Orgenesis Completes Acquisition of Koligo Therapeutics and Announces Additional Acquisition of Icellator® Technology from Ti...
October 19 2020 - 6:30AM
Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the
“Company”), a global biotech company working to unlock the full
potential of cell and gene therapies, today announced
completion of the previously announced acquisition of Koligo
Therapeutics, Inc. (“Koligo”), a regenerative medicine company.
Additionally, the Company announced that it has acquired
substantially all of the assets of Tissue Genesis, LLC (“Tissue
Genesis”), adding to a growing list of POCare technology resources.
The acquisition of Tissue Genesis was initially undertaken via
Koligo Therapeutics, Inc., and became part of the Koligo
acquisition transaction. Orgenesis will now own the entire
inventory of Tissue Genesis Icellator® devices, related kits and
reagents, a broad patent portfolio to protect the technology,
registered trademarks, clinical data, and existing business
relationships for commercial and development stage use of the
Icellator technology.
The Icellator device is a point-of-care cell isolation
technology that rapidly recovers high yields of stromal and
vascular cells (“SVF”) from adipose tissue (fat) to be used
therapeutically. Adipose tissue is recognized as a superior source
for adult stem cells found abundantly in the micro-vasculature and
stroma of human fat. Further details include:
- The device is commercially available in Korea and the Bahamas
where Orgenesis plans to continue commercial distribution.
- Icellator X clearance is expected in Japan in the first quarter
of 2021 subject to completion of manufacturing tests requested by
the Japanese Pharmaceutics and Medical Devices Agency.
- Tissue Genesis has initiated several phase 1 pilot trials of
the Icellator system in the United States under FDA IDEs for use in
erectile dysfunction, critical limb ischemia, tissue repair, and
other therapeutic indications.
- Orgenesis intends to deploy the Icellator technology to
potentially develop a broad range of point of care autologous cell
therapies with significantly reduced costs across a growing POCare
Network that includes leading hospitals and healthcare
institutions.
“With the Koligo acquisition closed, we believe that we are
making rapid progress on a number of fronts,” said Vered Caplan,
CEO of Orgenesis. “Specifically, we plan to leverage the therapies
and technologies from Koligo and Tissue Genesis across our POCare
Platform. One of our first goals is to accelerate the
commercial scaleup of KYSLECEL throughout the United States and,
subject to regulatory and logistical considerations, in
international markets as well. Subject to FDA review and clearance
of our IND application, we also look forward to commencing patient
recruitment for a phase 2 randomized clinical trial of KT-PC-301,
an autologous clinical development stage cell therapy candidate for
COVID-19-related Acute Respiratory Distress Syndrome, or
ARDS. We plan to use the Icellator device to support
scalable, cost-effective production of KT-PC-301. Additionally,
Koligo’s development stage 3D-V bioprinting technology for the
vascularization of autologous cells to create biodegradable and
shelf-stable three-dimensional cell and tissue implants will be
explored for diabetes and pancreatitis applications, with longer
term applications for neural, liver, and other cell/tissue
transplants also potentially explored.
“The Icellator system is highly complementary to our POCare
technology systems, as well as Koligo’s 3D-V bioprinting
technology. Technologies such as these support our mission of
improving the efficacy and lowering the costs of cell and gene
therapies by delivering autologous cell therapies at the point of
care through our global network of hospitals and healthcare
institutions,” concluded Caplan.
Under the terms of the Koligo merger agreement, Orgenesis
acquired all of the outstanding stock of Koligo from its
shareholders for approximately $14.5 million in shares of Orgenesis
common stock valued at $7.00 per share (with certain non-accredited
investors paid approximately $20,000 solely in cash) and an
assumption of $1.9 million in liabilities, estimated to be
substantially all of Koligo’s liabilities. Orgenesis acquired
substantially all the assets of Tissue Genesis for an additional
consideration of $500,000 in closing cash and future royalties.
Additional details of the transactions will be available in the
Company’s Form 8-K, which will be filed with the Securities and
Exchange Commission, and will be available at www.sec.gov.
Pearl Cohen Zedek Latzer Baratz LLP and KPMG advised Orgenesis
on the Koligo Transaction. Maxim Group LLC acted as a finder
and Nelson Mullins Riley & Scarborough, LLP advised Koligo on
the Transaction.
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 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 October 19, 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 following the closing of the Transaction, 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 approve 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:Crescendo Communications,
LLCTel: 212-671-1021ORGS@crescendo-ir.com
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