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SEC Comment Letters
Company Responses
Letter Text
Tvardi Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Tvardi Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
Tvardi Therapeutics, Inc.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2025-01-24
Tvardi Therapeutics, Inc.
References: January 15, 2025
↓
Company responded
2025-02-13
Tvardi Therapeutics, Inc.
References: February 11, 2025 | January 24, 2025
↓
Tvardi Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2025-02-11
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2025-02-11
Generating summary...
Tvardi Therapeutics, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2022-03-08
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2022-03-08
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↓
Company responded
2022-04-22
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2022-04-22
Generating summary...
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Company responded
2022-04-26
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2022-04-26
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↓
Company responded
2022-05-09
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2022-05-09
Generating summary...
Tvardi Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-03-22
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2019-03-22
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↓
Company responded
2019-04-02
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2019-04-02
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Tvardi Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-10-05
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2017-10-05
Generating summary...
Tvardi Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-09-12
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2017-09-12
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Company responded
2017-09-20
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2017-09-20
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Tvardi Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-03-22
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2017-03-22
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Company responded
2017-03-23
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2017-03-23
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Tvardi Therapeutics, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2015-04-03
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2015-04-03
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↓
Company responded
2015-05-13
Tvardi Therapeutics, Inc.
References: April 3, 2015
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2015-05-13
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Company responded
2015-05-13
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2015-05-13
Generating summary...
Tvardi Therapeutics, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2013-11-21
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2013-11-21
Generating summary...
↓
Company responded
2013-12-30
Tvardi Therapeutics, Inc.
References: November 20, 2013
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2013-12-30
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Company responded
2014-01-28
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2014-01-28
Generating summary...
↓
Company responded
2014-01-28
Tvardi Therapeutics, Inc.
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2014-01-28
Generating summary...
Tvardi Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2013-11-01
Tvardi Therapeutics, Inc.
Filing - SEC Comment Letter to Tvardi Therapeutics, Inc.
UPLOAD · 2013-11-01
Generating summary...
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Company responded
2013-11-08
Tvardi Therapeutics, Inc.
References: October 31, 2013
Filing - Correspondence from Tvardi Therapeutics, Inc.
CORRESP · 2013-11-08
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-08 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-05-07 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-295496 | Read Filing View |
| 2025-06-05 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-287675 | Read Filing View |
| 2025-02-14 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-13 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-11 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-283900 | Read Filing View |
| 2025-01-24 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-16 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-283900 | Read Filing View |
| 2022-05-09 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-26 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-03-08 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-03-22 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-10-05 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-20 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-12 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-23 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-22 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-05-13 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-05-13 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-04-03 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-01-28 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-01-28 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-12-30 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-11-21 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-11-08 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-11-01 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-07 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-295496 | Read Filing View |
| 2025-06-05 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-287675 | Read Filing View |
| 2025-02-11 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-283900 | Read Filing View |
| 2025-01-16 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | 333-283900 | Read Filing View |
| 2022-03-08 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-03-22 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-10-05 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-12 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-22 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-04-03 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-11-21 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-11-01 | SEC Comment Letter | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-08 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-14 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-13 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-24 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-05-09 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-26 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-20 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-23 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-05-13 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-05-13 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-01-28 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-01-28 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-12-30 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2013-11-08 | Company Response | Tvardi Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-05-08 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm TVARDI THERAPEUTICS, INC. 3 Sugar Creek Ctr. Blvd., Suite 525 Sugar Land. TX 77478 (713) 489-8654 May 8, 2026 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Information Technologies and Services 100 F Street, N.E. Washington, D.C. 20549 Re: Tvardi Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-295496 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 U.S. Securities and Exchange Commission (the " Commission ") take appropriate action to cause the Registration Statement on Form S-3 (File No. 333-295496) (the " Registration Statement ") to become effective on Tuesday, May 12, 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 " Staff "). The Registrant hereby authorizes Madison Jones 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 Madison Jones of Cooley LLP, counsel to the Registrant, at (202) 728-7087, or in her absence Divakar Gupta of Cooley LLP at (212) 479-6474. Very truly yours, TVARDI THERAPEUTICS, INC. By: /s/ Dan Conn Name: Dan Conn Title: Chief Financial Officer cc: Madison Jones, Cooley LLP Divakar Gupta, Cooley LLP
2026-05-07 - UPLOAD - Tvardi Therapeutics, Inc. File: 333-295496
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2026 Imran Alibhai Chief Executive Officer Tvardi Therapeutics, Inc. 3 Sugar Creet Ctr. Blvd. Suite 525 Sugar Land, TX 77478 Re: Tvardi Therapeutics, Inc. Registration Statement on Form S-3 Filed May 1, 2026 File No. 333-295496 Dear Imran Alibhai: 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 Jessica Dickerson at 202-551-8013 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Madison A. Jones, Esq. </TEXT> </DOCUMENT>
2025-06-05 - UPLOAD - Tvardi Therapeutics, Inc. File: 333-287675
June 5, 2025
Imran Alibhai, Ph.D.
Chief Executive Officer
Tvardi Therapeutics, Inc.
3 Sugar Creek Ctr. Blvd.
Suite 525
Sugar Land, TX 77478
Re:Tvardi Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 30, 2025
File No. 333-287675
Dear Imran Alibhai Ph.D.:
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 Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Divakar Gupta, Esq.
2025-02-14 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
Cara Therapeutics, Inc.
400 Atlantic Street
Suite 500
Stamford, CT 06901
February 14, 2025
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Cara Therapeutics, Inc.
Registration Statement on Form S-4 File
No. 333-283900
Request for Acceleration of Effectiveness
Ladies and Gentlemen:
In accordance with Rule 461 promulgated under
the Securities Act of 1933, as amended, Cara Therapeutics, Inc. (the “Company”) hereby requests acceleration
of the effective date of the Registration Statement on Form S-4 (File No. 333-283900), as amended (the “Registration
Statement”), so that it may become effective at 5:00 p.m., Washington, D.C. time, on February 14, 2025, or as soon as possible
thereafter.
The Company hereby authorizes Daniel A. Bagliebter, Esq.
and Jeffrey P. Schultz, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. to orally modify or withdraw this request for acceleration.
The Company respectfully requests that it be notified
of such effectiveness by a telephone call to Mr. Bagliebter at (212) 692-6856 and that such effectiveness also be confirmed in writing.
Any questions regarding this request may be addressed to Mr. Bagliebter.
Very truly yours,
CARA THERAPEUTICS, INC.
/s/ Christopher Posner
Christopher Posner
President and Chief Executive Officer
cc:
Cara Therapeutics, Inc.
Scott Terrillion, Esq.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Daniel A. Bagliebter, Esq.
Jeffrey P. Schultz, Esq
Tvardi Therapeutics, Inc.
Imran Alibhai
Cooley
LLP
Rama Padmanabhan, Esq.
Carlos Ramirez, Esq.
2025-02-13 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
919 Third Avenue
New York, NY 10022
212 935 3000
mintz.com
February 13, 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:
Jessica Dickerson
Joshua Gorsky
Re:
Cara Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed January 27, 2025
File No. 333-283900
Ladies and Gentlemen:
This letter sets forth the
response of Cara Therapeutics, Inc. (the “Company”) to the comments of the staff of the Division of Corporate
Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
set forth in your letter dated February 11, 2025, with respect to the above referenced Amendment No. 1 to the Registration Statement
on Form S-4.
Concurrently with the submission
of this letter, the Company is filing Amendment No. 2 to the Registration Statement on Form S-4 (the “Second Amended
Registration Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto
in the Second Amended Registration Statement.
Set forth below is the Company’s response
to the Staff’s comments. For the Staff’s convenience, we have incorporated your comments into this response letter in italics.
Boston Los
Angeles MIAMI New York San Diego San Francisco toronto Washington
Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
MINTZ
February 13, 2025
Page 2
Amendment No. 1 to Registration Statement on Form S-4
Prospectus Summary
The Companies
Cara Therapeutics, Inc., page 9
1. We note your response to prior comment 8 regarding the deficiency letters you received from Nasdaq.
We further note your statements that (i) the parties intend to satisfy each of the applicable Nasdaq listing criteria upon completion
of the proposed Merger such that the combined company will remain listed on the Nasdaq Capital Market and (ii) there can be no assurance
that you will be able to regain compliance with the minimum stockholders’ equity requirement within the applicable extension period.
Please disclose whether you intend to complete the Merger in the event you do not timely regain compliance with the requirement.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised the disclosure on page 11 of the Second Amended Registration Statement to clarify that the
continued listing of the shares of the Company’s common stock is a condition to closing that is subject to waiver by the Board of
Directors (“Tvardi Board”) of Tvardi Therapeutics, Inc. (“Tvardi”), and that
if the Company is unable to timely regain compliance with the requirement, it is unknown whether the Tvardi Board will grant a waiver
of this condition until such a time (if ever) that such a determination by the Tvardi Board becomes necessary.
Support Agreements, page 17
2. We note your response to prior comment 7. Similar to your revised disclosure on page 135, please
further revise your disclosure on page 17 to clarify that your officers and directors, and their affiliated funds, who collectively
own approximately 1% of your “outstanding” common stock entered into the support agreements.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised the disclosure on page 18 of the Second Amended Registration Statement to clarify that the
above referenced percentage reflects the Company’s “outstanding shares of common stock.”
MINTZ
February 13, 2025
Page 3
Opinion of Cara’s Financial Advisor, page 149
3. We note your response to prior comment 12. To help us further evaluate your response, please tell us
whether the omitted financial projections were used or relied upon by your financial advisor in considering the fairness determination.
Response: The Company respectfully acknowledges the
Staff’s comment. As noted in the Company’s response, dated January 24, 2025, to the Staff, certain balance sheet data with
respect to the cash and debt positions of Tvardi as of November 30, 2024 and quarterly financial forecasts relating to the business,
earnings, cash flows, and prospects of Tvardi from December 31, 2024 through December 31, 2026 (the “Tvardi Financial Forecasts”)
were prepared and provided by Tvardi’s management in connection with the Merger at the request of the Company to confirm Tvardi’s
then-expected future cash flows for diligence purposes. The Tvardi Financial Forecasts were then furnished to Piper Sandler & Co.
(“Piper Sandler”) as background information. As noted in the proxy statement/prospectus, Piper Sandler reviewed
and analyzed, among other things, the Tvardi Financial Forecasts. However, given the limited time periods for which they were available,
and given the limited information contained therein, Piper Sandler did not, and in fact was unable to, perform a discounted cash flow
analysis using the Tvardi Financial Forecasts.
The Company respectfully advises the Staff that the purpose of a cash forecast (such as the Tvardi Financial Forecasts) is to estimate
future cash flows, which are then used as a primary input for a discounted cash flow analysis. The Company further respectfully advises
the Staff that such cash forecasts generally are included in a proxy statement/prospectus where such forecasts are used to generate a
discounted cash flow analysis because, in those cases, the valuation analysis underlying the fairness opinion relies on, among other analyses,
a discounted cash flow analysis.
Absent the performance of a discounted cash flow analysis, the disclosure of the Tvardi Financial Forecasts is not otherwise necessary
to provide a fair summary of the financial analyses underlying the Piper Sandler Opinion.
4. We note your response to prior comment 13, and we reissue the comment in part. Please further revise
your disclosure to identify which party had the relationship with Piper Sandler in connection with the previously proposed financing and
clarify the nature of such relationship.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised the disclosure on page 174 of the Second Amended Registration Statement to clarify the parties’
relationship with Piper Sandler and the nature of such relationship.
Golden Parachute Compensation, page 164
5. In note 1 to the first table on page 165, please clarify what you mean by a lump sum of Mr. Posner’s
target bonus for 2024 “and” 2025. For example, clarify whether Mr. Posner would receive 1.5 times his target bonus for
each of the two years and, if so, how such payment is consistent with your disclosure on page 341.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised the disclosure on page 181 of the Second Amended Registration Statement to clarify that Mr. Posner
would receive a lump sum equal to 100% of his target bonus for 2024 and 150% of his target bonus for 2025.
Investor Agreements, page 358
6. We note your response to prior comment 19, specifically that Tvardi will enter into a registration
rights agreement with certain founders, directors and affiliates of Tvardi. Please identify which founders, directors and affiliates will
be party to the registration rights agreement, disclose the number of shares to be covered by the agreement, and clarify whether such
shares are also covered by the lock-up agreement.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised the disclosure on page 388 of the Second Amended Registration Statement to clarify which parties
will be subject to the registration rights agreement, to disclose the number of shares to be covered by the registration rights agreement
and to clarify that such shares are subject to the terms of the lock-up agreements.
MINTZ
February 13, 2025
Page 4
Unaudited Pro Forma Condensed Combined Financial Statements, page 382
7. Please address the following regarding your response to prior comment 21, including your revisions
on pages 23-24:
· You disclose on pages 23-24 that your assessment is based on “Cara’s discontinuation
of its research and development activities, Asset Disposition, and settlement of its other remaining operating assets and liabilities,
immediately prior to Closing, Cara’s pre-combination assets are expected to primarily be cash, cash equivalents, and marketable
securities.” Revise to confirm the extent to which you believe that Cara will have no or nominal operations after the completion
of the events listed here.
· Please similarly revise your pro forma Note 4 on page 390.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 25 and 423 of the Second
Amended Registration Statement to clarify that following the discontinuation of its research and development activities, Asset Disposition,
and settlement of its other remaining operating assets and liabilities on the closing date the Company is expected to have nominal operations
and nominal pre-combination assets.
*****
Sincerely,
/s/ Daniel A. Bagliebter
Daniel A. Bagliebter
Cc:
Jeffrey P. Schultz, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Christopher
Posner, Cara Therapeutics, Inc.
Scott
Terrillion, Cara Therapeutics, Inc.
Imran
Alibhai, Tvardi Therapeutics, Inc.
Rama
Padmanabhan, Esq., Cooley LLP
2025-02-11 - UPLOAD - Tvardi Therapeutics, Inc. File: 333-283900
February 11, 2025
Christopher Posner
Chief Executive Officer
Cara Therapeutics, Inc.
400 Atlantic Street
Suite 500
Stamford, CT 06901
Re:Cara Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed January 27, 2025
File No. 333-283900
Dear Christopher Posner:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our January 15, 2025 letter.
Amendment No. 1 to Registration Statement on Form S-4
Prospectus Summary
The Companies
Cara Therapeutics, Inc., page 9
We note your response to prior comment 8 regarding the deficiency letters you
received from Nasdaq. We further note your statements that (i) the parties intend to
satisfy each of the applicable Nasdaq listing criteria upon completion of the proposed
Merger such that the combined company will remain listed on the Nasdaq Capital
Market and (ii) there can be no assurance that you will be able to regain compliance
with the minimum stockholders’ equity requirement within the applicable extension
1.
February 11, 2025
Page 2
period. Please disclose whether you intend to complete the Merger in the event you do
not timely regain compliance with the requirement.
Support Agreements, page 17
2.We note your response to prior comment 7. Similar to your revised disclosure on page
135, please further revise your disclosure on page 17 to clarify that your officers and
directors, and their affiliated funds, who collectively own approximately 1% of your
"outstanding" common stock entered into the support agreements.
Opinion of Cara's Financial Advisor, page 149
3.We note your response to prior comment 12. To help us further evaluate your
response, please tell us whether the omitted financial projections were used or relied
upon by your financial advisor in considering the fairness determination.
4.We note your response to prior comment 13, and we reissue the comment in part.
Please further revise your disclosure to identify which party had the relationship with
Piper Sandler in connection with the previously proposed financing and clarify the
nature of such relationship.
Golden Parachute Compensation, page 164
5.In note 1 to the first table on page 165, please clarify what you mean by a lump sum
of Mr. Posner’s target bonus for 2024 “and” 2025. For example, clarify whether Mr.
Posner would receive 1.5 times his target bonus for each of the two years and, if so,
how such payment is consistent with your disclosure on page 341.
Investor Agreements, page 358
6.We note your response to prior comment 19, specifically that Tvardi will enter into a
registration rights agreement with certain founders, directors and affiliates of Tvardi.
Please identify which founders, directors and affiliates will be party to the registration
rights agreement, disclose the number of shares to be covered by the agreement, and
clarify whether such shares are also covered by the lock-up agreement.
Unaudited Pro Forma Condensed Combined Financial Statements, page 382
7.Please address the following regarding your response to prior comment 21, including
your revisions on pages 23-24:
•You disclose on pages 23-24 that your assessment is based on "Cara’s
discontinuation of its research and development activities, Asset Disposition, and
settlement of its other remaining operating assets and liabilities, immediately prior
to Closing, Cara’s pre-combination assets are expected to primarily be cash, cash
equivalents, and marketable securities." Revise to confirm the extent to which
you believe that Cara will have no or nominal operations after the completion of
the events listed here.
•Please similarly revise your pro forma Note 4 on page 390.
February 11, 2025
Page 3
Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jessica Dickerson at 202-551-8013 or Joshua Gorsky at 202-551-7836 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Daniel Bagliebter, Esq.
2025-01-24 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
919 Third Avenue
New York, NY 10022
212 935 3000
mintz.com
January 24, 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:
Jessica Dickerson
Joshua Gorsky
Re:
Cara Therapeutics, Inc.
Registration Statement on Form S-4
Filed December 18, 2024
File No. 333-283900
Ladies and Gentlemen:
This letter sets forth the
response of Cara Therapeutics, Inc. (the “Company”) to the comments of the staff of the Division of Corporate
Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
set forth in your letter dated January 15, 2025, with respect to the above referenced Registration Statement on Form S-4 (the
“Registration Statement”).
Concurrently with the submission
of this letter, the Company is filing Amendment No. 1 to the Registration Statement on Form S-4 (the “Amended Registration
Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Amended
Registration Statement.
Set forth below is the Company’s response
to the Staff’s comments. For the Staff’s convenience, we have incorporated your comments into this response letter in italics.
Boston Los
Angeles MIAMI New York San Diego San Francisco toronto Washington
Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
MINTZ
January 24, 2025
Page 2
Registration Statement on Form S-4
Cover Page
1. In the Notice of Special Meeting of Stockholders, the description of Proposal 1 appears to contemplate
the approval of two different actions. Specifically, it appears to contemplate (i) approval of the issuance of shares and (ii) approval
of the change of control. Please revise the description of the proposal to clarify, if true, that Proposal 1 covers one action (i.e.,
the issuance of shares), which will (i) represent more than 20% of the shares of your common stock outstanding immediately prior
to the Merger and (ii) result in a change of control. Please make similar revisions throughout the proxy statement/prospectus as
appropriate. Alternatively, tell us why you do not believe these revisions are appropriate.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the description of Proposal 1 on the Cover Page and
throughout the Amended Registration Statement.
Questions and Answers about the Merger
What will Cara's stockholders and option holders
receive in the Merger?, page 4
2. You state that, at the Effective Time, your outstanding options will be accelerated and that the number
of shares underlying such options will be adjusted based on the Reverse Stock Split. Please disclose whether the exercise price associated
with such options also will be adjusted based on the Reverse Stock Split.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on the Cover Page and pages 2,
4, 20 and 185 of the Amended Registration Statement to state that the exercise price of the options also will be adjusted based on
the Reverse Stock Split.
How many votes are needed to approve each Cara
Proposal?, page 5
3. Please disclose here the votes needed to approve the Reverse Stock Split Proposal.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 of the Amended Registration
Statement to state the vote needed to approve the Reverse Stock Split Proposal.
MINTZ
January 24, 2025
Page 3
What are the material U.S. Federal Income Tax
consequences of the Merger to holders of Cara common stock?, page 5
4. You state that there will be no material U.S. federal income tax consequences to your stockholders
as a result of the Merger. Please tell us what consideration you gave to disclosing any U.S. federal income tax consequences to your stockholders
resulting from the accelerated vesting of your outstanding restricted stock units at the Effective Time.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 5 of the Amended Registration
Statement to clarify that the U.S. federal income tax consequences to certain of the Company’s stockholders resulting from accelerated
vesting of RSUs at the Effective Time are not discussed in the Amended Registration Statement and encourages holders or beneficial owners
to consult their own tax advisors regarding any such consequences.
The Companies
Cara Therapeutics, Inc., page 10
5. Please revise your disclosure to clarify whether Cara Therapeutics, Inc. intends to complete the
Asset Disposition if the Merger is not consummated.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 10 of the Amended Registration
Statement to clarify that the Company intends to complete the Asset Disposition if the Merger is not consummated subject to the receipt
of the requisite stockholder approval needed to approve the Asset Disposition in the event that the Merger is terminated.
Prospectus Summary
Merger Consideration and Exchange Ratio, page 15
6. In the second paragraph, you state that you assume an amount of Conversion Shares of approximately
46,115,173 and that you expect you will issue approximately 46,115,173 shares of your common stock in the Merger. However, on page 188,
you state that you expect you will issue approximately 311,701,096 shares of your common stock in the Merger. Please revise your disclosures
as appropriate to reconcile this apparent inconsistency.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 16 of the Amended Registration
Statement to correct the number of shares of common stock expected to be issued in the Merger.
MINTZ
January 24, 2025
Page 4
Support Agreements, page 17
7. You state here that your officers and directors, and their affiliated funds that hold your common stock
and who collectively beneficially own approximately 1% of your common stock, entered into support agreements in favor of Tvardi relating
to the Merger. However, on page 101, you state that, as of December 1, 2024, your directors and executive officers owned approximately
4.2% of your common stock and that the directors and executive officers owning these shares are subject to support agreements. Please
revise your disclosures as appropriate to reconcile this apparent inconsistency. In addition, to the extent that only certain of your
officers, directors and their affiliates have entered into support agreements, as indicated on page 128, revise your disclosures
to identify which officers, directors and affiliates have entered into the support agreements.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 147 of the Amended Registration
Statement to clarify the percentage of the Company’s outstanding common stock owned by directors and executive officers that are
subject to support agreements.
8. Please include disclosures here regarding the deficiency letters you received from Nasdaq, the current
status of your efforts to regain compliance with Nasdaq’s minimum stockholders’ equity and minimum closing bid price requirements,
the deadlines for regaining compliance with these requirements, and the risk that your shares could potentially be delisted if you are
not successful in timely regaining compliance with these requirements. Please also update the "Risk Factors" section to address
this risk and any other material risks related to the deficiency letters.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 10, 11, 232 and 233 of
the Amended Registration Statement to describe the deficiency letters received from Nasdaq, the Company’s efforts to regain compliance
and the risk of delisting if not successful in timely regaining compliance. The Company has also included a risk factor discussing such
material risks on pages 73 and 74 of the Amended Registration Statement.
The Merger
Background of the Merger, page 104
9. We note your disclosure that from July through October 11, 2024, Cara management negotiated
a term sheet with CSL Vifor regarding "a potential asset disposition and the treatment of the HCR obligations." Please revise
your disclosure to explain how Cara management identified CSL Vifor as a potential counterparty to the asset disposition.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 151 of the Amended Registration
Statement to explain how Cara management identified CSL Vifor as a potential counterparty to the asset disposition.
MINTZ
January 24, 2025
Page 5
10. On page 108, you disclose that Tvardi sent you a revised term sheet on November 1, 2024 that,
among other things, modified your net cash closing condition to $20 million. You then state that Tvardi sent you a further revised term
sheet on November 2, 2024 that, among other things, modified your net cash closing condition to $18 million. Please clarify whether
there were any intervening events between these two deliveries that led to delivery of the further revised term sheet from Tvardi on November 2,
2024.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 155 of the Amended Registration
Statement to clarify the events that led to the delivery of the further revised term sheet from Tvardi on November 2, 2024.
Cara Reasons for the Merger, page 111
11. In addition to your reasons for the Merger, please also disclose Tvardi’s reasons for the Merger.
Refer to Item 4(a)(2) of Form S-4.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 160, 161 and 162 of the
Amended Registration Statement to add Tvardi’s reasons for the Merger.
Opinion of Cara's Financial Advisor, page 114
12. In the third and fourth bullet points on page 115, you state that, in arriving at the Piper Sandler
Opinion, Piper Sandler reviewed and analyzed certain information furnished to Piper Sandler by your management, including financial forecasts
related to both your business and Tvardi. However, it appears that only your management liquidation analysis is disclosed in the proxy
statement/prospectus. Please disclose the other forecasts and projections you provided to Piper Sandler that Piper Sandler used to reach
its fairness determination or tell us why you do not believe such disclosure is required.
Response:
Cara respectfully acknowledges the Staff’s comment. As noted in the proxy statement/prospectus, Piper Sandler reviewed and analyzed
certain information regarding Cara furnished to Piper Sandler, including management prepared internal financial forecasts with respect
to the estimated monthly cash expenditures and receipts of Cara from November 2024 until a projected closing date of March 31,
2025 (the “Cara Financial Forecasts”). Cara respectfully confirms to the Staff that, as now disclosed on pages 176
and 177 under the section titled “Certain Cara Unaudited Financial Projections” of the Amended Registration Statement, the
material portions of the information in the Cara Financial Forecasts have been added to the proxy statement/prospectus.
MINTZ
January 24, 2025
Page 6
Cara respectfully advises the Staff
that only the Cara Financial Forecasts have been added to the proxy statement/prospectus because the internal financial forecasts with
respect to Tvardi furnished to Piper Sandler by management of Cara for the periods between December 2024 and December 2026 (the
“Tvardi Financial Forecasts”) are not material to the stockholders of Cara and Tvardi in connection with their
consideration of the Merger. As disclosed on page 164 under the section titled “Opinion of Cara’s Financial Advisor”
of the Amended Registration Statement, Piper Sandler did not perform a discounted cash flow analysis of Tvardi because managements of
Cara and Tvardi advised Piper Sandler that Tvardi did not have, and could not reasonably be expected to prepare, current and reliable
financial forecasts regarding Tvardi’s future financial performance for a sufficient period of time that would allow Piper Sandler
to perform a discounted cash flow analysis.
The Tvardi Financial Forecasts were
instead prepared by Tvardi’s management in connection with the Merger at the request of Cara for due diligence purposes. The Tvardi
Financial Forecasts were then furnished by Tvardi to Cara and Piper Sandler as background information. The Tvardi Financial Forecasts
did not affect the consideration offered to Tvardi stockholders or otherwise influence any other material terms of the proposed transaction,
and such financial forecasts were neither prepared by Tvardi’s management nor furnished by Tvardi to Cara and subsequently, by Cara,
to Piper Sandler with the purpose of affecting the total mix of information made available to stockholders of Cara and Tvardi.
Moreover, the assumptions underlying
the Tvardi Financial Forecasts (as with most modeling and forecasting of the future in the biopharmaceutical industry) were highly speculative
in nature and the information therein was used to provide a wide range of possible results, none of which were relied upon by the Cara
Board as definitive or likely to reflect the results that would actually be achieved over the course of the forecasted periods. The Tvardi
Financial Forecasts were not considered by the Cara Board in its evaluation of the proposed transaction.
For these reasons, Cara respectfully
submits that the disclosure of the Tvardi Financial Forecasts is not (i) necessary because the proxy statement/prospectus already
provides a fair summary of the material information and the resulting analyses underlying the Piper Sandler Opinion or (ii) material
to an investor’s decision to approve the Merger and related matters. Furthermore, given the highly speculative nature of the assumptions
underlying the forecasts, the risk that investors will rely on the Tvardi Financial Forecasts if disclosed far outweigh any potential
benefits. Accordingly, Cara respectfully submits that disclosure of the Tvardi Financial Forecasts in the proxy statement/prospectus is
not required.
MINTZ
January 24, 2025
Page 7
13. On page 125, you state that, since January 1, 2022, Piper Sandler had no material relationships
with, and did not receive any fees for investment banking services from, Cara, Tvardi or their respective affiliates, except for a proposed
financing which was later abandoned. Please revise your disclosure to identify which party engaged Piper Sandler for the proposed financing
and to describe and quantify any compensation Piper Sandler received, or will receive, as a result of the relationship. Refer to Item
4(b) of Form S-4 and Item 1015(b)(4) of Regulation M-A.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 173 of the Amended Registration
Statement to state that Piper Sandler did not enter into an engagement letter with Cara or Tvardi with respect to the abandoned proposed
financing and has not, and does not expect to, receive any compensation relating to such proposed financing.
Proposal No. 4 (The Reverse Stock Split
Proposal)
Purpose, page 180
14. You briefly outline a few purposes for the Reverse Stock Split Proposal. Please also address the following:
· Disclose that there can be no guarantee or assurances that the Reverse Stock Split will have the intended
effects.
· With respect to the second bullet point, identify the approximate number of additional shares you anticipate
you will need to complete the Merger. In addition, clarify here whether you believe the Reverse Stock Split on its own will result in
a
2025-01-16 - UPLOAD - Tvardi Therapeutics, Inc. File: 333-283900
January 15, 2025
Christopher Posner
Chief Executive Officer
Cara Therapeutics, Inc.
400 Atlantic Street
Suite 500
Stamford, CT 06901
Re:Cara Therapeutics, Inc.
Registration Statement on Form S-4
Filed December 18, 2024
File No. 333-283900
Dear Christopher Posner:
We have reviewed your registration statement and have the following comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form S-4
Cover Page
1.In the Notice of Special Meeting of Stockholders, the description of Proposal 1
appears to contemplate the approval of two different actions. Specifically, it appears
to contemplate (i) approval of the issuance of shares and (ii) approval of the change of
control. Please revise the description of the proposal to clarify, if true, that Proposal 1
covers one action (i.e., the issuance of shares), which will (i) represent more than 20%
of the shares of your common stock outstanding immediately prior to the Merger and
(ii) result in a change of control. Please make similar revisions throughout the proxy
statement/prospectus as appropriate. Alternatively, tell us why you do not believe
these revisions are appropriate.
January 15, 2025
Page 2
Questions and Answers about the Merger
What will Cara's stockholders and option holders receive in the Merger?, page 4
2.You state that, at the Effective Time, your outstanding options will be accelerated and
that the number of shares underlying such options will be adjusted based on the
Reverse Stock Split. Please disclose whether the exercise price associated with such
options also will be adjusted based on the Reverse Stock Split.
How many votes are needed to approve each Cara Proposal?, page 5
3.Please disclose here the votes needed to approve the Reverse Stock Split Proposal.
What are the material U.S. Federal Income Tax consequences of the Merger to holders of
Cara common stock?, page 5
4.You state that there will be no material U.S. federal income tax consequences to your
stockholders as a result of the Merger. Please tell us what consideration you gave to
disclosing any U.S. federal income tax consequences to your stockholders resulting
from the accelerated vesting of your outstanding restricted stock units at the Effective
Time.
The Companies
Cara Therapeutics, Inc., page 10
5.Please revise your disclosure to clarify whether Cara Therapeutics, Inc. intends to
complete the Asset Disposition if the Merger is not consummated.
Prospectus Summary
Merger Consideration and Exchange Ratio, page 15
6.In the second paragraph, you state that you assume an amount of Conversion Shares
of approximately 46,115,173 and that you expect you will issue approximately
46,115,173 shares of your common stock in the Merger. However, on page 188, you
state that you expect you will issue approximately 311,701,096 shares of your
common stock in the Merger. Please revise your disclosures as appropriate to
reconcile this apparent inconsistency.
Support Agreements, page 17
7.You state here that your officers and directors, and their affiliated funds that hold your
common stock and who collectively beneficially own approximately 1% of your
common stock, entered into support agreements in favor of Tvardi relating to the
Merger. However, on page 101, you state that, as of December 1, 2024, your directors
and executive officers owned approximately 4.2% of your common stock and that the
directors and executive officers owning these shares are subject to support
agreements. Please revise your disclosures as appropriate to reconcile this apparent
inconsistency. In addition, to the extent that only certain of your officers, directors and
their affiliates have entered into support agreements, as indicated on page 128, revise
your disclosures to identify which officers, directors and affiliates have entered into
the support agreements.
January 15, 2025
Page 3
Nasdaq Stock Market Listing, page 23
8.Please include disclosures here regarding the deficiency letters you received from
Nasdaq, the current status of your efforts to regain compliance with Nasdaq’s
minimum stockholders’ equity and minimum closing bid price requirements, the
deadlines for regaining compliance with these requirements, and the risk that your
shares could potentially be delisted if you are not successful in timely regaining
compliance with these requirements. Please also update the "Risk Factors" section to
address this risk and any other material risks related to the deficiency letters.
The Merger
Background of the Merger, page 104
9.We note your disclosure that from July through October 11, 2024, Cara management
negotiated a term sheet with CSL Vifor regarding "a potential asset disposition and
the treatment of the HCR obligations." Please revise your disclosure to explain how
Cara management identified CSL Vifor as a potential counterparty to the asset
disposition.
10.On page 108, you disclose that Tvardi sent you a revised term sheet on November 1,
2024 that, among other things, modified your net cash closing condition to $20
million. You then state that Tvardi sent you a further revised term sheet on November
2, 2024 that, among other things, modified your net cash closing condition to $18
million. Please clarify whether there were any intervening events between these two
deliveries that led to delivery of the further revised term sheet from Tvardi on
November 2, 2024.
Cara Reasons for the Merger, page 111
11.In addition to your reasons for the Merger, please also disclose Tvardi’s reasons for
the Merger. Refer to Item 4(a)(2) of Form S-4.
Opinion of Cara's Financial Advisor, page 114
12.In the third and fourth bullet points on page 115, you state that, in arriving at the Piper
Sandler Opinion, Piper Sandler reviewed and analyzed certain information furnished
to Piper Sandler by your management, including financial forecasts related to both
your business and Tvardi. However, it appears that only your management liquidation
analysis is disclosed in the proxy statement/prospectus. Please disclose the other
forecasts and projections you provided to Piper Sandler that Piper Sandler used to
reach its fairness determination or tell us why you do not believe such disclosure is
required.
13.On page 125, you state that, since January 1, 2022, Piper Sandler had no material
relationships with, and did not receive any fees for investment banking services from,
Cara, Tvardi or their respective affiliates, except for a proposed financing which was
later abandoned. Please revise your disclosure to identify which party engaged Piper
Sandler for the proposed financing and to describe and quantify any compensation
Piper Sandler received, or will receive, as a result of the relationship. Refer to Item
4(b) of Form S-4 and Item 1015(b)(4) of Regulation M-A.
January 15, 2025
Page 4
Proposal No. 4 (The Reverse Stock Split Proposal)...
Purpose, page 180
14.You briefly outline a few purposes for the Reverse Stock Split Proposal. Please also
address the following:
•Disclose that there can be no guarantee or assurances that the Reverse Stock Split
will have the intended effects.
•With respect to the second bullet point, identify the approximate number of
additional shares you anticipate you will need to complete the Merger. In
addition, clarify here whether you believe the Reverse Stock Split on its own will
result in a number of authorized but unissued shares of your common stock
sufficient to complete the Merger or whether approval of the Authorized Share
Increase Proposal is also required to achieve this purpose.
Criteria to be Used for Determining Which Reverse Stock Split Ratio to Implement, page 181
15.In the last paragraph of this section, you state that you could be delisted from Nasdaq
if your shares begin to trade below the requisite $1.00 per share bid price needed to
maintain its listing. Please also disclose here that you have already received a
deficiency letter from Nasdaq regarding your non-compliance with this listing
requirement and disclose the status of your efforts to regain compliance with the
requirement.
Proposal No. 5 (The Authorized Share Proposal)..., page 188
16.In the second paragraph, you include disclosure regarding the number of shares of
your common stock expected to be available for future issuance following the
issuance of your shares in the Merger. Please also clarify how many of these shares
you expect will be reserved for future issuance (e.g., pursuant to your equity
compensation plans, for issuance upon the exercise of options, etc.).
17.In the last paragraph, you state that the issuance of additional shares of your common
stock could have dilutive effects. To the extent applicable, please also disclose any
potential anti-takeover or other effects of the Authorized Share Proposal.
Related Person Transactions of the Combined Company, page 266
18.To the extent applicable, please also include discussion here of the Tvardi support
agreements and the lock-up agreements entered into in connection with the Merger.
Investor Agreements, page 268
19.We note your statement that the registration rights set forth in Tvardi's amended and
restated investors' rights agreement will continue following completion of the Merger.
Please disclose the number of shares subject to registration rights and briefly describe
the material terms of such registration rights.
Where You Can Find More Information, page 284
We note that you incorporate certain registrant information into the proxy
statement/prospectus by reference to documents you previously filed with the 20.
January 15, 2025
Page 5
Commission. We further note that you incorporate by reference certain future filings
you may make with the Commission. However, it does not appear that you meet the
aggregate market value requirement of General Instruction I.B.1 of Form S-3, which
would permit you to incorporate certain information by reference into Form S-4.
Please provide us with an analysis of your eligibility to incorporate by reference or
revise your proxy statement/prospectus to include the information required by Item 14
of Form S-4. Refer to General Instruction B.1 of Form S-4. In addition, you should
include any other information required by Form S-4 and Schedule 14A that is
currently incorporated by reference, including, for example only, any relevant risk
factors and compensation disclosures. Regarding compensation disclosures, we note
that Item 8(b) of Schedule 14A requires disclosure of the information required by
Item 402 of Regulation S-K for the registrant when any compensation plan in which
any director, nominee for election as a director or executive officer of the registrant
will participate. We further note that you are seeking approval of two equity
compensation plans but that you have only included Item 402 disclosure for Tvardi’s
named executive officers.
Unaudited Pro Forma Condensed Combined Financial Statements, page 288
21.Revise Note 4 on page 297 as well as similar disclosure on page 23 to provide an
additional bullet supporting your merger accounting to describe the extent to which
you believe that, following the asset disposition and related transactions and
immediately prior to the merger with Tvardi, Cara Therapeutics, Inc. will effectively
be a non-operating shell company for accounting purposes.
Item 21 - Exhibits and Financial Statement Schedules, page II-3
22.Please file the following agreements as exhibits to the registration statement or tell us
why you do not believe you are required to do so:
•the stockholder support and lock-up agreements entered into in connection with
the Merger;
•Tvardi's December 2023 Note Purchase Agreement and related form of
promissory note;
•Tvardi's restricted stock purchase agreements with its founders, pursuant to which
Tvardi is obligated to pay royalties to each such founder; and
•the amended and restated investors' rights agreement setting forth the registration
rights of certain Tvardi stockholders.
23.We note you intend to file the form of preliminary proxy card as Exhibit 99.8. Please
note that the form of proxy card should be filed as an appendix rather than as an
exhibit to the registration statement. Refer to the Note to paragraph (a)(3) of Exchange
Act Rule 14a-4.
General
24.Please include the information required by Exchange Act Rule 14a-5(e). Refer to Item
18(a)(1) of Form S-4 and Item 1(c) of Schedule 14A.
January 15, 2025
Page 6
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.
Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jessica Dickerson at 202-551-8013 or Joshua Gorsky at 202-551-7836 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Daniel Bagliebter, Esq.
2022-05-09 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
Cara
Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street, 9th
Floor
Stamford, Connecticut
06902
May 9, 2022
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Michael Davis
Re:
Cara Therapeutics, Inc.
Registration Statement on Form S-3 (File No. 333-263165), as amended by Amendment No. 1
Request for Acceleration of Effective Date
Acceleration Request
Requested Date:
May 11, 2022
Requested Time:
4:00 p.m. Eastern Time
Mr. Davis:
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 take appropriate action to cause the above-referenced Registration Statement on Form S-3
(File No. 333-263165), as amended by Amendment No. 1 (the “Registration Statement”) to
become effective on May 11, 2022, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable.
Once the Registration Statement has been declared effective, please
orally confirm that event with Darren DeStefano of Cooley LLP, counsel to the Registrant, at (703) 456-8034.
[Signature page follows]
Very truly yours,
Cara Therapeutics, Inc.
By:
/s/ Christopher Posner
Christopher Posner
Chief Executive Officer and Director
cc: Christopher Posner, Cara Therapeutics, Inc.
Darren DeStefano, Cooley LLP
Signature Page to Company Acceleration
Request – S-3
2022-04-26 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
Cara
Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street, 9th
Floor
Stamford, Connecticut
06902
April 26, 2022
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Michael Davis
Re:
Request to Withdraw Acceleration Request of Cara Therapeutics,
Inc., (the “Company”), dated April 22, 2022 for the Registration Statement on Form S-3 (File No. 333-263165)
Mr. Davis,
On behalf of the Company, I hereby formally request the withdrawal
of the acceleration request of Cara Therapeutics, Inc. with respect to the above referenced registration statement, submitted via Edgar
on April 22, 2022.
Thank you for the Staff’s cooperation in connection with this
matter.
Very truly yours,
Cara Therapeutics, Inc.
By:
/s/ Christopher Posner
Christopher Posner
Chief Executive Officer and Director
cc: Darren
DeStefano, Cooley LLP
2022-04-22 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
Cara
Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street, 9th
Floor
Stamford, Connecticut
06902
April 22, 2022
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Michael Davis
Re:
Cara Therapeutics, Inc.
Registration Statement on Form S-3 (File No. 333-263165)
Request for Acceleration of Effective Date
Acceleration Request
Requested Date:
April 26, 2022
Requested Time:
4:00 p.m. Eastern Time
Mr. Davis:
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 take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-263165) (the
“Registration Statement”) to become effective on April 26, 2022, at 4:00 p.m. Eastern Time, or as
soon thereafter as is practicable.
Once the Registration Statement has been declared effective, please
orally confirm that event with Darren DeStefano of Cooley LLP, counsel to the Registrant, at (703) 456-8034.
[Signature page follows]
Very truly yours,
Cara Therapeutics, Inc.
By:
/s/ Christopher Posner
Christopher Posner
Chief Executive Officer and Director
cc: Christopher Posner, Cara Therapeutics, Inc.
Darren DeStefano, Cooley LLP
Signature Page to Company Acceleration
Request – S-3
2022-03-08 - UPLOAD - Tvardi Therapeutics, Inc.
United States securities and exchange commission logo
March 8, 2022
Christopher Posner
Chief Executive Officer
Cara Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street, 9th Floor
Stamford, Connecticut 06902
Re:Cara Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 1, 2022
File No. 333-263165
Dear Mr. Posner:
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 Michael Davis at 202-551-4385 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Darren DeStefano
2019-04-02 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP April 2, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Christine Westbrook Re: Cara Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-230333 Acceleration Request Requested Date: Thursday, April 4, 2019 Requested Time: 4:00 P.M. Eastern Daylight Time Dear Ms. Westbrook: 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 take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-230333) (the “Registration Statement”) to become effective on April 4, 2019, at 4:00 p.m. Eastern Daylight Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP, counsel to the Registrant, at (703) 456-8034, or in his absence, Alison Haggerty at (212) 479-6596. Very truly yours, Cara Therapeutics, Inc. By: /s/ Scott Terrillion Scott Terrillion General Counsel, Secretary and Chief Compliance Officer cc: Derek Chalmers, Ph.D., D.Sc., Cara Therapeutics, Inc. Darren K. DeStefano, Cooley LLP Alison A. Haggerty, Cooley LLP
2019-03-22 - UPLOAD - Tvardi Therapeutics, Inc.
March 22, 2019
Derek Chalmers, Ph.D., D.Sc.
Chief Executive Officer
Cara Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street, 9th Floor
Stamford, CT 06902
Re:Cara Therapeutics, Inc.
Registration Statement on Form S-3
Filed on March 15, 2019
File No. 333-230333
Dear Dr. Chalmers:
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: Alison A. Haggerty, Esq.
2017-10-05 - UPLOAD - Tvardi Therapeutics, Inc.
October 4, 2017 Derek Chalmers President and Chief Executive Officer Cara Therapeutics, Inc. 4 Stamford Plaza 107 Elm Street 9th Floor Stamford, Connecticut 06902 Cara Therapeutics, Inc. Form 10-K for Fiscal Year Ended December 31, 2016 Form 10-Q for Fiscal Quarter Ended June 30, 2017 File No. 001-36279Re: Dear Dr. Chalmers: We have completed our review of your filings. 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 by the staff. Division of Corporation Finance Office of Healthcare & Insurance cc: Scott Terrillion
2017-09-20 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP September 20, 2017 BY EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Ms. Suzanne Hayes Ms. Irene Paik Mr. Kevin Vaughn Ms. Keira Nakada Re: Cara Therapeutics, Inc. Form 10-K for the Fiscal Year Ended December 31, 2016 Form 10-Q for Fiscal Quarter Ended June 30, 2017 File No. 001-36279 Ladies and Gentlemen: Cara Therapeutics, Inc. (the “Company”) is providing this letter in response to the comment received regarding the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2017 (the “Form 10-Q”) in a letter, dated September 11, 2017, from the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) to Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of the Company. For your reference, the Staff’s comment is reproduced in bold, and the Company’s response is set forth below such comment in standard type. Capitalized terms used but not defined below have the meanings assigned to them in the Form 10-Q. Form 10-Q for the Fiscal Year Ended June 30, 2017 Product Development Pipeline, page 21 1. We note that the product development pipeline chart on your website appears inconsistent with information disclosed in your document. For example: • Your website indicates that you have completed Phase III testing of IV CR845 for post-op pain, while your Form 10-Q disclosure indicates that the revised trial is enrolling 450 patients undergoing a range of abdominal surgeries and will test two doses of IV CR845 versus placebo. • Your website indicates that you have completed Phase III testing of IV CR845 for Pruritus CKD-HD, while your Form 10-Q disclosure indicates that you plan to meet with the FDA in the third quarter of 2017 to finalize a pivotal program and expect to initiate a Phase III trial in the fourth quarter of 2017. Please explain these apparent inconsistencies. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the information contained in the Company’s filings with the SEC, including the Form 10-Q, are accurate and properly convey the stage of each trial disclosed therein. In response to the Staff’s comment, the Company has revised the product development pipeline chart on its website to more clearly define the status of the programs listed in the pipeline chart, consistent with the information disclosed in the Form 10-Q. The Company also supplementally advises the Staff that the Company has initiated a Phase 3 safety trial for IV CR845 for Pruritus CKD-HD and expects to initiate its Phase 3 pivotal efficacy trial in the fourth quarter of 2017, as disclosed in the Form 10-Q. * * * If you have any questions with regard to this response, need further information or would like to discuss any of the information covered in this letter, please contact me at (203) 406-3701 or Scott Terrillion, the Company’s General Counsel, at (203) 406-3706. Sincerely, /s/ Derek Chalmers, Ph.D., D.Sc. Derek Chalmers, Ph.D., D.Sc. President and Chief Executive Officer Cara Therapeutics, Inc. cc: Scott Terrillion, General Counsel Darren DeStefano, Cooley LLP Alison Haggerty, Cooley LLP
2017-09-12 - UPLOAD - Tvardi Therapeutics, Inc.
September 11, 2017
Derek Chalmers
President and Chief Executive Officer
Cara Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street 9th Floor
Stamford, Connecticut 06902
Cara Therapeutics, Inc.
Form 10-K for Fiscal Year Ended December 31, 2016
Form 10-Q for Fiscal Quarter Ended June 30, 2017
File No. 001-36279Re:
Dear Dr. Chalmers:
We have reviewed your filing 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-Q for the Fiscal Quarter Ended June 30, 2017
Product Development Pipeline, page 21
1. We note that the product development pipeline chart on your website appears inconsistent
with information disclosed in your document. For example:
• your website indicates that you have completed Phase III testing of IV CR845 for
post-op pain, while your Form 10-Q disclosure indicates that the revised trial is enrolling
450 patients undergoing a range of abdominal surgeries and will test two doses of IV
CR845 versus placebo.
Derek Chalmers
Cara Therapeutics, Inc.
September 11, 2017
Page 2
• Your website indicates that you have completed Phase III testing of IV CR845 for
Pruritus CKD-HD, while your Form 10-Q disclosure indicates that you plan to meet with
the FDA in the third quarter of 2017 to finalize a pivotal program and expect to initiate a
Phase III trial in the fourth quarter of 2017.
Please explain these apparent inconsistencies.
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 Keira Nakada at 202-551-3659 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any other questions.
Division of Corporation Finance
2017-03-23 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm Acceleration Request March 23, 2017 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Suzanne Hayes Re: Cara Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-216657 Acceleration Request Requested Date: Friday, March 24, 2017 Requested Time: 4:00 P.M. Eastern Daylight Time Dear Ms. Hayes: 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 take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-216657) (the “Registration Statement”) to become effective on March 24, 2017, at 4:00 p.m. Eastern Daylight Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Darren DeStefano of Cooley LLP, counsel to the Registrant, at (703) 456-8034, or in his absence, Alison Haggerty at (212) 479-6596. Very truly yours, Cara Therapeutics, Inc. By: /s/ Josef Schoell Josef Schoell Chief Financial Officer cc: Derek Chalmers, Ph.D., D.Sc., Cara Therapeutics, Inc. Darren K. DeStefano, Cooley LLP Alison A. Haggerty, Cooley LLP
2017-03-22 - UPLOAD - Tvardi Therapeutics, Inc.
Mail Stop 4546 March 22, 2017 Derek Chalmers, Ph.D., D.Sc. Chief Executive Officer Cara Therapeutics, Inc. 4 Stamford Plaza 107 Elm Street Stamford, Connecticut 06902 Re: Cara Therapeutics, Inc. Registration Statement on Form S-3 Filed March 13, 2017 File No. 333-216657 Dear Dr. Chalmers : 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, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Darren DeStefano Cooley LLP
2015-05-13 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm Correspondence Letter May 13, 2015 U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington D.C. 20549 Attn: Alla Berenshteyn RE: Cara Therapeutics, Inc. Registration Statement on Form S-3 Filed March 27, 2015 File No. 333-203072 Ladies and Gentlemen: On behalf of our client, Cara Therapeutics, Inc. (the “Company”), we are responding to the comment (the “Comment”) of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated April 3, 2015 (the “Comment Letter”), relating to the above referenced Registration Statement on Form S-3 (the “Registration Statement”). Set forth below is the Company’s response to the Comment. The numbering of the paragraph below corresponds to the numbering of the Comment, which for your convenience we have incorporated into this response letter. Capitalized terms used but not defined herein are used herein as defined in the Registration Statement. General 1. We note that your registration statement incorporates by reference your Form 10-K for the fiscal year ended December 31, 2014, which incorporates by reference Part III information from a proxy statement that has not yet been filed. Please amend your Form 10-K to include the Part III information, including executive compensation for the fiscal year ended December 31, 2014, or file your proxy statement including such information. Alternatively, please amend your registration statement to include such information. We refer you to Question 123.01 of the Securities Act Forms Compliance and Disclosure Interpretations for more information. Response to Comment 1 The Company acknowledges the Staff’s comment and has incorporated Part III by reference into the Registration Statement from the definitive proxy statement filed by the Company on April 24, 2015. ****** Please fax any additional comment letters concerning the Registration Statement to (703) 456-8100 and direct any questions or comments concerning the Registration Statement or this response letter to the undersigned at (703) 456-8034. Sincerely, /s/ Darren K. DeStefano Darren K. DeStefano cc: Derek Chalmers, Ph.D., D.Sc.
2015-05-13 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP
1
filename1.htm
Correspondence Letter
May 13, 2015
VIA EDGAR
Ms. Alla Berenshteyn
Securities and Exchange
Commission
Division of Corporation Finance
100 F Street,
N.E.
Washington, DC 20549
Re:
Cara Therapeutics, Inc. (the “Company”)
Form S-3, File No. 333-203072
Dear Ms. Berenshteyn:
The Company 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 4:30 p.m. (Eastern time) on Wednesday, May 13, 2015, or as soon as practicable thereafter.
The Company further 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 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.
Very truly yours,
CARA THERAPEUTICS, INC.
By:
/s/ Josef Schoell
Josef Schoell
Chief Financial Officer
cc: Darren K. DeStefano, Cooley LLP
2015-04-03 - UPLOAD - Tvardi Therapeutics, Inc.
April 3, 2015 Via E -mail Derek Chalmers, Ph.D., D.Sc. Chief Executive Officer Cara Therapeutics, Inc. 1 Parrott Drive Shelton, Connecticut 06484 Re: Cara Therapeutics, Inc. Registration Statement on Form S-3 Filed March 2 7, 2015 File No. 333-203072 Dear Dr. Chalmers : We have limited our review of your registration statement to the issue we have addressed in our comment. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our com ment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewi ng any amendment to your registration statement and the information you provide in response to our comment , we may have additional comments. General 1. We note that your registration statement incorporates by reference your Form 10 -K for the fiscal year ended December 31, 2014, which incorporates by reference Part III information from a proxy statement that has not yet been filed. Please amend your Form 10-K to include the Part III information , includ ing executive compensation for the fisc al year ended December 31, 2014, or file your proxy statement including such information . Alternatively, please amend your registration statement to include such information. We refer you to Q uestion 123.01 of the Securities Act Forms Compliance and Disclosure Interpretations for more information. 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 Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. April 3, 2015 Page 2 possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclo sures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration 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 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 reques ts 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 of the registration statement. Please contact Alla Berenshteyn at (202) 551 -4325 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Babak Yaghmaie , Esq. Cooley LLP
2014-01-28 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm Company Acceleration Request 1 Parrott Drive Shelton, Connecticut 06484 VIA EDGAR January 28, 2014 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attn: Mr. Jeffrey P. Riedler Mr. Scot Foley Mr. Bryan J. Pitko Ms. Ibolya Ignat Mr. Andrew Mew Re: Cara Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-192230 Acceleration Request Requested Date: Thursday, January 30, 2014 Requested Time: 4:00 P.M. Eastern Standard 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 above-referenced Registration Statement on Form S-1 to become effective on January 30, 2014, at 4:00 p.m., Eastern Standard Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the staff (the “Staff”). The Registrant hereby authorizes each of Babak Yaghmaie, Darren DeStefano and Hosea Chang 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 Hosea Chang of Cooley LLP, counsel to the Registrant, at (703) 268-8220. In connection with this request, the Registrant 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 Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the 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. Very truly yours, Cara Therapeutics, Inc. By: /s/ Derek Chalmers Derek Chalmers Chief Executive Officer cc: Babak Yaghmaie, Cooley LLP Darren DeStefano, Cooley LLP Stephane Levy, Cooley LLP Hosea Chang, Cooley LLP Peter N. Handrinos, Latham & Watkins LLP
2014-01-28 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm Underwriters Acceleration Request January 28, 2014 Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Cara Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-192230) Ladies and Gentlemen: As representatives of the several underwriters of the Company’s proposed public offering of common stock, we hereby join the Company’s request for acceleration of the above-referenced Registration Statement, requesting effectiveness for 4:00 p.m. (EST) on January 30, 2014 or as soon thereafter as is practicable. Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, we wish to advise you that we have effected the following distribution of the Company’s Preliminary Prospectus dated January 17, 2014, through the date hereof: Preliminary Prospectus dated January 17, 2014: 2,325 copies to prospective underwriters, institutional investors, dealers and others The undersigned advise that they have complied and will continue to comply, and that they have been informed by the participating underwriters and dealers that they have complied with and will continue to comply, with Rule 15c2-8 under the Securities Exchange Act of 1934. Very truly yours, STIFEL, NICOLAUS & COMPANY, INCORPORATED PIPER JAFFRAY & CO. As representatives of the several Underwriters By: STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Keith Lister Name: Keith Lister Title: Managing Director By: PIPER JAFFRAY & CO. By: /s/ Christie L. Christina Name: Christie L. Christina Title: Managing Director
2013-12-30 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm SEC Response Letter Babak Yaghmaie T: (212) 479-6556 F: (212) 479-6275 byaghmaie@cooley.com Via EDGAR and FedEx December 31, 2013 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Jeffrey P. Riedler Mr. Scot Foley Mr. Bryan J. Pitko Ms. Ibolya Ignat Mr. Andrew Mew Re: Cara Therapeutics, Inc. Registration Statement on Form S-1 Filed November 8, 2013 File No. 333-192230 Ladies and gentlemen: On behalf of our client, Cara Therapeutics, Inc. (“Cara Therapeutics” or the “Company”), we are responding to the comments (the “Comments”) of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated November 20, 2013 (the “Comment Letter”), relating to the above referenced Registration Statement (the “Registration Statement”). We are also sending a hard copy of this letter and Amendment No. 1 to the Registration Statement, including a version that is marked to show changes to the Registration Statement filed with the U.S. Securities and Exchange Commission (the “Commission”) on November 8, 2013 to the Staff in care of Mr. Foley. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of Amendment No. 1. Prospectus Summary Our Product Candidates, page 2 1. Please define the phrase “intravenous bolus injection.” Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 2 and 76 of the Registration Statement. December 31, 2013 Page Two Business Commercial Partnerships Maruishi Pharmaceutical Co., Ltd., page 89 2. We note your disclosure that you are eligible to receive payment of low double-digit royalties based on net sales, if any, under your agreement. Please revise your disclosure to provide a ten-percent range for the minimum royalty percentage and maximum royalty percentage Maruishi may be obligated to pay (e.g., “between 10% and 20%” or “in the twenties”). Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 90 of the Registration Statement. Chong Kun Dang Pharmaceutical Corporation, page 90 3. We note your disclosure that you are eligible to receive royalty payments up to a low double digit percentage based on net sales under your agreement. Please revise your disclosure to provide a ten-percent range for the maximum royalty percentage CKD may be obligated to pay. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 90 of the Registration Statement. * * * * * * * Please contact me at (212) 479-6556, Darren DeStefano of Cooley LLP at (703) 456-8034, or Stephane Levy of Cooley LLP at (212) 479-6838 with any questions or further comments regarding our responses to the Staff’s comments. Sincerely, Cooley LLP /s/ Babak Yaghmaie cc: Derek Chalmers, Cara Therapeutics, Inc. Stephane Levy, Cooley LLP Darren DeStefano, Cooley LLP Peter N. Handrinos, Latham & Watkins
2013-11-21 - UPLOAD - Tvardi Therapeutics, Inc.
November 20, 2013 Via E -mail Derek Chalmers, Ph.D., D.Sc. President and Chief Executive Officer Cara Therapeutics, Inc. 1 Parrot Drive Shelton, Connecticut 06484 Re: Cara Therapeutics, Inc. Registration Statement on Form S -1 Filed November 8, 2013 File No. 333-192230 Dear Dr. Chalmers : 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 circumstanc es 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. Prospectus Summary Our Product Candidates, page 2 1. Please define the phrase “intravenous bolus injection.” Business Commercial Partnerships Maruishi Pharmaceutical Co., Ltd. , page 89 2. We note your disclosure that you are eligible to receive payment of low double -digit royalties based on net sales , if any, under your agreement. Please revise your disclosure to provide a ten -percent range for the minimum royalty percentage and maximum royalty percentage Maruishi may be obligated to pay (e.g., “between 10% and 20%” or “in the twenties”). Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. November 20, 2013 Page 2 Chong Kun Dang Pharmaceutical Corporation , page 9 0 3. We note your disclosure that you are eligible to receive royalty payments up to a low double digit percentage based on net sales under your agreement. Please revise you r disclosure to provide a ten -percent range for the maximum royalty percentage CKD may be obligated to pay. 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 disclo sures 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 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 t o 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 effect iveness 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 accele ration 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 of the registration statement. Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. November 20, 2013 Page 3 You may c ontact I bolya Ignat at (202) 551 -3656 or Andrew Mew at (202) 551 -3377 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Babak Yaghmaie Stephanie Levy Darren DeStefano Cooley LLP 1114 Avenue of the Americas New York, New York 10036
2013-11-08 - CORRESP - Tvardi Therapeutics, Inc.
CORRESP 1 filename1.htm SEC Letter Babak Yaghmaie T: (212) 479-6556 F: (212) 479-6275 byaghmaie@cooley.com Via EDGAR and FedEx November 8, 2013 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Jeffrey P. Riedler Mr. Scot Foley Mr. Bryan J. Pitko Ms. Ibolya Ignat Mr. Andrew Mew Re: Cara Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted October 4, 2013 CIK No. 0001346830 Ladies and gentlemen: On behalf of our client, Cara Therapeutics, Inc. (“Cara Therapeutics” or the “Company”), we are responding to the comments (the “Comments”) of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated October 31, 2013 (the “Comment Letter”), relating to the above referenced Confidential Draft Registration Statement (the “DRS”). We also describe below the changes the Company has made in response to the Comments in the Registration Statement on Form S-1 filed today (the “Registration Statement”) and the prospectus included therein (the “Prospectus”). For the Staff’s convenience, we have included both a clean copy of the Registration Statement and a copy marked to show all changes from the DRS. Set forth below are the Company’s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Registration Statement. November 8, 2013 Page Two 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 acknowledges the Staff’s comment and advises the Staff that the images included in the Registration Statement are all of the graphic, visual or photographic information the Company currently intends to include in the Registration Statement. If the Company decides to use any additional images it will provide the Staff with proofs of such materials as soon as practicable. 2. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. 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 request. The Company has supplementally provided the Staff written communications presented to potential investors in reliance on Section 5(d) of the Securities Act. The Company advised the Staff that potential investors have not been permitted to retain copies of such written communications. The Company further advises the Staff that to its knowledge, as of the date hereof, no research reports have been distributed by any broker or dealer participating in the offering. The Company intends to supplementally provide the Staff copies of any such materials as promptly as practicable in the event that any additional materials are presented to potential investors pursuant to Section 5(d) of the Securities Act or any materials are distributed by any broker or dealer participating in the offering. Prospectus Summary General 3. We note that your registration statement includes several references to data attributed to IMS Health, Inc. Please briefly describe who IMS Health is. In addition, please disclose what your relationship is to IMS Health and whether the information attributed to IMS Health was compiled on your behalf. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 1 and 72 of the Registration Statement. As described in the revised disclosure in the Registration Statement, IMS Health is an independent market research firm. According to its website, www.imshealth.com, it is “…the world’s leading information, services and technology company dedicated to making healthcare perform better.” The Company confirms that it has no relationship with IMS Health and no information attributed to IMS Health in the Registration Statement was complied on the Company’s behalf. November 8, 2013 Page Three 4. Please revise your disclosure here and as necessary throughout the prospectus to explain the phrase “peripheral mechanism of action.” Please also explain how “peripherally-active” products are distinguishable from “centrally-active” products and why this is important to the development of CR845. Your discussion should specifically explain how “peripherally-active” kappa opioids, like CR845, avoid both the psychiatric side-effects of “centrally-active” prior kappa opioids and the CNS side effects of mu opioids. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 1, 55 and 72 of the Registration Statement. 5. Please define or explain your use of the following terms or phrases at their first use in the prospectus: • “short bolus;” • “anti-emetic;” • “NSAIDs;” • “oral bioavailability;” • “pharmacokinetic predictability;” • “somnolence;” and • “transient prolactin elevations;” Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 2, 3, 4, 16, 55, 72, 76, 83 and 88 of the Registration Statement. 6. Please explain the purpose of “rescue medication” as used in your clinical trials. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 3 of the Registration Statement. Our Product Candidates, page 2 7. In the “Status” column of your table, please indicate that I.V. CR845 has completed Phase 2 clinical testing. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 2 and 73 of the Registration Statement. 8. Please define the term “statistically significant.” Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on pages 3 and 77 of the Registration Statement. November 8, 2013 Page Four 9. Please briefly summarize the results of the Phase 1 clinical trial you have completed for Oral CR845. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 4 of the Registration Statement. Risk Factors “If we fail to supply CR845 to our collaboration partners...,” page 13 10. We note your risk factor disclosure that you currently have a single supplier for I.V. CR845 and that failure to provide adequate supply of CR845 product to your co-collaborators could result in a breach of your agreements and potential loss of revenue for the Company. Please identify the single supplier to which you are referring as required under Item 101(h)(4)((v) of Regulation S-K. Please also describe the terms of your current contractual arrangements with this supplier. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 13 of the Registration Statement. “The FDA may determine that I.V. CR845 or any of our other product candidates have undesirable side effects...,” page 16 11. Please revise your risk factor disclosure to identify the specific “poorly tolerated side effects” associated with kappa opioid agonists. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 16 of the Registration Statement. “If the manufacturers upon whom we rely fail to produce our product candidates...,” page 25 12. We note your disclosure that you have developed a formulation of Oral CR845 based on a third party’s proprietary technology but have not yet negotiated terms related to use of such technology for commercial manufacturing. Please revise your disclosure to describe the technology used, indicate how you obtained the rights to use the third party’s proprietary technology for the development of Oral CR845 and identify the party from whom you obtained such technology. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 25 of the Registration Statement. “We will incur increased costs as a result of operating as a public company,” page 38 13. Please include in this risk factor, to the extent practicable, an estimate of the annual costs associated with your reporting obligations. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 39 of the Registration Statement. November 8, 2013 Page Five Special Note Regarding Forward-Looking Statements, page 47 14. We note your statement that “there can be no assurances as to the accuracy or completeness” of information obtained from industry and general publications, studies and surveys. We also note your statement that results and estimates derived from internal research “have not been verified by any independent source.” Please revise your disclosure to remove these statements as it is not appropriate to directly or indirectly disclaim liability for information in the registration statement. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 47 of the Registration Statement. Use of Proceeds, page 48 15. Please separate the amount of net proceeds you intend to use to conduct the Phase 1 clinical trial of Oral CR845 and the amount you intend to use for the Phase 2a clinical trial. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 48 of the Registration Statement. Capitalization, page 50 16. It appears the total capitalization amount presented within the capitalization table represents in substance total liabilities, convertible preferred stock and stockholders’ equity rather than total capitalization. Please revise or advise us. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 49 of the Registration Statement. Selected Financial Data, page 54 17. Please present pro forma earnings per share data in this section consistent with your disclosure on page F-4. Response: In response to the Staff’s comment, the Company has revised the disclosure appearing on page 53 of the Registration Statement. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Share-Based Compensation, page 67 18. In order for us to fully understand the equity fair market valuations reflected in your financial statements, please include an itemized chronological schedule covering all equity instruments issued since January 1, 2012 through the date of your response. Separately represent to us that you will update this schedule for any appropriate issuances after the date of your response through the date you complete your offering. Please provide the following information separately for each equity instrument issuance: • The date of the transaction; November 8, 2013 Page Six • The number of shares/options issued/granted; • The exercise price or per share amount paid; • Your fair market value per share estimate and how the estimate was made; • The identity of the recipient, indicating if the recipient was a related party; • Nature and terms of concurrent transactions; and • The amount of any compensation or interest expense element. When you have determined the IPO price range, include a reconciliation that progressively bridges your fair market value determinations to the estimated IPO price range. Please reconcile and explain the differences between the mid-point of your estimated offering price range and the fair values included in your analysis. Response: In response to the Staff’s comment, the Company advises the Staff that, since January 1, 2012, aside from the issuance of common stock through the exercise of pre-existing common stock options, the Company has issued equity securities and convertible debt in five separate transactions: Equity Issuances Since January 1, 2012 Junior Preferred Stock Transaction Background On May 15, 2012, the Company issued and sold 173,611 shares of newly designated Junior Preferred Stock to Chong Kun Dang Pharmaceutical Corporation (“CKD”), an unrelated third party, in connection with the entry into a license agreement with CKD, pursuant to which the Company provided CKD with the exclusive rights to develop, manufacture and commercialize products containing CR845, the company’s lead product candidate, in South Korea. Under the agreement, the Company received a non-refundable and non-creditable amount of $1 million and is eligible to receive milestones payments totaling $3,750,000 relating to pre-defined clinical and regulatory events as well as royalties on sales of any marketed products containing CR845. Each share of Junior Preferred Stock is convertible into one share of the Company’s common stock at any time at the option of the holder or upon the occurrence of certain events, including an initial public offering meeting certain specified conditions. The purchase price of the Junior Preferred Stock was included within the $1 million amount noted above. The stated purchase price of the shares of Junior Preferred Stock, pursuant to the license agreement was $2.88 per share. November 8, 2013 Page Seven Fair Value Discussion Notwithstanding the stated purchase price of the shares, the Company estimated the fair market value of the Junior Preferred Stock as of May 15, 2012 to be $2.04 per share ($354,000 in total) based on a contemporaneous, independent third party valuation. Consistent with the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation (the “Practice Aid”), this valuation was derived using a discounted cash flow methodology to derive the implied value of the Company’s equity, and applying an option-pricing method to derive the value of the Junior Preferred Stock on a controlling, marketable basis and then further applying discounts for lack of control and marketability. The Company has expanded its disclosures on pages 68 and 69 to provide additional detail concerning this valuation. Accounting Discussion As both a license and the sale of Junior Preferred stock were included in this transaction, the Company determined that it represented a multiple element arrangement under ASC 605-25, Revenue Recognition – Multiple Element Arrangements. Regarding elements within an arrangement that are accounted for under topics in which separation and allocation are addressed, ASC 605-25-15-3A states: “If another Topic provides guidance regarding the determination of separate units of accounting and how to allocate arrangement consideration to those separate units of accounting, the arrangement or the deliverables in the arrangement that is within the scope of that Topic shall be accounted for in accordance with the relevant provisions of that Topic rather than the guidance in this Subtopic.” The above refers to Category 1 deliverables that have specific guidance within other topics of the codification. In addition, the Ernst & Young Accounting Manual on Category 1 elements states: Category 1 — Other ASC literature provides guidance on both the separation of multiple deliverables in a multiple
2013-11-01 - UPLOAD - Tvardi Therapeutics, Inc.
October 31, 2013 Via E -mail Derek Chalmers, Ph.D., D.Sc. President and Chief Executive Officer Cara Therapeutics, Inc. 1 Parrot Drive Shelton, Connecticut 06484 Re: Cara Therapeutics, Inc. Draft Registration Statement on Form S -1 Submitted October 4, 2013 CIK No. 0001346830 Dear Dr. Chalmers : 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 sta tement 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 thos e are not the only graphics, please provide any additional graphics prior to their use for our review. 2. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you , or anyone authorized to do so on your behalf , present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. 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 . Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. October 31, 2013 Page 2 Prospectus Summary General 3. We note that your registration statement includes several references to data attributed to IMS Health, Inc. Please briefly describe who IMS Health is. In addition, please disclose what your relationship is to IMS Health an d whether the information attributed to IMS Health was compiled on your behalf. 4. Please revise your disclosure here and as necessary throughout the prospectus to explain the phrase “peripheral mechanism of action.” Please also explain how “peripherally - active” products are distinguishable from “centrally -active” products and why this is important to the development of CR845. Your discussion should specifically explain how “peripherally -active” kappa opioids, like CR845, avoid both the psychiatric side - effects of “centrally -active” prior kappa opioids and the CNS side effects of mu opioids. 5. Please define or explain your use of the following terms or phrases at their first use in the prospectus: “short bolus;” “anti -emetic;” “NSAIDs;” “oral bioavailability;” “pharmacokinetic predictability;” “somnolence;” and “transient prolactin elevations;” 6. Please explain the purpose of “rescue medication” as used in your clinical trials. Our Product Candidates, page 2 7. In the “Status” column of your t able, please indicate that I.V. CR845 has completed Phase 2 clinical testing . 8. Please define the term “statistically significant.” 9. Please briefly summarize the results of the Phase 1 clinical trial you have completed for Oral CR845. Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. October 31, 2013 Page 3 Risk Factors “If we fail to supply CR845 to our collaboration partners…,” page 13 10. We note your risk factor disclosure that you currently have a single supplier for I.V. CR845 and that failure to provide adequate supply of CR845 product to your co - collaborators could result in a breach of your agreements and potential loss of revenue for the Company. Please identify the single supplier to which you are referring as required under Item 101(h)(4)((v) of Regulation S -K. Please also describe the terms of your current contractua l arrangement s with this supplier . “The FDA may determine that I.V. CR845 or any of our other product candidates have undesirable side effects…,” page 16 11. Please revise your risk factor disclosure to identify the specific “poorly tolerated side effects” associated with kappa opioid agonists. “If the manufacturers upon whom we rely fail to produce our product candidates…,” page 25 12. We note your disclosure that you have developed a formulation of Oral CR845 based on a third party’s proprietary technology but have not yet negotiated terms related to use of such technology for commercial manufacturing. Please revise your disclosure to describe the technology used, indicate how you obtained the rights to use the third party ’s proprietary technology for the d evelopment of Oral CR845 and identify the party from whom you obtained such technology. “We will incur increased costs as a result of operating as a public company,” page 38 13. Please include in this risk factor, to the extent practicable, an estimate of the annual costs associated with your reporting obligations. Special Note Regarding Forward -Looking Statements, page 47 14. We note your statement that “there can be no assurances as to the accuracy or completeness” of information obtained from industry an d general publications, studies and surveys. We also note your statement that results and estimates derived from internal research “have not been verified by any independent source.” Please revise your disclosure to remove these statements as it is not a ppropriate to directly or indirectly disclaim liability for information in the registration statement. Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. October 31, 2013 Page 4 Use of Proceeds, page 48 15. Please separate the amount of net proceeds you intend to use to conduct the Phase 1 clinical trial of Oral CR845 and the amount you intend to use for the Phase 2a clinical trial. Capitalization, page 50 16. It appears the total capitalization amount presented within the capitalization table represents in substance total liabilities, convertible preferred stock and stockhol ders’ equity rather than total capitalization. Please revise or advise us. Selected Financial Data, page 54 17. Please present pro forma earnings per share data in this section consistent with your disclosure on page F -4. Management’s Discussion and Analysi s of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Share -Based Compensation, page 67 18. In order for us to fully understand the equity fair market valuations reflected in your financial sta tements, please include an itemized chronological schedule covering all equity instruments issued since January 1, 2012 through the date of your response. Separately represent to us that you will update this schedule for any appropriate issuances after th e date of your response through the date you complete your offering. Please provide the following information separately for each equity instrument issuance: The date of the transaction; The number of shares/options issued/granted; The exercise price or per share amount paid; Your fair market value per share estimate and how the estimate was made; The identity of the recipient, indicating if the recipient was a related party; Nature and terms of concurrent transactions; and The amount of any compen sation or interest expense element. When you have determined the IPO price range, include a reconciliation that progressively bridges your fair market value determinations to the estimated IPO price range. Please reconcile and explain the differences between the mid -point of your Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. October 31, 2013 Page 5 estimated offering price range and the fair values included in your analysis. Business Our Product Candidates, page 73 19. Please revise your disclosure to explain how use of CR845 will avoid drug -drug interactions. 20. Please revise the discussion of the results of your clinical trials to identify what the corresponding p values refer to. 21. Please revise your tables at pages 7 9 and 83 to explain what the abbreviation “ ANOVA ” refers to. I.V. CR845, page 73 22. Please revise your disclosure to i ndicate whether total pain relief score, or TOTPAR, is an FDA -recognized endpoint for acute pain clinical trials . Principal Stockholders, page 119 23. Please amend this disclosure to include the individual(s) who has voting and/or investment power over the common shares held by Healthcare Private Equity Limited Partnership. Exhibit Index, page II -7 24. Please indicate in this index which of your exhibits will be the subject of your application for confidential treatment. 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 Division’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/cfannouncement s/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. Derek Chalmers, Ph.D., D.Sc. Cara Therapeutics, Inc. October 31, 2013 Page 6 You may c ontact Ibolya Ignat at (202) 551 -3656 or Andrew Mew at (202) 551 -3377 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Babak Yaghmaie Stephanie Levy Darren DeStefano Cooley LLP 1114 Avenue of the Americas New York, New York 10036
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