Pro forma Cash Expected to Fund
Manufacturing, Regulatory and Commercial Readiness Preparations
for Omidubicel and the Advancement of GDA-201 Clinical
Development
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy
company committed to developing and commercializing cures for blood
cancers and serious hematologic diseases, today announced the sale
of $75 million of 5.875% exchangeable senior notes due in 2026 (the
“notes”) to certain funds managed by Highbridge Capital Management,
LLC.
The proceeds from this sale of notes, together with the net
proceeds of Gamida Cell’s sale of $75 million of ordinary shares in
December 2020, are expected to provide Gamida Cell with sufficient
liquidity to fund the company’s operations into the second half of
2022. These capital infusions will be used to support
manufacturing, regulatory and commercial development activities for
omidubicel and to further the preclinical and clinical development
of GDA-201.
“Securing this financing from a respected industry investor
strengthens Gamida Cell’s financials at a pivotal time for our
company. It enables us to capitalize on positive Phase 3 clinical
results generated from omidubicel and to fund the key activities
required to bring this therapy forward to patients,” said Julian
Adams, CEO of Gamida Cell. “Moreover, these additional funds help
us to advance clinical development of GDA-201 by enabling us to
file an IND for this product candidate.”
“We are pleased to be able to provide this financing to Gamida
Cell, to meaningfully advance their vision of developing cures for
blood cancers and serious hematological diseases,” commented
Jonathan Segal, Co-Chief Investment Officer of Highbridge Capital
Management. “Following our extensive due diligence, we are
enthusiastic about the commercial potential for omidubicel. We are
also excited about the potential for GDA-201 to be an important
therapy and leader in the emerging field of NK cell therapy. We
look forward to continuing to work collaboratively with Gamida
Cell’s management team and board” added Jason Hempel, Co-Chief
Investment Officer of Highbridge Capital Management.
The notes were sold at 100% of the principal amount thereof, are
senior unsecured obligations of Gamida Cell and its wholly owned
subsidiary and will accrue interest at a rate of 5.875% per year.
Subject to certain limitations, the holders of the notes can elect
to exchange the notes for Gamida Cell’s ordinary shares at an
initial exchange rate of 56.3063 shares per $1,000 principal amount
of notes (equivalent to an exchange price of $17.76 per share). The
initial exchange price of the notes represents a premium of
approximately 50% over the closing price of Gamida Cell’s ordinary
shares on February 12, 2021 and a premium of approximately 122%
over the public offering price of Gamida Cell’s shares on December
17, 2020.
Gamida Cell may redeem all or a portion of the notes for cash,
at its option, at 100% of the principal amount plus accrued and
unpaid interest on the notes to be redeemed if the closing price of
its ordinary shares has been at least 130% of the exchange price
for at least 20 trading days during any 30 consecutive trading day
period.
Moelis & Company served as a transaction advisor to Gamida
Cell.
About Omidubicel
Omidubicel is an advanced cell therapy under development as a
potential life-saving allogeneic hematopoietic stem cell (bone
marrow) transplant solution for patients with hematologic
malignancies (blood cancers), for which it has been granted
Breakthrough Status by the US Food and Drug Administration. In both
Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299),
omidubicel demonstrated rapid and durable time to engraftment and
was generally well tolerated.12 Based on the recently completed
Phase 3 clinical study, in which omidubicel achieved statistically
significant and clinical meaningful results in the prespecified
primary and secondary endpoints, Gamida Cell plans to submit the
full Biologics License Application (BLA) to the FDA in the second
half of 2021. Omidubicel is also being evaluated in a Phase 1/2
clinical study in patients with severe aplastic anemia
(NCT03173937). The aplastic anemia investigational new drug
application is currently filed with the FDA under the brand name
CordIn®, which is the same investigational development candidate as
omidubicel. For more information on clinical trials of omidubicel,
please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and
efficacy have not been established by the FDA or any other health
authority.
About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell
expansion technology to develop GDA-201, an innate natural killer
(NK) cell immunotherapy for the treatment of hematologic and solid
tumors in combination with standard of care antibody therapies.
GDA-201 addresses key limitations of NK cells by increasing the
cytotoxicity and in vivo retention and proliferation in the bone
marrow and lymphoid organs of NK cells expanded in culture. GDA-201
is currently in Phase 1 development through an
investigator-sponsored study in patients with refractory
non-Hodgkin lymphoma and multiple myeloma.3 For more information on
the clinical study of GDA-201, please visit
www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and
efficacy has not been established by the FDA or any other health
authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to
developing and commercializing cures for patients with blood
cancers and serious blood diseases. We harness our cell expansion
platform to create therapies with the potential to redefine
standards of care in areas of serious medical need. For additional
information, please visit www.gamida-cell.com or follow Gamida Cell
on LinkedIn or Twitter at @GamidaCellTx.
Disclaimer
The offer and sale of the foregoing securities are being made in
a transaction not involving a public offering and have not been
registered under the Securities Act of 1933 or applicable state
securities laws. The securities may not be offered or sold in the
United States absent registration or an applicable exemption from
the registration requirements thereof. Gamida Cell has agreed to
file a registration statement with the Securities and Exchange
Commission registering the resale of the ordinary shares for which
the notes are exchangeable. This press release does not constitute
an offer to sell or the solicitation of an offer to buy the
securities, nor shall there be any sale of the securities in any
state in which such offer or sale would be unlawful prior to the
registration or qualification under the securities laws of such
state.
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 anticipated regulatory filings
(including the IND for GDA 201 and the BLA for omidubicel) and
approvals, planned commercialization and manufacturing
capabilities, and Gamida Cell’s expectations regarding the
sufficiency of its cash runway, which statements are subject to a
number of risks, uncertainties and assumptions, including, but not
limited to the scope, progress and expansion of Gamida Cell’s
clinical trials and ramifications for the cost thereof; the
company’s ability to prepare regulatory filings and the review
process therefor; complications in the company’s plans to
manufacture its products for commercial distribution; and clinical,
scientific, regulatory and technical developments. 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 Annual Report on Form 20-F, filed with the
Securities and Exchange Commission (SEC) on February 26, 2020 and
its Report on Form 6-K furnished to the SEC on August 12, 2020, 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. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Gamida Cell as of
the date of this release.
1 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al.
Phase I/II study of stem-cell transplantation using a single cord
blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019
Feb 10;37(5):367-374. 2 Gamida Cell press release, “Gamida Cell
Announces Positive Topline Data from Phase 3 Clinical Study of
Omidubicel in Patients with High-Risk Hematologic Malignancies,”
issued May 12, 2020. Last accessed August 31, 2020. 3
Clinicaltrials.gov identifier NCT03019666
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version on businesswire.com: https://www.businesswire.com/news/home/20210216005496/en/
For investors: Stephanie Ascher Stern Investor Relations,
Inc. stephanie.ascher@sternir.com 1-212-362-1200
For media: Matthew Corcoran Ten Bridge Communications
mcorcoran@tenbridgecommunications.com 1-617-866-7350
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