UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of August 2020
Commission File Number 001-38716
GAMIDA CELL LTD.
(Translation of registrant’s name
into English)
5 Nahum Heftsadie Street
Givaat Shaul, Jerusalem 91340 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will
file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 to this Report
on Form 6-K shall be deemed to be incorporated by reference into the Registration Statements on Form
F-3 (File No. 333-234701) and Form S-8 (File Nos. 333-228301 and 333-238115)
of Gamida Cell Ltd. (the “Company”) and to be a part thereof from the date on which this report is filed, to the extent
not superseded by documents or reports subsequently filed or furnished.
Exhibit 99.3 to this Report on Form
6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act.
RISK FACTORS
The risk factors set forth under the
caption “Risk Factors” in the Company’s Annual Report on Form 20-F filed on February 26, 2020 (the “Annual
Report”) shall be deemed to be incorporated by reference herein and to be a part thereof from the date on which this report
is filed, to the extent not superseded by documents or reports subsequently filed or furnished. Additional risks and uncertainties
not currently known to the Company, or that the Company currently deems to be immaterial, also may affect its business, financial
condition and/or future operating results.
The following risk factor will
supersede the risk factor previously disclosed in the Company’s Report on Form 6-K filed on May 18, 2020 and will
supplement the risk factors disclosed in the Annual Report:
Our business has been and could
continue to be adversely affected by the evolving and ongoing COVID-19 global pandemic in regions where we or third parties on
which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
The COVID-19 pandemic has adversely affected our operations, including at our U.S. headquarters, and at our clinical trial sites,
and it could continue to adversely affect such operations as well as the business or operations of our manufacturers, CROs or
other third parties with whom we conduct business.
Our business has been adversely affected
by the effects of the recent and evolving COVID-19 pandemic, which was declared by the World Health Organization as a global pandemic.
The COVID-19 pandemic has resulted in travel and other restrictions in order to reduce the spread of the disease including in
the Commonwealth of Massachusetts, where our U.S. operations are focused. The Commonwealth of Massachusetts declared a state of
emergency related to the spread of COVID-19, and the Governor of Massachusetts and other health officials in Massachusetts and
surrounding states have announced aggressive orders, health directives and recommendations to reduce the spread of the disease.
Further, the Governor of Massachusetts issued an executive order directing that all non-essential businesses close their physical
operations and implement work-from-home schedules, effective as of March 23, 2020. Accordingly, we implemented work-from-home
policies for all employees. The effects of the executive order and our work-from-home policies have delayed our expected timeline
for the submission of our investigational new drug, or IND, application for our product candidate GDA-201. Previously, we expected
to submit an IND for GDA-201 in the fourth quarter of 2020. As a result of COVID-19 related business disruptions, we now expect
to submit our application during the first half of 2021. The magnitude of further adverse effects on our business and operations
will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business
in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could further negatively impact
our business, operating results and financial condition.
Some of our third-party manufacturers
which we use for the supply of materials for product candidates or other materials necessary to manufacture product to conduct
preclinical tests and clinical trials are located in countries affected by COVID-19, and should they experience disruptions, such
as temporary closures or suspension of services, we would likely experience delays in advancing these tests and trials. Currently,
we expect no material impact on the clinical supply of omidubicel or any of our product candidates.
In addition, our clinical trials may
be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment may be delayed due to prioritization of
hospital resources toward the COVID-19 pandemic. Some patients may not be able to comply with clinical trial protocols if quarantines
impede patient movement or interrupt healthcare services. Similarly, our ability to recruit and retain patients and principal
investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 and adversely impact our clinical
trial operations.
The spread of COVID-19, which has
caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by, and the
duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global
financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity. In addition,
a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our
common stock.
The global pandemic of COVID-19 continues
to rapidly evolve. The extent to which the COVID-19 pandemic continues to impact our business, our clinical development and regulatory
efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate
geographic spread of the disease, the duration of the outbreak, travel restrictions, quarantines, social distancing requirements
and business closures in the United States and other countries, business disruptions and the effectiveness of actions taken in
the United States and other countries to contain and treat the disease. Accordingly, we do not yet know the full extent of potential
delays or impacts on our business, our clinical and regulatory activities, healthcare systems or the global economy as a whole.
However, these impacts could adversely affect our business, financial condition, results of operations and growth prospects.
In addition, to the extent the ongoing
COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of heightening many of
the other risks and uncertainties described in the “Risk Factors” section included in our Annual Report.
PFIC STATUS
If we are a passive foreign investment
company, or PFIC, we expect to provide investors, by annually posting a “PFIC Annual Information Statement” on our
website, with the information required to allow investors to make a qualified electing fund, or QEF, election for United States
federal income tax purposes.
EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
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Unaudited Interim Consolidated Statements of Financial Position as of June 30, 2020 and June 30, 2020, and Unaudited Interim Consolidated Statements of Comprehensive Loss, Statements of Changes in Shareholders’ Equity and Statements of Cash Flows for the three months ended June 30, 2020 and June 30, 2019
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99.2
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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99.3
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Press Release dated August 11, 2020
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101
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Interactive data files pursuant to Rule 405 of Regulation S-T: (i) Interim Consolidated Statements of Financial Position, (ii) Interim Consolidated Statements of Comprehensive Loss, (iii) Interim Consolidated Statements of Changes in Shareholders Equity, (iv) Interim Consolidated Statements of Cash Flows, and (v) the Notes to Interim Consolidated Financial Statements
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SIGNATURES
Pursuant to the requirements of the Exchange Act, the Registrant
has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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GAMIDA CELL LTD.
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August 12, 2020
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By:
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/s/ Shai Lankry
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Shai Lankry
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Chief Financial Officer
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3
Exhibit
99.2
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Gamida
Cell is an advanced cell therapy company committed to finding cures for 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.
While cell therapies have the potential to address a variety of diseases, they are limited by availability of donor cells, matching
a donor to the patient, and the decline in donor cell functionality when expanding the cells to achieve a therapeutic dose. We
have leveraged our nicotinamide, or NAM, cell expansion technology platform to develop a pipeline of products designed to address
the limitations of cell therapies. Our proprietary technology allows for the proliferation of donor cells while maintaining the
cells’ functional therapeutic characteristics, providing a treatment alternative for patients.
Our
most advanced product candidate, omidubicel, is an investigational advanced cell therapy designed to expand the life-saving benefits
of hematopoietic stem cell (bone marrow) transplant. Gamida Cell completed patient enrollment in a pivotal Phase 3 clinical trial
in 125 patients with various hematologic malignancies. Topline data from the study demonstrated that the median time to neutrophil
engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).
Neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a transplant are established and begin
to make healthy new cells, and rapid neutrophil engraftment has been associated with fewer infections and shorter hospitalizations.
The data from the Phase 3 study are consistent with results from our multi-center, Phase 1/2 study in 36 patients with advanced
hematologic malignancies which were published in the Journal of Clinical Oncology in December 2018. Based on the results
of our Phase 1/2 clinical trials, we received Breakthrough Therapy Designation for omidubicel in the United States from the U.S.
Food and Drug Administration, or the FDA. Furthermore, we received orphan drug designation from both the FDA and the European
Medicines Agency.
We
are also developing omidubicel for the treatment of other rare, life-threatening hematologic diseases, including severe aplastic
anemia, a bone marrow failure disease, which is currently being investigated in a Phase 1/2 trial sponsored by the National Institutes
of Health. In addition, we have applied our NAM cell expansion technology to natural killer cells, to develop our product candidate,
GDA-201, an investigational cancer immunotherapy now being evaluated in a Phase 1 investigator-sponsored trial for the treatment
of relapsed or refractory non-Hodgkin lymphoma, or NHL, and multiple myeloma. Data from the first 25 patients in this study demonstrated
that GDA-201 was clinically active and generally well tolerated. Among the eleven patients with NHL, seven patients achieved a
complete response and one patient achieved a partial response.
We
have incurred significant net losses since our formation in 1998. Our net losses were $25.7 million and $15.1 million for the
six months ended June 30, 2020 and 2019. As of June 30, 2020, our accumulated deficit was $229.2 million. We expect to continue
to incur losses for the foreseeable future, and our losses may fluctuate significantly from year to year. We expect that our expenses
will increase substantially in connection with our ongoing activities as we:
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●
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continue
the clinical and preclinical development of our product candidates;
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●
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file
a Biologics License Application seeking regulatory approval for any of our product candidates;
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●
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establish
a sales, marketing and distribution infrastructure and scale up manufacturing capabilities to commercialize any products for
which we obtain regulatory approval;
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●
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maintain,
expand and protect our intellectual property portfolio;
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●
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add
equipment and physical infrastructure, including construction of our Kiryat Gat manufacturing facility, to support our research
and development and commercialization efforts;
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●
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hire
additional clinical development, regulatory, commercial, quality control and manufacturing personnel; and
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●
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add
operational, financial and management information systems and personnel, including personnel to support our product development
and planned future commercialization.
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We
will need substantial additional funding to support our operating activities as we advance our product candidates through clinical
development, seek regulatory approval and prepare for and, if any of our product candidates are approved, proceed to commercialization.
Adequate funding may not be available to us on acceptable terms, or at all.
To
continue to fund our operations, we expect to continue to raise capital. We may obtain additional financing in the future through
the issuance of our ordinary shares, through other equity or debt financings or through collaborations or partnerships with other
companies. We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital
as and when needed could compromise our ability to execute on our business plan. Although it is difficult to predict future liquidity
requirements, we believe that our current total existing funds will be sufficient to fund our operations into the second half
of 2021. However, our ability to successfully transition to profitability will be dependent upon achieving a level of revenue
adequate to support our cost structure. We cannot assure you that we will ever be profitable or generate positive cash flow from
operating activities.
Components
of Results of Operations
Revenue
We
do not currently have any products approved for sale and, to date, we have not recognized any revenue. In the future, we may generate
revenue from a combination of product sales, reimbursements, up-front payments and future collaborations. If we fail to achieve
clinical success or obtain regulatory approval of any of our product candidates in a timely manner, our ability to generate future
revenue will be impaired.
Research
and development expenses, net
The
largest component of our total operating expenses has historically been, and we expect will continue to be, research and development.
Our research and development expenses, net of grants from the Israel Innovation Authority, or IIA, consist primarily of:
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●
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salaries
and related costs, including share-based compensation expense, for our personnel in research and development functions;
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●
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expenses
incurred under agreements with third parties, including CROs, subcontractors, suppliers and consultants, preclinical studies
and clinical trials;
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●
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expenses
incurred to acquire, develop and manufacture preclinical study and clinical trial materials; and
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●
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facility
and equipment costs, including depreciation expense, maintenance and allocated direct and indirect overhead costs.
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Research
expenditures are recognized in profit or loss when incurred. An intangible asset arising from a development project or from the
development phase of an internal project is recognized if we can demonstrate: the technical feasibility of completing the intangible
asset so that it will be available for use or sale; our intention to complete the intangible asset and use or sell it; our ability
to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate
technical, financial and other resources to complete the intangible asset; and our ability to measure reliably the expenditure
attributable to the intangible asset during its development. Since our development projects are subject to regulatory approval
procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not
satisfied and, therefore, development expenditures are recognized in profit or loss when incurred.
Through
June 30, 2020, we have received grants of approximately $31.9 million in the aggregate from the IIA for research and development
funding. Pursuant to the terms of the grants, we are obligated to pay the IIA royalties, at the rate of between 3% to 4% on all
our revenue, up to a limit of 100% of the amounts of the U.S. dollar-linked grants received, plus annual interest calculated at
a rate based on 12-month LIBOR. We have not paid any royalties to the IIA to date.
The
United Kingdom’s, Financial Conduct Authority, which regulates the London Interbank Offered Rate (LIBOR), announced
in July 2017 that it will no longer persuade or require banks to submit rates for LIBOR after 2021. The grants received
from the IIA bear an annual interest rate based on the 12-month LIBOR. Accordingly, there is considerable uncertainty regarding
the publication of LIBOR beyond 2021. While it is not currently possible to determine precisely whether, or to what extent, the
withdrawal and replacement of LIBOR would affect us, the implementation of alternative benchmark rates to LIBOR may increase our
financial liabilities to the IIA.
In
addition to paying any royalties due, we must abide by other restrictions associated with receiving such grants under the Encouragement
of Research, Development and Technological Innovation in the Industry Law 5744-1984, which will also continue to apply to us following
the repayment in full of the amounts due to the IIA. The Innovation Law restricts our ability to manufacture products and transfer
technologies outside of Israel and may impair our ability to enter into agreements that involve IIA-funded products or know-how
without the approval of the IIA. Any approval, if given, will generally be subject to additional financial obligations by us.
Failure to comply with the requirements under the Innovation Law may subject us to mandatory repayment of grants received by us,
together with interest and penalties as well as expose us to criminal proceedings.
In
June 2017, new rules, or the Licensing Rules, were published by the IIA allowing a grant recipient to enter into licensing arrangements
or grant other rights in know-how developed under IIA programs outside of Israel, subject to the prior consent of the IIA and
payment of license fees, calculated in accordance with the Licensing Rules. The amount of the license fees is based on various
factors, including the consideration received by the licensor in connection with the license, and shall not exceed six times the
amount of the grants received by the grants recipient (plus accrued interest) for the applicable know-how being licensed. In certain
cases, such as when the license consideration includes nonmonetary compensation or when a “special relationship” exists
between the licensor and licensee (e.g., when a party controls the other party or is the other party’s exclusive
distributor), or when the agreed upon consideration does not reflect, in the IIA’s opinion, the market value of the license,
the IIA may base the value of the transaction on an economic assessment that it obtains for such purpose. See “Taxation
– Material Israeli Tax Considerations” for more information.
Government
grants received from the IIA are recognized upon receipt as a liability if future economic benefits are expected from the project
that will result in royalty-bearing revenue. If no such economic benefits are expected, the grants are recognized as a reduction
of the related research and development expenses.
We
are currently focused on advancing our product candidates, and our future research and development expenses will depend on their
clinical success. Research and development expenses will continue to be significant and will increase over at least the next several
years as we continue to develop our product candidates and conduct preclinical studies and clinical trials of our product candidates.
These
research and development costs include share-based compensation and other employment costs, regulatory, quality assurance and
intellectual property costs. The costs incurred in research and development expenses are to advance the development of our product
candidates and preclinical research and development programs. A substantial majority of our research and development expenses
are related to the development of omidubicel.
We
do not believe that it is possible at this time to accurately project total expenses required for us to reach commercialization
of our product candidates. Due to the inherently unpredictable nature of preclinical and clinical development, we are unable to
estimate with certainty the costs we will incur and the timelines that will be required in the continued development and approval
of our product candidates. Clinical and preclinical development timelines, the probability of success and development costs can
differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations,
if and when such arrangements will be entered into, if at all, and to what degree such arrangements would affect our development
plans and capital requirements.
Commercial
activities
Commercial
activities consist primarily of personnel costs, including share-based compensation, related to executive and commercial functions,
and external consulting service fees.
We
anticipate that our commercial activities will increase in the future following successful BLA for omidubicel as we will increase
our commercial headcount and infrastructure to support commercialization of our product candidates.
General
and administrative expenses
General
and administrative expenses consist primarily of personnel costs, including share-based compensation, related to directors, executive,
finance, and administrative functions, facility costs and external professional service costs, including legal, accounting and
audit services and other consulting fees.
We
anticipate that our general and administrative expenses will increase in the future as we increase our administrative headcount
and infrastructure to support our continued research and development programs and the potential approval and commercialization
of our product candidates. We also anticipate that we will incur increased expenses related to audit, legal, regulatory and tax-related
services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance premiums, executive
compensation, and other customary costs associated with being a public company.
Finance
income (expenses), net
Finance
income (expenses), net, is calculated by subtracting our financing expense from our financing income, and adding or subtracting
the gain or loss, as applicable, that we have realized due to revaluation at fair value of warrants and the IIA royalty-bearing
grants liability, offset by interest income from deposits and marketable securities.
Income
taxes
We
have yet to generate taxable income in Israel, as we have historically incurred operating losses resulting in carry forward tax
losses totaling approximately $135.5 million (including capital losses of $0.5 million) as of December 31, 2019, in addition,
the US subsidiary has net operating losses carryforward of $4.5 million for the federal tax purposes as of December 31, 2019.
We anticipate that we will continue to generate tax losses for the foreseeable future and that we will be able to carry forward
these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel until we have taxable
income after the full utilization of our carry forward tax losses. Deferred tax assets are recognized to the extent that it is
probable that taxable profit will be available against which the unused tax losses can be utilized. As of June 30, 2020, we did
not recognize deferred tax assets for carryforward losses because their utilization in the foreseeable future is not probable.
Analysis
of Results of Operations
Comparison
of the six months and three months ended June 30, 2020 and 2019
The
following table summarizes our results of operations for the six months and three months ended June 30, 2020 and 2019:
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|
|
Six
months ended
June 30,
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|
|
Three
months ended
June 30,
|
|
|
|
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2020
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|
|
2019
|
|
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2020
|
|
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2019
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|
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(unaudited,
in thousands)
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(unaudited,
in thousands)
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Operating Expenses:
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|
|
|
|
|
|
|
|
|
|
|
|
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Research
and development expenses, net(1)
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|
$
|
17,198
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|
|
$
|
14,536
|
|
|
$
|
9,319
|
|
|
$
|
7,253
|
|
|
Commercial
activities
|
|
|
2,497
|
|
|
|
2,090
|
|
|
|
1,029
|
|
|
|
1,092
|
|
|
General
and administrative expenses(1)
|
|
|
5,490
|
|
|
|
5,267
|
|
|
|
2,496
|
|
|
|
2,452
|
|
|
Operating
loss
|
|
|
25,185
|
|
|
|
21,893
|
|
|
|
12,844
|
|
|
|
10,797
|
|
|
Financial
expenses (income), net
|
|
|
472
|
|
|
|
(12,448
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)
|
|
|
2,211
|
|
|
|
(16,833
|
)
|
|
Loss
before taxes on income
|
|
|
25,657
|
|
|
|
9,445
|
|
|
|
15,055
|
|
|
|
(6,036
|
)
|
|
Taxes
on income
|
|
|
|
|
|
|
100
|
|
|
|
|
|
|
|
74
|
|
|
Net
loss
|
|
$
|
25,657
|
|
|
$
|
9,545
|
|
|
$
|
15,055
|
|
|
$
|
(5,962
|
)
|
|
(1)
|
Includes
share-based compensation expense as follows:
|
|
|
|
Six
months ended
June 30,
|
|
|
Three
months ended
June 30,
|
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
|
|
(unaudited,
in thousands)
|
|
|
(unaudited,
in thousands)
|
|
|
Research
and development, net
|
|
$
|
613
|
|
|
$
|
736
|
|
|
$
|
419
|
|
|
$
|
507
|
|
|
Commercial
activities
|
|
|
(177
|
)
|
|
|
634
|
|
|
|
(355
|
)
|
|
|
434
|
|
|
General
and administrative expenses
|
|
|
785
|
|
|
|
1,040
|
|
|
|
258
|
|
|
|
378
|
|
|
Total
share-based compensation
|
|
$
|
1,221
|
|
|
$
|
2,410
|
|
|
$
|
322
|
|
|
$
|
1,319
|
|
Research
and development expenses
Research
and development expenses increased by approximately $2.7 million to $17.2 million in the six months ended June 30, 2020 from $14.5
million in the six months ended June 30, 2019. The increase was attributable mainly to a $1.3 million increase in clinical activities
relating to both our Phase 3 and GDA 201 clinical programs, an increase of $0.9 million in salaries and benefits, consisting primarily
of additional headcount focused on clinical development, a decrease of $0.3 million in royalty-bearing grants from the IIA, and
an increase of $0.1 million in other expenses.
Commercial
activities
Our
commercial organization was established in 2019 and its expenses increased by approximately $0.4 million to $2.5 million for the
six months ended June 30, 2020 compared to $2.1 million for the six months ended June 30, 2019. The increase was attributable
mainly to a $1.1 million increase in professional services offset by $0.7 million in non-cash expenses related to share base compensation
General
and administrative expenses
General
and administrative expenses increased by approximately $0.2 million to $5.5 million in the six months ended June 30, 2020, up
from $5.3 million in the six months ended June 30, 2020. The increase was attributable mainly to a $0.8 million increase in professional
services expenses and other expenses associated with being a publicly-traded company offset by $0.3 million in non-cash expenses
related to share based compensation and a $0.3 million decrease in other expenses.
Finance
income, net
Finance
expenses (income), net, increased by approximately $12.9 million to $0.5 million in expenses in the six months ended June 30,
2020, compare to $12.4 million in expenses in the six months ended June 30, 2019. The increase in finance expenses was primarily
due to a $12.8 million increase in non-cash expenses resulting from revaluation of warrants owned by our shareholders, a decrease
of $0.4 million in cash management and a $0.1 million decrease in non-cash revaluation expenses of the Israeli Innovation Authority
royalty-bearing grant liability offset by a $0.4 million decrease in non-cash expenses related to IFRS 16 accounting standard
and other expenses.
Liquidity
and Capital Resources
Sources
of Liquidity
Since
our inception, we have incurred losses and negative cash flows from our operations. For the six months ended June 30, 2020, we
incurred net losses of $25.7 million, and net cash used of $ $22.8 million was used in our operating activities. As of June 30,
2020, we had working capital of $77.3 million, and an accumulated deficit of $229 million. Our principal sources of liquidity
as of June 30, 2020 consisted of cash and cash equivalents, and short-term deposits of $88.6 million.
Capital
resources
Overview
Through
June 30, 2020, we have financed our operations primarily through private placements of equity securities and through the grants
received from the IIA. Since November 2019, we have also financed our operations through the proceeds of our public offerings,
including $63.9 million in proceeds from the May 2020 issuance of our ordinary shares, net of issuance expenses.
Cash
flows
The
following table summarizes our statement of cash flows for the six months ended June 30, 2020 and 2019:
|
|
|
Six
months ended
June 30,
|
|
|
|
|
2020
|
|
|
2019
|
|
|
|
|
(unaudited,
in thousands)
|
|
|
Net cash provided
by (used in)
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|
|
|
|
|
|
|
Operating
activities
|
|
$
|
(22,779
|
)
|
|
$
|
(17,320
|
)
|
|
Investing
activities
|
|
|
6,442
|
|
|
|
14,862
|
|
|
Financing
activities
|
|
|
63,085
|
|
|
|
(826
|
)
|
Net
cash used in operating activities
The
cash used in operating activities during the aforementioned periods resulted primarily from our net losses incurred during such
periods, as adjusted for non-cash charges and measurements and changes in components of working capital. Adjustments to net losses
for non-cash items mainly consisted of fair value adjustment of warrants, revaluation of the liability to the IIA and share-based
compensation.
Net
cash used in operating activities was $22.8 million during the six months ended June 30, 2020, compared to $17.3 million used
in operating activities during the six months ended June 30, 2019. The $5.5 million increase in cash used was attributable primarily
to an increase in our cash burn rate from operating activities.
Net
cash provided by (used in) investing activities
Net
cash provided by investing activities was $6.4 million during the six months ended June 30, 2020, compared to $14.9 million provided
during the six months ended June 30, 2019. The $8.5 million increase in cash provided is primarily related to the sale and maturity
of available for sale assets during 2020 and 2019 offset by a $6.2 million increase in purchase of equipment.
Net
cash provided by financing activities
Net
cash provided by financing activities was $63.1 million during the six months ended June 30, 2020, compared to $0.8 million used
in financing activities during the six months ended June 30, 2019. The increase is primarily related to $63.9 million in proceeds
from the issuance of our ordinary shares, net of issuance expenses.
Critical
Accounting Policies and Estimates
Our
management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
statements, which we have prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International
Accounting Standards Board. The preparation of our consolidated financial statements requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date
of the consolidated financial statements, as well as the reported revenue and expenses during the reporting periods. Actual results
may differ from these estimates under different assumptions or conditions.
While
our significant accounting policies are more fully described in the notes to our consolidated financial statements, we believe
that the accounting policies discussed below are critical to our financial results and to the understanding of our past and future
performance, as these policies relate to the more significant areas involving management’s estimates and assumptions. We
consider an accounting estimate to be critical if: (i) it requires us to make assumptions because information was not available
at the time or it included matters that were highly uncertain at the time we were making our estimate; and (ii) changes in the
estimate could have a material impact on our financial condition or results of operations.
Government
Grants from the Israeli Innovation Authority (formerly the Office of the Chief Scientist)
Research
and development grants received from the IIA are recognized upon receipt as a liability if future economic benefits are expected
from the project that will result in royalty-bearing revenue. The amount of the liability for the loan is first measured at fair
value using a discount rate that reflects a market rate of interest that reflects the appropriate degree of risks inherent in
our business. The difference between the amount of the grant received and the fair value of the liability is accounted for as
a government grant and recognized as a reduction of research and development expenses. After initial recognition, the liability
is measured at amortized cost using the effective interest method. Royalty payments are treated as a reduction of the liability.
If no economic benefits are expected from the research activity, the grant receipts are recognized as a reduction of the related
research and development expenses. In that event, the royalty obligation is treated as a contingent liability in accordance with
IAS 37, “Provisions, Contingent Liabilities and Contingent Assets.”
At
the end of each reporting period, we evaluate whether there is reasonable assurance that the liability recognized will be repaid
based on our best estimate of future sales and, if not, the appropriate amount of the liability is derecognized against a corresponding
reduction in research and development expenses. See note 2—“Government Investment Grants” of the accompanying
unaudited consolidated financial statements.
Share-Based
Compensation
We
account for our equity-based compensation for employees in accordance with the provisions of IFRS 2 “Share-based Payment,”
which requires us to measure the cost of equity-based compensation based on the fair value of the award on the grant date.
For
option grants prior to our initial public offering, or IPO, we selected the binominal pricing model as the most appropriate method
for determining the estimated fair value of our equity-based awards. The resulting cost of an equity incentive award is recognized
as an expense over the requisite service period of the award, which is usually the vesting period. We recognize compensation expense
over the vesting period using the accelerated method pursuant to which each vesting tranche is treated as a separate amortization
period from grant date to vest date and classify these amounts in our consolidated financial statements based on the department
to which the related employee reports.
Our
determinations of the grant date fair value of options using the binomial model is affected by estimates and assumptions regarding
a number of complex and subjective variables. These variables include the fair value of our share price as of the grant date,
the expected volatility of our share price over the expected term of the options (estimated using historical data of comparable
companies), share option exercise and cancellation behaviors, risk-free interest rates, expected dividend yields (assumed to be
zero as we have historically not paid and do not intend to pay dividends on our ordinary shares):
|
Grant
Date
|
|
Amount
Granted
|
|
|
Type
of Shares
|
|
April 24, 2020
|
|
|
35,000
|
|
|
Ordinary Shares
|
|
February 24,
2020
|
|
|
363,200
|
|
|
Ordinary
Shares
|
|
January 12,
2020
|
|
|
85,000
|
|
|
Ordinary
Shares
|
|
November 12,
2019
|
|
|
62,000
|
|
|
Ordinary
Shares
|
|
July 8, 2019
|
|
|
183,500
|
|
|
Ordinary
Shares
|
|
June 4, 2019
|
|
|
138,000
|
|
|
Ordinary
Shares
|
|
March 14, 2019
|
|
|
316,800
|
|
|
Ordinary
Shares
|
|
January 7, 2019
|
|
|
90,000
|
|
|
Ordinary
Shares
|
|
October 30,
2018
|
|
|
65,000
|
|
|
Ordinary
Shares
|
|
July 23, 2018
|
|
|
90,000
|
|
|
Ordinary
Shares
|
|
July 20, 2018
|
|
|
195,056
|
|
|
Ordinary
Shares
|
|
May 14, 2018
|
|
|
401,921
|
|
|
Ordinary
Shares
|
|
December 28,
2017
|
|
|
606,574
|
|
|
Ordinary
Shares
|
|
November 16,
2017
|
|
|
416,574
|
|
|
Ordinary
Shares
|
|
March 2, 2017
|
|
|
134,800
|
|
|
Ordinary
Shares
|
|
March 2, 2017
|
|
|
178,067
|
|
|
Ordinary C Shares
|
Prior
to our IPO, the fair value of our ordinary shares was determined by our management with the assistance of an appraiser and was
determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid,
Valuation of Privately-Held-Company Equity Securities Issued as Compensation, or the AICPA Practice Aid. For options granted after
our IPO, the fair value of our ordinary shares is determined as the closing price of our ordinary shares as reported on The Nasdaq
Global Market on the grant date. The assumptions used in our valuation model are based on future expectations combined with management’s
judgment, and considered a number of objective, complex and subjective factors to determine the best estimate of the fair value
of our ordinary shares, including contemporaneous and retrospective valuations of our ordinary shares performed by an unrelated
valuation specialist, valuations of comparable peer companies, operating and financial performance, the lack of liquidity of our
share capital, and general and industry specific economic outlook. Based on the fair value of our ordinary shares as of June 30,
2020 and June 20, 2019, the intrinsic value of the awards outstanding as of June 30, 2020 and June 30, 2019 was $2.1 million and
$4.9 million, respectively.
The
dates of our valuations historically did not always coincide with the dates of our share-based compensation grants. In such instances,
management’s estimates were based on the most recent valuation of our ordinary shares. For grants occurring between valuation
dates, for financial reporting purposes, we used the closest valuation date before the grant, as we believed that the ordinary
share valuation represented the valuation at the date of grant. The following table lists the valuation dates of our ordinary
shares:
|
Valuation
Date
|
|
Type
of Shares
|
|
Fair
Value per Share
in
Dollars
|
|
|
June 30, 2018
|
|
Ordinary
Shares
|
|
$
|
6.90
|
|
|
December 31,
2017
|
|
Ordinary
Shares
|
|
$
|
4.90
|
|
|
March 31, 2017
|
|
Ordinary
Shares
|
|
$
|
5.40
|
|
|
March 31, 2017
|
|
Ordinary
C Shares(1)
|
|
$
|
6.20
|
|
We
determined our ordinary share value as of June 30, 2018 and December 31, 2017 using the income approach. The income approach estimates
the aggregate enterprise value of our company based on the present value of future estimated cash flows. Cash flows are estimated
for future periods based on projected revenue and costs. These future cash flows are discounted to their present values using
an appropriate discount rate. The discounted projected cash flows are summed together to arrive at an indicated aggregate enterprise
value under the income approach. In applying the income approach, we derived the discount rate from an analysis of the weighted-average
cost of capital based on company industry peers as of each valuation date and adjusted it to reflect the risks inherent in our
business cash flows. In estimating our projected revenues, we used data from bone marrow registries such as the European Society
for Blood and Marrow Transplantation and from the Center for International Blood and Marrow Transplant Research.
We
then allocated the estimated enterprise value among different classes of our equity by applying the Probability Weighted Expected
Return method, which was based on potential exit events from a strategic acquirer or initial public offering. The Probability
Weighted Expected Return method requires significant assumptions, including, in particular, the probability that such exit scenarios
will occur, the time until investors in our company would experience an exit event, and the volatility of our shares (which we
determine based on public companies with business and financial risks comparable to our own).
We
applied a discount to the resulting valuation due to the lack of marketability of our ordinary shares. We calculated this using
an Asian put option model. The significant assumptions involved were the same as described above. Since our initial public offering,
the fair value of our ordinary shares has been determined based on the closing price of our ordinary shares on the Nasdaq Global
Market.
Liability
Related to Certain Warrants
We
issued certain warrants to investors in connection with our financings to date. We accounted for these warrants according to the
provisions of IAS 32, “Financial instruments – presentation,” based on the anti-dilution protections provisions
and cashless exercise mechanism contained in the warrants agreements. We classified the warrants as non-current liabilities, measured
at fair value each reporting period until they will be exercised or expired, with changes in the fair values being recognized
in our statement of comprehensive loss as financial income or expense.
As
of June 30, 2020, we estimated the fair value of these warrants using a Black-Scholes option pricing model, which is affected
by estimates and assumptions regarding a number of complex and subjective variables. These variables are estimated as follows:
|
|
●
|
Risk-free
Interest Rate. The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with a term equivalent
to the contractual life of the warrants.
|
|
|
●
|
Volatility.
The expected share price volatility was based on the historical equity volatility of the ordinary shares of comparable companies
that are publicly traded with adjustments to reflect our capital structure.
|
|
|
●
|
Dividend
Yield. We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable
future. Consequently, we used an expected dividend yield of zero.
|
Recent
Accounting Pronouncements
See
note 4 of the accompanying unaudited consolidated financial statements for the six months ended June 30, 2020.
Internal
Control over Financial Reporting
Failure
to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002, or Section
404, could have a material adverse effect on our business, results of operation or financial condition. In addition, current and
potential shareholders could lose confidence in our financial reporting, which could have a material adverse effect on the price
of our ordinary shares. Pursuant to Section 404 and the related rules adopted by the SEC and the Public Company Accounting Oversight
Board, our management is required to report on the effectiveness of our internal control over financial reporting. In addition,
once we no longer qualify as an “emerging growth company” under the JOBS Act and lose the ability to rely on the exemptions
related thereto discussed above, our independent registered public accounting firm will also need to attest to the effectiveness
of our internal control over financial reporting under Section 404. We have completed the process of determining whether our existing
internal controls over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses
or significant deficiencies in our existing internal controls. Based on this process, our management concluded that the Company’s
internal controls over financial reporting were effective as of June 30, 2020.
JOBS
Act
As
an “emerging growth company,” as defined in the JOBS Act, we may take advantage of certain temporary exemptions from
various reporting requirements, including, but not limited to, not being required to comply with the auditor attestation requirements
of Section 404 (and the rules and regulations of the SEC thereunder). When these exemptions cease to apply, we expect to incur
additional expenses and devote increased management effort toward ensuring compliance with them. We cannot predict or estimate
the amount of additional costs we may incur as a result of becoming a public company or the timing of such costs.
Cautionary
Statement Regarding Forward-Looking Statements
Forward-looking
statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding
our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can
be identified by the use of forward-looking words such as “anticipate”, “believe”, “continue”,
“could”, “estimate”, “expect”, “intend”, “may”, “might”,
“ongoing”, “objective”, “plan”, “potential”, “predict”, “should”,
“will” and “would”, or the negative of these and similar expressions. Forward-looking statements are based
on our management’s beliefs and assumptions and on information currently available to our management. Such statements are
subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking
statements due to various factors, including, but not limited to, those identified under the section entitled “Item 3.D-Risk
Factors” in the Annual Report on Form 20-F for the year ended December 31, 2019, or the Annual Report, filed with the U.S.
Securities and Exchange Commission, or the SEC, pursuant to the U.S. Securities and Exchange Act of 1934, as amended, and the
section entitled “Risk Factors” in the Prospectus Supplement dated May 18, 2020, filed with the SEC pursuant to the
U.S. Securities Act of 1933, as amended. These risks and uncertainties include factors relating to:
|
|
●
|
the
timing and conduct of our clinical trials of omidubicel, GDA-201 and our other product
candidates, including statements regarding the timing, progress and results of current
and future preclinical studies and clinical trials, and our research and development
programs;
|
|
|
●
|
the
clinical utility, potential advantages and timing or likelihood of regulatory filings
and approvals of omidubicel, GDA-201 and our other product candidates;
|
|
|
●
|
the
Company’s ability to maintain operations, development programs, clinical trials
and to raise capital as a result of the COVID-19 pandemic;
|
|
|
●
|
our
plans regarding utilization of regulatory pathways that would allow for accelerated marketing
approval in the United States, the European Union and other jurisdictions;
|
|
|
●
|
our
expectations regarding timing for application for and receipt of regulatory approval
for any of our product candidates;
|
|
|
●
|
our
recurring losses from operations, which raised substantial doubt regarding our ability
to continue as a going concern absent access to sources of liquidity;
|
|
|
●
|
our
ongoing and planned discovery and development of product candidates;
|
|
|
●
|
our
expectations regarding future growth, including our ability to develop, and obtain regulatory
approval for, new product candidates;
|
|
|
●
|
our
expectations regarding when certain patents may be issued and the protection and enforcement
of our intellectual property rights;
|
|
|
●
|
our
plans to develop and commercialize our product candidates;
|
|
|
●
|
our
estimates regarding the market opportunity for our product candidates;
|
|
|
●
|
our
ability to maintain relationships with certain third parties;
|
|
|
●
|
our
estimates regarding anticipated capital requirements and our needs for additional financing;
|
|
|
●
|
our
planned level of capital expenditures;
|
|
|
●
|
our
expectations regarding licensing, acquisitions and strategic partnering;
|
|
|
●
|
our
expectations regarding the maintenance of our foreign private issuer status;
|
|
|
●
|
the
impact of government laws and regulations; and
|
|
|
●
|
our
expectations regarding the maintenance of our foreign private issuer status; and
|
|
|
●
|
the
impact of government laws and regulations.
|
Forward-looking
statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information
or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances
or to reflect the occurrence of unanticipated events.
10
Exhibit
99.3
Gamida
Cell Reports Second Quarter 2020 Financial Results and Provides Company Update
–
Secondary endpoints from positive Phase 3 study of omidubicel and initiation of BLA submission expected in the fourth quarter
of 2020; Expanded access program for omidubicel now underway; Initial data from research collaboration with CIBMTR to be presented
in September –
–
Additional data from GDA-201, an investigational NK cell immunotherapy, expected in the fourth quarter of 2020; Company provides
updated guidance for IND submission –
–
Company expands executive team –
–
Company to host conference call at 8:30 a.m. ET today –
Boston,
Mass. – August 11, 2020 – Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding
cures for blood cancers and serious blood diseases, today reported financial results for the
quarter ended June 30, 2020. The company also highlighted progress with omidubicel,
an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of
bone marrow transplant, and GDA-201, a natural killer (NK) cell immunotherapy in Phase 1 development in patients with non-Hodgkin
lymphoma (NHL).
Omidubicel,
an investigational advanced cell therapy for allogeneic
bone marrow transplant
During
the quarter, Gamida Cell reported that its Phase 3 study of omidubicel
met its primary endpoint, demonstrating a highly statistically significant reduction (p < 0.001) in time to neutrophil engraftment,
a key milestone in recovery from a bone marrow transplant. Omidubicel is the first bone marrow transplant product to receive Breakthrough
Therapy Designation from the U.S. Food and Drug Administration (FDA).
“The
primary endpoint data for omidubicel underscore its potential to become an important treatment option for patients by providing
a reliable graft source that can enable rapid neutrophil engraftment, which has been linked to other important outcomes such as
fewer infections and hospitalizations,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We look
forward to reporting secondary endpoints from the study and to initiating the biologics license application, or BLA, for omidubicel
to the FDA on a rolling basis, both in the fourth quarter of this year.”
Program
highlights for omidubicel:
|
|
●
|
Initial
data from collaboration with CIBMTR to be presented: Next month, Gamida Cell will
report initial data from an observational study that includes data contemporaneous to
the Phase 3 study of omidubicel. This study utilizes data from the CIBMTR registry, which
consists of clinical outcomes data on more than 500,000 stem cell transplants, to analyze
long-term safety and efficacy data for patients with hematologic malignancies who underwent
a bone marrow transplant with an alternative donor source following myeloablative conditioning.
The criteria for inclusion of patients and the outcomes evaluated in the analyses are
consistent with those in the Phase 3 study of omidubicel. These data will be highlighted
in a poster presentation at the Cord Blood Connect Meeting, which is being held virtually
on September 10 and September 17.
|
|
|
●
|
Initiated
expanded access program for omidubicel: Gamida Cell today announced that it has initiated
an open-label, single-arm study to provide access to omidubicel for patients with high-risk
hematologic malignancies who are in need of a bone marrow transplant and meet protocol
criteria. This study is currently open at three sites in the U.S., and additional sites
are expected to open in the coming months.
|
|
|
●
|
Reported
positive Phase 3 data for omidubicel: In May, Gamida Cell announced that the international,
randomized Phase 3 study of omidubicel achieved its primary endpoint of time to neutrophil
engraftment. The study was designed to evaluate the safety and efficacy of omidubicel
in 125 patients with high-risk hematologic malignancies undergoing a bone marrow transplant
compared to a comparator group of patients who received a standard umbilical cord blood
transplant. In the intent-to-treat analysis, the median time to neutrophil engraftment
was 12 days (95% CI: 10-15 days) for patients who were randomized to omidubicel compared
to 22 days (95% CI: 19-25 days) for the comparator group (p<0.001). Omidubicel was
generally well tolerated. Among patients who were transplanted per protocol, 96 percent
of patients who received omidubicel achieved successful neutrophil engraftment, compared
to 88 percent of patients in the comparator group.
|
Gamida
Cell expects to present the full data set, including secondary endpoint data, at a medical meeting in the fourth quarter of 2020.
The company also expects to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in
the fourth quarter of 2020.
|
|
●
|
Continued
to focus on activities required to successfully bring omidubicel to patients: Gamida
Cell is continuing to advance key activities required to bring omidubicel to patients
in a commercial setting, including building out manufacturing infrastructure, assembling
an experienced commercial team with expertise in cell therapy and transplant, establishing
hospital services and patient assistance programs, and exploring coverage and reimbursement
models to enable access.
|
GDA-201,
an innate NK cell immunotherapy
“We
are encouraged by data from the Phase 1 study of GDA-201, which has shown a high complete response rate in patients with non-Hodgkin
lymphoma,” stated Dr. Adams. “NK cell immunotherapies offer tremendous potential for transforming the care of hematologic
malignancies. We are pleased to be pioneering a novel approach that harnesses the power of our cell expansion technology, which
uniquely improves antibody-dependent cellular toxicity (ADCC), cytotoxic killing and the in vivo homing potential of GDA-201 to
address potential limitations of NK cells.”
Program
highlights for GDA-201
|
|
●
|
Continued
advancing Phase 1 study of GDA-201: Earlier this year, Gamida Cell reported data
from the first 25 patients in its ongoing Phase 1 study in patients with NHL and multiple
myeloma, which demonstrated that GDA-201 was clinically active and generally well tolerated.
Among the eleven patients with NHL, seven patients achieved a complete response and one
patient achieved a partial response. Gamida Cell expects to provide updated data from
the study at a medical conference in the fourth quarter of 2020.
|
|
|
●
|
Responded
to COVID-19 pandemic: Gamida Cell has implemented additional safety measures designed
to comply with applicable government guidelines, including shift work to allow for appropriate
social distancing. The company now expects to submit an investigational new drug (IND)
application for GDA-201 to the FDA in the first half of 2021. The company continues to
be on track to initiate a multi-center, Phase 1/2 clinical study in patients with NHL
next year.
|
Corporate
Highlights
|
|
●
|
Executed
a public offering: In May, Gamida Cell executed an underwritten public offering resulting
in the sale of 15.3 million shares of common stock
at $4.50 per share. Aggregate gross proceeds to the company were approximately $69
million before deducting underwriting discounts,
commissions and offering expenses.
|
|
|
●
|
Appointed
Matthew Metivier as vice president, human resources: Today Gamida Cell announced
the appointment of Matthew Metivier to the role of vice president, human resources. Mr.
Metivier brings more than 20 years of human resources experience, primarily in the life
sciences industry. Mr. Metivier brings over 20 years of experience in human resources.
Prior to joining Gamida Cell, Mr. Metivier worked at Sage Therapeutics, Inc., most recently
as the vice president of human resources, where he helped develop and lead the company’s
global human resources strategy. Before joining Sage, Mr. Metivier spent almost a decade
at Infinity Pharmaceuticals in multiple human resource roles. He has also held prior
human resource positions at various healthcare and high-tech companies, including Idenix
Pharmaceuticals (acquired by Merck & Co) and Therion Biologics Corp. Mr. Metivier
holds a B.A. in Political Science and Business Studies from Providence College and an
MBA from Suffolk University.
|
|
|
●
|
Appointed
Michele Korfin as chief operating and chief commercial officer: In July, Gamida Cell
appointed Michele Korfin to the role of chief operating and chief commercial officer.
Ms. Korfin brings over 20 years of experience in oncology, focused on business operations
and commercialization of novel therapies, including cell therapy experience as vice president
of market access at Kite Pharma, where she oversaw the market access strategy, including
payer relations, reimbursement and government affairs for Yescarta®, the
first approved CAR-T therapy in lymphoma.
|
|
|
●
|
Appointed
David Fox to Gamida Cell’s board of directors: In July, Gamida Cell appointed
David Fox to its board of directors as an independent member. Mr. Fox was most recently
a partner at Kirkland & Ellis LLP and served as a member of its Global Executive
Management Committee.
|
Second
Quarter 2020 Financial Results
|
|
●
|
Research
and development expenses in the second quarter of 2020 were $9.3 million, compared to
$7.3 million for the same period in 2019. The increase was mainly due to clinical activities
relating to the advancement of GDA-201 and a decrease in grants received from the Israel
Innovation Authority.
|
|
|
●
|
Commercial
expenses in the second quarter of 2020 were $1.0 million compared to $1.1 million for
the same period in 2019. The decrease was mainly attributed to non-cash compensation
offset by omidubicel commercial readiness activities.
|
|
|
●
|
General
and administrative expenses were $2.5 million for the second quarter of 2020 and for
the second quarter of 2019.
|
|
|
●
|
Finance
expense, net, was $2.2 million for the second quarter of 2020, compared to finance income,
net, of $16.8 million in the same period in 2019. The increase was primarily due to noncash
expenses resulting from revaluation of warrants owned by the company’s shareholders.
|
|
|
●
|
Net
loss for the second quarter of 2020 was $15.1 million, compared to a net income of $6.0
million in the same period in 2019.
|
|
|
●
|
As
of June 30, 2020, Gamida Cell had total cash, cash equivalents and available-for-sale
securities of $88.6 million, compared to $55.4 million as of December 31, 2019.
|
2020
Financial Guidance
Gamida
Cell expects cash used for ongoing operating activities in 2020 to range from $60 million to $70 million.
Gamida
Cell expects that its current cash, cash equivalents and available-for-sale securities will support the company’s ongoing
operating activities into the second half of 2021. This cash runway guidance is based on the Company’s current operational
plans and excludes any additional funding beyond the follow-on offering that closed in May 2020 and any business development activities
that may be undertaken.
Expected
2020-2021 Milestones
Gamida
Cell plans to achieve the following milestones during 2020-2021:
Omidubicel
|
|
●
|
Present
data from the Phase 3 study at a medical meeting in the fourth quarter of 2020
|
|
|
●
|
Initiate
the submission of the BLA to the FDA, on a rolling basis, in the fourth quarter of 2020
|
|
|
●
|
Report
additional data from the Phase 1/2 study in patients with severe aplastic anemia in the
fourth quarter of 2020
|
|
|
●
|
Launch
omidubicel in 2021, contingent upon FDA approval
|
GDA-201
|
|
●
|
Present
additional data from the Phase 1 study in the fourth quarter of 2020
|
|
|
●
|
Submit
company-sponsored IND application to the FDA in the first half of 2021
|
|
|
●
|
Initiate
a Phase 1/2 clinical study in patients with NHL in 2021
|
Conference
Call Information
Gamida
Cell will host a conference call today, August 11, 2020, at 8:30 a.m. ET to discuss these financial results and company updates.
A live webcast of the conference call can be accessed in the “Investors & Media” section of Gamida Cell’s
website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or +1-409-216-0605 (international)
and refer to conference ID number 8888903. A recording of the webcast will be available approximately two hours after the event,
for approximately 30 days.
About
Omidubicel
Omidubicel,
the company’s lead clinical program, 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). Omidubicel
is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and
has also received Orphan Drug Designation in the U.S. and EU. In both Phase 1/2 and Phase 3 clinical studies (NCT01816230 and
NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. 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.
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 in Phase 1 development through an investigator-sponsored study
in patients with refractory non-Hodgkin lymphoma and multiple myeloma (NCT03019666).
Omidubicel
and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration
or any other health authority.
About
Gamida Cell
Gamida
Cell is an advanced cell therapy company committed to finding cures for 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.
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 timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s
product candidates, anticipated regulatory filings, commercialization efforts and Gamida Cell’s expectations regarding its
projected operating expenses and 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 variability, and ramifications
for the cost thereof; 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, its Reports on Form 6-K filed
with the SEC on May 18, 2020, and August 11, 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.
|
Contacts:
Jaren
Irene Madden
jaren@gamida-cell.com
1-617-286-6264
|
Matthew
Corcoran (media)
mcorcoran@tenbridgecommunications.com
1-617-866-7350
|
INTERIM
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S.
dollars in thousands
|
|
|
June
30
|
|
|
December
31,
|
|
|
|
|
2020
|
|
|
2019
|
|
|
2019
|
|
|
|
|
Unaudited
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
88,638
|
|
|
$
|
37,078
|
|
|
$
|
41,838
|
|
|
Available-for-sale
financial assets
|
|
|
-
|
|
|
|
4,618
|
|
|
|
13,559
|
|
|
Prepaid
expenses and other current assets
|
|
|
2,241
|
|
|
|
886
|
|
|
|
1,306
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
90,879
|
|
|
|
42,582
|
|
|
|
56,703
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net
|
|
|
14,204
|
|
|
|
3,437
|
|
|
|
6,298
|
|
|
Right-of-use
assets
|
|
|
7,490
|
|
|
|
6,157
|
|
|
|
5,133
|
|
|
Other
assets
|
|
|
642
|
|
|
|
1,355
|
|
|
|
641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
non-current assets
|
|
|
22,336
|
|
|
|
10,949
|
|
|
|
12,072
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
113,215
|
|
|
$
|
53,531
|
|
|
$
|
68,775
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
$
|
2,738
|
|
|
$
|
2,121
|
|
|
$
|
1,164
|
|
|
Employees
and payroll accruals
|
|
|
3,187
|
|
|
|
2,753
|
|
|
|
3,443
|
|
|
Current maturities
of lease liabilities
|
|
|
2,145
|
|
|
|
1,945
|
|
|
|
1,870
|
|
|
Accrued
expenses and other payables
|
|
|
5,509
|
|
|
|
2,699
|
|
|
|
4,918
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
13,579
|
|
|
|
9,518
|
|
|
|
11,395
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
presented at fair value
|
|
|
4,551
|
|
|
|
7,654
|
|
|
|
5,221
|
|
|
Employee benefit
liabilities, net
|
|
|
773
|
|
|
|
274
|
|
|
|
773
|
|
|
Lease liabilities
|
|
|
5,946
|
|
|
|
4,627
|
|
|
|
4,101
|
|
|
Liability
to Israel Innovation Authority (IIA)
|
|
|
13,816
|
|
|
|
10,906
|
|
|
|
12,302
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
non-current liabilities
|
|
|
25,086
|
|
|
|
23,461
|
|
|
|
22,397
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’
EQUITY:
|
|
|
74,550
|
|
|
|
20,552
|
|
|
|
34,983
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders’ equity
|
|
$
|
113,215
|
|
|
$
|
53,531
|
|
|
$
|
68,775
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
INTERIM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
U.S.
dollars in thousands (except share and per share data)
|
|
|
Six
months ended
June
30,
|
|
|
Three
months ended
June
30,
|
|
|
Year
ended
December
31,
|
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
2019
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development,
net
|
|
$
|
17,198
|
|
|
$
|
14,536
|
|
|
$
|
9,319
|
|
|
$
|
7,253
|
|
|
$
|
31,462
|
|
|
Commercial activities
|
|
|
2,497
|
|
|
|
2,090
|
|
|
|
1,029
|
|
|
|
1,092
|
|
|
|
4,692
|
|
|
General and administrative
|
|
|
5,490
|
|
|
|
5,267
|
|
|
|
2,316
|
|
|
|
2,452
|
|
|
|
12,091
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
25,185
|
|
|
|
21,893
|
|
|
|
12,664
|
|
|
|
10,797
|
|
|
|
48,245
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance expense
|
|
|
1,366
|
|
|
|
1,604
|
|
|
|
2,320
|
|
|
|
1,336
|
|
|
|
3,325
|
|
|
Finance income
|
|
|
(894
|
)
|
|
|
(14,052
|
)
|
|
|
(109
|
)
|
|
|
(18,169
|
)
|
|
|
(17,149
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes on income
|
|
|
25,657
|
|
|
|
9,445
|
|
|
|
14,875
|
|
|
|
(6,036
|
)
|
|
|
34,421
|
|
|
Taxes on income
(benefit)
|
|
|
-
|
|
|
|
100
|
|
|
|
-
|
|
|
|
74
|
|
|
|
(70
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (income)
|
|
|
25,657
|
|
|
|
9,545
|
|
|
|
14,875
|
|
|
|
(5,962
|
)
|
|
|
34,351
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss (income) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss (income)
per share
|
|
$
|
0.69
|
|
|
$
|
0.38
|
|
|
$
|
0.37
|
|
|
$
|
(0.23
|
)
|
|
$
|
1.17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per
share
|
|
$
|
0.69
|
|
|
$
|
0.87
|
|
|
$
|
0.37
|
|
|
$
|
0.44
|
|
|
$
|
1.69
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
|
|
|
Six
months ended
June
30,
|
|
|
Three
months ended
June
30,
|
|
|
Year
ended
December
31,
|
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
2019
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
(loss) income
|
|
$
|
(25,657
|
)
|
|
$
|
(9,545
|
)
|
|
$
|
(15,055
|
)
|
|
$
|
5,962
|
|
|
$
|
(34,351
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to net cash (used in) provided by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to the profit or loss items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
of property, equipment and right-of-use assets
|
|
|
1,106
|
|
|
|
1,245
|
|
|
|
556
|
|
|
|
703
|
|
|
|
2,143
|
|
|
Financial
income, net
|
|
|
(260
|
)
|
|
|
(569
|
)
|
|
|
(128
|
)
|
|
|
(378
|
)
|
|
|
(775
|
)
|
|
Cost
of share-based compensation
|
|
|
1,221
|
|
|
|
2,410
|
|
|
|
322
|
|
|
|
1,319
|
|
|
|
4,868
|
|
|
Change
in employee benefit liabilities, net
|
|
|
-
|
|
|
|
8
|
|
|
|
-
|
|
|
|
(3
|
)
|
|
|
126
|
|
|
Amortization
of premium on available-for-sale financial asses
|
|
|
4
|
|
|
|
101
|
|
|
|
-
|
|
|
|
51
|
|
|
|
184
|
|
|
Revaluation
of financial derivatives
|
|
|
(670
|
)
|
|
|
(13,471
|
)
|
|
|
1,778
|
|
|
|
(17,378
|
)
|
|
|
(15,904
|
)
|
|
Revaluation
of liability to IIA
|
|
|
1,315
|
|
|
|
1,199
|
|
|
|
593
|
|
|
|
631
|
|
|
|
2,531
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,716
|
|
|
|
(9,077
|
)
|
|
|
3,121
|
|
|
|
(15,055
|
)
|
|
|
(6,827
|
)
|
|
Changes
in asset and liability items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease
(increase) in prepaid expenses, other current assets and other assets
|
|
|
(1,065
|
)
|
|
|
117
|
|
|
|
(607
|
)
|
|
|
(292
|
)
|
|
|
(150
|
)
|
|
Increase
(decrease) in trade payables
|
|
|
1,574
|
|
|
|
244
|
|
|
|
(360
|
)
|
|
|
1,088
|
|
|
|
(821
|
)
|
|
Increase
(decrease) in accrued expenses and other payables
|
|
|
(624
|
)
|
|
|
162
|
|
|
|
2,472
|
|
|
|
141
|
|
|
|
2,807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(115
|
)
|
|
|
523
|
|
|
|
1,325
|
|
|
|
937
|
|
|
|
1,836
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
received during the period for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
received
|
|
|
357
|
|
|
|
830
|
|
|
|
9
|
|
|
|
309
|
|
|
|
1,546
|
|
|
Interest
paid
|
|
|
(80
|
)
|
|
|
(51
|
)
|
|
|
(33
|
)
|
|
|
(23
|
)
|
|
|
(134
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
277
|
|
|
|
779
|
|
|
|
(24
|
)
|
|
|
286
|
|
|
|
1,412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(22,779
|
)
|
|
|
(17,320
|
)
|
|
|
(10,453
|
)
|
|
|
(7,870
|
)
|
|
|
(37,930
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of property, plant and equipment
|
|
|
(7,109
|
)
|
|
|
(878
|
)
|
|
|
(4,990
|
)
|
|
|
(528
|
)
|
|
|
(3,055
|
)
|
|
Purchase
of marketable securities
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(32,021
|
)
|
|
Proceed
from sale of marketable securities
|
|
|
13,551
|
|
|
|
15,740
|
|
|
|
-
|
|
|
|
1,847
|
|
|
|
-
|
|
|
Proceed
from maturity of marketable securities
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
38,742
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by (used in) investing activities
|
|
$
|
6,442
|
|
|
$
|
14,862
|
|
|
$
|
(4,990
|
)
|
|
$
|
1,319
|
|
|
$
|
3,666
|
|
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
|
|
|
Six
months ended
June
30,
|
|
|
Three
months ended
June
30,
|
|
|
Year
ended
December
31,
|
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
2019
|
|
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Receipt
of grants from the IIA
|
|
$
|
200
|
|
|
$
|
167
|
|
|
$
|
147
|
|
|
$
|
167
|
|
|
$
|
224
|
|
|
Proceeds
from secondary offering, net
|
|
|
63,860
|
|
|
|
(346
|
)
|
|
|
63,860
|
|
|
|
(108
|
)
|
|
|
37,140
|
|
|
Proceeds
from issuance of shares, initial public offering (payment of issuance expenses), net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(238
|
)
|
|
Payment
of lease liabilities
|
|
|
(1,122
|
)
|
|
|
(764
|
)
|
|
|
(335
|
)
|
|
|
(324
|
)
|
|
|
(1,529
|
)
|
|
Exercise
of options
|
|
|
147
|
|
|
|
117
|
|
|
|
141
|
|
|
|
117
|
|
|
|
132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash (used in) provided by financing activities
|
|
|
63,085
|
|
|
|
(826
|
)
|
|
|
63,813
|
|
|
|
(148
|
)
|
|
|
35,729
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange
differences on balances of cash and cash equivalents
|
|
|
52
|
|
|
|
90
|
|
|
|
(24
|
)
|
|
|
28
|
|
|
|
101
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents
|
|
|
46,800
|
|
|
|
(3,194
|
)
|
|
|
48,346
|
|
|
|
(6,671
|
)
|
|
|
1,566
|
|
|
Cash
and cash equivalents at beginning of period
|
|
|
41,838
|
|
|
|
40,272
|
|
|
|
40,292
|
|
|
|
43,749
|
|
|
|
40,272
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
|
$
|
88,638
|
|
|
$
|
37,078
|
|
|
$
|
88,638
|
|
|
$
|
37,078
|
|
|
$
|
41,838
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
10