Full Press Release Details
CELL THERAPEUTICS REPORTs FOURTH QUARTER AND FULL YEAR 2020 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
| Completed Enrollment in Phase 1/2a Clinical Trial of OpRegen for the Treatment of Dry Age-Related Macular Degeneration | ||
| Announced First Known Report of Human Retinal Tissue Restoration; Persisted to 23 Months with Improved Vision | ||
| Made Significant Improvements to OPC1 Manufacturing, Including to Process, Purity, and Scale | ||
| Reacquired the VAC Immuno-Oncology Platform and Reported Initial Data in Ongoing Phase 1 Clinical Trial in Non-Small Cell Lung Cancer | ||
| Received $24.6 Million Installment Payment from Juvenescence Ltd. Related to Sale of AgeX Therapeutics | ||
| Current Cash Position Expected to Support Operations Well Into 2023 |
CA - March 11, 2021 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology
company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the fourth
quarter and full year 2020. 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 2020 financial and operating results and to provide a business update.
goal is to build Lineage into the preeminent allogeneic cell transplant company, and we hit our stride in 2020, reaching significant
clinical, manufacturing, and business milestones and creating substantial value for our shareholders. We also positioned ourselves
for success in 2021 and beyond," stated Brian M. Culley, Lineage CEO. "We know of no other company that possesses
a comparable combination of cell therapy patent breadth, in-house manufacturing capabilities, and encouraging clinical evidence
in three distinct disease areas, each with large unmet needs and billion-dollar commercial opportunities. We believe the field
of cell therapy is poised for explosive growth in the months and years ahead. Our objective is to be positioned for that growth
by continuing to provide evidence that allogeneic approaches can generate safety and efficacy data which leads to commercial and
clinical advantages over alternate approaches. Importantly, Lineage also recently added $35.9 million in new capital through the
timely sales of our equity and marketable securities. We believe this new capital will ensure we are funded to deliver additional
significant milestones from our novel cell therapy pipeline and provide us with optionality in ongoing partnership discussions."
of the significant milestones we achieved during 2020 include:
of the events and milestones that our shareholders can look forward to in 2021 include:
cash equivalents, and marketable securities totaled $41.6 million as of December 31, 2020. Marketable securities as of December
31, 2020 include our remaining ownership of unrestricted securities in OncoCyte, and Hadasit Bio-Holdings Ltd (Hadasit).
2020, we funded our operations primarily by receiving payment in full for a total of $24.6 million on the Juvenescence promissory
note, and by selling a portion of our marketable securities, resulting in net proceeds of approximately $13.1 million.
during 2020, we selectively sold 3,094,322 of our common shares under the ATM offering for gross proceeds of approximately $5.1
million (which excludes $0.3 million of cash in transit related to 2020 sales that settled in 2021).
fundraising activities
January 1, 2021 through March 5, 2021, we sold an additional portion of our marketable securities, resulting in net proceeds of
approximately $10.1 million and an additional $19.9 million in gross proceeds through sales of 7,941,122 of our common shares
under the ATM offering (which includes $0.3 million in cash in transit related to 2020 sales that settled in 2021). As of March
5, 2021, the value of the Company's cash and cash equivalents were in excess of $57 million.
of March 5, 2021, we hold 1,122,401 shares of OncoCyte stock valued at approximately $4.2 million and 169,167 shares of Hadasit
stock valued at approximately $330,000, in each case based on the closing prices of those shares on March 5, 2021.
Company anticipates that net operational spend for 2021 will be approximately $20.0 to $22.0 million, which is similar to 2020
spending levels. The Company believes that it is well funded into 2023 as a result of sustained cost savings initiatives in 2020
and recent fundraising activities.
Quarter Operating Results
Lineage's revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three
months ended December 31, 2020 were approximately $0.4 million, a decrease of $0.8 million as compared to $1.2 million for the
same period in 2019. The decrease was primarily related to an approximate $0.6 million decrease in royalties and licensing fees,
which was primarily driven by the absence of a $0.6 million upfront payment from a new license agreement in 2019, and a $0.2 million
decrease in grant revenues due to the timing of grant related activities.
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, 2020 were $6.1 million, a decrease of $1.9 million
as compared to $8.0 million for the same period in 2019.
Expenses: R&D expenses for the three months ended December 31, 2020 were $2.6 million, a decrease of $0.9 million as compared
to $3.5 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, and $0.1 million in Renevia and HyStem related expenses, offset by an increase of $0.5 million in OPC1 expenses, attributable
primarily to an increase in manufacturing activities, and a $0.3 million increase in VAC program expenses.
Expenses: G&A expenses for the three months ended December 31, 2020 were $3.5 million, a decrease of $1.0 million as compared
to $4.5 million for the same period in 2019. The decrease was primarily attributable to decreases of $0.4 million in legal and
patent expenses, $0.3 million in rent expense, $0.3 million in expenses related to our merger with Asterias Biotherapeutics, Inc.
(Asterias Merger) and $0.2 million in accounting and consulting expenses, offset by a $0.2 million increase related to the cessation
of shared services reimbursements.
from Operations: Loss from operations for the three months ended December 31, 2020 was $5.9 million, a decrease of $1.0 million
as compared to $6.9 million for the same period in 2019.
Income/(Expenses), Net: Other income/(expenses), net for the three months ended December 31, 2020 reflected other income, net
of $6.9 million, compared to other income, net of $1.5 million for the same period in 2019. The variance was primarily related
to the gain on sale of marketable securities and changes in the value of marketable equity securities for the applicable periods,
as well as foreign currency translation adjustments related to Lineage's international subsidiaries.
Income/(Loss) attributable to Lineage: The net income attributable to Lineage for the three months ended December 31, 2020 was
$2.0 million, or $0.01 per share (basic and diluted), compared to a net loss attributable to Lineage of ($4.5) million, or ($0.03)
per share (basic and diluted), for the same period in 2019.
Year Operating Results
Lineage's revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the year
ended December 31, 2020 were $1.8 million, a decrease of $1.7 million as compared to $3.5 million for the same period in 2019.
The decrease was primarily related to a $1.0 million decrease in grant revenue due to less grant-related activities, $0.4 million
decrease in royalties from product sales and license fees, and a $0.3 million decrease in the sale of research products and services
due to the cessation of such sales.
Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended
December 31, 2020 were $27.9 million, a decrease of $14.1 million as compared to $42.0 million for the same period in 2019.
Expenses: R&D expenses for the year ended December 31, 2020 were $12.3 million, a decrease of $5.6 million as compared to
$17.9 million for the same period in 2019. The overall decrease was primarily related to a decrease of $6.5 million in OpRegen
and other ophthalmic application expenses, attributable primarily to a decrease in manufacturing activities in 2020 as compared
to 2019, a decrease of $0.8 million in Renevia and other related expense as we are spending less and actively looking for a commercialization
partner, and a $0.5 million decrease in OPC1-related expenses, primarily driven by a return of unspent project funds of approximately
$0.8 million from a former Asterias service provider, offset by a $2.2 million increase in VAC program expenses, primarily related
to the accrual of the signature fee of 1.25 million ($1.6 million) to Cancer Research UK.
Expenses: G&A expenses for the year ended December 31, 2020 were $15.6 million, a decrease of approximately $8.4 million as
compared to $24.0 million for the same period in 2019. The decrease was primarily attributable to a $5.5 million decrease in Asterias
Merger related expenses, a $2.1 million reduction in compensation costs as a result of headcount reductions in 2019, a $0.9 million
reduction in accounting expenses, a $0.5 million reduction in rent and utilities, a $0.3 million reduction in travel expenses,
a $0.3 million reduction in office and information technology related expenses and a $0.2 million reduction in consulting expenses,
offset by a $0.9 million increase related to the cessation of shared services reimbursements and a $0.5 million increase in legal
and patent expenses.
from Operations: Loss from operations for the year ended December 31, 2020 was $26.4 million, a decrease of $12.5 million as compared
to $38.9 million for the same period in 2019.
Income, Net: Other income, net for the year ended December 31, 2020 reflected other income, net of $4.5 million, compared to other
income, net of $19.6 million for the same period in 2019. The variance was primarily related to the changes in the value of equity
method investments and marketable equity securities for the applicable periods, gain on sale of marketable securities for the
applicable periods, as well as foreign currency translation adjustments related to Lineage's international subsidiaries.
loss attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2020 was $20.6 million, or
$0.14 per share (basic and diluted), compared to a net loss attributable to Lineage of $11.7 million, or $0.08 per share (basic
and diluted), for 2019.
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 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 March 19, 2021, 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 4176568.