Orgenesis Third Quarter 2020 Revenue Increases 40% Reflecting Continued Progress of POCare Platform
November 05 2020 - 8:30AM
Orgenesis Inc. (NASDAQ:
ORGS) (“Orgenesis” or the “Company”), a global
biotech company working to unlock the full potential of
cell and gene therapies, today provides a business update for
the third quarter of 2020. Revenue increased 40% to $1.7 million
compared to $1.2 million for the third quarter of 2019. The Company
also reported approximately $88.8 million of cash and cash
equivalents as of September 30, 2020.
Vered Caplan, CEO of Orgenesis, stated,
“Orgenesis continues to gain traction with a disruptive, point of
care strategy for potentially commercializing life-changing
treatments at reduced costs for large numbers of patients. In Q3
2020, we expanded the POCare Platform to include new POCare
Therapeutics, Technologies, and a growing global Network.”
“Orgenesis recently completed an acquisition of
Koligo Therapeutics, Inc., a regenerative medicine company,
including substantially all of the assets of Tissue Genesis, LLC.
This acquisition helped to expand our therapeutic and technology
resources, while adding a highly experienced US team to help
further bolster Orgenesis’ POCare Network in the US.”
“On the therapeutic front, Orgenesis is focused
on several key verticals, including immuno-oncology, anti-viral,
and metabolic/auto-immune diseases. A near-term goal is expanding
the availability of KYSLECEL® from the recent Koligo acquisition.
KYSLECEL is commercially available in the United States for chronic
and recurrent acute pancreatitis. We are also planning patient
recruitment for a phase 2 randomized clinical trial of KT-PC-301,
subject to FDA review and clearance of an investigational new drug
(IND) application. KT-PC-301 is an autologous clinical development
stage cell therapy candidate for COVID-19-related Acute Respiratory
Distress Syndrome, which we also acquired as part of the Koligo
acquisition. Additionally, Orgenesis is preparing for a Phase 2
study of Ranpirnase for the treatment of conditions caused by human
papilloma virus pending a planned IND submission to the
FDA.
“Orgenesis intends to leverage our network of
regional partners to advance the development and commercialization
of our therapeutic pipeline. Towards this end, our partners have
committed to funding the clinical programs. In turn, Orgenesis
typically grants its partners geographic rights in exchange for
future royalties, and a partnership with Orgenesis to support the
supply of the targeted therapies. Through this unique model,
Orgenesis has already signed contracts, which we expect to generate
over $40 million in revenue over the next three years, if fully
realized. There are also plans to continue to develop, license and
form partnerships around a variety of POCare Technologies to
support work in areas such as Tumor Infiltrating Lymphocytes
(TILS), CAR-T, CAR-NK, dendritic cell therapies, and mesenchymal
stem cell (MSC) based therapies.”
“Finally, Orgenesis is ready to announce
advancements on proprietary, cell and gene processing units and
labs that are being developed using first-in-class automation
technologies. Orgenesis Mobile Processing Units & Labs
(“OMPULs”) are designed to provide an economical industrial
alternative for our POCare Network partners to produce cell and
gene therapies at the point of care. Orgenesis intends to roll
these OMPULs out in centers that we are establishing across the US,
Europe, Asia, and the Middle East.”
The Company’s complete financial results are
available in the Company’s Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on November 5, 2020 which is
available at www.sec.gov and on the Company’s website.
About OrgenesisOrgenesis is a
global biotech company working to unlock the full potential of
cell and gene therapies (CGTs) in an affordable and accessible
format at the point of care. The Orgenesis
POCare Platform is comprised of three
enabling components: a pipeline of licensed POCare
Therapeutics that are processed and produced in
closed, automated POCare Technology systems
across a collaborative POCare Network.
Orgenesis identifies promising new therapies and leverages its
POCare Platform to provide a rapid, globally harmonized pathway for
these therapies to reach and treat large numbers of patients at
lowered costs through efficient, scalable, and decentralized
production. The POCare Network brings together patients, doctors,
industry partners, research institutes and hospitals worldwide to
achieve harmonized, regulated clinical development and production
of the therapies. Learn more about the work Orgenesis is doing
at www.orgenesis.com.
Notice Regarding Forward-Looking
Statements
The information in this release is as of
November 5, 2020. Orgenesis assumes no obligation to update
forward-looking statements contained in this release as a result of
new information or future events or developments. This release
contains forward looking statements about Orgenesis, Koligo,
Koligo’s technology, and potential development and business
opportunities of Koligo and Orgenesis, each of which involve
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the commercial success of the Company’s
products; the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for our clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when any such
regulatory authorities may approved the Company’s development
products, and, if approved, whether such product candidates will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of the Company’s products; uncertainties regarding the impact of
COVID-19 on the Company’s business, operations and financial
results and competitive developments.
A further description of risks and uncertainties
can be found in the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2019 and in its subsequent reports
on Form 10-Q, including in the sections thereof captioned “Risk
Factors” and “Forward-Looking Information,” as well as in its
subsequent reports on Form 8-K, all of which are filed with the
U.S. Securities and Exchange Commission and available at
www.sec.gov.
Contact for Orgenesis:David
WaldmanCrescendo Communications, LLCTel: 212-671-1021
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