Mail Stop 3561
June 26, 2018
Dr. Julian Adams
Chief Executive Officer
Gamida Cell Ltd.
5 Nahum Heftsadie Street
Givaat Shaul, Jerusalem 91340
Israel
Re: Gamida Cell Ltd.
Draft Registration Statement on Form F-1
Submitted June 1, 2018
CIK No. 0001600847
Dear Dr. Adams:
We have reviewed your draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and
either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.
After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
General
1. Please supplementally provide us with copies of all written
communications, as
defined in Rule 405 under the Securities Act, that you, or anyone
authorized to do so
on your behalf, present to potential investors in reliance on Section
5(d) of the
Securities Act, whether or not they retain copies of the communications.
Dr. Julian Adams
Gamida Cell Ltd.
June 26, 2018
Page 2
Prospectus Summary
Overview, page 1
2. You state in the first paragraph that your technology "allows for the
proliferation of
donor cells while maintaining the cells' functional therapeutic
characteristics,
providing a treatment alternative for patients." You then state on page
3 that your
technology "increases engraftment efficiency in HSCT and enables
engraftment and
immune system reconstitution," and that NiCord thus "may serve as a
universal,
readily-available, reliable and effective alternative to existing
sources of donor cells
for HSCT." You also state on page 92 that "NiCord delivers a
therapeutically
effective dose of stem cells, leading to rapid engraftment and immune
reconstitution."
Since an efficacy determination is solely within the FDA's authority and
is
continuously evaluated throughout all phases of the clinical
development, please
remove these and all other statements or implications regarding the
potential efficacy
of your product candidates.
3. Please revise your pipeline chart here and on page 86 to specify the
"hematologic
malignancies" which NiCord and NAM-NK are being tested to treat. Also,
given that
NAM-NK is currently in a Phase 1 trial, please revise your pipeline
charts to present
Phase 1 and Phase 2 in separate columns or explain why you believe the
current
presentation is appropriate.
NiCord as a Universal Stem Cell Graft for Allogeneic HSCT, page 3
4. Please revise to define the terms "neutrophil engraftment" and "platelet
engraftment"
as used within the context of your clinical trials. In doing so, please
enhance these
definitions to explain the "key indicators of clinical benefits" you
discuss of "rapid
engraftment and immune reconstitution."
5. Please revise to identify the sponsor of the completed Phase 1/2
clinical trials you
describe here.
Risk Factors
Risks Related to our Reliance on Third Parties
We rely on third parties to supply the raw materials . . . ., page 34
6. You state here that you "have a relationship with a single supplier,
Miltenyi Biotec
GmbH, for certain equipment (columns and beads) necessary to create
[y]our product
candidates." Please file your supply agreement with Miltenyi Biotech
GmbH or tell
Dr. Julian Adams
Gamida Cell Ltd.
June 26, 2018
Page 3
us why you do not believe you are required to do so. Refer to Item
601(b)(10)(ii)(B)
of Regulation S-K.
Use of Proceeds, page 66
7. Please expand your disclosure regarding the proceeds to be used for your
product
candidates to describe how far in the development process of each
candidate you
estimate the allocated proceeds from this offering will enable you to
reach.
Dilution, page 70
8. Reference is made to the last two bullet points on page 71. Please tell
us your
consideration of also disclosing that the tables and discussion exclude
warrants to
purchase ordinary shares upon the closing of this offering that are
expected to remain
outstanding at the consummation of this offering,
Management's Discussion & Analysis
Analysis of Results of Operations
Comparison of the years ended December 31, 2017 and 2016, page 76
9. When you describe two or more reasons that contributed to a material
change in a
financial statement line item between periods, please quantify, to the
extent
practicable, the incremental impact of each individual reason on the
overall
change. For example, in your discussion of general and administrative
expenses
please quantify the impact of the decrease in share-based payment and
the increase in
salaries and professional services expenses. Please also provide an
analysis of the
underlying reasons for each significant change you identify.
Critical Accounting Policies and Estimates
Share-Based Compensation, page 80
10. We note that you determined your ordinary share value as of December 31,
2017
using the Income Approach. Please disclose the nature of the material
assumptions
involved. For example, disclose that this method involves estimating
future cash
flows and discounting those cash flows at an appropriate rate. Please
also disclose
the extent to which the estimates are considered highly complex and
subjective.
11. Once you have an estimated offering price or range, please explain to us
how you
determined the fair value of the ordinary shares underlying your equity
issuances and
Dr. Julian Adams
Gamida Cell Ltd.
June 26, 2018
Page 4
the reasons for any differences between recent valuations of your
ordinary shares
leading up to the IPO and the estimated offering price.
Business, page 84
12. Tell us the basis for your statement "... a full match is not required
for a successful
transplant using cord blood."
13. For each of the clinical trials discussed in this section, please
disclose the dosage
administered to participants. In addition, if any serious adverse
effects or events
other than GvHD, infection, engraftment failures, or death were observed
in these
trials, please revise to describe their nature and prevalence. We note
in that regard
your related risk factor disclosure on page 22.
NAM-Based Cell Expansion Technology, page 87
14. Please explain the significance of the p-values at the top of the charts
on pages 89, 93,
94, and 97, and discuss how these values relate to the FDA's evidentiary
standards of
efficacy.
NiCord is designed to Address the Limitations of HSCT, page 91
15. For the table on page 92, please provide support for your depiction of
the donor
source's ability to overcome the significant challenges you identify
here. Also, the
key you use does not appear to offer the reader a meaningful
differentiation between
"more favorable" and "less favorable;" if there is a reason for this,
please explain why
or revise to use a different depiction.
NiCord for HSCT and Hematologic Malignancies
NiCord: Phase 1/2 Clinical Trial Results, page 93
16. Explain your reference to myeloablative conditioning therapy and why it
is relevant
to your study.
17. We note your disclosure regarding additional endpoint data in the final
paragraph of
page 93. Please revise to include high grade acute and chronic GvHD
rates and
overall two-year survival rate in the historic controls. Please also
specify the rate of
sporadic engraftment failure in the test group and in the historic
controls. We note in
that regard your disclosure on page 22 regarding "a low level of
sporadic engraftment
failures" observed in this trial.
Dr. Julian Adams
Gamida Cell Ltd.
June 26, 2018
Page 5
NAM-NK: Our Immuno-Oncology Product Candidate, page 96
18. Clarify your description of the current phase of this product candidate
as your
disclosure here differs from the description provided on page 1 and
elsewhere.
NiCord for the Treatment of Non-Hematologic Disorders, page 98
19. We note your description here of Phase 1/2 clinical trials testing
NiCord for treatment
of SCD. Please revise to disclose the median days to initial
engraftment, number of
patients with long-term engraftment, and number of disease free patients
in the
comparison study you subsequently discuss. Please also advise us as to
why you do
not reflect this product use in your product pipeline charts.
Intellectual Property, page 100
20. Please revise your discussion to disclose for each material patent and
patent
application the specific product(s) to which such patents or patent
applications relate,
the type of patent protection, patent expiration dates, and applicable
jurisdictions.
You may contact Adam Phippen, Staff Accountant, at (202) 551-3336 or
Donna Di
Silvio, Staff Accountant, at (202) 551-3202 if you have questions regarding
comments on the
financial statements and related matters. Please contact Parhaum J. Hamidi,
Special Counsel,
at (202) 551-3421 or me at (202) 551-3720 with any other questions.
Sincerely,
/s/ Mara L. Ransom
Mara L. Ransom
Assistant Director
Office of Consumer
Products