SEC Comment Letter for MetaVia Inc. (MTVA) (CIK 0001638287) (MTVA) — Oct 7, 2015
MetaVia Inc. (MTVA) (CIK 0001638287)
Date: Oct. 7, 2015 · CIK: 0001638287 · Accession: 0000000000-15-048926
AI Filing Summary & Sentiment
Reasoning
Letter
Mail Stop 4546 October 7, 2015 Via E -mail Mina Sooch Chief Executive Officer Gemphire Therapeutics Inc. 43334 Seven Mile Road, Suite 1000 Northville, Michigan 48167
Re: Gemphire Therapeutics Inc. Draft Registration Statement on Form S-1 Submitted September 11, 2015 CIK No. 0001638287
Dear Ms. Sooch :
We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statemen t, we may have additional comments.
General
1. Please supplementally provide us with copies of all written communications, as defined in Securities Act Rule 405, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Securities Act Section 5(d), whether or not they retain copies of the communications.
2. We note that you have requested confidential treatment for one of your exh ibits. We intend to send comments on your confidential treatment request under separate cover.
Mina Sooch Gemphire Therapeutics Inc. October 7, 2015 Page 2
3. Please include disclosure regarding the directed share program in your “Risk Factors,” “Certain Relationships and Related Party Transactions” and “Plan of Dist ribution” sections, or tell us why such disclosure is not required. See Items 503, 404 and 508 of Regulation S - K.
Risk Factors, page 11
Provisions in our corporate charter documents …, page 46
4. Where you state that provisions in your corporate charter and bylaws will limit who may call stockholder meetings, please revise to clarify, if true, that stockholders will be prohibited from calling special meetings.
Our executive officers, directors, principal stockholders…, page 48
5. Please advise as to whet her you anticipate being a “controlled company,” as defined by NASDAQ, upon completion of this offering. If so, please include an appropriate risk factor.
Use of Proceeds, page 56
6. We note that management “will have broad discretion in the application of the net proceeds.” Please revise your disclosure to comply with Instruction 7 to Item 504 of Regulation S -K, or delete the reservation regarding the use of proceeds from this section and from the risk factor on page 48.
Management’s Discussion and Anal ysis of Financial Condition and Results of Operations, page 65
Liquidity and Capital Resources , page 70
7. Please revise to disclose the amount of capital you will need to sustain operations through December 31, 2015, as well as the amount of capital you will need to sustain operations through the next 18 months, including your EOP2 meeting with the FDA and the commencement of your Phase 3 registration trials.
8. We note your disclosure regarding the July 2015 convertible note financing. Assuming you do not complete a stock financing resulting in at least $5.0 million of new invested capital prior to the comple tion of this public offering, please disclose whether you intend to use any portion of the proceeds from this offering to repay the holders of the convertible notes.
Mina Sooch Gemphire Therapeutics Inc. October 7, 2015 Page 3
Critical Accounting Policies and Estimates, page 74
Common Stock Valuation, page 76
9. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences bet ween recent valuations of your common stock leading up to the IPO and the estimated offering price.
Business, page 80
Overview, page 80
10. Please provide support substantiating your claims on page 82 that Drs. John Kastelein, Evan Stein, Robert Hegele and Dirk Blom are “key opinion leaders” and “are recognized worldwide experts in the drug development of lipid -lowering therapies ,” and that your management team, including Ms. Mina, has a “ successful track record of discovering, developing and commercializing treatments in the cardiovascular and orphan markets .” Also clarify whether Ms. Mina or any members of the management team actually discovered the treatments referenced or assisted in some other capacity.
Our Strategy, page 82
11. Refer to the following s entence on page 83: “ As a result, we believe that we have identified indications for gemcabene with favorable regulatory pathways and the highest likelihood of commercial success. ” Please revise to clarify, if accurate, that you are referring to the likelihood of commercial success of your target indications as compared to other potential indications for gemcabene that you considered.
Our Target Indications, page 85
12. In the diagram on page 86, please clarify the meaning of the dotted line.
Gemcabene Clinical Development Plan, page 100
13. On page 101, please briefly explain what a peroxisome proliferation -activated receptor agonist is.
Undertakings, page II -6
14. As this is your initial distribution of securities, please include the undertaking set fort h in
Mina Sooch Gemphire Therapeutics Inc. October 7, 2015 Page 4
Item 512(a)(6) of Regulation S -K.
Exhibits
15. Please file as an exhibit to your registration statement the documentation relating to the July 2015 convertible note financing. See Item 601(b)(4) of Regulation S -K.
You may contact Sasha Parikh, Staff Accoun tant, at (202) 551 -3627 or Sharon Blume , Accounting Branch Chief , at (202) 551 -3474 if you have questions regarding comments on the financial statements and related matters. Please contact Alexandra M. Ledbetter, Staff Attorney , at (202) 551 -3317 or Lilyanna Peyser, Special Counsel, at (202) 551 -3222 with any other questions.
Sincerely,
/s/ Lilyanna Peyser for
Show Raw Text
Mail Stop 4546
October 7, 2015
Via E -mail
Mina Sooch
Chief Executive Officer
Gemphire Therapeutics Inc.
43334 Seven Mile Road, Suite 1000
Northville, Michigan 48167
Re: Gemphire Therapeutics Inc.
Draft Registration Statement on Form S-1
Submitted September 11, 2015
CIK No. 0001638287
Dear Ms. Sooch :
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on EDGAR.
If you do not believe our comments apply to your facts and circumstances or do not believe an
amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statemen t, we may have additional
comments.
General
1. Please supplementally provide us with copies of all written communications, as defined in
Securities Act Rule 405, that you, or anyone authorized to do so on your behalf, present to
potential investors in reliance on Securities Act Section 5(d), whether or not they retain
copies of the communications.
2. We note that you have requested confidential treatment for one of your exh ibits. We intend
to send comments on your confidential treatment request under separate cover.
Mina Sooch
Gemphire Therapeutics Inc.
October 7, 2015
Page 2
3. Please include disclosure regarding the directed share program in your “Risk Factors,”
“Certain Relationships and Related Party Transactions” and “Plan of Dist ribution” sections,
or tell us why such disclosure is not required. See Items 503, 404 and 508 of Regulation S -
K.
Risk Factors, page 11
Provisions in our corporate charter documents …, page 46
4. Where you state that provisions in your corporate charter and bylaws will limit who may
call stockholder meetings, please revise to clarify, if true, that stockholders will be
prohibited from calling special meetings.
Our executive officers, directors, principal stockholders…, page 48
5. Please advise as to whet her you anticipate being a “controlled company,” as defined by
NASDAQ, upon completion of this offering. If so, please include an appropriate risk
factor.
Use of Proceeds, page 56
6. We note that management “will have broad discretion in the application of the net
proceeds.” Please revise your disclosure to comply with Instruction 7 to Item 504 of
Regulation S -K, or delete the reservation regarding the use of proceeds from this section
and from the risk factor on page 48.
Management’s Discussion and Anal ysis of Financial Condition and Results of Operations, page 65
Liquidity and Capital Resources , page 70
7. Please revise to disclose the amount of capital you will need to sustain operations through
December 31, 2015, as well as the amount of capital you will need to sustain operations
through the next 18 months, including your EOP2 meeting with the FDA and the
commencement of your Phase 3 registration trials.
8. We note your disclosure regarding the July 2015 convertible note financing. Assuming
you do not complete a stock financing resulting in at least $5.0 million of new invested
capital prior to the comple tion of this public offering, please disclose whether you intend to
use any portion of the proceeds from this offering to repay the holders of the convertible
notes.
Mina Sooch
Gemphire Therapeutics Inc.
October 7, 2015
Page 3
Critical Accounting Policies and Estimates, page 74
Common Stock Valuation, page 76
9. We may have additional comments on your accounting for equity issuances including stock
compensation and beneficial conversion features. Once you have an estimated offering
price, please provide us an analysis explaining the reasons for the differences bet ween
recent valuations of your common stock leading up to the IPO and the estimated offering
price.
Business, page 80
Overview, page 80
10. Please provide support substantiating your claims on page 82 that Drs. John Kastelein,
Evan Stein, Robert Hegele and Dirk Blom are “key opinion leaders” and “are recognized
worldwide experts in the drug development of lipid -lowering therapies ,” and that your
management team, including Ms. Mina, has a “ successful track record of discovering,
developing and commercializing treatments in the cardiovascular and orphan markets .”
Also clarify whether Ms. Mina or any members of the management team actually
discovered the treatments referenced or assisted in some other capacity.
Our Strategy, page 82
11. Refer to the following s entence on page 83: “ As a result, we believe that we have identified
indications for gemcabene with favorable regulatory pathways and the highest likelihood of
commercial success. ” Please revise to clarify, if accurate, that you are referring to the
likelihood of commercial success of your target indications as compared to other potential
indications for gemcabene that you considered.
Our Target Indications, page 85
12. In the diagram on page 86, please clarify the meaning of the dotted line.
Gemcabene Clinical Development Plan, page 100
13. On page 101, please briefly explain what a peroxisome proliferation -activated receptor
agonist is.
Undertakings, page II -6
14. As this is your initial distribution of securities, please include the undertaking set fort h in
Mina Sooch
Gemphire Therapeutics Inc.
October 7, 2015
Page 4
Item 512(a)(6) of Regulation S -K.
Exhibits
15. Please file as an exhibit to your registration statement the documentation relating to the
July 2015 convertible note financing. See Item 601(b)(4) of Regulation S -K.
You may contact Sasha Parikh, Staff Accoun tant, at (202) 551 -3627 or Sharon Blume ,
Accounting Branch Chief , at (202) 551 -3474 if you have questions regarding comments on the
financial statements and related matters. Please contact Alexandra M. Ledbetter, Staff Attorney , at
(202) 551 -3317 or Lilyanna Peyser, Special Counsel, at (202) 551 -3222 with any other questions.
Sincerely,
/s/ Lilyanna Peyser for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Phillip D. Torrence, Esq.
Honigman Miller Schwartz and Cohn LLP