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Letter Text
InflaRx N.V.
Awaiting Response
0 company response(s)
High
InflaRx N.V.
Response Received
1 company response(s)
High - file number match
↓
InflaRx N.V.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-07-06
InflaRx N.V.
Summary
Generating summary...
↓
InflaRx N.V.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-15
InflaRx N.V.
Summary
Generating summary...
↓
InflaRx N.V.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2018-05-01
InflaRx N.V.
Summary
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↓
↓
InflaRx N.V.
Response Received
6 company response(s)
High - file number match
Company responded
2017-10-18
InflaRx N.V.
References: July 20, 2017
Summary
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↓
SEC wrote to company
2017-10-25
InflaRx N.V.
Summary
Generating summary...
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Company responded
2017-10-26
InflaRx N.V.
References: October 25, 2017
Summary
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Company responded
2017-10-30
InflaRx N.V.
References: October 27, 2017
Summary
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Company responded
2017-10-31
InflaRx N.V.
References: October 30, 2017
Summary
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↓
InflaRx N.V.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-10-31
InflaRx N.V.
Summary
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InflaRx N.V.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-10-27
InflaRx N.V.
Summary
Generating summary...
InflaRx N.V.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-09-21
InflaRx N.V.
Summary
Generating summary...
↓
Company responded
2017-10-13
InflaRx N.V.
References: September 21, 2017
Summary
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InflaRx N.V.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-08-16
InflaRx N.V.
Summary
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InflaRx N.V.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-07-21
InflaRx N.V.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-11 | SEC Comment Letter | InflaRx N.V. | Netherlands | 001-38283 | Read Filing View |
| 2025-06-03 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2025-05-22 | SEC Comment Letter | InflaRx N.V. | Netherlands | 001-38283 | Read Filing View |
| 2023-07-07 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2023-07-06 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2020-07-16 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2020-07-15 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2018-05-02 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2018-05-02 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2018-05-01 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-11-03 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-11-03 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-31 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-31 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-30 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-27 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-26 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-25 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-18 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-13 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-09-21 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-08-16 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-07-21 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-11 | SEC Comment Letter | InflaRx N.V. | Netherlands | 001-38283 | Read Filing View |
| 2025-05-22 | SEC Comment Letter | InflaRx N.V. | Netherlands | 001-38283 | Read Filing View |
| 2023-07-06 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2020-07-15 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2018-05-01 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-31 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-27 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-25 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-09-21 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-08-16 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-07-21 | SEC Comment Letter | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-03 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2023-07-07 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2020-07-16 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2018-05-02 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2018-05-02 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-11-03 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-11-03 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-31 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-30 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-26 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-18 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
| 2017-10-13 | Company Response | InflaRx N.V. | Netherlands | N/A | Read Filing View |
2025-06-11 - UPLOAD - InflaRx N.V. File: 001-38283
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 11, 2025 Thomas Taapken Chief Financial Officer InflaRx N.V. Winzerlaer Str. 2 07745 Jena, Germany Re: InflaRx N.V. Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-38283 Dear Thomas Taapken: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-06-03 - CORRESP - InflaRx N.V.
CORRESP 1 filename1.htm InflaRx N.V. Winzerlaer Str. 2 07745 Jena, Germany June 3, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tracie Mariner and Jenn Do Re: InflaRx N.V. Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-38283 Dear Ms. Mariner and Ms. Do: This letter sets forth the response of InflaRx N.V. (the “ Company ”) to the comment letter dated May 22, 2025 from the staff of the Division of Corporate Finance (the “ Staff ”) of the U.S. Securities and Exchange Commission regarding the Company’s annual report for fiscal year ended December 31, 2024 on Form 20-F, filed on March 20, 2025 (File No. 001-38283) (“ Form 20-F ”), transmitted to Thomas Taapken, Chief Financial Officer of the Company. For your convenience, set forth below is the text of the Staff’s comment and the Company’s response thereto. Form 20-F for Fiscal Year Ended December 31, 2024 Operating and Financial Review and Prospects Results of operations Comparison of the years ended December 31, 2024 and 2023 Research and development expenses, page 96 1. Staff’s comment : We note from your disclosures, as well as the pipeline table on page 59, that vilobelimab and INF904 are each in clinical development for two or more indications. Considering the significant research and development expenses you have historically incurred and expect to continue to incur, please provide revised disclosure in future filings to disclose the costs incurred during each period presented for each of your key product candidates by indication. If you do not track your research and development costs by candidate and/or indication, disclose that fact and explain why you do not maintain and evaluate research and development costs by candidate and/or indication and, in this case, break out external research and development costs by clinical and pre-clinical. In this regard, we note the disclosure on page F-20 of the makeup of your third-party services expenses which includes aggregated costs attributable to clinical and pre-clinical studies. If you cannot disaggregate these amounts, please disclose that fact and explain why not. Include draft disclosure with your response. Response : The Company respectfully acknowledges the Staff’s comment. Currently, the Company’s internal tracking system allows it to disaggregate research and development (“ R&D ”) expenses by key product candidate, but not by indication. In future filings, the Company will disclose third-party and other R&D expenses incurred during each reporting period for each key product candidate. The Company cannot disaggregate R&D expenses by indication in a reliable manner due to the nature of the Company’s clinical development activities. As the Company’s key product candidates are currently in early and mid-stages of clinical development, certain of the Company’s significant R&D activities, including pharmacology, toxicology, metabolism, formulation and several other studies, are performed for the benefit of advancing a product candidate across a range of different future clinical indications and not on an indication-by-indication basis. The Company advises the Staff that it is not currently pursuing pre-clinical development of any potentially key product candidates. However, if the Company engages in pre-clinical development of a potentially key product candidate in the future, the Company will evaluate the relevance of breaking out external R&D costs by pre-clinical and clinical costs at such time. Below is the draft R&D expenses table the Company intends to include in its future filings. In addition to such quantitative disclosure, the Company intends to include narrative disclosure highlighting any qualitative period-to-period insights of management related to the R&D expenses of its key product candidates on a disaggregated basis. [Current Period] [Prior Period] Change (in €) Third-party expenses thereof for vilobelimab thereof for INF904 thereof for unallocated Personnel expenses Legal and consulting fees Other expenses thereof for vilobelimab thereof for INF904 thereof for unallocated Total We hope that the foregoing has been responsive to the Staff’s comment. If you have any questions, please contact Sophia Hudson, P.C. at (212) 446-4750 or Leia Pearl Andrew at (212) 390-4313, each of Kirkland & Ellis LLP, counsel to the Company. Sincerely, InflaRx N.V. By: /s/ Thomas Taapken Name: Thomas Taapken Title: Chief Financial Officer cc: Sophia Hudson, P.C. Leia Pearl Andrew Kirkland & Ellis LLP 2
2025-05-22 - UPLOAD - InflaRx N.V. File: 001-38283
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 22, 2025 Thomas Taapken Chief Financial Officer InflaRx N.V. Winzerlaer Str. 2 07745 Jena, Germany Re: InflaRx N.V. Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-38283 Dear Thomas Taapken: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 20-F for Fiscal Year Ended December 31, 2024 Operating and Financial Review and Prospects Results of operations Comparison of the years ended December 31, 2024 and 2023 Research and development expenses, page 96 1. We note from your disclosures, as well as the pipeline table on page 59, that vilobelimab and INF904 are each in clinical development for two or more indications. Considering the significant research and development expenses you have historically incurred and expect to continue to incur, please provide revised disclosure in future filings to disclose the costs incurred during each period presented for each of your key product candidates by indication. If you do not track your research and development costs by candidate and/or indication, disclose that fact and explain why you do not maintain and evaluate research and development costs by candidate and/or indication and, in this case, break out external research and development costs by clinical and pre-clinical. In this regard, we note the disclosure on page F-20 of the makeup of your third-party services expenses which includes aggregated costs attributable to clinical and pre-clinical studies. If you cannot disaggregate these amounts, please disclose that May 22, 2025 Page 2 fact and explain why not. Include draft disclosure with your response. In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tracie Mariner at 202-551-3744 or Jenn Do at 202-551-3743 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2023-07-07 - CORRESP - InflaRx N.V.
CORRESP
1
filename1.htm
InflaRx N.V.
Winzerlaer Str. 2
07745 Jena, Germany
July 7, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
InflaRx N.V.
Registration Statement on Form F-3
Filing Date June 30, 2023
File No. 333-273058
REQUEST FOR ACCELERATION OF EFFECTIVENESS
Pursuant to Rule 461 under the Securities Act of 1933, as amended, InflaRx N.V. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form F-3 (the “Registration Statement”), File No.
333-273058, to 9:30 a.m., Eastern Time, on July 11, 2023, or as soon thereafter as practicable.
Please contact Sophia Hudson of Kirkland & Ellis LLP, counsel to the Company, at (212) 446-4750 as soon as the Registration Statement has been declared effective, or if you have any other questions or concerns regarding this matter.
Sincerely,
/s/ Niels Riedemann
Niels Riedemann
Chief Executive Officer
2023-07-06 - UPLOAD - InflaRx N.V.
United States securities and exchange commission logo
July 6, 2023
Niels Riedemann
Chief Executive Officer
InflaRx N.V.
Winzerlaer Str. 2
07745 Jena, Germany
Re:InflaRx N.V.
Registration Statement on Form F-3
Filed June 30, 2023
File No. 333-273058
Dear Niels Riedemann:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, P.C.
2020-07-16 - CORRESP - InflaRx N.V.
CORRESP
1
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InflaRx N.V.
Winzerlaer Str. 2
07745 Jena, Germany
July 16, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
InflaRx N.V.
Registration Statement on Form F-3
Filing Date July 8, 2020
File No. 333-239759
REQUEST FOR ACCELERATION OF EFFECTIVENESS
Pursuant to Rule 461 under the Securities Act of 1933, as amended, InflaRx N.V. (the “Company”) hereby requests acceleration of the effective
date of its Registration Statement on Form F-3 (the “Registration Statement”), File No. 333-239759, to 4:30 p.m., Eastern Time, on July 17, 2020, or as soon thereafter as practicable.
Please contact Sophia Hudson of Kirkland & Ellis LLP, counsel to the Company, at (212) 446-4750 as soon as the Registration Statement has been declared
effective, or if you have any other questions or concerns regarding this matter.
Sincerely,
/s/ Niels Riedemann
Niels Riedemann
Chief Executive Officer
2020-07-15 - UPLOAD - InflaRx N.V.
United States securities and exchange commission logo
July 15, 2020
Niels Riedemann
Chief Executive Officer
InflaRx N.V.
Winzerlaer Str. 2
07745 Jena, Germany
Re:InflaRx N.V.
Registration Statement on Form F-3
Filed July 8, 2020
File No. 333-239759
Dear Mr. Riedemann:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at (202) 551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, P.C.
2018-05-02 - CORRESP - InflaRx N.V.
CORRESP
1
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May
2, 2018
United
States Securities and Exchange Commission
Division
of Corporate Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Ms. Ada D. Sarmento
Ms. Erin Jaskot
Re:
InflaRx
N.V.
Registration
Statement on Form F-1 (SEC File No. 333-224596)
Dear
Ms. Sarmento and Ms. Jaskot:
In
connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended
(the “Act”), we hereby join in the request of InflaRx N.V. that the effective date of the Registration Statement be
accelerated so that it will be declared effective at 4:00 p.m., Eastern time, on May 3, 2018 or as soon thereafter as practicable.
Pursuant
to Rule 460 under the Act, please be advised that we have distributed 1,020 copies of the Preliminary Prospectus dated May
2, 2018 (the “Preliminary Prospectus”) through the date hereof, to underwriters, dealers, institutions and
others.
(Signature
page follows)
J.P.
MORGAN SECURITIES LLC
LEERINK
PARTNERS LLC
BMO
CAPITAL MARKETS CORP.
For
themselves and as representatives of the syndicate of
underwriters
for the offering
J.P.
MORGAN SECURITIES LLC
By:
/s/ David Ke
Authorized Signatory
LEERINK
PARTNERS LLC
By:
/s/ Jack Fitzgerald
Authorized Signatory
BMO
CAPITAL MARKETS CORP.
By:
/s/ Mihir Mantri
Authorized Signatory
2018-05-02 - CORRESP - InflaRx N.V.
CORRESP
1
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InflaRx N.V.
Winzerlaer Str. 2
07745 Jena, Germany
May 2, 2018
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628
Attn: Ms. Ada D. Sarmento
Ms. Erin Jaskot
Re:
InflaRx N.V.
Registration Statement on Form F-1
Registration No. 333-224596
Dear Ms. Sarmento and Ms. Jaskot:
Pursuant to Rule 461 under the Securities Act of 1933, as amended,
the undersigned registrant hereby requests that the effective date for the Registration Statement referred to above be accelerated
so that it will be declared effective at 4:00 p.m. Eastern Daylight Time on May 3, 2018 or as soon thereafter as is practicable.
By separate letter, the underwriters of the issuance of the securities being registered join in this request for acceleration.
Please do not hesitate to contact Sophia Hudson of Davis Polk
& Wardwell LLP at (212) 450-4762 with any questions or comments with respect to this letter.
[Signature Page Follows]
Sincerely,
INFLARX N.V.
By:
/s/ Niels Riedemann
Name: Niels Riedemann
Title: Chief Executive Officer
Via EDGAR
CC: Sophia Hudson, Davis Polk & Wardwell LLP
2018-05-01 - UPLOAD - InflaRx N.V.
May 1, 2018
Niels Riedemann
Chief Executive Officer
InflaRx N.V.
Winzerlaer Str. 2
07745 Jena, Germany
Re:InflaRx N.V.
Draft Registration Statement on Form F-1
Submitted April 23, 2018
CIK No. 0001708688
Dear Mr. Riedemann:
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 number of shares offered by the company will be
determined based on the public offering price per common share. Please revise your filing
to disclose the number of shares of common stock to be offered. Please also tell us
whether you will use the recent stock price listed on the prospectus cover page to
determine the offering price of the common stock. If not, please include disclosure on the
cover page indicating the method by which the offering price will be determined. For
guidance concerning disclosure of the principal amount of securities to be offered, please
FirstName LastNameNiels Riedemann
Comapany NameInflaRx N.V.
June 16, 2017 Page 2
FirstName LastName
Niels Riedemann
InflaRx N.V.
May 1, 2018
Page 2
refer to Question 227.02 of the Division of Corporation Finance's Securities Act Rules
Compliance and Disclosure Interpretations.
Please contact Ada D. Sarmento at 202-551-3798 or Erin Jaskot at 202-551-3442 with
any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson, Esq.
2017-11-03 - CORRESP - InflaRx N.V.
CORRESP
1
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November
3, 2017
VIA
EDGAR AND E-MAIL
United States Securities and
Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington,
D.C. 20549-6010
Attention: Dorrie Yale
Erin
Jaskot
Re: Fireman B.V.
Public
Offering of Up to 7,667,050 Common Shares
Registration
Statement on Form F-1 (Registration No. 333-220962)
Ladies and
Gentlemen:
In connection
with the above-captioned Registration Statement and offering, we wish to advise you that, pursuant to Rule 460 of the General
Rules and Regulations under the Securities Act of 1933, as amended, the underwriters have distributed approximately 2,425 copies
of the Preliminary Prospectus dated October 30, 2017 through the date hereof, to underwriters, dealers, institutions and others.
We will
comply, and have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.
We hereby
join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated
to 2:00 p.m. Eastern Time, on Tuesday, November 7, 2017 or as soon thereafter as practicable.
[signature
page follows]
Very truly yours,
J.P. MORGAN
SECURITIES LLC
LEERINK
PARTNERS LLC
BMO CAPITAL
MARKETS CORP.
For themselves and as representatives
of the syndicate of underwriters for the offering
By J.P.
Morgan Securities LLC
By:
/s/ David Ke
Authorized Representative
By LEERINK
PARTNERS LLC
By:
/s/ Jack Fitzgerald
Authorized Representative
By BMO
CAPITAL MARKETS CORP.
By:
/s/
Mihir Mantri
Authorized Representative
2017-11-03 - CORRESP - InflaRx N.V.
CORRESP
1
filename1.htm
Fireman B.V.
Winzerlaer Str. 2
07745 Jena, Germany
November 3, 2017
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628
Attn: Ms. Dorrie Yale
Ms. Erin Jaskot
Re:
Fireman B.V.
Registration Statement on Form F-1
Registration No. 333-220962
Dear Ms. Yale and Ms. Jaskot:
Pursuant to Rule 461 under the Securities Act of 1933, as amended,
the undersigned registrant hereby requests that the effective date for the Registration Statement referred to above be accelerated
so that it will be declared effective at 2:00 p.m. Eastern Daylight Time on November 7, 2017 or as soon thereafter as is practicable.
By separate letter, the underwriters of the issuance of the securities being registered join in this request for acceleration.
Please do not hesitate to contact Sophia Hudson of Davis
Polk & Wardwell LLP at (212) 450-4762 with any questions or comments with respect to this letter.
Sincerely,
FIREMAN B.V.
By:
/s/ Niels Riedemann
Name: Niels Riedemann
Title: Chief Executive Officer
Via EDGAR
CC: Sophia Hudson, Davis Polk & Wardwell LLP
2017-10-31 - CORRESP - InflaRx N.V.
CORRESP 1 filename1.htm CORRESP New York Northern California Washington DC São Paulo London Paris Madrid Tokyo Beijing Hong Kong Sophia Hudson Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 212 450 4762 tel 212 450 5800 fax sophia.hudson@davispolk.com October 31, 2017 Re: Fireman B.V. Amendment No. 2 to Registration Statement on Form F-1 Filed October 30, 2017 File No. 333-220962 CONFIDENTIAL Ms. Dorrie Yale Ms. Erin Jaskot Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-3628 Dear Ms. Dorrie Yale and Ms. Erin Jaskot, On behalf of our client, Fireman B.V., a Dutch private company with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) relating to Amendment No. 2 to the Company’s Registration Statement on Form F-1 (the “Registration Statement”) contained in the Staff’s letter dated October 30, 2017 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is publicly filing a revised Registration Statement (“Amendment No. 3”) together with this response letter. We are also sending, under separate cover, a copy of Amendment No. 3 and three marked copies of Amendment No. 3 showing the changes to Amendment No. 2 publicly filed on October 30, 2017. Set forth below are the Company’s responses to the Staff’s comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For convenience, the Staff’s comments are repeated below in italics, followed by the Company’s response to the comments as well as a summary of the responsive actions taken. We have included page numbers to refer to the location in Amendment No. 3 submitted herewith where the revised language addressing a particular comment appears. Capitalized terms used but not defined herein are used herein as defined in Amendment No. 3. Ms. Dorrie Yale Ms. Erin Jaskot Division of Corporation Finance U.S. Securities and Exchange Commission 2 October 31, 2017 Amendment No. 2 to Registration Statement on Form F-1 Summary consolidated historical and other financial information, page 10 1. Pro forma net loss per share should only be presented for the latest year and interim period. Please delete pro forma net loss per share of 2015 and the six months ended June 30, 2016. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 10 of Amendment No. 3 to delete the pro forma net loss per share for the fiscal year ended 2015 and the six months ended June 30, 2016. Dilution, page 78 1. You state in the paragraph following the table on page 79 that “Each $1.00 increase (decrease) in the offering price per share, respectively, would increase (decrease) the total consideration paid by new investors by approximately $6.2 million (€5.4 million) and increase (decrease) the percentage of total consideration paid by new investors by approximately 1.6%, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. Similarly, each increase (decrease) of 1.0 million shares offered by us at the assumed initial public offering price would increase (decrease) the percentage of total consideration paid by new investors by approximately 3.3%.” Tell us why the increase (decrease) in total consideration would not be $6.7 million, 6.7 million shares times $1. Also, provide us your computation of the 1.6% and 3.3% and revise as necessary. Response: The Company’s computation of the total consideration payable by new investors in the event of an increase (decrease) of $1.00 in price per share and 1.0 million increase (decrease) in number of shares sold has been revised to reflect the gross proceeds that would be paid by new investors, as reflected in the table below and on page 79 of Amendment No. 3. In response to the Staff’s comment, the Company has further revised its disclosure on page 79 of Amendment No. 3 as necessary. Percentage of total consideration paid by new investors 50.9 % Percentage of total consideration paid by existing investors 49.1 % Percentage payable by new investors following a $1.00 per share increase in the offering price per share 52.5 % Percent increase (decrease) in total consideration payable by new investors 1.6 % Percentage payable by new investors following a 1.0 million increase in the number of common shares sold in the offering 54.4 % Percent increase (decrease) in total consideration payable by new investors 3.5 % Ms. Dorrie Yale Ms. Erin Jaskot Division of Corporation Finance U.S. Securities and Exchange Commission 3 October 31, 2017 Please do not hesitate to contact me at (212) 450-4762, (212) 450-5800 (fax) or sophia.hudson@davispolk.com if you have any questions regarding the foregoing or if I can provide any additional information. Very truly yours, /s/ Sophia Hudson Sophia Hudson cc: Via E-mail Niels Riedemann, Chief Executive Officer Arnd Christ, Chief Financial Officer Fireman B.V.
2017-10-31 - UPLOAD - InflaRx N.V.
October 30, 2017
Niels Riedemann
Chief Executive Officer
Fireman B.V.
Winzerlaer Str. 2
07745 Jena, Germany
Re:Fireman B.V.
Amendment No. 2 to Registration Statement on Form F-1
Filed October 30, 2017
File No. 333-220962
Dear Mr. Riedemann:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our October 27, 2017 letter.
Amendment No. 2 to Registration Statement on Form F-1
Summary consolidated historical and other financial information, page 10
1.Pro forma net loss per share should only be presented for the latest year and interim
period. Please delete pro forma net loss per share of 2015 and the six months ended June
30, 2016.
Dilution, page 78
2.You state in the paragraph following the table on page 79 that "Each $1.00 increase
(decrease) in the offering price per share, respectively, would increase (decrease) the total
FirstName LastNameNiels Riedemann
Comapany NameFireman B.V.
June 16, 2017 Page 2
FirstName LastName
Niels Riedemann
Fireman B.V.
October 30, 2017
Page 2
consideration paid by new investors by approximately $6.2 million (€5.4 million) and
increase (decrease) the percentage of total consideration paid by new investors by
approximately 1.6%, assuming that the number of shares offered by us, as set forth on the
cover page of this prospectus, remains the same. Similarly, each increase (decrease) of
1.0 million shares offered by us at the assumed initial public offering price would
increase (decrease) the percentage of total consideration paid by new investors by
approximately 3.3%." Tell us why the increase (decrease) in total consideration would
not be $6.7 million, 6.7 million shares times $1. Also, provide us your computation of
the 1.6% and 3.3% and revise as necessary.
You may contact Mark Brunhofer at 202-551-3638 or Lisa Vanjoske at 202-551-3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson
2017-10-30 - CORRESP - InflaRx N.V.
CORRESP 1 filename1.htm CORRESP New York Northern California Washington DC São Paulo London Paris Madrid Tokyo Beijing Hong Kong Sophia Hudson Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 212 450 4762 tel 212 450 5800 fax sophia.hudson@davispolk.com October 30, 2017 Re: Fireman B.V. Amendment No. 1 to Registration Statement on Form F-1 Filed October 26, 2017 File No. 333-220962 CONFIDENTIAL Ms. Dorrie Yale Ms. Erin Jaskot Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-3628 Dear Ms. Dorrie Yale and Ms. Erin Jaskot, On behalf of our client, Fireman B.V., a Dutch private company with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) relating to the Amendment No. 1 to the Company’s Registration Statement on Form F-1 ( “Amendment No. 1”) contained in the Staff’s letter dated October 27, 2017 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is publicly filing a revised Registration Statement ( “Amendment No. 2”) together with this response letter. We are also sending, under separate cover, a copy of Amendment No. 2 (including exhibits) and three marked copies of each of Exhibits 5.1 and 8.1 to Amendment No. 2 showing the changes to such exhibits included with Amendment No. 1 publicly filed on October 26, 2017. Set forth below are the Company’s responses to the Staff’s comments in the Comment Letter. The responses and information below are based on information provided to us by the Company and its counsel. For convenience, the Staff’s comments are repeated below in italics, followed by the Company’s response to the comments as well as a summary of the responsive actions taken. Capitalized terms used but not defined herein are used herein as defined in Amendment No. 2. Ms. Dorrie Yale Ms. Erin Jaskot Division of Corporation Finance U.S. Securities and Exchange Commission 2 October 30, 2017 Amendment No. 1 to Registration Statement on Form F-1 Exhibits 1. We acknowledge the revised Exhibit 5.1 opinion, your response to prior comment 1, and your confirmation that you will file an appropriately unqualified Exhibit 5.1 opinion as an exhibit to a post-effective amendment prior to the closing of the offering. However, based on the definition of “Option Shares,” “Offer Shares,” and “Shares” it continues to be unclear whether the opinion opines on shares of Fireman B.V. or shares of InflaRx N.V. Please file a revised opinion that clearly opines on the issuance of InflaRx N.V. common shares. Response: In response to the Staff’s comment, the Company has filed a revised executed copy of the Exhibit 5.1 opinion with Amendment No. 2 that clearly opines on the issuance of InflaRx N.V.’s common shares. 2. We acknowledge the revised opinions in response to prior comment 3. However, we note that both Exhibit 5.1 and Exhibit 8.1 include language that the communication is “confidential” and that your counsel’s general terms and conditions apply to third parties relying on your counsel’s statements, including a limitation of liability clause. Please remove such language or clarify that this paragraph does not apply to the investors in the offering. Response: In response to the Staff’s comment, the Company has filed revised executed copies of the Exhibit 5.1 opinion and the Exhibit 8.1 opinion with Amendment No. 2 to remove the “confidential” references and references to such counsel’s general terms and conditions applying to third parties relying on such counsel’s statements. Ms. Dorrie Yale Ms. Erin Jaskot Division of Corporation Finance U.S. Securities and Exchange Commission 3 October 30, 2017 Please do not hesitate to contact me at (212) 450-4762, (212) 450-5800 (fax) or sophia.hudson@davispolk.com if you have any questions regarding the foregoing or if I can provide any additional information. Very truly yours, /s/ Sophia Hudson Sophia Hudson cc: Via E-mail Niels Riedemann, Chief Executive Officer Arnd Christ, Chief Financial Officer Fireman B.V.
2017-10-27 - UPLOAD - InflaRx N.V.
October 27, 2017
Niels Riedemann
Chief Executive Officer
Fireman B.V.
Winzerlaer Str. 2
07745 Jena, Germany
Re:Fireman B.V.
Amendment No. 1 to Registration Statement on Form F-1
Filed October 26, 2017
File No. 333-220962
Dear Mr. Riedemann:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our October 25, 2017 letter.
Amendment No. 1 to Registration Statement on Form F-1
Exhibits
1.We acknowledge the revised Exhibit 5.1 opinion, your response to prior comment 1, and
your confirmation that you will file an appropriately unqualified Exhibit 5.1 opinion as
an exhibit to a post-effective amendment prior to the closing of the offering. However,
based on the definition of "Option Shares," "Offer Shares," and "Shares" it continues to
be unclear whether the opinion opines on shares of Fireman B.V. or shares of InflaRx
N.V. Please file a revised opinion that clearly opines on the issuance of InflaRx N.V.
common shares.
FirstName LastNameNiels Riedemann
Comapany NameFireman B.V.
June 16, 2017 Page 2
FirstName LastName
Niels Riedemann
Fireman B.V.
October 27, 2017
Page 2
2.We acknowledge the revised opinions in response to prior comment 3. However, we
note that both Exhibit 5.1 and Exhibit 8.1 include language that the communication is
"confidential" and that your counsel's general terms and conditions apply to third parties
relying on your counsel's statements, including a limitation of liability clause. Please
remove such language or clarify that this paragraph does not apply to the investors in the
offering.
You may contact Mark Brunhofer at 202-551-3638 or Lisa Vanjoske at 202-551-3614
if you have questions regarding comments on the financial statements and related matters.
Please contact Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson
2017-10-26 - CORRESP - InflaRx N.V.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 450 5800 fax
sophia.hudson@davispolk.com
October 26, 2017
Re:
Fireman B.V.
Registration Statement on Form F-1
Filed October 13, 2017
File No. 333-220962
CONFIDENTIAL
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Dorrie Yale and Ms. Erin Jaskot,
On behalf of our client, Fireman B.V., a Dutch private company
with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to the Company’s Registration Statement
on Form F-1 (the “Registration Statement”) contained in the Staff’s letter dated October 25, 2017 (the
“Comment Letter”). In response to the comments set forth in the Comment Letter, the Company has revised the
Registration Statement and is publicly filing a revised Registration Statement ( “Amendment No. 1”) together
with this response letter. We are also sending, under separate cover, a copy of Amendment No. 1 (including exhibits) and three
marked copies of each of Exhibits 5.1, 8.1 and 8.2 to Amendment No. 1 showing the changes to such exhibits included with the Registration
Statement publicly filed on October 13, 2017.
Set forth below are the Company’s responses to the Staff’s
comments in the Comment Letter. The responses and information below are based on information provided to us by the Company and
its counsel. For convenience, the Staff’s comments are repeated below in italics, followed by the Company’s response
to the comments as well as a summary of the responsive actions taken. Capitalized terms used but not defined herein are used herein
as defined in Amendment No. 1.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
2
October 26, 2017
Registration Statement on Form F-1
Exhibits
1. We note that your counsel's Exhibit. 5.1 opinion is with respect to Option Shares and Offer Shares, which are ordinary shares
of Fireman B.V. However, your registration statement relates to the offering of common shares of InflaRx N.V. Please file a revised
opinion to cover the issuance of InflaRx N.V. common shares. In the event that such opinion refers to assumptions relating to the
reorganization occurring after effectiveness, please confirm that you will file an appropriately unqualified opinion by post-effective
amendment no later than the closing date of the offering. For guidance, please see Section II.B.2.e. of Staff Legal Bulletin No.
19.
Response: In response to the Staff’s comment, the Company has filed a revised copy of the Exhibit 5.1 form of opinion with
Amendment No. 1. The Company respectfully advises the Staff that while the Company has filed a revised form of the Exhibit
5.1 opinion with Amendment No. 1, it intends to file the
executed version of the Exhibit 5.1 opinion as an exhibit to the
Company’s anticipated next amendment to its Registration Statement, which amendment would also include the preliminary
prospectus containing a bona fide price range per share. The Company also confirms that it will file an Exhibit 5.1 opinion
that is appropriately unqualified as an exhibit to a post-effective amendment to the Registration Statement following
the pricing of the
offering and prior
to the closing of the offering (the “Pre-Closing
Exhibit 5.1 Opinion”).
2. It is inappropriate to include assumptions that are too broad or assume material facts underlying the opinion. The assumptions
set forth in paragraphs (d), (e) (to the extent it does not relate to pricing resolutions), and (j)(i) of your Exhibit 5.1 opinion
appear to assume material facts related to the issue of whether the shares will be validly issued. Please file an amended 5.1 opinion
that does not include these assumptions or explain why each such assumption is necessary and appropriate. For guidance, please
see Section II.B.3.a. of Staff Legal Bulletin No. 19.
Response: In response to the Staff’s comment, the Company has filed a revised copy of the Exhibit 5.1 form of opinion with
Amendment No. 1. Certain assumptions that relate to the pricing of the offering (including the assumption in paragraph
(j)(i), which relates to the execution of the underwriting agreement pursuant to which the Company will grant the
overallotment option) will be removed in the Pre-Closing Exhibit 5.1 Opinion.
3. Please remove the limitations set forth in the last paragraph on page 1 and the first paragraph on page 2 of Exhibit 5.1, the
first full paragraph on page 2 of Exhibit 8.1, and paragraphs 6.2 and 7 of Exhibit 8.2. In the alternative, please explain why
they’re appropriate and consistent with Section 14 of the Securities Act. In addition, please delete the first sentence in
the third paragraphs of each of Exhibit 5.1 and 8.1 as they are statements limiting reliance. For guidance, please see Section
II.B.3.d of Staff Legal Bulletin No. 19.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
3
October 26, 2017
Response: In response to the Staff’s comment, the Company has filed revised copies of the Exhibit 5.1 form of opinion, the
Exhibit 8.1 opinion and the Exhibit 8.2 opinion with Amendment No. 1.
4. Paragraphs 4 of your Exhibit 5.1 and Exhibit 8.1 opinions, and paragraph 3 of your Exhibit 8.2 opinion, include inappropriate
limitations on the documents reviewed and review conducted. Counsel may indicate that the identified items were the only items
reviewed if it also states that it determined that the identified documents included all documents that it deemed relevant to rendering
an opinion. Please file amended opinions that either remove the language indicating that such counsel's review was limited to the
identified items or include a statement that counsel determined that the identified items were the only documents and searches
relevant to rendering an opinion.
Response: In response to the Staff’s comment, the Company has filed revised copies of the Exhibit
5.1 form of opinion, the Exhibit 8.1 opinion and the Exhibit 8.2 opinion with Amendment No. 1.
5. Please correct the registration statement number referenced in the definition of "Registration Statement" in your
Exhibit 8.2.
Response: In response to the Staff’s comment, the Company has filed a revised copy of the Exhibit 8.2 opinion with Amendment No.
1.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
4
October 26, 2017
Please do not hesitate to contact me at (212) 450-4762, (212) 450-5800 (fax) or sophia.hudson@davispolk.com if you have any questions
regarding the foregoing or if I can provide any additional information.
Very truly yours,
/s/ Sophia Hudson
Sophia Hudson
cc:
Via E-mail
Niels Riedemann, Chief Executive Officer
Arnd Christ, Chief Financial Officer
Fireman B.V.
2017-10-25 - UPLOAD - InflaRx N.V.
October 25, 2017
Niels Riedemann
Chief Executive Officer
Fireman B.V.
Winzerlaer Str. 2
07745 Jena, Germany
Re:Fireman B.V.
Registration Statement on Form F-1
Filed October 13, 2017
File No. 333-220962
Dear Mr. Riedemann:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1
Exhibits
1.We note that your counsel's Exhibit. 5.1 opinion is with respect to Option Shares and
Offer Shares, which are ordinary shares of Fireman B.V. However, your registration
statement relates to the offering of common shares of InflaRx N.V. Please file a revised
opinion to cover the issuance of InflaRx N.V. common shares. In the event that such
opinion refers to assumptions relating to the reorganization occurring after
effectiveness, please confirm that you will file an appropriately unqualified opinion by
post-effective amendment no later than the closing date of the offering. For guidance,
please see Section II.B.2.e. of Staff Legal Bulletin No. 19.
FirstName LastNameNiels Riedemann
Comapany NameFireman B.V.
June 16, 2017 Page 2
FirstName LastNameNiels Riedemann
Fireman B.V.
October 25, 2017
Page 2
2.It is inappropriate to include assumptions that are too broad or assume material facts
underlying the opinion. The assumptions set forth in paragraphs (d), (e) (to the extent it
does not relate to pricing resolutions), and (j)(i) of your Exhibit 5.1 opinion appear to
assume material facts related to the issue of whether the shares will be validly issued.
Please file an amended 5.1 opinion that does not include these assumptions or explain
why each such assumption is necessary and appropriate. For guidance, please see
Section II.B.3.a. of Staff Legal Bulletin No. 19.
3.Please remove the limitations set forth in the last paragraph on page 1 and the first
paragraph on page 2 of Exhibit 5.1, the first full paragraph on page 2 of Exhibit 8.1, and
paragraphs 6.2 and 7 of Exhibit 8.2. In the alternative, please explain why they’re
appropriate and consistent with Section 14 of the Securities Act. In addition, please
delete the first sentence in the third paragraphs of each of Exhibit 5.1 and 8.1 as they are
statements limiting reliance. For guidance, please see Section II.B.3.d of Staff Legal
Bulletin No. 19.
4.Paragraphs 4 of your Exhibit 5.1 and Exhibit 8.1 opinions, and paragraph 3 of your
Exhibit 8.2 opinion, include inappropriate limitations on the documents reviewed and
review conducted. Counsel may indicate that the identified items were the only
items reviewed if it also states that it determined that the identified documents included
all documents that it deemed relevant to rendering an opinion. Please file amended
opinions that either remove the language indicating that such counsel's review was
limited to the identified items or include a statement that counsel determined that the
identified items were the only documents and searches relevant to rendering an opinion.
5.Please correct the registration statement number referenced in the definition of
"Registration Statement" in your Exhibit 8.2.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
FirstName LastNameNiels Riedemann
Comapany NameFireman B.V.
June 16, 2017 Page 3
FirstName LastName
Niels Riedemann
Fireman B.V.
October 25, 2017
Page 3
You may contact Mark Brunhofer at 202-551-3638 or Lisa Vanjoske at 202-551-3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson
2017-10-18 - CORRESP - InflaRx N.V.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 450 5800 fax
sophia.hudson@davispolk.com
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Fireman B.V.
October 18, 2017
Re:
Fireman B.V.
Registration Statement on Form F-1
File No. 333-220962
CIK No. 0001708688
CONFIDENTIAL
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Dorrie Yale and Ms. Erin Jaskot,
On behalf of our client, Fireman B.V., a
Dutch private company with limited liability (the “Company”), we are providing the information that follows
to the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in
response to comment number 21 contained in the Staff’s letter dated July 20, 2017 (the “Comment Letter”)
relating to the Company’s Draft Registration Statement on Form F-1, originally confidentially submitted on June 23, 2017
(the “Registration Statement”), in connection with the initial public offering of the Company’s common
shares (the “Offering”).
The response and information below are based
on information provided to us by the Company. For convenience, the Staff’s comments are repeated below in italics, followed
by the Company’s response to the comment. Capitalized terms used but not defined herein are used herein as defined in the
Registration Statement. References to the Company include InflaRx GmbH, which will become Fireman B.V.’s wholly owned subsidiary
upon completion of the corporate reorganization to be completed prior to the closing of the Offering.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission 2 October 18, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Fireman B.V.
Notes to consolidated financial statements
InflaRx GmbH - Consolidated Financial Statements
Note 13 Share-based payments, page F-19
21. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common
stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity
issuances including stock compensation and beneficial conversion features.
Historical Fair Value Determination Methodology
For an explanation of how the Company determined
the fair value of the common shares underlying its issuances of equity, the Company respectfully refers the Staff to the discussion
of its general approach set forth in the Registration Statement in “Note 13. Share-based payments” and “Note
14. Preferred shares” to the Company’s audited consolidated financial statements as of and for the periods ended December
31, 2016 and 2015, as well as “Note 4. Share-based payments” and “Note 5. Preferred shares” to the Company’s
unaudited condensed consolidated financial statements as of and for the period ended June 30, 2017.
As there has been no public market for the
Company’s common shares to date, the estimated fair value of the common shares has been determined by the Company as of the
date of each option grant, with input from management, using a hybrid method which considers the value of the Company as a whole
and allocates such value to the common shares and preferred shares under an option pricing model, assuming a probability weighting
of two scenarios: an initial public offering or a future sale of the Company.
Various objective and subjective factors
that the Company believed were relevant in determining estimated fair value at each grant date, including the recent grant dates
in November 2016, March 2017 and July 2017, included:
· the prices at which the Company sold preferred
shares during the relevant period. In July 2016, the Company entered into an investment agreement pursuant to which it sold Series
C preferred shares for €656 per share (for an aggregate pre-money valuation of €80 million) (the “Series C Financing”)
and the superior rights and preferences of the Company’s preferred shares relative to the common shares at the time of each
grant;
· the progress of the Company’s research
and development programs, including the status of preclinical studies and clinical trials for its product candidate IFX-1, the
commencement of the Company’s Phase IIa study of IFX-1 in patients suffering from Hidradenitis Suppurativa (“HS”)
in the first quarter of 2017 and the receipt by the Company of positive interim results in March 2017 and final results in August
2017;
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission 3 October 18, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Fireman B.V.
· the Company’s stage of development
and its business strategy, external market conditions affecting the biotechnology industry, and trends within the biotechnology
industry, the Company’s financial position, including cash on hand, and its historical and forecasted performance and operating
results;
· the lack of an active public market for
the common shares and preferred shares;
· the likelihood of achieving a liquidity
event, such as an initial public offering, in light of prevailing market conditions; and
· the analysis of initial public offerings
and the market performance of similar companies in the biopharmaceutical industry.
The Company further informs the Staff that
on October 12, 2017, the Company entered into an investment and adherence agreement pursuant to which it agreed to sell Series
D preferred shares in a private placement to certain U.S. institutional healthcare-specialist investors (the “Series
D Financing”) for aggregate gross proceeds to the Company of approximately €25.6 million ($30 million) at a price
per Series D preferred share of €927.92, with an implied pre-money valuation of €179 million (approximately $210 million)
on a fully diluted basis.
Estimated Offering Price
The Company hereby advises the Staff that
the underwriters in the Offering have indicated to the Company that the anticipated offering price to the public of the Company’s
common shares in the Offering is expected to be between approximately $[***Redacted***] and $[***Redacted***] per
share. Please note that this price range does not reflect the impact of the ratio for the exchange of shares of InflaRx GmbH for
shares of the Fireman B.V. in the corporate reorganization, which will have the effect of a forward share split. This price range
implies a pre-money valuation for the Company of approximately $[***Redacted***] to $[***Redacted***].
The actual price range to be included on
the cover of the Company’s preliminary prospectus (which will comply with the Staff’s interpretation regarding the
parameters of a bona fide price range) has not yet been finally determined and remains subject to adjustment based on factors outside
of the Company’s control. However, the Company believes that the foregoing indicative price range will not be subject to
significant change and that the actual price range will be within the range stated above (adjusting for the exchange ratio that
will be determined in conjunction with the finalizing of the actual price range).
The Company notes that, as is typical in
initial public offerings, the estimated price range for the Offering was not derived using a formal determination of fair value,
but was determined by negotiation between the Company and its underwriters for the Offering. Among the factors that were considered
in setting this range were the Company’s prospects and the history of and prospects for its industry, the general condition
of the securities markets, the recent market prices of, and the demand for, publicly traded shares of generally comparable companies
and preliminary discussions with the underwriters for the Offering regarding potential valuations of the Company.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission 4 October 18, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Fireman B.V.
Since January 1, 2015, the Company has issued the following equity awards to its directors, executive officers and employees in
the form of options. The Company has not issued any options since July 2017.
Period
Number of
options granted
Exercise
price per
share
Fair value
per common share
November 2016
11,223
€656.00
€431.00
November 2016
484
€1.00
€431.00
March 2017
3,380
€656.00
€831.00
July 2017
150
€656.00
€831.00
Based on the hybrid method described above for determining fair
value of the common shares, the Company determined that the fair value per common share in November 2016 was €431, based on
a fair value per common share of €[***Redacted***] for the initial public offering scenario (weighted at [***Redacted***]%)
and a fair value per common share of €[***Redacted***] for the Company sale exit scenario (weighted at [***Redacted***]%).
In March and July 2017, the Company determined that the fair value per common share was €831, based on a fair value per common
share of €[***Redacted***] for the initial public offering scenario (weighted at [***Redacted***]%), a fair
value per common share of €[***Redacted***] for the Company sale scenario (weighted at [***Redacted***]%) and
a discount factor of [***Redacted***] calculated using a risk adjusted discount rate of [***Redacted***]%, based on the weighted average
cost of capital for other private companies in similar stages of development, and a discounting term of [***Redacted***]
years.
With
respect to the Staff’s request for the reasons explaining the difference between the estimated offering price and recent
valuations of the Company’s common shares, the Company believes that the differences in value reflected between the estimated
price range for the Offering and the fair value per share for each of the periods set forth in the table above were primarily
the result of the following factors and circumstances:
· The Company entered into the Series C Financing
in July 2016. The option awards granted in November 2016 have exercise prices of €656 for grants issued under the Company’s
2016 Stock Option Plan and €1 per common share for other share-based awards issued without any performance or vesting conditions,
reflecting the price per preferred share issued and sold in the Series C Financing and reflecting the Company’s intention
to provide share-based awards to certain of its executive officers that are designed to simulate a cash bonus, respectively.
· The Company commenced its Phase IIa study
of IFX-1 in patients with HS in the first quarter of 2017 and first received positive interim results from such trial in March
2017 and positive final results in August 2017. Accordingly, options granted in March 2017 and July 2017 have an exercise price
of €656 per common share, reflecting the price per preferred share issued and sold in the Series C Financing, and the fair
value per share was €831, reflecting the positive development with respect to the Company’s Phase IIa study of IFX-1
in patients with HS.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission 5 October 18, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Fireman B.V.
· The Company engaged underwriters in April
2017 in connection with the Offering and submitted a confidential draft registration statement to the Commission in June 2017.
Thereafter, the Company commenced testing-the-waters meetings with potential investors in which the Company received favorable
feedback and as a result of which the Company elected to continue to pursue the Offering. In October 2017, the Company publicly
filed the Registration Statement with the Commission to position itself for the anticipated launch of the Offering.
· The Company anticipates participating in
a pre-IND meeting for IFX-1 with the U.S. Food and Drug Administration in late October 2017.
· The Company entered into the agreement
for the Series D Financing with prominent U.S. institutional healthcare-specialist investors on October 12, 2017.
· The Offering is expected to create liquidity,
and the estimated price range assumes that an initial public offering has occurred, a public market for the Company’s common
shares has been created and the Company’s preferred shares have converted into common shares in connection with the offering.
The estimated price range excludes any marketability or illiquidity discount for the Company’s common shares.
· The Company expects to accrue significant
benefits as a result of becoming publicly traded through the Offering, including (i) a substantial increase in the Company’s
cash position after receiving the net proceeds from the IPO, (ii) an improved ability to raise equity and debt capital going forward,
including from the public equity and debt markets, and at a lower expected cost of capital and with reduced borrowing costs, and
(iii) the expected increased attractiveness of the Company’s equity as a currency to raise capital, compensate employees
and complete strategic transactions.
· The Company’s currently outstanding
preferred shares have economic rights and preferences superior to the Company’s common shares, in particular, a liquidation
preference with a dividend rate of 6% or 8% per annum, depending on the series of preferred shares. The estimated price range assumes
the exchange of the Company’s preferred shares for common shares in the corporate reorganization and the corresponding elimination
of such superior economic rights and preferences.
· The estimated price range for the Offering
is based only upon a scenario in which the Company completes the Offering and is not probability weighted, in contrast to the Company’s
prior valuations of the Company’s common shares in connection with its option grants, which considered multiple potential
outcomes, thus resulting in a lower value of the Company’s common shares than the estimated price range for the Offering.
· As is the case for the biotechnology industry
where the value of clinical-stage companies oftentimes depends on their ability or perceived ability to execute on their
business plans, including obtaining regulatory approval of their product candidates, rather than quantitative results of operations,
the Company believes that
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission 6 October 18, 2017
FOIA Confidential Treatment Request
Pursuant to Rule 83 by Fireman B.V.
the price that investors are willing to pay for the Company’s
common shares in the Offering may take into account other factors that have not been expressly considered in the Company’s
prior valuations but are significant to investors in their own subjective and qualitative assessment of the Company.
The Company respectfully requests that the
Staff return to the undersigned this letter pursuant to Rule 418 of the Securities Act of 1933, as amended, once the Staff has
completed its review. For the convenience of the Staff, we have provided a self-addressed stamped envelope for this purpose. We
respectfully reserve the right to request that this letter be returned to us at an earlier date.
Please do not hesitate to contact me at
(212) 450-4762, (212) 450-5800 (fax) or sophia.hudson@davispolk.com if y
2017-10-13 - CORRESP - InflaRx N.V.
CORRESP
1
filename1.htm
New York
Northern California
Washington DC
São Paulo
London
Paris
Madrid
Tokyo
Beijing
Hong Kong
Sophia Hudson
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
212 450 4762 tel
212 450 5800 fax
sophia.hudson@davispolk.com
October 13, 2017
Re:
Fireman B.V.
Amendment No. 2 to Draft Registration Statement on
Form F-1
Submitted September 11, 2017
CIK No. 0001708688
CONFIDENTIAL
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-3628
Dear Ms. Dorrie Yale and Ms. Erin Jaskot,
On behalf of our client, Fireman B.V., a Dutch private company
with limited liability (the “Company”), we are responding to the comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to the Company’s confidential amended
draft Registration Statement on Form F-1 (the “Draft Registration Statement”) contained in the Staff’s
letter dated September 21, 2017 (the “Comment Letter”). In response to the comments set forth in the Comment
Letter, the Company has revised the Draft Registration Statement and is publicly filing a revised Registration Statement (the “Registration
Statement”) together with this response letter. The Registration Statement also contains certain additional updates and
revisions. We are also sending, under separate cover, a copy of the Registration Statement (including exhibits) and three marked
copies of the Registration Statement showing the changes to the Draft Registration Statement confidentially submitted on September
11, 2017.
Set forth below are the Company’s responses to the Staff’s
comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For
convenience, the Staff’s comments are repeated below in italics, followed by the Company’s response to the comments
as well as a summary of the responsive actions taken. We have included page numbers to refer to the location in the Registration
Statement submitted herewith where the revised language addressing a particular comment appears. Capitalized terms used but not
defined herein are used herein as defined in the Registration Statement.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
2
October 13, 2017
Draft Registration Statement on Form F-1
Prospectus Summary, page 2
1. We acknowledge your response to prior comment 1. However, we note that your Phase IIa trial studied 12 patients, and that
you have not started your larger, multi-center, international Phase IIb trial. In light of these factors, please tell us why
you believe the first bar in your product pipeline table is appropriate or please reduce the length of the bar here and in
the Business section.
Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 2 and 90 of the Registration Statement
to reduce the length of the bar for Hidradenitis Suppurativa. The Company respectfully notes that the explanatory text under the
“Current Status” and “Next Milestone” columns also clarifies the current status of Phase II clinical trials
for IFX-1 in Hidradenitis Suppurativa.
Material U.S. Federal Tax Considerations for U.S. Holders
of Common Shares
Material Dutch Tax Considerations
German Tax Considerations, page 154
2. We note your revised disclosure in response to prior comment 5. However, we note that the tax disclosure sections state that
in the opinions of your counsels, the disclosure is a description of the material tax consequences, or that the disclosure describes
the material tax considerations. The disclosure in the prospectus must state clearly that the disclosure in the tax consequences
sections of the prospectus is the opinion of the applicable named counsel. It is not appropriate to say that in the opinion of
counsel the disclosure describes the material tax consequences, as the content of the disclosure is not the appropriate subject
of the opinion. Counsel must opine on the tax consequences of the offering, not the manner in which they are described in the prospectus.
Further, we note certain inappropriate assumptions and qualifications such as the statement that you "should" qualify
as a corporation subject to German unlimited income taxation, or the statements subject to "applicable limitations" in
the opinion provided by U.S. tax counsel. Please revise your disclosure accordingly. See Staff Legal Bulletin No. 19 for guidance.
Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 146, 147, 150, 154, 157 and 158 of
the Registration Statement.
Ms. Dorrie Yale
Ms. Erin Jaskot
Division of Corporation Finance
U.S. Securities and Exchange Commission
3
October 13, 2017
Please do not hesitate to contact me at (212) 450-4762, (212)
450-5800 (fax) or sophia.hudson@davispolk.com if you have any questions regarding the foregoing or if I can provide any additional
information.
Very truly yours,
/s/ Sophia Hudson
Sophia Hudson
cc:
Via E-mail
Niels Riedemann, Chief Executive Officer
Arnd Christ, Chief Financial Officer
Fireman B.V.
2017-09-21 - UPLOAD - InflaRx N.V.
September 21, 2017 Niels Riedemann Chief Executive Officer Fireman B.V. Winzerlaer Str. 2 07745 Jena, Germany Fireman B.V. Amendment No. 2 to Draft Registration Statement on Form F-1 Submitted September 11, 2017 CIK No. 0001708688Re: Dear Mr. Riedemann: We have reviewed your amended 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 amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our August 15, 2017 letter. Draft Registration Statement on Form F-1 Prospectus Summary, page 2 1. We acknowledge your response to prior comment 1. However, we note that your Phase IIa trial studied 12 patients, and that you have not started your larger, multi-center, international Phase IIb trial. In light of these factors, please tell us why you believe the first bar in your product pipeline table is appropriate or please reduce the length of the bar here and in the Business section. Niels Riedemann Fireman B.V. September 21, 2017 Page 2 Material U.S. Federal Tax Considerations for U.S. Holders of Common Shares Material Dutch Tax Considerations German Tax Considerations, page 154 2. We note your revised disclosure in response to prior comment 5. However, we note that the tax disclosure sections state that in the opinions of your counsels, the disclosure is a description of the material tax consequences, or that the disclosure describes the material tax considerations. The disclosure in the prospectus must state clearly that the disclosure in the tax consequences sections of the prospectus is the opinion of the applicable named counsel. It is not appropriate to say that in the opinion of counsel the disclosure describes the material tax consequences, as the content of the disclosure is not the appropriate subject of the opinion. Counsel must opine on the tax consequences of the offering, not the manner in which they are described in the prospectus. Further, we note certain inappropriate assumptions and qualifications such as the statement that you "should" qualify as a corporation subject to German unlimited income taxation, or the statements subject to "applicable limitations" in the opinion provided by U.S. tax counsel. Please revise your disclosure accordingly. See Staff Legal Bulletin No. 19 for guidance. You may contact Mark Brunhofer at 202-551-3638 or Lisa Vanjoske at 202-551-3614 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any other questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Sophia Hudson
2017-08-16 - UPLOAD - InflaRx N.V.
August 15, 2017 Niels Riedemann Chief Executive Officer Fireman B.V. Winzerlaer Str. 2 07745 Jena, Germany Fireman B.V. Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted August 3, 2017 CIK No. 0001708688Re: Dear Mr. Riedemann: We have reviewed your amended 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. Amendment No. 1 to Draft Registration Statement on Form F-1 Prospectus Summary, page 1 1. We acknowledge your response to comment 2. However, in light of the fact that you have not yet received final results from your Phase IIa trial and that you do not expect to start your Phase IIb trial until 2018, please tell us why you believe the first bar in your product pipeline table is appropriate or please reduce the length of the bar here and in the Business section. In addition, in your description of the status of the Phase IIa trial, please indicate that the results remain pending. Niels Riedemann Fireman B.V. August 15, 2017 Page 2 Business Our proprietary anti-C5a technology and product candidates, page 87 2. We note your revised disclosure in response to comment 13. However, it remains unclear why there is a potential for fast recruitment for HS, as you state on page 91, when your revised disclosure on page 19 states that there may be enrollment of a limited or insufficient number of trial participants. Please reconcile your statements. 3. We refer to your revised disclosure on page 91 regarding your Phase IIa trial in response to comment 9. Please also disclose the dosage of IFX-1 used in this trial. Intellectual Property, page 98 4. We acknowledge your revised disclosure in response to comment 18. Please clarify in your disclosure whether all your U.S. patents cover the treatment of HS and AAV. In addition, please clarify in which foreign jurisdictions you have patents or pending patent applications covering the treatment of HS and AAV. Dutch Tax Considerations Material U.S. Federal Tax Consequences for U.S. Holders of Common Shares German Tax Considerations, page 135 5. We note your revisions in response to comment 20, however the disclosure continues to contain disclaim reliance and does not provide firm opinions on material federal and foreign tax consequences to U.S. investors. As examples only, we note disclaimers that the disclosure is a "summary," is for "general information purposes only," or "does not constitute a legal opinion or tax advice." Please remove all disclaimers in these sections that suggest the disclosure is not an opinion or that investors are not entitled to rely on the opinion. Please also clearly state that the disclosure is the opinion of counsel. Please revise the disclosure to express a firm conclusion for each material tax consequence to U.S. investors. As currently drafted, the disclosure states that counsel "expects" certain tax consequences, U.S. holders "should not be required" to recognize certain gain or loss, or tax consequences are subject to exceptions. These are only examples. To the extent counsel is unable to provide the opinion, the disclosure should state this fact, provide the reason for the inability to opine on the material tax consequence, and discuss the possible alternatives and risks. For guidance, please refer to Section III of Staff Legal Bulletin No. 19. Niels Riedemann Fireman B.V. August 15, 2017 Page 3 You may contact Lisa Vanjoske at 202-551-3614 or Mark Brunhofer at 202-551-3638 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any other questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Sophia Hudson
2017-07-21 - UPLOAD - InflaRx N.V.
July 20, 2017
Niels Riedemann
Chief Executive Officer
Fireman B.V.
Winzerlaer Str. 2
07745 Jena, Germany
Fireman B.V.
Draft Registration Statement on Form F-1
Submitted June 23, 2017
CIK No. 0001708688Re:
Dear Mr. Riedemann:
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 submitted June 23, 2017
Prospectus Summary
Overview, page 2
1. Please revise your disclosure here and elsewhere as appropriate to specifically disclose
how many of the 12 patients participating in the Phase IIa trial failed to respond to
adalimumab. Please also clearly disclose that no placebo or control group is being used in
the Phase IIa trial.
2. Please revise your product pipeline table here and in the Business section to reduce the
length of the arrow shown in the first row since your Phase IIa trial of 12 patients is still
Niels Riedemann
Fireman B.V.
July 20, 2017
Page 2
ongoing. Please also delete the statement that you have completed the open-label Phase
IIa trial, or tell us why this is an accurate statement.
3. We refer to your statement in the first paragraph that IFX-1 is a "first-in-class" antibody
that has demonstrated disease-modifying clinical activity, safety and tolerability in
multiple clinical settings." Please balance your disclosure by explaining that IFX-1 is a
novel antibody and that its potential therapeutic benefit is unproven. In addition, a safety
and efficacy determination is solely within the FDA’s authority. Accordingly, please also
remove the statement here, and similar statements appearing frequently in your
prospectus, that your product candidate has demonstrated safety, is safe, or has a
favorable safety profile, as well as statements that IFX-1 is "highly efficacious," showed
"remarkable efficacy," has demonstrated efficacy, or any other similar statements.
Our programs, page 3
4. Please supplementally provide support for your statement that approximately 50% or
more of patients with moderate to severe HS do not respond to adalimumab. Please also
balance your disclosure by indicating the number of participants in the adalimumab
trials versus the Phase IIa clinical trial of IFX-1.
5. We note your discussion on page 4 of the results from your ongoing Phase IIa trial by
reference to the "validated HiSCR endpoint." Please briefly explain what is required to
achieve the HiSCR endpoint. In addition, although it was used for the approval of
adalimumab, since you state on page 19 that there is no guarantee that the FDA will allow
you to use it as your primary endpoint, please remove the term "validated" here and
elsewhere as appropriate.
Implications of being an emerging growth company and a foreign private issuer, page 5
6. 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.
Use of Proceeds, page 64
7. Please clarify your disclosure to explain whether you expect you will be able to complete
the Phase IIb HS trial and the Phase II AAV trial with the allocated amount.
Management's Discussion and Analysis
Research and Development Expenses, page 77
8. You state "We did not track the costs of these activities on a program-by-program basis
until 2016." Please disaggregate research and development expense for 2016 by program
and by clinical trial, if available, or revise the disclosure to indicate why expense by
program/trial is not disclosed.
Niels Riedemann
Fireman B.V.
July 20, 2017
Page 3
Business, page 82
9. For each of the pre-clinical and clinical trials discussed in this section, please expand
the description of these trials to provide specific details and results of the studies,
including, the date(s) of the trials and the location; the identity of any trial sponsor, as
applicable; patient information (e.g., number of patients enrolled and treated and the
criteria for participation in the study); duration of treatment and dosage information (both
amount and frequency); the specific endpoints established by the trial protocol; and actual
results observed, including whether statistical significance was demonstrated and the p-
values supporting statistical significance.
Our Strategy, page 83
10. We note your statement in the second bullet on page 84 that the pre-clinical development
of IFX-2 is supported by a German government grant, and note references to grants
elsewhere in your disclosure. Please tell us whether the governments (or their related
agencies) providing these grants are entitled to ownership of any of your intellectual
property or to receive any material payments from you in the future.
Our proprietary anti-C5a technology and product candidates, page 87
11. We note your statement on page 89 that in all completed studies, IFX-1 blocked C5a with
"high statistical significance." Please provide an explanation of the term "statistical
significance" and discuss how statistical significance relates to the FDA´s evidentiary
standards of efficacy. Please expand your disclosure to provide the results, including p-
values, of the component analyses showing statistical significance for "all completed
studies" and tell us what you consider to be "high statistical significance." Please provide
similar disclosure elsewhere where you discuss statistical significance.
12. We note your statement that you have "established first clinical proof of concept" for
IFX-1 as a therapy for HS. Please explain specifically what you mean by this statement.
Please also address here, and elsewhere as appropriate, the potential implications of
having only 12 participants in the trial on certain of your findings, including proof of
concept and statistical significance.
13. We refer to your statement in the last bullet on page 91 that you believe HS is an
attractive lead indication for IFX-1 because of the potential for fast recruitment. However
we note that you intend to seek orphan designation for the drug in the U.S. because of its
small patient population, and your statement on page 20 that the small number of patients
could result in slow enrollment of clinical trial participants. Please reconcile your
statements.
14. Please revise the disclosure explaining the chart on page 93 to more clearly explain the
results the graph represents. Please also disclose the amount of IFX-1 that was used.
15. We note your statement on your website that MAC formation may not play a major role
in the AAV disease. Please discuss the role of MAC formation in your disclosure of
Niels Riedemann
Fireman B.V.
July 20, 2017
Page 4
AAV on pages 93-94.
16. Please explain your statement in the fourth paragraph on page 94 that recent studies of
Chemocentryx's CCX168 provided a "proof of concept for the role of the C5a/C5aR
signaling axis in AAV patients," including the specific results that support this statement.
17. We note your disclosure on page 95 that you have determined to focus on HS and AAV
as opposed to SCIENS because of the "variable nature of the sepsis indication." Please
explain what you mean by "variable nature" and how it influenced your decision to focus
on HS and AAV.
Intellectual Property, page 98
18. We refer to your statement in the fourth paragraph of this section relating to patents and
pending patent applications covering antibodies that block C5a and its use in the
treatment of "various diseases." Please clarify the indications that are covered by the
patents and pending applications, including whether HS and AAV are included.
Principal Shareholders, page 117
19. Please include the information required by Item 7.A.2 of Form 20-F.
Dutch Tax Considerations
German Tax Considerations, page 143
20. You disclose here that these sections contain descriptions of certain material Dutch and
German tax consequences and/or principles. Please remove the term “certain” to clarify
that this section addresses all material consequences. In addition, we note that you intend
to file short-form tax opinions and the tax disclosure in these sections and in the section
on U.S. tax consequences will serve as tax opinions. Accordingly, please revise these
sections to remove language stating that "generally" certain tax consequences will apply
and express a firm opinion for each material tax consequence or explain why such an
opinion cannot be given. For guidance, please refer to Section III of Staff Legal Bulletin
No. 19.
Notes to consolidated financial statements
InflaRx GmbH - Consolidated Financial Statements
Note 13 Share-based payments, page F-19
21. Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features.
Niels Riedemann
Fireman B.V.
July 20, 2017
Page 5
22. Please provide us the names and volatility of each of the peer companies you used to
estimate expected volatility of 63% for 2016. Also explain why you believe each
company was similar to you. In your response, at a minimum, specifically tell us whether
these peer companies have any product revenues and the following information regarding
their development pipelines:
• The number of product candidates in the pipeline;
• The general therapeutic area of these product candidates; and
• The phase of development for these product candidates.
Note 17 Financial risk management
Liquidity risk, page F-26
23. You state here that you raised funding in September 2016, however, in Note 14 you state
you sold preferred shares in July 2016. Please reconcile these two statements and
revise the disclosure as necessary.
You may contact Lisa Vanjoske at 202-551-3614 or Mark Brunhofer at 202-551-3638 if
you have questions regarding comments on the financial statements and related matters. Please
contact Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Sophia Hudson