REHOVOT, Israel, Jan. 24,
2023 /PRNewswire/ -- CollPlant (Nasdaq:
CLGN), a regenerative and aesthetics medicine company
developing innovative technologies and products for tissue
regeneration and organ manufacturing, is pleased to issue the
following letter from its Chief Executive Officer, Yehiel Tal,
to its shareholders.
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Dear shareholders,
As we look toward a promising and exciting year ahead,
I am proud to reflect on CollPlant's achievements throughout 2022.
We leveraged our pioneering collagen-based platform and dynamic
workforce to strengthen existing business collaborations, as well
as form new ones. We continued to develop products with safety and
performance advantages that will lead to further innovation in the
fields of regenerative and aesthetic medicine. We are excited with
our progress while remaining extremely focused on advancing our
goal to become a global leader in regenerative medicine.
I am proud to share with you a few important highlights from
this past year.
Strategy
We draw upon the collective strength of our company, which
includes our technology, intellectual property, human capital and
global partners – to drive innovation and create value. Our
business model includes:
- Co-development and collaboration agreements with tier-1
industry partners which include milestone payments and future sales
royalties from our partners as well as sales of rhCollagen.
- Internal development of regenerative scaffolds and tissues,
including a photocurable dermal filler, 3D bioprinted breast
implant, and a bioprinted gut-on-a-chip model, which address
multibillion-dollar market opportunities.
- Sales and/or in-licensing of our highly precise rhCollagen, and
rhCollagen-based BioInk formulations that constitute the ideal
building blocks for regenerative medicine applications such as cell
culture, drug discovery, personalized medicine and tissue and organ
manufacturing.
We will continue to strengthen our intellectual property by
expanding our portfolio of global patents so that we can
maintain a high barrier-to-entry to potential competitors.
Collaborations
We made significant progress during 2022 with our development
partners to advance and diversify our product portfolio, which
targets large commercial opportunities in both existing and new
markets, including medical aesthetics and personalized
medicine.
Our long-term collaboration with AbbVie to develop a
paradigm-shifting regenerative dermal and soft tissue filler,
continues to move forward according to plan. Per the agreement,
CollPlant has the potential to receive an additional milestones and
option products payments, and will receive royalties on product
sales. AbbVie continues to advance the filler program and CollPlant
expects that the first of these milestones could be achieved is
2023. In addition, CollPlant continues to develop the option
products such as the photocurable dermal filler.
We also made the decision to strategically expand into
personalized medicine, and we signed a collaboration agreement in
November with Tel Aviv University and
Sheba Medical Center to co-develop a bioprinted human intestine
model for drug discovery and personalized treatment of ulcerative
colitis. The 3D bioprinted model is designed to emulate the human
intestine tissue in order to allow medical professionals to
identify drug targets and personalized therapeutic responses that
can lead to improved patient outcomes. CollPlant will have the
rights to commercialize the product once ready to market.
We are currently engaged in partnering discussions with
several industry leaders and academic institutions seeking to
leverage our rhCollagen technology and expertise in 3D
bioprinting to develop therapeutics and medical
applications.
Products and processes
I am very pleased with the company's execution and significant
advances across our diverse and expanding product portfolio. We are
targeting large commercial opportunities where we believe our
rhCollagen has the ability to deliver clear and distinct
advantages, including better bio-functionality, greater homogeneity
and improved safety.
We successfully completed a 12-month preclinical study with our
photocurable dermal and soft tissue fillers, demonstrating superior
tissue regeneration, lifting capacity and volume retention when
compared to a commercial standard. CollPlant granted AbbVie the
right of first negotiation to obtain a worldwide exclusive license
for this product.
Additionally, we successfully completed a large animal study for
our 3D bioprinted regenerative breast implant program, with full
achievement of study objectives, demonstrating tissue regeneration
which included the formation of maturing connective tissue and
neovascular networks, as the implant gradually biodegrades. We are
planning to initiate a follow-up large animal study using
commercial-size implants in 2023, which we believe will support
subsequent human studies and future product commercialization. The
promising results we have seen to date take us another step forward
in the development of a revolutionary alternative to silicone
implants for aesthetic and reconstructive procedures.
We expanded our commercial portfolio of rh-Collagen-based
bioinks with two new products, including Collink.3D™ 90, which
offers increased mechanical properties and Collink™ 50L, our
first bioink available in powder form to provide enhanced
operational flexibility. Our bioink platform, which was established
in 2021 with the launch of Collink.3D™ 50, allows our
biopharma and academia customers to streamline their process of new
product development by utilizing an animal-free alternative that
delivers improved bio-functionality, safety and
reproducibility.
Our existing production capacity is anticipated to
support expected demand for rhCollagen over the next four years
and we are continuously expanding our production capacity to
accommodate commercial demand.
We have also developed and are implementing an aseptic process
to mass produce sterile rhCollagen. The sterile collagen will serve
as an ideal substrate for stem cells, induced pluripotent stem
cells and all kinds of primary human cells. It will also address
production processes where collagen as major constituent should be
sterile.
Finally, we continued to strengthen our position as thought
leaders in the area of 3D bioprinting by delivering presentations
and managing exhibition booths at leading industry conferences,
including Tissue Engineering and Regenerative Medicine
International Society (TERMIS) and International Conference on
Biofabrication (ISBF).
Corporate responsibility
Consistent with our mission of helping people live longer,
healthier lives through regenerative medicine, we are committed to
supporting a more sustainable ecosystem that benefits all
stakeholders, including patients, our employees, and our
shareholders.
To this end, our we are bolstering our environment, social, and
governance (ESG) commitments with the aim of furthering promoting
responsibility to the environment, diversity and equality,
investing in the communities in which we live and work, undertaking
corporate social responsibility reporting and integrating ESG goals
into our daily work.
During 2022, we initiated an ESG action plan to formalize
metrics, goals and workplans to bridge the gaps between the current
status and the desired future objectives, while remaining committed
to creating a financially sound and profitable company.
This year, Dr. Elana Gazal joined
CollPlant as a Vice President of Research and Development,
increasing our female representation on the management team to a
company record high of 57%. Overall, during 2022 we hired 21 new
employees, of which more than half were women.
Societies and organizations
We continued to actively support societies and organizations at
the forefront of creating industry standards to advance
biofabrication technologies through increased participation
and by pursuing leadership roles. We are concluding our
5th year as a member of ReMDO (Regenerative
Medicine Development Organization), an advanced biomanufacturing
initiative in which we contribute to the development of a universal
BioInk with tunable properties for 3D bioprinting of tissues and
organs.
I had the honor of moderating a virtual event of the
International Society for Biofabrication (ISBF), where I also serve
as board member, to discuss the future outlook of biofabrication of
microphysiological systems used for drug discovery and screening.
ISBF is a scientific and professional society which promotes
advances in biofabrication research, development, education,
training, and medical and clinical applications.
We concluded our third year partnering with the Advanced
Regenerative Manufacturing Institute (ARMI), a consortium of over
150 partner organizations from industry, academia, and the U.S.
federal government. In addition, CollPlant is an active member of
two of the industry's most respected and globally recognized
technical standard development organizations – ASTM international,
the American Society for Testing and Materials, and ASME, the
American Society of Mechanical Engineers.
We remain committed to supporting these organizations
with our leadership and expertise as we believe the
development of industry standards for biofabrication will
eventually form the basis for the FDA's draft
guidance for biofabrication related technologies, including
printers and bioInks.
Summary
Tissue and organ shortage is a major medical challenge arising
from a combination of donor scarcity and patient rejection. The
evolving landscape of 3D bioprinting technology will enable
CollPlant to address this challenge by utilizing our rhCollagen to
help to create an unlimited supply of tissues and organs.
Additionally, we believe helping to develop tissue models that can
mimic a variety of human disease conditions will be a driver for
our strategic expansion into personalized medicine.
Our advances in 3D bioprinting of tissues and organs coupled
with the many advantages of our high performance, non-animal
Collagen will enable CollPlant to be a market leader in
regenerative and aesthetic medicine.
In 2023, we plan to further advance and expand our diverse
portfolio of innovative products and value-creating partnerships,
alongside our commitment to support a more sustainable and
equitable world.
Finally, I would like to thank our employees for the
tremendous progress we made toward this goal in 2022 and for
their unwavering commitment to improving patients' lives around the
world.
I would also like to thank my fellow shareholders for
their continued trust and support of CollPlant's mission
to become a global leader in regenerative and aesthetic
medicine.
Respectfully submitted,
Yehiel Tal
Chief Executive Officer
CollPlant Biotechnologies
About CollPlant
CollPlant is a regenerative and aesthetic medicine company
focused on 3D bioprinting of tissues and organs, and medical
aesthetics. The Company's products are based on its rhCollagen
(recombinant human collagen) produced with CollPlant's proprietary
plant based genetic engineering technology. These products address
indications for the diverse fields of tissue repair, aesthetics,
and organ manufacturing, and are ushering in a new era in
regenerative and aesthetic medicine.
In 2021 CollPlant entered into a development and global
commercialization agreement for dermal and soft tissue fillers with
Allergan, an AbbVie company, the global leader in the dermal filler
market. For more information about CollPlant, visit
http://www.collplant.com.
Safe Harbor Statements
This press release may include forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to CollPlant's objectives plans and strategies,
as well as statements, other than historical facts, that address
activities, events or developments that CollPlant intends, expects,
projects, believes or anticipates will or may occur in the future.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements. Many factors could cause CollPlant's actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, the following: the Company's history of significant
losses, its ability to continue as a going concern, and its need to
raise additional capital and its inability to obtain additional
capital on acceptable terms, or at all; the impact of the COVID-19
pandemic; the Company's expectations regarding the timing and cost
of commencing clinical trials with respect to tissues and organs
which are based on its rhCollagen based BioInk and products for
medical aesthetics; the Company's ability to obtain favorable
pre-clinical and clinical trial results; regulatory action with
respect to rhCollagen based BioInk and medical aesthetics products
including but not limited to acceptance of an application for
marketing authorization review and approval of such application,
and, if approved, the scope of the approved indication and
labeling; commercial success and market acceptance of the Company's
rhCollagen based products in 3D Bioprinting and medical aesthetics;
the Company's ability to establish sales and marketing capabilities
or enter into agreements with third parties and its reliance on
third party distributors and resellers; the Company's ability to
establish and maintain strategic partnerships and other corporate
collaborations; the Company's reliance on third parties to conduct
some or all aspects of its product manufacturing; the scope of
protection the Company is able to establish and maintain for
intellectual property rights and the Company's ability to operate
its business without infringing the intellectual property rights of
others; the overall global economic environment; the impact of
competition and new technologies; general market, political, and
economic conditions in the countries in which the Company operates;
projected capital expenditures and liquidity; changes in the
Company's strategy; and litigation and regulatory proceedings. More
detailed information about the risks and uncertainties affecting
CollPlant is contained under the heading "Risk Factors" included in
CollPlant's most recent annual report on Form 20-F filed with the
SEC, and in other filings that CollPlant has made and may make with
the SEC in the future. The forward-looking statements contained in
this press release are made as of the date of this press release
and reflect CollPlant's current views with respect to future
events, and CollPlant does not undertake and specifically disclaims
any obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Photo -
https://mma.prnewswire.com/media/1720317/CollPlant_Biotechnologies.jpg
Contact at CollPlant:
Eran Rotem
Deputy CEO & CFO
+ 972-73-2325600
eran@collplant.com
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SOURCE CollPlant