Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-03-06
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-14
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2022-04-21
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-02
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2020-07-09
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-05-29
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2020-05-29
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-11-12
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2019-11-12
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-09-06
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2019-09-06
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-06-27
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2019-06-27
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2018-05-18
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2018-06-05
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2018-06-05
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2019-05-10
Cardiff Oncology, Inc.
References: May 9, 2019
Summary
Generating summary...
↓
Company responded
2019-05-21
Cardiff Oncology, Inc.
References: May 20, 2019
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-05-20
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-05-09
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-02-25
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2019-03-06
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2019-03-08
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2017-11-07
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2017-11-17
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2017-12-13
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2017-12-13
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2016-06-09
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2016-06-09
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2016-06-10
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-11-24
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2015-11-24
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2012-04-25
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-05-23
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-05-23
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-05-24
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-05-24
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-05-29
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-05-29
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-03-19
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-03-15
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-03-14
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2011-11-30
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2012-02-03
Cardiff Oncology, Inc.
References: January 27, 2012
Summary
Generating summary...
↓
Company responded
2012-02-14
Cardiff Oncology, Inc.
References: January 27, 2012
Summary
Generating summary...
↓
Company responded
2012-03-02
Cardiff Oncology, Inc.
References: February 13, 2012 | February 24, 2012
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-02-24
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-01-27
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2011-11-25
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2005-11-14
Cardiff Oncology, Inc.
Summary
Generating summary...
↓
Company responded
2006-01-10
Cardiff Oncology, Inc.
References: November
28, 2005 | September 2, 2005
Summary
Generating summary...
↓
Company responded
2006-02-14
Cardiff Oncology, Inc.
References: February
2, 2006
Summary
Generating summary...
↓
Company responded
2006-03-01
Cardiff Oncology, Inc.
References: February
22, 2006
Summary
Generating summary...
↓
Company responded
2006-03-15
Cardiff Oncology, Inc.
References: March 13,
2006
Summary
Generating summary...
↓
Company responded
2006-03-16
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-03-15
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-03-10
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-02-15
Cardiff Oncology, Inc.
Summary
Generating summary...
Cardiff Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-01-25
Cardiff Oncology, Inc.
References: September
2,
2005 | September 2,
2005 | September 2, 2005
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-12 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2025-03-06 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | 333-285327 | Read Filing View |
| 2022-04-21 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-14 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-07-09 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-07-02 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-05-29 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-05-29 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-12 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-12 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-09-06 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-09-06 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-06-27 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-06-27 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-21 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-20 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-10 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-09 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-03-08 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-03-06 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-02-25 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-06-05 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-06-05 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-05-18 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-11-07 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-06-10 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-06-09 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-06-09 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2015-11-24 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2015-11-24 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-29 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-29 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-24 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-24 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-23 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-23 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-04-25 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-19 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-15 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-14 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-02 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-02-24 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-02-14 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-02-03 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-01-27 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2011-11-30 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2011-11-25 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-16 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-15 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-15 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-10 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-01 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-02-15 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-02-14 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-01-25 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-01-10 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2005-11-14 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-06 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | 333-285327 | Read Filing View |
| 2022-04-14 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-07-02 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-05-29 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-12 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-09-06 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-06-27 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-20 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-09 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-02-25 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-05-18 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-11-07 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-06-09 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2015-11-24 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-04-25 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-19 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-15 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-14 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-02-24 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-01-27 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2011-11-30 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-15 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-10 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-02-15 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-01-25 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2005-11-14 | SEC Comment Letter | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-12 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-21 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-07-09 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2020-05-29 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-12 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-09-06 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-06-27 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-21 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-05-10 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-03-08 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-03-06 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-06-05 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-06-05 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-06-10 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-06-09 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2015-11-24 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-29 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-29 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-24 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-24 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-23 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-05-23 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-03-02 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-02-14 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2012-02-03 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2011-11-25 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-16 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-15 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-03-01 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-02-14 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
| 2006-01-10 | Company Response | Cardiff Oncology, Inc. | DE | N/A | Read Filing View |
2025-05-12 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP CARDIFF ONCOLOGY, INC. 11055 Flintkote Ave. San Diego, CA 92121 May 12, 2025 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Cardiff Oncology, Inc. Registration Statement on Form S-3 Filed February 27, 2025 File No. 333-285327 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Cardiff Oncology, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above (the “Registration Statement”) be accelerated so that it becomes effective at 4:00 p.m., Eastern Time, on Tuesday, May 13, 2025, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Sincerely, CARDIFF ONCOLOGY, INC. By: /s/ Mark Erlander Name: Mark Erlander Title: Chief Executive Officer - 1 -
2025-03-06 - UPLOAD - Cardiff Oncology, Inc. File: 333-285327
March 6, 2025
Mark Erlander
Chief Executive Officer
Cardiff Oncology, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Cardiff Oncology, Inc.
Registration Statement on Form S-3
Filed February 27, 2025
File No. 333-285327
Dear Mark Erlander:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeffrey Fessler
2022-04-21 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
Document
Cardiff Oncology, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
April 21, 2022
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Doris Gama
Re: Cardiff Oncology, Inc.
Form S-3
File No. 333-264148
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Cardiff Oncology, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:00 p.m., Eastern Daylight Time, on Monday, April 25, 2022, or as soon thereafter as possible.
Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
Thank you,
CARDIFF ONCOLOGY, INC.
By: /s/ Mark Erlander
Name: Mark Erlander
Title: Chief Executive Officer
2022-04-14 - UPLOAD - Cardiff Oncology, Inc.
United States securities and exchange commission logo
April 14, 2022
Mark Erlander
Chief Executive Officer
Cardiff Oncology, Inc.
11055 Flintkote Avenue
SAN dIEGO, ca 92121
Re:Cardiff Oncology, Inc.
Registration Statement on Form S-3
Filed April 5, 2022
File No. 333-264148
Dear Dr. Erlander:
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 Doris Gama at 202-551-3188 or Suzanne Hayes at 202-551-3675 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey J. Fessler, Esq.
2020-07-09 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
Cardiff
Oncology, Inc.
11055
Flintkote Avenue
San Diego,
CA 92121
July
9, 2020
VIA
EDGAR
United States
Securities
and Exchange Commission
100 F Street,
N.E.
Washington,
D.C. 20549
Attention:
Abby Adams
Re:
Cardiff Oncology, Inc.
Form S-1
File No. 333-239464
Ladies and
Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Cardiff
Oncology, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred
to above be accelerated so that it will become effective at 4:00 p.m., Eastern Daylight Time, on Friday, July 10, 2020, or as
soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon
as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
Thank you,
CARDIFF ONCOLOGY, INC.
By:
/s/
Mark Erlander
Name: Mark Erlander
Title: Chief Executive Officer
-1-
2020-07-02 - UPLOAD - Cardiff Oncology, Inc.
United States securities and exchange commission logo
July 2, 2020
Mark Erlander
Chief Executive Officer
Cardiff Oncology, Inc.
11055 Flintkote Avenue
San Diego, California 92121
Re:Cardiff Oncology, Inc.
Registration Statement on Form S-1
Filed June 26, 2020
File No. 333-239464
Dear Mr. Erlander:
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
2020-05-29 - UPLOAD - Cardiff Oncology, Inc.
United States securities and exchange commission logo
May 29, 2020
Mark Erlander
Chief Executive Officer
Cardiff Oncology, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Cardiff Oncology, Inc.
Registration Statement on Form S-1
Filed May 22, 2020
File No. 333-238623
Dear Mr. Erlander:
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 Laura Crotty at (202) 551-7614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler
2020-05-29 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Cardiff Oncology, Inc. 11055 Flintkote Avenue San Diego, CA 92121 May 29, 2020 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Laura Crotty Re: Cardiff Oncology, Inc. Form S-1 File No. 333-238623 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Cardiff Oncology, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 9:00 a.m., Eastern Daylight Time, on Tuesday, June 2, 2020, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, CARDIFF ONCOLOGY, INC. By: /s/ Mark Erlander Name: Mark Erlander Title: Chief Executive Officer 1
2019-11-12 - UPLOAD - Cardiff Oncology, Inc.
November 12, 2019
Thomas H. Adams
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Registration Statement on Form S-1
Filed November 1, 2019
File No. 333-234442
Dear Mr. Adams:
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 Gregory Dundas, Attorney Adviser, at (202) 551-3436 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2019-11-12 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92921 November 12, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Greg Dundas Re: Trovagene Inc. Registration Statement on Form S-1, as amended File No. 333-234442 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:00 p.m., Eastern Standard Time, on Wednesday, November 13, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, TROVAGENE, INC. By: /s/ Thomas H. Adams Name: Thomas H. Adams Title: Chief Executive Officer
2019-09-06 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92121 September 6, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Sonia Bednarowski Re: Trovagene, Inc. Form S-1 File No. 333-233568 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:30 p.m., Eastern Daylight Time, on Tuesday, September 10, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, TROVAGENE, INC. By: /s/ Thomas Adams Name: Thomas Adams Title: Chief Executive Officer
2019-09-06 - UPLOAD - Cardiff Oncology, Inc.
September 6, 2019
Thomas H. Adams
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Registration Statement on Form S-1
Filed August 30, 2019
File No. 333-233568
Dear Mr. Adams:
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 Sonia Bednarowski at 202-551-3666 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-06-27 - UPLOAD - Cardiff Oncology, Inc.
June 27, 2019
Thomas Adams
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Registration Statement on Form S-3
Filed June 25, 2019
File No. 333-232321
Dear Mr. Adams:
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 Donald Field at 202-551-3680 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-06-27 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92121 June 27, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Donald Field Re: Trovagene, Inc. Form S-3 File No. 333-232321 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:00 p.m., Eastern Daylight Time, on Monday, July 1, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, TROVAGENE, INC. By: /s/ Thomas Adams Name: Thomas Adams Title: Chief Executive Officer
2019-05-21 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm May 21, 2019 Division of Corporation Finance Securities and Exchange Commission 100 F. Street, NE Washington, DC 20549 Attention: Jeffrey Gabor Re: Trovagene, Inc. Post-Effective Amendment No. 3 to Form S-1 Filed May 17, 2019 File No. 333-224808 Dear Mr. Gabor: This letter sets forth the response of Trovagene, Inc., a Delaware corporation (the “Company” or “we”), to the comment received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated May 20, 2019 (“Comments Letter”) concerning the Company’s Post-Effective Amendment No. 3 to Form S-1 (the “Registration Statement”). Post-Effective Amendment No. 3 to Form S-1 General 1. Please revise to include a complete prospectus that includes all of the disclosure items required by Part I. Refer to Securities Act Rule 472(b). Response: We have revised Post-Effective Amendment No. 3 to Form S-1 to include a complete prospectus. * * * * If you have any further comments and/or questions, please contact me at (212) 634-3067. Very truly yours, /s/ Jeffrey Fessler 1
2019-05-20 - UPLOAD - Cardiff Oncology, Inc.
May 20, 2019
Thomas H. Adams
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Post-Effective Amendment No. 3 to Form S-1
Filed May 17, 2019
File No. 333-224808
Dear Mr. Adams:
We have reviewed your post-effective amendment and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments.
Post -Effective Amendment No. 3 to Form S-1
General
1.Please revise to include a complete prospectus that includes all of the disclosure items
required by Part I. Refer to Securities Act Rule 472(b).
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 LastNameThomas H. Adams
Comapany NameTrovagene, Inc.
May 20, 2019 Page 2
FirstName LastName
Thomas H. Adams
Trovagene, Inc.
May 20, 2019
Page 2
You may contact Jeffrey Gabor at 202-551-2544 or Mary Beth Breslin at 202-551-3625
with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jeffrey Fessler, Esq.
2019-05-10 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm May 10, 2019 Division of Corporation Finance Securities and Exchange Commission 100 F. Street, NE Washington, DC 20549 Attention: Jeffrey Gabor Re: Trovagene, Inc. Post-Effective Amendment No. 1 to Form S-1 Filed April 25, 2019 File No. 333-224808 Dear Mr. Gabor: This letter sets forth the response of Trovagene, Inc., a Delaware corporation (the “Company” or “we”), to the comment received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated May 9, 2019 (“Comments Letter”) concerning the Company’s Post-Effective Amendment No. 1 to Form S-1 (the “Registration Statement”). Post-Effective Amendment No. 1 to Form S-1 General 1. We note that this post-effective amendment seeks to update the prospectuses included in the Form S-1 (333-224808) initially filed on May 10, 2018, and the Form S-1 (333-225510) filed June 8, 2018 in which you registered a primary offering of Class A units, Class B units, and Common Stock issuable upon the exercise of warrants. Since the initial filings did not register a resale offering, it is inappropriate to add a resale offering by means of a post-effective amendment. Please amend your filing to remove the resale offering. Response: We have amended Post-Effective Amendment No. 1 to Form S-1 to exclude a resale offering. * * * * If you have any further comments and/or questions, please contact me at (212) 634-3067. Very truly yours, /s/ Jeffrey Fessler 1
2019-05-09 - UPLOAD - Cardiff Oncology, Inc.
May 9, 2019
Thomas H. Adams
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Post-Effective Amendment to Form S-1
Filed April 25, 2019
File No. 333-224808
Dear Mr. Adams:
We have reviewed your post-effective amendment and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments.
Post -Effective Amendment No. 1 to Form S-1
General
1.We note that this post-effective amendment seeks to update the prospectuses included in
the Form S-1 (333-224808) initially filed on May 10, 2018, and the Form S-1 (333-
225510) filed June 8, 2018 in which you registered a primary offering of Class A units,
Class B units, and Common Stock issuable upon the exercise of warrants. Since the initial
filings did not register a resale offering, it is inappropriate to add a resale offering by
means of a post-effective amendment. Please amend your filing to remove the resale
offering.
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 LastNameThomas H. Adams
Comapany NameTrovagene, Inc.
May 9, 2019 Page 2
FirstName LastName
Thomas H. Adams
Trovagene, Inc.
May 9, 2019
Page 2
You may contact Jeffrey Gabor at 202-551-2544 or Mary Beth Breslin at 202-551-3625
with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jeffrey Fessler, Esq.
2019-03-08 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92121 March 8, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Donald Field Re: Trovagene, Inc. Amendment No. 1 to Form S-3 File No. 333-229693 Ladies and Gentlemen: Please withdraw our acceleration request dated March 6, 2019. Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:00 p.m., Eastern Standard Time, on Monday, March 11, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, TROVAGENE, INC. By: /s/ Thomas Adams Name: Thomas Adams Title: Chief Executive Officer
2019-03-06 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Acceleration Request Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92121 March 6, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Donald Field Re: Trovagene, Inc. Form S-3 File No. 333-229693 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:00 p.m., Eastern Standard Time, on Friday, March 8, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, TROVAGENE, INC. By: /s/ Thomas Adams Name: Thomas Adams Title: Chief Executive Officer
2019-02-25 - UPLOAD - Cardiff Oncology, Inc.
February 22, 2019
Thomas Adams
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Registration Statement on Form S-3
Filed February 14, 2019
File No. 333-229693
Dear Mr. Adams:
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 Donald Field at 202-551-3680 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-06-05 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP ThinkEquity A division of Fordham Financial Management, Inc. 17 State Street, 22nd Floor New York, NY 10004 June 5, 2018 VIA EDGAR U.S. Securities and Exchange Commission 100 F St., NE Washington, D.C. 20549 Attention: Dorrie Yale Re: Trovagene, Inc. Registration Statement on Form S-1 (File No. 333-224808) Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, ThinkEquity, a division of Fordham Financial Management, Inc., as representative of the underwriters, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on June 7, 2018, or as soon thereafter as practicable. Pursuant to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter, who is reasonably anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Very truly yours, ThinkEquity A division of Fordham Financial Management, Inc. By: /s/ Eric Lord Name: Eric Lord Title: Head of Investment Banking
2018-06-05 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92921 June 5, 2018 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: Trovagene Inc. Registration Statement on Form S-1, as amended File No. 333-224808 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:00 p.m., Eastern Standard Time, on Thursday, June 7, 2018, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, TROVAGENE, INC. By: /s/ William Welch Name: William Welch Title: Chief Executive Officer
2018-05-18 - UPLOAD - Cardiff Oncology, Inc.
May 18, 2018
William Welch
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Registration Statement on Form S-1
Filed May 10, 2018
File No. 333-224808
Dear Mr. Welch:
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 Dorrie Yale at 202-551-8776 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jeffrey Fessler
2017-12-13 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP December 13, 2017 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Re: TROVAGENE, INC. Registration Statement on Form S-1 (Registration No. 333-221115) - Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as placement agent for the referenced offering, hereby concurs in the request by Trovagene, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:15 P.M. Eastern Time on Thursday, December 14, 2017, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. Very truly yours, H.C. WAINWRIGHT & CO., LLC By: /s/ Mark Viklund Name: Mark Viklund Title: Chief Executive Officer
2017-12-13 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92921 December 13, 2017 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Christine Westbrook Re: Trovagene Inc. Registration Statement on Form S-1, as amended File No. 333-221115 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:15 p.m., Eastern Standard Time, on Thursday, December 14, 2017, or as soon thereafter as possible. In connection with this request, 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 Registration Statement; • The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement 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 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. Thank you, TROVAGENE, INC. By: /s/ William Welch Name: William Welch Title: Chief Executive Officer
2017-11-17 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Sheppard, Mullin, Richter & Hampton LLP 30 Rockefeller Plaza New York, NY 10112 November 17, 2017 Securities and Exchange Commission 100 F Street, NE Washington, DC 20549-4720 Attention: Christine Westbrook Re: Trovagene, Inc. Registration Statement on Form S-1 Filed October 25, 2017 File No. 333-221115 Dear Ms. Westbrook: This letter sets forth the responses of Trovagene, Inc., a Delaware corporation (the “Company” or “we”), to the comments received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on November 7, 2017 concerning the Company’s registration statement on Form S-1. Form S-1 filed 10/25/2017 Cover Page 1. It appears that shares of common stock and warrants will be offered and priced together as a unit. Please amend your registration statement to add units or tell us why such disclosure is not required. Please also revise your cover page disclosure to include the method by which the price of the securities is to be determined. Refer to Instruction 2 to Item 501(b)(3) of Regulation S-K. Amendment No. 1 to Form S-1 has been modified to add units. In addition, we have added disclosure to the front cover page of the prospectus describing the method by which the price of the securities will be determined. 2. We note your disclosure on page 38 that H.C. Wainwright & Co., LLC will use its reasonable best efforts to arrange for the sale of the securities offered by the prospectus. Please also revise the cover page to include all of the information required by Item 501(b)(8) of Regulation S-K. We have revised the front cover page of the prospectus in Amendment No. 1 to Form S-1 to include the information required by Item 501(b)(8) of Regulation S-K. Sincerely, /s/ Jeffrey J. Fessler Jeffrey J. Fessler
2017-11-07 - UPLOAD - Cardiff Oncology, Inc.
November 7, 2017
William J. Welch
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
Re:Trovagene, Inc.
Registration Statement on Form S-1
Filed October 25, 2017
File No. 333-221115
Dear Mr. Welch:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Form S-1 filed 10/25/17
Cover page
1.It appears that shares of common stock and warrants will be offered and priced together
as a unit. Please amend your registration statement to add units or tell us why such
disclosure is not required. Please also revise your cover page disclosure to include the
method by which the price of the securities is to be determined. Refer to Instruction 2 to
Item 501(b)(3) of Regulation S-K.
2.We note your disclosure on page 38 that H.C. Wainright & Co., LLC will use its
reasonable best efforts to arrange for the sale of the securities offered by the prospectus.
FirstName LastNameWilliam J. Welch
Comapany NameTrovagene, Inc.
June 16, 2017 Page 2
FirstName LastName
William J. Welch
Trovagene, Inc.
November 7, 2017
Page 2
Please revise the cover page to include all of the information required by Item 501(b)(8)
of Regulation S-K.
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.
Please contact Christine Westbrook at (202) 551-5019 or Mary Beth Breslin at (202)
551-3625 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jeffrey Fessler, Esq.
2016-06-10 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92921 June 10, 2016 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: Trovagene Inc. Registration Statement on Form S-3 File No. 333-211705 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4 p.m., Eastern Daylight Time, on Monday, June 13, 2016, or as soon thereafter as possible. The Company acknowledges that: 1) 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; 2) 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 3) 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. TROVAGENE, INC. By: /s/ William Welch Name: William Welch Title: Chief Executive Officer
2016-06-09 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92921 June 9, 2016 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: Trovagene Inc. Registration Statement on Form S-3 File No. 333-211705 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4 p.m., Eastern Daylight Time, on Monday, June 13, 2016, or as soon thereafter as possible. The Company acknowledges that: 1) 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; 2) 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 3) the Company may not assert 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. TROVAGENE, INC. By: /s/ William Welch Name: William Welch Title: Chief Executive Officer
2016-06-09 - UPLOAD - Cardiff Oncology, Inc.
Mail Stop 4720
June 9, 2016
William Welch
Chief Executive Officer
Trovagene, Inc.
11055 Flintkote Avenue, Suite A
San Diego, CA 92121
Re: Trovagene, Inc.
Registration Statement on Form S-3
Filed May 27, 2016
File No. 333-211705
Dear Mr. Welch :
This is to advise you that we have not reviewed and will not review 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 193 3 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.
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 delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action wit h 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 th e 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 statement as confirmation
William Welch
Trovagene, Inc.
June 9, 2016
Page 2
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 registered securities .
Please contact Dorrie Yale at 202 -551-8776 or Erin Jaskot, Special Counsel, at 202-551-
3442 with any qu estions.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assistant Director
Office of Insurance and Healthcare
cc: Jeffrey Fessler, Esq.
Sichenzia Ross Friedman Ference LLP
2015-11-24 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92921 November 24, 2015 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Scot Foley Re: Trovagene Inc. Registration Statement on Form S-3 File No. 333-208010 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 9 a.m., Eastern Standard Time, on Monday, November 30, 2015, or as soon thereafter as possible. The Company acknowledges that: 1) 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; 2) 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 3) the Company may not assert 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. TROVAGENE, INC. By: /s/ Antonius Schuh Name: Antonius Schuh Title: Chief Executive Officer
2015-11-24 - UPLOAD - Cardiff Oncology, Inc.
Mail Stop 4720 November 24, 2015 Via E -mail Antonius Schuh, Ph.D Chief Executive Officer Trovagene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: Trovagene , Inc. Registration Statement on Form S-3 Filed November 1 3, 2015 File No. 333-208010 Dear Dr. Schuh : This is to advise you that we have not reviewed and will not review 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 193 3 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. In the event you request acceleration of t he 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 delegated authority, declare the filing effective, it does not foreclos e 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 ad equacy 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 Unit ed States. Antonius Schuh, Ph.D. Trovagene , Inc. November 24, 2015 Page 2 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 statement as confirmation of the fact that those requesting acceleration are aw are 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 registered securities . Please contact Scot Foley at (202) 551 -3383 or me a t (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director cc: Jeffrey J. Fessler, Esq. Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, New York 10006
2012-05-29 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
Trovagene, Inc.
11055 Flintkote Avenue
San Diego, CA 92121
May 25, 2012
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Karen Ubell
Re: Trovagene, Inc.
Registration Statement on Form S-1
File No. 333-180810
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5 p.m., Washington D.C., on May 29, 2012, or as soon thereafter as possible. The Company acknowledges that: 1) 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; 2) 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 3) the Company may not assert 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.
TROVAGENE, INC.
By:
/s/ Antonius Schuh
Name: Antonius Schuh
Title: Chief Executive Officer
2012-05-29 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm AEGIS CAPITAL CORP. 810 7TH Avenue New York, New York 10019 May 25, 2012 VIA EDGAR AND TELECOPY Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Trovagene, Inc. (the “Company”) File No. 333-180810 Registration Statement on Form S-1 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we, as representatives of the several underwriters, hereby request acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m., Washington D.C. time, on Tuesday, May 29, 2012, or as soon thereafter as practicable. The following is supplemental information supplied under Rule 418(a)(7) and Rule 460 under the Securities Act of 1933: (i) Date of preliminary prospectus: May 8, 2012, as amended on May 18, 2012, May 22, 2012, May 23, 2012 and May 25, 2012 (ii) Dates of distribution: May 8, 2012 — May 29, 2012 (iii) Number of prospective underwriters and dealers to whom the preliminary prospectus was furnished: 4 (iv) Number of prospectuses so distributed: 600 The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Very truly yours, AEGIS CAPITAL CORP. By: /s/ Kevin C. McKenna Name: Kevin C. McKenna Title: Chief Compliance Officer
2012-05-24 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
AEGIS CAPITAL CORP.
810 7TH Avenue
New York, New York 10019
May 24, 2012
VIA EDGAR AND TELECOPY
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Trovagene, Inc. (the “Company”)
File No. 333-180810
Registration Statement on Form S-1
Ladies and Gentlemen:
We, as representatives of the several underwriters, hereby request the withdrawal of our request for acceleration, dated May 22, 2012, of the effective date of the above-referenced Registration Statement that was requested to become effective at 5:00 p.m., Washington D.C. time, on May 24, 2012, or as soon thereafter as practicable.
Very truly yours,
AEGIS CAPITAL CORP.
By:
/s/ Kevin C. McKenna
Name: Kevin C. McKenna
Title: Chief Compliance Officer
2012-05-24 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92121 May 24, 2012 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Karen Ubell Re: Trovagene, Inc. Registration Statement on Form S-1 File No. 333-180810 Ladies and Gentlemen: Trovagene, Inc. hereby respectfully requests the withdrawal of its request for acceleration dated May 22, 2012, of the effective date of the registration statement referred to above that was requested to become effective at 5:00 p.m., Washington D.C. time, on Thursday, May 24, 2012, or as soon thereafter as practicable. TROVAGENE, INC. By: /s/ Antonius Schuh Name: Antonius Schuh Title: Chief Executive Officer
2012-05-23 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Trovagene, Inc. 11055 Flintkote Avenue San Diego, CA 92121 May 23, 2012 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Karen Ubell Re: Trovagene, Inc. Registration Statement on Form S-1 File No. 333-180810 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Trovagene, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5 p.m., Washington D.C., on May 24, 2012, or as soon thereafter as possible. The Company acknowledges that: 1) 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; 2) 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 3) the Company may not assert 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. TROVAGENE, INC. By: /s/ Antonius Schuh Name: Antonius Schuh Title: Chief Executive Officer
2012-05-23 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm AEGIS CAPITAL CORP. 810 7TH Avenue New York, New York 10019 May 22, 2012 VIA EDGAR AND TELECOPY Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Trovagene, Inc. (the “Company”) File No. 333-180810 Registration Statement on Form S-1 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we, as representatives of the several underwriters, hereby request acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m., Washington D.C. time, on May 24, 2012, or as soon thereafter as practicable. The following is supplemental information supplied under Rule 418(a)(7) and Rule 460 under the Securities Act of 1933: (i) Date of preliminary prospectus: May 8, 2012, as amended on May 18, 2012 and May 22, 2012 (ii) Dates of distribution: May 8, 2012 — May 24, 2012 (iii) Number of prospective underwriters and dealers to whom the preliminary prospectus was furnished: 4 (iv) Number of prospectuses so distributed: 600 The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Very truly yours, AEGIS CAPITAL CORP. By: /s/ Kevin C. McKenna Name: Kevin C. McKenna Title: Chief Compliance Officer
2012-04-25 - UPLOAD - Cardiff Oncology, Inc.
April 25, 2012 Via E-mail Antonius Schuh, Ph.D Chief Executive Officer Trovagene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: Trovagene, Inc. Registration Statement on Form S-1 Filed April 19, 2012 File No. 333-180810 Dear Dr. Schuh: We have limited our review of your registrati on statement to the issue we have addressed in our comment below. After reviewing any amendment to your regi stration statement, we may have additional comments. We note that at time of filing of the re gistration statement you were not required to include interactive data exhibits (XBRL) pursuan t to Item 601(b)(101) of Regulation S-K. Please note, however, that you will be required to include inter active data exhibits with any amendment to the registration statement if you am end the registration statement after the 30 day grace period following the due date of your Fo rm 10-Q for the quarter ending March 31, 2012. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes 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 disc losure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please pr ovide a written statement from the company acknowledging that: should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission from taking any action with respect to the filing; Antonius Schuh, Ph.D Trovagene, Inc. April 25, 2012 Page 2 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 a nd 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 re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in th e above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Karen Ubell at (202) 551-3873 or me at (202) 551-3715 with any questions. Sincerely, /s/ Jeffrey Riedler Jeffrey Riedler Assistant Director
2012-03-19 - UPLOAD - Cardiff Oncology, Inc.
March 19, 2012 Via E-mail Dr. Antonius Schuh, Ph.D. Chief Executive Officer TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: TrovaGene, Inc. Preliminary Proxy Statement on Form PRE 14A Filed March 7, 2012 File No. 000-54556 Dear Dr. Schuh: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director
2012-03-15 - UPLOAD - Cardiff Oncology, Inc.
March 15, 2012 Via E-mail Dr. Antonius Schuh, Ph.D. Chief Executive Officer TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: TrovaGene, Inc. Preliminary Proxy Statement on Form PRE 14A Filed March 7, 2012 File No. 000-54556 Dear Dr. Schuh: 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 this letter by amending your filing. If you do not believe our comments apply to your facts and circumstances or do not be lieve an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Preliminary Proxy Statement on Form PRE 14A 1. Please disclose your current plans, if any, to make awards under the amended 2004 Stock Option Plan. 2. Please disclose whether you currently have, or do not have, any plans, arrangements or understandings, written or oral, to issue any of the authoriz ed but unissued shares that would become available as a result of the appr oval of the amendment to the Certificate of Incorporation to effect a reverse stock split of common stock. If so, describe those plans, arrangements or understandings. We note that the number of authorized shares of common stock is not being reduced in propor tion to the reverse stock split ratio. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. March 15, 2012 Page 2 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. In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. You may contact Rose Zukin at (202) 551-3239 or me at (202) 551-3710 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director
2012-03-14 - UPLOAD - Cardiff Oncology, Inc.
March 14, 2012 Via E-mail Dr. Antonius Schuh, Ph.D. Chief Executive Officer TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: TrovaGene, Inc. Registration Statement on Form 10-12G Filed November 25, 2011 File No. 000-54556 Dear Dr. Schuh: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director
2012-03-02 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Sichenzia Ross Friedman Ference LLP 61 Broadway New York, NY 10006 March 2, 2012 Securities and Exchange Commission 100 F Street, NE Washington, DC 20549-4720 Attention: Dan Greenspan Re: TrovaGene, Inc. Amendment No. 2 to Registration Statement on Form 10-12G/A Filed February 15, 2012 File No. 000-54556 Dear Mr. Greenspan: This letter sets forth the responses of TrovaGene, Inc., a Delaware corporation (the “Company” or “we”), to the comments received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated February 24, 2012 (“Comments Letter”) concerning the Company’s Amendment No. 2 to Form 10-12G/A filed on February 15, 2012(the “Filing”). The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comments Letter. For your convenience, we set forth each comment from your comment letter in bold type-face and include the Company’s response below it. Amendment No. 2 to Registration Statement on Form 10-12G/A General 1. Please update your financial statements and related financial information through the period ended December 31, 2011 as required by Rule 8-08 of Regulation S-X. As discussed with Ibolya Ignat on February 28, 2012, we believe that the Form 10 does not have to be updated with financial statements and related financial information through the period ended December 31, 2011 because of Section 1220.9 in the Division of Corporate Finance Financial Reporting Manual. As noted in our response to comment number 1 in our letter to the Staff dated February 13, 2012, the Form 10 went effective automatically on January 24, 2012 so as of the date of effectiveness, the audited financial statements for December 31, 2010 and the interim financial statements for September 30, 2010 and 2009 included in the filing were not stale. Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies Royalty and License Revenues, page 26 2. Please refer to your responses to comments 31 and 44. The policy provided here is very vague and generic. It is unclear from your disclosure why recognizing $20,000, $10,000 and $500,000 in license fee revenues during the nine months ended September 30, 2011 and the years ended December 31, 2010 and 2009 respectively was considered appropriate. Please revise your disclosure to clarify, in all periods presented, the basis for recognizing your license fee revenues. Disclose the counterparty to the agreement that resulted in the recognition of such revenues. Please assure that all revenue generating activities with the counterparty and your accounting policy for each are disclosed. For your multiple element arrangements discuss the factors that substantiate that any deliverables qualify as separate units of accounting. Please refer to ASU 2009-13. In Amendment No. 3 to Form 10 we have revised our disclosure in Item 2. MD&A — Critical Accounting Policies — Royalty and License Revenues and in Item 13. Financial Statements to clarify our policies in recognizing license and royalty income. We believe based on the policy revisions that were made along with the details of the license agreements and revenue recognized as noted in Item 13 of the Financial Statements that the revenue recognition is more transparent or clearer. Item 6. Executive Compensation, page 36 Summary Compensation Table, page 36 3. Please refer to your response to comment 39. Please expand this table to provide compensation information for the fiscal years ended December 31, 2011 and December 31, 2010. In Amendment No. 3 to Form 10 we have expanded the Summary Compensation Table to provided compensation information for the fiscal year ended December 31, 2010. In connection with our response to the Staff’s comments, we acknowledge that: · The Company is responsible for the adequacy and accuracy of the disclosure in the filing; · Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and · The Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the Unites States. Sincerely, /s/ Jeffrey J. Fessler Jeffrey J. Fessler
2012-02-24 - UPLOAD - Cardiff Oncology, Inc.
February 24, 2012 Via E-mail Dr. Antonius Schuh, Ph.D. Chief Executive Officer TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: TrovaGene, Inc. Amendment No. 2 to Registration Statement on Form 10-12G/A Filed February 15, 2012 File No. 000-54556 Dear Dr. Schuh: 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 this letter within ten business days by amending your filing, by providing the requested information, or by advi sing us when you will provide the requested response. If you do not believe our comments apply to your fact s and circumstances or do not believe an amendment is appropriate, pl ease tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Amendment No. 2 to Registration Statement on Form 10-12G/A General 1. Please update your financial statements and related financial in formation through the period ended December 31, 2011 as require d by Rule 8-08 of Regulation S-X. Item 2. Management’s Discussion and Analys is of Financial Condition and Results of Operations Critical Accounting Policies Royalty and License Revenues, page 26 2. Please refer to your responses to comments 31 and 44. The policy provided here is very vague and generic. It is unclear from your disclo sure why recognizing $20,000, $10,000 and $500,000 in license fee revenues during th e nine months ended September 30, 2011 Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. February 24, 2012 Page 2 and the years ended December 31, 2010 and 2009 respectively was considered appropriate. Please revise your disclosure to clarify, in all periods presented, the basis for recognizing your license fee revenues. Disclose the counterparty to the agreement that resulted in the recognition of such revenues. Please assure that all revenue generating activities with the counterparty and your accounting policy for each are disclosed. For your multiple element arrangements discuss th e factors that substantiate that any deliverables qualify as separate units of accounting. Please refer to ASU 2009-13. Item 6. Executive Compensation, page 36 Summary Compensation Table, page 36 3. Please refer to your response to comment 39. Please expand this table to provide compensation information for the fiscal years ended December 31, 2011 and December 31, 2010. Please note that Item 402(n)(1) requi res compensation information for each of your last two completed fiscal years. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. 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. In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. February 24, 2012 Page 3 You may contact Ibolya Igna t at (202) 551-3656 or Lisa Va njoske at (202) 551-3614 if you have questions regarding comments on the fina ncial statements and related matters. Please contact Rose Zukin at (202) 551-3239, Dan Green span at (202) 551-3623 or me at (202) 551- 3710 with any other questions. Sincerely, /s/ Daniel S. Greenspan for Jeffrey P. Riedler Assistant Director cc: Jeffrey J. Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2012-02-14 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Sichenzia Ross Friedman Ference LLP 61 Broadway New York, NY 10006 February 14, 2012 Securities and Exchange Commission 100 F Street, NE Washington, DC 20549-4720 Attention: Dan Greenspan Re: TrovaGene, Inc. Amendment No. 1 to Registration Statement on Form 10-12G/A Filed December 30, 2011 File No. 000-54556 Dear Mr. Greenspan: This letter sets forth the responses of TrovaGene, Inc., a Delaware corporation (the “Company” or “we”), to the comments received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated January 27, 2012 (“Comments Letter”) concerning the Company’s Amendment No. 1 to Form 10-12G/A filed on December 30, 2011(the “Filing”). The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comments Letter. For your convenience, we set forth each comment from your comment letter in bold type-face and include the Company’s response below it. General 1. As you are aware, your Form 10 goes effective by lapse of time within 60 days of the date filed pursuant to Exchange Act Section 12(g)(1). Please note that the effectiveness of your Form 10 will commence your periodic reporting obligations under the Exchange Act even if all of our comments have not yet been resolved. We are aware that our Form 10 went effective on January 24, 2012 and we note that the effectiveness of our Form 10 will commence our periodic reporting obligations under the Exchange Act even if all of the comments on our Form 10 have not been resolved. 2. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not exhaustive lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. We note that where the Staff provides examples to illustrate what it means by its comments, they are examples and not exhaustive lists. Item 1. Business, page 3 3. To the extent material, please expand the Business section to discuss the sources and availability of the raw materials used in your research and development, and the names of principal suppliers. Please refer to Item 101(h)(4)(v) of Regulation S-K. In Item 1 Business-Background of Amendment No. 2 to Form 10, we have added a paragraph discussing the sources and availability of the raw materials used in our research and development and the names of the principal suppliers. Background, page 3. 4. It is unclear from your filing whether and when you intend to seek FDA approval for your product. Pages 4, 8, 10, and 15 suggest you intend to seek FDA approval, yet on page 16 you state your expectation that your product candidates will be “an LDT and not a diagnostic kit,” and therefore not subject to FDA regulation. Please revise your filing to clearly explain your intention. If you intend to seek FDA approval for your product, please clearly so state on page 3 when you discuss your planned pursuit of a CE Mark, and revise the risk factor on pages 15-16 entitled “If the FDA were to begin regulating genomic tests . . .” accordingly. Please also expand your filing to disclose when you intend to pursue regulatory approval. In Item 1 Business- Background of Amendment No. 2 to Form 10, we have modified the disclosure to make it clear that we will determine on a case by case basis whether an FDA review is necessary. In addition, in Item 1 Business — Our Business Strategy, we have modified our disclosure to state “If we intend to pursue FDA review ….” and deleted the clause regarding the planned pursuit of a CE mark. 5. On page 3, you state that you in-licensed a new DNA-based biomarker specific for a subtype of AML. Since 2006, you have executed out-license agreements incorporating this biomarker with Ipsogen S.A. and Asuragen, Inc., which has resulted in royalty and license fee revenues. In addition, you have also signed license agreements with various labs including LabCorp, Invivoscribe, Skyline Diagnostics, MLL Munich Leukemia and Warnex, each of which entitles you to various payments under certain circumstances. Please revise your disclosure in the Business section to describe the material terms of each agreement. In this respect, the descriptions on pages F-37 and F-38 must also be expanded as necessary. Your disclosure in the Business section should include the following information: · The name of each party to each material license agreement; · The material obligations of each party, including any financial obligations; · A description of the royalty rates payable under the agreement, expressed within a ten percent range (for example, “single digits,” “teens”, “twenties,” etc); · The potential aggregate milestones payable, if any; · The amounts paid to date; · The term of the agreement; and · The termination provisions of the agreement. In addition, please file all identified license agreements as exhibits to your Form 10, or provide us with a legal analysis as to why these agreements need not be filed pursuant to Item 601(b)(10)(2)(ii) of Regulation S-K. In Item 1 Business — Background of Amendment No. 2 to Form 10 we have added the requested disclosure regarding the sublicenses we have entered into. In addition, we have filed as exhibits all of the sublicenses we have entered into. 6. Please define the abbreviation “CLIA” in the first instance you use this term. In Item 1. Business — Background of Amendment No. 2 to Form 10 we have defined the abbreviation “CLIA.” Our Technologies, page 4 7. On page 4, you describe clinical trials that you conducted in India. Please clearly indicate in your filing, wherever you discuss these clinical trials, that these clinical trials have not been sanctioned by the FDA nor conducted under the guidance of the FDA, and that the results of these clinical trials are irrelevant to your ability to receive regulatory approval. In Item 1. Business — Our Technologies in Amendment No. 2 to Form 10, we have modified the disclosure to state the information reflected in the comment. 8. Please expand your discussion on page 4 to provide more detail regarding the clinical trials conducted in India. Your description should include the following information: · When the clinical study was held; · How long the clinical study was active; · How you targeted patients to enroll; · Whether you conducted this study with any other parties; and · The steps taken to ensure the accuracy of the results. In Item 1 Business — Our Technologies in Amendment No. 2 to Form 10, we have added disclosure regarding the clinical trials conducted in India. The Market, page 5 9. Please provide sources for all quantified information on pages 5-8 of this section. By overnight courier, we are supplementally providing the Staff with the sources for the quantified information on pages 5-8 of this section. 10. Please define the abbreviations “RA” on page 6, “EGFR” on page 7, and “OEM” on page 8. In Item 1. Business - The Market of Amendment No. 2 to Form 10, we have defined the abbreviations, “RA,” “EGFR” and “OEM.” Our Business Strategy, page 8 11. Please expand your disclosure to describe the significance of a CLIA lab, the term “home brew,” and how these relate to the FDA approval process. In Item 1 Business — Our Business Strategy of Amendment No. 2 to Form 10, we have added disclosure discussing the significance of a CLIA lab and how it relates to the FDA approval process. Research and Development, page 9 12. On page 9, you state that you have a “small group of dedicated scientists.” Please quantify the number of scientists that are located in your San Diego office. In Item 1 Business — Research and Development of Amendment No. 2 to Form 10, we have modified the disclosure to quantify the number of scientists located in our San Diego office. 13. You indicate that it is your “goal” to have at least two self-funded development projects ongoing at all times. Please estimate when you anticipate meeting this goal. In Item 1 Business — Research and Development of Amendment No. 2 to Form 10, we have modified the language to state that the two self-funded development projects will start in 2012. Manufacturing and Distribution, page 10 14. You indicate that you plan to introduce assays into the marketplace through ASR or LDTs in CLIA licensed laboratories. Please estimate when you anticipate meeting this goal. In Item 1 Business — Manufacturing and Distribution, we have indicated that we plan to introduce assays into the marketplace through ASR or LDTs in 2012. Government Regulation, page 10 15. You state on page 3 of your filing that you will pursue a CE mark for marketing approval. However, the process for receiving a CE mark is not described in this subsection. Please revise your filing accordingly. In Amendment No. 2 to Form 10, Item 1. Business — Background, we have explained the process for receiving a CE mark. Item 1A. Risk Factors “Our independent registered public accounting firm has expressed doubt . . . ,” page 11 16. The title of this risk factor indicates that there is a risk to your company that your questionable ability to continue as a going concern may hinder your ability to obtain future financing. However, this risk is not discussed in the risk factor text. Please revise accordingly. We have revised the risk factor “Our independent registered public accounting firm has expressed doubt ….” to include the risk that our ability to continue as a going concern may hinder our ability to obtain future financing. “We will need to raise substantial additional capital to commercialize . . .,” page 11 17. Please quantify your working capital as of the latest practicable date. We have revised the risk factor “We will need to raise substantial additional capital to commercialize ….” to include our working capital as of February 10, 2012. 18. You disclose in this risk factor that your existing capital resources will not be sufficient to fund your operations for the next 12 months. Please disclose how long your existing resources will fund your operations. Please also approximate how much additional capital you will need to sustain operations for 12 months. We have revised this risk factor to disclose how long our existing capital resources will fund our operations and how much additional capital we will need to sustain operations for the next 12 months. 19. To the extent practicable, please quantify the additional capital you will need to advance your current product candidates to market. We have revised this risk factor to disclose the amount of additional capital needed to advance our business strategy. 20. On page 12 in this risk factor, you indicate that “if” your capital resources are insufficient to meet future requirements you will have to raise additional funds to continue the development and commercialization of your technology. However, on page 11 you indicate that you do not have existing capital resources to fund your operations for the next 12 months. Please revise this risk factor on page 12 to clearly indicate that your capital resources are insufficient to meet future requirements. We have revised this risk factor to indicate that we will have to raise additional funds during the next 12 months to continue the development and commercialization of our transrenal molecular technology. “Reimbursement may not be available for products based upon . . .,” page 13 21. This risk factor appears to discuss a risk that is substantially similar to the risk discussed on page 12 entitled “Our ability to successfully commercialize our technology will depend largely upon the extent to which third-party payors reimburse our tests.” Please revise your filing to combine these risk factors. We have combined the risk factor “Reimbursement may not be available for products based upon …” into the risk factor “Our ability to successfully commercialize our technology will depend largely upon the extent to which third-party payors reimburse our tests.” “If our potential medical diagnostic tests are unable to compete effectively . . .,” page 13 22. This risk factor appears to discuss a risk that is substantially similar to the risk immediately prior to it on page 13 entitled “Many of our competitors have financial, marketing and human resource assets greater than ours . . . .” Please revise your filing to combine these risk factors. We have combined the risk factor “Many of our competitors have financial, marketing and human resource assets greater than ours…..” into the risk factor “If our potential medical diagnostic tests are unable to compete effectively…” “Our failure to convince medical practitioners to order tests using . . .,” page 14 23. This risk factor appears to discuss a risk that is substantially similar to the risk discussed on page 13 entitled “The commercial success of our product candidates will depend upon the degree of market acceptance of these products among physicians, patients, health care payors and the medical community.” Please revise your filing to combine these risk factors. We have combined the risk factor “Our failure to convince medical practitioners to order tests using …..” into the risk factor “The commercial success of our product candidates will depend upon the degree of market acceptance of these products among physicians, patients, health care payors and the medical community.” “Our failure to obtain human urine samples from medical institutions . . .,” page 14 24. The last three sentences of this risk factor appear to discuss a risk that is not described in the heading of this risk factor, and appear to be more appropriate to the discussion of the risk described in the risk factor on page 13 entitled “The commercial success of our product candidates will depend upon the degree of market acceptance . . . .” Please revise your filing to incorporate the discussion of your need for the support of thought leaders into the earlier risk factor. We have moved the last three sentences of the risk factor “Our failure to obtain human urine samples from medical institutions …” to the risk factor “The commercial success of our product candidates will depend upon the degree of market acceptance ….” “We depend upon our officers, and if we are not able to retain them . . .,” page 14 25. Please identify your key employees. In the risk factor “We depend upon our officers, and if we are not able to retain them…” we have identified Dr. Antonius Schuh, our CEO, as our current key employee. 26. If you have had difficulty attracting personnel in the past, please so disclose. We have not had difficulty attracting personnel in the past. “If we do not receive regulatory approvals, we will not be able to develop . . .,” page 15 27. You indicate on page 3 that one of your corporate priorities is to pursue and receive a CE Mark for your HPV urine-based test. However, you do not mention the risk of not receiving a CE Mark in this risk factor. Please revise accordingly. We have added disclosure to this risk factor with respect to the risk of not receiving a CE Mark. “If the FDA were to begin regulating genomic tests, we could be forced . . .,” page 15 28. Please expand this risk factor to briefly describe the FDA regulations Quality System Regulation and Medical Device Reporting. We have added disclosure t
2012-02-03 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Sichenzia Ross Friedman Ference LLP 61 Broadway New York, NY 10006 February 3, 2012 VIA EDGAR U. S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549-4720 Attn: Dan Greenspan Re: TrovaGene, Inc. (the “Company”) Amendment No. 1 to Registration Statement on Form 10-12G/A Filed December 30, 2011 File No. 000-54556 Dear Mr. Greenspan: The Company is in receipt of your comment letter dated January 27, 2012. The Company would like to respectfully request an extension to respond to the comment letter to February 13, 2012. Respectfully yours, /s/ Jeffrey J. Fessler
2012-01-27 - UPLOAD - Cardiff Oncology, Inc.
January 27, 2012 Via E-mail Dr. Antonius Schuh, Ph.D. Chief Executive Officer TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: TrovaGene, Inc. Amendment No. 1 to Registration Statement on Form 10-12G/A Filed December 30, 2011 File No. 000-54556 Dear Dr. Schuh: 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 this letter within ten business days by amending your filing, by providing the requested information, or by advi sing us when you will provide the requested response. If you do not believe our comments apply to your fact s and circumstances or do not believe an amendment is appropriate, pl ease tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. General 1. As you are aware, your Form 10 goes effective by lapse of time with in 60 days of the date filed pursuant to Excha nge Act Section 12(g)(1). Please note that the effectiveness of your Form 10 will commence your periodic reporting obligations under the Exchange Act even if all of our comments have not yet been resolved. 2. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not exhaus tive lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 2 Item 1. Business, page 3 3. To the extent material, please expand the Bu siness section to discuss the sources and availability of the raw materials used in your research and development, and the names of principal suppliers. Please refer to Item 101(h)(4)(v) of Regulation S-K. Background, page 3 4. It is unclear from your filing whether a nd when you intend to seek FDA approval for your product. Pages 4, 8, 10, and 15 suggest you intend to seek FDA approval, yet on page 16 you state your expectation that your pr oduct candidates will be “an LDT and not a diagnostic kit,” and therefore not subject to FDA regulation. Please revise your filing to clearly explain your intent ion. If you intend to seek FDA approval for your product, please clearly so state on pa ge 3 when you discuss your planned pursuit of a CE Mark, and revise the risk factor on pages 15-16 en titled “If the FDA were to begin regulating genomic tests . . .” accordingly. Please also expand your filing to disclose when you intend to pursue regulatory approval. 5. On page 3, you state that you in-licensed a new DNA-based biomarker specific for a subtype of AML. Since 2006, you have execute d out-license agreem ents incorporating this biomarker with Ipsogen S.A. and Asurag en, Inc., which has re sulted in royalty and license fee revenues. In addition, you have also signed license agre ements with various labs including LabCorp, Invivoscribe, Sky line Diagnostics, MLL Munich Leukemia and Warnex, each of which entitles you to various payments under certain circumstances. Please revise your disclosure in the Business section to describe the material terms of each agreement. In this resp ect, the descriptions on pages F-37 and F-38 must also be expanded as necessary. Your disclosure in the Business secti on should include the following information: The name of each party to each material license agreement; The material obligations of each part y, including any financial obligations; A description of the royalty rates payabl e under the agreement, expressed within a ten percent range (for example, “single digits,” “teens”, “twenties,” etc); The potential aggregate mile stones payable, if any; The amounts paid to date; The term of the agreement; and The termination provisions of the agreement. In addition, please file all iden tified license agreements as exhibits to your Form 10, or provide us with a legal analysis as to why these agreements need not be filed pursuant to Item 601(b)(10)(2)(ii) of Regulation S-K. 6. Please define the abbreviation “CLIA” in the first instance you use this term. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 3 Our Technologies, page 4 7. On page 4, you describe clini cal trials that you conducted in India. Please clearly indicate in your filing, wherever you discuss these clinical trials , that these clinical trials have not been sanctioned by the FDA nor c onducted under the guidance of the FDA, and that the results of these clini cal trials are irrelevant to your ability to receive regulatory approval. 8. Please expand your discussion on page 4 to pr ovide more detail rega rding the clinical trials conducted in India. Your descript ion should include the following information: When the clinical study was held; How long the clinical study was active; How you targeted patients to enroll; Whether you conducted this study with any other parties; and The steps taken to ensure th e accuracy of the results. The Market, page 5 9. Please provide sources for all quantified info rmation on pages 5-8 of this section. 10. Please define the abbreviations “RA” on page 6, “EGFR” on page 7, and “OEM” on page 8. Our Business Strategy, page 8 11. Please expand your disclosure to describe the significance of a CLIA lab, the term “home brew,” and how these relate to the FDA approval process. Research and Development, page 9 12. On page 9, you state that you have a “small group of dedicated scie ntists.” Please quantify the number of scientists that are located in your San Diego office. 13. You indicate that it is your “goal” to have at least two self-funded development projects ongoing at all times. Please estimate when you anticipate meeting this goal. Manufacturing and Distribution, page 10 14. You indicate that you plan to introduce assa ys into the marketplace through ASR or LDTs in CLIA licensed laboratories. Please estimate when you anticipate meeting this goal. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 4 Government Regulation, page 10 15. You state on page 3 of your filing that you will pursue a CE mark for marketing approval. However, the process for receiving a CE mark is not described in this subsection. Please revise your filing accordingly. Item 1A. Risk Factors “Our independent registered public accounti ng firm has expressed doubt . . .,” page 11 16. The title of this risk factor indicates that there is a ri sk to your company that your questionable ability to continue as a goi ng concern may hinder your ability to obtain future financing. However, this risk is not disc ussed in the risk factor text. Please revise accordingly. “We will need to raise substantial additiona l capital to commercialize . . .,” page 11 17. Please quantify your working capital as of the latest practicable date. 18. You disclose in this risk fact or that your existing capital re sources will not be sufficient to fund your operations for the next 12 mont hs. Please disclose how long your existing resources will fund your operations. Please also approximate how much additional capital you will need to sustai n operations for 12 months. 19. To the extent practicable, please quantify the additional capital you will need to advance your current product candidates to market. 20. On page 12 in this risk fact or, you indicate that “if” your cap ital resources are insufficient to meet future requirements you will have to raise additional funds to continue the development and commercialization of your technology. However, on page 11 you indicate that you do not have existing capital resources to fund your operations for the next 12 months. Please revise this risk factor on page 12 to clearly indicate that your capital resources are insufficient to meet future requirements. “Reimbursement may not be available for products based upon . . .,” page 13 21. This risk factor appears to disc uss a risk that is substantiall y similar to the risk discussed on page 12 entitled “Our ability to succe ssfully commercialize our technology will depend largely upon the extent to which third-pa rty payors reimburse our tests.” Please revise your filing to comb ine these risk factors. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 5 “If our potential medical diagnostic tests are unable to compet e effectively . . .,” page 13 22. This risk factor appears to discuss a risk that is substa ntially similar to the risk immediately prior to it on page 13 entitled “Many of our competit ors have financial, marketing and human resource asse ts greater than ours . . . .” Please revise your filing to combine these risk factors. “Our failure to convince medical practitione rs to order tests using . . .,” page 14 23. This risk factor appears to disc uss a risk that is substantiall y similar to the risk discussed on page 13 entitled “The commercial success of our product candidates will depend upon the degree of market acceptance of these pr oducts among physicians, patients, health care payors and the medical community.” Please revise your filing to combine these risk factors. “Our failure to obtain human urine samples from medical institutions . . .,” page 14 24. The last three sentences of this risk factor appear to discuss a risk that is not described in the heading of this risk factor , and appear to be more approp riate to the discussion of the risk described in the risk factor on page 13 entitled “The commercial success of our product candidates will depend upon the degree of market acceptance . . . .” Please revise your filing to incorporate the discussion of your need for the support of thought leaders into the earlier risk factor. “We depend upon our officers, and if we are not able to retain them . . .,” page 14 25. Please identify your key employees. 26. If you have had difficulty attracting pers onnel in the past, please so disclose. “If we do not receive regulatory approvals, we will not be able to develop . . .,” page 15 27. You indicate on page 3 that one of your corporat e priorities is to pursue and receive a CE Mark for your HPV urine-based test. Ho wever, you do not mention the risk of not receiving a CE Mark in this risk factor. Please revi se accordingly. “If the FDA were to begin regulating genomic tests, we could be forced . . .,” page 15 28. Please expand this risk factor to briefly describe the FDA regulations Quality System Regulation and Medica l Device Reporting. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 6 “We may incur substantial costs as a result of litigation or other proceedings . . .,” page 17 29. If third parties have previously challenged the validity of your patents, please so disclose to describe the circumstances. “We have not paid dividends on our comm on stock in the past . . .,” page 19 30. Please clearly state in this risk factor that reader s should not rely on an investment in your company if they require dividend income. Item 2. Management’s Discussion and Analys is of Financial Condition and Results of Operations Critical Accounting Policies Royalty and License Revenues, page 21 31. Please include a description of your collaborative agreements to identify th e products or product candidates that are the subject of your research. Disclose e ach party’s rights and obligations under the agreement and termination provisions. To the extent that the agreement grants licenses to any of the part ies, the terms of the license(s) should be described. Allowance for Doubtful Accounts, page 21 32. Please disclose the nature of your accounts receivable. Also di sclose any significant debtor concentration. Clarify why accounts receivable increa sed significantly during the periods presented. Research and Development, page 22 33. Please provide quantitative and qualitative di sclosure about the amount of costs, both internal and external, incurred during each peri od presented and incurred to date on each of your major research and deve lopment projects. To the exte nt that you cannot attribute costs to a project, please expl ain why management does not ma intain and evaluate those costs by project. Convertible Debentures, page 23 34. Please tell us what authoritative literatu re you used to account for the Forbearance Agreement entered into during 2009 and for the subsequent modifications and the eventual extinguishment of your convertible debentures. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 7 Results of Operations, page 23 35. Please provide a more robust discussion explai ning the change in revenues during the three months ended September 30, 2011 and 2010; and the nine months ended September 30, 2011 and 2010. Item 3. Properties, page 25 36. Please file your lease as an exhibit to your Form 10 pursuant to Item 601(b)(10)(2)(iv) of Regulation S-K. Item 5. Directors and Executive Officers, page 26 37. Please expand the biographical information of Ms. Cerrone to describe her business experience from January 2005 to July 2008. Pl ease refer to Item 401(e)(1) of Regulation S-K. Director Independence, page 28 38. You state that a majority of the board consists of members that are currently “independent,” as that term is defined under NASDAQ listing standards. Please identify all independent directors. Please refer to Item 407(a) of Regulation S-K. Item 6. Executive Compensation, page 29 Summary Compensation Table, page 29 39. Please update this table, and the compensa tion tables on page 30, with compensation information for the fiscal year ended December 31, 2011. Item 9. Market Price of and Dividends on the Registrant’s Comm on Equity and Related Stockholder Matters, page 33 40. Please update the Equity Compensation Plan Information table on page 34 to provide information for the fiscal year ended December 31, 2011. 41. We note your disclosure regarding equ ity compensation plans not approved by stockholders. Please briefly descri be the material features of these plans. Please refer to Item 201(d)(3) of Regulation S-K. Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 8 Item 10. Recent Sales of Unregistered Securities, page 34 42. Regarding each instance of private placement financings, please name the persons or identify the class of persons to whom the securities were sold. Please refer to Item 701(b) of Regulation S-K. Consolidated Financial Statements Consolidated Statements of Operations, page F-4 43. Tell us why you do not present revenues fr om royalties separately from revenues attributable to license fees on the face of your consolidated statements of operations. Notes to Consolidated Financial Statements 3. Summary of Significant Accounting Policies Royalty and License Revenues, page F-15 44. It is unclear from your current policy note di sclosure how your policy is applied to each of your revenue streams. For example, typically consideration allocate d to license fees is recognized when earned if the license has st and-alone value. Revenue on substantive milestone payments is recognized in the pe riod in which the milestone is achieved. Royalty revenue is generally recorded in the same period as the sales that generate the royalty payment. Please revise your policy not e here and in the MD&A to discuss your revenue recognition policy separately for each of your revenue streams. Please refer to ASC 605-25 as necessary in your response. Consolidated Financial Statements at September 30, 2011, unaudited 45. Please revise your interim fi nancial statement disclosures based on the preceding comments, as applicable. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in th
2011-11-30 - UPLOAD - Cardiff Oncology, Inc.
November 30, 2011 Via E-mail Dr. Antonius Schuh, Ph.D. Chief Executive Officer TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121 Re: TrovaGene, Inc. Registration Statement on Form 10-12G Filed November 25, 2011 File No. 000-54556 Dear Dr. Schuh: Our preliminary review of your registration st atement indicates that it fails in certain material respects to comply with the requirements of the Securi ties Act of 1933, the rules and regulations under that Act, and th e requirements of the form. We note in part icular that interim financial statements included in th e filing are not current as requir ed by Article 8-08 of Regulation S-X. You will need to amend your filing to pr ovide updated inte rim financial statements and an updated letter of consent fr om the company’s auditor. We will not perform a detailed examination of the registrati on statement and we will not issue comments because to do so would delay the review of other di sclosure documents that do not appear to contain comp arable deficiencies. If you were to request acceleratio n of the effective date of the registration statement in its present form, we would likely reco mmend that the Commissi on deny your request. We suggest that you consider filing a substa ntive amendment to correct the deficiencies. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Jeffrey J. Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2011-11-25 - CORRESP - Cardiff Oncology, Inc.
CORRESP 1 filename1.htm Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006 November 23, 2011 VIA EDGAR Securities and Exchange Commission 100 F Street, NE Washington, DC 20549-4720 Re: TrovaGene, Inc. Registration Statement on Form 10 Ladies and Gentlemen: TrovaGene, Inc. (the “Company”) is filing its registration statement on Form 10 via EDGAR concurrently with this transmittal letter. The Company, formerly known as Xenomics, Inc., previously filed periodic reports with the SEC pursuant to Section 15(d) of the Securities Exchange of 1934 since it became subject to such requirements after the effective date of its first registration statement under the Securities Act of 1933 on May 19, 2003. The Company, as a result of financial difficulties and the inaction of prior management, has not filed a periodic report containing financial statements of the Company subsequent to the filing of the Form 10-Q for the quarterly period ended October 31, 2006. In October 2009, I had a conversation with the Staff on the best approach to bringing the Company’s filing current and the Staff concurred with counsel’s opinion that the Company file a Form 10 registration statement. The Company will be filing an amendment to Form 10 as soon as possible in order to incorporate September 30, 2011 and 2010 interim financial statements prior to effectiveness. Sincerely, /s/ Jeffrey J. Fessler Jeffrey J. Fessler cc: Antonius Schuh
2006-03-16 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
Acceleration Request
Xenomics,
Inc.
420
Lexington Avenue, Suite 1701
New
York, New York 10170
March
16,
2006
VIA
FACSIMILE AND EDGAR
United
States Securities
and
Exchange Commission
100
F
Street, NE
Washington,
D.C. 20549
Attention:
William Bennett, Esq.
Re:
Xenomics,
Inc.
Registration
Statement on Form SB-2
File
No. 333-127071
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of
1933, as amended (the “Act”), Xenomics, Inc. (the “Company”) respectfully
requests that the effective date of the registration statement referred to
above
be accelerated so that it will become effective at 4:00 p.m., Eastern Standard
Time, on Thursday, March 16, 2006, or as soon thereafter as possible. The
Company acknowledges that: 1) 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;
2)
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 3) the Company may not assert this action as defense in any
proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
XENOMICS,
INC.
By:
/s/ L.
David Tomei
Name:
L. David Tomei
Title:
Chief Executive Officer
2006-03-15 - UPLOAD - Cardiff Oncology, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
MAIL STOP 3720
March 13, 2006
L. David Tomei, Ph.D.
Chief Executive Officer
Xenomics, Inc.
420 Lexington Avenue, Suite 1701
New York, New York 10170
Re: Xenomics, Inc.
Amendment No. 4 to Registration Statement on Form SB-2
File No. 333-127071
Filed March 1, 2006
Dear Dr.Tomei:
We have reviewed your amended filing and have the following
comments. Where indicated, we think you should revise your
document
in response to these comments.
Risk Factors, page 5
1. Please either include a risk factor addressing the weaknesses
in
your disclosure controls and procedures as is evidenced by the
prior
restatements made to your financial statements or tell us why such
a
risk factor is not necessary.
Management`s Discussion and Analysis..., page 12
2. We note your responses to prior comments 5 and 6. Please
expand
MD&A to state why you continue to believe that your disclosure
controls and procedures were effective for the financial statement
periods in light of the various restatements to your financial
statements. Summarize the restatements in MD&A and state the
specific reasons why you continue to believe that your disclosure
controls were effective.
3. Revise MD&A to discuss the enhancements to your disclosure
controls and procedures as summarized in your response to prior
comments 5 and 6 and disclose any changes in internal control over
financial reporting made to date.
1934 Act Periodic Reports
3. For each periodic report affected by the restatements, amend
your disclosures in MD&A to summarize the restatements and the
specific reasons why you continue to believe that your disclosure
controls and procedures were effective.
Closing Comments
As appropriate, please amend your registration statement in
response to these comments. Provide us with marked copies of the
amendment to expedite our review. Please furnish a cover letter
with
your amendment that keys your responses to our comments and
provides
any requested supplemental information. Detailed cover letters
greatly facilitate our review. Please understand that we may have
additional comments after reviewing your amendment and responses
to
our comments.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
Any questions regarding the accounting comments may be
directed
to Carlton Tartar at (202) 551-3387. Questions on other
disclosure
issues may be directed to William Bennett at (202) 551-3389.
Sincerely,
John Reynolds
Assistant Director
cc: Jeffrey J. Fessler
Fax: 212-930-9725
??
??
??
??
L. David Tomei, Ph.D
Xenomics, Inc.
March 13, 2006
p. 1
</TEXT>
</DOCUMENT>
2006-03-15 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
Xenomics Response Letter
March 15,
2006
Securities
and Exchange Commission
Division
of Corporation Finance
100
F
Street, NE
Washington,
D.C. 20549
Attention:
John Reynolds, Esq.
Re:
Xenomics,
Inc.
Form
SB-2 filed August 1, 2005
Amendment
No. 4 to Form SB-2 filed March 1, 2006
File
No. 333-127071
Dear
Mr.
Reynolds:
This
letter sets forth the responses of Xenomics, Inc., a Florida corporation (the
“Company” or “we”), to the comments received from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) by letter dated March 13,
2006 concerning Amendment No. 4 to the Company’s Registration Statement on Form
SB-2 (File No. 333-127071) filed with the Commission on March 1, 2006 (the
“Registration Statement”). We are authorized by the Company to provide the
responses contained in this letter on behalf of the Company.
The
numbers of the responses in this letter correspond to the numbers of the Staff’s
comments as set forth in its letter to the Company dated March 13, 2006.
References in the text of the responses herein to captions and page numbers
are
to Amendment No. 5 to Form SB-2 which is being filed herewith. For your
convenience, we set forth each comment from your comment letter in bold typeface
and include the Company’s response below it.
Risk
Factors, page 5
1.
Please
either include a risk factor addressing the weaknesses in your disclosure
controls and procedures as is evidenced by the prior restatements
made to
your financial statements or tell us why such a risk factor is not
necessary.
On
page 5
of Amendment No. 5 to Form SB-2 we have added a risk factor addressing the
weaknesses in or disclosure controls and procedures as is evidenced by the
prior
restatements made to our financial statements.
Management’s
Discussion and Analysis …, page 12
2.
We
note your response to prior comments 5 and 6. Please expand MD&A to
state why you continue to believe that your disclosure controls and
procedures were effective for the financial statement periods in
light of
the various restatements to your financial statements. Summarize
the
restatements in MD&A and state the specific reasons why you continue
to believe that your disclosure controls were effective.
On
page
13 of Amendment No. 5 to Form SB-2 we have summarized the restatements and
stated that we do not believe that our disclosure controls and procedures were
effective during the financial statement periods disclosed.
3.
Revise
MD&A to discuss the enhancements to your disclosure controls and
procedures as summarized in your response to prior comments 5 and
6 and
disclose any changes in internal control over financial reporting
made to
date.
On
page 13 of Amendment No. 5 to Form SB-2 we have added in a discussion of
the enhancements of our disclosure controls and procedures designed to remediate
the weaknesses in our disclosure controls and procedures and disclosed certain
changes in our internal controls over financial reporting made to
date.
4.
For
each periodic report affected by the restatements, amend your disclosures
in MD&A to summarize the restatements and the specific reasons why you
continue to believe that your disclosure controls and procedures
were
effective.
In
Amendment No. 3 to Form 10-KSB for the year ended January 31, 2005, Amendment
No. 2 to Form 10-QSB for the quarter ended April 30, 2005, Amendment No. 5
to
Form 10-QSB for the quarter ended July 31, 2005 and Amendment No. 3 to Form
10-QSB for the quarter ended October 31, 2005 we have summarized the
restatements and
stated that we do not believe that our disclosure controls and procedures were
effective during the financial statement periods disclosed. In addition we
have
modified the Controls and Procedures section of each of the periodic filings
to
disclose that our Chief Executive Officer and Chief Financial Officer do not
believe that our disclosure controls and procedures were effective as of the
periods ended in such periodic reports. We have also disclosed the actions
we
have taken to date to remediate such weaknesses.
Very
truly yours,
/s/
Jeffrey J. Fessler
2006-03-10 - UPLOAD - Cardiff Oncology, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
MAIL STOP 3720
February 22, 2006
V. Randy White, Ph.D
Chief Executive Officer
Xenomics, Inc.
420 Lexington Avenue, Suite 1701
New York, New York 10170
Re: Xenomics, Inc.
Amendment No. 3 to Registration Statement on Form SB-2
File No. 333-127071
Filed February 14, 2006
Dear Dr. White:
We have reviewed your amended filing and have the following
comments. Where indicated, we think you should revise your
document
in response to these comments.
Executive Compensation
1. The table should include compensation amounts for the past
three
years. See Instruction to Item 402(b) of Regulation S-B.
Financial Statements
Note 4 - Stockholders` Equity, page F-25
2. We note your response to prior comment nine. Please tell us
why
you believe it was appropriate to record an expense for the fair
value of the warrants at the date of issuance. To the extent that
liability classification is required under EITF 00-19, the
instrument
should be recorded at fair value on the date of issuance. For a
private placement, this typically occurs through the allocation of
a
portion of the proceeds. Generally, it would not be appropriate
to
record an expense at the date of issuance unless the fair value of
the instruments that were required to be classified as derivative
liabilities exceeded the net proceeds received. Please revise the
financial statements accordingly, or tell us why you believe that
no
revisions are required.
3. Please revise the description of the warrant liability on the
balance sheet to clearly indicate that the amount is a liability.
Also, please revise your disclosure in Note 4 to state why the
amount
is recorded as a non-current liability.
4. Please tell us why you believe that the income or expense
relating
to the valuation of the warrants is appropriately classified in
the
cash flow statement as a financing activity, or revise your
disclosures accordingly.
1934 Act Periodic Reports
5. Your response to prior comment 14 did not address the majority
of
the adjustments relating to stock-based compensation expense,
which
were unrelated to the use of quoted market prices as discussed in
your supplemental response. Please tell us the specific factors
that
you considered in determining your disclosure controls and
procedures
were effective despite the restatements related to the Trilogy
warrants and the application of EITF 96-18.
6. You state the restatements and related accounting were
thoroughly
discussed with the accounting firm and "reliance upon the
Independent
Registered Public Accounting Firm" was one of the primary factors
that enabled you to determine that your disclosure controls and
procedures were effective. Please explain the specific nature of
this reliance. Please explain how the discussion of the
restatement
and the related accounting with the accounting firm provided any
basis for originally concluding disclosure controls and procedures
were effective, since the accounting for these transactions
resulted
in material errors to the financial statements.
Closing Comments
As appropriate, please amend your registration statement in
response to these comments. Provide us with marked copies of the
amendment to expedite our review. Please furnish a cover letter
with
your amendment that keys your responses to our comments and
provides
any requested supplemental information. Detailed cover letters
greatly facilitate our review. Please understand that we may have
additional comments after reviewing your amendment and responses
to
our comments.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
Any questions regarding the accounting comments may be
directed
to Carlton Tartar at (202) 551-3387. Questions on other
disclosure
issues may be directed to William Bennett at (202) 551-3389.
Sincerely,
John Reynolds
Assistant Director
cc: Jeffrey J. Fessler
Fax: 212-930-9725
??
??
??
??
V. Randy White, Ph.D
Xenomics, Inc.
February 22, 2006
p. 1
</TEXT>
</DOCUMENT>
2006-03-01 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
Xenomics Comment Letter
March 1,
2006
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, NE
Washington,
D.C. 20549
Attention:
John Reynolds, Esq.
Re:
Xenomics,
Inc.
Form
SB-2 filed August 1, 2005
Amendment
No. 3 to Form SB-2 filed February 14, 2006
File
No. 333-127071
Dear
Mr. Reynolds:
This
letter sets forth the responses of Xenomics, Inc., a Florida corporation
(the
“Company” or “we”), to the comments received from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) by letter dated February
22, 2006 concerning Amendment No. 3 to the Company’s Registration Statement on
Form SB-2 (File No. 333-127071) filed with the Commission on February 14,
2006
(the “Registration Statement”). We are authorized by the Company to provide the
responses contained in this letter on behalf of the Company.
The
numbers of the responses in this letter correspond to the numbers of the
Staff’s
comments as set forth in its letter to the Company dated February 22, 2006.
References in the text of the responses herein to captions and page numbers
are
to Amendment No. 4 to Form SB-2 which is being filed herewith. For your
convenience, we set forth each comment from your comment letter in bold typeface
and include the Company’s response below it.
Executive
Compensation
1.
The
table should include compensation amounts for the past three years.
See
Instruction to Item 402(b) of Regulation
S-B.
On
page 27
of Amendment No. 4 to Form SB-2, we have modified the Summary Compensation
Table
to include compensation amounts for the past three years.
Financial
Statements
Note
4-Stockholders’ Equity, page F-25
2.
We
note your response to prior comment nine. Please tell us why you
believe
it was appropriate to record an expense for the fair value of the
warrants
at the date of issuance. To the extent that liability classification
is
required under EITF 00-19, the instrument should be recorded at
fair value
on the date of issuance. For a private placement, this typically
occurs
through the allocation of a portion of the proceeds. Generally,
it would
not be appropriate to record an expense at the date of issuance
unless the
fair value of the instruments that were required to be classified
as
derivative liabilities exceeded the net proceeds received. Please
revise
the financial statements accordingly, or tell us why you believe
that no
revisions are required.
The
original accounting for the fair value for the warrants as an immediate charge
to expense was overly conservative and not an appropriate interpretation
of
applicable guidance in accounting literature. On pages F-16, F-20, F-21,
and
F-26 of Amendment No. 4 to Form SB-2, we have modified the financial statements
and related disclosures to reflect the establishment of a liability for the
fair
value of the warrants at the date of issuance with a corresponding reduction
to
proceeds allocated to preferred stock. Further, we have marked that liability
to
market at subsequent balance sheet dates and recorded a corresponding charge
or
benefit in the statement of operations.
3.
Please
revise the description of the warrant liability on the balance
sheet to
clearly indicate that the amount is a liability. Also, please revise
your
disclosure in Note 4 to state why the amount is recorded as a non-current
liability.
On
page F-16 of Amendment No. 4 to Form SB-2, we have modified the financial
statements as requested. Additionally, on page F-26 we have disclosed why
the
warrant liability has been classified as a non-current liability as
requested.
4.
Please
tell us why you believe that the income or expense relating to
the
valuation of the warrants is appropriately classified in the cash
flow
statement as a financing activity, or revise your disclosures
accordingly.
On
page F-21 of Amendment No. 4 to Form SB-2, we have modified the financial
statements as described in the response to comment #2 above. Consequently,
the
charge to expense representing the total value of the warrants, which was
classified as a financing activity in the cash flow statement, has been removed.
Additionally, the charge or benefit in the statement of operations relating
to
the change in the warrant liability (to mark this liability to market) has
been
classified in the cash flow statement as an operating activity.
1934
Act Periodic Reports
5.
Your
response to prior comment 14 did not address the majority of the
adjustments relating to stock-based compensation expense, which
were
unrelated to the use of quoted market prices as discussed in your
supplemental response. Please tell us the specific factors that
you
considered in determining your disclosure controls and procedures
were
effective despite the restatements related to the Trilogy warrants
and the
application of EITF 96-18.
Introduction:
The
paragraphs below describe the specific factors considered by our Chief Executive
Officer and Principal Financial Officer in determining our disclosure controls
and procedures were effective despite the restatements related to the Trilogy
warrants and the application of EITF 96-18.
Further,
the changes described therein such as appointment to the Board of Directors
and
the Audit Committee of
an
"audit committee financial expert" (as defined in Item 401(e) of Regulation
S-B), appointment of a new Chief Financial Officer and his inclusion in all
meetings of the Board of Directors, establishment of a Disclosure Committee,
etc., have had an immediate benefit to the Company and its financial and
control
environment. Such changes demonstrate the Company's commitment to quality
financial reporting and effective controls and procedures both now and for
the
future.
Specific
Factors Considered:
The
following specific factors were considered by our Chief Executive Officer
and
Principal Financial Officer in evaluating the effectiveness of the Company's
disclosure controls and procedures.
1)
The
Control Environment
This
factor overarches and sets the tone for all other disclosure controls
and
procedures. This factor includes the professionalism and qualifications
of
those officers and directors involved in the financial reporting
process.
2)
Corporate
Governance
This
factor relates to the structure of corporate management and board
of
directors responsibilities regarding the oversight of financial
reporting.
3)
Accounting
Policies, Audit and Reporting Procedures
This
factor relates to the integrity of
the
financial reporting process and management’s
application of Generally
Accepted Accounting Principles.
4) Internal
Controls
This
factor relates to accounting systems, proper segregation of duties,
account reconciliations and approvals at the transaction
level.
The
Control Environment
This
disclosure control factor involves the number, position, duties and professional
qualifications of the individuals involved in the Company’s financial reporting
process. On July 2, 2004, Xenomics, Inc., formerly Used Kar Parts, Inc. acquired
all of the outstanding common stock of Xenomics and concurrently completed
a
private placement for aggregate proceeds of approximately $2.5 million. Prior
to
this acquisition both Used Kar Parts and Xenomics had limited
operations.
From
July 2004 through the present, the Company has diligently recruited and hired
a
strong and highly experienced team of officers, directors, employees and
advisors capable of addressing the issues related to being a newly public
company. The following is a chronology of those actions which have contributed
to management’s conclusion that disclosure controls and procedure were
effective:
a)
On
September 3, 2004, the Company appointed V. Randy White, Ph.D.
as Chief
Executive Officer. Dr. White has over thirty years of executive
management
experience with both public and private companies. (Effective
February 23, 2006, Mr. White has left the Company to pursue other
interests and Dr. L. David Tomei, co-founder of Xenomics and Co-Chairman
of the Xenomics Board of Directors as been appointed Chief Executive
Officer.)
b)
On
January 28, 2005, the Company's audit committee engaged Lazar Levine
&
Felix LLP as its principal Independent Registered Public Accounting
Firm
and Baum & Company, PA resigned as the principal Independent
Registered Public Accounting Firm. Lazar Levine & Felix, LLP is a firm
with a broad
public company practice and SEC reporting experience. This change
was
reported in Form 8-K filed on February 3, 2005, Item 4.01, Changes
in
Registrant's Certifying Accountant.
c)
On
February 14, 2005, the Company appointed Bernard Denoyer as Vice
President-Controller for a
period
of one year. Mr. Denoyer is a Certified Public Accountant and has
over
thirty years of financial management experience which includes
serving as
principal financial officer for several public companies.
d)
On
December 1, 2005, the Board of Directors appointed
John Brancaccio as director and Chairman of the Audit Committee.
Mr.
Brancaccio is a retired CPA and has over 30 years of financial
management
experience. He currently serves as the Chief Financial Officer
of
Accelerated Technologies, Inc., a medical device company, and on
the
boards of the following publicly-held companies: Callisto Pharmaceuticals,
Inc., Alfacell Corporation, and FermaVir
Pharmaceuticals, Inc. Mr. Brancaccio was formerly the acting Chief
Financial Officer and Treasurer of Memory Pharmaceuticals Corporation.
This appointment was reported in Form 8-K filed on December 7, 2005, Item
5.02: Departure of Directors or Principal Officers; Election of Directors;
Appointment of Principal Officers.
e)
On
January 16, 2006 the Company appointed Frederick Larcombe as Chief
Financial Officer. Mr. Larcombe is a Certified Public Accountant
and has
over twenty-five years of financial management experience which
includes
serving as Chief Financial Officer and Vice President of Finance
with
MicroDose Technologies, Inc., a privately held drug delivery company,
and
ProTeam.com, Inc., a publicly held Internet-oriented retailer.
Prior to
that, he held financial positions with Cambrex Corporation, a
publicly-held life sciences company, and PriceWaterhouseCoopers.
This
appointment was reported in Form 8-K filed on January 20,
2006, Item
5.02: Departure of Directors or Principal Officers; Election of
Directors;
Appointment of Principal Officers.
Corporate
Governance
One
of the most important aspects of corporate governance, as it relates to
disclosure controls and procedures, is the Audit Committee of the Board of
Directors. As you are aware, the Audit Committee is responsible for: (i)
reviewing the independence, qualifications, services, fees, and performance
of
the independent auditors, (ii) appointing, replacing and discharging the
independent auditors, (iii) pre-approving the professional services provided
by
the independent auditors, (iv) reviewing the scope of the annual audit and
reports and recommendations submitted by the independent auditors, and (v)
reviewing our financial reporting and accounting policies, including any
significant changes, with management and the independent auditors. Members
of
the Company's Audit Committee have been consistently active in these capacities
and fulfilling the related responsibilities.
During
the period from October
25,
2004 through December 1, 2005 the Audit Committee consisted of Thomas Adams
and
Donald Picker. They are "independent" as that term is defined under applicable
SEC rules. With the appointment
of John Brancaccio to the Audit Committee on December 1, 2005, the Company
now
has an "audit committee financial expert" as defined in Item 401(e) of
Regulation S-B.
Accounting
Policies, Audit and Reporting Procedures
The
restatements related to the Trilogy warrants and the application of EITF
2006-02-15 - UPLOAD - Cardiff Oncology, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
MAIL STOP 3561
February 2, 2006
V. Randy White, Ph.D
Chief Executive Officer
Xenomics, Inc.
420 Lexington Avenue, Suite 1701
New York, New York 10170
Re: Xenomics, Inc.
Amendment No. 2 to Registration Statement on Form SB-2
File No. 333-127071
Filed January 9, 2006
Dear Dr. White:
We have reviewed your amended filing and have the following
comments. Where indicated, we think you should revise your
document
in response to these comments.
General
1. Please clarify throughout what "cGMP" means and who or what
authority the guidelines come from.
2. The company`s preferred dividend obligation should be discussed
in
MD&A under Liquidity and Capital Resources. Any arrearages should
be
indicated.
3. Please remove what appear to be tags of some sort (<R>)
throughout the unmarked EDGAR version of the filing.
Risk Factors, page 5
4. The first risk factor refers to an inception date of April 26,
2002, which appears to be in error; it should reconcile with that
used in the financial statements.
Executive Compensation, page 27
5. As previously requested, since none of the persons listed
annual
salary and bonus exceeded $100,000, clarify the reference to
compensation of "$100,000 or more" in the first paragraph. Refer
to
Item 402(a)(2) of Regulation S-B for the persons required to be
listed.
6. In addition, please update all disclosure hereunder for the
most
recent fiscal year.
Plan of Distribution
7. The references to "donees, pledgees, transferees or other
successors-in-interest" should be removed or a statement added
that
the identities of such persons will be added by post effective
amendment.
Financial Statements, page F-1
Note 2 - Basis of Presentation, page F-9
8. We note your response to prior comment 27. Please expand the
APB
20 disclosures in Note 2 on page F-9 and Note 6 on page F-28 to
show
the amount and nature of each material revision. For example,
expand
the line item, "additional stock-based compensation" to disclose
the
effect of revisions including:
* expense recognition for the Trilogy warrants,
* expense resulting from the use of quoted market price,
* the application of EITF 96-18 to options granted to non-
employees.
For each material revision, describe the original accounting
treatment and the nature of the error correction. Disclose both
amounts recorded in the financial statements prior to correction,
as
well as the revised amounts.
Note 4 - Stockholders` Equity, page F-25
9. We note your response to prior comment 30. While the agreement
may provide that the liquidated damages are required to be paid in
cash, the ability to have the registration statement declared
effective remains outside of the control of the issuer. We note
that
the liquidated damages are material and appear to be potentially
unlimited, which renders the settlement option of providing
unregistered shares to settle the warrants uneconomic.
Accordingly,
we believe the warrants are required to be initially classified as
liabilities under EITF 00-19, and then adjusted to fair value at
each
subsequent balance sheet date, with changes in fair value
reflected
in the statement of operations. See paragraphs 14 - 17 of EITF
00-
19. Please revise your financial statements and related
disclosures
accordingly.
10. We note your response to prior comment 42. Please revise the
statement of stockholders` equity and the calculation of net loss
per
share applicable to common shareholders to reflect the dividend,
or
tell us why you believe that no revisions are required.
Part II
Undertakings
11. In your amended filing, please revise to include the new
undertakings that became effective on December 1, 2005. See
Questions 3 through 6 in Securities Offering Reform Transition
Questions and Answers, which is available on our web site at
http://www.sec.gov/divisions/corpfin/transitionfaq.htm. See new
Item
512(a)(4) and 512(g) of Regulation S-B, which were adopted in
Securities Offering Reform, Release No. 33-8591 (July 19, 2005),
which is available on our web site at
http://www.sec.gov/rules/final/33-8591fr.pdf.
Signatures
12. Please have your Chief Financial Officer and Chief Accounting
Officer sign in those capacities.
1934 Act Periodic Reports
13. We note your response to prior comment 27. We also note that
no
filings were made under Item 4.02 of Form 8-K relating to the
various
restatements. Please file the required disclosures under Item
4.02
of Form 8-K as soon as possible.
14. We note your disclosure under Item 307 of Regulation S-B in
each
amended periodic report concludes your disclosure controls and
procedures were effective. Please tell us the specific factors
you
considered in determining your disclosure controls and procedures
were effective, in light of the restatements to your financial
statements disclosed in Note 2 to the financial statements for the
year ended January 31, 2005, and in Note 6 to the financial
statements for the six months ended July 31, 2005.
Closing Comments
As appropriate, please amend your registration statement in
response to these comments. Provide us with marked copies of the
amendment to expedite our review. Please furnish a cover letter
with
your amendment that keys your responses to our comments and
provides
any requested supplemental information. Detailed cover letters
greatly facilitate our review. Please understand that we may have
additional comments after reviewing your amendment and responses
to
our comments.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
Any questions regarding the accounting comments may be
directed
to Carlton Tartar at (202) 551-3387. Questions on other
disclosure
issues may be directed to William Bennett at (202) 551-3389.
Sincerely,
John Reynolds
Assistant Director
cc: Jeffrey J. Fessler
Fax: 212-930-9725
??
??
??
??
V. Randy White, Ph.D
Xenomics, Inc.
February 2, 2006
p. 1
</TEXT>
</DOCUMENT>
2006-02-14 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
SEC Response Letter
February 14,
2006
Securities
and Exchange Commission
Division
of Corporation Finance
100
F
Street, NE
Washington,
D.C. 20549
Attention:
John Reynolds, Esq.
Re:
Xenomics,
Inc.
Form
SB-2 filed August 1, 2005
Amendment
No. 2 to Form SB-2 filed January 9, 2006
File
No. 333-127071
Dear
Mr.
Reynolds:
This
letter sets forth the responses of Xenomics, Inc., a Florida corporation (the
“Company” or “we”), to the comments received from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) by letter dated February
2, 2006 concerning the Company’s Registration Statement on Form SB-2 (File No.
333-127071) filed with the Commission on January 9, 2006 (the “Registration
Statement”). We are authorized by the Company to provide the responses contained
in this letter on behalf of the Company.
The
numbers of the responses in this letter correspond to the numbers of the Staff’s
comments as set forth in its letter to the Company dated January 9, 2006.
References in the text of the responses herein to captions and page numbers
are
to Amendment No. 3 to Form SB-2 which is being filed herewith. For your
convenience, we set forth each comment from your comment letter in bold typeface
and include the Company’s response below it.
General
1.
Please
clarify throughout what “cGMP” means and who or what authority the
guidelines come from.
On
page 7
of Amendment No. 3 to Form SB-2 we have defined cGMP and stated that such
guidelines are promulgated by the FDA.
2.
The
company’s preferred dividend obligation should be discussed in MD&A
under Liquidity and Capital Resources. Any arrearages should be
indicated.
On
page
16 of Amendment No. 3 to Form SB-2 we have added a new paragraph under Liquidity
and Capital Resources discussing our preferred dividend obligations and
indicating
there are no arrearages.
3.
Please
remove what appear to be tags of some sort (<R>) throughout
the unmarked EDGAR version of the
filing.
We
have
removed the tags in Amendment No. 3 to Form SB-2.
Risk
Factors, page 5
4.
The
first risk factor refers to an inception date of April 26, 2002,
which
appears to be in error; it should reconcile with that used in the
financial statements.
On
page 5
of Amendment No. 3 to Form SB-2 we have changed the inception date to August
4,
1999.
Executive
Compensation, page 27
5.
As
previously requested, since none of the persons listed annual salary
and
bonus exceeded $100,000, clarify the reference to compensation of
“$100,000 or more” in the first paragraph. Refer to Item 402(a)(2) of
Regulation S-B for the persons required to be
listed.
On
page
27 of Amendment No.3 to Form SB-2 we have updated the information in the Summary
Compensation Table to include the year ended January 31, 2006. We have deleted
the 2005 numbers because none of the executives had compensation over
$100,000.
6.
In
addition, please update all disclosure hereunder for the most recent
fiscal year.
As
stated
in the prior response, we have updated the disclosure for the most recent fiscal
year.
Plan
of Distribution
7.
The
references to “donees, pledgees, transferees or other
successors-in-interest” should be removed or a statement added that the
identities of such persons will be added by post effective
amendment.
On
page
40 of Amendment No. 3 to Form SB-2 we have added in the statement that the
identities of such persons will be added by a post-effective
amendment.
Financial
Statements, page F-1
Note
2 - Basis of Presentation, page F-9
8.
We
note your response to prior comment 27. Please expand the APB
20
disclosures
in Note 2 on page F-9 and Note 6 on page F-28 to show the amount
and
nature of each material revision. For example, expand the line
item,
“additional stock-based compensation” to disclose the effect of revisions
including:
·
expense
recognition for the Trilogy
warrants,
·
expense
resulting from the use of quoted market
price,
·
the
application of EITF 96-18 to options granted to
non-employees.
For
each material revision, describe the original accounting treatment and the
nature of the error correction. Disclose both amounts recorded in the financial
statements prior to correction, as well as the revised
amounts.
On
page
F-9 and F-28 of Amendment No. 3 to Form SB-2 we have expanded the description
of
the restatements to include the requested disclosures.
Note
4- Stockholders’ Equity, page F-25
9.
We
note your response to prior comment 30. While the agreement may
provide
that the liquidated damages are required to be paid in cash,
the ability
to have the registration statement declared effective remains
outside of
the control of the issuer. We note that the liquidated damages
are
material and appear to be potentially unlimited, which renders
the
settlement option of providing unregistered shares to settle
the warrants
uneconomic. Accordingly, we believe the warrants are required
to be
initially classified as liabilities under EITF 00-19, and then
adjusted to
fair value at each subsequent balance sheet date, with changes
in fair
value reflected in the statement of operations. See paragraphs
14-17 of
EITF 00-19. Please revise your financial statements and related
disclosures
accordingly.
We
have
amended our Forms 10-QSB for the quarters ended July 31, 2005 and October
31,
2005 to reflect the charge to expense and related liability associated with
the
warrants issued in connection with the financing transaction on July 13,
2005 in
accordance with the provisions of EITF #00-19.
10.
We
note your response to prior comment 42. Please revise the
statement of
stockholders’ equity and the calculation of net loss per share applicable
to common shareholders to reflect the dividend, or tell us
why you believe
that no revisions are
required.
On
page
F-17 and F-20 of Amendment No. 3 to Form SB-2 we have revised the calculation
of
net loss per share applicable to the common shareholders and the statement
of
stockholders’ equity.
Part
II
Undertakings
11.
In
your amended filing, please revise to include the new undertakings
that
became effective on December 1, 2005. See Questions 3 through
6 in
Securities Offering Reform Transition Questions and Answers,
which is
available on our web site at http://www.sec.gov/divisions/corpfin/transitionfaq.htm.
See new Item 5l2(a)(4) and 512(g) of Regulation S-B, which
were adopted in
Securities Offering Reform, Release No. 33-8591 (July 19, 2005),
which is
available on our web site at http://www.sec.gov/rules/final/33-8591fr.pdf.
We
have
reviewed the undertakings set forth in Part II of Amendment No. 3 to Form
SB-2
and we believe we are subject to only those undertakings
indicated.
Signatures
12.
Please
have your Chief Financial Officer and Chief Accounting Officer
sign in
those
capacities.
Our
Chief
Financial Officer and Principal Financial Officer has signed Amendment No.
3 to
Form SB-2.
1934
Act Periodic Reports
13.
We
note your response to prior comment 27. We also note that
no filings were
made under Item 4.02 of Form 8-K relating to the various
restatements.
Please file the required disclosures under Item 4.02 of Form
8-K as soon
as
possible.
We
have
filed all of the relevant Form 8-K’s related to the various
restatements.
14.
We
note your disclosure under Item 307 of Regulation S-B in
each amended
periodic report concludes your disclosure controls and procedures
were
effective. Please tell us the specific factors you considered
in
determining your disclosure controls and procedures were
effective, in
light of the restatements to your financial statements disclosed
in Note 2
to the financial statements for the year ended January 31,
2005, and in
Note 6 to the financial statements for the six months ended
July 31,
2005.
Our
Chief
Executive Officer and Principal Financial Officer have concluded that our
disclosure controls and procedures applicable to the preparation of the
financial statements
for the year ended January 31, 2005 and the six months ended July 31, 2005
were
effective at the time those financial statements were filed and have reaffirmed
those conclusions in amended filings. The following paragraph provides
information necessary for an understanding of the Company's position on this
topic.
The
financial statements included in the amended filings were restated in connection
with deferred founders compensation, purchased in-process research and
development, and stock-based compensation. The restatement adjustment for the
first topic was not material in nature to the operating results for the year
ended January 31, 2005. The restatement adjustment for the second topic involved
the interpretation and application of accounting principles applicable to the
accounting for a business combination. Specifically, the Company accounted
for
the acquisition of the Xenomics operating company by Used Kar Parts, Inc. as
a
conventional acquisition. Upon subsequent re-examination of the circumstances,
it was deemed that this transaction would be appropriately accounted for as
a
reverse merger. The restatement adjustment for the third topic involved the
determination of the most appropriate value of the Company's common shares
to be
used in the calculation of stock compensation. Specifically, the Company elected
to use $1.95 per share for such calculations rather than the quoted market
price
with a simple average of $3.70 during the applicable period. The Company viewed
the former amount was a better representation of the Company's value since
$5.3
million was raised from new investors at that price while the latter was the
result of very limited trading of the Company's stock, frequently only a few
hundred shares per day, in the over-the-counter-market.
As
previously indicated, the restatement for the first topic was not material
in
nature. The restatement for the second and third topics and the accounting
related thereto required professional and business judgment and were thoroughly
discussed with the Company's Chief Executive Officer and Independent Registered
Public Accounting Firm prior to the filing of the original financial statements.
Review of these topics at the highest level of the Company coupled with reliance
upon the Independent Registered Public Accounting Firm are the two primary
factors considered in the development of the Company's statements regarding
the
effectiveness of disclosure controls and procedures.
Very truly yours,
/s/
Jeffrey J. Fessler
2006-01-25 - UPLOAD - Cardiff Oncology, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
MAIL STOP 3561
November 28, 2005
V. Randy White, Ph.D
Chief Executive Officer
Xenomics, Inc.
420 Lexington Avenue, Suite 1701
New York, New York 10170
Re: Xenomics, Inc.
Amendment No. 1 to Registration Statement on Form SB-2
File No. 333-127071
Filed October 28, 2005
Dear Dr. White:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments.
Table of Contents
1. Please remove or relocate the boiler-plate paragraph following
the
table of contents.
Prospectus Summary
2. The background and development of both Used Kar Parts, Inc. and
Xenomics Sub should be fully discussed pursuant to Item 101 of
Regulation S-B.
Risk Factors, page 6
3. As noted in prior comment 10 to our letter dated September 2,
20052, several of your risk factors and subheadings are too broad
and
generic and should be revised to state the material risk that is
specific to Xenomics, Inc. As a general rule, a risk factor is
probably too generic if it is readily transferable to other
offering
documents or describes circumstances or factual situations that
are
equally applicable to other similarly situated businesses. Risk
factors 10, 12, 14, 21, 27 and 28 should be revised, deleted or
moved
to another section of the prospectus.
4. The second risk factor does not appear material in view of the
liquid assets of the company at the latest balance sheet date and
the
disclosure on page 16 that "we expect that existing capital
resources
will be sufficient...for at least the next twelve months."
5. The 23rd and 24th risk factors are duplicative.
Note Regarding Forward-Looking Statements, page 13
6. We continue to note the statement that you "undertake no
obligation to update or revise any of the forward-looking
statements
after the date of this prospectus to conform forward-looking
statements to actual results." As stated in prior comment 13 to
our
letter dated September 2, 2005, if new information or certain
events
arise that would make your current forward-looking statements
materially misleading, you would need to update your disclosure as
required by federal securities law and the undertakings in Item 28
to
the registration statement.
Management`s Discussion and Analysis of Financial Condition or
Plan
of Operation
History, page 13
7. As requested in prior comment 15 to our letter dated September
2,
2005, provide the name and the identity of the control persons and
promoters of the company and its predecessors.
8. We note that statement in the fourth paragraph that
substantially
all of the $9.6 million you have raised from the sale of your
securities as of July 31, 2005 has been used on development of the
TR-DNA technology. We also note that as of July 31, 2005, you
have
total current assets of $6.5 million, which we presume also was
generated from the sale of your securities. Given that you have
not
generated any revenue to date, we do not understand how you could
have expended substantially all of the $9.6 million raised to date
on
development of the TR-DNA technology and still show total current
assets of $6.5 million as of July 31, 2005. We further note that
from inception to July 31, 2005, only $2.8 million has been spent
on
R&D. Please revise.
Plan of Operations, page 15
9. Please allocate the amounts necessary over the next 12 months
to
cover the following budgeted expenses: (1) characterizing
molecular
markers for two prenatal tests; (2) optimizing detection methods;
(3)
demonstrating measurement of the markers; (4) converting existing
research into methods that can be commercialized; (5) making the
required changes to your existing facility or moving to a new
facility that meets cGMP guidelines; and (6) purchasing bulk
quantities of materials and reagents.
10. We note that you do not have any prior manufacturing
experience
and that this may result in your inability to develop reproducible
and effective manufacturing processes. Please consider discussing
this in a risk factor.
11. The disclosure in the fifth paragraph indicates that your
current
facility does not meet cGMP guidelines. In the last sentence of
the
same paragraph you also state that your facilities will be
adequate
for your anticipated level of activity during 2006. Given that
your
stated level of activity during the second half of 2006
anticipates
you operating under cGMP guidelines, we find these statements
confusing.
12. Update the table of contractual obligations on page 16 to at
least the most recent balance sheet date.
13. The paragraph following the table under Contractual
Obligations
and Commitments should be updated to the effective date to state
the
amount owing to the selling stockholders as a result of not having
the filing effective on October 25, 2005.
14. Correct the two references to "registration statement", which
apparently should be "registration rights agreement".
Description of Business, page 24
15. Research and development expenditures for each of the past two
fiscal years should be indicated; see Item 101(b)(10).
Directors and Executive Officers, page 25
16. Include the disclosure required pursuant to Item 401(a)(3) of
Regulation S-B.
17. Under "Compliance with Section 16(a) of the Exchange Act," you
indicate that during 2005, your common stock was not registered
under
Section 12 of the Exchange Act. Please advise how you satisfy the
OTCBB listing criteria that all companies be registered under
Section
12 prior to trading on the bulletin board.
Executive Compensation, page 28
18. Please move the discussion of the consulting agreement with
Mr.
Cerrone this section.
19. Under "Stock Option Plan," please advise to whom the 1,290,000
options were issued and the value attributed to these options. In
this regard, distinguish between third party consultants and
employees. Disclose when you will seek stock holder approval for
an
increase in the number of shares that can be granted under the
plan.
20. Clarify the reference to compensation of "$100,000 or more" in
the first paragraph.
Security Ownership of Certain Beneficial Owners and Management,
page
33
21. Reference is made to footnotes (1) and (3). Beneficial
ownership
is to be determined in accordance with the Instruction to Item 403
of
Regulation S-B and not in accordance with Rule 13d or Section 16
of
the Exchange Act. As such, revise the disclosure in footnotes one
and three regarding Rule 13d and Section 16 and delete the
disclaimer
of beneficial ownership in footnote three since Section 16 is not
applicable.
22. As requested in prior comment 37 to our letter dated September
2,
2005, please identify the control person(s) for Panetta Partners,
Ltd. Please also reconcile the reference to Mr. Cerrone as the
"Managing Partner" with page 37 which refers to him as "the
general
partner."
23. It is not clear whether the table reflects the common shares
issuable upon conversion of the Series A Convertible Preferred.
Indicate the holders of the preferred.
Selling Stockholders, page 37
24. Identify via footnotes the selling shareholders that are
parties
to the 2004 voting agreement, which we believe illustrates a
material
relationship with the company beyond a mere investor. See Item
507
of Regulation S-B.
Certain Relationships and Related Transactions, page 37
25. As requested in prior comment 40 to our letter dated September
2,
2005, please include the full disclosure regarding transactions
with
promoters during the past 5 years, including their identity, as
required under Item 404(d) of Regulation S-B. See Rule 405 of
Regulation C for the definition of "promoter."
Financial Statements, page F-1
26. We note your response to prior comment 52. Please revise the
financial statements to provide footnote disclosures describing
the
material terms of the contributed services.
27. We note the revisions made to the financial statements in
response to prior comments 52, 56, 64 and 65. Please disclose on
the
face of the financial statements that they have been restated,
disclose in a note the nature and amount of the restatements as
required by paragraph 37 of APB 20 and direct your independent
accountant to refer to the restatement of the annual financial
statements in its report and dual-date or redate the report.
Provide
similar disclosures in your amended Form 10-KSB and Form 10-QSB
filings for the affected periods.
Notes 5 and 4 - Stockholders` Equity, pages F-11 and F-24
28. We note your response to prior comment 63. Please clarify the
specific liquidated damage provisions that are applicable to each
of
the private placements that closed on January 28, 2005, February
5,
2005, April 7, 2005, and July 13, 2005. Based on the registration
rights agreement filed on February 3, 2005, it appears that, with
respect to the first three offerings, a penalty was incurred
relating
to the initial filing of the registration statement, but no
additional penalties will be incurred if the registration
statement
is not declared effective or effectiveness is not maintained.
Please
tell us whether this is the case, and revise your disclosures
accordingly.
29. Please disclose the fair value of the warrants issued to the
investors in the private placements that closed on each of January
28, 2005, April 7, 2005 and July 13, 2005, along with the major
assumptions used to value the warrants. We note that the fair
value
of the warrants issued to the placement agents is disclosed, but
not
the fair value of the warrants sold to the investors in each
offering.
30. With respect to the July 13, 2005 private placement, based on
the
registration rights agreement filed on July 19, 2005, it would
appear
that the fair value of the warrants should be recorded as a
liability
in your financial statements, because all of the conditions for
equity classification under EITF 00-19 are not met. Specifically,
we
note that the liquidated damage provisions of the agreement
effectively require the warrants to be settled in registered
shares,
which is considered to be outside of the control of the issuer.
The
warrants should be fair-valued at each subsequent balance sheet
date
and changes in fair value should be reflected in the statement of
operations. Provide the necessary disclosures in an explanatory
footnote.
31. We note your response to prior comment 64. Please tell us why
you believe that it is appropriate to amortize the stock-based
compensation expense over the one year period. We note the
warrants
are exercisable upon issuance, which would indicate that no future
service is required, and that the full amount of measured
compensation expense should be recognized at the date of issuance.
Alternatively, if future service is required, the warrants would
need
to be remeasured at each balance sheet date in accordance with
EITF
96-18. Please revise your financial statements and related
disclosures accordingly, or explain in more detail why you believe
that no revisions are required.
Note 6 - Stock Option Plan, page F-12
32. We note your response to prior comment 65. Please revise your
disclosure in the annual financial statements and MD&A to provide
similar disclosures to those made in the interim financial
statements. In addition, please revise your disclosure in
critical
accounting policies on page 18 to state the amount of additional
compensation expense that would be required to be recorded with
respect to these options at the most recent balance sheet date.
Refer to Section V of the Commission`s MD&A guidance in Release
33-
8350, which may be obtained at http://www.sec.gov/rules/interp/33-
8350.htm, and revise your disclosures accordingly. Also, please
revise your disclosures to specifically identify the option grants
that are subject to shareholder approval.
33. According to your response to prior comment 66 and Exhibit 1
to
your response, prior to January 31, 2005, you used the most recent
private placement price to determine stock-based compensation
because
you felt the closing price on the thinly traded over-the-counter
market was not indicative of market value. While this treatment
may
be appropriate for periods prior to July 27, 2004, when your
shares
were first traded on the Bulletin Board, this treatment does not
appear appropriate for options issued on and after that date.
Even
when the company`s stock is thinly traded, it is still necessary
to
use the quoted market price in valuing the stock award. In
paragraph
10 of APB 25, the Board acknowledges "market quotations at a given
date are not necessarily conclusive evidence" of fair value of
shares
of stock but concludes that, for purposes of the Opinion, the
unadjusted quoted market price of a share of stock should be used
in
measuring compensation. Please revise the financial statements
and
footnotes accordingly.
34. We note your response to prior comment 70. Please consider
the
impact of the option grants to Dr. White on the tax-qualified
status
of the option plan, as well as whether the grant of the options
represents an illegal act by the Company. If you believe there
may
be any resulting impact on the financial statements, please revise
your disclosures accordingly.
Note 5 - Commitments and Contingencies, page F-25
35. We note your response to prior comment 73. While the
acceleration has not yet resulted in the affected employees being
able to exercise options that would have otherwise expired
unexercised, this will be the case if any of the employees
terminate
their employment prior to the date they would have otherwise fully
vested in the award. If this were to occur, then you will be
required to record compensation expense based on the intrinsic
value
on the date of modification. Note that your situation is
analogous
to that outlined in Illustration 3(a) of FIN 44, except that with
a
relatively small number of affected employees, there would be no
basis for recording an estimate of future terminations.
Accordingly,
while compensation expense would be measured at the date of
modification, no compensation expense would actually be recorded
until the date of any future terminations prior to the original
vesting date. Please provide discussion of this matter in MD&A
and
the footnotes, and disclose the amount of intrinsic value
resulting
from the acceleration of options granted to Mr. Umansky and Mr.
Melkonyan that would be recognized in the future if these
individuals
terminated their employment prior to the original vesting dates.
Note that since Mr. Cerrone and Dr. Tomei are non-employees, the
modifications relating to these individuals should be accounted
for
under EITF 96-18 rather than FIN 44. Please revise accordingly.
36. We note your response to prior comment 74. Please revise the
biographical information on page 25 to include the services
performed
by Mr. Cerrone on behalf of the Company prior to June 2005.
37. In your supplemental response to prior comment 74, you state
Mr.
Cerrone`s options were subject to shareholder approval. Please
explain why these 1,050,000 options were subject to shareholder
approval, since they appear to be among the first 5,000,000 shares
issued under the plan.
38. In your supplemental response to prior comment 75, you discuss
Dr. Tomei`s 2005 options, but do not address the options for
1,012,500 shares issued in 2004. Please explain to us how you
have
complied with EITF 96-18 in accounting for the issuance and
subsequent acceleration of these options.
39. We note your response to prior comments 74 and 75. Note that
since EITF 96-18 is applicable to the option grants to Mr. Cerrone
and Dr. Tomei, accounting recognition appears to be required
irrespective of whether a measurement date has occurred. The
options
should initially be measured at fair value, and should be
remeasured
at each balance sheet date until the later of the date the awards
are
fully vested, or when a final measurement date is det
2006-01-10 - CORRESP - Cardiff Oncology, Inc.
CORRESP
1
filename1.htm
SEC Response Letter
January
10, 2006
Securities
and Exchange Commission
Division
of Corporation Finance
100
F
Street, NE
Washington,
D.C. 20549
Attention:
John Reynolds, Esq.
Re:
Xenomics,
Inc.
Form
SB-2 filed August 1, 2005
Amendment
No. 1 to Form SB-2 filed October 28, 2005
File
No. 333-127071
Dear
Mr.
Reynolds:
This
letter sets forth the responses of Xenomics, Inc., a Florida corporation (the
“Company” or “we”), to the comments received from the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) by letter dated November
28, 2005 concerning the Company’s Registration Statement on Form SB-2 (File No.
333-127071) filed with the Commission on October 28, 2005 (the “Registration
Statement”). We are authorized by the Company to provide the responses contained
in this letter on behalf of the Company.
The
numbers of the responses in this letter correspond to the numbers of the Staff’s
comments as set forth in its letter to the Company dated November 28, 2005.
References in the text of the responses herein to captions and page numbers
are
to Amendment No. 2 to Form SB-2 which is being filed herewith. For your
convenience, we set forth each comment from your comment letter in bold typeface
and include the Company’s response below it.
Table
of Contents
1.
Please
remove or relocate the boiler-plate paragraph following the table
of
contents.
We
have
removed the boiler plate paragraph following the table of contents in Amendment
No. 2 to Form SB-2.
Prospectus
Summary
2.
The
background and development of both Used Kar Parts, Inc. and Xenomics
Sub
should be fully discussed pursuant to Item 101 of Regulation
S-B.
On
page 4
of Amendment No. 2 to Form SB-2 we have modified the Prospectus Summary to
include the background and development of Used Kar Parts, Inc. and Xenomics
Sub.
Risk
Factors, page 6
3.
As
noted in prior comment 10 to our letter dated September 2, 2005,
several
of your risk factors and subheadings are too broad and generic and
should
be revised to state the material risk that is specific to Xenomics,
Inc.
As a general rule, a risk factor is probably too generic if it is
readily
transferable to other offering documents or describes circumstances
or
factual situations that are equally applicable to other similarly
situated
businesses. Risk factors 10, 12, 14, 21, 27 and 28 should be revised,
deleted or moved to another section of the
prospectus.
On
pages 5
to 11of Amendment No. 2 to Form SB-2 we have revised Risk Factors 10, 12, 14,
21, 26 and 27.
4.
The
second risk factor does not appear material in view of the liquid
assets
of the company at the latest balance sheet date and the disclosure
on page
16 that “we expect that existing capital resources will be sufficient for
at least the next twelve
months.”
On
page 5
of Amendment No. 2 to Form SB-2 we have revised the second risk
factor.
5.
The
23rd
and 24th
risk factors are
duplicative.
On
page 10
of Amendment No. 2 to Form SB-2 we have consolidated the 23rd
and
24th
risk
factor in to one risk factor.
Note
Regarding Forward-Looking Statements, page 13
6.
We
continue to note the statement that you “undertake no obligation to update
or revise any of the forward-looking statements after the date of
this
prospectus to conform forward-looking statements to actual results.” As
stated in prior comment 13 to our letter dated September 2, 2005,
if new
information or certain events arise that would make your current
forward-looking statements materially misleading, you would need
to update
your disclosure as required by federal securities law and the undertakings
in Item 28 to the registration
statement.
On
page 12
of Amendment No. 2 to Form SB-2 we have deleted the statement that we “undertake
no obligation to update or revise any of the forward-looking statements after
the date of this prospectus to conform forward-looking statements to actual
results.”
Management’s
Discussion and Analysis of Financial Condition or Plan of
Operation
History,
page 13
7.
As
requested in prior comment 15 to our letter dated September 2, 2005,
provide the name and the identity of the control persons and promoters
of
the company and its
predecessors.
On
page 12 of Amendment No. 2 to Form SB-2 we have added the names and
identity of the control persons and promoters of the Company and
its
predecessors.
8.
We
note that statement in the fourth paragraph that substantially all
of the
$9.6 million you have raised from the sale of your securities as
of July
31, 2005 has been used on development of the TR-DNA technology. We
also
note that as of July 31, 2005, you
have total current assets of $6.5 million,
which we presume also was generated from the sale of your securities.
Given that you have not generated any revenue to date, we do not
understand how you could have expended substantially all of the $9.6
million raised to date on development of the TR-DNA technology and
still
show total current assets of $6.5 million
as of July 31, 2005. We
further note that from inception to July 31, 2005, only $2.8 million
has
been spent on R&D. Please
revise.
On
page 13
of Amendment No. 2 to Form SB-2 we have revised the fourth paragraph under
History to state that we anticipate that substantially all of the $9,643,738
raised will be used on development of the Tr-DNA technology.
Plan
of Operations, page 15
9.
Please
allocate the amounts necessary over the next 12 months to cover the
following budgeted expenses: (1) characterizing molecular markers
for two
prenatal tests; (2) optimizing detection methods; (3) demonstrating
measurement of the markers; (4) converting existing research into
methods
that can be commercialized; (5) making the required changes to your
existing facility or moving to a new facility that meets cGMP guidelines;
and (6) purchasing bulk quantities of materials and
reagents.
The
expenses related to the product development milestones listed in
the
fourth paragraph of Plan of Operations will primarily consist of
labor
costs and reagent and chemical costs. On page 14 of Amendment No.
2 to
Form SB-2, we have disclosed the aggregate amount of labor costs
and
reagent and chemical costs we believe will be sufficient for our
plan of
operations in 2006. It
is not possible to accurately predict the exact costs associated
with each
of these product development steps since our scientific personnel
work
simultaneously on multiple projects and the various projects may
proceed
faster or slower than expected, especially those for Down syndrome
that
are dependent upon gaining access to human clinical samples that
are
positive for the genetic disorder and the frequency of obtaining
such
positive sample is beyond our control. We
believe it would be misleading to the reader for us to estimate the
amount
of expenses allocated to each of our product development milestones
since
there are many variables associated with each product development
step and
we have no way of predicting the amount of labor costs allocated
to each
milestone. We believe that an estimate of the aggregate amount of
expenses
related to what we believe will be accomplished in 2006 is more relevant
to the reader.
10.
We
note that you do not have any prior manufacturing experience and
that this
may result in your inability to develop reproducible and effective
manufacturing processes. Please consider discussing this in a risk
factor.
On
page 8
of Amendment No. 2 to Form SB-2 we have added a risk factor entitled
“We
have
limited manufacturing experience and once our products are approved, if at
all,
we may not be able to manufacture sufficient quantities at an acceptable
cost.
11.
The
disclosure in the fifth paragraph indicates that your current facility
does not meet cGMP guidelines. In the last sentence of the same paragraph
you also state that your facilities will be adequate for your anticipated
level of activity during 2006. Given that your stated level of activity
during the second half of 2006 anticipates you operating under cGMP
guidelines, we find these statements
confusing.
On
page 15
of Amendment No. 2 to Form SB-2 we have modified the last paragraph in our
Plan
of Operations.
12.
Update
the table of contractual obligations on page 16 to at least the most
recent balance sheet date.
On
page 16
of Amendment No. 2 to Form SB-2 we have updated the table of contractual
obligations to October 31, 2005.
13.
The
paragraph following the table under Contractual Obligations and
Commitments should be updated to the effective date to state the
amount
owing to the selling stockholders as a result of not having the filing
effective on October 25,
2005.
On
page 16
of Amendment No. 2 to Form SB-2 we have modified the paragraph following the
table of contractual obligations to state that $27,710 is paid every 30 days
until the registration statement is effective. We have also added the amount
paid to date to such selling stockholders.
14.
Correct
the two references to “registration statement”, which apparently should be
“registration rights
agreement”.
On
page 16
of Amendment No. 2 to Form SB-2 we have corrected the two references to
registration statement.
Description
of Business, page 24
15.
Research
and development expenditures for each of the past two fiscal years
should
be indicated; see Item
l0l(b)(10).
On
page 20
of Amendment No. 2 to Form SB-2 we have added in our Research and Development
expenditures for each of the past two fiscal years and the nine months ended
October 31, 2005 and 2004.
Directors
and Executive Officers, page 25
16.
Include
the disclosure required pursuant to Item 401(a)(3) of Regulation
S-B.
On
page 24
of Amendment No. 2 to Form SB-2 we have added in the disclosure required
pursuant to Item 401(a)(3) of Regulation S-B.
17.
Under
“Compliance with Section 16(a) of the Exchange Act,” you indicate that
during 2005, your common stock was not registered under Section 12
of the
Exchange Act. Please advise how you satisfy the OTCBB listing criteria
that all companies be registered under Section 12 prior to trading
on the
bulletin board.
With
all
due respect we believe that companies are not required to be registered under
Section 12 to be listed on the OTCBB. According to the OTCBB Eligibility Rule,
OTCBB issuers must be registered with the SEC under Section 13 or 15(d) of
the
Securities and Exchange Act of 1934.
Executive
Compensation, page 28
18.
Please
move the discussion of the consulting agreement with Mr. Cerrone
to this
section.
The
discussion of the consulting agreement with Mr. Cerrone has been moved to
“Executive Compensation-Consulting Agreement” on page 28 of Amendment No. 2 to
Form SB-2.
19.
Under
“Stock Option Plan,” please advise to whom the 1,290,000 options were
issued and the value attributed to these options. In this regard,
distinguish between third party consultants and employees. Disclose
when
you will seek stockholder approval for an increase in the number
of shares
that can be granted under the
plan.
On
page 29
of Amendment No. 2 to Form SB-2 we have disclosed to whom the 1,326,000 options
were granted to as well as the value of such options and the affiliation of
such
person to the Company. In addition we have disclosed that we will seek
stockholder approval in April 2006 for an increase in the number of shares
that
can be granted under the plan.
20.
Clarify
the reference to compensation of “$100,000 or more” in the first
paragraph.
On
page 27
of Amendment No. 2 to Form SB-2 we have clarified the reference to compensation
of $100,000 or more.
Security
Ownership of Certain Beneficial Owners and Management, page
33
21.
Reference
is made to footnotes (1) and (3). Beneficial ownership is to be de
2005-11-14 - UPLOAD - Cardiff Oncology, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
MAIL STOP 3561
September 2, 2005
V. Randy White, Ph.D
Chief Executive Officer
Xenomics, Inc.
420 Lexington Avenue, Suite 1701
New York, New York 10170
Re: Xenomics, Inc.
Registration Statement on Form SB-2
File No. 333-127071
Filed August 1, 2005
Dear Dr. White:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Prospectus Cover Page
1. Please include only the information required by Item 501 of
Regulation S-B. Thus, all of the information relating to private
placements should be removed.
2. Please highlight the risk factor cross reference by prominent
type
or in another manner. See Item 501(a)(5) of Regulation S-B.
3. We note the statement that you do not know "when, how or if the
selling stockholders" intend the sell their shares. "How" they
intend to sell their shares is set forth in the Plan of
Distribution
and should therefore be deleted from the cover page.
4. Please provide the dealer prospectus delivery obligation on the
outside back cover page of the prospectus as set forth in Item
502(b)
of Regulation S-B.
5. Please advise how you arrived at the 103,200 shares of common
stock to be issued as "in kind dividends."
Prospectus Summary, page 5
6. The background and development of the predecessor company
should
be fully discussed pursuant to Item 101 of Regulation S-B.
7. Please reconcile the disclosure under "Shares offered by the
Selling Stockholders" with the cover page and fee table.
8. Please provide your website address.
Risk Factors, page 6
9. The introductory paragraph suggests that you are incorporating
information from other reports. As you know, incorporation by
reference is not available on Form SB-2. Please revise the
introductory paragraph or delete it.
10. Several of your risk factors are too broad and generic and
should
be revised to state the material risk that is specific to
Xenomics,
Inc. As a general rule, a risk factor is probably too generic if
it
is readily transferable to other offering documents or describes
circumstances or factual situations that are equally applicable to
other similarly situated businesses. Risk factors 9, 11, 13, 20,
22, 23, 24, 26 and 27 should be revised, deleted or moved to
another
section of the prospectus as appropriate.
11. The second paragraph of risk factor two addresses a risk
distinct
from the subheading. Please provide an appropriate subheading to
address the risk of dilution to shareholders.
12. Clarify in risk factor 12 whether you have filed an
application
with the FDA.
Note Regarding Forward-Looking Statements, page 13
13. We note your statement that "[w]e undertake no obligation to
update forward-looking statements." If new information or certain
events arise that would make your current forward-looking
statements
materially misleading, you would need to update your disclosure as
required by federal securities law. As such, please revise your
disclosure accordingly.
14. We also note your reference to the Private Securities
Litigation
Reform Act of 1995. Be advised that Section 27A(b)(1)(C) of the
Securities Act and Section 21E(b)(1)(C) of the Securities Exchange
Act expressly state that the safe harbor for forward looking
statements does not apply to statements made by companies that
issue
penny stock. Please either:
* delete any references to the Private Securities Litigation
Reform
Act; or
* make clear, each time you refer to the Litigation Reform Act,
that
the safe harbor does not apply to your company.
Management`s Discussion and Analysis of Financial Condition or
Plan
of Operation, page 13
History
15. Item 101(a) of Regulation S-B requires that you describe the
business development of the company for the past 3 years. Such a
discussion would include the business history of the company, its
subsidiary, and its predecessor(s) as well as the name and the
identity of the control persons and promoters of the same and the
consideration paid in all merger transactions and share purchase
agreements. "Predecessor" is defined in Rule 405 of Regulation C.
16. Elaborate on the material terms of the Voting Agreement,
including the identity of the parties.
17. We note you granted an option to the former Xenomics Sub
shareholders that becomes exercisable in the event you fail to
apply
at least 50% of the net proceeds you raise during the period
ending
July 1, 2006. Please quantify what this amount will be or is
expected to be. Indicate whether you have any plans, formal or
otherwise, to secure such funding. Disclose the material terms of
the option, including the exercise price, option price and cure
provision.
Plan of Operations
18. Please allocate the amounts necessary over the next 12 months
to
cover all budgeted expenses deemed material. Discuss the
anticipated
milestones in implementing your plan of operation over the next 12
months and the time frame and cost for beginning and completing
each.
Contractual Obligations and Commitments
19. Reference is made to Note 5 of the financial statements. It
appears that the shares issued in January 2005 and April 2005
carry
registration rights which require that the company file a
registration statement with the Commission by the 120th day after
closing and that failure to do so will result in certain penalties
to
the company that accrue on a monthly basis. Please disclose this
fact and the status of all such penalties.
Critical Accounting Policies
20. We note your disclosure that the results of operations for
Xenomics are included in the consolidated results of operations
only
since July 2, 2004, the date of the transaction, along with
similar
disclosure on page 14 under the caption "Business Combination".
Since the transaction was treated as a recapitalization rather
than a
business combination, the results of operations should be those of
Xenomics since inception. Please revise your disclosures
accordingly.
21. Please correct the reference to "this Annual Report on Form
10-
KSB."
Description of Business, page 17
The Market
22. Your website discloses that the DNA testing market is growing
at
35%-45% per annum. Please disclose this fact in the prospectus
and
provide substantiating support. Alternatively, delete this claim
from your website.
SpaXen Joint Venture
23. Please disclose the role of the supervisory board and its
level
of authority.
Intellectual Property
24. Please elaborate on your patents, including duration. See
Item
101(b)(7) of Regulation S-B.
25. You disclose that you have no foreign patents. Your website
indicates you do.
Manufacturing
26. Please include the information required by Item 101(b)(5) of
Regulation S-B regarding raw materials and suppliers.
27. Please provide the disclosure required under Item 101(b)(2) of
Regulation S-B regarding distribution.
Government Regulation
28. If applicable, please provide the disclosure required by Item
101(b)(11) of Regulation S-B regarding compliance with
environmental
laws.
Description of Property
29. Please file all leases as exhibits.
Directors and Executive Officers, page 24
30. Please disclose the number of hours per week that Dr. Tomei
will
contribute to SpaXen.
31. Please disclose Mr. Cerrone`s affiliation with Panetta
Partners
and the business of Panetta. In this regard, we note that Panetta
purchased 97% of the outstanding shares of Used Kar Parts prior to
the share exchange with Xenomics. Also disclose Mr. Cerrone`s
relationship with Venus Beauty Supply and Fermavir
Pharmaceuticals.
32. Please disclose Mr. White`s business activity from December
2002
to September 2004.
33. The disclosure for Dr. Melkonyan indicates that he was
"associated" with Xenomics from 1999 until 2004. Please clarify
"associated."
Executive Compensation, page 27
34. Please include the information required by Item 402 of
Regulation
S-B for the last three completed fiscal years. See Item 402(b) of
Regulation S-B.
35. Please file all employment and consulting agreements as
exhibits.
Market for Common Equity and Related Stockholder Matters, page 31
36. Please provide the full disclosure required by Item 201(a)(ii)
of
Regulation S-B. We do not understand reference to Fiscal 2006.
Security Ownership of Certain Beneficial Owners and Management,
page
32
37. Reference is made to footnote 2. Please identify the control
person for Panetta Partners. If the control person is Mr.
Cerrone,
we do not understand the basis for his disclaimer of beneficial
ownership.
38. It is not clear whether the disclosure reflects the voting
agreement. Please clarify.
Selling Stockholders, page 34
39. Reference is made to the last sentence of the fifth paragraph
regarding the number of shares in this offering being
automatically
increased by the number of shares of common stock issued as in-
kind
dividends. Please provide us with an analysis as to why these
additional shares will not need to be added to this registration
statement by amendment.
Certain Relationships and Related Transactions, page 20
40. Please include the full disclosure regarding transactions with
promoter during the past 5 years as required under Item 404(d) of
Regulation S-B. See Rule 405 of Regulation C for the definition
of
"promoter."
41. Please indicate whether there are any existing relationships
or
plans to create relationships between the company and the various
entities affiliated with your officers, directors, principal
shareholders and promoters. In this regard, we note that several
of
the entities affiliated with your officers, directors, principal
shareholders and promoters are engaged in similar fields. See for
example, Callisto Pharmaceuticals and Fermavir Pharmaceutical.
42. We note your statement that the principal purpose of redeeming
shares held by Panetta was to lower Panetta`s level of share
ownership relative to non-affiliates. Based on a Form 8-K filing
made on March 11, 2004, it appears to us that the principal
purpose
of the redemption was to compensate Mr. Cerrone and/or Panetta for
the 2,000,000 shares which were purchased in February 2004 for
$386,400 and to allow for the July 2004 share exchange with the
Xenomics Sub shareholders.
43. Please disclose the $50,000 signing bonus to be paid to Mr.
Cerrone and the annual 15% cash bonus.
44. Supplementally advise as to the relationship between your
officers, directors, principal shareholders and promoters and
Rivington Technologies.
45. Concerning the redemption of shares of Panetta Partners Ltd.,
please add the following:
* The basis of the $500,000 valuation;
* Whether paid in cash;
* The percentage of shares owned by Panetta at the time of the
transaction;
* The date of purchase by Panetta and the price(s) paid;
* Dollar amount of gain to Panetta as a result of the transaction;
* The control person(s) of Panetta at the time of the transaction.
Description of Securities, page 38
46. Please disclose whether the common stock has cumulative voting
rights.
47. Briefly discuss the "subsequent equity sales" provision of the
Series A shares.
48. The statement that all of the outstanding shares of common
stock
are "fully paid and nonassessable" is a legal conclusion that you
are not qualified to make. Either attribute this statement to
counsel and file counsel`s consent to be named in this section, or
delete it.
Where You Can Find More Information, page 42
49. Please be advised of the Commission`s new address:
100 F Street, NE
Washington, DC 20549
In doing so, please also be advised that the Chicago and New York
public reference facilities are no longer operational.
Financial Statements
50. Please provide a currently dated consent in any amendment and
ensure the financial statements are updated as required by Item
310(g) of Regulation S-B.
Audit Report, page F-2
51. The audit report refers only to the income statement period
ended
January 31, 2005, but the financial statements also include
information relating to the year ended January 31, 2004, and the
period from inception to January 31, 2005. Please discuss with
your
auditor and ask them to revise the report to reference all periods
presented in the financial statements.
Statement of Operations, page F-4
52. We note that the statement of operations includes virtually no
operating expenses for the year ended January 31, 2004. Please
explain how this could be the case, if Xenomics maintained
operations
during this period. We note your disclosures on page 24 that Dr.
Tomei and Mr. Umansky co-founded Xenomics in 1998. Please tell us
the approximate amount of time that was incurred by these
individuals
on company business during the year ended January 31, 2004. Note
that all costs of doing business should be included in the
registrant`s financial statements, including expenses incurred on
its
behalf by its major shareholders. Where services are performed for
the company by its major shareholders at no charge, we believe
that
the substance of such transactions is the payment of the company`s
expenses through a capital contribution by the shareholder. See
Staff Accounting Bulletin Topics 1.B.1 and 5.T. Please revise the
financial statements accordingly, or tell us why you believe that
no
revisions are required.
Statement of Stockholders` Equity, page F-5
53. Please revise the statement to include the relevant balances
since inception, as required by FAS 7 for development stage
companies.
54. Please explain why the statement of stockholders` equity
reports
13,166,502 shares outstanding as of January 31, 2003. While we
would
expect 13,166,502 shares to be outstanding after the merger on
July
2, 2004, it is not clear why the 10.9 million shares of Used Kar
Parts would be reported prior to the merger. Also, we note the
recapitalization appears to have resulted in a significant
increase
to equity for Xenomics, based on the financial statements of
Xenomics
provided in your 8-K/A filed on September 15, 2004. Please tell
us
how this could have occurred, as a recapitalization would
typically
not result in an increase to equity, unless cash or other assets
were
received in the transaction.
Cash Flow Statement, page F-6
55. Please revise the presentation of the financing activities
section of the statement to present repurchases of common stock
separately from issuances. Also, disclose cash paid for interest
and
taxes. If none, please indicate this in your disclosure.
Note 1 - Business Overview, page F-7
56. Please explain, in detail, how you determined that a charge
for
purchased in-process development was appropriate, when you state
that
the transaction was accounted for as a recapitalization. We note
that purchased in-process research and development charges
typically
occur in a transaction accounted for as a business combination as
discussed in paragraph 42 of FAS 141. By contrast, in a
recapitalization, no goodwill or intangible assets are recorded
since
no business combination has occurred.
57. Please tell us why the shares transferred to escrow were
recorded
at their par value, rather than the fair value of t