SEC Comment Letter for Addex Therapeutics Ltd. (ADXN) (CIK 0001574232) (ADXN) — Oct 24, 2019
Addex Therapeutics Ltd. (ADXN) (CIK 0001574232)
Date: Oct. 24, 2019 · CIK: 0001574232 · Accession: 0000000000-19-014823
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October 23, 2019
Tim Dyer
Chief Executive Officer
Addex Therapeutics Ltd.
Chemin des Mines 9,
CH-1202 Geneva,
Switzerland
Re:Addex Therapeutics Ltd.
Draft Registration Statement on Form F-1
Submitted September 24, 2019
CIK No. 0001574232
Dear Mr. Dyer:
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
Cover Page
1.We note your disclosure that the last reported sale price of your ordinary shares on SIX
was CHF 1.51 per share, equivalent to $ 1.47 per share or $__ per ADS. You may use the
most recent home market trading price, converted to U.S. dollars at the most recent
exchange rate, assuming the U.S. IPO price will be substantially similar to the home
market trading price. If you expect that the U.S. IPO price will not be substantially similar
to the home market trading price, please disclose on the prospectus cover page a bona fide
price range of the offered securities. If you intend to price the securities based on the
SIX market price, you may disclose a percentage range based on that price (for example,
FirstName LastNameTim Dyer
Comapany NameAddex Therapeutics Ltd.
October 23, 2019 Page 2
FirstName LastNameTim Dyer
Addex Therapeutics Ltd.
October 23, 2019
Page 2
10% of the home market price) within which you intend to price the securities. See Item
501(b)(3) of Regulation S-K.
Prospectus Summary, page 1
2.The prospectus summary should include a balanced presentation of your business,
including your competitive position in the industry. Given the current state of
development of your product candidates, it does not appear that you have a basis for your
statement that you have a "leading position in allosteric modulation" and other similar
statements of leadership throughout the prospectus. Please revise. Also balance your
summary by providing equally prominent disclosure about the competitive and regulatory
challenges you face.
3.Please revise your statements here and elsewhere in the prospectus that certain of your
product candidates are potentially "first-in-class" and "best-in-class." These statements
imply an expectation of regulatory approval and are inappropriate given the length of time
and uncertainty with respect to securing marketing approval.
Product Pipeline, page 2
4.Your pipeline appears to include every in-house development program as well as certain
programs that are licensed to other entities for development. Please revise the table to
include only those programs that are material to the company. If you believe that every
program listed is material, please provide us with an analysis explaining your belief. In
particular, to the extent that your programs in the lead optimization stage are material to
the company, please discuss this in your analysis. Please also revise to limit your pipeline
table to product candidates in which you have a role in developing or commercializing.
5.We note several references to statistically significant results here and elsewhere in the
prospectus. Please explain whether statistical significance is relevant to the
evidentiary standards for drug approval in the jurisdictions where you seek approval of
your product candidates.
6.We note your disclosure that Janssen has announced that ADX71149 demonstrated
synergistic efficacy with levetiracetam in preclinical models of epilepsy. Please explain
what is meant by "synergistic efficacy." We also note your statements on page 73 that
your GABAB PAM drug candidates have demonstrated "excellent preclinical efficacy"
and have also "proven efficacy." Efficacy is a determination that is solely within the
authority of the FDA or similar foreign regulators. You may present clinical trial end
points and objective data resulting from trials without concluding efficacy. Please revise
these statements.
Implications of Being an Emerging Growth Company and a Foreign Private Issuer, page 6
7.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,
FirstName LastNameTim Dyer
Comapany NameAddex Therapeutics Ltd.
October 23, 2019 Page 3
FirstName LastNameTim Dyer
Addex Therapeutics Ltd.
October 23, 2019
Page 3
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Business, page 53
8.We note your disclosure in this section that your Phase 2a proof of concept clinical trial of
dipraglurant in PD-LID "illustrated safety" and that dipraglurant exhibited an "acceptable
safety profile" in a clinical trial. Safety is a determination that is solely within the
authority of the FDA or similar foreign regulators. You may state that your product
candidates have been well tolerated if true. Please revise such statements.
Our Product Candidates
Dipraglurant, page 61
9.Please explain what you mean by your registration clinical trial for dipraglurant will be
"fully powered."
10.Please disclose the source for the information regarding levodopa in Figure 1 on page 62.
Outcome Measures, page 64
11.Please disclose what ECG stands for in this section.
12.Please expand to provide the basis for the statement following Figure 5 that a 30%
reversal in peak mAIMS scores is acknowledged as being clinically meaningful.
Safety and Tolerability Data, page 67
13.Please revise to make clear that all treatment-emergent serious adverse events have been
disclosed, and expand your disclosure as necessary.
UDysRS, the Primary Endpoint, page 70
14.We note your disclosure that the "the objective assessment by the rater included in the
UDysRS, should favor dipraglurant in study 301." Please revise this statement to remove
any implication that you will achieve favorable results.
mGlu2 NAM for the treatment of mild cognitive impairment, page 75
15.We note your statement that you believe you are developing "the most advanced subtype
selective mGlu2 NAM." Please delete this statement given the early stage of development
of this candidate.
Material agreements, page 77
16.For both material agreements discussed in this section, please disclose the duration of the
agreement, the royalty term and the termination provisions.
FirstName LastNameTim Dyer
Comapany NameAddex Therapeutics Ltd.
October 23, 2019 Page 4
FirstName LastNameTim Dyer
Addex Therapeutics Ltd.
October 23, 2019
Page 4
Intellectual Property
Patents and Proprietary Rights, page 78
17.For each patent family, please disclose the applicable jurisdictions for your granted
patents to the extent that you have not already done so.
Principal Holders, page 101
18.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by Addex Pharma SA, Growth Equity
Opportunities Fund IV, LLC, New Leaf Biopharma Opportunities I, L.P. and CS (CH)
Small Cap Switzerland Equity Fund.
Financial Statements
Notes to Financial Statements
13. Revenue from contract with customer
License & research agreement with Indivior PLC, page F-30
19.You concluded that "The contract contained two distinct performance obligations, the
provision of a license to intellectual property (IP) and the provision of research services to
discover novel GABAB PAM compounds" and the full upfront payment of CHF 5 million
was allocated to the right-of-use license of intellectual property based on the stand-alone
selling price and was recorded when the right to use the IP was transferred in January
2018. Please explain to us how you considered that because it appears Indivior cannot
benefit from the license without the research services, you did not conclude that the
license and the research services are not capable of being distinct, and the promises should
be accounted for as a combined performance obligation. Our understanding is that
Indivior has not selected drug candidates yet.
General
20.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Vanessa Robertson at 202-551-3649 or Lisa Vanjoske at 202-551-3614
if you have questions regarding comments on the financial statements and related
matters. Please contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-
3625 with any other questions.
FirstName LastNameTim Dyer
Comapany NameAddex Therapeutics Ltd.
October 23, 2019 Page 5
FirstName LastName
Tim Dyer
Addex Therapeutics Ltd.
October 23, 2019
Page 5
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Joshua A. Kaufman, Esq.