Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded
autologous cell therapies for the treatment of patients with
serious diseases and conditions, today announced the initiation of
its License Agreement with Innovative Cellular Therapeutics (ICT)
following receipt of a $5.1 million upfront and warrant payment
from ICT. The transfer of funds was executed following review
and approval by the State Administration of Foreign Exchange of the
People's Republic of China.
Under the terms of the agreement, ICT will develop and
distribute MACI®, Epicel®, ixmyelocel-T and Carticel® in Greater
China, South Korea, Singapore, and other countries in the region.
The payment was comprised of an upfront license fee and $4.2
million for a warrant to purchase 818,424 shares of the Company’s
common stock based on the closing price as of December 6, 2017 at
an exercise price of $0.01 per share. On December 27, 2017,
ICT exercised the warrant via a cashless exercise in exchange for
816,850 shares of the Company’s common stock. Vericel also is
eligible to receive approximately $8.0 million in development and
first commercial sale milestones and tiered low to middle double
digit royalties equal to a percentage of net sales of each licensed
product. ICT will be responsible for funding the development
of the programs and manufacturing the products for
commercialization in China and the rest of the territory.
“We are very pleased to begin our strategic collaboration and
initiate technology transfer activities with ICT,” said Gerard
Michel, chief financial officer and VP of corporate development of
Vericel. “Based on the continued momentum in MACI uptake following
launch and expanded Epicel utilization, we anticipate that this
funding, together with our recently expanded $25 million debt
facilities with Silicon Valley Bank and MidCap Financial, will
allow the Company to reach profitability without raising additional
capital.”
“We look forward to rapidly bringing Vericel’s cell therapy
products to patients in China and other Asian countries, said Dr.
Lei Xiao, Chairman of ICT. With the addition of Vericel’s
portfolio to our existing CAR-T pipeline and marketed products, ICT
has one of the broadest and most advanced cell therapy portfolios
in China.”
About Vericel CorporationVericel develops,
manufactures, and markets expanded autologous cell therapies for
the treatment of patients with serious diseases and conditions.
The company markets two cell therapy products in the United
States. Vericel is marketing MACI (autologous cultured chondrocytes
on porcine collagen membrane), an autologous cellularized scaffold
product indicated for the repair of symptomatic, single or multiple
full-thickness cartilage defects of the knee with or without bone
involvement in adults. Vericel is also marketing Epicel (cultured
epidermal autografts), a permanent skin replacement for the
treatment of patients with deep dermal or full thickness burns
greater than or equal to 30% of total body surface area. For more
information, please visit the company's website at
www.vcel.com.
About MACI MACI® (autologous cultured
chondrocytes on porcine collagen membrane) is an autologous
cellular scaffold product that is indicated for the repair of
symptomatic single or multiple full-thickness cartilage defects of
the knee with or without bone involvement in adults. The MACI
implant consists of autologous cultured chondrocytes seeded onto a
resorbable Type I/III collagen membrane. Autologous cultured
chondrocytes are human-derived cells which are obtained from the
patient's own cartilage for the manufacture of MACI.
About Carticel Carticel® (autologous cultured
chondrocytes), is a first-generation autologous cellular implant
indicated for the repair of symptomatic cartilage defects of the
femoral condyle (medial, lateral or trochlea) caused by acute or
repetitive trauma, in patients who have had an inadequate response
to a prior arthroscopic or other surgical repair procedure.
Carticel received a BLA approval in 1997 and is no longer marketed
in the U.S. Carticel was replaced at the end of the second
quarter of 2017 by MACI, which was approved on December 13, 2016 by
the FDA.
About Epicel Epicel® (cultured epidermal
autografts) is a permanent skin replacement indicated for use in
adult and pediatric patients who have deep dermal or full thickness
burns comprising a total body surface area greater than or equal to
30%. Epicel may be used in conjunction with split-thickness
autografts or alone in patients for whom split-thickness autografts
may not be an option due to the severity and extent of their burns.
The probable benefit of Epicel, mainly related to survival, was
demonstrated in two Epicel databases and one physician-sponsored
study. Epicel has been used in the United States and
internationally to treat severely burned patients since 1988, and
was approved in the United States in 2007 as a Humanitarian Use
Device (HUD) under a Humanitarian Device Exemption (HDE).
About Ixmyelocel-T Ixmyelocel-T is an
investigational autologous expanded multicellular therapy
manufactured from the patient's own bone marrow using Vericel's
proprietary, highly automated, fully closed cell-processing system.
This process selectively expands the population of mesenchymal
stromal cells and alternatively activated macrophages, which are
responsible for production of anti-inflammatory and pro-angiogenic
factors known to be important for repair of damaged tissue.
Ixmyelocel-T has received orphan drug, fast track development, and
regenerative medicine advanced therapy (RMAT) designation by the
U.S. Food and Drug Administration for use in the treatment of
advanced heart failure due to DCM. The Company does not plan
to conduct any additional clinical studies for ixmyelocel-T unless
fully funded by a partner.
Epicel®, Carticel®, and MACI® are registered trademarks of
Vericel Corporation. © 2017 Vericel Corporation. All
rights reserved.
About Innovative Cellular
TherapeuticsInnovative Cellular Therapeutics (ICT) is a
clinical-stage cell therapy company based in Shanghai, China. ICT
has established a broad portfolio of CAR-T products to treat cancer
patients. ICT’s proprietary 19CAR series has achieved outstanding
clinical results in treating late stage leukemia and lymphoma
patients who failed to respond to standard of care therapies. The
company also has multiple discovery candidates targeting a wide
range of solid tumors as well as a universal allogeneic CAR-T
therapy. For more information, please visit the company's website
at www.ictbio.com.This document contains forward-looking
statements, including, without limitation, statements concerning
anticipated progress, objectives and expectations regarding the
commercial potential of our products and growth in revenues,
intended product development, clinical activity timing, regulatory
progress, and objectives and expectations regarding our company
described herein, all of which involve certain risks and
uncertainties. These statements are often, but are not always, made
through the use of words or phrases such as "anticipates,"
"intends," "estimates," "plans," "expects," "we believe," "we
intend," and similar words or phrases, or future or conditional
verbs such as "will," "would," "should," "potential," "could,"
"may," or similar expressions. Actual results may differ
significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are the inherent uncertainties associated with
competitive developments, clinical trial and product development
activities, regulatory approval requirements, ability to achieve or
maintain profitability, estimating the commercial growth potential
of our products and product candidates and growth in revenues and
improvement in costs, market demand for our products, our ability
to secure consistent reimbursement for our products, and our
ability to supply or meet customer demand for our products. These
and other significant factors are discussed in greater detail in
Vericel's Annual Report on Form 10-K for the year ended December
31, 2016, filed with the Securities and Exchange Commission ("SEC")
on March 13, 2017, Quarterly Reports on Form 10-Q and other filings
with the SEC. These forward-looking statements reflect management's
current views and Vericel does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release
except as required by law.
Global Media Contacts:David SchullRusso
Partners LLC+1 212-845-4271 (office)+1 858-717-2310
(mobile)David.schull@russopartnersllc.com
Karen ChaseRusso Partners LLC+1 646-942-5627 (office)+1
917-547-0434 (mobile)Karen.chase@russopartnersllc.com
Investor Contacts: Chad RubinThe Trout
Groupcrubin@troutgroup.com +1 (646) 378-2947
Lee SternThe Trout Grouplstern@troutgroup.com+1 (646)
378-2922
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