REHOVOT, Israel, Feb. 15,
2024 /PRNewswire/ -- CollPlant Biotechnologies
(Nasdaq: CLGN), a regenerative and aesthetics medicine
company developing innovative technologies and products based on
its non-animal-derived collagen for tissue regeneration and organ
manufacturing, is pleased to issue the following letter from its
Chief Executive Officer, Yehiel
Tal.
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Dear Shareholders,
As we look toward a promising and exciting year ahead, I am
proud to reflect on CollPlant's main achievements throughout 2023.
We leveraged our pioneering collagen-based platform and dynamic
workforce to strengthen existing business collaborations, as well
as to initiate and advance new opportunities. We continued to
develop products with safety and performance advantages that we
believe 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 these fields.
Collaborations
During 2023, we made significant progress with our development
partner, AbbVie, to advance our dermal and soft tissue filler
toward commercialization. Furthermore, we continue to be engaged in
partnering discussions with several industry leaders seeking to
leverage our rhCollagen technology and expertise in 3D bioprinting
to develop therapeutics and medical applications.
AbbVie
Our long-term collaboration with AbbVie to develop a
paradigm-shifting regenerative dermal and soft tissue filler
continues to advance. In June of last year, we announced the
achievement of an important milestone under this collaboration
which triggered a $10 million payment
from AbbVie to CollPlant. Per CollPlant's agreement with AbbVie,
CollPlant has the potential to receive additional milestones and
option products payments, as well as receive meaningful royalties
on product sales. AbbVie continues to advance the filler program
which is now in clinical studies.
Stratasys
In April of last year, we announced a joint development and
commercialization agreement with Stratasys Ltd. to collaborate on
the development of a solution to bio-fabricate human tissues and
organs using Stratasys' P3 technology-based bioprinter and
CollPlant's rh-Collagen-based bioinks. The first project focuses on
the development of an industrial-scale solution for CollPlant's
regenerative breast implants program. The new bioprinter, based on
Stratasys' precise P3™ 3D printing technology in combination with
CollPlant's flagship bioinks, is designed to enable the production
of CollPlant's state of the art breast implants, which are being
developed to regenerate an individual's natural breast tissue
without eliciting immune response, providing a potentially
revolutionary alternative for both aesthetic and reconstructive
procedures.
Under the agreement, both companies have agreed to cross-promote
each other's bioprinting products. Stratasys' bioprinter will be
offered to customers together with CollPlant's bioinks, and
similarly Stratasys' bioprinter will be offered to CollPlant's
business partners and customers.
Products Pipeline
I am proud to share with you a few important highlights from
this past year related to our products pipeline, which targets
large commercial opportunities in both, medical aesthetics and
personalized medicine markets. At the cornerstone of our success
lies the many advantages of our high-performance non-animal,
recombinant human (rh)Collagen.
Regenerative Breast Implants
One of our most exciting products in development is our
regenerative breast implants, addressing the $2.6 billion global breast implant market.
Additionally, breast reconstruction and augmentation procedures
represent the second most common plastic surgery procedure
performed worldwide today. The most common breast augmentation or
reconstruction procedures today are based on synthetic silicone
breast implantations, an artificial substitution for natural
regenerated tissue with risks of complications.
Currently, there are no commercial products that allow
regeneration of soft tissues such as the breast. In the U.S. alone,
hundreds of thousands of people per year experience adverse events
that range from autoimmune symptoms to the very serious breast
implant-associated anaplastic large cell lymphoma (BIA-ALCL).
CollPlant's breast implants that are comprised of the Company's
proprietary plant-derived rhCollagen and other biomaterials, are
expected to regenerate breast tissue without eliciting immune
response, and thus may provide a revolutionary alternative for
aesthetic and reconstructive procedures, including postmastectomy
for cancer patients.
In January of last year, we announced the successful completion
of a large animal study for our recombinant human collagen
(rhCollagen)-based 3D bioprinted regenerative breast implants. The
preclinical study demonstrated progressive stages of tissue
regeneration after three months, as highlighted by the formation of
maturing connective tissue and neovascular networks within the
implants, with no adverse events reported. This study was followed
by additional large animal studies that were intended to further
optimize the implant design and composition. New tissue formation
and neovascularization with no adverse tissue reactions were
demonstrated confirming previous results.
Supported by these promising results, in December 2023, we initiated a large-animal study
to evaluate commercial-size,3D-bioprinted, regenerative breast
implants. This study will be used to obtain data that will be used
to support subsequent human studies and future product
commercialization.
The achievements we demonstrated to date take us another step
forward in the development of a revolutionary alternative to
silicone implants for aesthetic and reconstructive procedures.
Gut-on-a-Chip Tissue Model
CollPlant decided in 2022 to expand into the promising field of
personalized medicine. Our lead program in this space is our
gut-on-a-chip program that is addressing the need to provide
therapeutic choices for inflammatory bowel diseases. Our specific
focus is on ulcerative colitis, or UC.
We are developing a bioprinted human intestine model that can be
used in drug discovery and personalized treatment of UC. 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.
We remain extremely excited about the prospects for this program
and plan to provide an update with the next steps for this program
as we enter the next phase of development.
Intellectual Property
In November of last year, we announced that the U.S. Patent and
Trademark Office has granted a patent that covers CollPlant's
photocurable dermal filler product candidate, being developed for
the aesthetics market.
The U.S. Patent (No. 11,801,329) is directed, among other
things, to a method of filling tissue space under the epidermis by
introducing a polymerizable filler solution into the tissue space
and applying external light to induce in-situ polymerization. This
newly issued patent is related to CollPlant's photocuring
technology and serves as the basis of our photocurable dermal
filler product pipeline currently under development. The
polymerizable solution injected into the tissue space is comprised
of a chemically modified recombinant human collagen (rhCollagen)
and other constituents such as hyaluronic acid.
This patent represents an integral part of the Company's
strategy to expand the uses for its novel, rhCollagen technology
into new, high-value markets. The U.S. is one of CollPlant's
strategic target markets, and we see the strengthening of our
intellectual property in this territory as a significant
achievement.
In addition to its superior skin lifting capacity, the
photocurable filler is designed to enable tissue regeneration and
tissue contouring ability. This issued patent expiring in 2039
provides coverage for a regenerative photocurable dermal filler
with contouring capabilities and we believe this will strengthen
our position in the market for many years to come.
Corporate Responsibility
Our rhCollagen production process utilizes plant-based genetic
engineering technology. This approach eliminates the need for
traditional animal-derived collagen sources, reducing the
environmental strain associated with traditional methods and
promoting more ethical and sustainable practices.
In the second quarter of 2023, CollPlant hired a dedicated
expert to lead our Environment, Social and Governance (ESG)
effort. Our goal was to identify CollPlant's strengths in the
areas of ESG that are already in line with our mission and
communicate these practices to business partners and the
public.
In line with this initiative, in September last year,
CollPlant announced that it joined the United Nations Global
Compact, the world's largest initiative for sustainable and
responsible corporate governance. As a new participant of
this voluntary leadership platform, CollPlant strengthens its
commitment to operate sustainably as it is also producing
sustainable alternatives to the regenerative and aesthetics
medicine products and technologies that currently exist.
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.
In Closing
Tissue and organ shortage is a major medical challenge arising
from a combination of donor scarcity and patient rejection. As
technologies evolve with 3D bioprinting technology, we believe this
will enable CollPlant to address the challenge by utilizing our
rhCollagen to help to create an unlimited supply of tissues and
organs.
Additionally, as we develop tissue models that can mimic a
variety of human disease conditions, this will be a driver for our
strategic expansion into personalized medicine.
In 2024, 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.
Especially this challenging year, I would like to thank our
employees – who continue to show an unwavering commitment to
improving patients' lives - for their dedication and passion, which
has launched us to the next level of performance and closer towards
becoming the leaders in regenerative medicine.
Finally, and importantly, I would also like to thank my fellow
shareholders for their continued trust and support for CollPlant's
mission to become a global leader in regenerative and aesthetic
medicine.
With Appreciation and Optimism,
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.
Forward-Looking Statements
This communication 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 need to raise additional capital and its
inability to obtain additional capital on acceptable terms, or at
all; the Company's expectations regarding the timing and cost of
commencing pre-clinical and clinical trials with respect to breast
implants, tissues and organs which are based on its rhCollagen
based BioInk and other products for medical aesthetics, and
specifically the Company's ability to initiate its next
large-animal study for its breast implants in a timely manner, or
at all; the Company's ability to develop a printing solution for
its breast implants program, or at all; 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, including its partnership with
AbbVie and its ability to continue to receive milestone and
royalties payments under the AbbVie agreement; 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; current or future
unfavorable economic and market conditions and adverse developments
with respect to financial institutions and associated liquidity
risk; the impact of competition and new technologies; general
market, political, and economic conditions in the countries in
which the Company operates, including, with respect to the
Israel- Hamas war, 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
are 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.
Contact at CollPlant:
Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Eran@collplant.com
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