Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, today provided a year-end review
and an outline of its plans for 2021.
To Our Shareholders,
As we reach the end of an eventful 2020, we are inspired by the
many healthcare providers and biopharmaceutical companies that
worked to combat the COVID-19 pandemic. This year has been
difficult, but it has reinforced the importance of our mission: to
treat and potentially even reverse the effects of serious diseases
and conditions by advancing our novel cell therapy product
candidates through clinical trials and into the hands of
physicians. Although our industry has enjoyed many successes
lately, those affected by the conditions we are focused on still
need better choices.
Following changes to our leadership team in late 2018 and early
2019, we have sought to transform Lineage into the preeminent
allogeneic cell transplant company. Our work began modestly, but we
hit our stride in 2020 and reached important clinical,
manufacturing, and business milestones this year, which created
substantial value and advanced us toward our ultimate goal. In
parallel, a number of cell therapy milestones were reached by other
companies and academic institutions, strengthening our belief that
the field has entered a turning point and is poised for explosive
growth in the months and years ahead. We want to be prepared for
that growth, so we are looking toward 2021 and mapping out
additional milestones we want to deliver to our shareholders next
year.
We are fortunate to have attracted may new shareholders this
past year, so it is important from time to time to outline our
basic approach to building a successful company and explain how it
differs in advantageous ways from many others working in cell
therapy.
Our basic approach is akin to transplant medicine, in which
specific cell types are used to replace the ones which have been
lost to disease, not unlike a bone marrow transplant. In certain
settings, we believe that transplanting whole human cells can offer
a more attractive safety profile and predictable behavior than
introducing foreign molecules into the body.
Most importantly, our therapeutic products are derived from
well-characterized pluripotent stem cell lines. These cells can
become any of the cell types in your body, from bone to brain to
blood, and starting with pluripotent stem cell lines means we have
a virtually unlimited supply of starting material. From these cells
we apply proprietary methods to manufacture pure populations of
only the cell types which we wish to use in patients. Notably, we
never modify the DNA of these cells, which avoids some of the
safety concerns that have been reported with certain gene-editing
technologies.
Deriving cell therapy products from pluripotent stem cells
offers a second critical advantage; it allows our cells to be used
as allogeneic or “off the shelf” transplants in patients – an
approach which offers major advantages in terms of cost and scale
of production, and which may be able to offer additional benefits
which traditional therapeutic modalities are unable to achieve,
such as restoring lost tissue.
We next make intelligent investments in our manufacturing and
delivery methods, to help establish best-in-class products for
end-users and strong competitive advantages to protect our products
and intellectual property over the long term. As a reminder, there
currently is no FDA approval pathway to develop a generic or
biosimilar copy of a cell therapy product, which provides a
significant barrier-to-entry from generic competition.
Finally, we seek to generate compelling clinical data to support
moving into late-stage clinical trials and eventual marketing
authorizations. We believe that we already are seeing data that
supports advancing all three of our clinical-stage products into
additional trials which, in some cases, may be registrational.
Therapeutic product development is a long process, but we’re
making great progress. Our goal of building Lineage into the
preeminent cell therapy company is ambitious but attainable. 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 medical needs and billion-dollar commercial
opportunities. The safety and efficacy data we have seen to date
encourages us to continue advancing our product candidates closer
to late-stage clinical trials and potential corporate
partnerships.
In addition to our overall product development strategy, we’ve
conducted some transactions which can help build value for Lineage
shareholders over the longer term. For example, we have
successfully monetized portions of Lineage’s non-core patent
portfolio, including through the creation and subsequent sale of
businesses like AgeX and OncoCyte, transactions which helped fund
our clinical programs without the need for traditional equity
financings. It is worth highlighting that we have not needed to
conduct a traditional equity financing in more than three years,
avoiding the dilution that comes along with such offerings during a
period of significant business transition. We also have established
a culture of responsible spending and cost cutting to advance our
programs in the most efficient way possible. Furthermore, we have
enjoyed significant cost synergies by combining all of our
manufacturing activity at one facility, sequentially applying our
team’s know-how and best practices to all three clinical programs
without having to increase our headcount.
The most significant milestones we achieved in 2020
include:
- Completion of enrollment in a 24 patient Phase 1/2a clinical
study of OpRegen® for the treatment of dry age-related macular
degeneration (AMD) with geographic atrophy (GA) with encouraging
preliminary signs of tolerability and efficacy;
- Announcing the first known finding of retinal tissue
restoration in a patient who received a retinal pigment epithelium
(RPE) cell transplant;
- Making major manufacturing improvements to our OPC1 acute
spinal cord injury (SCI) program, including to the process, purity,
potency, and scale, and to the development of a “ready-to-inject”
formulation, enabling use at a much larger number of treatment
centers;
- The early exercise of our option with Cancer Research UK to
bring the VAC immuno-oncology platform in-house; and
- Reporting encouraging preliminary Phase 1 clinical study
results with VAC2 for the treatment of non-small cell lung cancer
with high levels of antigen-specific immunogenicity observed.
The achievement of these milestones, alongside increased efforts
to generate awareness about Lineage’s mission, have led to
meaningful share appreciation this past year. Looking ahead, we
believe the field of cell therapy will experience years of rapid
growth, especially in conditions for which small molecules or
antibodies have failed, such as dry AMD and spinal cord injuries.
In oncology, we believe that innate immune cells such as our
dendritic cells will enjoy a resurgence as a promising complement
to chimeric antigen receptor T cells (CAR-T) and more recently, the
emerging natural killer (NK) cell therapies. We seek not only to be
well-positioned for that growth, but also to contribute to the
understanding that allogeneic approaches are generating a growing
body of safety and efficacy data which can lead to compelling
commercial advantages and clinical outcomes.
Among our 2021 objectives will be to move all three of our
clinical programs forward, achieve further improvements in our
overall product profiles via manufacturing and delivery system
improvements, and enter into validating and enabling partnerships
to accelerate our timelines. An additional objective this year will
be to build greater awareness for our past achievements and our
future plans.
Some of the events and milestones that our shareholders can
look forward to in 2021 include:
- Present new and accumulated OpRegen data from the ongoing Phase
1/2a clinical study on two occasions during the first and second
quarters of 2021;
- Complete VAC2 patient enrollment in the ongoing Phase 1
clinical study for the treatment of non-small cell lung cancer by
the end of the first quarter of 2021;
- Evaluate delivery device solutions for our OPC1 program,
enabling access to a greater number of clinical sites, currently
ongoing and throughout 2021;
- Meet with the FDA to discuss further development of the OPC1
program, including a late stage clinical study, during the first
half of 2021;
- Host a Therapeutic Expert Call to discuss our OPC1 program for
the treatment of spinal cord injury, in January or February of
2021;
- Evaluate opportunities for new VAC product candidates based on
newly discovered tumor antigens/neoantigens, throughout 2021;
- Evaluate partnership opportunities and expansion of existing
external collaborations and identification of new collaborations
for OpRegen, OPC1 and VAC2, currently ongoing and throughout 2021;
and
- Continuing to participate in a large number of investor and
partnering meetings and medical and industry conferences to broaden
the knowledge of our work.
This is an exciting time to be part of the greater Lineage
family because our technologies give us an opportunity to make a
profound impact on an enormous number of people. As we have seen
this year, there is no other industry which can impact the human
condition as much as biopharmaceuticals can, and patient need
provides us with inspiration each and every day. To understand
better what that means on a personal level, we encourage you to
visit our Media page and hear directly from the patients whom we
aim to treat and their families. We are thankful for the courage
and trust of patients who participate in our clinical studies and
we are grateful to our shareholders for sharing our work with their
friends and their continued support of our efforts.
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. 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 growth of the cell therapy field and Lineage’s planned
investor presentations, manufacturing improvements, regulatory
meetings, and partnership discussions. 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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version on businesswire.com: https://www.businesswire.com/news/home/20201228005066/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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