a Conformité Européenne (CE) Mark for Renevia®, the Company's facial aesthetics product, with an intended use in adults for the treatment of facial lipoatrophy. The CE Mark enables us to sell Renevia in Europe and we are actively pursuing a commercialization partner for this activity.
    • Announced that after reviewing promising preliminary data from the ongoing OpRegen Phase 1/2a clinical trial, our independent data safety monitoring board removed the protocol-mandated treatment stagger. Accordingly, we are opening two new U.S. clinical sites to accelerate patient enrollment and broaden surgical experience among dry AMD experts.

    Potential key events for 2020:

    • Complete patient enrollment in the U.S. with the Gyroscope SDS in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.
    • Present new OpRegen data from the ongoing Phase 1/2a clinical trial in May 2020 and as available throughout the year.
    • Meet with the U.S. Food and Drug Administration (FDA) to discuss the further clinical development of OpRegen.
    • Evaluate partnership opportunities for the OpRegen program.
    • Enhance commercial utility of OPC1 program by introducing commercially enabling improvements to the manufacturing process in our GMP manufacturing facility.
    • Meet with the FDA to discuss the manufacturing and further clinical development of OPC1.
    • Provide further clinical updates from the SCiStar Trial for SCI.
    • Evaluate partnership opportunities for Renevia in Europe.
    • Evaluate VAC2 clinical data from the initial patients in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK and evaluate potential early exercise of option to acquire data.
    • Continue engagement with the investment and medical communities with participation at medical and healthcare industry conferences, ongoing throughout 2020.
    • Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine, and Cancer Research UK.

    Balance Sheet Highlights

    Cash, cash equivalents, and marketable securities totaled $30.7 million as of December 31, 2019. Marketable securities include our remaining ownership of unrestricted securities in OncoCyte, AgeX Therapeutics, and Hadasit Bio-Holdings Ltd (Hadasit).

    During 2019, we were able to fund our operations primarily by selling a portion of our marketable securities. We sold 6,250,000 shares of OncoCyte's common stock for net proceeds of approximately $10.7 million. We also sold 765,889 shares of AgeX common stock for net proceeds of approximately $1.8 million and 1,048,147 shares of Hadasit common stock for net proceeds of approximately $1.7 million. On January 2, 2020, we sold 2,383,090 shares of OncoCyte stock for net proceeds of approximately $5.0 million. We continue to hold approximately 6 million shares of OncoCyte stock that are valued at $13.8 million as of March 10, 2020. All of our marketable securities are now in companies in which we hold less than 10% of the outstanding shares.

    In conjunction with the sale of AgeX shares to Juvenescence Limited (Juvenescence) in 2018, we also hold a $21.6 million promissory note bearing 7% annual interest that matures on August 30, 2020. As of December 31, 2019, the outstanding principal and accrued interest on the note was $23.6 million. If, prior to August 30, 2020, Juvenescence completes an initial public offering resulting in gross proceeds of at least $50.0 million, the promissory note automatically converts into the Juvenescence securities. Lineage has the right to review Juvenescence's financial statements twice per year.

    In summary, as of December 31, 2019, the value of the Company's cash, cash equivalents, marketable securities, and the balance of the Juvenescence promissory note due August 2020 were in excess of $54 million.

    The Company has implemented significant cost savings initiatives and anticipates that net operational spend for 2020 will be approximately $16 million. This planned spending level represents a significant reduction from 2019 spending levels of $32 million and 2018 spending levels of $43 million for Lineage and Asterias combined. Lineage acquired Asterias on March 8, 2019. Assuming the Juvenescence note is paid in cash at maturity, the Company believes that it is funded well into 2021 as a result of these cost savings initiatives.

    Fourth Quarter Operating Results

    Revenues: Lineage's revenue is generated primarily from royalties, licensing fees, research grants and the sale of research products. Total revenues for the three months ended December 31, 2019 were $1.2 million, an increase of $0.4 million as compared to $0.8 million for the same period in 2018. The increase was primarily related to a $0.7 million increase in royalties and licensing fees, offset by a $0.2 million decrease in grant revenue and $0.1 million decrease in the sale of research products.

    Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended December 31, 2019 were $8.0 million, a decrease of $2.8 million as compared to $10.8 million for the same period in 2018.

    R&D Expenses: R&D expenses for the three months ended December 31, 2019 were $3.5 million, a decrease of $0.3 million as compared to $3.8 million for the same period in 2018. The decrease was primarily related to decreases of $0.7 million in Renevia and HyStem expenses and a decrease of $0.2 million in OpRegen expenses, offset by an increase of $0.6 million in OPC1 and VAC2 expenses (these programs were acquired in the Asterias merger).

    G&A Expenses: G&A expenses for the three months ended December 31, 2019 were $4.5 million, a decrease of $2.5 million as compared to $7.0 million for the same period in 2018. The decrease was primarily attributable to a $1.8 million decrease in salaries, benefits and severance costs primarily related to terminated personnel, a $0.5 million reduction in severance, legal, accounting and other expenses related to the Asterias Merger, a $0.3 million reduction in accounting and consulting expenses and a $0.2 million reduction in travel expenses, offset by a $0.2 million increase in rent expense, which is primarily related to the implementation of ASC 842 Leases in 2019.

    Loss from Operations: Loss from operations for the three months ended December 31, 2019 was $6.9 million, a decrease of $3.2 million as compared to $10.1 million for the same period in 2018.

    Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended December 31, 2019 reflected other income, net of $1.5 million, compared to other expense, net of ($35.2) million for the same period in 2018. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods.

    Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2019 was $4.5 million, or $0.03 per share (basic and diluted), compared to a net loss attributable to Lineage of $45.0 million, or $0.35 per share (basic and diluted), for the same period in 2018.

    Full Year Operating Results

    Note regarding AgeX: On August 30, 2018, Lineage deconsolidated AgeX from its consolidated financial statements due to the sale by Lineage of 14,400,000 shares of AgeX common stock to Juvenescence and the related decrease of Lineage's ownership position in AgeX. Accordingly, Lineage ceased recognizing revenue and expenses related to AgeX and its programs on such date.

    Revenues: Lineage's revenue is generated primarily from royalties, licensing fees, research grants and the sale of research products. Total revenues for the year ended December 31, 2019 were $3.5 million, a decrease of $1.5 million as compared to $5.0 million for the same period in 2018. The decrease was primarily related to a $1.5 million decrease in grant revenue and a $0.7 million decrease in subscription and advertising revenues, partially offset by a $0.8 million increase in royalties from product sales and license fees.

    Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2019 were $42.0 million, a decrease of $4.5 million as compared to $46.5 million for the same period in 2018.

    R&D Expenses: R&D expenses for the year ended December 31, 2019 were $17.9 million, a decrease of $3.9 million as compared to $21.8 million for the same period in 2018. The decrease was primarily related to a decrease of $4.6 million related to the AgeX deconsolidation and the absence of AgeX R&D expenses incurred after August 30, 2018, a decrease of $3.8 million in Renevia and HyStem expenses and a decrease of $0.2 million in OpRegen expenses, offset by an increase of $4.8 million in OPC1 and VAC2 expenses (these programs were acquired in the Asterias merger).

    G&A Expenses: G&A expenses for the year ended December 31, 2019 were $24.0 million, a decrease of $0.7 million as compared to $24.7 million for the same period in 2018. The decrease was primarily attributable to a $3.1 million decrease in AgeX related general and administrative expenses, a $1.4 million decrease in salaries, benefits and severance costs primarily related to terminated personnel, a $1.1 million reduction in legal and patent expenses and a $0.7 million reduction in consulting expenses, offset by a $5.6 million increase in severance, legal, accounting and other expenses related to the Asterias Merger.

    Loss from Operations: Loss from operations for the year ended December 31, 2019 was $38.9 million, a decrease of $2.9 million as compared to $41.8 million for the same period in 2018.

    Other Income/(Expenses), Net: Other income/(expenses), net for the year ended December 31, 2019 reflected other income, net of $19.6 million, compared to other expense, net of ($5.3) million for the same period in 2018. The variance was primarily related to the 2018 gain on the sale of AgeX shares and deconsolidation of AgeX and changes in the value of equity method investments and marketable equity securities for the applicable periods.

    Net loss attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2019 was $11.7 million, or $0.08 per share (basic and diluted), compared to a net loss attributable to Lineage of $46.0 million, or $0.36 per share (basic and diluted), for 2018.

    Conference Call and Webcast

    Lineage will host a conference call and webcast today, at 1:30 pm PT/4:30 pm ET to discuss its fourth quarter and full year 2019 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through March 20, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 3827019.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's anticipated net operational spend, manufacturing plans, enrollment activities, discussions with Cancer Research UK regarding data generated from the ongoing trial of VAC2, data presentations, clinical trial advancement, drug evaluation, planned meetings with the FDA and partnership evaluations. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONSOLIDATED BALANCE SHEETS

    (IN THOUSANDS)

     

    ASSETS

    December 31,

    2019

     

    December 31,

    2018

    CURRENT ASSETS

     

     

     

     

     

    Cash and cash equivalents

    $

    9,497

     

     

    $

    23,587

     

    Marketable equity securities

     

    21,219

     

     

     

    7,154

     

    Promissory note from Juvenescence

     

    23,616

     

     

     

    -

     

    Trade accounts and grants receivable, net

     

    317

     

     

     

    767

     

    Landlord receivable

     

    -

     

     

     

    840

     

    Receivables from affiliates, net

     

    7

     

     

     

    2,112

     

    Prepaid expenses and other current assets

     

    2,863

     

     

     

    1,898

     

    Total current assets

     

    57,519

     

     

     

    36,358

     

     

     

     

     

     

     

    NONCURRENT ASSETS

     

     

     

     

     

    Property and equipment, net

     

    8,175

     

     

     

    5,835

     

    Deposits and other long-term assets

     

    864

     

     

     

    505

     

    Promissory note from Juvenescence

     

    -

     

     

     

    22,104

     

    Equity method investment in OncoCyte, at fair value

     

    -

     

     

     

    20,250

     

    Equity method investment in Asterias, at fair value

     

    -

     

     

     

    13,483

     

    Goodwill

     

    10,672

     

     

     

    -

     

    Intangible assets, net

     

    48,248

     

     

     

    3,125

     

    TOTAL ASSETS

    $

    125,478

     

     

    $

    101,660

     

     

     

     

     

     

     

    LIABILITIES AND SHAREHOLDERS' EQUITY

     

     

     

     

     

    CURRENT LIABILITIES

     

     

     

     

     

    Accounts payable and accrued liabilities

    $

    5,226

     

     

    $

    6,463

     

    Financing lease and right-of-use liabilities, current portion

     

    1,223

     

     

     

    237

     

    Promissory notes, current portion

     

    -

     

     

     

    70

     

    Deferred grant revenue

     

    45

     

     

     

    42

     

    Total current liabilities

     

    6,494

     

     

     

    6,812

     

     

     

     

     

     

     

    LONG-TERM LIABILITIES

     

     

     

     

     

    Deferred tax liability

     

    3,315

     

     

     

    -

     

    Deferred rent liabilities, net of current portion

     

    -

     

     

     

    244

     

    Deferred revenues

     

    200

     

     

     

    -

     

    Right-of-use lease liability, net of current portion

     

    3,868

     

     

     

    1,854

     

    Financing lease, net of current portion

     

    77

     

     

     

    104

     

    Liability classified warrants and other long-term liabilities

     

    277

     

     

     

    400

     

    TOTAL LIABILITIES

     

    14,231

     

     

     

    9,414

     

     

     

     

     

     

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

     

     

     

    SHAREHOLDERS' EQUITY

     

     

     

     

     

    Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of December 31, 2019 and 2018, respectively

     

    -

     

     

     

    -

     

    Common shares, no par value, authorized 250,000 shares; 149,804 and 127,136 shares issued and outstanding as of December 31, 2019 and 2018, respectively

     

    387,062

     

     

     

    354,270

     

    Accumulated other comprehensive (loss) income

     

    (681

    )

     

     

    1,426

     

    Accumulated deficit

     

    (273,422

    )

     

     

    (261,856

    )

    Lineage Cell Therapeutics, Inc. shareholders' equity

     

    112,959

     

     

     

    93,840

     

    Noncontrolling interest (deficit)

     

    (1,712

    )

     

     

    (1,594

    )

    Total shareholders' equity

     

    111,247

     

     

     

    92,246

     

    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

    $

    125,478

     

     

    $

    101,660

     

     

    LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (IN THOUSANDS, EXCEPT PER SHARE DATA)

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

    2019

     

    2018

     

    2019

     

    2018

     

    REVENUES:

     

     

     

     

     

     

     

     

     

     

    Grant revenue

    $

    409

     

    $

    587

     

    $

    2,037

     

    $

    3,572

     

    Royalties from product sales and license fees

     

    831

     

     

    80

     

     

    1,221

     

     

    392

     

    Subscription and advertisement revenues

     

    -

     

     

    -

     

     

    -

     

     

    691

     

    Sale of research products and services

     

    1

     

     

    91

     

     

    257

     

     

    333

     

    Total revenues

     

    1,241

     

     

    758

     

     

    3,515

     

     

    4,988

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of sales

     

    (123

    )

     

    (52

    )

     

    (412

    )

     

    (302

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

    Gross profit

     

    1,118

     

     

    706

     

     

    3,103

     

     

    4,686

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    OPERATING EXPENSES: