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SEC Comment Letter for IMMUNIC, INC. (IMUX) (CIK 0001280776) (IMUX) — Apr 7, 2014

IMMUNIC, INC. (IMUX) (CIK 0001280776)
Date: April 7, 2014 · CIK: 0001280776 · Accession: 0000000000-14-017305

Financial Reporting Regulatory Compliance Risk Disclosure

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
April 3, 2013
Author
/s/ Bryan J. Pitko for
Form
UPLOAD
Company
IMMUNIC, INC. (IMUX) (CIK 0001280776)

Letter

April 7 , 2014 Via E -Mail Terrence E. Winters, Ph.D. Co-Chairman of the Board & Chief Executive Officer Vital Therapies, Inc. 15222 Avenue of Science, Suite B San Diego, CA 92128

Re: Vital Therapies, Inc. Amendment No. 5 to Registration Statement on Form S -1 Filed April 3, 2013 File No. 333 -191711

Dear Dr. Winters:

We have reviewed your amended registration statement and have the following comment s.

Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comment s apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your registration statement and the informatio n you provide in response to th ese comment s, we may have additional comment s.

Use of Proceeds, page 41

1. We note your response to our prior comment 4 and the associated revisions to your registration statement. Pursuant to the requirements of Item 504 of Regulation S -K, where you have identified the specific purposes for which you intend to use the offering proceeds, you must disclose the approximate amount of proceeds intended to be used for each such purpose. In this regard, we note your disclosed expectation that the proceeds from the offering and existing cash and cash equi valents will be sufficient to fund development through receipt of initial data from leading Phase 3 trials. Please revise your disclosure in this section to indicate how your use of proceeds from the offering will be allocated towards the clinical develop ment for each of VTI -208, VTI -210, and VTI - 212, respectively.

We understand that the company has not yet made such specific determination, but that does not relieve you of your obligation to provide investors with your best estimate,

Terrence E. Winters, Ph.D. Vital Therapies, Inc. April 7 , 2014 Page 2

based on reasonable assumptions, of the manner in which you will allocate investors’ funds. You may, as necessary, provide additional disclosure that advises investors of the particular factors and assumptions that form the basis of your estimate, any uncertainty surroundin g these amounts and the reasons that the actual use of proceeds could vary. Please make any necessary conforming changes to your Prospectus Summary as well.

2. Please clarify your reference to receipt of “initial data ,” with respect to the level of clinical development you expect to reach using net proc eeds from this offering and your existing cash and cash equivalents . In particular, please revise your disclosure to clarify whether you are referring to preliminary data obtained prior to the co mpletion of Phase 3 trials of VTI -208, VTI -210, and VTI -212, data obtained following completion of such trials, or data obtained at some other point.

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 1933 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 f or the accuracy and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowled ging 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 reque sts 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 Securitie s 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 effectiv e date of the registration statement.

Terrence E. Winters, Ph.D. Vital Therapies, Inc. April 7 , 2014 Page 3

Please contact Christina De Rosa at (202) 551 -3577, Bryan Pitko at (202) 551 -3203, or me a t (202) 551 -3715 with any questions.

Sincerely,
/s/ Bryan J. Pitko for

Show Raw Text
April 7 , 2014

Via E -Mail
Terrence E. Winters, Ph.D.
Co-Chairman of the Board &
Chief Executive Officer
Vital Therapies, Inc.
15222 Avenue of Science, Suite B
San Diego, CA 92128

Re: Vital Therapies, Inc.
Amendment No. 5 to Registration Statement on Form S -1
Filed April 3, 2013
  File No. 333 -191711

Dear Dr. Winters:

We have reviewed your amended registration statement and have the following
comment s.

Please respond to this letter by amending your registration statement and providing the
requested information.   If you do not believe our comment s apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the informatio n you
provide in response to th ese comment s, we may have additional comment s.

Use of Proceeds, page 41

1. We note your response to our prior comment 4 and the associated revisions to your
registration statement.   Pursuant to the requirements of Item 504 of Regulation S -K,
where you have identified the specific purposes for which you intend to use the offering
proceeds, you must disclose the approximate amount of proceeds intended to be used for
each such purpose.  In this regard, we note your disclosed expectation that the proceeds
from the offering and existing cash and cash equi valents will be sufficient to fund
development through receipt of initial data from leading Phase 3 trials.  Please revise
your disclosure in this section to indicate how your use of proceeds from the offering will
be allocated towards the clinical develop ment for each of VTI -208, VTI -210, and VTI -
212, respectively.

We understand that the company has not yet made such specific determination, but that
does not relieve you of your obligation to provide investors with your best estimate,

Terrence E. Winters, Ph.D.
Vital Therapies, Inc.
April 7 , 2014
Page 2

 based on reasonable  assumptions, of the manner in which you will allocate investors’
funds.  You may, as necessary, provide additional disclosure that advises investors of the
particular factors and assumptions that form the basis of your estimate, any uncertainty
surroundin g these amounts and the reasons that the actual use of proceeds could vary.
Please make any necessary conforming changes to your Prospectus Summary as well.

2. Please  clarify your reference to receipt of “initial data ,” with respect to the level of
clinical development you expect to reach using net proc eeds from this offering and your
existing cash and cash equivalents .  In particular, please revise your disclosure to clarify
whether you are referring to preliminary data obtained prior to the co mpletion of Phase 3
trials of VTI -208, VTI -210, and VTI -212, data obtained following completion of such
trials, or data obtained at some other point.

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 1933 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 f or the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowled ging 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 reque sts 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 Securitie s 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 effectiv e date of the
registration statement.

Terrence E. Winters, Ph.D.
Vital Therapies, Inc.
April 7 , 2014
Page 3

 Please contact Christina De Rosa at (202) 551 -3577, Bryan Pitko at (202) 551 -3203,  or
me a t (202) 551 -3715 with any questions.

Sincerely,

 /s/ Bryan J. Pitko for

 Jeffrey P. Riedler
Assistant Director
cc:  Via E -Mail
 Martin J. Wa ters
 Wilson Sonsini Goodrich & Rosati,
 Professional Corporation
 12235 El Camino Real, Suite 200
San Diego, CA 92130 -3002