Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the
development of NAM-enabled cell therapies for patients with
hematologic and solid cancers and other serious diseases, announced
the closing of a senior secured convertible term loan of $25
million with certain funds managed by Highbridge Capital
Management, LLC (collectively, “Highbridge”). Pursuant to the loan
agreement, Gamida Cell’s wholly-owned subsidiary, as borrower, will
draw down $25 million from the facility with a maturity date of
December 12, 2024.
The proceeds from the term loan, together with the net proceeds
from Gamida Cell’s $20 million public offering of ordinary shares
announced on September 27, 2022 and its existing cash and cash
equivalents and trading financial assets, are expected to (i) fund
commercial readiness and initial launch activities to support
launch of omidubicel, if approved; (ii) fund the continued
development of its NK product pipeline, including clinical stage
asset GDA-201; and (iii) be used for general corporate purposes,
including general and administrative expenses and working
capital.
“We are pleased to secure additional capital from an existing
investor as we continue to prepare for the launch of omidubicel,
which is pending FDA review. Omidubicel has the potential to
address the unmet need for patients with hematologic malignancies
in need of an allogeneic hematopoietic stem cell transplant,” said
Abbey Jenkins, CEO of Gamida Cell. “As we anticipate our shift from
clinical to commercial stage, we are now in a stronger financial
position to prepare for launch while continuing development of our
promising NK pipeline, including our clinical stage asset
GDA-201.”
The term loan was made at 97% of the principal amount thereof,
constitutes a senior secured obligation of Gamida Cell and its
wholly owned subsidiaries and will accrue interest at an annual
rate of 7.5% per year The facility, which has a maturity of
December 12, 2024, calls for interest only payments for the first
four months and principal and interest payments amortized over the
remaining term. Installment payments may be payable in cash or in
ordinary shares subject to certain conditions. Subject to certain
limitations, the term loan may be exchanged into Gamida Cell’s
ordinary shares, in certain cases at the option of Highbridge and
in others at the option of Gamida Cell, at an initial exchange rate
of 0.52356 ordinary shares per $1.00 principal amount of notes
(equivalent to an exchange price of $1.91 per ordinary share).
“We have been encouraged by Gamida’s milestone achievements this
year, including BLA acceptance with Priority Review,” commented
Jonathan Segal, Co-Chief Investment Officer of Highbridge Capital
Management. “We look forward to continuing to work collaboratively
with Gamida Cell’s management team and board.”
Gamida Cell may prepay all but not less than all of the term
loan for cash, at its option, at 100% of the principal amount, plus
a make whole amount comprised of all accrued and unpaid and
remaining coupons due through the maturity date and a prepayment
premium of 5% on the principal amount to be prepaid.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a
potential life-saving allogeneic hematopoietic stem cell (bone
marrow) transplant for patients with blood cancers. Omidubicel
demonstrated a statistically significant reduction in time to
neutrophil engraftment in comparison to standard umbilical cord
blood in an international, multi-center, randomized Phase 3 study
(NCT0273029) in patients with hematologic malignancies undergoing
allogeneic bone marrow transplant. The Phase 3 study also showed
reduced time to platelet engraftment, reduced infections and fewer
days of hospitalization. One-year post-transplant data showed
sustained clinical benefits with omidubicel as demonstrated by
significant reduction in infectious complications as well as
reduced non-relapse mortality and no significant increase in
relapse rates nor increases in graft-versus-host-disease (GvHD)
rates. Omidubicel is the first stem cell transplant donor source to
receive Breakthrough Therapy Designation from the FDA and has also
received Orphan Drug Designation in the US and EU. The BLA for
omidubicel has been assigned a Prescription Drug User Fee Act
(PDUFA) target action date of May 1, 2023. If approved, omidubicel
will be the first allogeneic advanced stem cell therapy donor
source for patients with blood cancers in need of a stem cell
transplant.
Omidubicel is an investigational stem cell therapy candidate,
and its safety and efficacy have not been established by the FDA or
any other health authority. For more information about omidubicel,
please visit https://www.gamida-cell.com.
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide
(NAM)-enabled cell expansion technology to develop GDA-201, an
innate NK cell immunotherapy candidate for the potential treatment
of hematologic and solid tumors in combination with standard of
care antibody therapies. GDA-201, the lead candidate in the
NAM-enabled NK cell pipeline, has demonstrated promising initial
clinical study data. Preclinical studies have shown that GDA-201
may address key limitations of NK cells by increasing the
cytotoxicity and in vivo retention and proliferation in the bone
marrow and lymphoid organs. Furthermore, these data suggest GDA-201
may improve antibody-dependent cellular cytotoxicity (ADCC) and
tumor targeting of NK cells. There are approximately 40,000
patients with relapsed/refractory lymphoma in the US and EU, which
is the patient population that will be studied in the currently
ongoing GDA-201 Phase 1/2 clinical trial.
For more information about GDA-201, please visit
https://www.gamida-cell.com. For more information on the Phase 1/2
clinical trial of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational cell therapy candidate, and its
safety and efficacy have not been established by the FDA or any
other health authority.
About NAM Technology
Our NAM-enabling technology is designed to enhance the number
and functionality of targeted cells, enabling us to pursue a
curative approach that moves beyond what is possible with existing
therapies. Leveraging the unique properties of NAM (nicotinamide),
we can expand and metabolically modulate multiple cell types —
including stem cells and natural killer cells — with appropriate
growth factors to maintain the cells’ active phenotype and enhance
potency. Additionally, our NAM technology improves the metabolic
fitness of cells, allowing for continued activity throughout the
expansion process.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of
potentially curative cell therapy candidates for patients with
solid tumor and blood cancers and other serious blood diseases. We
apply a proprietary expansion platform leveraging the properties of
NAM to allogeneic cell sources including umbilical cord
blood-derived cells and NK cells to create therapy candidates with
potential to redefine standards of care. These include omidubicel,
an investigational product with potential as a life-saving
alternative for patients in need of bone marrow transplant, and a
line of modified and unmodified NAM-enabled NK cells targeted at
solid tumor and hematological malignancies. For additional
information, please visit www.gamida-cell.com or follow Gamida Cell
on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including with respect to the use of proceeds from the term
loan, previously announced public offering and other existing cash
and cash equivalents and trading financial assets, our commercial
relationship with Highbridge, regulatory filings submitted to the
FDA (including the potential timing of and prospects for the FDA’s
review of the BLA for omidubicel), commercialization planning
efforts, and the potentially life-saving or curative therapeutic
and commercial potential of Gamida Cell’s product candidates
(including omidubicel). Any statement describing Gamida Cell’s
goals, expectations, financial or other projections, intentions or
beliefs is a forward-looking statement and should be considered an
at-risk statement. Such statements are subject to a number of
risks, uncertainties and assumptions, including those related to
the impact that the COVID-19 pandemic could have on our business,
and including the scope, progress and expansion of Gamida Cell’s
clinical trials and ramifications for the cost thereof; clinical,
scientific, regulatory and technical developments; and those
inherent in the process of developing and commercializing product
candidates that are safe and effective for use as human
therapeutics, and in the endeavor of building a business around
such product candidates. In light of these risks and uncertainties,
and other risks and uncertainties that are described in the Risk
Factors section and other sections of Gamida Cell’s Quarterly
Report on Form 10-Q, filed with the Securities and Exchange
Commission (SEC) on November 14, 2022, as amended, and other
filings that Gamida Cell makes with the SEC from time to time
(which are available at http://www.sec.gov), the events and
circumstances discussed in such forward-looking statements may not
occur, and Gamida Cell’s actual results could differ materially and
adversely from those anticipated or implied thereby. Although
Gamida Cell’s forward-looking statements reflect the good faith
judgment of its management, these statements are based only on
facts and factors currently known by Gamida Cell. As a result, you
are cautioned not to rely on these forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20221212005265/en/
For investors: Courtney Turiano Stern Investor Relations,
Inc. Courtney.Turiano@sternir.com 1-212-362-1200
For media: Heather DiVecchia Director, Investor Relations
and Corporate Communications Heather@gamida-cell.com
1-617-892-9083
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