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MetaVia Inc.
Response Received
1 company response(s)
High - file number match
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
MetaVia Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2018-08-14
MetaVia Inc.
Summary
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
MetaVia Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-22
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-04-17
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2023-01-25
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2022-09-22
MetaVia Inc.
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-06-25
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-05-21
MetaVia Inc.
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MetaVia Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-04-26
MetaVia Inc.
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-03-23
MetaVia Inc.
Summary
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-02-18
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-01-27
MetaVia Inc.
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MetaVia Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-10-03
MetaVia Inc.
Summary
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Company responded
2019-10-29
MetaVia Inc.
References: October 25, 2019
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-10-28
MetaVia Inc.
Summary
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MetaVia Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-08-28
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-09-07
MetaVia Inc.
Summary
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MetaVia Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-04-18
MetaVia Inc.
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MetaVia Inc.
Response Received
9 company response(s)
High - file number match
Company responded
2016-04-22
MetaVia Inc.
References: October 7, 2015
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SEC wrote to company
2016-05-02
MetaVia Inc.
Summary
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Company responded
2016-05-03
MetaVia Inc.
References: May 2, 2016
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Company responded
2016-06-15
MetaVia Inc.
References: October 7, 2015
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MetaVia Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-10-07
MetaVia Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2025-07-08 | SEC Comment Letter | MetaVia Inc. | DE | 333-288486 | Read Filing View |
| 2025-05-06 | SEC Comment Letter | MetaVia Inc. | DE | 001-37809 | Read Filing View |
| 2025-05-02 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2025-04-28 | SEC Comment Letter | MetaVia Inc. | DE | 001-37809 | Read Filing View |
| 2024-07-22 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2024-07-22 | SEC Comment Letter | MetaVia Inc. | DE | 333-280865 | Read Filing View |
| 2024-04-19 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2024-04-17 | SEC Comment Letter | MetaVia Inc. | DE | 333-278646 | Read Filing View |
| 2023-01-27 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2023-01-25 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2022-09-22 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-06-10 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-05-24 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-05-21 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-04-28 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-04-26 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-03-02 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-02-18 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-01-27 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-01-27 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-11-04 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-10-29 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-10-28 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-10-03 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2018-08-28 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2018-08-22 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2018-08-14 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-09-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-09-07 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-04-19 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-04-18 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-07-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-07-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-06-20 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-06-20 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-06-15 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-05-03 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-05-02 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-04-22 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2015-10-07 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-08 | SEC Comment Letter | MetaVia Inc. | DE | 333-288486 | Read Filing View |
| 2025-05-06 | SEC Comment Letter | MetaVia Inc. | DE | 001-37809 | Read Filing View |
| 2025-04-28 | SEC Comment Letter | MetaVia Inc. | DE | 001-37809 | Read Filing View |
| 2024-07-22 | SEC Comment Letter | MetaVia Inc. | DE | 333-280865 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | MetaVia Inc. | DE | 333-278646 | Read Filing View |
| 2023-01-25 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2022-09-22 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-05-21 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-04-26 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-02-18 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-01-27 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-10-28 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-10-03 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2018-08-28 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2018-08-14 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-09-07 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-04-18 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-05-02 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| 2015-10-07 | SEC Comment Letter | MetaVia Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2025-05-02 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2024-07-22 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2024-04-19 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2023-01-27 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-06-10 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-05-24 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-04-28 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-03-02 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2021-01-27 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-11-04 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2019-10-29 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2018-08-22 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-09-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2017-04-19 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-07-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-07-08 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-06-20 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-06-20 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-06-15 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-05-03 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
| 2016-04-22 | Company Response | MetaVia Inc. | DE | N/A | Read Filing View |
2025-07-08 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm July 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Tyler Howes Re: MetaVia Inc. Registration Statement on Form S-3 File No. 333-288486 Acceleration Request Requested Date: July 10, 2025 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rules 460 and 461 under the Securities Act of 1933, as amended, MetaVia Inc. (the "Company" ) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 (File No. 333-288486) (the "Registration Statement" ) be declared effective on the "Requested Date" and at the "Requested Time" set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip D. Torrence and Joshua W. Damm of Honigman LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman LLP by telephone at (269) 337-7702 or Joshua W. Damm of Honigman LLP by telephone at (313) 465-7714. Sincerely, MetaVia Inc. /s/ Hyung Heon Kim Hyung Heon Kim President, Chief Executive Officer and Director cc: Marshall Woodworth, Chief Financial Officer MetaVia Inc. Phillip D. Torrence, Esq. Joshua W. Damm, Esq. Honigman LLP [Signature Page – Acceleration Request]
2025-07-08 - UPLOAD - MetaVia Inc. File: 333-288486
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 8, 2025 Hyung Heon Kim Chief Executive Officer MetaVia Inc. 545 Concord Avenue, Suite 210 Cambridge, MA 02138 Re: MetaVia Inc. Registration Statement on Form S-3 Filed July 2, 2025 File No. 333-288486 Dear Hyung Heon Kim: 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 Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Josh Damm, Esq. </TEXT> </DOCUMENT>
2025-05-06 - UPLOAD - MetaVia Inc. File: 001-37809
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 6, 2025 Marshall Woodworth Chief Financial Officer MetaVia Inc. 545 Concord Avenue, Suite 210 Cambridge, MA 02138 Re: MetaVia Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-37809 Dear Marshall Woodworth: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-05-02 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm May 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Tracie Mariner Re: MetaVia Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-37809 Ladies and Gentlemen: Set forth below is the response of MetaVia Inc., a Delaware corporation (the “Company , ” “we , ” or “our” ), to the comment made by the staff (the “Staff” ) of the U.S. Securities and Exchange Commission (the “Commission” ) by letter dated April 28, 2025 (the “Comment Letter” ), that relates to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (File No. 001-37809), originally filed by the Company with the Commission on March 20, 2025. To assist in your review, set forth below in bold is the comment of the Staff contained in the Comment Letter. Immediately below the comment is the response of the Company with respect thereto. Form 10-K for Fiscal Year Ended December 31, 2024 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Operating expenses and loss from operations, page 68 1. You disclose the following on page 66, “Our direct research and development expenses also include fees incurred under third-party license agreements. We use our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources to manage CMO and CRO activities. These employees work across multiple programs. We do not track our costs by product candidate.” Please provide revised disclosure to be included in future filings to address the following: ● Revise to clarify the extent to which you track any research and development expenses by product or program, particularly including your direct expenses. ● To the extent you do track any expenses, revise your future filings to break out the tracked research and development expenses by product candidate (e.g., DA-1241, DA-1726). ● If you do not track any expenses by product or program, including your direct expenses, please disclose that fact and explain why not. ● For all other research and development expenses, provide us with other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e., by nature or type of expense) for each period presented which should reconcile to total research and development expense on the Statements of Operations. MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 U.S. Securities and Exchange Commission Division of Corporation Finance May 2, 2025 Page 2 Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, commencing with its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, the Company will provide the requested disclosure to clarify the extent to which the Company tracks any research and development expenses by product or program, particularly including the Company’s direct expenses, substantially in the form provided below, in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Key operating information–Research and development expenses.” Research and development expenses R&D expenses consist primarily of costs incurred in connection with the development of our product candidates. These expenses include: Direct costs ● expenses incurred in connection with the clinical development of our product candidates, including under agreements with third parties, such as clinical research organizations (“CROs”) and consultants; ● the cost of manufacturing and storing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants and Clinical Manufacturing Organizations (“CMOs”); ● costs related to compliance with regulatory requirements; and ● payments made under third-party licensing agreements, including the Shared Services Agreement with Dong-A (related party). Indirect costs ● employee-related expenses, including salaries, related benefits and stock-based compensation, for employees engaged in research and development functions; and ● consulting and other expenses not directly tied to a product candidate. MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 U.S. Securities and Exchange Commission Division of Corporation Finance May 2, 2025 Page 2 We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our service providers. This process involves reviewing contracts and purchase orders, communicating with our clinical research staff to identify services that have been performed on our behalf, and estimating the level of service provided and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered. Our direct R&D expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research laboratories and outside consultants in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under third-party license agreements, including the Shared Services Agreement with Dong-A (related party) . We utilize our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We utilize internal resources to manage CRO and CMO activities. These employees work across multiple programs. Our direct R&D expenses consist of (i) expenses attributable to our product candidates and (ii) certain other R&D expenses, including non-clinical and preclinical services or other R&D expenses that are not attributable to a single product candidate. Our indirect R&D expenses consist of (i) employment-related expenses for compensation and benefits, which are internal costs, and (ii) consulting expenses. MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 U.S. Securities and Exchange Commission Division of Corporation Finance May 2, 2025 Page 3 Clinical development activities are central to our business model. We do not believe that our historical costs are indicative of the future costs associated with these programs, nor do they represent the costs of future programs we may initiate. Product candidates in later stages of clinical development generally have higher development costs than those in preclinical development or in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We have some control over the timing of these expenses, but costs may be difficult to control once clinical trials have commenced. The successful development and commercialization of our product candidates are highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. Additionally, because of the risks inherent in novel treatment discovery and development, we cannot reasonably estimate or know: ● the timing and progress of preclinical and clinical development activities; ● the number and scope of preclinical and clinical programs that we decide to pursue; ● our ability to maintain our current development programs and to establish new ones; ● establishing an appropriate safety profile with IND-enabling studies; ● successful patient enrollment in, and the initiation and completion of, clinical trials; ● the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; ● the receipt of regulatory approvals from applicable regulatory authorities; ● the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; ● our ability to establish new licensing or collaboration arrangements; ● establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates is approved; ● development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; ● obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; ● launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; ● maintaining a continued acceptable safety profile of the product candidates following commercialization; or ● the effect of competing technological and market developments. A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate. The Company further advises the Staff that in future filings, commencing with its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, the Company will provide the requested disclosure to break out the tracked research and development expenses by product candidate and to provide quantitative and qualitative disclosure that provides more transparency as to the type of research and development expenses incurred for each period presented, substantially in the form of the table provided below, as well as narrative disclosure accompanying such table tailored to the results for each period presented, in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Results of operations- Three months ended March 31, 2025 compared to three months ended March 31, 2024- Total operating expenses and loss from operations.” We will include similar tables MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 U.S. Securities and Exchange Commission Division of Corporation Finance May 2, 2025 Page 4 and accompanying narrative disclosure in each Quarterly Report on Form 10-Q and Annual Report on Form 10-K on a prospective basis. Total operating expenses and loss from operations Our total operating expenses and loss from operations for the three months ended March 31, 2025 were $ million, [an increase / a decrease] of $ million, or %, compared to the three months ended March 31, 2024. This [increase / decrease] was attributable to [higher / lower] R&D expenses and [higher / lower] general and administrative expenses for the three months ended March 31, 2025. Our R&D expenses were $ million for the three months ended March 31, 2025, [an increase / a decrease] of $ million, or %, compared to the three months ended March 31, 2024. Our general and administrative expenses were $ million for the three months ended March 31, 2025, [an increase / a decrease] of $ million, or %, compared to the three months ended March 31, 2024. The following table summarizes our R&D expenses for the three months ended March 31, 2025 and 2024 (in thousands): Three Months Ended March 31, 2025 2024 Direct costs DA-1241 $ $ DA-1726 Other R&D costs Indirect costs Employee compensation and benefits Consulting expenses Total research and development This $ million [increase / decrease] in R&D expenses reflects [increased / decreased] R&D activities related to Phase 2a clinical trial for DA-1241 and [increased / decreased] R&D activities related to Phase 1 trial for DA-1726 for 2024 as compared to the three months ended March 31, 2024. Specifically, the [increase / decrease] in R&D expenses was primarily attributable to (i) $ million in [higher / lower] direct R&D expenses related to DA-1241 product development and (ii) $ million in [higher / lower] direct other R&D costs. These [increases / decreases] were partially offset by (i) $ million in [higher / lower] direct R&D expenses related to DA-1726 product development and (ii) $ million in [higher / lower] indirect R&D expenses related to employee compensation and benefits. Included in direct R&D costs were expenses totaling $ million and $ million for the three months ended March 31, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A (related party). The $ million [increase / decrease] in general and administrative expenses was primarily attributable to (i) $ million in [higher / lower] consulting expenditures and (ii) $ million in [higher / lower] other G&A expenses. These [increases / decreases] were partially offset by $ million in [lower / higher] employee compensation and benefits. ******** As requested, in connection with responding to the Staff’s comments, the Company acknowledges that it 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 feel free to contact the undersigned should you have any questions or comments at (646) 770-5179, or in my absence, Marshall H. Woodworth, the Company’s Chief Financial Officer at (919) 749-8748. MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 U.S. Securities and Exchange Commission Division of Corporation Finance May 2, 2025 Page 4 [ Signature Page Follows ] MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 U.S. Securities and Exchange Commission Division of Corporation Finance May 2, 2025 Page 5 Sincerely, /s/ Hyung Heon Kim Hyung Heon Kim President and Chief Executive Officer cc: Marshall H. Woodworth, Chief Financial Officer MetaVia Inc. Phillip D. Torrence, Esq. Joshua W. Damm, Esq. Honigman LLP 60320847
2025-04-28 - UPLOAD - MetaVia Inc. File: 001-37809
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 28, 2025 Marshall Woodworth Chief Financial Officer MetaVia Inc. 545 Concord Avenue, Suite 210 Cambridge, MA 02138 Re: MetaVia Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-37809 Dear Marshall Woodworth: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for Fiscal Year Ended December 31, 2024 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Operating expenses and loss from operations, page 68 1. You disclose the following on page 66, "Our direct research and development expenses also include fees incurred under third-party license agreements. We use our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources to manage CMO and CRO activities. These employees work across multiple programs. We do not track our costs by product candidate. Please provide revised disclosure to be included in future filings to address the following: Revise to clarify the extent to which you track any research and development expenses by product or program, particularly including your direct expenses. April 28, 2025 Page 2 To the extent you do track any expenses, revise your future filings to break out the tracked research and development expenses by product candidate (e.g., DA-1241, DA1726). If you do not track any expenses by product or program, including your direct expenses, please disclose that fact and explain why not. For all other research and development expenses, provide us with other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e., by nature or type of expense) for each period presented which should reconcile to total research and development expense on the Statements of Operations. In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Vanessa Robertson at 202-551-3649 or Tracie Mariner at 202-551- 3744 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2024-07-22 - CORRESP - MetaVia Inc.
CORRESP
1
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July 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Washington, D.C. 20549
Attention: Jimmy McNamara
Re:
NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-1
File No. 333-280865
Acceleration Request
Requested Date: July 24,
2024
Requested Time: 5:00
P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement on Form S-1 (File No. 333-280865) (the “Registration Statement”)
be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable
thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of
Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip Torrence and Josh Damm of
Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness
of the Registration Statement with Phillip Torrence of Honigman LLP by telephone at (269) 337-7702 or Josh Damm of Honigman LLP by telephone
at (313) 465-7714.
Sincerely,
NeuroBo Pharmaceuticals, Inc.
/s/ Hyung Heon Kim
Hyung Heon Kim
President, Chief Executive Officer and Director
cc:
Marshall Woodworth, Chief Financial Officer
NeuroBo Pharmaceuticals, Inc.
Phillip D. Torrence, Esq.
Joshua W. Damm, Esq.
Samuel Katz, Esq.
Honigman LLP
NeuroBo Pharmaceuticals, Inc.
545 Concord Avenue, Suite 210
Cambridge, MA 02138
857.702.9600
2024-07-22 - UPLOAD - MetaVia Inc. File: 333-280865
July 22, 2024
Hyung Heon Kim
Chief Executive Officer
NeuroBo Pharmaceuticals, Inc.
545 Concord Avenue, Suite 210
Cambridge, Massachusetts 02138
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed July 18, 2024
File No. 333-280865
Dear Hyung Heon Kim:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joshua W. Damm
2024-04-19 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm L-120P (Audit Engagement - Public Co).docx April 19, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Dan Crawford Re:NeuroBo Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-278646 Acceleration Request Requested Date:April 23, 2024 Requested Time:5:30 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rules 460 and 461 under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 (File No. 333-278646) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip Torrence, Samuel Katz and Rachel Rhodes of Honigman LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Phillip Torrence of Honigman LLP by telephone at (269) 337-7702, Samuel Katz of Honigman LLP by telephone at (313) 465-8137 or Rachel Rhodes of Honigman LLP by telephone at (313) 465-7977. Sincerely, NEUROBO PHARMACEUTICALS, INC. /s/ Hyung Heon Kim Hyung Heon Kim President and Chief Executive Officer cc: Phillip D. Torrence, Honigman LLP Samuel Katz, Honigman LLP Rachel Rhodes, Honigman LLP NeuroBo Pharmaceuticals, Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138 857.702.9600 info@neurobopharma.com
2024-04-17 - UPLOAD - MetaVia Inc. File: 333-278646
United States securities and exchange commission logo
April 17, 2024
Hyung Heon Kim
President and Chief Executive Officer
NeuroBo Pharmaceuticals, Inc.
545 Concord Avenue, Suite 210
Cambridge, MA 02138
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 12, 2024
File No. 333-278646
Dear Hyung Heon Kim:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phil Torrence, Esq.
2023-01-27 - CORRESP - MetaVia Inc.
CORRESP
1
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January 27, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Jimmy McNamara
Re:
NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-3
File No. 333-369365
Acceleration Request
Requested Date:
January 31, 2023
Requested Time:
5:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rules 460 and
461 under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement on Form S-3 (File No. 333-369365) (the “Registration Statement”)
be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable
thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of
Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip Torrence, Samuel Katz and
Garrett Packer of Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness
of the Registration Statement with Phillip Torrence of Honigman LLP by telephone at (269) 337-7702, Samuel Katz of Honigman LLP by telephone
at (313) 465-8137 or Garrett Packer of Honigman LLP by telephone at (313) 465-8090.
[Signature page follows]
****
Sincerely,
NeuroBo Pharmaceuticals, Inc.
/s/ Joseph Hooker
Joseph Hooker
Interim President and Chief Executive Officer
cc:
Phillip Torrence, Honigman LLP
Samuel Katz, Honigman LLP
Garrett Packer, Honigman LLP
2023-01-25 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
January 25, 2023
Joseph Hooker
Interim Chief Executive Officer and President
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, Massachusetts, 02116
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed January 23, 2023
File No. 333-269365
Dear Joseph Hooker:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence
2022-11-03 - CORRESP - MetaVia Inc.
CORRESP
1
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November 3, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Ada D. Sarmento
Re: NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-1
File No. 333-267482
Acceleration Request
Requested Date: November 4, 2022
Requested Time: 9:00 A.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement on Form S-1 (File No. 333-267482) (the “Registration Statement”)
be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable
thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of
Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip Torrence, Samuel Katz and
Garrett Packer of Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness
of the Registration Statement with Phillip Torrence of Honigman LLP by telephone at (269) 337-7702, Samuel Katz of Honigman LLP by telephone
at (313) 465-8137 or Garrett Packer of Honigman LLP by telephone at (313) 465-8090.
[Signature page follows]
****
Sincerely,
NeuroBo Pharmaceuticals, Inc.
/s/ Gil Price
Gil Price, M.D.
President and Chief Executive Officer
cc: Phillip Torrence, Honigman LLP
Samuel Katz, Honigman LLP
Garrett Packer, Honigman LLP
2022-11-03 - CORRESP - MetaVia Inc.
CORRESP
1
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Ladenburg Thalmann & Co. Inc.
640 Fifth Avenue, 4th Floor
New York, New York 10019
November 3, 2022
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re: NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-1
(Registration No. 333-267482)
Concurrence in Acceleration Request
Ladies and Gentlemen:
Ladenburg Thalmann &
Co. Inc. (“Ladenburg”), as representative of the underwriters for the referenced offering, hereby concurs in the request
by NeuroBo Pharmaceuticals, Inc. that the effective date of the above-referenced registration statement be accelerated to 9:00 a.m. (Eastern
Time), or as soon as practicable thereafter, on November 4, 2022, pursuant to Rule 461 under the Securities Act. Ladenburg affirms
that it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
LADENBURG THALMANN & CO. INC.
By:
/s/ Nicholas Stergis
Name: Nicholas Stergis
Title: Managing Director
2022-09-22 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
September 22, 2022
Gil Price, M.D.
Chief Executive Officer
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, MA 02116
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed September 16, 2022
File No. 333-267482
Dear Dr. Price:
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 Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence, Esq.
2021-06-25 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
June 25, 2021
Richard Kang
President and Chief Executive Officer,
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, MA 02116
Re:NeuroBo Pharmaceuticals, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed February 2, 2021
File No. 001-37809
Dear Dr. Kang:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey H. Kuras
2021-06-10 - CORRESP - MetaVia Inc.
CORRESP
1
filename1.htm
Jeffrey H. Kuras
Office:
313.465.7446
Mobile:
313.550.4250
jkuras@honigman.com
June 10, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, DC 20549
Attention: Dillon Hagius, Joe McCann
Re:
NeuroBo Pharmaceuticals, Inc.
Amendment No. 1 to Preliminary
Proxy Statement on Schedule 14A
Filed March 2, 2021
File No. 001-37809
Dear Mr. Hagius:
This letter is submitted
on behalf of NeuroBo Pharmaceuticals, Inc. (the “Company,” “we”, “us”,
or “our”) to respond to comments of the staff (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) raised in your letter dated March 23, 2021 with respect to the Company’s
amendment no. 1 to preliminary proxy statement filed with the Commission on February 2, 2021 (the “Proxy Statement”)
pursuant to Section 14(a) of the Securities Exchange Act of 1934, as amended. The Company is concurrently filing Amendment No. 2
to the Proxy Statement (“Amendment No. 2”), which includes changes that reflect responses to the Staff’s
comments.
For convenience of reference,
we have set forth the Staff’s comment below, followed by our response. Capitalized terms used in this letter without definition
have the same meanings given to them in the Proxy Statement unless otherwise indicated.
The responses provided
herein are based upon information provided to Honigman LLP by the Company.
Preliminary Proxy Statement on Schedule 14A – Amendment
No. 1
General
1.
We note your response to Comment 1; however we cannot agree that Item 14 information is not required in your preliminary proxy statement. Note A to Schedule 14A provides that "[w]here any item calls for information with respect to any matter to be acted upon and such matter involves other matters with respect to which information is called for by other items of this schedule, the information called for by such other items also shall be given." Here, Proposal 1 is a solicitation of your shareholders for the purpose of issuing shares pursuant to an Agreement and Plan of Merger with ANA Therapeutics, a solicitation that directly implicates Item 14. In addition, we note that your disclosure on page 10 indicates that for purposes of Nasdaq Marketplace Rule 5635(a) the issuance of additional shares of Common Stock to former ANA Equityholders in connection with the Milestone Payments are aggregated with the shares you previously issued as Closing Consideration. Accordingly, please revise to provide all information that is required by Item 14 of Schedule 14A.
June 10, 2021
Page 2
Response:
In
response to the Staff’s comment, and pursuant to Item 14 of Schedule 14A, the Company has revised the disclosure contained in Amendment
No. 2 to (i) add a Summary Term Sheet (pages i and ii), (ii) expand on the existing description of the Merger Agreement
to highlight the provisions material to the vote at issue (pages 9 and 10), (iii) add a statement regarding restrictions on
resale of any shares issued in satisfaction of the Milestone Payments (pages 9 and 11), (iv) add risk factors specific to the
products obtained in the ANA Acquisition and risks related to the failure to pass Proposal 1, including the risk of the need to offer
additional shares at a lower price to defend a lawsuit against non-payment (pages 16–19), (v) add an overview of the business
of ANA (page i), (vi) add a statement regarding the inapplicability of dissenters’ or appraisal rights in the ANA Acquisition
(page 11), and (vii) add a statement clarifying that holders of a majority of the shares entitled to vote have agreed to vote
in favor of Proposal 1 (pages 11 and 13).
The Company respectfully
submits that disclosure regarding the background of the ANA Acquisition (which would typically include a discussion of an auction process
or other sale process that were not present here) and a general discussion of negotiations regarding the ANA Acquisition would be immaterial
to the matter being voted upon, which relates solely to the potential issuance of future shares in the event certain milestones are met,
and not to approval of the ANA Acquisition itself, which has already been consummated. The Company respectfully advises the Staff that
certain other disclosures potentially responsive to Item 14 of Schedule 14A either were not present with respect to the ANA Acquisition
or are immaterial to the voting decision. For example, as disclosed on page i of Amendment No. 2, neither the Company nor ANA
utilized financial advisors in connection with the ANA Acquisition, and no fairness opinion or third party appraisal was obtained by either
party. Rather, management of the Company utilized their industry expertise and examined recent acquisition activity to arrive at the purchase
price. Also, the ANA Acquisition, while legally structured as a merger to allow for shares to be used as consideration given the paucity
of cash in development-stage life sciences companies, was accounted for as an asset acquisition (see further discussion under comment
2 below).
Notably, as indicated
on page 12 of Amendment No. 2, the ANA Equityholders are not entitled to vote on Proposal 1 and are not counted in determining
votes cast for purposes of Proposal 1. Stockholders of the Company were not entitled to dissenters’ or appraisal rights in connection
with the ANA Acquisition (and we have added disclosure to this effect on page 11 of Amendment No. 2). Similarly, the tax consequences
disclosures required by Item 14 of Schedule 14A are equally irrelevant to the Company Stockholders, as the ANA Acquisition did not involve
any exchange of their shares or potential tax consequences to any stockholders other than those of ANA.
June 10, 2021
Page 3
Finally, we respectfully
submit that the financial information specified under Item 14(b)(8)-(11) of Schedule 14A is immaterial to investors in the Company’s
industry, other than with respect to ANA’s historical in-process research and development (“IPR&D”)
expense and net loss from its March 2020 inception through September 30, 2020, which are disclosed on page 9 of Amendment
No. 2.
2.
We refer to your Significance Analysis included as part
of your response to prior comment 1. Please address the following:
· We
note your disclosure on page 6 that your preliminary estimate of the fair value of the contingent consideration was approximately
$4.76 million. We also note from your response that you determined that the likelihood of payment of the contingent consideration was
remote and that you have excluded the contingent consideration from total purchase consideration in your analysis. Please describe to
us how the fair value was determined, including how the likelihood of payment factored into the determined fair value.
· We
note your disclosure on page 7 that in the event you do not have stockholder authorization to pay certain of the Milestone Payments
in shares of common stock, you will make such payments in cash. Please tell us how you intend to make the milestone payments if authorization
is not received, given such payments may exceed the amount of cash. In addition, describe to us the implications under the agreement if
you are unable to make required payments.
Response:
In
response to the Staff’s comment, we note that the third party valuation was subsequently revised on April 1, 2021. The original
valuation, commissioned in order to satisfy Section 3.6 of the Merger Agreement for purposes of ensuring compliance with the requirements
for the tax-free nature of the exchange, valued only the contingent consideration that could potentially be triggered by the Milestone
Payments. The valuation was subsequently revised in part to fully include the potential royalty payments to the ANA Equityholders as well
as potential royalty payments pursuant to the YourChoice Therapeutics, Inc. License Agreement that was assumed in connection with
the ANA Acquisition, which, as disclosed in the Company’s Form 8-K/A filed with the Commission on March 1, 2021, includes
certain potential single-digit royalty payments and milestone payments in the aggregate amount of $19.5 million. As a result, the final
fair value of the contingent consideration was ultimately estimated at $18.3 million. We have revised page 10 of Amendment
No. 2 accordingly.
June 10, 2021
Page 4
While the third party valuation was originally
commissioned to satisfy Section 3.6 of the Merger Agreement, the revised valuation was also used for accounting purposes to value
the intellectual property obtained in the ANA Acquisition. The fair value of the contingent consideration in the third party valuation
was arrived at as follows:
· The Approval Milestone Payment, which would become payable upon FDA approval of the Company’s Niclosamide Product (as defined
in the Merger Agreement), was estimated based on management’s most likely estimate of FDA approval (assumed approval milestone date
of June 1, 2022 with a contractual payment date 60 days thereafter of August 1, 2022), a discount rate that is commensurate
with risk of achievement and incorporation of counterparty risk, and clinical trial approval data based on “Clinical Development
Success Rates 2006-2015,” BIO, Biomedtracker, Amplion.
· The Sales Milestone Payments and the Royalty Payments were estimated using a Monte Carlo simulation involving a quarterly revenue
forecast curve developed based on an 8-year revenue forecast provided by management, and were risk-adjusted using a discount rate that
is commensurate with risk of achievement and incorporation of counterparty risk.
This methodology resulted in a single-step contingent
consideration value of $5.07 million, with a mean sensitivity analysis value of $18.3 million.
Notwithstanding
the foregoing, the Company respectfully advises the Staff that for financial reporting purposes under Accounting Standards Codification
(“ASC”) Topic 805: Business Combinations (“ASC 805”), the contingent consideration
is not recognized at fair value as of December 31, 2020 for an asset purchase not deemed a business under ASC 805-50. See, e.g.,
Note 4 to the Company’s audited 2020 financial statements contained in its Form 10-K filed with the Commission on April 15,
2021 (noting that the ANA Acquisition was accounted for as an asset acquisition and not as a business combination pursuant to ASC 805,
as substantially all of the fair value of the assets acquired were concentrated in one asset, and the acquired asset did not have outputs,
and further noting that “as of December 31, 2020, no Royalty Payment had been accrued as there were no potential milestones
yet considered probable”). As stated in Note 4 to the Company’s December 31, 2020 financial statements: “[p]ursuant
to Topic 805, Business Combinations, in an asset acquisition, contingent consideration is only recognized when it becomes
probable or reasonably possible to occur as prescribed under ASC 450, Contingencies. As of the 2020 Merger close date, the contingent
consideration outlined above was not deemed probable or reasonably possible to occur, and as such, was excluded from the 2020 Merger purchase
price…”
The
analysis underlying the excerpt from the Company’s December 31, 2020 audited financial statements is as follows. Pursuant
to ASC 805, in an asset acquisition, contingent consideration is only recognized at fair value if, pursuant to ASC 450, “Contingencies”,
it becomes probable or reasonably possible to occur. The U.S. generally accepted accounting principles (“GAAP”)
Master Glossary defines the following terms when evaluating loss contingencies:
o Probable: The future event or events is likely to occur.
June 10, 2021
Page 5
o Reasonably possible: The chance of the future event or events occurring is more than remote but less than
likely.
o Remote. The chance of the future event or events occurring is slight.
In analyzing the qualitative factors to determine
the classification of the contingent consideration, the Company (i) considered that ANA had not yet completed a Phase 1 trial, (ii) consulted
industry analyses regarding the likelihood of a Phase 1 clinical candidate successfully obtaining FDA approval, (iii) considered
the fact that the primary indication for ANA-001 is COVID-19, which has a short history and many unknowns regarding the disease, (iv) considered
the intense competition to address COVID-19, and (v) considered the relative progress of vaccinations, which could dramatically lower
the COVID-19 incidence rate. Based on these factors, the Company concluded that the likelihood that it would pay the Milestone Payments
or Royalty Payments was remote. For the same reason, the fair value of the contingent consideration was also properly excluded from the
investment test of the significance analysis, as previously described to the Staff.1
The
Company further respectfully advises the Staff that it is likely that the Company would not have sufficient cash to pay the initial $45.0
million Milestone Payment upon first receipt of marketing approval for any Niclosamide Product, as this milestone would occur prior to
commercialization of any Niclosamide Product. Accordingly, absent approval of Proposal 1, the Company would expect to need to raise cash
through an additional equity offering. While the Company would expect that achievement of the milestone would enable the Company
to successfully raise additional capital at a more attractive price than the Company’s current market price, the offering would
also require underwriting fees and expenses that would cause more dilution to existing shareholders than would a direct issuance of shares
in satisfaction of the Milestone Payment amount, as such direct issuance would be based on an average market price without underwriting
fees and expenses. The later Milestone Payments and Royalty Payments in contrast could likely be settled in cash, as such payments are
conditioned upon actual net sales of Niclosamide Products, which would itself generate enough cash to cover the payments. As disclosed
on page 12 and in the risk factor included on page 19 of Amendment No. 2, failure to pay the Milestone Payments or Royalty
Payments could subject the Company to a 1.5% penalty interest rate, compounded quarterly, and contractual claims for nonpayment under
the terms of the Merger Agreement.
1
The Company notes that on May 20, 2020, the Commission adopted rules that substantially changed the requirements of the
significance test required by Rule 3-05 of Regulation S-X, which amendments indicated that a registrant’s “investments in”
the tested subsidiary must include the fair value of contingent consideration if required to be recognized at fair value by the registrant
at the acquisition date under U.S. GAAP or IFRS-IASB, as applicable. If recognition at fair value is not required, however, it must include
all contingent consideration, except contingent consideration for which the likelihood of payment is remote.
June 10, 2021
Page 6
3.
Please revise the proxy on page 6 to disclose the results of the independent valuation of the Contingent Consideration.
Response:
In
response to the Staff’s comment, we have revised pages 6 and 10 of Amendment No. 2 to disclose the final results
of the independent valuation of the Contingent Consideration.
4.
We note your response to Comment 1 that your amended filing incorporates by reference the information set forth in Item 13(a). Please provide your analysis as to how you determined your eligibility for incorporation by reference or provide the information required by Item 13.
Response:
In response to the Staff’s comments, we have
revised Amendment No. 2 to eliminate the incorporation by reference statement with respect to Item 13(a) of Schedule 14A. The
Company respectfully submits that beca
2021-05-24 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm May 24, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Abby Adams Re:NeuroBo Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-256135 Acceleration Request Requested Date:May 26, 2021 Requested Time:4:01 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 (File No. 333-256135) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip D. Torrence, Jeff Kuras and Patrick Valenti of Honigman LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman LLP by telephone at 269.337.7702, Jeff Kuras of Honigman LLP by telephone at 313.465.7446 or Patrick Valenti of Honigman LLP by telephone at 313.465.7985. Sincerely, NEUROBO PHARMACEUTICALS, INC. By: /s/ Richard Kang Name: Richard Kang, Ph.D. Title: CEO and President cc: Phillip D. Torrence, Honigman LLP Jeff Kuras, Honigman LLP Patrick Valenti, Honigman LLP
2021-05-21 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
May 21, 2021
Richard Kang, Ph.D.
Chief Executive Officer
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, 19th Floor
Boston, Massachusetts 02116
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 14, 2021
File No. 333-256135
Dear Dr. Kang:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence, Esq.
2021-04-28 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm April 28, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Deana Virginio Re: NeuroBo Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-255418 Acceleration Request Requested Date: April 30, 2021 Requested Time: 4:01 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 (File No. 333-255418) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Phillip D. Torrence, Jeff Kuras and Patrick Valenti of Honigman LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman LLP by telephone at 269.337.7702, Jeff Kuras of Honigman LLP by telephone at 313.465.7446 or Patrick Valenti of Honigman LLP by telephone at 313.465.7985. Sincerely, NEUROBO PHARMACEUTICALS, INC. By: /s/ Richard Kang Name: Richard Kang, Ph.D. Title: CEO and President cc: Phillip D. Torrence, Honigman LLP Jeff Kuras, Honigman LLP Patrick Valenti, Honigman LLP
2021-04-26 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
April 26, 2021
Richard Kang, Ph.D.
Chief Executive Officer
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, MA 02116
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 21, 2021
File No. 333-255418
Dear Dr. Kang:
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 Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence, Esq.
2021-03-23 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
March 23, 2021
Richard Kang
President and Chief Executive Officer,
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, MA 02116
Re:NeuroBo Pharmaceuticals, Inc.
Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A
Filed March 2, 2021
File No. 001-37809
Dear Dr. Kang:
We have reviewed your filing 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 these comments 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
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A - Amendment No. 1
General
1.We note your response to Comment 1; however we cannot agree that Item 14 information
is not required in your preliminary proxy statement. Note A to Schedule 14A provides
that "[w]here any item calls for information with respect to any matter to be acted upon
and such matter involves other matters with respect to which information is called for by
other items of this schedule, the information called for by such other items also shall be
given." Here, Proposal 1 is a solicitation of your shareholders for the purpose of issuing
shares pursuant to an Agreement and Plan of Merger with ANA Therapeutics, a
solicitation that directly implicates Item 14. In addition, we note that your disclosure on
page 10 indicates that for purposes of Nasdaq Marketplace Rule 5635(a) the issuance of
additional shares of Common Stock to former ANA Equityholders in connection with the
Milestone Payments are aggregated with the shares you previously issued as Closing
Consideration. Accordingly, please revise to provide all information that is required by
FirstName LastNameRichard Kang
Comapany NameNeuroBo Pharmaceuticals, Inc.
March 23, 2021 Page 2
FirstName LastName
Richard Kang
NeuroBo Pharmaceuticals, Inc.
March 23, 2021
Page 2
Item 14 of Schedule 14A.
2.We refer to your Significance Analysis included as part of your response to prior
comment 1. Please address the following:
•We note your disclosure on page 6 that your preliminary estimate of the fair value of
the contingent consideration was approximately $4.76 million. We also note from
your response that you determined that the likelihood of payment of the contingent
consideration was remote and that you have excluded the contingent consideration
from total purchase consideration in your analysis. Please describe to us how the fair
value was determined, including how the likelihood of payment factored into the
determined fair value.
•We note your disclosure on page 7 that in the event you do not have stockholder
authorization to pay certain of the Milestone Payments in shares of common stock,
you will make such payments in cash. Please tell us how you intend to make the
milestone payments if authorization is not received, given such payments may exceed
the amount of cash. In addition, describe to us the implications under the agreement
if you are unable to make required payments.
3.Please revise the proxy on page 6 to disclose the results of the independent valuation of
the Contingent Consideration.
4.We note your response to Comment 1 that your amended filing incorporates by reference
the information set forth in Item 13(a). Please provide your analysis as to how you
determined your eligibility for incorporation by reference or provide the information
required by Item 13.
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 Dillon Hagius at 202-551-7976 or Joe McCann at 202-551-6262 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey H. Kuras
2021-03-02 - CORRESP - MetaVia Inc.
CORRESP
1
filename1.htm
Jeffrey H. Kuras
Office:
313.465.7446
Mobile:
313.550.4250
jkuras@honigman.com
March 2, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, DC 20549
Attention: Dillon Hagius, Joe McCann
Re:
NeuroBo Pharmaceuticals, Inc.
Preliminary Proxy Statement
on Schedule 14A
Filed February 2, 2021
File No. 001-37809
Dear Mr. Hagius:
This letter is
submitted on behalf of NeuroBo Pharmaceuticals, Inc. (the “Company,” “we”, “us”,
or “our”) to respond to comments of the staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) raised in your letter dated February 17, 2021 with respect
to the Company’s preliminary proxy statement filed with the Commission on February 2, 2021 (the “Proxy Statement”)
pursuant to Section 14(a) of the Securities Exchange Act of 1934. The Company is concurrently filing Amendment No. 1
to the Proxy Statement, which includes changes that reflect responses to the Staff’s comments.
For convenience
of reference, we have set forth the Staff’s comment below, followed by our response. Capitalized terms used in this letter
without definition have the same meanings given to them in the Proxy Statement unless otherwise indicated.
The responses
provided herein are based upon information provided to Honigman LLP by the Company. In addition to submitting this letter via EDGAR,
we are sending via Federal Express four (4) copies of this letter.
Preliminary Proxy Statement on Schedule 14A
Proposal 1, page 8
1.
With
reference to Note A of Schedule 14A, we note that Proposal 1 is a solicitation of your shareholders for the purpose of issuing
shares pursuant to an Agreement and Plan of Merger with ANA Therapeutics, Inc. We further note your disclosure on page 5
concerning your belief that an understanding of the ANA Acquisition is necessary in order to make an informed voting decision
with respect to the potential issuance of the securities in connection with Milestone Payments. Accordingly, please revise to
provide all information that is required by Items 11, 13 and 14 of Schedule 14A, including
March 2, 2021
Page 2
financial
statements for ANA Therapeutics and pro forma financial information for the combined
company, as applicable. Refer, as applicable, to Item 14(e) of Schedule 14A concerning
use of Incorporation by Reference.
Response:
In
response to the Staff’s comment, and pursuant to Item 11 of Schedule 14A, the Company has revised the disclosure on
pages 6 and 9 of Amendment No. 1 to the Proxy Statement to clarify the method of calculating the number of its
common stock to be issued upon satisfaction of the milestones (the “Contingent Shares”). The
Company respectfully notes that the actual number of Contingent Shares is not currently determinable since the number is
dependent on the Company’s future share price. Additionally, the Company respectfully notes that pursuant to Item
11(b) of Schedule 14A, because the Contingent Shares are of the same class as the Company’s currently outstanding
common stock, the information called for by Item 202 of Regulation S-K is not required other than as set forth
in Item 11(b). The Company further notes the disclosure on page 16 of Amendment No. 1 incorporates by
reference the information set forth in Item 13(a).
Inapplicability of Item 14
The Company respectfully
advises the Staff that it does not believe that Item 14 of Schedule 14A is applicable, and that the information called for therein
is not material to, and may potentially mislead, the Company’s stockholders in connection with their voting decision on Proposal
1.
Note A to Schedule
14A acknowledges that certain proposals to be acted upon by stockholders may involve the matters described by, and would therefore
require the disclosure of information pursuant to, more than one item of Schedule 14A. Note A goes on to provide an example of
such a circumstance “where a solicitation of security holders is for the purpose of approving the authorization of
additional securities which are to be used to acquire another specified company, and the registrants’ security holders
will not have a separate opportunity to vote upon the transaction, the solicitation to authorize the securities is also a solicitation
with respect to the acquisition.” (emphasis added)
The Company respectfully
submits to the Staff that the instruction in Note A is inapplicable to Proposal 1 because it does not involve a solicitation seeking
stockholder approval of the authorization of additional securities which are to be used to acquire another company. Rather, Proposal
1 seeks stockholder approval in accordance with Nasdaq Listing Rule 5635(a) and 5635(b) for the issuance of Contingent
Shares upon the satisfaction of future milestones to the extent the issuance of Contingent Shares would exceed 20% of the outstanding
shares of the Company before the Acquisition (as defined below) or result in a change of control.
While the Company
is asking its stockholders to approve the issuance of the Contingent Consideration, these additional shares to be issued, if ever,
will not be used for the purpose of consummating the acquisition of ANA (the “Acquisition”) or any other
assets or company. The Company respectfully notes that the Acquisition closed on December 31, 2020 and the closing was not
contingent upon, or subject to, stockholder approval of the Contingent Shares.
March 2, 2021
Page 3
Under the Company’s
organizational documents, Delaware law and the listing rules of Nasdaq, the Company and its board of directors had the authority,
without stockholder approval, to consummate the Acquisition and issue the upfront consideration of 3,243,875 unregistered shares
of the Company’s common stock. The stockholders’ right is, instead, to vote now on whether the Company may issue the
Contingent Shares upon the achievement of the milestones. If the stockholders do not approve Proposal 1 then the Company will settle
such contingent obligation in cash as provided for in the Agreement and Plan of Merger and Reorganization relating to the Acquisition
without the need for any further action on the part of its stockholders.
Significance Analysis
The Company further
respectfully submits that the financial statements of ANA are not required by Regulation S-X or material to an investor. The Company
undertook the requisite analysis under Rule 8-04 of Regulation S-X and determined that the significance of the Acquisition
did not exceed 20% under any of the investment test, the asset test or the income test set forth therein, as further described
below.1
ANA
was formed in March of 2020 and operated as a private company from commencement of operations at such time until its merger
with and into the Company effective as of 1:00 pm on December 31, 2020. ANA was a development stage enterprise as its
principal operations had commenced but it had not yet generated significant revenue as of the acquisition date and the acquired
assets have yet to generate significant revenue. ANA’s expense structure has been similar after the acquisition as before
the acquisition and many of the other factors indicating continuity of operations are present. The Company therefore believes that
the acquisition of ANA is the acquisition of a “business” as such term is defined in Rule 11-01(d) of Regulation
S-X and accordingly the significance analysis is required to determine whether certain financial statements of ANA will be required.
Rule 8-04 of Regulation
S-X requires the Company to apply Rule 3-05 of Regulation S-X, substituting Rule 8-02 and Rule 8-03, as applicable,
wherever Rule 3-05 references Rule 3-01 and Rule 210.3-02. Rule 3-05 of Regulation S-X requires a public company
acquiror to disclose audited financial statements of an acquired business depending on quantitative tests that measure the significance
of the transaction to the acquiror. Audited financial statements and pro forma historical financial statements of the acquiror
that give effect to the acquisition as if it occurred at a prior date may be required when any of the three tests described below
result in a significance level above 20%. The Company respectfully notes that unless any of the significance tests discussed below
exceed 50%, financial statements of an acquired entity would not be required in a proxy statement with a mailing date that occurs
during the 71-day grace period afforded by the instructions to Form 8-K. See Financial Reporting Manual (“FRM”)
2040.1.
1
The Company notes that it filed a Current Report on Form 8-K on January 6, 2021 (the “January 8-K”)
reporting the acquisition of ANA under Item 2.01 – Completion of Acquisition or Disposition of Assets and undertook to provide
certain financial statements under Item 9.01. At the time of the filing of the January 8-K, the Company’s significance analysis
was still unsettled. The Company has concurrently amended the 8-K to remove the reference to Item 2.01 and the undertaking to
provide certain financial statements under Item 9.01.
March 2, 2021
Page 4
The highest
of the three percentages calculated from the following three significance tests determines whether audited and pro forma financial
statements are required and for what periods:
· Investment Test. The percentage calculated by dividing the acquiror’s
investment in, and advances to, the acquired business2 by
the acquiror’s worldwide market value of voting and non-voting equity, averaged over the last five trading days of the
acquiror’s most recently completed month ending prior to the earlier of the acquiror’s announcement date or
agreement date of the acquisition or disposition;
· Assets Test. The percentage calculated by dividing the total assets of the acquired
business by the acquiror’s total assets (measured by the acquiror’s most recent audited financial statements); and
· Income Test. The lower percentage calculated by either:
(i) dividing the income
(or loss) from continuing operations before income taxes, extraordinary items and cumulative effect of a change in accounting principle
of the acquired business for the most recently completed fiscal year by the acquiror’s income (or loss) from continuing operations
before income taxes, extraordinary items and cumulative effect of a change in accounting principle (measured by the acquiror’s
most recent audited financial statements, or in some cases, by the average of the income from the last five fiscal years); or
(ii) dividing the total
revenue of the acquired business by the acquiror’s total consolidated revenues for the most recently completed fiscal year.
The alternative calculation in clause (ii) does
not apply where, as here, both the Company and the target did not have material revenue in each of the two most recently completed
fiscal years. Accordingly, only the calculation in clause (i) may be used.
The Company is accounting for the Acquisition
as an asset acquisition pursuant to FASB Accounting Standards Codification (ASC) 805, because substantially all (greater than 90%)
of the fair value of the assets acquired is concentrated in one class of assets – ANA’s intellectual property in ANA-001,
a proprietary capsule formulation of Niclosamide for coronavirus indications. This accounting conclusion was supported by an independent
third party valuation, performed at the Company’s request, which allocated 97% of the net assets acquired to ANA-
2 For purposes of the Investment
Test, investments in the acquired business include the fair value of any contingent consideration, if the acquisition is accounted
for as a business combination and the fair value is required to be recognized at fair value at the acquisition date under GAAP.
If the acquisition is accounted for as an equity investment or an asset acquisition (e.g., if more than 90% of the assets acquired
are one class of assets), all contingent consideration must be included except where the likelihood of payment is remote. See
further discussion below.
March 2, 2021
Page 5
001.3
The Company has also determined that the likelihood of the Company paying out the contingent milestone payments is remote.
Utilizing this
accounting treatment, the Company then applied the significance tests to the financial information made available to it by ANA
which led to the following results.
Calculation of Significance Tests
· Investment Test. The Company’s investment in ANA consists of the fair value of the
shares issuable in accordance with the Agreement and Plan of Merger for the Merger plus any closing cash payable. The fair value
of the common shares issued is $17,030,506 based on the Company’s Nasdaq closing price of $5.25 per share on December 31,
2020. The worldwide market value of the Company’s voting and non-voting equity, averaged over the last five trading days
of November 2020 is calculated as $5.414 * 16,427,307 = $88,937,440. The percentage yielded is 19.15%.
· Asset
Test. The asset test is measured based on the acquired company’s and the registrant’s most recent annual financial
statements.4 However, ANA had no most recent annual
financial statements, having commenced operations in March of 2020 and was acquired before the end of 2020. Applying this
test strictly, the asset test produces a zero numerator and accordingly yields 0%.5
ANA’s total assets at September 30, 2020 were reported to the Company by ANA as $2,890,166, and the Company’s
total assets at its last fiscal year end of December 31, 2019 were $14,468,000. If this calculation were to apply, the percentage
yielded would be 19.98%.
· Income
Test. Section 2025.5 of the FRM states that if the acquired company has been in business for less than one year, “do
not annualize the historical statement of comprehensive income; measure significance using the audited historical statement of
comprehensive income that complies with the age of financial statement requirements, regardless of the number of months it includes.”
ANA’s total consolidated loss inception through September 30, 20206
was reported to the Company by ANA as $(3,213,975), and the Company’s loss before income taxes in the year
ended December 31, 2019 was ($21,312,000). This results in a percentage of 15.1%.
3
Copies of the valuation report will be made available to the Staff upon request.
4 FRM
2015.2
5 We note that the FRM has no equivalent of Section
2025.5, referenced below, for the asset test of an entity that has been in business for less than one year.
6 The Company respectfully submits that assets as
of September 30, 2020 and consolidated loss from inception through September 20, 2020 are the relevant measurement date and
period as ANA did not complete the fourth quarter of 2020 as a result of the effective date and time of the Acquisition. See FRM
2045.9 regarding no need to update for incomplete interim periods.
March 2, 2021
Page 6
As a result of
such analysis, the Company believes that the acquisition of ANA does not require the presentation of financial information pursuant
to Rules 8-04 and 3-05 and Article 11 of Regulation S-X. In addition, the Company respectfully submits
that the inclusion of any such financials may confuse an investor as to the significance of the Acquisition.
ANA’s Historical Financial
Statements are no
2021-02-18 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
February 17, 2021
Richard Kang
President and Chief Executive Officer,
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, MA 02116
Re:NeuroBo Pharmaceuticals, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed February 2, 2021
File No. 001-37809
Dear Dr. Kang:
We have reviewed your filing 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 these comments 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
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A
Proposal 1, page 8
1.With reference to Note A of Schedule 14A, we note that Proposal 1 is a solicitation of
your shareholders for the purpose of issuing shares pursuant to an Agreement and Plan of
Merger with ANA Therapeutics, Inc. We further note your disclosure on page 5
concerning your belief that an understanding of the ANA Acquisition is necessary in order
to make an informed voting decision with respect to the potential issuance of the securities
in connection with Milestone Payments. Accordingly, please revise to provide all
information that is required by Items 11, 13 and 14 of Schedule 14A, including financial
statements for ANA Therapeutics and pro forma financial information for the combined
company, as applicable. Refer, as applicable, to Item 14(e) of Schedule 14A concerning
use of Incorporation by Reference.
FirstName LastNameRichard Kang
Comapany NameNeuroBo Pharmaceuticals, Inc.
February 17, 2021 Page 2
FirstName LastName
Richard Kang
NeuroBo Pharmaceuticals, Inc.
February 17, 2021
Page 2
2.Please revise and, if applicable, update your disclosure concerning the merger
consideration. In this regard, please disclose the relative valuations attributed to the two
companies and clarify the equity stake that former ANA holders would hold in the
combined company if all merger consideration were paid out to them. Also disclose the
fair market value of the Milestone Payments and Royalty Payments and all other material
information concerning the Contingent Consideration. With respect to the Royalty
Payments, disclose the milestone payments or tell us why you believe that the actual
percentages are not material to the voting decision.
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 Dillon Hagius at (202) 551-7976 or Joe McCann at (202) 551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey H. Kuras
2021-01-27 - CORRESP - MetaVia Inc.
CORRESP
1
filename1.htm
January 27, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: David Gessert
Re: NeuroBo
Pharmaceuticals, Inc.
Registration
Statement on Form S-3
File
No. 333-252412
Acceleration
Request
Requested
Date:
January
29, 2021
Requested
Time:
9:00
A.M. Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, NeuroBo Pharmaceuticals, Inc. (the “Company”)
hereby respectfully requests that the above-referenced Registration Statement on Form S-3 (File No. 333-252412) (the “Registration
Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth
above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone
call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes
each of Phillip D. Torrence and Jeff Kuras of Honigman LLP, counsel to the Company, to make such request on its behalf.
Please
confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman LLP by telephone at 269.337.7702
or Jeff Kuras of Honigman LLP by telephone at 313.465.7446.
Sincerely,
NeuroBo
Pharmaceuticals, Inc.
By: /s/ Richard Kang, Ph.D.
Name: Richard
Kang, Ph.D.
Title: CEO
and President
cc: Phillip
D. Torrence, Honigman LLP
Jeff Kuras, Honigman LLP
2021-01-27 - UPLOAD - MetaVia Inc.
United States securities and exchange commission logo
January 27, 2021
Richard Kang, Ph.D.
Chief Executive Officer
NeuroBo Pharmaceuticals, Inc.
200 Berkeley Street, Office 19th Floor
Boston, MA 02116
Re:NeuroBo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed January 25, 2021
File No. 333-252412
Dear Mr. Kang:
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 David Gessert at 202-551-2326 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-11-04 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm November 4, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Christine Westbrook Mary Beth Breslin Re: Gemphire Therapeutics Inc. Registration Statement on Form S-4 File No. 333-233588 Acceleration Request Requested Date: November 6, 2019 Requested Time: 9:00 A.M. Eastern Time Dear Ms. Westbrook: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Gemphire Therapeutics Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-4 (File No. 333-233588) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Meredith Ervine and Emily Johns of Honigman LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Meredith Ervine of Honigman LLP by telephone at (616) 649-1942 or, in her absence, Emily Johns of Honigman LLP by telephone at (616) 649-1908. [Signature page follows] **** Sincerely, GEMPHIRE THERAPEUTICS INC. /s/ Steven Gullans Steven Gullans President and Chief Executive Officer cc: Phillip D. Torrence, Honigman LLP Meredith Ervine, Honigman LLP
2019-10-29 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm October 29, 2019 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Christine Westbrook Mary Beth Breslin Re: Gemphire Therapeutics Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed October 11, 2019 File No. 333-233588 Dear Ms. Westbrook and Ms. Breslin: Gemphire Therapeutics Inc. (“Gemphire”) is filing Amendment No. 2 (“Amendment No. 2”) to its Registration Statement on Form S-4 (File No. 333-233588), originally filed on September 3, 2019 (“Original Registration Statement”), as amended by Amendment No. 1 filed on October 11, 2019 (“Amendment No. 1”). This letter, which is being submitted on behalf of Gemphire, responds to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Amendment No. 1 contained in your letter, dated October 25, 2019 (the “Comment Letter”). For your convenience, we have included the text of the applicable comment from the Comment Letter in bold immediately before our response. Except as otherwise noted below, all page references contained in our responses below are to the pages of Amendment No. 2 expected to be filed with the Commission shortly after this letter. Amendment No. 1 to Registration Statement on Form S-4 Filed on October 11, 2019 Risk Factors Risks Related to Gemphire Common Stock Gemphire’s amended and restated bylaws designate the Court of Chancery of the State of Delaware as to the sole and exclusive forum..., page 89 1. We note your response to comment 2, which we reissue in part. Please ensure that the exclusive forum provision in your bylaws includes a statement to the effect that the provision is not intended to apply to any actions arising under the Exchange Act or Securities Act or the rules and regulations promulgated thereunder, or tell us how you will inform investors in future filings that the provision is not intended to apply to such claims. In response to the Staff´s comment, Gemphire has amended the exclusive forum provision in its bylaws as follows: “Section 48. FORUM FOR ADJUDICATION OF DISPUTES. Unless the corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) shall be the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (a) any derivative action or proceeding brought on behalf of the corporation, (b) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the corporation to the corporation or the corporation’s stockholders, (c) any action asserting a claim arising pursuant to any provision of the DGCL, the Certificate of Incorporation or these Bylaws or (d) any action asserting a claim governed by the internal affairs doctrine, in all cases to the fullest extent permitted by law and subject to the court’s having personal jurisdiction over the indispensable parties named as defendants. This Section 48 shall not apply to actions brought to enforce a duty or liability created by the 1934 Act or the Securities Act of 1933, as amended, or any claim for which the federal courts have exclusive jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the corporation shall be deemed to have notice of and consented to the provisions of this Section 48.” We also revised the risk factor disclosure in Amendment No. 2 as follows: “The Gemphire’s amended and restated bylaws Bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by Gemphire Stockholders, which could limit Gemphire Stockholders’ ability to obtain a favorable judicial forum for disputes with Gemphire or its directors, officers or employees. The Gemphire’s amended and restated bylaws Bylaws provide that, unless Gemphire consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will generally be the sole and exclusive forum for any derivative action or proceeding brought on its behalf, any action asserting a claim of breach of a fiduciary duty owed by any of its directors, officers or other employees to Gemphire or Gemphire Stockholders, any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, as amended, the Gemphire Certificate of Incorporation or the Gemphire Bylaws or any other action asserting a claim governed by the internal affairs doctrine. This provision isdoes not intended to apply to claims arising under the Securities Act and the Exchange Act. To the extent the provision could be construed to apply to such claims, there is uncertainty as to whether a court would enforce the provision in such respect, and our stockholders will not be deemed to have waived compliance with federal securities laws and the rules and regulations thereunder or any claim for which the federal courts have exclusive jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in shares of Gemphire capital stock shall be deemed to have notice of and to have consented to the provisions of its amended and restated bylawsthe Gemphire Bylaws described above. This choice of forum provision may limit a Gemphire Stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with Gemphire or Gemphire’s directors, officers or other employees, which may discourage such lawsuits against Gemphire and its directors, officers and employees. Alternatively, if a court were to find this provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, Gemphire may incur additional 2 costs associated with resolving such matters in other jurisdictions, which could adversely affect Gemphire’s business and financial condition.” U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of NeuroBo Common Stock, page 184 2. We note your statement that the disclosure in this section constitutes the opinion of counsel as to the tax consequences of the merger, and that the parties “intend” for the merger to be treated as a tax-free contribution or a reorganization. We further note that this section describes the tax consequences to holders “assuming the qualification of the merger as a tax-free contribution or a reorganization.” However, in Exhibit 8.2, counsel confirms that “the merger shall qualify either as a tax-free contribution pursuant to Section 351 of the Code, or as a ‘reorganization’ within the meaning of Section 368(a) of the Code.” The disclosure constituting the opinion should clearly identify each material tax consequence to holders being opined upon, and set forth an opinion as to each identified tax item and the basis for the opinion. It is inappropriate to assume any legal conclusion underlying the opinion. For guidance, please refer to Sections III.C.1 and III.C.3 of Staff Legal Bulletin No. 19. In response to the Staff’s comment, we have revised the disclosure on page 187 of Amendment No. 2 as set forth on Annex A hereto, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. has provided an updated opinion filed as Exhibit 8.2 to Amendment No. 2. Agreements Related to the Merger Contingent Value Rights Agreement, page 209 3. We note your response to comment 5, which we reissue in part. Although the tax treatment of the Contingent Value Rights (CVRs) may be subject to uncertainty, counsel must opine on each material tax consequence and may provide a “should” or “more likely than not” opinion and describe the related uncertainty where a “will” opinion is not given. Accordingly, please revise your disclosure to provide an opinion as to the tax consequences of the receipt of the CVRs to Gemphire shareholders. In response to the Staff’s comment, we have revised the disclosure on pages 7, 15 and 213 of Amendment No. 2 as follows: “In the opinion of Honigman LLP, Gemphire’s legal counsel, based on the facts, representations and assumptions set forth herein, Gemphire intends to treat the issuance of the CVRs to Gemphire U.S. Holders under the terms expressed in the form of the CVR Agreement included in Annex A to this proxy statement/prospectus/information statement is more likely than not to be treated as a distribution of property with respect to its Gemphire common stock.” 3 NeuroBo Business Intellectual Property, page 308 4. We note your response to comment 13. Please expand your disclosure to provide the expiry dates for NeuroBo’s issued patents. In response to the Staff’s comment, we have revised the second, third and fourth paragraphs of the disclosure under “NeuroBo Business—Intellectual Property” in Amendment No. 2 as follows: “NeuroBo has licensed or acquired rights to patent applications directed to its product candidates, preclinical compounds and related technologies to establish intellectual property positions on these compounds and their uses in disease. As of October 8,25, 2019, NeuroBo has two issued U.S. patents, comprised of one patent directed to use and another to composition of matter and four U.S. patent applications, three of which are directed to composition of matter, and one to use. The issued US patents have expiration dates of May 9, 2027 and December 29, 2031. NeuroBo also has approximately 71 foreign patents, comprised of 21 granted patents to composition of matter and 50 granted patents to use, and 11 pending applications, comprised of 10 applications to composition of matter and one application to use. The granted foreign patents have expiration dates ranging from October 27, 2026 to December 3, 2035. The jurisdictions for the foreign patents and applications include: Brazil, Canada, China, the European Patent Convention (including Austria, Belgium, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Switzerland, Turkey, and the Unites Kingdom), India, Japan, Mexico, the Republic of Korea, and Russia. In addition to the granted and issued patents, NeuroBo continues to prosecute patent applications with respect to NB-01. As of October 9,25, 2019, NeuroBo’s intellectual property portfolio for NB-01 included two issued U.S. patents, comprised of one patent directed to composition of matter and another directed to use, and two pending U.S. non-provisional patent applications, comprised of one directed to composition of matter and another directed to use, and 65 granted foreign patents, comprised of eight patents directed to composition of matter and 57 patents directed to use, and two pending foreign applications directed to composition of matter; these patents and applications are related to its NB-01 clinical programs in peripheral neuropathy and neurological conditions. The issued patents have expiration dates ranging from October 27, 2026 to December 29, 2031. Patents issuing from these applications, if any, are expected to expire between 2026 and 2031. One patent family including some of the above patents and patent applications for NB-01 is assigned to University-Industry Cooperation Group of Kyung Hee University, and is exclusively licensed from Kyung Hee University to Dong-A ST and then from Dong-A ST to NeuroBo pursuant to the terms of the corresponding agreements. The other two patent families including the other above patents and patent applications for NB-01 are assigned to Dong-A ST and exclusively licensed to NeuroBo. As of October 9,25, 2019, NeuroBo’s intellectual property portfolio for NB-02 included two pending U.S. non-provisional patent applications directed to composition of matter and approximately 6 corresponding foreign patents and, 6 foreign granted patents, and 9 foreign patent applications, all of which are directed to compositions of matter. Patents issuing from these applications, if any, are expected to expire around 2035. The issued patents have an expiration date of December 3, 2035. All of the above patents and patent applications for NB-02 were assigned to NeuroBo pursuant to the terms of the corresponding agreement.” 4 We hope that the foregoing, and the revisions set forth in Amendment No. 2, have been responsive to the Staff’s comments. Please contact Phillip D. Torrence at (269) 337-7702 or ptorrence@honigman.com or Meredith Ervine at (616) 649-1942 or mervine@honigman.com if you have any comments or questions about this letter. Very truly yours, /s/ Steve Gullans Steve Gullans President and Chief Executive Officer Gemphire Therapeutics Inc. cc: Phillip D. Torrence Meredith Ervine (Honigman LLP) 5 ANNEX A U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of NeuroBo Common Stock Subject to the Tax Opinion Representations and Assumptions (as defined below) (i) in the opinion of Mintz, the merger will qualify as either a tax-free contribution pursuant to Section 351 of the Code or a ““reorganization”“ within the meaning of Section 368(a) of the Code. This discussion assumes that the merger so qualifies., and (ii) the discussion contained herein under the heading “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” pertaining to the U.S. federal income tax consequences of the merger, insofar as such discussion constitutes statements of U.S. federal income tax law or legal conclusions, represents Mintz’s opinion as to the material U.S. federal income tax consequences of the merger to U.S. holders of NeuroBo common stock (together, the “Tax Opinion”). The Tax Opinion will be based on customary assumptions andIn rendering the Tax Opinion, Mintz assumes that: (i) the statements and facts concerning the merger set forth in this proxy statement/prospectus/information statement and in the Merger Agreement, are true and accurate in all respects, and that the merger will be completed in accordance with this proxy statement/prospectus/information statement and the merger agreement; (ii) the truth and accuracy of certain representations from Gemphire, Neurobo and Merger Sub, as well as certain warranties,and covenants and undertakings by Gemphire, Neurobo and Merger Sub (collectively, the “as to factual matters made by Gemphire, NeuroBo, and Merger Sub in the tax representation letters provided to counsel (the “Tax Representation Letters”); (iii) any representation made in the Merger Agreement or the Tax Representation Letters that are “to the best knowledge” (or similar qualification) of any person or party will be correct without such qualification; (iv) as to all matters for which a person or entity has represented, in the Merger Agreement or the Tax Representation Letters, that such person or entity is not a party to, does not have, or is not aware of, any plan, intention, understanding, or agreement, there is no such plan, intention, understanding, or agreement; and (v) that there will be no change in U.S. federal income tax rules or the interpretation thereof (collectively, the “Tax Opinion Representations and Assumptions”). If any of these assumptions is inaccurate, the tax consequences of the merger could differ from those described in this proxy statement/prospectus/information statement. If any of the Tax Opinion Representations and Assumptions is incorrect, incomplete or inaccurate, or is violated, the val
2019-10-28 - UPLOAD - MetaVia Inc.
October 25, 2019
Steven Gullans, Ph.D.
President & Chief Executive Officer
Gemphire Therapeutics Inc.
P.O. Box 130235
Ann Arbor, MI 48113
Re:Gemphire Therapeutics Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed October 11, 2019
File No. 333-233588
Dear Dr. Gullans:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our October 2, 2019 letter.
Amendment No. 1 to Registration Statement on Form S-4 filed on October 11, 2019
Risk Factors
Risks Related to Gemphire Common Stock
Gemphire's amended and restated bylaws designate the Court of Chancery of the State of
Delaware as to the sole and exclusive forum..., page 89
1.We note your response to comment 2, which we reissue in part. Please ensure that the
exclusive forum provision in your bylaws includes a statement to the effect that the
provision is not intended to apply to any actions arising under the Exchange Act or
Securities Act or the rules and regulations promulgated thereunder, or tell us how you will
inform investors in future filings that the provision is not intended to apply to such
claims.
FirstName LastNameSteven Gullans, Ph.D.
Comapany NameGemphire Therapeutics Inc.
October 25, 2019 Page 2
FirstName LastName
Steven Gullans, Ph.D.
Gemphire Therapeutics Inc.
October 25, 2019
Page 2
U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of NeuroBo Common
Stock, page 184
2.We note your statement that the disclosure in this section constitutes the opinion of
counsel as to the tax consequences of the merger, and that the parties "intend" for the
merger to be treated as a tax-free contribution or a reorganization. We further note that
this section describes the tax consequences to holders "assuming the qualification
of the merger as a tax-free contribution or a reorganization." However, in Exhibit 8.2,
counsel confirms that "the merger shall qualify either as a tax-free contribution pursuant
to Section 351 of the Code, or as a 'reorganization' within the meaning of
Section 368(a) of the Code." The disclosure constituting the opinion should
should clearly identify each material tax consequence to holders being opined upon, and
set forth an opinion as to each identified tax item and the basis for the opinion. It is
inappropriate to assume any legal conclusion underlying the opinion. For guidance,
please refer to Sections III.C.1 and III.C.3 of Staff Legal Bulletin No. 19.
Agreements Related to the Merger
Contingent Value Rights Agreement, page 209
3.We note your response to comment 5, which we reissue in part. Although the tax
treatment of the Contingent Value Rights (CVRs) may be subject to uncertainty, counsel
must opine on each material tax consequence and may provide a "should" or "more likely
than not" opinion and describe the related uncertainty where a "will" opinion is not given.
Accordingly, please revise your disclosure to provide an opinion as to the tax
consequences of the receipt of the CVRs to Gemphire shareholders.
NeuroBo Business
Intellectual Property, page 308
4.We note your response to comment 13. Please expand your disclosure to provide the
expiry dates for NeuroBo's issued patents.
You may contact Ibolya Ignat at 202-551-3636 or Sharon Blume at 202-551-3474 if you
have questions regarding comments on the financial statements and related matters. Please
contact Christine Westbrook at 202-551-5019 or Mary Beth Breslin at 202-551-3625 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence, Esq.
2019-10-03 - UPLOAD - MetaVia Inc.
October 2, 2019
Steven Gullans, Ph.D.
President & Chief Executive Officer
Gemphire Therapeutics Inc.
P.O. Box 130235
Ann Arbor, MI 48113
Re:Gemphire Therapeutics Inc.
Registration Statement on Form S-4
Filed September 3, 2019
File No. 333-233588
Dear Dr. Gullans:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4 filed on September 3, 2019
Questions and Answers About the Merger
What is the Pre-Closing Financing ?, page 7
1.We note your disclosure that shares of NeuroBo Series B preferred stock that will be
issued in the Pre-Closing Financing will be converted into shares of NeuroBo common
stock pursuant to the Preferred Stock Conversion and into shares of Gemphire common
stock in the merger. Please expand your disclosure to indicate that shares of NeuroBo
preferred stock will convert to NeuroBo common stock on a one-for-one basis, as
disclosed on page 213, and to provide the purchase price per share in the Pre-Closing
Financing. Refer to Note A of Schedule 14A.
FirstName LastNameSteven Gullans, Ph.D.
Comapany NameGemphire Therapeutics Inc.
October 2, 2019 Page 2
FirstName LastNameSteven Gullans, Ph.D.
Gemphire Therapeutics Inc.
October 2, 2019
Page 2
Risk Factors
Risks Related to Gemphire Common Stock
Gemphire’s amended and restated bylaws designate the Court of Chancery of the State of
Delaware as the sole and exclusive forum for certain , page 89
2.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please disclose whether this provision applies to actions arising under the
Securities Act or Exchange Act. In this regard, we note that Section 27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or
liability created by the Exchange Act or the ruled and regulations thereunder, and Section
22 of the Securities Act created concurrent jurisdiction for federal and state courts over all
suits brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act claims, please revise your
prospectus to state that there is uncertainty as to whether a court would enforce such
provision and that investors cannot waive compliance with the federal securities laws and
the rules and regulations thereunder. If this provision does not apply to actions arising
under the Securities Act or Exchange Act, please also ensure that the exclusive forum
provision in the governing documents states this clearly, or tell us how you will inform
investors in future filings that the provision does not apply to any actions arising under the
Securities Act or Exchange Act.
The Merger
Background of the Merger, page 154
3.Please provide us supplementally with copies of all materials prepared by Ladenburg
Thalmann & Co. Inc. and shared with the Gemphire Board, including copies of all board
books and all transcripts and summaries, that were material to the Board's decision to
approve the merger agreement and the transactions contemplated thereby.
4.Please revise your disclosure to discuss details as to how Gemphire management
determined the proposed exchange ratio.
Agreements Related to the Merger
Contingent Value Rights Agreement
Receipt of CVRs by Gemphire U.S. Holders, page 209
5.To the extent you intend the disclosure in this section to serve as the tax opinion and
Exhibit 8 will be filed to confirm this, please revise your disclosure to state that the
discussion constitutes the opinion of named counsel. If such opinion is subject to
uncertainty, counsel may provide a "should' or "more likely than not" opinion and explain
why a "will" opinion cannot be given and describe the degree of uncertainty. For
guidance, please refer to Sections III.B.2 and III.C.4 of Staff Legal Bulletin No. 19.
FirstName LastNameSteven Gullans, Ph.D.
Comapany NameGemphire Therapeutics Inc.
October 2, 2019 Page 3
FirstName LastNameSteven Gullans, Ph.D.
Gemphire Therapeutics Inc.
October 2, 2019
Page 3
Agreements Related to the Merger
Voting Agreements and Written Consents, page 211
6.We note your disclosure that NeuroBo shareholders owning approximately 90% of the
NeuroBo outstanding capital stock on an as converted basis have entered into a voting
agreement whereby such shareholders have agreed to vote in favor of the merger and that
such shareholders will execute a written consent providing for such approval following
effectiveness of the registration statement. Please confirm that, with respect to NeuroBo
shareholders, the voting agreement was entered into only by executive officers, directors,
affiliates and holders of 5% or more of NeuroBo’s voting equity securities, and that
NeuroBo is soliciting consents only from shareholders who have not signed the voting
agreement and would be ineligible to purchase in a private offering. Refer to Securities
Act Sections Compliance and Disclosure Interpretations 239.13.
Proposal No. 2: Approval of an Amendment to the Gemphire Certificate of Incorporation
Effecting the Gemphire Reverse Stock Split
Principal Effects of the Gemphire Reverse Stock Split, page 245
7.We note your disclosure that the reverse stock split will effectively increase the proportion
of authorized shares which are unissued, which could result in the Gemphire board being
able to issue more shares without further shareholder approval. Please expand your
disclosure to discuss the potential dilution to Gemphire shareholders if the reverse stock
split is approved.
NeuroBo Business
Overview, page 297
8.We note your reference here and on page 12 to NeuroBo’s pipeline as having the potential
to deliver efficacy with a superior safety profile. Please revise these and similar statements
throughout the registration statement that state or imply that NeuroBo’s product
candidates are safe or effective as these determinations are solely within the authority of
the U.S. Food and Drug Administration and comparable regulatory bodies. As a non-
exhaustive list of illustrative examples only, we note the following:
•NeuroBo expects NB-02 to have a positive safety profile.
•NB-01 has generated compelling data on efficacy and safety in a 128-subject Phase 2
clinical trial.
•NeuroBo’s current pipeline leverages natural drugs that can deliver requisite efficacy
along with minimal side effects.
•The Phase 2 trial provided preliminary evidence of NB-01's efficacy in the target
population.
•In addition to NB-01's safety profile, the data from the Phase 2 study show
preliminary efficacy signals that NB-01 may be equivalent in effectiveness to that of
other FDA-approved therapeutics for the treatment of diabetic neuropathic pain
FirstName LastNameSteven Gullans, Ph.D.
Comapany NameGemphire Therapeutics Inc.
October 2, 2019 Page 4
FirstName LastNameSteven Gullans, Ph.D.
Gemphire Therapeutics Inc.
October 2, 2019
Page 4
(DNP).
We will not object to a discussion of whether NeuroBo’s product candidates were well-
tolerated or discussion of whether trial endpoints were met.
9.We note your disclosure that the Phase 3 clinical program for NB-01 is expected to launch
in late 2019. We note the disclosure on page 304 stating NeuroBo expects to screen the
first subject for this trial in the first quarter of 2020. Please revise or advise. In your
pipeline development chart, please shorten the arrow corresponding to the development of
NB-01 for the treatment of DNP so that it reflects you have not yet commenced Phase 3
development. Please also revise your statement on page 13 referencing current Phase 3
development accordingly.
NeuroBo’s Novel Approach to Neurogenerative Diseases
NB-01: Treatment of DNP and Peripheral Neuropathic Conditions, page 300
10.Please cite the source for the graphic in Figure 2 on page 300 and explain how the graphic
illustrates the referenced efficacy concerns for existing approved therapies for DNP.
11.We note your comparison to duloxetine and pregabalin in the graphic on page 304. As this
comparison is not based on head-to-head studies, please tell us why you believe it is
appropriate to include this comparison. In your response, please tell us whether you expect
to be able to rely on such comparison to support marketing approval for NB-01 from the
FDA or other comparable regulators.
NB-01 Development Plan Through NDA , page 305
12.Given the contingencies to NeuroBo successfully completing the two planned Phase 3
clinical trials, we object to your illustration on page 305 as speculative and without full
and proper context. In this regard, we note your disclosure that prior to the initiation of the
second Phase 3 trial of NB-01, NeuroBo plans to request a Type C meeting with the FDA
and to obtain scientific advice from the European Medicines Agency to ensure alignment
with these regulators, and further that NeuroBo will continue with its development
program following a positive recommendation from the Data and Safety Monitoring
Board. Accordingly, please remove this chart. We will not object to a narrative discussion
of NeuroBo’s clinical development plans in which relevant context is provided.
Intellectual Property, page 308
13.Please revise your disclosure to specify the number of issued patents versus patent
applications and the type of patent protection (e.g., composition of matter, use or
process).
FirstName LastNameSteven Gullans, Ph.D.
Comapany NameGemphire Therapeutics Inc.
October 2, 2019 Page 5
FirstName LastName
Steven Gullans, Ph.D.
Gemphire Therapeutics Inc.
October 2, 2019
Page 5
Related Party Transactions of Directors and Executive Officers of the Combined Organization
Agreements with Dong-A ST
Manufacturing Agreement, page 367
14.Please expand your disclosure to include the material terms of your manufacturing
agreement with Dong-A ST, including the financial terms and termination provisions.
Unaudited Pro Forma Condensed Combined Financial Information , page 372
15.We acknowledge your disclosure on page 380 regarding pro forma adjustment J. Please
disclose and provide us with a reconciliation of your historical basic and diluted earnings
per share to your pro forma basic and diluted earnings per share for all periods presented.
Please clearly describe how you have computed both the denominator and numerator in
your pro forma earnings per share calculation.
Principal Stockholders of NeuroBo, page 405
16.Please disclose the natural persons who have beneficial ownership of the shares held by
Dong-A ST. Refer to Item 403 of Regulation S-K required by Item 6 of Schedule 14A
required by Item 18(a)(5)(ii) of Form S-4.
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.
You may contact Ibolya Ignat at 202-551-3636 or Sharon Blume at 202-551-3474 if you
have questions regarding comments on the financial statements and related matters. Please
contact Christine Westbrook at 202-551-5019 or Mary Beth Breslin at 202-551-3625 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip D. Torrence, Esq.
2018-08-28 - UPLOAD - MetaVia Inc.
August 27, 2018
Jeffrey S. Mathiesen
Chief Financial Officer
Gemphire Therapeutics Inc.
17199 N. Laurel Park Dr.
Suite 401
Lavonia, MI 48152
Re:Gemphire Therapeutics Inc.
Form 10-K for the Fiscal year Ended December 31, 2017
Filed March 20, 2018
File No. 001-37809
Dear Mr. Mathiesen:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-08-22 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm gemp_CORRESP August 22, 2018 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention:Sasha Parikh Kevin Vaughn Re:Gemphire Therapeutics Inc. Form 10‑K for the Fiscal Year Ended December 31, 2017 Filed March 20, 2018 File No. 001‑37809 Dear Ms. Parikh and Mr. Vaughn: On behalf of Gemphire Therapeutics Inc. (the “Company”), this letter sets forth the response of the Company to the comment contained in your letter dated August 13, 2018. The Company respectfully acknowledges to the Staff that it inadvertently omitted paragraph 4(b) from the certifications filed as Exhibits 31.1 and 31.2 to the Company’s Annual Report on Form 10‑K for the fiscal year ended December 31, 2017 (File No. 001‑37809) (the “Annual Report”). In response to the Staff’s comment and as required by Item 601(b)(31) of Regulation S‑K and Regulation S‑K C&DI 246.13, the Company is concurrently filing Amendment No. 1 on Form 10‑K/A to the Company’s Annual Report including revised certifications filed as Exhibits 31.1 and 31.2 that include the statements required by Item 601(b)(31) of Regulation S‑K in the introductory portion of paragraph 4 and in paragraph 4(b). If you have any questions or comments concerning this response or the revised certifications, please do not hesitate to call the undersigned at 612‑961‑7875. Sincerely yours, /s/ Jeffrey S. Mathiesen Cc: Dr. Steven Gullans, Gemphire Therapeutics Inc.
2018-08-14 - UPLOAD - MetaVia Inc.
August 13, 2018
Jeffrey S. Mathiesen
Chief Financial Officer
Gemphire Therapeutics Inc.
17199 N. Laurel Park Dr.
Suite 401
Lavonia, MI 48152
Re:Gemphire Therapeutics Inc.
Form 10-K for the Fiscal year Ended December 31, 2017
Filed March 20, 2018
File No. 001-37809
Dear Mr. Mathiesen:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we ask you to provide us with
information so we may better understand your disclosure.
Please respond to the 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 the comment, we may have additional comments.
Form 10-K for the Fiscal year Ended December 31, 2017
Exhibits 31.1 and 31.2, page 1
1.Refer to the guidance of Item 601(b)(31) of Regulation S-K as well as Regulation S-K
C&DI 246.13. We note your disclosure that paragraph 4(b) of the certification was
"intentionally omitted." Please provide revised certifications that included paragraph 4(b)
of the certification in an amendment to your Form 10-K for the Fiscal Year Ended
December 31, 2017.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
FirstName LastNameJeffrey S. Mathiesen
Comapany NameGemphire Therapeutics Inc.
August 13, 2018 Page 2
FirstName LastName
Jeffrey S. Mathiesen
Gemphire Therapeutics Inc.
August 13, 2018
Page 2
You may contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2017-09-08 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm SEC Acceleration request for S-3 Effectiveness-9-8-17 September 8, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention:Irene Paik Re: Gemphire Therapeutics Inc. Registration Statement on Form S-3 File No. 333-220315 Acceleration Request Requested Date: September 12, 2017 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Gemphire Therapeutics Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-220315) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Gabrielle L. Sims of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. Please confirm the effectiveness of the Registration Statement with Gabrielle L. Sims of Honigman Miller Schwartz and Cohn LLP by telephone at (313) 465-7620. Sincerely, Gemphire Therapeutics Inc. /s/ Steven Gullans Steven Gullans Interim President and Chief Executive Officer cc: Jeffrey S. Mathiesen, Gemphire Therapeutics Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Gabrielle L. Sims, Honigman Miller Schwartz and Cohn LLP
2017-09-07 - UPLOAD - MetaVia Inc.
September 7, 2017 Steven Gullans Interim President and Chief Executive Officer Gemphire Therapeutics Inc. 17199 N. Laurel Park Drive, Suite 401 Livonia, Michigan 48152 Gemphire Therapeutics Inc. Registration Statement on Form S-3 Filed September 1, 2017 File No. 333-220315Re: Dear Dr. Gullans: 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 Irene Paik at (202) 551-6553 with any questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Meredith Ervine, Esq. - Honigman Miller Schwartz and Cohn LLP
2017-04-19 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm April 19, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Suzanne Hayes and Mary Beth Breslin Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 File No. 333-217296 Acceleration Request Requested Date: April 20, 2017 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Gemphire Therapeutics Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-217296) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Gabrielle L. Sims of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. In connection with the acceleration request, the Company hereby acknowledges that: · should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; · 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 Registration Statement; 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 confirm the effectiveness of the Registration Statement with Gabrielle L. Sims of Honigman Miller Schwartz and Cohn LLP by telephone at (313) 465-7620. [Signature page follows] **** Sincerely, GEMPHIRE THERAPEUTICS INC. /s/ MINA SOOCH Mina Sooch President and Chief Executive Officer cc: Jeffrey S. Mathiesen, Gemphire Therapeutics Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Gabrielle L. Sims, Honigman Miller Schwartz and Cohn LLP
2017-04-18 - UPLOAD - MetaVia Inc.
Mail Stop 4546 April 18, 2017 Mina Sooch Chief Executive Officer Gemphire Therapeutics Inc. 17199 N. Laurel Park Drive, Suite 401 Livonia, Michigan 48152 Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 Filed April 13, 2017 File No. 333-217296 Dear Ms. Sooch : 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/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Meredith Ervine, Esq. Honigman Miller Schwartz and Cohn LLP
2016-08-04 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm August 4, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Suzanne Hayes Joshua Samples Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 File No. 333-210815 Acceleration Request Requested Date: August 4, 2016 Requested Time: 4:30 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Gemphire Therapeutics Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-210815) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Gabrielle L. Sims of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. The Company hereby acknowledges that: · should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman Miller Schwartz and Cohn LLP by telephone at (269) 337-7702. [Signature page follows] **** Sincerely, GEMPHIRE THERAPEUTICS INC. /s/ MINA SOOCH Mina Sooch President, Chief Executive Officer and Treasurer cc: Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Gabrielle L. Sims, Honigman Miller Schwartz and Cohn LLP Divakar Gupta, Cooley LLP Charles S. Kim, Cooley LLP Siana E. Lowrey, Cooley LLP
2016-08-04 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm August 4, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes Joshua Samples Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 (File No. 333-210815) Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between June 13, 2016 and the date hereof, approximately 993 copies of the Preliminary Prospectus dated June 13, 2016 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement. We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:30 p.m. Eastern Time, on Thursday, August 4, 2016 or as soon thereafter as practicable. [signature page follows] Very truly yours, JEFFERIES LLC RBC CAPITAL MARKETS, LLC As representatives of the several underwriters JEFFERIES LLC By: /s/ Dustin Tyner Name: Dustin Tyner Title: Managing Director RBC CAPITAL MARKETS, LLC By: /s/ Lorenzo Paoletti Name: Lorenzo Paoletti Title: Director [Signature Page to Acceleration Request of the Underwriters]
2016-07-08 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm July 8, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Suzanne Hayes Joshua Samples Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 File No. 333-210815 Ladies and Gentlemen: Effective immediately, the undersigned withdraws the request for acceleration sent to your office via EDGAR on June 20, 2016, which requested that the Commission take appropriate action to cause the above-referenced Registration Statement to become effective at 4:00 p.m. Eastern Time on June 22, 2016 or as soon as practicable thereafter. [signature page follows] Sincerely, GEMPHIRE THERAPEUTICS INC. /s/ MINA SOOCH Mina Sooch President, Chief Executive Officer and Treasurer cc: Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Gabrielle L. Sims, Honigman Miller Schwartz and Cohn LLP Divakar Gupta, Cooley LLP Charles S. Kim, Cooley LLP Siana E. Lowrey, Cooley LLP
2016-07-08 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm July 8, 2016 Via EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Joshua Samples Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 (File No. 333-210815) Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on June 20, 2016, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for June 22, 2016 at 4:00 p.m. Eastern time or as soon thereafter as practicable in accordance with Rule 461 of the Securities Act of 1933, as amended. As representatives of the several underwriters of the proposed public offering, we hereby respectfully withdraw our request for acceleration of the effectiveness of the above-referenced Registration Statement set forth in our June 20, 2016 letter. [signature page follows] Very truly yours, JEFFERIES LLC RBC CAPITAL MARKETS, LLC As representatives of the several underwriters JEFFERIES LLC By: /s/ Ashley Delp Walker Name: Ashley Delp Walker Title: Managing Director RBC CAPITAL MARKETS, LLC By: /s/ Lorenzo Paoletti Name: Lorenzo Paoletti Title: Director cc: Mina Sooch, Gemphire Therapeutics Inc. Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Gabrielle L. Sims, Honigman Miller Schwartz and Cohn LLP Divakar Gupta, Cooley LLP Charles S. Kim, Cooley LLP Siana E. Lowrey, Cooley LLP [Signature Page to Withdrawal of Underwriters’ Acceleration Request]
2016-06-20 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm June 20, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes Joshua Samples Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 (File No. 333-210815) Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between June 13, 2016 and the date hereof, approximately 941 copies of the Preliminary Prospectus dated June 13, 2016 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement. We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Wednesday, June 22, 2016 or as soon thereafter as practicable. [signature page follows] Very truly yours, JEFFERIES LLC RBC CAPITAL MARKETS, LLC As representatives of the several underwriters JEFFERIES LLC By: /s/ Dustin Tyner Name: Dustin Tyner Title: Managing Director RBC CAPITAL MARKETS, LLC By: /s/ Lorenzo Paoletti Name: Lorenzo Paoletti Title: Director [Signature Page to Acceleration Request of the Underwriters]
2016-06-20 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm June 20, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Suzanne Hayes Joshua Samples Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 File No. 333-210815 Acceleration Request Requested Date: June 22, 2016 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Gemphire Therapeutics Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-210815) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company hereby authorizes each of Phillip D. Torrence, Meredith Ervine and Gabrielle L. Sims of Honigman Miller Schwartz and Cohn LLP, counsel to the Company, to make such request on its behalf. The Company hereby acknowledges that: · should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please confirm the effectiveness of the Registration Statement with Phillip D. Torrence of Honigman Miller Schwartz and Cohn LLP by telephone at (269) 337-7702. [Signature page follows] **** Sincerely, GEMPHIRE THERAPEUTICS INC. /s/ MINA SOOCH Mina Sooch President, Chief Executive Officer and Treasurer cc: Phillip D. Torrence, Honigman Miller Schwartz and Cohn LLP Meredith Ervine, Honigman Miller Schwartz and Cohn LLP Gabrielle L. Sims, Honigman Miller Schwartz and Cohn LLP Divakar Gupta, Cooley LLP Charles S. Kim, Cooley LLP Siana E. Lowrey, Cooley LLP
2016-06-15 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm Phillip D. Torrence (269) 337-7702 Fax: (269) 337-7703 ptorrence@honigman.com April 22, 2016 *FOIA Confidential Treatment Request* Confidential Treatment Requested by Gemphire Therapeutics Inc. in connection with Registration Statement on Form S-1 (File No. 333-210815) Via EDGAR and FedEx U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Alexandra M. Ledbetter Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 Registration No. 333-210815 Ladies and Gentlemen: On behalf of our client, Gemphire Therapeutics Inc. (the “Company”), in response to a comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated October 7, 2015 (the “Comment Letter”), relating to the Company’s registration statement on Form S-1, originally confidentially submitted with the Commission on September 11, 2015, resubmitted to the Commission on January 19, 2016 and subsequently filed by the Company with the Commission on April 18, 2016 (File No. 333-210815) (the “Registration Statement”), we submit this supplemental letter to further address comment 9 of the Comment Letter. Confidential Treatment Request Due to the commercially sensitive nature of information contained herein, the Company hereby requests, pursuant to 17 C.F.R. § 200.83, that certain portions of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person as they contain confidential information. The Company has filed a separate copy of this letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. § 200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days advance notice of any intended release so that the Company may, if deemed necessary or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 2 appropriate, pursue any remedies available to it. In such an event, we request that you telephone the undersigned rather than rely upon the U.S. mail for such notice. Staff Comment and Company Response For the convenience of the Staff, we have recited the prior comment from the Staff in italicized type and have followed the comment with the Company’s response. 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 between recent valuations of your common stock leading up to the IPO and the estimated offering price. The Company advises the Staff that the Company preliminarily estimates a price range of $3.53 to $4.17 per share (the “Price Range”) for its initial public offering (the “IPO”), before giving effect to an anticipated reverse stock split. The preliminary Price Range has been estimated based, in part, upon current market conditions, the Company’s financial condition and prospects and input received from Jefferies LLC and Cowen & Company, LLC, the lead underwriters for the IPO, including discussions that took place on April 21, 2016 between senior management of the Company and representatives of the lead underwriters. The Price Range does not take into account the current lack of liquidity for the Company’s common stock and assumes a successful IPO with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold in an acquisition transaction. The Company and underwriters had not had any specific discussions regarding the Price Range prior to April 21, 2016. The reverse stock split ratio has not yet been determined. The Company expects to include the post-split Price Range in an amendment to the Registration Statement that would shortly precede the commencement of the Company’s road show. However, due to the recent volatility in the financial markets and the volatilities evident in the market for recent IPO issuers, the Price Range of the common stock may change. The Company confirms to the Staff that in accordance with Item 501(b)(3) of Regulation S-K and CD&I 134.04, the Price Range will not be in excess of 20% of the high end of the range. The parameters of the Price Range will be subject to then-current market conditions, continuing discussions with the underwriters and any business developments impacting the Company. We are providing this information to the Staff supplementally to facilitate its review process. The Company advises the Staff as follows: CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 3 The following table summarizes stock options granted to the Company’s employees, consultants and non-employee directors during the year ended December 31, 2015 (no options have been granted in 2016 to date). Grant Date Number of Options Granted Exercise Price May 21, 2015 82,000 $0.431 June 1, 2015 100,000 $0.431 June 29, 2015 136,522 $0.431 August 17, 2015 266,600 $0.680 September 25, 2015 160,000 $1.150 November 13, 2015 20,000 $1.140 November 25, 2015 100,000 $1.140 December 24, 2015 87,000 $1.140 In connection with share-based awards under the Company’s 2015 Equity Incentive Plan, the Company’s board of directors (the “Board”) has historically set the exercise price of stock options based on a price per share not less than the estimated fair value of the Company’s common stock on the date of grant. Because there has been no public market for the Company’s common stock, the Board has taken into consideration numerous objective and subjective factors to determine the fair value, including: · valuations of comparable securities transactions; · sales of convertible preferred stock to unrelated third parties and the rights, preferences and privileges of the Company’s common stock versus preferred stock; · the Company’s operating and financial performance; · the Company’s stage of development, current business conditions, projections and business developments; · the lack of liquidity of the Company’s capital stock; and · general and industry specific economic outlook. To determine the estimated fair value of the common stock at each grant date in order to set the exercise price of each stock option, the Board considered the factors listed above, as well as the results of various independent third-party valuations of the Company’s common stock. As further described below, for grants that occurred in fiscal 2015, the Board relied on valuations as of March 31, 2015, June 30, 2015 and September 30, 2015 and received an additional valuation as of September 18, 2015 in connection with an award in September 2015. At the time of the grants in May and June 2015, the Board relied in part on an independent third-party valuation of the Company’s common stock as of March 31, 2015. The March 31, 2015 valuation provided an estimated fair value of the common stock of $0.431 per share and was approved by the Board in April 2015, prior to the granting of stock options in May 2015. The Board determined the valuation was reasonable and that the estimated fair value of the common stock as of May 21, 2015 was $0.431 per share. On each of June 1, 2015 and June 29, 2015, the Board determined that no significant business or market developments had occurred since the valuation date that would warrant a change in the fair value of the Company’s common stock. At the time of the grants on August 17, 2015, the Board relied in part on an independent third-party valuation of the Company’s common stock as of June 30, 2015. The June 30, 2015 valuation, completed on August 3, 2015, provided an estimated fair value of the common stock of $0.620 per share. In addition to the valuation, the CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 4 Board considered the Company’s efforts focused on preparing for a potential IPO and, for purposes of determining the value of the Company’s common stock for the grants in August 2015, decided to increase the value of the Company’s common stock from the June 30, 2015 valuation by approximately 10%. Therefore, the Board determined the estimated fair value of the Company’s common stock as of August 17, 2015 was $0.680 per share. Between August 17, 2015 and September 18, 2015, the Company made significant progress towards the proposed IPO, including by holding the organizational meeting for the IPO, engaging underwriters and submitting the initial draft registration statement to the SEC. In connection with the grants in September 2015, the Board determined that the fair value of the Company’s common stock was $1.15 per share based in part on the results of a an independent third-party valuation as of September 18, 2015, completed on September 25, 2015. The Board determined the valuation was reasonable and that the estimated fair value of the common stock as of September 25, 2015 was $1.15 per share. For the grants made on November 13, 2015, the Board relied in part on an independent third-party valuation of the common stock as of September 30, 2015. The valuation was completed on October 4, 2015 and provided an estimated fair value of the common stock of $1.14 per share. The slight $0.01 decrease in the estimated fair value of the Company’s common stock from September 18 to September 30 was due to a minor [***]% increase in the discount for lack of marketability (“DLOM”) as of September 30, 2015 due to an increase in market volatility between the two dates and the negative state of the capital markets at the time. The Board set the exercise price of the options granted on November 13, 2015 at the estimated fair value of the common stock as of September 30, 2015 provided by the independent third-party valuation firm. For the awards made on each of November 25, 2015 and December 24, 2015, the Board determined that no significant business or market developments had occurred since the valuation date that would warrant a change in the fair value of the Company’s common stock. No awards have been granted since December 24, 2015. All of the valuations described above (the “Valuations”) were conducted based on the guidance set forth by the American Institute of Certified Public Accountants (“AICPA”), in the AICPA Accounting and Valuation Guide, Valuation of Privately-Held-Company Securities Issued as Compensation (the “AICPA Practice Aid”). Given the uncertainty associated with valuing a private company, the Company believes the Board exercised reasonable judgment, considering the results of the Valuations and the objective and subjective factors described above, in connection with establishing the fair value of the Company’s common stock on each grant date. In order to determine the estimated fair value of the Company’s common stock, the Company and the independent third-party valuation firm utilized a probability-weighted return methodology (“PWERM”) to allocate enterprise value. The Valuations as of March 31, 2015 and June 30, 2015 relied on the indications of value realized in the Company’s Series A preferred stock financing that closed in March 2015. The fair value of the common stock was estimated using a hybrid of two market approaches. Specifically, the non-IPO exit scenario valued the Company based on the backsolve calculation of the implied equity value from the Company’s recent Series A preferred stock financing, and the IPO exit scenario was based on the post-money calculation of the implied equity value from the Series A preferred stock financing. This later approach considers implied equity value based on a common equivalent capitalization table associated with an IPO exit. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 5 The Valuations as of September 18, 2015 and September 30, 2015 estimated the fair value of the Company’s common stock by using a hybrid of two market approaches: (1) the value of a potential Series B preferred stock financing utilizing the backsolve method and (2) the value of a potential Series B financing post-money as a common stock equivalent for an IPO exit. A non-IPO exit scenario that valued the Company based on the backsolve calculation of the implied equity value from the Company’s recent Series A preferred stock financing was also considered in the event that a Series B preferred stock financing or an IPO could not be achieved. The Company believes that the primary differences between the per share value determined in the Valuations and the estimated Price Range for the IPO are reasonable as a result of the following factors: The Price Range assumes a successful IPO, with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company, and that the Company’s common stock is listed on an exchange. As a result, the Price Range excludes any marketability or liquidity discount and takes into account that the IPO would provide significant additional cash proceeds to the Company to help fund the development of the Company’s product and substantially strengthen its balance sheet. In contrast, the IPO scenario in the Valuations was weighted at an aggregate probability of [***]% and [***]% as of March 31, 2015 and June 30, 2015, respectively, and the IPO scenario (with a Series B preferred stock financing) was weighted at an aggregate possibility of [***]% in each of the September 18, 2015 and September 30, 2015 Valuations. The probability that the Company would remain private was weighted at [***]% and [***]% as of March 31, 2015 and June 30, 2015, respectively, and was weighted at [***]% (including with the probability of a Series B preferred stock financing at [***]% and with no Series B preferred stock financing at [***]%) as of each of September 18, 2015 and September 30, 2015. In the non-IPO exit scenarios, the Valuations used the backsolve method, using the Option Pricing Method to calculate an implied value based on a recent transaction taking into account the economic rights of the recently issued security (i.e., the Series A preferred stock) in relation to the rights of other equity holders. The Valuations estimate that the fair value of the Company’s c
2016-05-03 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm Phillip D. Torrence (269) 337-7702 Fax: (269) 337-7703 ptorrence@honigman.com May 3, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Alexandra M. Ledbetter Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 Registration No. 333-210815 Ladies and Gentlemen: On behalf of our client, Gemphire Therapeutics Inc. (the “Company”), this letter sets forth the response to a comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated May 2, 2016 relating to the Company’s registration statement on Form S-1, originally confidentially submitted with the Commission on September 11, 2015, resubmitted to the Commission on January 19, 2016 and subsequently filed by the Company with the Commission on April 18, 2016 (File No. 333-210815) (the “Registration Statement”). In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response. Critical Accounting Policies and Estimates Stock-Based Compensation Common Stock Valuation, page 78 1. We noted the use of the potential Series B convertible preferred stock financing (potential Series B financing) in your September 18 and 30, 2015 valuations. Please provide us additional information with regards to the potential Series B financing so we may better understand your valuations. In this regard, tell us: · why it is appropriate to include the potential Series B financing in both of your September 2015 valuations; · when the discussions began for this financing round, when you expect to complete the financing, and any difficulties you are facing in completing the financing; · with whom are you discussing the potential financing with (i.e. new investors, prior investors, related parties); 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing · the economic rights you are anticipating granting to the Series B preferred stock holders in relation to the rights of other equity holders; and · your intention with respect to providing disclosure regarding the potential Series B financing in your registration statement. In response to the Staff’s comment, the Company advises the Staff that the Company and its independent third-party valuation firm considered the Series B scenario as one factor in the September 2015 valuations because, at such time, the Company was in discussions, which began in April 2015, with several new venture capital investors regarding a potential Series B financing. In the September 2015 valuations, the Company and its independent third-party valuation firm considered the possibilities that the Company could (1) complete a Series B financing prior to publicly filing a registration statement for its contemplated initial public offering (the “IPO”) and, following such Series B financing, pursue an IPO, (2) complete a Series B financing and not pursue an IPO or (3) remain private without completing a Series B financing. At the time of the September 2015 valuations, the Company expected to complete a Series B financing prior to the end of 2015. However, as a result of a subsequent pronounced downturn in the biotechnology market, the Company did not complete the Series B financing as previously anticipated. Moreover, terms of a potential Series B financing, including the economic rights that would have been granted to any potential Series B stockholder, were never set, as the Company was negotiating at arms-length and did not receive a term sheet from a potential lead investor (for purposes of the September 2015 valuations, it was assumed that the economic rights granted to Series B stockholders would be identical to the rights of the holders of the Company’s Series A preferred stock). In addition, it is important to note that taking into consideration a potential Series B financing resulted in a higher fair value determination than would have been made had that potential financing not been taken into consideration. The Company advises the Staff that it does not intend to pursue a potential Series B financing or any other financing outside of the Company’s IPO at this time. Therefore, the Company respectfully submits to the Staff that it will not be including disclosure regarding a potential Series B financing, or any other potential financing, in the Registration Statement, but rather will be appropriately disclosing details regarding the Company’s IPO and all financings that have been completed by the Company to date. If you have any questions or comments concerning this response or the Revised Registration Statement, please do not hesitate to call Phillip D. Torrence at (269) 337-7702. Yours sincerely, /s/ Phillip D. Torrence Phillip D. Torrence Cc: Gemphire Therapeutics Inc. Mina Sooch Jeffrey S. Mathiesen David Lowenschuss 2
2016-05-02 - UPLOAD - MetaVia Inc.
Mail Stop 4546
May 2, 2016
Via E -mail
Mina Sooch
Chief Executive Officer
Gemphire Therapeutics Inc.
43334 Seven Mile Road, Suite 1000
Northville, Michigan 48167
Re: Gemphire Therapeutics Inc.
Registration Statement on Form S -1
Response dated April 22, 2016
File No. 333-210815
Dear Ms. Sooch :
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information . If you do not believe our comments apply to your facts and
circumstances or do no t 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.
Critical Accounti ng Policies and Estimates
Stock -Based Compensation
Common Stock Valuation, page 78
1. We noted the use of the potential Series B convertible preferred stock financing (potential
Series B financing) in your Septem ber 18 and 30, 2015 valuations. Please provide us
additional information with regards to the potential Series B financing so we may better
understand your valuations. In this regard, tell us:
Mina Sooch
Gemphire Therapeutics Inc.
May 2, 2016
Page 2
why it is appropriate to include the potential Series B financing in both of your
September 20 15 valuations;
when the discussions began for this financing round, when you expect to complete the
financing, and any difficulties you are facing in completing the financing;
with whom are you discussing the potential financing with (i.e. new investors, prior
investors, related parties);
the economic rights you are anticipating granting to the Series B preferred stock
holders in relation to the rights of other equity holders; and
your intention with respect to providing disclosure regarding the potential Series B
financing in your registration statement .
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 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 for the accuracy
and adequacy of the disclosures they have made.
Notwith standing 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 delega ted 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, doe s not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and
the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceleration of the effective date of the registration stateme nt 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 speci fied 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.
Mina Sooch
Gemphire Therapeutics Inc.
May 2, 2016
Page 3
You may contact Sasha Parikh, Staff Accountant, 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 (2 02) 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
2016-04-22 - CORRESP - MetaVia Inc.
CORRESP 1 filename1.htm Phillip D. Torrence (269) 337-7702 Fax: (269) 337-7703 ptorrence@honigman.com April 22, 2016 *FOIA Confidential Treatment Request* Confidential Treatment Requested by Gemphire Therapeutics Inc. in connection with Registration Statement on Form S-1 (File No. 333-210815) Via EDGAR and FedEx U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Alexandra M. Ledbetter Lilyanna Peyser Sharon Blume Sasha Parikh Re: Gemphire Therapeutics Inc. Registration Statement on Form S-1 Registration No. 333-210815 Ladies and Gentlemen: On behalf of our client, Gemphire Therapeutics Inc. (the “Company”), in response to a comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated October 7, 2015 (the “Comment Letter”), relating to the Company’s registration statement on Form S-1, originally confidentially submitted with the Commission on September 11, 2015, resubmitted to the Commission on January 19, 2016 and subsequently filed by the Company with the Commission on April 18, 2016 (File No. 333-210815) (the “Registration Statement”), we submit this supplemental letter to further address comment 9 of the Comment Letter. Confidential Treatment Request Due to the commercially sensitive nature of information contained herein, the Company hereby requests, pursuant to 17 C.F.R. § 200.83, that certain portions of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person as they contain confidential information. The Company has filed a separate copy of this letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. § 200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days advance notice of any intended release so that the Company may, if deemed necessary or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 2 appropriate, pursue any remedies available to it. In such an event, we request that you telephone the undersigned rather than rely upon the U.S. mail for such notice. Staff Comment and Company Response For the convenience of the Staff, we have recited the prior comment from the Staff in italicized type and have followed the comment with the Company’s response. 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 between recent valuations of your common stock leading up to the IPO and the estimated offering price. The Company advises the Staff that the Company preliminarily estimates a price range of $[***] to $[***] per share (the “Price Range”) for its initial public offering (the “IPO”), before giving effect to an anticipated reverse stock split. The preliminary Price Range has been estimated based, in part, upon current market conditions, the Company’s financial condition and prospects and input received from Jefferies LLC and Cowen & Company, LLC, the lead underwriters for the IPO, including discussions that took place on April 21, 2016 between senior management of the Company and representatives of the lead underwriters. The Price Range does not take into account the current lack of liquidity for the Company’s common stock and assumes a successful IPO with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold in an acquisition transaction. The Company and underwriters had not had any specific discussions regarding the Price Range prior to April 21, 2016. The reverse stock split ratio has not yet been determined. The Company expects to include the post-split Price Range in an amendment to the Registration Statement that would shortly precede the commencement of the Company’s road show. However, due to the recent volatility in the financial markets and the volatilities evident in the market for recent IPO issuers, the Price Range of the common stock may change. The Company confirms to the Staff that in accordance with Item 501(b)(3) of Regulation S-K and CD&I 134.04, the Price Range will not be in excess of 20% of the high end of the range. The parameters of the Price Range will be subject to then-current market conditions, continuing discussions with the underwriters and any business developments impacting the Company. We are providing this information to the Staff supplementally to facilitate its review process. The Company advises the Staff as follows: CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 3 The following table summarizes stock options granted to the Company’s employees, consultants and non-employee directors during the year ended December 31, 2015 (no options have been granted in 2016 to date). Grant Date Number of Options Granted Exercise Price May 21, 2015 82,000 $0.431 June 1, 2015 100,000 $0.431 June 29, 2015 136,522 $0.431 August 17, 2015 266,600 $0.680 September 25, 2015 160,000 $1.150 November 13, 2015 20,000 $1.140 November 25, 2015 100,000 $1.140 December 24, 2015 87,000 $1.140 In connection with share-based awards under the Company’s 2015 Equity Incentive Plan, the Company’s board of directors (the “Board”) has historically set the exercise price of stock options based on a price per share not less than the estimated fair value of the Company’s common stock on the date of grant. Because there has been no public market for the Company’s common stock, the Board has taken into consideration numerous objective and subjective factors to determine the fair value, including: · valuations of comparable securities transactions; · sales of convertible preferred stock to unrelated third parties and the rights, preferences and privileges of the Company’s common stock versus preferred stock; · the Company’s operating and financial performance; · the Company’s stage of development, current business conditions, projections and business developments; · the lack of liquidity of the Company’s capital stock; and · general and industry specific economic outlook. To determine the estimated fair value of the common stock at each grant date in order to set the exercise price of each stock option, the Board considered the factors listed above, as well as the results of various independent third-party valuations of the Company’s common stock. As further described below, for grants that occurred in fiscal 2015, the Board relied on valuations as of March 31, 2015, June 30, 2015 and September 30, 2015 and received an additional valuation as of September 18, 2015 in connection with an award in September 2015. At the time of the grants in May and June 2015, the Board relied in part on an independent third-party valuation of the Company’s common stock as of March 31, 2015. The March 31, 2015 valuation provided an estimated fair value of the common stock of $0.431 per share and was approved by the Board in April 2015, prior to the granting of stock options in May 2015. The Board determined the valuation was reasonable and that the estimated fair value of the common stock as of May 21, 2015 was $0.431 per share. On each of June 1, 2015 and June 29, 2015, the Board determined that no significant business or market developments had occurred since the valuation date that would warrant a change in the fair value of the Company’s common stock. At the time of the grants on August 17, 2015, the Board relied in part on an independent third-party valuation of the Company’s common stock as of June 30, 2015. The June 30, 2015 valuation, completed on August 3, 2015, provided an estimated fair value of the common stock of $0.620 per share. In addition to the valuation, the CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 4 Board considered the Company’s efforts focused on preparing for a potential IPO and, for purposes of determining the value of the Company’s common stock for the grants in August 2015, decided to increase the value of the Company’s common stock from the June 30, 2015 valuation by approximately 10%. Therefore, the Board determined the estimated fair value of the Company’s common stock as of August 17, 2015 was $0.680 per share. Between August 17, 2015 and September 18, 2015, the Company made significant progress towards the proposed IPO, including by holding the organizational meeting for the IPO, engaging underwriters and submitting the initial draft registration statement to the SEC. In connection with the grants in September 2015, the Board determined that the fair value of the Company’s common stock was $1.15 per share based in part on the results of a an independent third-party valuation as of September 18, 2015, completed on September 25, 2015. The Board determined the valuation was reasonable and that the estimated fair value of the common stock as of September 25, 2015 was $1.15 per share. For the grants made on November 13, 2015, the Board relied in part on an independent third-party valuation of the common stock as of September 30, 2015. The valuation was completed on October 4, 2015 and provided an estimated fair value of the common stock of $1.14 per share. The slight $0.01 decrease in the estimated fair value of the Company’s common stock from September 18 to September 30 was due to a minor [***]% increase in the discount for lack of marketability (“DLOM”) as of September 30, 2015 due to an increase in market volatility between the two dates and the negative state of the capital markets at the time. The Board set the exercise price of the options granted on November 13, 2015 at the estimated fair value of the common stock as of September 30, 2015 provided by the independent third-party valuation firm. For the awards made on each of November 25, 2015 and December 24, 2015, the Board determined that no significant business or market developments had occurred since the valuation date that would warrant a change in the fair value of the Company’s common stock. No awards have been granted since December 24, 2015. All of the valuations described above (the “Valuations”) were conducted based on the guidance set forth by the American Institute of Certified Public Accountants (“AICPA”), in the AICPA Accounting and Valuation Guide, Valuation of Privately-Held-Company Securities Issued as Compensation (the “AICPA Practice Aid”). Given the uncertainty associated with valuing a private company, the Company believes the Board exercised reasonable judgment, considering the results of the Valuations and the objective and subjective factors described above, in connection with establishing the fair value of the Company’s common stock on each grant date. In order to determine the estimated fair value of the Company’s common stock, the Company and the independent third-party valuation firm utilized a probability-weighted return methodology (“PWERM”) to allocate enterprise value. The Valuations as of March 31, 2015 and June 30, 2015 relied on the indications of value realized in the Company’s Series A preferred stock financing that closed in March 2015. The fair value of the common stock was estimated using a hybrid of two market approaches. Specifically, the non-IPO exit scenario valued the Company based on the backsolve calculation of the implied equity value from the Company’s recent Series A preferred stock financing, and the IPO exit scenario was based on the post-money calculation of the implied equity value from the Series A preferred stock financing. This later approach considers implied equity value based on a common equivalent capitalization table associated with an IPO exit. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 350 E. Michigan Avenue, Suite 300 · Kalamazoo, Michigan 49007 Detroit · Ann Arbor · Bloomfield Hills · Chicago · Kalamazoo · Lansing April 22, 2016 Page 5 The Valuations as of September 18, 2015 and September 30, 2015 estimated the fair value of the Company’s common stock by using a hybrid of two market approaches: (1) the value of a potential Series B preferred stock financing utilizing the backsolve method and (2) the value of a potential Series B financing post-money as a common stock equivalent for an IPO exit. A non-IPO exit scenario that valued the Company based on the backsolve calculation of the implied equity value from the Company’s recent Series A preferred stock financing was also considered in the event that a Series B preferred stock financing or an IPO could not be achieved. The Company believes that the primary differences between the per share value determined in the Valuations and the estimated Price Range for the IPO are reasonable as a result of the following factors: The Price Range assumes a successful IPO, with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company, and that the Company’s common stock is listed on an exchange. As a result, the Price Range excludes any marketability or liquidity discount and takes into account that the IPO would provide significant additional cash proceeds to the Company to help fund the development of the Company’s product and substantially strengthen its balance sheet. In contrast, the IPO scenario in the Valuations was weighted at an aggregate probability of [***]% and [***]% as of March 31, 2015 and June 30, 2015, respectively, and the IPO scenario (with a Series B preferred stock financing) was weighted at an aggregate possibility of [***]% in each of the September 18, 2015 and September 30, 2015 Valuations. The probability that the Company would remain private was weighted at [***]% and [***]% as of March 31, 2015 and June 30, 2015, respectively, and was weighted at [***]% (including with the probability of a Series B preferred stock financing at [***]% and with no Series B preferred stock financing at [***]%) as of each of September 18, 2015 and September 30, 2015. In the non-IPO exit scenarios, the Valuations used the backsolve method, using the Option Pricing Method to calculate an implied value based on a recent transaction taking into account the economic rights of the recently issued security (i.e., the Series A preferred stock) in relation to the rights of other equity holders. The Valuations estimate that the fair value of the Company’s
2015-10-07 - UPLOAD - MetaVia Inc.
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