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Minerva Neurosciences, Inc.
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Minerva Neurosciences, Inc.
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SEC wrote to company
2022-09-21
Minerva Neurosciences, Inc.
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Minerva Neurosciences, Inc.
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Minerva Neurosciences, Inc.
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2022-09-14
Minerva Neurosciences, Inc.
References: September 12, 2022
Minerva Neurosciences, Inc.
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Minerva Neurosciences, Inc.
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Minerva Neurosciences, Inc.
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Company responded
2014-06-23
Minerva Neurosciences, Inc.
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Minerva Neurosciences, Inc.
Response Received
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SEC wrote to company
2014-04-22
Minerva Neurosciences, Inc.
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Company responded
2014-04-23
Minerva Neurosciences, Inc.
References: March 14, 2014
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2014-06-10
Minerva Neurosciences, Inc.
References: April 22, 2014
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Minerva Neurosciences, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2014-03-14
Minerva Neurosciences, Inc.
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2014-04-09
Minerva Neurosciences, Inc.
References: March 14, 2014
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-02 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2025-12-31 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | 333-292410 | Read Filing View |
| 2023-08-07 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2023-08-07 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-21 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-21 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-21 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-14 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-12 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2018-08-22 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2018-08-20 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2015-07-24 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2015-07-23 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-30 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-30 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-23 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-23 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-10 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-04-23 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-04-22 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-04-09 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-03-14 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-31 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | 333-292410 | Read Filing View |
| 2023-08-07 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-21 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-21 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-12 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2018-08-20 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2015-07-23 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-04-22 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-03-14 | SEC Comment Letter | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-02 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2023-08-07 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-21 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2022-09-14 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2018-08-22 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2015-07-24 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-30 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-30 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-23 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-23 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-06-10 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-04-23 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
| 2014-04-09 | Company Response | Minerva Neurosciences, Inc. | MA | N/A | Read Filing View |
2026-01-02 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm CORRESP January 2, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Daniel Crawford Re: Minerva Neurosciences, Inc. Registration Statement on Form S-3 File No. 333-292410 Acceleration Request Requested Date: January 6, 2026 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the Registration Statement on Form S-3 (File No.: 333-292410) (the “ Registration Statement ”) to become effective on Tuesday, January 6, 2026 at 4:00 p.m. Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Ryan S. Sansom of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Ryan S. Sansom of Cooley LLP, counsel to the Registrant, at (617) 937-2335. Very truly yours, Minerva Neurosciences, Inc. By: /s/ Remy Luthringer Remy Luthringer Chief Executive Officer cc: Remy Luthringer, Chief Executive Officer, Minerva Neurosciences, Inc. Geoff Race, President, Minerva Neurosciences, Inc. Marc Recht, Cooley LLP Ryan S. Sansom, Cooley LLP
2025-12-31 - UPLOAD - Minerva Neurosciences, Inc. File: 333-292410
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> December 31, 2025 Remy Luthringer Chief Executive Officer and Chairman of the Board of Directors Minerva Neurosciences, Inc. 1500 District Avenue Burlington, MA 01803 Re: Minerva Neurosciences, Inc. Registration Statement on Form S-3 Filed December 23, 2025 File No. 333-292410 Dear Remy Luthringer: 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ryan Sansom, Esq. </TEXT> </DOCUMENT>
2023-08-07 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm CORRESP August 7, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Jimmy McNamara Re: Minerva Neurosciences, Inc. Registration Statement on Form S-3 File No. 333-273686 Acceleration Request Requested Date: August 9, 2023 Requested Time: 4:00 PM Eastern Daylight Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-3 (File No. : 333-273686) (the “Registration Statement”) to become effective on Wednesday, August 9, 2023 at 4:00 p.m. Eastern Daylight Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Ryan S. Sansom of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Ryan S. Sansom of Cooley LLP, counsel to the Registrant, at (617) 937-2335. Very truly yours, Minerva Neurosciences, Inc. By: /s/ Frederick Ahlholm Frederick Ahlholm Chief Financial Officer cc: Remy Luthringer, Chief Executive Officer, Minerva Neurosciences, Inc. Geoff Race, President, Minerva Neurosciences, Inc. Marc Recht, Cooley LLP Ryan S. Sansom, Cooley LLP
2023-08-07 - UPLOAD - Minerva Neurosciences, Inc.
United States securities and exchange commission logo
August 7, 2023
Remy Luthringer
Chief Executive Officer
Minerva Neurosciences, Inc.
1500 District Avenue
Burlington, MA 01803
Re:Minerva Neurosciences, Inc.
Registration Statement on Form S-3
Filed August 4, 2023
File No. 333-273686
Dear Remy Luthringer:
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 Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ryan S. Sansom
2022-09-21 - UPLOAD - Minerva Neurosciences, Inc.
United States securities and exchange commission logo
September 21, 2022
Remy Luthringer, Ph.D.
Chief Executive Officer
Minerva Neurosciences, Inc.
1500 District Avenue
Burlington, MA 01803
Re:Minerva Neurosciences, Inc.
Registration Statement on Form S-3
Filed September 14, 2022
File No. 333-267424
Dear Dr. Luthringer:
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 Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Marc Recht, Esq.
2022-09-21 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm CORRESP September 21, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Abby Adams Re: Minerva Neurosciences, Inc. Registration Statement on Form S-3 File No. 333- 267424 Acceleration Request Requested Date: September 23, 2022 Requested Time: 4:00 PM Eastern Daylight Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-3 (File No. 333- 267424) (the “Registration Statement”) to become effective on Friday, September 23, 2022 at 4:00 p.m. Eastern Daylight Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Ryan S. Sansom of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Ryan S. Sansom of Cooley LLP, counsel to the Registrant, at (617) 937-2335. Very truly yours, Minerva Neurosciences, Inc. By: /s/ Frederick Ahlholm Frederick Ahlholm Chief Financial Officer cc: Remy Luthringer, Chief Executive Officer, Minerva Neurosciences, Inc. Geoff Race, President, Minerva Neurosciences, Inc. Marc Recht, Cooley LLP Ryan S. Sansom, Cooley LLP
2022-09-14 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm CORRESP MINERVA NEUROSCIENCES, INC. 1500 District Avenue Burlington, MA 01803 September 14, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Julie Sherman Brian Cascio Re: Minerva Neurosciences, Inc. (the “Company”) Form 10-K for the Fiscal Year Ended December 31, 2021 (the “Annual Report”) Filed March 1, 2022 File No. 001-36517 Ladies and Gentlemen: We are in receipt of the letter dated September 12, 2022 from the staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above referenced Annual Report on Form 10-K for the year ended December 31, 2021. We are responding to the Staff’s comment included in the letter. For ease of reference, we have set forth the Staff’s comment and the Company’s response below. Form 10-K for the Fiscal Year Ended December 31, 2021 Financial Statements Note 2 - Goodwill, page F-11 1. We note the disclosure on page 12 that during 2021 you focused your resources on the lead drug candidate roluperidone and deferred the future development of MIN-301 until additional resources become available and as a result of your limited resources and development deferral combined with the overall market conditions, you recognized a noncash charge of $15.2 million as of December 31, 2021 related to the impairment of the intangible asset for MIN-301. It appears that a significant portion of your goodwill was also recorded as part of this acquisition. Please explain to us how this decision and the overall market conditions were considered in your review of any possible goodwill impairment. The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company impaired the intangible asset for MIN-301 following the review of the value of the in-process research and development (“IPR&D”) associated with the MIN-301 asset, as disclosed in the Annual Report. At the time, the Company had diverted its internal efforts to focus on the late-stage clinical development and submission of a New Drug Application (“NDA”) for its lead program, Roluperidone, for the treatment of the negative symptoms of schizophrenia. In addition, limited human resources (the Company had 9 full-time employees as of December 31, 2021) and constrained funding, resulting from deteriorating financial markets during 2021, meant that the original development plan for MIN-301 was significantly delayed. The Company performed an annual impairment test for the asset, using a multi-period excess earning valuation method, and determined that the value of the MIN-301 asset was zero at the measurement date of November 30, 2021 compared to a carrying value of $15.2 million. The Company concluded that MIN-301 was fully impaired as of November 30, 2021. United States Securities and Exchange Commission September 14, 2022 Page Two The Company separately performed its annual goodwill impairment assessment also as of November 30, 2021. The Company has a single reporting unit, which is the level that the goodwill impairment test is performed. In accordance with ASC 350-20-35-31 the Company first recorded the impairment for the IPR&D asset before its impairment assessment of goodwill. For the Company’s annual goodwill impairment assessment, it performed a qualitative analysis that considered the factors in ASC 350-20-35-5, where the Company determined that there were no indicators that the fair value of the reporting unit exceeded the carrying value. In making that determination the Company considered that on November 30, 2021, the Company’s market capitalization was $41.5 million (42.7 million shares outstanding multiplied by the closing price of $0.9710), and net equity was approximately $11.9 million. As such, there was an excess fair value of $29.6 million. The Company updated this comparison at December 31, 2021. The Company also considered that at the date of the goodwill impairment assessment, the Company had recently completed its Phase 3 trial of Roluperidone for the treatment of Negative Symptoms of Schizophrenia and the Company was preparing to meet with the FDA to discuss the submission of an NDA in 2022. In addition, the Company sold its rights to receive royalties under a prior co-development program and expected to receive significant milestone payments under that arrangement in future periods. All of these factors indicated that the fair value of the reporting unit was in excess of the carrying value. Please direct any questions regarding the foregoing to the undersigned (via email: grace@minervaneurosciences.com) or Fred Ahlholm, Chief Financial Officer of the Company (via email: fahlholm@minervaneurosciences.com). Sincerely, Minerva Neurosciences, Inc. /s/ Geoff Race Geoff Race President, Minerva Neurosciences, Inc. cc: Remy Luthringer, Minerva Neurosciences, Inc. Fred Ahlholm, Minerva Neurosciences, Inc. Marc Recht, Cooley LLP Ryan Sansom, Cooley LLP
2022-09-12 - UPLOAD - Minerva Neurosciences, Inc.
United States securities and exchange commission logo
September 12, 2022
Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
1601 Trapelo Road
Suite 286
Waltham, MA 02451
Re:Minerva Neurosciences, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed March 1, 2022
File No. 001-36517
Dear Mr. Ahlholm:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to this comment 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 our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2021
Financial Statements
Note 2 - Goodwill, page F-11
1.We note the disclosure on page 12 that during 2021 you focused your resources on
the lead drug candidate roluperidone and deferred the future development of MIN-301
until additional resources become available and as a result of your limited resources and
development deferral combined with the overall market conditions, you recognized a non-
cash charge of $15.2 million as of December 31, 2021 related to the impairment of the
intangible asset for MIN-301. It appears that a significant portion of your goodwill was
also recorded as part of this acquisition. Please explain to us how this decision and the
overall market conditions were considered in your review of any possible goodwill
impairment.
FirstName LastNameFrederick Ahlholm
Comapany NameMinerva Neurosciences, Inc.
September 12, 2022 Page 2
FirstName LastName
Frederick Ahlholm
Minerva Neurosciences, Inc.
September 12, 2022
Page 2
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.
You may contact Julie Sherman at (202) 551-3640 or Brian Cascio, Accounting Branch
Chief, at (202) 551-3676 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2018-08-22 - CORRESP - Minerva Neurosciences, Inc.
CORRESP
1
filename1.htm
CORRESP
August 22, 2018
VIA EDGAR
United States
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Minerva Neurosciences, Inc.
Registration Statement on Form S-3 (File No. 333-226783)
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange
Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective at 4:00 p.m. Eastern Time on
August 24, 2018 or as soon thereafter as is practicable.
Sincerely,
MINERVA NEUROSCIENCES, INC.
By:
/s/ Devin Smith
Name: Devin Smith
Title: General Counsel
cc:
Marc A. Recht, Esq.
Ryan S. Sansom, Esq.
2018-08-20 - UPLOAD - Minerva Neurosciences, Inc.
August 17, 2018
Remy Luthringer, Ph.D.
Chief Executive Officer
Minerva Neurosciences, Inc.
1601 Trapelo Road
Suite 286
Waltham, MA 02451
Re:Minerva Neurosciences, Inc.
Registration Statement on Form S-3
Filed August 10, 2018
File No. 333-226783
Dear Dr. Luthringer:
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 Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ryan Sansom, Esq.
2015-07-24 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm CORRESP July 24, 2015 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Minerva Neurosciences, Inc. Registration Statement on Form S-3 (File No. 333-205764) Ladies and Gentlemen: The undersigned registrant hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective at 4:00 p.m. Eastern Time on July 27, 2015 or as soon thereafter as is practicable. The undersigned registrant hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the undersigned registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the undersigned registrant may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, MINERVA NEUROSCIENCES, INC. By: /s/ Mark S. Levine Mark S. Levine Senior Vice President, General Counsel and Secretary cc: Marc A. Recht, Esq.
2015-07-23 - UPLOAD - Minerva Neurosciences, Inc.
July 23, 2015 Via E -mail Remy Luthringer President and Chief Executive Officer Minerva Neurosciences, Inc. 1601 Trapelo Road Suite 284 Waltham, MA 02451 Re: Minerva Neurosciences, Inc. Registration Statement on Form S-3 Filed July 21, 2015 File No. 333-205764 Dear Mr. Luthringer : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Remy Luthringer Minerva Neurosciences, Inc. July 2 3, 2015 Page 2 Please refer to Rules 460 and 4 61 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities u nder the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Scot Foley at (202) 551 -3383 or Bryan Pitko (202) 551 -3203 with any questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Marc Recht Nicole Brookshire Richard Segal Cooley LLP 500 Boylston Street, 14th Floor Boston, MA 02116
2014-06-30 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm June 30, 2014 VIA ELECTRONIC SUBMISSION Securities and Exchange Commission Mail Stop 3561 Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Jeffrey P. Riedler, Assistant Director Daniel Greenspan Re: Minerva Neurosciences, Inc. Registration Statement Filed on Form S-1 Registration No. 333-195169 Ladies and Gentlemen: Pursuant to Rule 460 under the Securities Act of 1933, we wish to advise you that we have distributed approximately 829 copies of the Preliminary Prospectus issued June 10, 2014 through the date hereof, to underwriters, dealers, institutions and others. We 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 4:00 p.m. Eastern Time, on Monday, June 30, 2014 or as soon thereafter as practicable. [signature page follows] Very truly yours, JEFFERIES LLC As representative of the several Underwriters JEFFERIES LLC By: /s/ Ashley L. Delp Name: Ashley Delp Title: Managing Director [SIGNATURE PAGE TO ACCELERATION REQUEST OF THE UNDERWRITERS]
2014-06-30 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm Minerva Neurosciences 245 First Street Suite 1800 Cambridge, MA 02142 June 30, 2014 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Riedler Assistant Director Re: Minerva Neurosciences, Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-195169 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 pm, Washington, D.C. time on June 30, 2014, or as soon thereafter as is practicable, or at such later time as the Company may orally request via telephone call to the staff. The Registrant hereby authorizes David W. Pollak, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Morgan, Lewis & Bockius LLP, by calling David W. Pollak at (212) 309-6058. The Company hereby acknowledges that: · should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defence in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Minerva Neurosciences, Inc. By: /s/ Rogerio Vivaldi Coelho Name: Rogerio Vivaldi Coelho Title: Chief Executive Officer cc: Morgan, Lewis & Bockius LLP 2
2014-06-23 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm June 23, 2014 VIA ELECTRONIC SUBMISSION Securities and Exchange Commission Mail Stop 3561 Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Jeffrey P. Riedler, Assistant Director Daniel Greenspan Re: Minerva Neurosciences, Inc. Registration Statement Filed on Form S-1 Registration No. 333-195169 Ladies and Gentlemen: Pursuant to Rule 460 under the Securities Act of 1933, we wish to advise you that we have distributed approximately 829 copies of the Preliminary Prospectus issued June 10, 2014 through the date hereof, to underwriters, dealers, institutions and others. We 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 4:00 p.m. Eastern Time, on Wednesday, June 25, 2014 or as soon thereafter as practicable. [signature page follows] Very truly yours, JEFFERIES LLC As representative of the several Underwriters JEFFERIES LLC By: /s/ Ashley L. Delp Name: Ashley L. Delp Title: Managing Director [SIGNATURE PAGE TO ACCELERATION REQUEST OF THE UNDERWRITERS]
2014-06-23 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm Minerva Neurosciences 245 First Street Suite 1800 Cambridge, MA 02142 June 23, 2014 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Riedler Assistant Director Re: Minerva Neurosciences, Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-195169 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 pm, Washington, D.C. time on June 25, 2014, or as soon thereafter as is practicable, or at such later time as the Company may orally request via telephone call to the staff. The Registrant hereby authorizes David W. Pollak, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Morgan, Lewis & Bockius LLP, by calling David W. Pollak at (212) 309-6058. The Company hereby acknowledges that: · should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defence in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Minerva Neurosciences, Inc. By: /s/ Rogerio Vivaldi Coelho Name: Rogerio Vivaldi Coelho Title: Chief Executive Officer cc: Morgan, Lewis & Bockius LLP 2
2014-06-10 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 101 Park Avenue New York, NY 10178 June 10, 2014 United States Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Attention: Jeffrey P. Riedler Assistant Director Re: Minerva Neurosciences, Inc. Registration Statement on Form S-1 Filed on April 9, 2014 File No. 333-195169 Dear Mr. Riedler: On behalf of our client, Minerva Neurosciences, Inc. (the “Company”), set forth below is the Company’s response to the comments contained in the letter dated April 22, 2014 (the “Comment Letter”) from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), which relates to the Company’s Registration Statement on Form S-1 filed on April 9, 2014 (the “Registration Statement”). The Company is filing Amendment No.1 to the Registration Statement (the “First Amendment”) simultaneously with this letter. All references to page numbers in the responses below are to page numbers in the First Amendment. In order to facilitate your review, we have repeated each comment (each, a “Comment”) in its entirety in the original numbered sequence. Capitalized terms used in this letter but not defined herein have the meanings given to them in the First Amendment. Information provided in this letter on behalf of the Company have been provided to us by the Company. Management’s Discussion and Analysis of Financial Condition and Results of Operations Contractual Arrangements, page 74. 1. We note your response to our prior comment 12 and your revisions on pages 115-117 of the revised registration statement. As you have done on pages 115-117, please describe in this section the duration of your MIN-101 and MIN-117 license agreements. In this regard, we note that your revised disclosure on pages 76 and 115-117 provides that the duration of the MIN-101 and MIN-117 licenses is conditioned on your continuing obligation to pay royalties. Similarly, we note that the MIN-202 license agreement shall remain in effect until you have no more payment obligations to Janssen under the agreement. Accordingly, please revise your disclosure here and on pages 115-117 to specify when these payment obligations expire under the terms of the respective agreements. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 78-79 and 119-120 and of the First Amendment. 2. We note that you amended your license agreements for MIN-101 and MIN-117 in January 2014 and that the amended agreements provide that in the event you sell the rights to the licenses, the licensor will be entitled to a percentage of royalties received by you in the “low double digits.” Please revise your disclosure to more narrowly specify the royalty percentage by providing a range within a ten percent range (e.g. “single digits,” “teens,” “twenties,” etc…). Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 78 and 119-120 of the First Amendment. Please contact the undersigned at (212) 309-6058 or Anna Tomczyk at (212) 309-6217 if you have any questions regarding the foregoing Very truly yours, /s/ David W. Pollak David W. Pollak cc: Minerva Neurosciences, Inc. Deloitte & Touche LLP 2
2014-04-23 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm April 23, 2014 United States Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Attention: Jeffrey P. Riedler Assistant Director Re: Minerva Neurosciences, Inc. Registration Statement on Form S-1 (File No. 333-195169) This letter is furnished supplementally on behalf of Minerva Neurosciences, Inc. (the “Company”) in connection with the review by the Securities and Exchange Commission (the “Commission”) of the above-mentioned Registration Statement (the “Registration Statement”). The purpose of this letter is to provide supplemental information to the Staff regarding the preliminary estimated public offering price per share for the Company’s proposed initial public offering and to provide a further response to comment 13 in the Staff’s letter to the Company dated March 14, 2014. The Company’s response set forth in this letter is numbered to correspond to the numbered comment in the Staff’s letter. All terms used but not defined herein have the meanings assigned to such terms in the Registration Statement. For ease of reference, we have set forth the Staff’s comment in italics below, followed by the Company’s response. Confidential Treatment Request. Due to the commercially sensitive nature of information contained herein, the Company hereby requests, pursuant to 17 C.F.R. § 200.83, that certain portions of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person as they contain confidential information. The Company has filed a separate copy of this letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. § 200.83(d)(1), if any person (including any governmental employee who is not an employee of the Securities and Exchange Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days advance notice of any intended release so that the Company may, if deemed necessary or appropriate, pursue any remedies available to it. In such an event, we request that you telephone the undersigned rather than rely upon the U.S. mail for such notice. Fair Value of Common Stock, page 79 13. We may have additional comments on your accounting for stock compensation and related disclosure once you have disclosed an estimated offering price. Please provide quantitative and qualitative disclosures explaining the difference between the estimated offering price and the fair value of each equity issuance. Estimated Offering Price and Reverse Stock Split The Company advises the Staff that it presently estimates a preliminary price range for its initial public offering between $[****] and $[****] per share (the “Preliminary Assumed IPO Price”). Please note that the foregoing per-share amounts do not reflect the impact of an anticipated reverse stock split of 3.5 to 1 which the Company plans to effect prior to the closing of the offering. The lead underwriter on the proposed initial public offering first communicated their estimated Preliminary Price Range to the Company on April 21, 2014. The Preliminary Price Range does not take into account the current lack of liquidity for the Company’s common stock and assumes a successful initial public offering with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold in an acquisition transaction. **** Redacted confidential information. Historical Fair Value Determination and Methodology The Company’s discussion of stock-based compensation is primarily contained in the section of the Registration Statement entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Stock-Based Compensation” (the “Section”), which has previously been filed and is included on pages 77 through 84 of the Registration Statement. As described in the Section, the Company has historically determined the fair value of its common stock using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants (the “AICPA”), Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation (the “AICPA Practice Guide”). The Company has contemporaneous documentation to support each valuation including third party valuation reports. In addition, as described in the Section, the Company’s Board of Directors has historically considered various objective and subjective factors to determine the fair value of the Company’s common stock, including, among others: the conclusions of contemporaneous or retrospective third-party valuations of the Company and its common stock, historical operating and financial performance, the Company’s stage of development and risks related to its business or industry, the progress of its research and development programs, the Company’s results of operations and financial position, the rights associated with convertible loan notes , the lack of marketability of the Company’s common stock and external market and economic conditions affecting the pharmaceutical and biotechnology industries. The Company also considered the likelihood of achieving a liquidity event such as an IPO or sale of the Company in light of prevailing market conditions, and then used the Probability Weighted Expected Return Method (“PWERM”) to allocate the fair value of the Company to the Company’s stock. The PWERM is an accepted valuation method under the AICPA Practice Guide. Most Recent Fair Value Determinations As described in the Section, on December 20, 2013, the date of the Company’s most recent option grants, the Company determined the fair value of its common stock to be $2.71 per share (the “Estimated Fair Value”). This determination was based on the Board’s evaluation of the factors described above, including a review of a third-party valuation of the Company’s common stock, which had been conducted using the PWERM as of November 12, 2013 which resulted in a fair value determination of $2.71 per share. The Company also had a third party valuation on December 31, 2013 with such valuation approximating the $2.71 (within $0.02) per share. The fact that the fair value remained substantially unchanged during the period between such determinations is consistent with the fact that there were no significant developments with respect to the Company during such period. On March 31, 2014, the Company determined the value of its common stock to be $3.86 per share. This determination was based on the Board’s evaluation of the factors described above, including a review of the Company’s most recent third-party valuation of its common stock which had been conducted using the PWERM as of March 31, 2014 which had resulted in a fair valuation determination of $3.86 per share. The increase in value from November 12, 2013 and March 31, 2014 was attributable to the increased proximity to IPO, as the Company confidentially submitted its Registration Statement with the SEC on February 14, 2014, and certain positive effects on the Company’s business including: · The Company concluded a Co-Development and Commercialisation Agreement with Janssen, a Johnson & Johnson company for MIN-202 a pharmaceutical treatment for primary and secondary insomnia on February 12, 2014 to be effective upon the IPO. In addition, Johnson & Johnson Development Corporation has entered into a Share Purchase Agreement to purchase $26 million of the Company’s shares at the IPO price. · The Company concluded the acquisition of 100% of the share capital of Mind-NRG SA on February 11, 2014, a Swiss company which owns exclusive rights to a biopharmaceutical treatment renamed MIN-301 for the treatment of Parkinson’s Disease. The consummation of these transactions made the IPO more probable as compared to the November 12, and December 31, 2013 valuations where there was still some risk that management would not be able to complete these transactions and secure all of the Minerva programs and is quantified by the shift in the probability of the IPO occurring from 80% to 95% and in the discount for lack of **** Redacted confidential information. marketability from 10% to 6%. The balance of the difference was attributable to the aforementioned transactions, and less appetite for a smaller program portfolio, investor fatigue towards biotech IPO pitches and broader macroeconomic concerns at the end of 2013. Comparison of Estimated Fair Value and Assumed IPO Price The Company advises the Staff that the following disclosure will be included in the next pre-effective amendment to the Registration Statement in response to the Staff’s comment to provide the primary factors that contributed to the increase in the estimated public offering price from the Company’s Estimated Fair Value: “We note that, as is typical in IPOs, the estimated price range for this offering was not derived using a formal determination of fair value, but was determined by negotiation between us and the underwriters. Among the factors that were considered in setting this range were the following: · an analysis of the typical valuation ranges seen in recent IPOs for companies in our industry; · the general condition of the securities markets and the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies; · an assumption that there would be a receptive public trading market for clinical stage biopharmaceutical companies such as us; and · an assumption that there would be sufficient demand for our common stock to support an offering of the size contemplated by this prospectus. We believe that the difference between the fair value of our common stock as of March 31, 2014 and the midpoint of the price range for this offering is the result of these factors and the following factors with respect to our business that occurred subsequent to March 31, 2014: · The PWERM uses a probability weighted approach as described above, and the resulting calculation of the fair value of our common stock as of March 31, 2014 included the potential for an IPO and alternative liquidity events and assigned a probability for each potential outcome. The discount from the mid point of the proposed IPO range is driven by the accounting of other lower value liquidity events as well as discounts for present value as well as for lack of marketability. By concluding that the Company will achieve its IPO and excluding the other lower value liquidity events in the PWERM the associated discount is removed with the effect that the valuation increases by around $0.10. On completion of an IPO the discounts associated with present value and lack of marketability are also removed with a resultant increase in valuation of $0.09 and $0.25 respectively. Conclusion The Company has historically determined the fair value of its common stock consistent with the guidance set forth in the AICPA Practice Guide, including, specifically, its use of PWERM, which is an accepted valuation method under the AICPA Practice Guide. The Company believes that the deemed per share fair values used as the basis for determining stock-based compensation in connection with its stock option grants since January 1, 2013 and the Preliminary Assumed IPO Price are reasonable and appropriate for the reasons described herein and in the Section. If you have any questions, please contact the undersigned at (212) 309-6058 or Anna Tomczyk at (212) 309-6217. Very truly yours, /s/ David W. Pollak David W. Pollak cc: Minerva Neurosciences, Inc. **** Redacted confidential information.
2014-04-22 - UPLOAD - Minerva Neurosciences, Inc.
April 22, 2014 Via E -mail Mr. Rogerio Vivaldi Coelho Chief Executive Officer Minerva Neurosciences, Inc. 245 First Street Suite 1800 Cambridge, MA 02142 Re: Minerva Neurosciences, Inc. Registration Statement on Form S -1 Filed April 9, 2014 File No. 333 -195169 Dear Mr. Coelho : 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. Management’s Discussion and Analysis of Financial Condition and Results of Operations Contractual Arrangements, page 74 1. We note your response to our prior comment 12 and your revisions on pages 115 -117 of the revised registration statement. As you have done on pages 115 -117, please describe in this section the duration of your MIN -101 and MIN -117 license agreements. In this regard, we note that your revised disclosure on pages 76 and 115 -117 provides that the duration of the MIN -101 and MIN -117 licenses is conditioned on your continuing oblig ation to pay royalties. Similarly, we note that the MIN -202 license agreement shall remain in effect until you have no more payment obligations to Janssen under the agreement. Accordingly, please revise your disclosure here and on pages 115 -117 to specif y when these payment obligations expire under the terms of the respective agreements. Rogerio Vivaldi Coelho Minerva Neurosciences , Inc. April 22 , 2014 Page 2 2. We note that you amended your license agreements for MIN -101 and MIN -117 in January 2014 and that the amended agreements provide that in the event you sell the rights t o the licenses, the licensor will be entitled to a percentage of royalties received by you in the “low double digits.” Please revise your disclosure to more narrowly specify the royalty percentage by providing a range within a ten percent range (e.g. “sin gle digits,” “teens,” twenties,” etc…). We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing ef fective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date o f the registration statement. Rogerio Vivaldi Coelho Minerva Neurosciences , Inc. April 22 , 2014 Page 3 You may contact Dana Hartz at (202) 551 -3648 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Johnny Gharib a t (202) 551 -3170, Dani el Greenspan at (202) 551 -3623 or me at (202) 551-3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail David W. Pollak, Esq. Morgan Lewis & Bockius LLP
2014-04-09 - CORRESP - Minerva Neurosciences, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 101 Park Avenue New York, NY 10178 April 9, 2014 United States Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Attention: Jeffrey P. Riedler Assistant Director Re: Minerva Neurosciences, Inc. Draft Registration Statement on Form S-1 Submitted Confidentially on February 14, 2014 CIK No. 0001598646 Dear Mr. Riedler: On behalf of our client, Minerva Neurosciences, Inc. (the “Company”), set forth below is the Company’s response to the comments contained in the letter dated March 14, 2014 (the “Comment Letter”) from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), which relates to the Company’s Draft Registration Statement on Form S-1 confidentially submitted on February 14, 2014 (the “Registration Statement”). The Company is filing the Registration Statement (the “Revised Registration Statement”) simultaneously with this letter. All references to page numbers in the responses below are to page numbers in the Revised Registration Statement. In order to facilitate your review, we have repeated each comment (each, a “Comment”) in its entirety in the original numbered sequence. Capitalized terms used in this letter but not defined herein have the meanings given to them in the Revised Registration Statement. Information provided in this letter on behalf of the Company have been provided to us by the Company. General 1. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our review. Response: The Company confirms that the graphics included in the Revised Registration Statement are the only graphics the Company will use in its prospectus. 2. We note that you intend to request confidential treatment for portions of information contained in your exhibits. If you have not done so, please submit your application for confidential treatment as soon as possible so that we may begin our review of your request. Any staff comments to your application will be sent separately from comments to your draft registration statement. Response: The Company acknowledges that the Staff will provide separate comments to the Company’s confidential treatment request, which was submitted on March 31, 2014. 3. 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. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. Response: The Company acknowledges the Staff’s comment and will supplementally provide the Staff with such Rule 405 Communications. The Company does not anticipate that any research reports will be published or distributed by any broker or dealer participating in this offering in reliance on Section 2(a)(3) of the Securities Act; however, if such reports are published or distributed, the Company will provide such research reports to the Staff. Risk Factors, page 10 4. Please add a risk factor regarding foreign currency exchange risk in connection with your operations in Europe. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 28 of the Revised Registration Statement. 5. You disclose your plan to initially conduct further clinical trials in Europe and that intend to put off any clinical trials in the United State until 2015. Accordingly, please also discuss here any risks to your product development and domestic commercialization strategy from conducting trials outside of the United States. For example, you should address the possibility that the FDA may not accept the results of such trials and how such lack of acceptance could impact the regulatory approval process. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 14 of the Revised Registration Statement. “We plan to use potential future operating losses . . .,” page 12 6. We refer to your disclosure on page 69 under the caption “Net Operating Losses and Carryforwards.” Please expand this risk factor so that it includes all of the material information about your net operating loss carryforwards that you have provided on page 69. For example: · Please quantify your net operating loss carryforwards as of the most recent practicable date; · Briefly describe why you may be subject to Section 382 limitations, specifying the transactions that might trigger an ownership change; · State the likelihood that an ownership change occurred for purposes of Section 382; and · If practicable, estimate the reduction on your available NOL carryforwards if Section 382 were triggered. If the entire amount of NOL carryforwards is at risk, please state as much. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 69 of the Revised Registration Statement. The Company supplementally advises the Staff that it does not intend to perform a detailed analysis to determine the likelihood that an ownership change has occurred for the purposes of Section 382, as the Company believes that this exercise would result in undue cost and effort, given the potential utilization of any net operating loss carryforwards is several years from present. 2 “We are heavily dependent on the success of our two lead product candidates . . ., page 12” 7. Please refer here to the comprehensive discussion beginning on page 117 of the process for regulatory approval in the European Union and the FDA. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 12 of the Revised Registration Statement. 8. You state in the risk factor entitled “Our disclosure controls and procedures may not prevent . . .” that you have historically operated without full time employees. If your executive officers devote less than full time to the operation of your business, please add a separate risk factor with this information, and include how many hours per week they devote to the business. Response: The Company advises the Staff that its current executive officers are all full time employees of the Company. “If we are unable to obtain or protect intellectual property rights . . .,” page 38 9. Please expand this risk factor to identify the licenses material to your business that give you the right to prepare, file and prosecute patent applications, and which licenses do not give you such rights. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 39-40 of the Revised Registration Statement. “We may become involved in lawsuits to protect or enforce our patents...,” page 40 “We may not be able to protect our intellectual property rights...,” page 42 “Obtaining and maintaining our patent protection depends on compliance . . .,” page 42 10. If you are aware or have experienced any challenges or infringements to your rights, or situations of material noncompliance with governmental rules regarding the patent process as described in these risk factors, as applicable, please so disclose. Response: The Company advises the Staff that the Company is not aware of and has not experienced any challenges to its intellectual property rights. As a result, the Company has not revised the disclosure on pages 41-44. Special Note Regarding Forward-Looking Statements, page 49 11. Please note that it is not appropriate to state or imply that you do not have liability for the statements in your registration statement. Your statement on page 50 that you “have not independently verified any third-party information” could imply that you are not taking liability for the statistical and other industry and market data included in your registration statement. In order to eliminate any inference that you are not liable for all of the information in your registration statement, please delete these statements or include a statement specifically accepting liability for these statements. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 52 of the Revised Registration Statement by deleting the following statement: “Although we believe that the data from these third party sources are reliable, we have not independently verified any third party information.” 3 Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 66 Contractual Arrangements, page 74 12. Here and on pages 109-110, please expand your descriptions of the license agreements related to MIN-101, MIN-117, and MIN-202 to describe the duration of each license agreement. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 115-117 of the Revised Registration Statement. Fair Value of Common Stock, page 79 13. We may have additional comments on your accounting for stock compensation or any beneficial conversion features once you have disclosed an estimated offering price. Please supplementally provide us with a quantitative and qualitative analysis explaining the difference between the estimated offering price and the fair value of each equity issuance since December 20, 2013 through the date of effectiveness. Response: The Company acknowledges the Staff’s comment and will supplementally provide the Staff with a quantitative and qualitative analysis explaining the difference between the estimated offering price and the fair value of each equity issuance since December 20, 2013 through the date of effectiveness. Business, page 85 Our Pipeline, page 90 14. Please include in your disclosure a brief discussion of the importance and use of statistical significance in preclinical and clinical trial analytics. Please also provide an explanation of “p-values” in layman’s terms and put this terminology in context by explaining why p-values of .05 or less would be viewed as statistically significant. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 97 of the Revised Registration Statement. 15. When you first describe the mechanism(s) of action for your pipeline compounds, please revise so that your discussion and use of technical terminology is sufficiently comprehensible to lay investors. By way of example only: · When you discuss the properties of MIN-101 as “an antagonist of 5-HT2A and sigma2 receptors,” you should briefly explain this terminology, the significance of the 5-HT2A and sigma2 receptors and the biochemical effect and cellular response of these antagonists binding with the specified receptors; and · When you discuss the differentiating attributes of MIN-301, you should briefly explain what a recombinant protein is, how MIN-301 “activates” ErbB4 target and describe the cellular 4 response, the significance of ErbB4, and how activation of ErbB4 results in neurological effects. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 89-91 of the Revised Registration Statement. 16. Please revise to specify, as applicable, the specific quantitative primary and secondary endpoints of all of the trials discussed, and compare that to actual results observed. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 96-100, 104-105, 110 and 111-112 of the Revised Registration Statement. 17. In the illustrative charts appearing throughout your Business section to describe results of trials, please revise to ensure that the reader has a clear idea of the meaning and significance of the units of measurement employed. For example: · On pages 94 and 95, the vertical axes of your graphs denote “changes from baseline” but it is not readily apparent what these units of change represent or how to put total score decreases on the PANSS scale in their proper context; and · On page 96, it is not clear what the acronym “PCP” stands for, nor is the scale of social interaction upon which test subjects were presumably measured ever defined. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 97-100, 105-107, 110 and 113-114 of the Revised Registration Statement. 18. We note that your Phase IIa clinical trial of MIN-101 “was not powered to achieve statistically significant results.” Yet, you go on to state that “statistical significance was reached in both the PPC and the FAS for the 5 [factor] negative score” and that the “3 factor negative scores were nearly statistically significant.” Please revise to reconcile these statements and explain how not powering the trial for statistical significance bears on the weight to which investors should attach to your observations of statistical significance and near-statistical significance. In addition, you should explain the extent to which you may rely on these results in your regulatory filings to support claims of statistically significant treatment effects. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 96-97 of the Revised Registration Statement. 19. Similarly, we note your discussion on page 100 of “statistically significant improvements” observed in a Phase I study if MIN-117. As Phase I studies are not customarily powered for statistical significance, please clarify the appropriateness of your discussion of it here. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 105 of the Revised Registration Statement. 5 20. Where your clinical trials were powered for statistical significance or where you observed either statistical significance or near-statistical significance, please disclose the respective sample size of trial subjects. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 96, 105 and 110 of the Revised Registration Statement. 21. On page 93, please revise to explain the meaning and significance of “per protocol” and “full analysis” sets and why you have chosen to present charts illustrating clinical results for PPC and not also FAS. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 97 of the Revised Registration Statement. 22. On page 95, please disclose the cardiac events that occurred in the MIN-101 subjects. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 99 of the Revised Registration Statement. 23. In addition, on page 95 please explain the meaning and significance of QT/QTc prolongation and specifically differentiate the rates exhibited by the MIN-101 and placebo group. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 99-100 of the Revised Registration Statement. 24. On page 96, please specifically describe the “other reasons” MTPC decided to discontinue development of MIN-101 of which you are aware and which you have not articulated. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 100 of the Revis
2014-03-14 - UPLOAD - Minerva Neurosciences, Inc.
March 14 , 2014 Via E -mail Rogerio Vivaldi Coelho Chief Executive Officer 245 First Street Suite 1800 Cambridge, MA 02142 Re: Minerva Neurosciences, Inc. Draft Registration Statement on Form S-1 Submitted Confidentially on February 14, 2014 CIK No. 0001598646 Dear Mr. Coelho : We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. General 1. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our review. 2. We note that you intend to request confidential treatment for portions of information contained in you r exhibits. If you have not done so, please submit your application for confidential treatment as soon as possible so that we may begin our review of your request. Any staff comments to your application will be sent separately from comments to your draft registration statement. 3. 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, Rogerio Vivaldi Coelho Minerva Neurosciences, Inc. March 14 , 2014 Page 2 present to potential investors in r eliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of t he Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. Risk Factors , page 10 4. Please add a risk factor regarding foreign currency exchange risk in connection with your operations in Europe. 5. You disclose your plan to initi ally conduct further clinical trials in Europe and that intend to put off any clinical trials in the United State until 2015. Accordingly, please al so discuss here a ny risks to your product development and domestic commercialization strategy from conducti ng trials outside of the United States. For example, you should address the possibility that the FDA may not accept the results of such trials and how such lack of acceptance could impact the regulatory approval process. “We plan to use potential future operating losses . . .,” page 12 6. We refer to your disclosure on page 69 under the caption “Net Operating Losses and Carryforwards.” P lease expand this risk factor so that it includes all of the mat erial information about your net operating loss carryforwards that you have provided on page 69. For example : Please quantify your net operating loss carryforwards as of the most recent practicable date ; Briefly describe why you may be subject to Section 382 limitations , specifying the transactions that might trigger an ownership change; State the likelihood that an o wnership change occurred for purposes of Section 382; and If practicable, estimate the reduction on your available NOL carryforwards if Section 382 were triggered. If the entire amount of NOL carryforwards is at risk, please state as much. “We are heavily dependent on the succ ess of our two lead product candidates . . ., page 12” 7. Please refer here to the comprehensive discussion beginning on page 117 of the process for regulatory approval in the European Union and the FDA. 8. You state in the risk factor entitled “Our disclosure controls and procedures may not prevent . . .” that you have historically operated without full time employees. If you r executive Rogerio Vivaldi Coelho Minerva Neurosciences, Inc. March 14 , 2014 Page 3 officers devote less than full time to the operation of your business, please add a separate risk factor with this information, and include how many hours per week they devote to the business. “If we are unable to obtain or protect intellectua l property rights . . .,” page 38 9. Please expand this risk factor to identify the licenses material to your business that give you the right to prepare, file and prosecute patent applications, and which licenses do not give you such rights. “We may become involved in lawsuits to protect or enforce our patents…,” page 40 “We may not be able to protect our intellectual property rights…,” page 42 “Obtaining and maintaining our patent protection depends on compliance . . .,” page 42 10. If you are aware or have experienced any challenges or infringements to your rights , or situations of material noncompliance with governmental rules regarding the patent process as described in these risk factor s, as applicable , please so disclose. Special Note Regarding Forward -Looking Statements, page 49 11. Please note that it is not appropriate to state or imply that you do not have liability for the statemen ts in your registration statement. Your statement on page 50 that you “ have not independently verifi ed any third -party information” could imply that you are not taking liability for the statistical and other industry and market data included in your regis tration statement. In order to eliminate any inference that you are not liable for all of the information in your registration statement, please delete these statements or include a statement specifically accepting liability for these statements. Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 66 Contractual Arrangements, page 74 12. Here and on pages 109 -110, please expand your descriptions of the license agreements related to MIN -101, MIN -117, and MIN -202 to describe the durat ion of each license agreement. Fair Value of Common Stock, page 79 13. We may have additional comments on your accounting for stock compensation or any beneficial conversion features once you have disclosed an estimated offering price. Please supplementally provide us with a quantitative and qualitative analysis explaining the difference between the estimated offering price and the fair value of each equity issuance since December 20, 2013 through the date of effectiveness. Rogerio Vivaldi Coelho Minerva Neurosciences, Inc. March 14 , 2014 Page 4 Business, page 85 Our Pipeline, p age 90 14. Please include in your disclosure a brief discussion of the importance and use of statistical significance in preclinical and clinical trial analytics. Please also provide an explanation of “p-values” in layman’s terms and put this terminology in context by explaining why p-value s of .05 or less would be viewed as statistically significant. 15. When you first describe the mechanism(s) of action for your pipeline compounds, please revise so that your discussion and use of technical terminology is sufficiently comprehensible to lay investors. By way of example only: When you discuss the properties of MIN -101 as “an antagonist of 5 -HT2A and sigma2 receptors,” you should briefly explain this terminology, the significance of the 5-HT2A and sigma2 receptors and the biochemical effect and cellular response of these antagonists bindi ng with the specified recept ors; and When you discuss the differentiating attributes of MIN -301, you should briefly explain what a recombinant protein is, how MIN -301 “activates” ErbB4 target and describe the cellular response, the significance of ErbB4, and how activation of ErbB4 results in neurological effects. 16. Please revise to specify, as applicable, the specific quantitative primary and secondary endpoints of all of the trials discussed, and compare that to actual results observed. 17. In the illustrative charts appearing throughout your Business section to describe results of trials, please revise to ensure that the reader has a clear idea of the meaning and significance of the units of measurement employed. For example: On pages 94 and 95, the vertical axes of your graphs denote “changes from baseline” but it is not readily apparent what these units of change represent or how to put total score decreases on the PANSS scale in their proper context; and On page 96, it is not clear what the acronym “PCP” stands for, nor is the scale of social interaction upon which test subjects were presumably measured ever defined. 18. We not e that your Phase IIa clinical trial of MIN -101 “was not powered to achieve statistically significant results.” Yet, you go on to state that “statistical significance was reached in both the PPC and the FAS for the 5 [factor] negative score” and that the “ 3 factor negative scores were nearly statistically significant.” Please revise to reconcile these statements and explain how not powering the trial for statistical significance bears on the weight to which investors should attach to your observations of s tatistical significance and near-statistical significance. In addition, you should explain the extent to which you may Rogerio Vivaldi Coelho Minerva Neurosciences, Inc. March 14 , 2014 Page 5 rely on these results in your regulatory filings to support claims of statistically significant treatment effects . 19. Simi larly, we note your discussion on page 100 of “statistically significant improvements” observed in a Phase I study if MIN -117. As Phase I studies are not customarily powered for statistical significance, please clarify the appropriateness of your discussi on of it here. 20. Where your clinical trials were powered for statistical significance or where you observed either statistical significance or near -statistical significance, please disclose the respective sample size of trial subjects. 21. On page 93, p lease revise to explain the meaning and significance of “per protocol” and “full analysis” sets and why you have chosen to present charts illustrating clinical results for PPC and not also FA S. 22. On page 95, pleas e disclose the cardiac events that occurred in the MIN -101 subjects. 23. In addition, on page 95 please explain the meaning and significance of QT/QTc prolongation and specifically differentiate the rates exhibited by the MIN -101 and placebo g roup. 24. On page 96, please specifically describe the “other reasons ” MTPC decided to discontinue development of MIN -101 of which you are aware and which you have not articulated. 25. We note your intention to conduct a “confirma tory” Phase IIb clinical trial for MIN -101 in 2014 , as well as plans to initiate a Phase II clinical trial in 2014 for MIN -117 which you hope will serve as one of three planned “pivotal trials.” As it is more typical for Phase III trials to serve as pivot al or confirmatory trials for determining efficacy and safety, please address in your disclosure whether your development strategy is customary and whether relying on a Phase II trial, rather than a Phase III trial, as the basis for marketing approval from regulatory authorities poses any difficulties or challenges. 26. Please define the abbreviation MPTP in the first instance you use it, on page 107, in the context of MIN -301. Competition, page 110 27. For all competing products described on pages 111 -12, please disclose the manufa cturer. Government Regulation and Product Approval, page 117 28. Throughout your prospectus, you indicate that all c linical trials must be designed, conducted and performed in accordance with applicable regulatory requirements and ethical principles. Please provide more detail in this section regarding the “ethical principles” you must satisfy while conducting clinical trials. Rogerio Vivaldi Coelho Minerva Neurosciences, Inc. March 14 , 2014 Page 6 Management, page 133 29. Please describe the business experience of Marc Beer from 200 9 through 2010. Description of Capital Stock, page 155 Forum, page 156 30. We note your disclosu re entitled Forum on page 156. Please disclose that although you will provide a cho ice of forum clause in your restated certification of incorporation, it is possible that a court could rule that such provision is inapplicable or unenforceable. Exhibit Index 31. Please file the following agreements as exhibits to your registration statement: Agreement and Plan of Merger dated November 12, 2013 between Sonk ei Pharmaceuticals and Cyrenaic Pharmaceuticals; The acquisition agreement between the company and M ind-NRG ; The assignment agreement with ProteoSys, pursuant to which Mind -NRG acquired the rights to MIN -301; The common stock purchase ag reement dated Febru ary 12, 2014 with JJDC; Promissory Notes sold by the Company to affiliates of Care Capital and Index Ventures; Registration Rights Agreement with JJDC; Consulting agreement between the company and Geoff Race dated September 1, 2011 and any amendments there to; Consulting agreement between the company and Remy Luthringer dated January 11, 2011, and any amendments thereto ; and The 2013 Equity Incentive Plan. If you intend to respond to these comments with an amended draft registration statement, please submit it and any associated correspondence in accordance with the guidance we provide in the Di vision’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm. Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm). If you intend to use Rule 83 (17 CFR 200.83) to request confidential trea tment of information in the correspondence you submit on EDGAR, please properly mark that information in each of yo ur confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. Rogerio Vivaldi Coelho Minerva Neurosciences, Inc. March 14 , 2014 Page 7 You may contact Dana Har tz at (202) 551 -3648 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Rose Zukin at (202) 551 -3239, Dan Greenspan at (202) 551 -3623, or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: David W. Pollak Morgan Lewis & Bockius LLP 101 Park Avenue New York, NY 10178