Company reports positive feedback and continued
progress on transplant center onboarding and payer coverage around
launch of Omisirge® (omidubicel-onlv), a new cell therapy for
allogeneic stem cell transplant approved April 17 by the FDA
Company successfully completed public offering,
raising gross proceeds of $22.8 million
Company reports positive momentum on
two-pronged corporate strategy: executing commercial plan and
pursuing strategic partnerships to support Omisirge launch
Company to host conference call today at 4:30
p.m. ET
Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working
to turn cells into powerful therapeutics, today provided a business
update and reported financial results for the quarter ended March
31, 2023.
Gamida Cell recently announced that the U.S. Food and Drug
Administration (FDA) has approved Omisirge® (omidubicel-onlv) for
patients with hematologic malignancies who are planned for
allogeneic hematopoietic stem cell transplantation. Please see full
Prescribing Information, including the Boxed Warning.
“With the recent approval of Omisirge and the funds raised via
our public offering, Gamida Cell is making progress on our
two-pronged strategy: executing our commercial plan while seeking
partnerships to accelerate patient access and product uptake,” said
Abbey Jenkins, President and Chief Executive Officer of Gamida
Cell. “Our team was launch-ready by April 15, which allowed us to
move swiftly to initiate onboarding of transplant centers and
secure payer coverage to make Omisirge available to patients in
need of stem cell transplant.”
First Quarter and Recent Developments
Omisirge® (omidubicel-onlv)
- FDA approval of Omisirge: On April 17, the company
announced that the FDA approved Gamida Cell’s allogeneic cell
therapy, Omisirge, as a new donor source for allogeneic stem cell
transplant. Omisirge had previously received orphan drug,
breakthrough therapy and priority review designations. Omisirge is
the first enhanced and expanded cell therapy approved for stem cell
transplant.
- Commercial progress: The company continues to advance
efforts throughout the organization to execute the launch of
Omisirge. As of May 15, 2023:
- The company is on target to complete the goal of onboarding
10-15 of the top 70 transplant centers in 2023.
- The company has confirmed coverage with commercial payers that
cover 65% of targeted lives and has discussions ongoing with other
commercial payers and the Centers for Medicare & Medicaid
Services.
Corporate developments
- Public offering of securities: The company announced a
$22.8 million public offering of its securities. The underwritten
public offering consisted of 17,500,000 ordinary shares and
accompanying warrants to purchase 17,500,000 ordinary shares at a
public offering price of $1.30 per ordinary share and accompanying
warrant, for gross proceeds of $22.8 million, before deducting
underwriting discounts and commissions and estimated offering
expenses. The warrants have an exercise price of $1.35 per share,
are exercisable immediately upon issuance, and will expire five
years following the date of issuance. The net proceeds from the
offering will be used to support the launch of Omisirge, the
continued development of GDA-201 and for general corporate
purposes.
- Debt reduction: The company announced that between
January and May 2023, Highbridge Capital Management, LLC, which
issued Gamida Cell a $25 million senior secured convertible term
loan in December 2022, voluntarily exchanged an aggregate of $11.5
million in principal of that loan for ordinary shares in Gamida
Cell. The share redemptions were priced at $1.91 per share. In
addition, the company repaid an additional $1 million of principal
through an ordinary share issuance. As a result, the outstanding
principal balance of this loan has been reduced from $25 million to
$12.5 million.
- Special shareholders meeting: The company will hold a
special shareholders meeting May 19 to vote on an amendment to the
company’s articles of incorporation that increases the number of
ordinary shares authorized for issuance from 150,000,000 to
225,000,000. The purposes of this increase — which include
providing the company with the flexibility to issue ordinary shares
in connection with a commercial or strategic partnership, to pay
down debt or to fund operations — are outlined in the company’s
proxy statement. Following the increase, if approved, all ordinary
shares issuable from the company’s authorized share capital would
have the same voting rights and rights to any dividends or other
distributions by the company as the ordinary shares currently
issuable from its share capital.
- Strategic partnerships: The company continues to explore
partnerships or broader strategic alternatives that would provide
additional resource to support the launch of Omisirge and
associated commercial activities in the United States and the rest
of the world. The company recently announced it has hired Moelis
& Company LLC to support these efforts.
First Quarter 2023 Financial Results
- Research and development expenses were $8.8 million in the
first quarter of 2023, compared to $11.3 million in the same
quarter in 2022. The decrease was attributable mainly to a $2.4
million decrease in payments to Lonza for manufacturing services, a
$1.3 million decrease in clinical activities relating to the
conclusion of our Phase 3 clinical trial, offset by an increase of
$1.2 million in the GDA-201 clinical program.
- Commercial expenses were $5.6 million in the first quarter of
2023, compared to $3.9 million in the first quarter of 2022. The
increase was attributable mainly to an increase in launch readiness
activities. We anticipate that our commercial expenses will
increase over time due to the recent FDA approval of Omisirge.
- General and administrative expenses were $5.2 million in the
first quarter of 2023, compared to $4.1 million in the same period
in 2022. The increase was primarily due to professional services
expenses.
- Finance expenses, net, were $1.4 million in the first quarter
of 2023, compared to $0.9 million in the same period in 2022. The
increase was attributable to interest due on the convertible notes
issued in 2022, offset by interest income from cash
management.
- Net loss was $21.0 million in the first quarter of 2023,
compared to a net loss of $20.2 million in the first quarter of
2022.
2023 Financial Guidance
As of March 31, 2023, Gamida Cell had total cash and cash
equivalents of $46.8 million. This amount does not include the
approximately $25 million in net proceeds from its April 2023
underwritten public offering of securities and sales through its
ATM facility. The company expects its current cash and cash
equivalents to support its ongoing operating activities into 2024.
This guidance is based on Gamida Cell’s current operational plans
and excludes commercialization activities beyond the initial launch
of Omisirge and any additional financing activities that may be
undertaken.
Conference Call Information
Gamida Cell will host a conference call today, May 15, 2023, at
4:30 p.m. ET to discuss these financial results and company
updates. To access the conference call, please register here and be
advised to do so at least 10 minutes prior to joining the call. A
live conference call webcast can be accessed in the “Investors
& Media” section of Gamida Cell’s website at
www.gamida-cell.com. A webcast replay will be available
approximately two hours after the event for approximately 30
days.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into
powerful therapeutics. The company’s proprietary nicotinamide (NAM)
technology leverages the properties of NAM to enhance and expand
cells, creating allogeneic cell therapy products and candidates
that are potentially curative for patients with hematologic
malignancies. These include Omisirge®, an FDA-approved nicotinamide
modified allogeneic hematopoietic progenitor cell therapy, and
GDA-201, an intrinsic NK cell therapy candidate being investigated
for the treatment of hematologic malignancies. For additional
information, please visit www.gamida-cell.com or follow
Gamida Cell on LinkedIn, Twitter, Facebook or
Instagram.
Omisirge® is a registered trademark of Gamida Cell Inc. © 2023
Gamida Cell Inc. All Rights Reserved.
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 potentially life-saving or
curative therapeutic and commercial potential of Omisirge®
(omidubicel-onlv), the company’s plans for commercial or strategic
partnerships to support the launch of Omisirge and the company’s
anticipated financial runway. 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 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. 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 10-K, filed with the Securities and Exchange
Commission (SEC) on March 31, 2023, 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.
March 31,
December 31,
2023
2022
(unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
46,763
$
64,657
Prepaid expenses and other current
assets
1,404
1,889
Total current
assets
48,167
66,546
NON-CURRENT ASSETS:
Restricted deposits
3,680
3,668
Property, plant and equipment, net
45,644
44,319
Operating lease right-of-use assets
4,726
7,024
Severance pay fund
1,649
1,703
Other long-term assets
1,266
1,513
Total
non-current assets
56,965
58,227
Total
assets
$
105,132
$
124,773
March 31,
December 31,
2023
2022
(unaudited)
LIABILITIES AND SHAREHOLDERS' DEFICIT
CURRENT LIABILITIES:
Trade payables
$
4,398
$
6,384
Employees and payroll accruals
4,333
5,300
Operating lease liabilities
2,082
2,648
Accrued interest of convertible senior
notes
986
1,652
Accrued expenses and other current
liabilities
10,474
8,891
Total current
liabilities
22,273
24,875
NON-CURRENT LIABILITIES:
Convertible senior notes, net
90,646
96,450
Accrued severance pay
1,862
1,914
Long-term operating lease liabilities
2,976
4,867
Other long-term liabilities
2,742
4,690
Total
non-current liabilities
98,226
107,921
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS' EQUITY (DEFICIT):
Share capital - Ordinary shares
of NIS 0.01 par value
222
211
Treasury ordinary shares of NIS
0.01 par value
*
*
Additional paid-in capital
422,203
408,598
Accumulated deficit
(437,792
)
(416,832
)
Total shareholders' deficit
(15,367
)
(8,023
)
Total liabilities and shareholders' equity
$
105,132
$
124,773
Three months ended
March 31,
2023
2022
(unaudited)
(unaudited)
Research and development
expenses, net
$
8,840
$
11,305
Commercial expenses
5,576
3,879
General and administrative
expenses
5,164
4,139
Total operating loss
19,580
19,323
Financial expenses, net
1,380
900
Net Loss
$
20,960
$
20,223
Net loss per share attributable
to ordinary shareholders, basic and diluted
0.27
0.34
Three months ended
March 31,
2023
2022
(unaudited)
(unaudited)
Cash flows
from operating activities:
Net Loss
$
(20,960
)
$
(20,223
)
Adjustments to reconcile loss to
net cash used in operating activities:
Depreciation of property, plant
and equipment
106
112
Financing expense (income),
net
(464
)
(1,172
)
Share-based compensation
1,499
1,194
Amortization of debt discount and
issuance costs
196
191
Changes in operating assets and
liabilities:
Operating lease right-of-use
assets
527
562
Operating lease liabilities
(686
)
(613
)
Accrued severance pay, net
2
33
Decrease (increase) in prepaid
expenses and other assets
607
(889
)
Decrease in trade payables
(1,986
)
(3,927
)
Decrease in accrued expenses and
current liabilities
(1,125
)
(996
)
Net cash used in operating
activities
(22,284
)
(25,728
)
Cash flows
from investing activities:
Purchase of property, plant and
equipment
(830
)
(723
)
Purchase of marketable
securities
-
(2,086
)
Proceeds from maturity of
marketable securities
-
14,126
Proceeds from restricted
deposits
-
500
Net cash provided by (used in)
investing activities
$
(830
)
$
11,817
Cash flows
from financing activities:
Proceeds from exercise of
options
$
-
$
76
Proceeds from share issuance,
net
5,217
-
Net cash provided by financing
activities
5,217
76
Decrease in cash and cash
equivalents
(17,894
)
(13,835
)
Cash and cash equivalents at
beginning of period
64,657
55,892
Cash and cash equivalents at end
of period
$
46,763
$
42,057
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version on businesswire.com: https://www.businesswire.com/news/home/20230515005707/en/
Investor and Media Contact: Dan Boyle Orangefiery
media@orangefiery.com 1-818-209-1692
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