REHOVOT, Israel, Feb. 18,
2021 /PRNewswire/ -- CollPlant Biotechnologies
(NASDAQ: CLGN) today announced the following letter from its
Chief Executive Officer, Yehiel Tal, to its shareholders.
Dear shareholders,
What a year it has been – and how it has changed our way of
life! All of us have been affected in some way by Covid-19. We are
optimistic that we will soon be able to return to normal life.
Despite the difficulties arising from the pandemic, we advanced
several activities in 2020 making it a transformational year for
CollPlant Biotechnologies.
Our partnerships
During the past year, we fostered existing partnerships and
created new ones with Tier One companies. These collaborations
further validate CollPlant's technology as the gold standard in
human collagen and the optimal building block for regenerative and
aesthetic medicine.
2021 kicked off with the exciting news of CollPlant entering
into a development and commercialization agreement with Allergan
Aesthetics, an AbbVie company, for CollPlant's type I
recombinant human collagen (rhCollagen) to be used in dermal and
soft tissue filler products. Combining rhCollagen's superior
properties with Allergan's propriety technologies, this
collaboration is expected to create a paradigm shift in the medical
aesthetic field by providing next-generation regenerative products
with long lasting results.
We expanded our collaboration with United Therapeutics
which exercised its option with CollPlant to cover a second
lifesaving organ, human kidneys, in addition to lungs. This
expanded collaboration aims to help reduce global organ shortages
of kidney transplants and potentially save the lives of millions of
patients on kidney waiting lists.
CollPlant and 3D Systems have recently established a
platform for collaboration in the field of 3D bioprinting, bringing
together CollPlant's expertise in rhCollagen-based BioInks and
regenerative medicine, with 3D Systems' expertise in 3D printing
and healthcare. The collaboration aims to jointly address an unmet
market need for a comprehensive solution to produce tissues and
scaffolds for regenerative medicine applications.
We entered into a supply agreement with STEMCELL
Technologies, Canada's largest
privately owned biotechnology company, for use of CollPlant's
rhCollagen in a broad range of cell culture applications. The
recently signed agreement follows the companies' established
business relationship, which started in 2014 when STEMCELL began
purchasing and incorporating CollPlant's rhCollagen into some of
its cell culture expansion and differentiation media kits. To date,
hundreds of companies, as well as research and academic institutes,
have used these kits for research and development projects. Under
the supply agreement, STEMCELL distributes the kits globally for
use in the regenerative medicine research market. The cell culture
market is just one example of the vast potential of our rhCollagen
platform technology in life science applications that have the
potential to enable breakthroughs that improve patients' lives.
Our product pipeline
Our R&D team continued accelerating development of all our
major programs.
CollPlant develops a variety of BioInk formulations that are
tissue and organ specific. These BioInks enable the printing of
constructs that mimic the properties of the target tissues or
organs to facilitate optimal regeneration. CollPlant's rhCollagen
has superior properties such as bio-functionality, homogeneity, and
safety, and therefore it is the ideal building block for tissue and
organ transplants used in regenerative medicine. Furthermore,
CollPlant established a bioprinting lab to develop 3D bioprinted
products alone or under collaboration with partners.
Our development program for injectable and bioprinted
regenerative breast implants is moving forward quickly. These
implants are designed to gradually degrade and be replaced by newly
grown natural breast tissue that is free of any foreign material.
This program is currently in the pre-clinical phase. In addition,
we are on track with the development of photocurable formulations
which are based on rhCollagen and other ingredients for
dermal/soft tissue filler products used in the medical
aesthetics market. CollPlant granted AbbVie a right of first
negotiation to obtain a worldwide exclusive license for the
abovementioned injectable breast implant and for the photocurable
dermal filler products.
In November 2020, we announced our
development program for an antiviral agent for potential
treatment of COVID-19 patients. In-vitro early results of our
formulations based on our proprietary rhCollagen imbedded with
silver nanoparticles (AgNP) showed significant inhibition of avian
coronavirus infectivity. Further studies are ongoing to optimize
the formulations and doses. We intend to develop an anti-viral
inhalation formulation to limit the spread of coronavirus in the
upper and lower respiratory systems. With the pandemic inflicting a
high human and financial toll, an available treatment can benefit
millions worldwide and allow rapid recovery of social and economic
activity while reducing the probability for new waves of
infection.
Our activities in consortiums and societies
We continue to increase and cultivate our participation and
leadership in societies and organizations that are at the forefront
of creating industry standards and advancing biofabrication
technologies.
As a member of the Industry Relations Committee of ISBF
(International Society for Biofabrication), a scientific and
professional society promoting advancements in biofabrication, I
hosted ISBF's virtual event held in January
2021. The event titled "Translation of laboratory
discoveries into large scale manufacturing of tissues and organs"
featured experts in the field from academia and industry, and
attracted great interest and participation.
In January 2020, we partnered with
the Advanced Regenerative Manufacturing Institute (ARMI), a
consortium of over 150 partner organizations from industry,
academia, and the U.S. federal government. ARMI's mission is to
make practical the large-scale manufacturing of engineered tissues
and tissue-related technologies. As members of the ARMI consortium,
CollPlant contributes its expertise in BioInks for 3D bioprinting
of tissues and organs.
As part of the ARMI activity, CollPlant is also a 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. Being a part of these
committees enables us to contribute our expertise and knowhow in
the development of industry standards for biofabrication, and
positions CollPlant as a leading player in regenerative
medicine.
We are concluding our 3rd year as a member at the ReMDO
(RegenMed Development Organization) advanced biomanufacturing
initiative, where we contribute to the development of a universal
BioInk with tunable properties for 3D bioprinting of tissues and
organs.
Our financials
CollPlant reports on a preliminary basis unaudited revenue of
approximately $6 million for the year
ended December 31, 2020, an increase
of 160% compared to audited revenue of $2.3
million for the year ended December
31, 2019. Unaudited revenue for the year ended December 31, 2020 was derived mainly from sales
of CollPlant's BioInk for the development of 3D bioprinting of
human lungs, the exercise of an option by United Therapeutics for
licensing CollPlant technology to print kidneys, and sales of
rhCollagen to AbbVie for medical aesthetics product development.
CollPlant has approximately $50
million of unaudited cash reserves and no debt as of the
date hereof. Unaudited cash reserves include $14 million that Collplant expects to receive in
February 2021 as an upfront payment
from AbbVie as part of the recently entered into strategic
agreement with AbbVie.
I am happy with the increase in revenue from our long-term
collaborators, as well as from our cash position that gives us the
ability to execute our strategic plan. The preliminary estimate of
revenue for the year ended December 31,
2020 and the unaudited cash reserve and debt as of the date
hereof are based on currently available information, are subject to
change and may vary from actual results. Collpant is under no
obligation to update the preliminary estimate of revenue for the
year ended December 31, 2020 and the
cash reserve and debt as of the date hereof for any subsequent
changes or events.
In summary,
These are exciting times at CollPlant Biotechnologies. There is
much to be proud of, and yet much more to do. We believe we have
all it takes to become the leader in regenerative medicine, helping
people live longer and better through our innovative collagen
technology. My deep appreciation goes out to our employees for
their dedication and commitment to the advancement of our
activities throughout these challenging times. I thank the board of
directors and all of our shareholders for your continued support.
We greatly appreciate the trust you have placed in us and look
forward to reporting our continuing progress during 2021.
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. CollPlant's products are based on its rhCollagen
(recombinant human collagen) that is produced with CollPlant's
proprietary plant based genetic engineering technology. CollPlant's
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. CollPlant's
flagship rhCollagen BioInk product line is ideal for 3D bioprinting
of tissues and organs. In 2018, CollPlant entered into a licensing
agreement with United Therapeutics, whereby United Therapeutics is
using CollPlant's BioInks in the manufacture of 3D bioprinted lungs
for transplant in humans. CollPlant recently signed an agreement
for dermal filler and soft tissue fillers with Allergan, an AbbVie
company, the global leader in the dermal filler market.
For more information, 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.
Contact at CollPlant:
Eran
Rotem
Deputy CEO & Chief Financial Officer
Tel: + 972-73-2325600/631
Email: Eran@collplant.com
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SOURCE CollPlant