Full Press Release Details
CELL THERAPEUTICS REPORTS SECOND QUARTER 2020
RESULTS AND PROVIDES UPDATE on ALL clinical programs
| 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 |
CA - August 6, 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 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.
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.
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.
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.
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
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. |
Sheet and Cash Flow Highlights
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
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.
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.
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.
Quarter Operating Results
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.
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.
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.
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.
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.
(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.
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.
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.
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 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.
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,"