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
that it has entered into a Commitment Letter with certain funds
managed by Highbridge Capital Management, LLC (“Highbridge”),
pursuant to which Highbridge has committed to provide a $25 million
senior secured, convertible term loan (the “term loan”).
The Commitment Letter does not represent a definitive credit
facility and is subject to certain conditions, including the
consummation of a Gamida Cell equity offering resulting in gross
proceeds of not less than $20 million. The Commitment Letter
provides, among other things, for: (i) a maturity date 24 months
from the closing date for the term loan; and (ii) an annual
interest rate of 7.50%, subject to increase to 12.00% upon the
occurrence of certain events, payable on a quarterly basis, and,
subject to certain conditions, payable in Gamida Cell’s ordinary
shares which will be valued at 95% of the volume weighted average
price over a period to be agreed upon. Obligations under the term
loan will be secured by substantially all of our assets and the
assets of our subsidiaries.
Subject to certain limitations, the lenders will be entitled to
convert the term loan, together with a make-whole premium, equal to
all accrued and unpaid, and remaining coupons due through the
maturity date (the “make whole amount”), into Gamida Cell’s
ordinary shares at a conversion price to be equal to a 35% premium
to the arithmetic mean of the volume weighted average price of
Gamida Cell’s ordinary shares for the three-trading day period
commencing on September 28, 2022, which price is subject to
adjustment in the event of ordinary share dividends,
reclassifications and certain other fundamental transactions
affecting the ordinary shares. Subject to certain conditions, the
term loan will be immediately callable at 100% of the principal
amount plus accrued and unpaid interest to the redemption date,
plus the make whole amount, plus a redemption premium of 5%.
Commencing four months after the closing date for the term loan,
Gamida Cell will begin monthly repayments on the term loan of
principal and accrued but unpaid interest on such amount with the
make-whole amount. Such installment payments can be paid to
Highbridge in either cash or stock.
Gamida Cell expects to pay certain fees and expenses of
Highbridge and to enter into a registration rights agreement with
Highbridge, pursuant to which Gamida Cell will be required to file
a registration statement registering the resale by Highbridge of
any ordinary shares of Gamida Cell issuable pursuant to the terms
of the term loan within 30 days after the closing date for the term
loan.
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.
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 ability of Gamida Cell and
Highbridge to agree on mutually acceptable loan terms, whether
Gamida Cell will offer the ordinary shares or consummate an equity
offering, timing of initiation and progress of, and data reported
from, the clinical trials of Gamida Cell’s product candidates
(including omidubicel), regulatory filings submitted to the FDA
(including the potential timing of 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), and Gamida Cell’s expectations for the expected
clinical development milestones set forth herein. 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 August 15, 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.
1CIBMTR 2019 – allogeneic transplants in patients 12+ years with
hematological malignancies. 2Gamida Cell market research
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version on businesswire.com: https://www.businesswire.com/news/home/20220927006163/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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