October 25, 2018
Frank G. Haluska
Chief Executive Officer
Anchiano Therapeutics Ltd.
1/3 High-Tech Village, Givat Ram
P.O. Box 39264
Jerusalem, 9139102
Israel
Re: Anchiano Therapeutics Ltd.
Draft Registration Statement on Form F-1
Submitted September 28, 2018
CIK No. 0001534248
Dear Dr. Haluska:
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.
Draft Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1. Please revise throughout the prospectus to remove any implication that
your
product candidates are more likely than others to receive FDA approval
or explain to us
why these statements are appropriate given the stage of your product
candidates. We note
by way of example statements on page 1 regarding your belief "that the
regulatory
Frank G. Haluska
FirstNameTherapeutics Ltd.G. Haluska
Anchiano LastNameFrank
Comapany NameAnchiano Therapeutics Ltd.
October 25, 2018
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pathway to approval for commercialization and wide distribution of our
product is a
straightforward extension of the clinical trial program we have
accomplished to date";
your belief "that the prospects for regulatory approval are
significantly improved by the
unmet need of the patient population . . . "; and your assertions here
and in the Business
section that your proposed clinical development plan "will support
approval."
2. Please revise throughout to remove any inference regarding the safety
and efficacy of your
product candidates. Given that the determination of a product's safety
and efficacy is
solely within the FDA's authority and your product candidates have not
yet completed
clinical trials, these inferences are not appropriate. We note by way
of example
statements here regarding the potential "therapeutic efficacy" of your
product candidates;
your belief that "inodiftagene can demonstrate efficacy and safety
against early stage
bladder cancer . . . "; and your statement on page 56 that "the
potential for efficacy is
optimized without attendant risk of significant adverse effects for
the patient. . . ."
3. Please disclose in what countries your six clinical trials were
conducted.
4. We note your disclosure in the first paragraph on page 2 and in the
Business section that
the results of your trials "compare favorably with historical
outcomes." Please tell us
whether you conducted studies of inodiftagene on a head to head basis.
If not, please
remove this comparison from your disclosure or tell us why you believe
this comparison
is appropriate. Please also explain how the results of your trials
compare favorably "with
regulatory guidance in this field."
5. Please substantiate your statement in the second paragraph on page 2
that "[b]oth of these
studies have been reviewed by the FDA and other international
regulatory bodies, who
have stated that either or both will support regulatory approval."
Please also describe the
FDA review process and how this relates to the broader FDA approval
process.
Our Pipeline, page 2
6. Please add columns in your pipeline here and on page 54 to show all
phases of the FDA
approval process.
Our Growth Strategy, page 6
7. We note your disclosure that "[r]egulatory agencies in the European
Union and Canada
have also reviewed our pivotal program, and concurred that our trials
will support
approval." Please disclose whether any of your product candidates have
already received
approval in the European Union and Canada. In addition, please delete
the statement that
you "believe that regulatory approval will follow from the studies
meeting their primary
endpoints."
Implications of Being an Emerging Growth Company, page 8
8. Please provide us with copies of all written communications, as
defined in Rule 405
Frank G. Haluska
FirstNameTherapeutics Ltd.G. Haluska
Anchiano LastNameFrank
Comapany NameAnchiano Therapeutics Ltd.
October 25, 2018
October 25, 2018 Page 3
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FirstName LastName
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.
Risk Factors
If serious adverse or undesirable side effects are identified, page 17
9. Please disclose the serious adverse events experienced by the patients
in the trial.
Use of Proceeds, page 38
10. We note your disclosure that you intend to use the proceeds of this
offering to further the
development of your pipeline projects, general research and
development and for general
corporate purposes. Please specify how far in the development of your
pipeline projects
you expect to reach with the proceeds of the offering. If any material
amounts of other
funds are necessary to accomplish the specified purposes, state the
amounts and sources of
other funds needed for each specified purpose and the sources. Refer
to Instruction 3 to
Item 504 of Regulation S-K.
Business
We have positive FDA input on our pivotal development program, page 57
11. We note your disclosure regarding obtaining special protocol
assessment from the FDA.
Please balance your disclosure in this section by stating that the
existence of an SPA
agreement does not guarantee that your trial results will be adequate
to support approval.
Inodiftagene Clinical Trial Experience, page 59
12. Please disclose and quantify all adverse effects and severe adverse
effects referenced on
page 60, in the Phase 1/2 Study on page 62, and in the Phase 2 study
on page 63.
Government Regulation
Special Protocol Assessment, page 73
13. Please clarify that the SPA agreement does not imply that FDA has
reviewed or concurs
with protocol details that do not affect approvability or guarantee
that a marketing
application will be filed or approved, even if the trial is conducted
in accordance with the
protocol.
Notes to the Consolidated Financial Statements
NOTE 2--BASIS OF PREPARATION
A. Statement of compliance, page F-9
14. We note that you do not indicate here whether the financial statements
comply with IFRS
as issued by the IASB. Please tell us, and revise your disclosure here
to clarify this fact.
Frank G. Haluska
Anchiano Therapeutics Ltd.
October 25, 2018
Page 4
NOTE 3--SIGNIFICANT ACCOUNTING POLICIES
I. Grants for participation in research and development expenses, page F-13
15. With regard to the grants from the Israel Innovation Authority (IIA),
please tell us why
these amounts are accounted for as forgivable loans according to IAS 20.
Cite the
relevant stipulations that indicate that such grants can be waived. In
your response,
specifically tell us whether the intellectual property underlying the
research and
development (R&D) supported by these grant must be transferred to the IIA
or other
government agency if you abandon the R&D or otherwise cannot generate
product or
licensing revenues from the R&D.
Condensed Consolidated Interim Financial Statements:
Notes to the Condensed Consolidated Interim Financial Statements
NOTE 4--SIGNIFICANT EVENTS DURING THE REPORT PERIOD, page F-39
16. With respect to C. and F., please disclose the inputs used to value the
shares and options
discussed in these sub-notes. Additionally, please disclose how you
accounted for these
transactions.
17. With respect to E., please clarify for us, and in your disclosure, the
nature of the
"additional rights" granted the investors and your accounting therefor.
Part II
Item 8. Exhibits and Financial Statement Schedules, page II-4
18. Please file the following agreements as exhibits to your registration
statement or tell us
why you believe the respective agreement is not material to you:
2017 Share Option Plan disclosed on page 92;
employment agreements with your executive officers disclosed on page
95; and
clinical research agreement with Syneos Health disclosed on pages 50
and F-32.
You may contact Tabatha McCullom at (202) 551-3658 or Mark Brunhofer at
(202) 551-
3638 if you have questions regarding comments on the financial statements and
related
matters. Please contact Tonya Aldave at (202) 551-3601 or J. Nolan McWilliams,
Attorney-
Advisor, at (202) 551-3217 with any other questions.
Sincerely,
FirstName LastNameFrank G. Haluska
Division of
Corporation Finance
Comapany NameAnchiano Therapeutics Ltd.
Office of
Healthcare & Insurance
October 25, 2018 Page 4
cc: Anna T. Pinedo
FirstName LastName