DRSLTR 1 filename1.htm

 

 

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December 23, 2020

 

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance 100 F Street, N.E.

Washington, D.C. 20549

Attn: Christine Westbrook and Mary Beth Breslin

 

Re:Biophytis SA
  Draft Registration Statement on Form F-1
  Submitted on November 20, 2020
  CIK No. 0001768946

 

Dear Ms. Sarmento and Mr. Buchmiller:

 

On behalf of our client, Biophytis SA (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) issued in its letter dated December 17, 2020 (the “Comment Letter”) relating to the above-referenced Draft Registration Statement on Form F-1 (the “Registration Statement”). We are concurrently submitting via EDGAR this letter and a revised draft of the Registration Statement (the “Revised Registration Statement”).

 

Set forth below in bold are comments from the Comment Letter. For your convenience, each of the numbered paragraphs below corresponds to the numbered comment in the Comment Letter and includes the caption used in the Comment Letter. Immediately following each comment is the Company’s response to that comment, including, where applicable, a cross-reference to the location of changes made in the Revised Registration Statement in response to the Staff’s comment. All page references in the responses set forth below refer to page numbers in the Revised Registration Statement. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in the Revised Registration Statement.

 

Draft Registration Statement on Form F-1 Prospectus Summary

 

Our Clinical Pipeline, page 4

 

1.Please shorten the lines for BIO101 for the Sarcopenia and COVID-19 indications to reflect that you have not completed Phase 2 clinical trials yet. Please also shorten the line for BIO101 for the DMD indication to reflect that you have not yet begun the Phase 1 clinical trial and shorten the line for BIO201 for the dry AMD indication since you are still conducting animal studies to support IND and clinical trial applications. We also note that you have included in your pipeline table BIO201 for the treatment of Stargardt disease. Given the early-stage development of this program, please explain why you believe it is sufficiently material to your business to warrant inclusion in your pipeline table.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the pipeline diagram on page 4 of the Revised Registration Statement to more clearly reflect the current stage of each clinical trial.

 

 

 

 

Securities and Exchange Commission
December 23, 2020
Page 2

  

The Company believes that Sarconeos (BIO101) development in Stargardt disease is material enough to be included in the pipeline as it is the result of 10+ years of research and underscores the Company’s strategy to develop drugs in genetic, orphan diseases, in addition to its primary focus on age related diseases (i.e., dry AMD in this case) and its ongoing research in cellular and animal models of Stargardt disease.

 

Implications of Being an "Emerging Growth Company", page 12

 

2.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.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it agrees to provide copies of all written communication as requested above.

 

We have benefited from certain reimbursable financial advances and non-reimbursable subsidies from the French government, page 22

 

3.Please revise to disclose the contractual conditions that you are required to comply with in order to receive the financial advances and subsidies from the French government and the maximum amount that you would have to reimburse the French government should you fail to comply.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the description of the reimbursable financial advances and non-reimbursable subsidies it receives from the French government on page 22 of the Revised Registration Statement to describe the contractual conditions that it is required to comply with in order to receive these financial advances and subsidies and the maximum amount that would have to be reimbursed to the French government should the Company fail to comply.

 

 

 

 

Securities and Exchange Commission
December 23, 2020
Page 3

 

The Public Company Accounting Oversight Board, or PCAOB, is currently unable to inspect the audit work and practices..., page 65

 

4.Please enhance your risk factor by disclosing that this lack of inspection prevents the PCAOB from regularly evaluating your auditor’s audits and its quality control procedures.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the risk factor regarding the PCAOB’s inability to inspect the audit work and practices of auditors operating in France, including our auditor, on page 65 of the Revised Registration Statement, to explain that the current inability of the PCAOB to conduct inspections of auditors in France makes it more difficult to evaluate the effectiveness of our auditor's audit procedures or quality control procedures as compared to auditors outside France that are subject to PCAOB inspections.

 

Use of Proceeds, page 80

 

5.Please revise to disclose how far you intend to get in the development of Sarconeos in DMD using the proceeds of this offering and clarify exactly where you are in the process. For example, we note your disclosure here that you will use the proceeds to commence your development of Sarconeos in DMD while your pipeline table appears to indicate that you are in Phase 2 for this indication and the Summary indicates that you hope to begin a Phase 1 trial in the first half of 2021.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the “Use of Proceeds” section on page 79 of the Revised Registration Statement to clarify that the Company intends to use the proceeds from the offering to commence development of Sarconeos in DMD (with the enrollment of the first patient in this trial). The Company has also updated other references to this clinical trial throughout the Revised Registration Statement to clarify that it expects to commence its Phase 1 trial for DMD in the first half of 2021, subject to COVID-19 conditions.

 

Capitalization, page 83

 

6.Please disclose the amount of each adjustment shown within the second bullet point that you used to determine the pro forma amounts in the table.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the second bullet on page 82 of the Revised Registration Statement to disclose the amount of each adjustment shown within this bullet.

 

Dilution, page 86

 

7.Please show us how you determined your historical and pro forma net tangible book value, including how you considered your intangible assets.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has provided on Exhibit A its calculation of historical and pro forma net tangible book value.

 

 

 

 

Securities and Exchange Commission
December 23, 2020
Page 4

 

Business

 

Sarcopenia (the SARA clinical program), page 117

 

8.We note your disclosure that you believe that Sarconeos has the potential to achieve clinically relevant functional mobility endpoints necessary for marketing approval based on the potential mechanism-of-action and your preclinical cellular and animal model data. Please remove this statement as it is speculative given your current stage of development.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has removed this statement from the Revised Registration Statement.

 

Potential Mechanism-of-Action, page 122

 

9.We note your disclosure that Sarconeos can be used in most elderly patients even in those suffering from hypertension controlled with ACE inhibitors or ARBs since it did not show an effect on blood pressure or heart rate when compared to enalapril in preclinical studies. Please revise this statement to avoid making a conclusion about the effects of your product candidate given its current stage of development.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has removed this statement from the F-1.

 

Research and Collaboration Agreements with Sorbonne University and Other Academic Research Institutions, page 146

 

10.Please revise to clarify whether the royalty term for the S-Commercialization Agreement and the M-Commercialization Agreement end upon termination of the agreements.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the descriptions of the S-Commercialization Agreement and M-Commercialization Agreement on page 146 of the Revised Registration Statement to clarify that the payments made under the S-Commercialization Agreement and M-Commercialization Agreement will end upon the termination of these agreements.

 

Current Intellectual Property Portfolio, page 147

 

11.We note your disclosure that an opposition procedure is currently being pursued regarding Patent No. EP2790706 and that this could lead to cancellation of the patent. Please revise to disclose if you expect the potential cancellation of this patent to have any material impact on your development plans for your product candidates, your patent portfolio and your business.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the description of the opposition procedure regarding Patent No. EP2790706 on page 150 of the Revised Registration Statement to explain that the Company does not expect the potential cancellation of this patent to have any material impact on the Company’s development plans for its product candidates, its patent portfolio or its business.

 

 

 

 

Securities and Exchange Commission
December 23, 2020
Page 5

 

Commercialization/License Agreements, page 150

 

12.We note that you intend to file one amendment to the S-Commercialization Agreement as Exhibit 10.6. Your disclosure here indicates that another amendment was entered into on November 6, 2020. Please also file the November amendment.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the exhibit index of the Revised Registration Statement to include the amendment to the S-Commercialization Agreement that was entered into on November 6, 2020 and will file this agreement by amendment to the Revised Registration Statement.

 

Intellectual Property Agreement with Stanislas Veillet, page 151

 

13.We note that payments to Mr. Veillet are capped per platform. Please briefly explain in this section how the term "platform" is defined in the agreement. Please also revise to disclose the term of the agreement and the termination provisions.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the description of the Intellectual Property Agreement with Stanislas Veillet on page 152 of the Revised Registration Statement to explain how “platform” is defined under this agreement.

 

Chief Executive Officer Compensation, page 178

 

14.We note that Mr. Veillet benefits from a "GSC" private unemployment insurance policy. Please briefly explain what GSC means in this section.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has included a description of “GSC” on page 179 of the Revised Registration Statement.

 

Differences in Corporate Law, page 201

 

15.We note that you refer shareholders to Delaware law and French law. It is not appropriate to qualify your disclosure by reference to information that is not included in the filing or filed as an exhibit. Please revise accordingly.

 

The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has removed this statement from the Revised Registration Statement.

 

 

 

 

Securities and Exchange Commission
December 23, 2020
Page 6

 

Should you have any questions concerning any of the foregoing, please contact me by telephone at (212) 549-0393.

 

  Sincerely,
   
  /s/ Aron Izower
  Reed Smith LLP

 

cc: Stanislas Veillet, Ph.D.  
  Chairman and Chief Executive Officer of  
  Biophytis SA  

 

 

 

 

Securities and Exchange Commission
December 23, 2020
Page 7

 

Exhibit A

 

Calculation of Historical and Pro Forma Net Tangible Book Value

 

 

 

 

BIOPHYTIS

DILUTION COMPUTATION AS OF DECEMBER 16, 2020

 

Statement of financial position from

June 30, 2020 IFRS accounts

 

(amounts in thousands of euros)  JUNE
30, 2020
      Items to be included in the net tangible book value     Net tangible book value as of June 30, 2020      Impact of proceeds on cash   Impact of the issuance of shares on equity   Impact of issuance of debt (redemption value)   Impact of conversions on June 30, 2020 existing liabilities (IFRS value)  Impact of bonds conversions (bonds issued in H2) (redemption value)   Net tangible book value as of June 30, 2020 as adjusted   
ASSETS                                                  
Patents and software   2,586      No     0                             0   
Property, plant and equipment   134      Yes     134                             134   
Other non-current financial assets   371      Yes     371                             371   
Total non-current assets   3,091                                              
                                               0   
Other receivables   3,319      Yes     3,319                             3,319   
Other current financial assets   255      Yes     255                             255   
Cash and cash equivalents   12,183      Yes     12,183       19,186                     31,369   
Total current assets   15,757                                              
                                                   
TOTAL ASSETS   18,848      Total tangible assets in euros     16,262       19,186    0    0   0   0   35,448   
                                                   
                                                   
LIABILITIES AND SHAREHOLDERS' EQUITY                                                  
Shareholders' equity                                                  
Share capital   10,967      No     0            9,000                0   
Premiums related to the share capital   7,163      No     0            13,436                0   
Treasury shares   -42      No     0                             0   
Foreign currency translation adjustment   -78      No     0                             0   
Accumulated deficit - attributable to shareholders of Biophytis   -12,956      No     0                             0   
Net loss - attributable to shareholders of Biophytis   -9,460      No     0                             0   
Shareholders' equity - attributable to shareholders of Biophytis   -4,406                                              
Non-controlling interests   -32      No     0                             0   
Total shareholders' equity   -4,438      Total equity in euros     N/A       N/A    N/A    N/A   N/A   N/A   N/A   
                                                   
Liabilities                                                  
Employee benefit obligations   139      Yes     139                             139   
Non-current financial liabilities   3,733      Yes     3,733                             3,733   
Total non-current liabilities   3,872                                              
                                                   
Current financial liabilities   7,622      Yes     7,622                 3,000   -2,772   -2,250   5,600   
Provisions   266      Yes     266                             266   
Trade payables   9,595      Yes     9,595                             9,595   
Tax and social liabilities   1,511      Yes     1,511                             1,511   
Derivative financial instruments   198      Yes     198                             198   
Other creditors and miscellaneous liabilities   222      Yes     222                             222   
Total current liabilities   19,414                                              
           Total liabilities in euros     23,286       0    0    3,000   -2,772   -2,250   21,264   
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY   18,848                                              
           Net tangible book value in euros     -7,024       19,186    0    -3,000   2,772   2,250   14,184   
           Assuming foreign exchange rate of   $ 1.12  per Euro                        $ 1.12  per Euro
           Net tangible book value in usd     -7,867                             15,886   
                                                   
           Number of shares     54,834,978            45,002,456                99,837,434   
                                                   
        Net tangible book value per shares in euros        -0.13                             0.14   
        Net tangible book value per shares in usd        -0.14                             0.16   
                                                   
                                                   
              H2 2020 Private Placements          16,140    16,140                    
              H2 2020 Warrant Conversions          46    46                    
              Conversion of Bonds               6,250                    
              Issuance of bonds          3,000                         
                         19,186    22,436