Full Press Release Details
Orgenesis Provides Update Regarding AIP Cell-Based Therapy
for Type 1 Diabetes,
MaSTherCell Cell Manufacturing Subsidiary and Overall
GERMANTOWN, MD March 8, 2017 Orgenesis Inc. (OTCQB:
ORGS), a vertically-integrated biopharmaceutical company with expertise and
unique experience in cell therapy development and manufacturing, today provided
a business update from the Company s CEO, Vered Caplan. The Company also
reported that revenue for the fiscal year ending November 30, 2016 increased
115% to $6.4 million from $3.0 million in fiscal 2015 due to growth of
MaSTherCell, the Company s cell therapy manufacturing subsidiary.
Vered Caplan, CEO of Orgenesis, commented, 2016 was a
transformative year for the Company and we continue to be very encouraged by the
outlook for the business. A summary of our accomplishments are as follows:
subsidiary, we continue to advance our unique cell-based therapy, the Autologous
Insulin Producing ( AIP ) cells, into clinical development. AIP cells utilize
the technology of cellular transdifferentiation to transform an autologous
adult liver cell into a fully functional and physiologically glucose-responsive
insulin-producing cell. Because the AIP cells are autologous, this benefit
should be achieved and maintained without the need for concomitant
immunosuppressive therapy. Diabetes is one of the most challenging health
problems globally, incurring staggering health, societal, and economic impact.
We believe our platform technology will provide Type 1 diabetes patients with
long-term insulin independence, which would transform the lives of patients
suffering from this debilitating disease.
Through our wholly-owned CDMO
subsidiary, MaSTherCell, we are establishing a global reputation as a premier
service provider in the regenerative medicine industry. While academic and
industrial research has greatly advanced scientific development in the sector,
industrialization and manufacturing expertise remains insufficient. We plan to
fill this gap by providing two types of services to our customers: (i) process
and assay development and optimization services; and (ii) current Good
Manufacturing Practices (cGMP) contract manufacturing services. In 2016,
MaSTherCell entered agreements with a number of the leading pharmaceutical and
biotech companies, as well as research institutions and hospitals involved in
cutting-edge cell therapy companies. As the industry continues to mature and a
growing number of cell therapy companies approach commercialization, we believe
that MaSTherCell is well positioned to serve as an external manufacturing source
for a wide array of cell therapy companies.
We entered into several
strategic partnerships and joint venture agreements in 2016. In March, we
entered into a Joint Venture Agreement with CureCell, pursuant to which we are
collaborating in the contract development and manufacturing of cell therapy
products in Korea. In May 2016, Orgenesis Ltd, our Israeli subsidiary, entered
into a pharma Cooperation and Project Funding Agreement (CPFA) with KORIL and
CureCell, whereby KORIL will provide funding for a joint research and
development project for the use of AIP cells for the treatment of diabetes. Also
in May 2016, we entered into a joint venture agreement with Atvio Biotech Ltd.,
an Israeli company, to collaborate in the contract development and manufacturing
of cell and virus therapy products in the field of regenerative medicine.
We secured a number of grants
in 2016 to advance our platform through non-dilutive funding. In April 2016,
Orgenesis SPRL, our Belgian subsidiary, received formal approval from DGO6 for a
budgeted 1.3 million ($1.5 million) support program for the development of our
technology for Type 1 diabetes. In October 2016, Orgenesis SPRL received formal
approval from the DGO6 for a budgeted 12.3 million ($12.8 million) support
program for the GMP production of AIP cells for two clinical trials that are
scheduled to be performed in Germany and Belgium.
We were successful in raising
additional capital in 2016, and have since secured an additional commitment from
an institutional investor for $16 million, payable periodically through August
2018, with the first payment of $1 million already received in February 2017. We
believe this latest investment, which was consummated at a premium to market at
the time of the agreement, is further validation of both our technology and our
Looking ahead, through our Israeli subsidiary, we look forward
to rapidly advancing our proprietary and patented AIP technology for diabetes
through the regulatory and clinical pathway. We also look forward to
accelerating growth in our MaSTherCell subsidiary as we expand organically
around the world, and as pilot projects mature into commercialization
partnerships with leading pharmaceutical and biotech company. We also plan to
apply our expertise to emerging technologies in other cell therapy markets in
areas such as cell-based cancer immunotherapies and neurodegenerative diseases.
We appreciate the continued support of our shareholders and look forward to
providing further updates in the near future.
About Orgenesis Inc.
Orgenesis is a vertically-integrated biopharmaceutical company
with expertise and unique experience in cell therapy development and
manufacturing. Through its Israeli subsidiary, Orgenesis Ltd., Orgenesis is a
pioneer in the development of technology designed to successfully reprogram
human liver cells into glucose-responsive, fully functional, Insulin Producing
Cells (IPCs). Orgenesis believes that converting the diabetic patient's own
tissue into insulin-producing cells has the potential to overcome the
significant issues of donor shortage, cost and exposure to chronic
immunosuppressive therapy associated with islet cell transplantation. In
addition, through its Belgian subsidiary, MaSTherCell S.A., a global Contract
Development and Manufacturing Organization (CDMO), Orgenesis is able to deliver
optimized process industrialization capacities to cell therapy companies, and
speed up the arrival of their therapies onto the market. From technology
selection to business modeling, GMP manufacturing, process development, quality
management and assay development, MaSTherCell s teams are fully committed to
helping our customers fulfill their objective of providing sustainable and
affordable therapies to their patients. The company operates in a validated and
flexible facility located in the strategic center of Europe within the Walloon
healthcare cluster, Biowin. This integrated approach supports Orgenesis's
business philosophy of bringing to market significant life-improving medical
treatments. For more information, visit www.orgenesis.com.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial uncertainties and risks. These forward-looking statements
are based upon our current expectations, estimates and projections and reflect
our beliefs and assumptions based upon information available to us at the date