SEC Comment Letter for Protara Therapeutics, Inc. (TARA) (CIK 0001359931) (TARA) — Aug 19, 2014
Protara Therapeutics, Inc. (TARA) (CIK 0001359931)
Date: Aug. 19, 2014 · CIK: 0001359931 · Accession: 0000000000-14-042001
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Letter
August 19, 2014 Via E -mail George Eldridge Chief Financial Officer Proteon Therapeutics, Inc. 200 West Street Waltham, MA 02451
Re: Proteon Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted August 6, 2014 CIK No. 0001359931
Dear Mr. Eldridge:
We have reviewed your amended 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 registra tion statement or filed registration statement, we may have additional comments.
Prospectus Summary, page 1
1. We note your response to our prior Comment 5 and associated revisions to your registration statement. We also note your response to our prior C omment 14, which states that “the FDA will not consider the Phase 2 results, including any non -prespecified analysis, when reviewing a BLA.” In light of this response, in addition to our original concerns, the appearance of the graphs in the Prospectus Su mmary is inappropriate. Please remove all graphs displaying the results of your clinical trials from the Prospectus Summary. Additionally, please disclose, where you discuss Phase 2 clinical trial results throughout the prospectus, that the FDA will not consider these results, including any non-prespecified analysis, when reviewing a BLA.
George Eldridge Proteon Therapeutics, Inc. August 19, 2014 Page 2
Risk Factors, page 13 “PRT -201 may cause undesirable side effects…,” page 22
2. Please define the term “protease” at its first use to enable a lay investor to understand such term.
Use of Proceeds, page 57
3. We note your response to our prior Comment 9. We understand that you can only provide your best estimate of how far you expect the offering proceeds will enable you to advance each of your clinical programs. Please expand your disclosure in this section to provide the information you provided in response to this comment. You may, as necessary, provide additional disclosure that advises investors of the particular factors and assumptions that form the basis of your e stimate, any uncertainty surrounding these estimates and the reasons that the actual developmental timelines could vary.
Notes to Financial Statements Note 9. Redeemable Convertible Preferred Stock , page F -21
4. Regarding your accounting for the individual purchase rights, you indicate that you will adjust the carrying value of such investor rights to its estimated fair value at each reporting date up to the closing of the tranche financing, which will occur at th e closing of this offering. Please address the following:
Please provide us an analysis with reference to authoritative literature supporting your accounting for the individual purchase rights as a liability recorded at fair value at each balance sheet date. Please revise to disclose why you will cease accountin g for the purchase rights as a liability recorded at fair value upon the closing of the tranche financing to support your eliminati on of this liability in your pro forma presentations throughout the filing. Revise to disclose the number of Series D prefer red stock and, after the closing of the IPO, c ommon s tock subject to the individual purchase rights provided in the Series D financing.
General
If you intend to respond to these comments with an amended draft registration statement, please submit it an d any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm.
You may contact Sasha Pari kh at (202) 551 -3627 or James Rosenberg at (202) 551 -3679 if you have questions regarding comments on the financial statements and related matters.
George Eldridge Proteon Therapeutics, Inc. August 19, 2014 Page 3
Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me at (202) 551 -3715 wit h any other questions.
Sincerely,
/s/ Daniel Greenspan for
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August 19, 2014 Via E -mail George Eldridge Chief Financial Officer Proteon Therapeutics, Inc. 200 West Street Waltham, MA 02451 Re: Proteon Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted August 6, 2014 CIK No. 0001359931 Dear Mr. Eldridge: We have reviewed your amended 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 registra tion statement or filed registration statement, we may have additional comments. Prospectus Summary, page 1 1. We note your response to our prior Comment 5 and associated revisions to your registration statement. We also note your response to our prior C omment 14, which states that “the FDA will not consider the Phase 2 results, including any non -prespecified analysis, when reviewing a BLA.” In light of this response, in addition to our original concerns, the appearance of the graphs in the Prospectus Su mmary is inappropriate. Please remove all graphs displaying the results of your clinical trials from the Prospectus Summary. Additionally, please disclose, where you discuss Phase 2 clinical trial results throughout the prospectus, that the FDA will not consider these results, including any non-prespecified analysis, when reviewing a BLA. George Eldridge Proteon Therapeutics, Inc. August 19, 2014 Page 2 Risk Factors, page 13 “PRT -201 may cause undesirable side effects…,” page 22 2. Please define the term “protease” at its first use to enable a lay investor to understand such term. Use of Proceeds, page 57 3. We note your response to our prior Comment 9. We understand that you can only provide your best estimate of how far you expect the offering proceeds will enable you to advance each of your clinical programs. Please expand your disclosure in this section to provide the information you provided in response to this comment. You may, as necessary, provide additional disclosure that advises investors of the particular factors and assumptions that form the basis of your e stimate, any uncertainty surrounding these estimates and the reasons that the actual developmental timelines could vary. Notes to Financial Statements Note 9. Redeemable Convertible Preferred Stock , page F -21 4. Regarding your accounting for the individual purchase rights, you indicate that you will adjust the carrying value of such investor rights to its estimated fair value at each reporting date up to the closing of the tranche financing, which will occur at th e closing of this offering. Please address the following: Please provide us an analysis with reference to authoritative literature supporting your accounting for the individual purchase rights as a liability recorded at fair value at each balance sheet date. Please revise to disclose why you will cease accountin g for the purchase rights as a liability recorded at fair value upon the closing of the tranche financing to support your eliminati on of this liability in your pro forma presentations throughout the filing. Revise to disclose the number of Series D prefer red stock and, after the closing of the IPO, c ommon s tock subject to the individual purchase rights provided in the Series D financing. General If you intend to respond to these comments with an amended draft registration statement, please submit it an d any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm. You may contact Sasha Pari kh at (202) 551 -3627 or James Rosenberg at (202) 551 -3679 if you have questions regarding comments on the financial statements and related matters. George Eldridge Proteon Therapeutics, Inc. August 19, 2014 Page 3 Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me at (202) 551 -3715 wit h any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Julio E. Vega , Esq. Bingham McCutchen LLP One Federal Street Boston, MA 02110