Full Press Release Details
CELL THERAPEUTICS REPORTS THIRD QUARTER 2020
RESULTS AND PROVIDES BUSINESS UPDATE
| Reported Encouraging VAC2 Clinical Data in the Ongoing Phase 1 Trial in Non-Small Cell Lung Cancer | ||
| Enrolled Additional Patients in Final Cohort of OpRegen Phase 1/2a Clinical Trial for the Treatment of Dry Age-Related Macular Degeneration (AMD) | ||
| Announced Extension of OpRegen Development Grant and New Grant for Development of a Bio-Retinal Patch from Israel Innovation Authority |
CA - November 4, 2020 - 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 third quarter ended September 30, 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 third quarter 2020 financial and operating results and to provide a business update.
moved all three of its clinical programs forward during the third quarter, particularly by reporting new data on VAC2 and by advancing
closer to the completion of patient enrollment in the OpRegen trial," said Brian M. Culley, Lineage CEO. "We look
forward to presenting updated data on OpRegen at the American Academy of Ophthalmology (AAO) Annual 2020 Meeting in mid-November,
and then completing patient enrollment in our Phase 1/2a clinical study of OpRegen, anticipated by the end of the year. With respect
to VAC2, we are working closely with Cancer Research UK and anticipate completing enrollment in the VAC2 Phase 1 study in non-small
cell lung cancer by the end of the first quarter of 2021. We also have made important progress with OPC1 and are excited to present
details on our manufacturing improvements later this year. The encouraging data in all three clinical programs to date support
advancing each product candidate into later stage trials. We are excited by the potential for these product candidates to help
patients who have high unmet medical needs and lack treatment options. Lineage is financially well-positioned to continue driving
our clinical programs toward key milestones, particularly following our receipt in August of $24.6 million of non-dilutive cash
has the following plans and objectives for the remainder of 2020 and early 2021:
| - | Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the AAO Annual 2020 Meeting in mid-November. | |
| - | Complete OpRegen patient enrollment in the U.S. in the ongoing Phase 1/2a clinical trial for the treatment of dry AMD by the end of 2020. | |
| - | Announce details of manufacturing improvements achieved with the OPC1 program by the end of 2020. | |
| - | Meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program during the first half of 2021. | |
| - | Complete VAC2 patient enrollment in the ongoing Phase 1 clinical trial for the treatment of non-small cell lung cancer by the end of the first quarter of 2021. |
Sheet and Cash Flow Highlights
cash equivalents, and marketable securities totaled $38.0 million as of September 30, 2020. Our cash balance includes $24.6 million
in proceeds from our note receivable payment from Juvenescence Limited in August 2020. Marketable securities as of September 30,
2020 include our ownership of unrestricted securities in OncoCyte Corporation (OncoCyte), AgeX Therapeutics, Inc. (AgeX) and Hadasit
Bio-Holdings Ltd (Hadasit).
continue to hold approximately 3.6 million shares of OncoCyte stock that are valued at $5.6 million as of November 3, 2020, based
on the closing price of its common stock on that date.
cash used in operating activities for the nine months ended September 30, 2020 was approximately $14.1 million, a decrease of
$12.3 million, or 47%, as compared to $26.4 million in the same period of 2019.
Quarter Operating Results
Lineage's revenue is generated primarily from research grants, royalties and licensing fees. Total revenues for the three
months ended September 30, 2020 were $0.6 million, consistent with the same period in 2019. A $0.2 million increase in royalties
from product sales and license fees was offset by a $0.1 million decrease in grant revenues due to the timing of grant related
activities and a $0.1 million decrease in the sale of research products and services due to the cessation of such sales.
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 September 30, 2020 were approximately $7.2 million, a decrease of
$1.7 million as compared to $8.9 million for the same period in 2019.
Expenses: R&D expenses for the three months ended September 30, 2020 were $3.6 million, a decrease of $0.7 million as
compared to $4.3 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.5 million
in OpRegen and other ophthalmic application expenses, attributable primarily to a decrease in manufacturing activities in 2020
as compared to 2019, $0.8 million in OPC1 expenses, primarily related to a return of unspent project funds of approximately $0.8
million from a former Asterias BioTherapeutics, Inc. (Asterias) service provider and $0.2 million in Renevia and other related
expenses, offset by an increase of $1.8 million in VAC program expenses related to the accrual of the signature fee of $1.6 million
to Cancer Research UK related to our exercise of the option to acquire data generated in the Phase 1 clinical trial of VAC2. The
signature fee will be paid in several installments through April 2021.
Expenses: G&A expenses for the three months ended September 30, 2020 were $3.6 million, a decrease of $1.0 million as
compared to approximately $4.6 million for the same period in 2019. The decrease was primarily attributable to a $0.9 million
reduction in compensation expenses, a $0.2 million reduction in expenses related to our merger with Asterias, a $0.1 million reduction
in travel expenses, a $0.1 million reduction in accounting expenses and a $0.1 million reduction in office related expenses, offset
by a $0.3 million increase in patent and legal expenses and $0.2 million increase related to the cessation of shared services
from Operations: Loss from operations for the three months ended September 30, 2020 was $6.7 million, a decrease of $1.7 million
as compared to $8.4 million for the same period in 2019.
(Expense) Income, Net: Other (expense)/income, net for the three months ended September 30, 2020 reflected other expense,
net of ($1.2) million, compared to other expense, net of ($9.1) million for the same period in 2019. The variance was primarily
related to the gain on sale of marketable equity securities and equity method investments and changes in the value of remaining
marketable equity securities and equity method investments 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 $8.3
million in the three months ended September 30, 2019, which contributed greatly to the overall balance in other expense, net for
loss attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2020 was $7.8
million, or $0.05 per share (basic and diluted), compared to a net loss attributable to Lineage of $16.5 million, or $0.11 per
share (basic and diluted), for the same period in 2019.
will host a conference call and webcast today, at 1:30 pm PT/4:30 pm ET to discuss its third 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 November
12, 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 7780879.
Lineage Cell Therapeutics, Inc.
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. For more information, please visit
www.lineagecell.com or follow the Company on Twitter @LineageCell.
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 planned announcement of manufacturing improvements, expected enrollment in the Phase 1/2a clinical study of
OpRegen and Phase 1 study of VAC2, data presentations, clinical trial advancement, 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.
Cell Therapeutics, Inc. IR