Orgenesis Inc. (NASDAQ: ORGS)
(“Orgenesis” or the “Company”), a global biotech company working to
unlock the full potential of cell and gene therapies, and Koligo
Therapeutics, Inc. (“Koligo”), a regenerative medicine company,
today announced that the two companies have entered into a
definitive merger agreement, subject to final closing conditions,
with expected completion before year-end (“Transaction”).
Koligo is a leader in developing personalized
cell therapies utilizing the patient’s own (autologous) cells.
Koligo has successfully launched its first commercial product,
KYSLECEL, and plans to commence a phase 2 trial of KT-PC-301 for
COVID-19-related ARDS. Koligo’s development stage technology
utilizes 3D bioprinting and vascularization with autologous cells
(“3D-V” technology) to create biodegradable and shelf-stable
three-dimensional cell and tissue implants. The 3D-V technology is
being developed for diabetes and pancreatitis, with longer term
applications for neural, liver, and other cell/tissue
transplants.
Following closing of the Transaction, Orgenesis
plans to accelerate the commercial scaleup of KYSLECEL throughout
the United States and, subject to regulatory and logistical
considerations, in international markets as well. After closing of
the Transaction, and subject to FDA review and clearance of the
Company’s Investigational New Drug application, Orgenesis expects
to start patient recruitment for a phase 2 randomized clinical
trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to
leverage Koligo’s 3D-V bioprinting technology across its POCare
platform.
Under the terms of the merger agreement,
Orgenesis will acquire all of the outstanding stock of Koligo from
its shareholders (the founders and staff of Koligo and a subsidiary
of Bergen Special Opportunity Fund, LP, an institutional investor
managed by Bergen Asset Management, LLC). The agreed consideration
terms are an aggregate of $15 million in shares of Orgenesis’
common stock valued at $7.00 per share which shall be issued to
Koligo’s accredited investors (with certain non-accredited
investors to be paid solely in cash) and an assumption of $1.3
million in Koligo’s liabilities, estimated to be substantially all
of Koligo’s liabilities. Additional details of the Transaction 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.
KYSLECEL®Koligo’s KYSLECEL is
commercially available in the United States for chronic and
recurrent acute pancreatitis in a surgical procedure commonly
called Total Pancreatectomy with Islet Autologous-Transplant
(“TPIAT”). TPIAT has been proven to provide significant pain
relief, improved quality of life, and a reduction in the need for
pain medication for patients suffering from chronic or recurrent
acute pancreatitis. KYSLECEL infusion after a total pancreatectomy
helps preserve insulin secretory capacity and reduce the risk of
diabetic complications. KYSLECEL is made from a patient’s own
pancreatic islets – the cells that make insulin to regulate blood
sugar.
Koligo has commenced its commercial pilot
program for KYSLECEL at six U.S. hospitals, treating 40 patients to
date. The KYSLECEL pilot program has generated approximately $2
million in sales revenue. KYSLECEL has also been shown to result in
significant savings to payors over traditional chronic pancreatitis
management. Following the closing of the Transaction, Orgenesis
plans to make KYSLECEL available to an increasing number of
hospitals throughout the United States through its POCare
Network.
KT-PC-301Koligo’s lead clinical
development program is for KT-PC-301, an autologous cell therapy
under investigation for the treatment of COVID-19-related Acute
Respiratory Disease Syndrome (ARDS). KT-PC-301 is comprised of
autologous stromal and vascular fraction cells (“SVF”) derived from
each patient’s adipose (fat) tissue. KT-PC-301 contains a
population of mesenchymal stem cells, vascular endothelial cells,
and immune cells which migrate to the patient’s lungs and other
peripheral sites of inflammation. Nonclinical and clinical evidence
demonstrate that KT-PC-301 may: (1) stabilize microcirculation to
improve oxygenation; (2) maintain T and B lymphocytes to support
antibody production; and (3) induce an anti-inflammatory
effect.
Koligo has completed a pre-IND (Investigational
New Drug) consultation with the U.S. Food and Drug Administration
to start clinical trials of KT-PC-301 in COVID-19-related
ARDS. Following the closing of the Transaction, and
subject to FDA review and clearance of the Company’s
Investigational New Drug application, Orgenesis expects to start
patient recruitment for a phase 2 randomized clinical trial of
KT-PC-301 in COVID-19 patients. As currently planned, the phase 2
trial is expected to enroll 75 patients and evaluate the safety and
efficacy of KT-PC-301. Mohamed Saad, MD, Chief of Division of
Pulmonary, Critical Care, and Sleep Disorders Medicine at the
University of Louisville, will be the lead clinical investigator on
the trial.
3D-V Technology Koligo’s 3D-V
bioprinting technology is designed to support development of a
number of product candidates for the treatment of diabetes, cancer,
neurodegenerative disease, and other serious diseases. The 3D-V
technology platform is able to print three-dimensional cell and
tissue constructs with a vascular network. Key benefits of the 3D-V
approach include: faster revascularization/inosculation of
cell/tissue transplant to improve engraftment; host tolerance of
the graft while minimizing need for immune suppressive drugs;
better site of transplant administration of such products; and
scaffolding to keep cell/tissue in place in vivo. These solutions
are ideally suited for islet transplant and other cell/tissue
transplant applications.
Koligo ManagementFollowing the
closing of the Transaction, Koligo’s management team will be
joining Orgenesis to continue commercial and development
activities. Koligo’s CEO, Matthew Lehman, is an accomplished
executive in the biotech and regenerative medicine fields. Prior to
co-founding Koligo, he was CEO of Prima Biomed Ltd (now Immutep
Ltd, a Nasdaq (IMMP) and ASX (IMM) listed biotech company). Stuart
Williams, PhD, Chief Technology Officer, is a bioengineer and
thought leader in regenerative medicine, with over 300 publications
and 20 issued patents in the field. Dr. Williams has co-founded
three other biotech companies and is an experienced
academic-industry collaborator. Michael Hughes, MD, Chief Medical
Officer, is a transplant surgeon who started the islet transplant
program at University of Louisville which was the genesis of
Koligo’s KYSLECEL program. He has successfully treated nearly 50
chronic pancreatitis patients with islet autologous transplant
after pancreatectomy. Balamurugan Appakalai, PhD, has more than 20
years of islet isolation experience, having processed more than 800
human pancreases. He is a leader in the field of islet transplant
with 100+ publications.
Vered Caplan, Chief Executive Officer of
Orgenesis, stated, “We are pleased to announce this transformative
acquisition, which we expect will add broad capabilities to our
therapeutic and technology platform, and will further our
leadership in the cell and gene therapy field. Based on several
phase 1 studies, Koligo’s KT-PC-301, using a patient’s own cells,
has demonstrated safety and tolerability, and has shown signs of
efficacy to support continued development in COVID-19-related ARDS.
If successful for the treatment of COVID-19-related ARDS, KT-PC-301
is likely to have applications in other acute and chronic
respiratory indications, areas that represent significant unmet
medical need. In addition, we see significant potential in
KYSLECEL, a commercial stage asset for the treatment of chronic and
acute recurrent pancreatitis, which we plan to introduce through
our global network of hospitals. Finally, Koligo’s 3D-V bioprinting
technology is highly complementary to our POCare Platform, as we
implement new technologies to improve efficacy and lower the costs
of cell and gene therapies. I would like to personally
welcome Matthew and the rest of the Koligo team to the Orgenesis
organization when the Transaction closes. We believe that their
skills and experience will be an important addition as we execute
on our strategy to unlock the power of cell and gene therapies and
make them accessible to all.”
Matthew Lehman, Chief Executive Officer of
Koligo Therapeutics, stated, “The merger with Orgenesis marks a
major milestone for our company and builds on our recent progress,
including the Pre-IND package submitted to the U.S. FDA for
KT-PC-301 and our pilot commercial program for KYSLECEL. The
Orgenesis team brings extensive clinical, regulatory, and
manufacturing expertise well suited to supporting Koligo’s goals.
Orgenesis’ intellectual property is highly complementary to
Koligo’s technology and the combined companies will work to advance
a robust commercial and development product portfolio. Orgenesis’
POCare technologies are also ideally suited for low-cost and
efficient production of autologous cell therapies at the point of
care, which we believe will considerably enhance the delivery of
these therapies to patients. Additionally, we believe Orgenesis’
global network of leading hospitals and healthcare institutions
will enable us to accelerate the commercial rollout of KYSLECEL. We
are quite encouraged by the outlook for the business and look
forward to leveraging Orgenesis’ POCare Platform in order to
accelerate the timeline to bringing our innovative cell therapies
to market. Through this merger, we believe we can maximize value
for all shareholders and we are grateful to Orgenesis for this
opportunity.”
Pearl Cohen Zedek Latzer Baratz LLP and KPMG
advised Orgenesis on the Transaction. Maxim Group LLC acted as a
finder and Nelson Mullins Riley & Scarborough, LLP advised
Koligo on the Transaction.
About Koligo Therapeutics
Koligo Therapeutics, Inc. is a US regenerative medicine company.
Koligo’s first commercial product is KYSLECEL® (autologous
pancreatic islets) for chronic and acute recurrent pancreatitis.
Koligo’s 3D-V technology platform incorporates the use of advanced
3D bioprinting techniques and vascular endothelial cells to support
development of transformational cell and tissue products for
serious diseases. More information is available at
www.koligo.net.
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
September 29, 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 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:Crescendo Communications,
LLCTel: 212-671-1021ORGS@crescendo-ir.com
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