SEC Comment Letter for Traws Pharma, Inc. (TRAW) (CIK 0001130598) (TRAW) — Jul 15, 2013
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Date: July 15, 2013 · CIK: 0001130598 · Accession: 0000000000-13-038456
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Letter
July 15, 2013 Via E -mail Ramesh Kumar, Ph.D. President and Chief Executive Officer Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18940
Re: Onconova Therapeutics, Inc. Amendment No. 1 to Registration Statement on Form S -1 Filed July 11, 2013 File No. 333 -189358
Dear Dr. Kumar:
We have reviewed your amended registration statement and correspondence dated July 11, 2013 and have the following comments. In some of our comments, we may ask you to provide us with infor mation so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and amending your registration statement. If you do not believe our comments apply to your facts and circu mstances or do not believe an amendment is a ppropriate, please tell us why in your response.
After revie wing the infor mation you provide in response to these com ments and your amended registrat ion state ment, we may have additio nal co mments.
Phase 1/2 Trial Results of Rigosertib IV in Patients with Myelodysplastic Syndromes , page 60
1. We note your discussion in this section of the length of survival of the 39 patients in Phase 1, Phase 2, and Ph ase 1/2 studies who had previously failed treatment with hypomethylating agents. You state that 23 patients lived for at least six months, 11 patients lived for more than one year, and 3 patients lived more than two years. This suggests that 16 of the 39 patients did not survive for at least six months. Please clarify if this is the case.
Report of Independent Registered Public Accounting Firm, pages F -2 and F -3
2. As a reminder, please assure that your auditors (both Ernst & Young LLP and EisnerAmper LLP) remove the explanatory language referencing the reverse stock
Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. July 15 , 2013 Page 2
split and include a signed audit report in the amendment for which you will request effectiveness. Also please file as Exhibits updated, signed consents from these independent auditors wi th that amendment.
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. Sin ce 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.
You may contact Jim Peklenk at (202) 551 -3661 or Mark Brunhofer at ( 202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551 -3623, or me at (202) 551-3715 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Show Raw Text
July 15, 2013
Via E -mail
Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re: Onconova Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S -1
Filed July 11, 2013
File No. 333 -189358
Dear Dr. Kumar:
We have reviewed your amended registration statement and correspondence dated July
11, 2013 and have the following comments. In some of our comments, we may ask you to
provide us with infor mation so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and amending
your registration statement. If you do not believe our comments apply to your facts and
circu mstances or do not believe an amendment is a ppropriate, please tell us why in your
response.
After revie wing the infor mation you provide in response to these com ments and your
amended registrat ion state ment, we may have additio nal co mments.
Phase 1/2 Trial Results of Rigosertib IV in Patients with Myelodysplastic Syndromes , page 60
1. We note your discussion in this section of the length of survival of the 39 patients in
Phase 1, Phase 2, and Ph ase 1/2 studies who had previously failed treatment with
hypomethylating agents. You state that 23 patients lived for at least six months, 11
patients lived for more than one year, and 3 patients lived more than two years. This
suggests that 16 of the 39 patients did not survive for at least six months. Please
clarify if this is the case.
Report of Independent Registered Public Accounting Firm, pages F -2 and F -3
2. As a reminder, please assure that your auditors (both Ernst & Young LLP and
EisnerAmper LLP) remove the explanatory language referencing the reverse stock
Ramesh Kumar , Ph.D.
Onconova Therapeutics, Inc.
July 15 , 2013
Page 2
split and include a signed audit report in the amendment for which you will request
effectiveness. Also please file as Exhibits updated, signed consents from these
independent auditors wi th that amendment.
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. Sin ce 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.
You may contact Jim Peklenk at (202) 551 -3661 or Mark Brunhofer at ( 202) 551 -3638 if
you have questions regarding comments on the financial statements and related matters. Please
contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551 -3623, or me at (202)
551-3715 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Jeffrey P. R iedler
Assista nt Direct or
cc: Via E -mail
David S. Rosenthal, Esq.
Dechert LLP