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Company Responses
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Forte Biosciences, Inc.
Response Received
1 company response(s)
High - file number match
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Forte Biosciences, Inc.
Response Received
1 company response(s)
High - file number match
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Forte Biosciences, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-09-05
Forte Biosciences, Inc.
Summary
UPLOAD · 2023-09-05
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Forte Biosciences, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2023-08-29
Forte Biosciences, Inc.
Summary
CORRESP · 2023-08-29
Generating summary...
Forte Biosciences, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-06-02
Forte Biosciences, Inc.
Summary
UPLOAD · 2023-06-02
Generating summary...
Forte Biosciences, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-06-03
Forte Biosciences, Inc.
Summary
UPLOAD · 2021-06-03
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Company responded
2021-06-03
Forte Biosciences, Inc.
Summary
CORRESP · 2021-06-03
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Forte Biosciences, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2020-04-22
Forte Biosciences, Inc.
Summary
UPLOAD · 2020-04-22
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Company responded
2020-04-27
Forte Biosciences, Inc.
References: April 21, 2020
Summary
CORRESP · 2020-04-27
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Company responded
2020-05-12
Forte Biosciences, Inc.
Summary
CORRESP · 2020-05-12
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Company responded
2020-05-12
Forte Biosciences, Inc.
References: May 11, 2020
Summary
CORRESP · 2020-05-12
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Company responded
2020-05-13
Forte Biosciences, Inc.
References: October 24, 2019
Summary
CORRESP · 2020-05-13
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Forte Biosciences, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-05-11
Forte Biosciences, Inc.
Summary
UPLOAD · 2020-05-11
Generating summary...
Forte Biosciences, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2018-05-21
Forte Biosciences, Inc.
Summary
CORRESP · 2018-05-21
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SEC wrote to company
2018-05-22
Forte Biosciences, Inc.
Summary
UPLOAD · 2018-05-22
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Forte Biosciences, Inc.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2017-03-23
Forte Biosciences, Inc.
Summary
UPLOAD · 2017-03-23
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Company responded
2017-03-28
Forte Biosciences, Inc.
References: November 16, 2015
Summary
CORRESP · 2017-03-28
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Company responded
2017-04-10
Forte Biosciences, Inc.
Summary
CORRESP · 2017-04-10
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Company responded
2017-04-10
Forte Biosciences, Inc.
Summary
CORRESP · 2017-04-10
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Forte Biosciences, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-03-06
Forte Biosciences, Inc.
Summary
UPLOAD · 2017-03-06
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Company responded
2017-03-09
Forte Biosciences, Inc.
References: March 6, 2017
Summary
CORRESP · 2017-03-09
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Forte Biosciences, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-07-21
Forte Biosciences, Inc.
Summary
UPLOAD · 2016-07-21
Generating summary...
Forte Biosciences, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-12-02
Forte Biosciences, Inc.
Summary
UPLOAD · 2015-12-02
Generating summary...
Forte Biosciences, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-11-17
Forte Biosciences, Inc.
Summary
UPLOAD · 2015-11-17
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-01 | SEC Comment Letter | Forte Biosciences, Inc. | DE | 333-286226 | Read Filing View |
| 2025-04-01 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-12-18 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Forte Biosciences, Inc. | DE | 333-283814 | Read Filing View |
| 2023-09-06 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2023-09-05 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2023-08-29 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2023-06-02 | SEC Comment Letter | Forte Biosciences, Inc. | DE | 001-38052 | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-13 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-11 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-04-27 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-04-22 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2018-05-22 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2018-05-21 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-04-10 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-04-10 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-28 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-23 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-09 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-06 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2016-07-21 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2015-12-02 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2015-11-17 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-01 | SEC Comment Letter | Forte Biosciences, Inc. | DE | 333-286226 | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Forte Biosciences, Inc. | DE | 333-283814 | Read Filing View |
| 2023-09-05 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2023-06-02 | SEC Comment Letter | Forte Biosciences, Inc. | DE | 001-38052 | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-11 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-04-22 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2018-05-22 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-23 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-06 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2016-07-21 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2015-12-02 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2015-11-17 | SEC Comment Letter | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-01 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-12-18 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2023-09-06 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2023-08-29 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-13 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2020-04-27 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2018-05-21 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-04-10 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-04-10 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-28 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
| 2017-03-09 | Company Response | Forte Biosciences, Inc. | DE | N/A | Read Filing View |
2025-04-01 - UPLOAD - Forte Biosciences, Inc. File: 333-286226
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 1, 2025 Paul Wagner, Ph.D. Chairman and Chief Executive Officer Forte Biosciences, Inc. 3060 Pegasus Park Drive, Building 6 Dallas, TX 75247 Re: Forte Biosciences, Inc. Registration Statement on Form S-3 Filed March 28, 2025 File No. 333-286226 Dear Paul Wagner Ph.D.: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Dan Koeppen, Esq. </TEXT> </DOCUMENT>
2025-04-01 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP April 1, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attn: Daniel Crawford Re: Forte Biosciences, Inc. Registration Statement on Form S-3 File No. 333-286226 Acceleration Request Requested Date: April 3, 2025 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rules 460 and 461 under the Securities Act of 1933, as amended, Forte Biosciences, Inc. (the “ Company ”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No.333-286226) (the “ Registration Statement ”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Dan Koeppen at (858) 350-2393 or via email at dkoeppen@wsgr.com . Sincerely, FORTE BIOSCIENCES, INC. /s/ Paul A. Wagner, Ph.D. Paul A. Wagner, Ph.D. Chief Executive Officer cc: Dan Koeppen, Wilson Sonsini Goodrich & Rosati, P.C. Ben Capps, Wilson Sonsini Goodrich & Rosati, P.C.
2024-12-18 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP December 18, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attn: Tim Buchmiller Re: Forte Biosciences, Inc. Registration Statement on Form S-3 File No. 333-283814 Acceleration Request Requested Date: December 20, 2024 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Forte Biosciences, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-283814) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Dan Koeppen at (858) 350-2393 or via email at dkoeppen@wsgr.com. Sincerely, FORTE BIOSCIENCES, INC. /s/ Paul A. Wagner, Ph.D. Paul A. Wagner, Ph.D. Chief Executive Officer cc: Dan Koeppen, Wilson Sonsini Goodrich & Rosati, P.C.
2024-12-16 - UPLOAD - Forte Biosciences, Inc. File: 333-283814
December 16, 2024
Paul A. Wagner, Ph.D.
Chief Executive Officer
Forte Biosciences, Inc.
3060 Pegasus Park Drive, Building 6
Dallas, Texas 75247
Re:Forte Biosciences, Inc.
Registration Statement on Form S-3
Filed December 13, 2024
File No. 333-283814
Dear Paul A. Wagner Ph.D.:
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 Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Dan Koeppen, Esq.
2023-09-06 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP September 6, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attn: Daniel Crawford Re: Forte Biosciences, Inc. Registration Statement on Form S-3 File No. 333-274257 Acceleration Request Requested Date: September 8, 2023 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Forte Biosciences, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-274257) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Dan Koeppen at (858) 350-2393 or via email at dkoeppen@wsgr.com. Sincerely, FORTE BIOSCIENCES, INC. /s/ Paul A. Wagner, Ph.D. Paul A. Wagner, Ph.D. Chief Executive Officer cc: Dan Koeppen, Wilson Sonsini Goodrich & Rosati, P.C.
2023-09-05 - UPLOAD - Forte Biosciences, Inc.
United States securities and exchange commission logo
September 5, 2023
Paul Wagner, Ph.D.
Chief Executive Officer
Forte Biosciences, Inc.
3060 Pegasus Park Drive, Building 6
Dallas, Texas 75247
Re:Forte Biosciences, Inc.
Registration Statement on Form S-3
Filed August 29, 2023
File No. 333-274257
Dear Paul Wagner:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Dan Koeppen, Esq.
2023-08-29 - CORRESP - Forte Biosciences, Inc.
CORRESP
1
filename1.htm
CORRESP
Wilson Sonsini Goodrich & Rosati Professional Corporation
650 Page Mill Road
Palo Alto, California 94304-1050
O: 650.493.9300
F: 650.493.6811
SEBASTIAN ALSHEIMER
Internet:
salsheimer@wsgr.com
Direct dial: (212) 453-2832
August 29, 2023
BY EDGAR
Mr. Dan Duchovny, Special Counsel
Office of Mergers and
Acquisitions
Division of Corporation Finance
Securities and
Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
Compliance with Rule 14a-13 (a)(3) in connection with the 2023
Annual Meeting of Stockholders of Forte Biosciences, Inc.
Dear Mr. Duchovny:
On behalf of our client, Forte Biosciences, Inc., a Delaware corporation (the “Company” or “FBRX”), we are responding to
verbal queries from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) regarding the Company’s compliance with Exchange Act Rule 14a-13(a)(3) (the
“Rule”) in connection with its 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled for September 19, 2023.
As the Staff is aware, the Rule requires broker searches to be conducted twenty (20) business days prior to the record date. By
initiating broker searches on July 31, 2023, the Company was not in technical compliance with the Rule. As a preliminary matter, we note that the Rule reflects a procedure adopted in 1986, prior to the digitization of the proxy solicitation
process and, indeed, the widespread use of computers in business. When the Rule was adopted, hard copies of requests were mailed out to brokers and responses were mailed back. The Rule was designed to provide sufficient time for broker houses to
respond to the inquiry. The Rule was also adopted prior to the outsourcing of the proxy back-office function to firms such as Broadridge Financial Solutions (“Broadridge”), which is now the provider for the vast majority of brokerage
firms. Today, the broker search process is conducted electronically, brokers respond within three business days of the broker search request, allowing Broadridge and its peers to provide information on beneficial owner accounts in only three
business days.1
1
For context, as the Staff is aware, for special meetings, Rule
14a-13(a)(3)(i) allows a registrant to shorten this window to “as many days before the record date of such meeting as is practicable” where “such inquiry is impractical 20 business days prior to
the record date.”
AUSTIN
BEIJING BOSTON BRUSSELS HONG KONG LONDON LOS ANGELES NEW YORK
PALO ALTO
SAN DIEGO SAN FRANCISCO SEATTLE
SHANGHAI WASHINGTON, DC WILMINGTON, DE
August 29, 2023
Page
2
On July 31, 2023, the Company initiated a broker search through Broadridge for an
estimated and tentative record date of August 10, 2023 and the Company’s proxy solicitor confirmed that the broker search was commenced on that date and has been completed (the “Original Broker Search”). No record date had been
set at the time by the Company’s board of directors (the “Board”). On August 16, 2023, the Board established a record date of August 17, 2023 (the “Record Date”), and an amended broker search was commenced with
respect to the Record Date at that time (the “Amended Broker Search”). Both the Original Broker Search and the Amended Broker Search have been completed and the Amended Broker Search information is available both to the Company and the
dissident shareholders waging a proxy contest. To be clear, only one record date has ever existed here: the Record Date of August 17, 2023. The Company promptly instructed its proxy solicitor to conduct the Amended Broker Search to ensure that the
most accurate data would be available for the Annual Meeting, and has received assurances from Broadridge that it has in fact produced a complete data set of stockholders, banks and brokers as of the Record Date.
Therefore, although the Company was not in technical compliance with the Rule, there are no adverse effects from its failure to comply. All
record holder accounts were captured by the Amended Broker Search and are known and available to both sides for mailing purposes. Mailing has already commenced, as has the voting of shares. Thus, changing the Record Date or the date of the Annual
Meeting at this point would be financially and operationally burdensome for the Company and, by extension, detrimental to its shareholders. The reality is that the Company’s technical failure to comply with the Rule will have no impact on any
stockholder’s ability to vote as of the Record Date. Furthermore, we believe that changing the Record Date or the date of the Annual Meeting would effectively result in a shorter solicitation period and/or a delay of the Annual Meeting, also to
the detriment of the Company’s shareholders and at odds with the criticisms of the dissident shareholders waging a proxy contest regarding the delay in holding the Annual Meeting.
If the Staff agrees, the Company intends to file a supplement to its definitive proxy statement, disclosing and explaining its non-compliance with the Rule in connection with the Annual Meeting.2 The Company believes that the inclusion of this information in a supplement will ensure that
the information is widely disseminated and is readily accessible to beneficial owners in keeping with the spirit and purpose of the Rule.
The Company acknowledges that the Staff reserves the right to make further inquiry into this matter and make any recommendations or referrals
deemed appropriate.
* * *
2
We note that the Staff has previously accepted additional disclosure as sufficient to mitigate non-compliance with the Rule – see, e.g., HomeStreet (May 28, 2019); ChinaCast Education Corporation (December 14, 2011).
August 29, 2023
Page
3
If the Staff has any questions or needs additional information concerning any of the
foregoing, please contact me at the number or email appearing on the first page of this letter.
Very truly yours,
WILSON SONSINI GOODRICH & ROSATI
Professional Corporation
Sebastian Alsheimer
cc:
Forte Biosciences, Inc.
Paul A. Wagner, Ph.D.
Wilson
Sonsini Goodrich & Rosati, Professional Corporation
Dan R. Koeppen
Remi P. Korenblit
2023-06-02 - UPLOAD - Forte Biosciences, Inc. File: 001-38052
United States securities and exchange commission logo
June 2, 2023
Ryan Nebel
Partner
Olshan Frome Wolosky LLP
1325 Avenue of the Americas
New York, NY 10019
Re:Forte Biosciences, Inc.
Preliminary Proxy Statement filed by Camac Fund, LP et al.
Filed May 25, 2023
File No. 001-38052
Dear Ryan Nebel:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement
Background to the Solicitation, page 6
1.Each statement or assertion of opinion or belief must be clearly characterized as such, and
a reasonable factual basis must exist for each such opinion or belief. Support for opinions
or beliefs should be self-evident, disclosed in the proxy statement or provided to the staff
on a supplemental basis. Provide support for the following:
•your stated belief that the company is "materially undervalued."
•your statement that the August 2022 sale of shares constituted an "unjustifiable
capital raise" and that it was "highly dilutive."
•your stated concern that the company adopted a form of change in control and
severance agreement "in response to Camac's investigation into possible
mismanagement at the Company and widespread stockholder discontent and that the
agreements could result in an unjustified transfer of wealth to insiders at the expense
FirstName LastNameRyan Nebel
Comapany NameOlshan Frome Wolosky LLP
June 2, 2023 Page 2
FirstName LastName
Ryan Nebel
Olshan Frome Wolosky LLP
June 2, 2023
Page 2
of stockholders."
•your statement, on page 8, that the company's focus on the development of FB-102 is
"early-stage, highly speculative..."
2.Refer to the entry for March 9, 2023. Please revise this entry to clarify why company
counsel indicated the company "seemed adamant" instead of presenting the company's
position directly. Clarify also the language that appears to indicate that the company
already believes Camac will prevail in the current contest.
Reasons for the Solicitation, page 8
3.You must avoid issuing statements that directly or indirectly impugn the character,
integrity or personal reputation or make charges of illegal, improper or immoral conduct
without factual foundation. Please provide a factual foundation for the disclosure
included below. In this regard, note that the factual foundation for such assertion must be
reasonable. Refer to Rule 14a-9.
•your statement that the company's focus on the development of FB-102 is "an effort
by management to keep their jobs rather than create value for stockholders."
•your statement that the company "seems content to disregard the views of its
stockholders..."
•your statement that "...it seems as though management believes the Company is theirs
to do as they please and they don't have to answer to stockholders."
4.Please provide us support for the disclosure in the first paragraph of the third bullet point
on page 8.
Proposal No. 1, Election of Directors, page 9
5.Please disclose in an appropriate location in the proxy statement whether the election of
your nominees will result in the triggering or acceleration of any company obligations.
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Dan Duchovny at (202) 551-3619.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2021-06-03 - UPLOAD - Forte Biosciences, Inc.
United States securities and exchange commission logo
June 3, 2021
Paul A. Wagner, Ph.D.
Chief Executive Officer
Forte Biosciences, Inc.
1124 W Carson Street MRL Building 3-320
Torrance, California 90502
Re:Forte Biosciences, Inc.
Registration Statement on Form S-3
Filed May 28, 2021
File No. 333-256611
Dear Dr. Wagner:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tom Hornish
2021-06-03 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP June 3, 2021 VIA EDGAR Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards Re: Forte Biosciences, Inc. Registration Statement on Form S-3 Filed May 28, 2021 File No. 333-256611 Acceleration Request Requested Date: June 7, 2021 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Forte Biosciences, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-256611) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, Professional Corporation, by calling Tom Hornish at (858) 350-2392. Sincerely, FORTE BIOSCIENCES, INC. /s/ Paul A. Wagner, Ph.D. Paul A. Wagner, Ph.D. Chief Executive Officer cc: Tony Riley, Forte Biosciences, Inc. Dan Koeppen, Wilson Sonsini Goodrich & Rosati, P.C. Tom Hornish, Wilson Sonsini Goodrich & Rosati, P.C.
2020-05-13 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP May 13, 2020 VIA EDGAR AND BY COURIER Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Julie Sherman Brian Cascio Courtney Lindsay Irene Paik Re: Tocagen Inc. Amendment No. 2 to Registration Statement on Form S-4 Filed May 12, 2020 File No. 333-237371 Ladies and Gentlemen: On behalf of Tocagen Inc. (“Tocagen”), we respectfully submit this letter in response to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) delivered verbally on May 13, 2020 (the “Comment”) regarding the above referenced Amendment No. 2 to Registration Statement on Form S-4 (the “Registration Statement”). Tocagen has also revised the Registration Statement in an Amendment No. 3 (the “Amendment”) as set forth below in response to the Comment and is filing the Amendment with the Commission concurrently with the submission of this letter. Page references in the text of Tocagen’s responses below correspond to the page numbers of the Amendment. Capitalized terms used herein but not defined herein shall have the meanings assigned to them in the Amendment. Summary of Comment: We note that the assumptions in the fairness opinion regarding the exchange ratio and net cash at closing are materially different than the assumptions that are now throughout the filing. Revise the discussion of the fairness opinion to disclose that the assumed exchange ratio and net cash at closing has changed and disclose that the Tocagen board confirmed its belief that the fairness opinion should be relied upon for approval the merger. If the board believes that the fairness opinion is no longer applicable, please disclose whether the board continues to recommend a vote in favor of the merger. Consider a risk factor regarding the assumptions in the fairness opinion no longer being applicable. May 13, 2020 Page 2 Response: Tocagen has revised the discussions of the fairness opinion on pages 110 and 119, to include the underlined text in the following excerpts from the Amendment. Further, Tocagen respectfully advises the Staff that the description of the fairness opinion already includes disclosure of the assumptions regarding the Tocagen Net Cash and the Exchange Ratio on page 120. Page 110: “On February 19, 2020, at a special telephonic meeting, the Tocagen Board met in consultation with Tocagen management and representatives of Cooley and Ladenburg. The Tocagen Board was updated on Forte’s financing and was informed that Forte had secured approximately $14.0 million in financing. The Tocagen Board was informed that the investors had negotiated for 100% warrant coverage, with an exercise price equal to that price per share of Tocagen common stock (after the conversion of such warrants in the Merger) wherein Tocagen’s market value, after the Merger, would be $120 million. The warrants expire 30 days after the announcement of Forte’s phase 2 clinical trial data planned for 2021. A representative of Ladenburg reviewed the impact of the financing and then rendered Ladenburg’s oral opinion to the Tocagen Board, subsequently confirmed by delivery of a written opinion later that day, that subject to the assumptions (including that the Exchange Ratio would be 1.7705 and that Tocagen’s net cash at Closing would be $7.5 million), qualifications, limitations and other matters set forth therein, the Exchange Ratio was fair, from a financial point of view, to the Tocagen stockholders. After further discussion among the Tocagen Board, the board unanimously (i) determined that the Merger and the other transactions contemplated by the merger agreement were fair to, advisable and in the best interests of Tocagen and its stockholders, (ii) approved and declared advisable the merger agreement and the transactions contemplated thereby, including the authorization and issuance of shares of Tocagen common stock to the stockholders of Forte pursuant to the terms of the merger agreement, the change of control of Tocagen, and other actions contemplated by the merger agreement, and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the merger agreement, that the Tocagen stockholders vote to approve the Closing Tocagen Stockholder Matters.” Page 119: “As stated above, pursuant to an engagement letter dated October 24, 2019, Tocagen retained Ladenburg to act as a financial advisor in connection with the Merger and to render the Opinion to the Tocagen Board as to the fairness of the Exchange Ratio, from a financial point of view, to the stockholders of Tocagen. On February 19, 2020, at the request of the Tocagen Board, Ladenburg rendered the oral opinion, subsequently confirmed by delivery of the written opinion dated February 19, 2020, to the Tocagen Board, that the Exchange Ratio (assumed, at the time, to be 1.7705) was fair, from a financial point of view, to the May 13, 2020 Page 3 stockholders of Tocagen as of the date of such Opinion and based upon the various assumptions, qualifications and limitations set forth therein.” Tocagen has added the following disclosure to page 112: “On May, 13, 2020 the Tocagen Board met to discuss Tocagen management’s revised expectations regarding the net cash Tocagen will have at the time of Closing to $0.3 million to $0.7 million and the related adjustment to the assumed Exchange Ratio to 3.4024. The Tocagen Board further discussed that the adjustments to the Exchange Ratio associated with Tocagen’s net cash as Closing were considered in its previous approval of the Merger, including as part of its review of the opinion of Ladenburg regarding the fairness of the Exchange Ratio and that the Tocagen Board had been continually updated regarding changes in the net cash assumptions since the delivery of such opinion, including as a result of delays in the Merger transaction closing, the status of the sale and transfer of Tocagen assets, and the fact that the purchase prices for such assets were significantly lower than expected, in part, due to bidders withdrawing from the process or being unable to raise necessary funding in a timely matter, and the impact of the global pandemic. Following such discussion, and with consideration of the reasons for the Merger set forth below, the Tocagen Board unanimously (i) determined that the opinion of Ladenburg previously provided to the Tocagen Board should be relied upon regardless of updated expectations regarding the net cash Tocagen will have at the time of Closing and the related adjustments to the assumed Exchange Ratio, as the Tocagen Board previously considered the assumptions in such opinion and was informed of, and agreed to, the potential adjustments to the Exchange Ratio at the time it approved the Merger and (ii) determined that the Merger continued to be fair to, advisable and in the best interests of Tocagen and its stockholders.” Tocagen respectfully advises the Staff that it does not think a risk factor regarding the assumptions in the fairness opinion is needed as there is extensive disclosure throughout the Amendment regarding the anticipated Exchange Ratio and a risk factor would place too much emphasis on the fairness opinion. The fairness opinion was only one part of the Tocagen Board’s process in considering and approving the Merger and the Tocagen Board is not recommending that Tocagen’s stockholders approve the Merger based solely on the assumptions in the fairness opinion. A non-exhaustive list of the numerous material factors considered by the Tocagen Board are described on pages 112-116. These factors were reconsidered by the Tocagen Board on May 13, 2020 and continued to be relevant despite the adjustment in the anticipated Exchange Ratio. Tocagen has added the following disclosure to page 116 to address this: “On May 13, 2020, the Tocagen Board reviewed the factors above in light of the revised assumption regarding Tocagen Net Cash of $0.3 million to $0.7 million and the revised assumption regarding the Exchange Ratio, to 3.4024 and determined that the reasons continued to be overall favorable to and supportive of its determination to approve the Merger and recommend that the Tocagen stockholders vote to approve the Merger.” * * * May 13, 2020 Page 4 If you have any questions, or if it would expedite your review in any way, please do not hesitate to contact the undersigned at (858) 550-6088. We thank the Staff in advance for its assistance. Sincerely, /s/ Karen Deschaine Karen Deschaine COOLEY LLP
2020-05-12 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP Tocagen Inc. 4445 Eastgate Mall, Suite 200 San Diego, CA 92121 (858) 412-8400 May 12, 2020 VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Julie Sherman Brian Cascio Courtney Lindsay Irene Paik Re: Request for Effectiveness for Tocagen Inc. Registration Statement on Form S-4 (File No. 333-237371) Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Tocagen Inc. (the “Registrant”) hereby respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 4:00 p.m. Eastern Time, on May 13, 2020, or as soon thereafter as practicable. The Registrant respectfully requests that you notify Karen Deschaine of Cooley LLP of such effectiveness by telephone at (858) 550-6088. If you have any questions or comments regarding the foregoing, please do not hesitate to contact Ms. Deschaine at the telephone number above. Very truly yours, Tocagen Inc. By: /s/ Mark Foletta Name: Mark Foletta Title: Chief Financial Officer cc: Karen Deschaine, Cooley LLP
2020-05-12 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP May 12, 2020 VIA EDGAR AND BY COURIER Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Julie Sherman Brian Cascio Courtney Lindsay Irene Paik Re: Tocagen Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed April 27, 2020 File No. 333-237371 Ladies and Gentlemen: On behalf of Tocagen Inc. (“Tocagen”), we respectfully submit this letter in response to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in a letter dated May 11, 2020 (the “Comment Letter”) regarding the above referenced Amendment No. 1 to Registration Statement on Form S-4 (the “Registration Statement”). Tocagen has also revised the Registration Statement in an Amendment No. 2 (the “Amendment”) as set forth below in response to the Comment Letter and is filing the Amendment with the Commission concurrently with the submission of this letter. The numbering of the paragraphs below corresponds to the numbering of the Staff’s comments which, for your convenience, we have incorporated into this response letter in italics. Page references in the text of Tocagen’s responses correspond to the page numbers of the Amendment. Capitalized terms used herein but not defined herein shall have the meanings assigned to them in the Amendment. Amendment 1 to Registration Statement on Form S-4 May 12, 2020 Page 2 Q: What is the Merger?, page 1 1. We note your revisions in response to our prior comment 4. Please also disclose the net cash closing condition and the anticipated range of $2.0 million to $4.0 million of net cash at closing here and elsewhere that you assume $3.0 million in net cash at closing. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 1, 2, 3, 13, 15, 26, 28 and 147 to disclose the net cash closing condition, noting that this condition has been waived by Forte, and the anticipated range of Tocagen net cash at closing. Additionally, Tocagen notes that it has revised the anticipated range to $0.3 million to $0.7 million and has revised the anticipated Tocagen net cash at closing amount to $0.5 million. Questions and Answers About the Merger, page 1 2. We note that you have entered into asset purchase agreements with Abintus Bio, Inc. for the sale of RNV Platform Assets and Denovo Biopharma LLC for the sale of RRV Platform Assets. Please disclose in this section and elsewhere that you discuss the disposition of Company Assets that you have entered into asset purchase agreements for the sale of the RNV Platform Assets and RRV Platform Assets. Please also describe the material terms of these agreements and file them as exhibits to your registration statement. See Item 601(b)(10) of Regulation S-K. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 10 and 137 to include a discussion of the asset purchase agreements, including their material terms. Tocagen has filed the Asset Purchase Agreement with Abintus Bio, Inc. as Exhibit 10.22 to the Amendment and the Asset Purchase Agreement with Denovo Biopharm LLC as Exhibit 10.23 to the Amendment. Merger Consideration and Exchange Ratio, page 143 3. We note your responses to our prior comments 12 and 13 that the final Exchange Ratio will be disclosed in a Form 8-K five business days prior to the meeting of the Tocagen stockholders to consider the merger. It appears from your disclosure that the Exchange Ratio is subject to adjustment until the Closing Date. Please disclose clearly the date on which the Exchange Ratio will be finalized. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 3 to disclose when the Exchange Ratio will be finalized. Additionally, Tocagen notes that our prior response to comment 13 that disclosed that the Exchange Ratio would be disclosed on a Form 8-K five business days prior to the Tocagen special meeting incorrectly stated the requirements of the Merger Agreement. Under the terms of the Merger Agreement, the Exchange Ratio is fixed prior to the “Anticipated Closing Date,” which is a date at least ten calendar days prior to the Tocagen special meeting. Following the final determination of the Tocagen’s net cash as of the Anticipated Closing Date, Tocagen and Forte will finalize the Exchange Ratio and issue a press release setting forth the final Exchange Ratio. The parties have agreed to publicly disclose the final Exchange Ratio as early as practicable prior to the Tocagen special meeting (and in no event will the press release or Form 8-K delay or cause the postponement of the Tocagen special meeting). * * * If you have any questions, or if it would expedite your review in any way, please do not hesitate to contact the undersigned at (858) 550-6088. We thank the Staff in advance for its assistance. Sincerely, /s/ Karen Deschaine Karen Deschaine COOLEY LLP
2020-05-11 - UPLOAD - Forte Biosciences, Inc.
United States securities and exchange commission logo
May 11, 2020
Martin J. Duvall
Chief Executive Officer
Tocagen Inc.
4445 Eastgate Mall, Suite 200
San Diego, California 92121
Re:Tocagen Inc.
Amendment 1 to Registration Statement on Form S-4
Filed April 27, 2020
File No. 333-237371
Dear Mr. Duvall:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our April 21, 2020 letter.
Amendment 1 to Registration Statement on Form S-4
Q: What is the Merger?, page 1
1.We note your revisions in response to our prior comment 4. Please also disclose the net
cash closing condition and the anticipated range of $2.0 million to $4.0 million of net cash
at closing here and elsewhere that you assume $3.0 million in net cash at closing.
Questions and Answers About the Merger, page 1
2.We note that you have entered into asset purchase agreements with Abintus Bio, Inc. for
the sale of RNV Platform Assets and Denovo Biopharma LLC for the sale of RRV
Platform Assets. Please disclose in this section and elsewhere that you discuss the
disposition of Company Assets that you have entered into asset purchase agreements for
FirstName LastNameMartin J. Duvall
Comapany NameTocagen Inc.
May 11, 2020 Page 2
FirstName LastName
Martin J. Duvall
Tocagen Inc.
May 11, 2020
Page 2
the sale of the RNV Platform Assets and RRV Platform Assets. Please also describe the
material terms of these agreements and file them as exhibits to your registration
statement. See Item 601(b)(10) of Regulation S-K.
Merger Consideration and Exchange Ratio, page 143
3.We note your responses to our prior comments 12 and 13 that the final Exchange Ratio
will be disclosed in a Form 8-K five business days prior to the meeting of the Tocagen
stockholders to consider the merger. It appears from your disclosure that the Exchange
Ratio is subject to adjustment until the Closing Date. Please disclose clearly the date on
which the Exchange Ratio will be finalized.
You may contact Julie Sherman at (202) 551-3640 or Brian Cascio at (202) 551-3676 if
you have questions regarding comments on the financial statements and related matters. Please
contact Courtney Lindsay at (202) 551-7237 or Irene Paik at (202) 551-6553 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Karen Deschaine
2020-04-27 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP April 27, 2020 VIA EDGAR AND BY COURIER Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Julie Sherman Brian Cascio Courtney Lindsay Irene Paik Re: Tocagen Inc. Registration Statement on Form S-4 Filed March 25, 2020 File No. 333-237371 Ladies and Gentlemen: On behalf of Tocagen Inc. (“Tocagen”), we respectfully submit this letter in response to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in a letter dated April 21, 2020 (the “Comment Letter”) regarding the above referenced Registration Statement on Form S-4 (the “Registration Statement”). Tocagen has also revised the Registration Statement in an Amendment No. 1 (the “Amendment”) as set forth below in response to the Comment Letter and is filing the Amendment with the Commission concurrently with the submission of this letter. The numbering of the paragraphs below corresponds to the numbering of the Staff’s comments which, for your convenience, we have incorporated into this response letter in italics. Page references in the text of Tocagen’s responses correspond to the page numbers of the Amendment. Capitalized terms used herein but not defined herein shall have the meanings assigned to them in the Amendment. Form S-4 filed March 25, 2020 Cover Page 1. With reference to your disclosure on page 11, where you disclose the 76.7% ownership percentage of Forte equity holders in the combined company, please revise to clarify that the equity holders of Forte prior to the Pre-Closing Financing are expected to hold approximately 46.7% of the combined company. April 27, 2020 Page 2 Response: Tocagen respectfully acknowledges the Staff’s comment and has revised the cover page of the Amendment to include the clarification that the equity holders of Forte prior to the Pre-Closing Financing are expected to hold approximately 50.1% of the combined company, which is based off the revised assumed Exchange Ratio of 2.5923, assuming Tocagen Net Cash of $3.0 million and a Pre-Closing Financing of $19.3 million. Questions and Answers About the Merger What is the Merger?, page 1 2. Disclose here, or provide a cross-reference to, the reasons why Forte entered into the security purchase agreements. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 1 of the Amendment to disclose the reason why Forte entered into the security purchase agreements, which was its need for capital to support the clinical development of its product candidates and to reach its next clinical milestone. Prospectus Summary Forte Biosciences, Inc., page 10 3. We note your statement here and elsewhere in your prospectus that “Forte’s clinical data validates safety,” FB-401 demonstrated a “clean safety profile,” “the first adult cohort study established that FB-401 is safe for use,” and “FB-401 demonstrated efficacy improvements.” Because FDA approval is dependent on the agency making a formal determination that a drug is safe and effective, it is premature for you to describe your clinical stage product as safe and effective, or that the results of any of your trials demonstrated or established safety or efficacy. Please remove or revise these statements. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 11, 12, 181, 183, 185, and 214 of the Amendment to remove any conclusive statements regarding the safety and/or efficacy of FB-401 due to the results of Forte’s clinical trials to date. Overview of the Merger Agreement and Agreements Related to the Merger Agreement Merger Consideration and Exchange Ratio, page 14 4. Please clearly disclose Tocagen’s current level of net cash and whether you anticipate net cash to be outside of the range of $7.5 million to $10 million for purposes of calculating the Exchange Ratio. To the extent this is a possibility, please also provide examples of estimated percentage ownership, including the estimated percentage ownership of each company if Tocagen were to have net cash at closing of $3 million. Please also clearly disclose here and elsewhere that you discuss adjustments to the Exchange Ratio based on Net Cash that Tocagen having net cash of $3.0 million is a condition to closing. April 27, 2020 Page 3 Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 15 of the Amendment to clearly disclose that Tocagen anticipates net cash to be between $2.0 million and $4.0 million for purposes of calculating the Exchange Ratio. Tocagen has also revised the introductory letter to Tocagen and Forte stockholders and pages 1, 2, 12, 13, 15, 16, 26, 28, 144, 172, 215, PF-5 and PF-7 to provide estimated percentage ownership of the equityholders of each company if Tocagen were to have net cash at closing of $3.0 million and has revised page 15 to disclose that Tocagen having net cash of $3.0 million is a condition to closing. Additionally, Tocagen has added a table to page 146 of the Amendment, under the subsection entitled “Exchange Ratio” that shows the effect of Tocagen’s net cash on the Exchange Ratio and percentage ownership of Tocagen equityholders. Termination and Termination Fees, page 17 5. You state that in the event of a “Forte Triggering Event” certain Forte stockholder’s obligations to, among other things, vote their shares in favor of the merger agreement would be modified. Please define here, or provide a direct cross-reference to, the definition of a “Forte Triggering Event.” Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 18 of the Amendment to provide a direct cross-reference to the definition of “Forte Triggering Event.” Interests of Certain Directors, Officers and Affiliates of Tocagen and Forte, page 18 6. State here and throughout your registration statement, where you deem appropriate, the amount of shares that would be covered by vested stock options owned by current Tocagen named executive officers and directors after giving effect to the terms of the merger agreement (i.e., options with an exercise price greater than $0.64 will be cancelled). Response: Tocagen respectfully acknowledges the Staff’s comment and has revised the introductory letter to Tocagen and Forte stockholders and pages 2, 16, 20, 126, 131, 147 of the Amendment to disclose the amount of shares that would be covered by vested stock options owned by current Tocagen executive officers and directors after giving effect to the terms of the Merger Agreement. Because the Merger will result in an ownership change under Section 382 of the Code for Tocagen..., page 27 7. Please quantify the NOLs and other tax attributes that are subject to limitation and clarify the factors that will determine the extent of the limitation. April 27, 2020 Page 4 Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 29, 42, and 63 of the Amendment. If Tocagen fails to comply with its obligations in the agreement under which Tocagen licenses intellectual property rights from the [USC]..., page 36 8. Please revise this risk factor to specify how Tocagen may “[fail] to comply with its obligations in the agreement.” Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 37 and 38 of the Amendment to disclose how Tocagen may “[fail] to comply with its obligations in the agreement.” In addition, this contract will be assigned to Denovo BioPharma LLC (“Denovo”) after Closing as part of the sale of the RRV Platform Assets to Denovo. The sale of the RRV Platform Assets is described in the Background of the Merger on pages 104-112. Cautionary Note Concerning Forward-Looking Statements, page 98 9. Please revise the last sentence of this section to indicate that you will update or revise forward-looking statements to the extent required by applicable law. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 98 of the Amendment. Background of the Merger, page 104 10. We note you disclose that on October 22, 2019, Tocagen selected Ladenburg to serve as a financial advisor. Provide more details regarding the selection process for financial advisors, including the qualifications considered. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 104 of the Amendment and provided more details regarding the selection process for financial advisors. 11. Discuss, where you deem appropriate, why Tocagen decided to sell the RNV Platform Assets as a separate transaction, rather than, for example, retaining them for the combined company. Please also provide a description of what is included in the RNV Platform Assets and provide any update on the plans to sell the RNV Platform Assets. April 27, 2020 Page 5 Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 107 of the Amendment to discuss why Tocagen decided to sell the RNV Platform Assets as a separate transaction, including that Forte attributed no value to the assets in its offer. Additionally, page 104 of the Amendment has been revised to provide a description of what is included in the RNV Platform Assets and an update on the plans to sell the RNV Platform Assets. 12. We note that in earlier stages of negotiations that certain assumptions were based on an exchange ratio of 1.7514 and that the most recent transaction assumptions are based on an exchange ratio of 1.8149. If material, expand your disclosure here to discuss this change and how the parties arrived at the exchange ratio. Response: Tocagen respectfully acknowledges the Staff’s comment and notes that the mechanism to calculate the Exchange Ratio is in the Merger Agreement that was agreed to after extensive negotiations, and this change to the Exchange Ratio from 1.7514 to 1.8149 was the result of investment by new investors that entered into the Investment and Subscription Agreement to purchase shares of Forte’s common stock after the signing of the Merger Agreement but prior to filing the Registration Statement. The Merger Agreement contemplated and provided a mechanism for the Exchange Ratio to be revised for such investment in Forte. Both the initial Exchange Ratio of 1.7514 and the revised Exchange Ratio of 1.8149 assumed Tocagen Net Cash at Closing to be $7.5 million and a reverse split ratio of 10-for-1, the mid-range of the reverse split originally agreed upon in the Merger Agreement. This change in the Exchange Ratio from 1.7514 to 1.8149 was not viewed as material because the increased investment in Forte and a revision in the Exchange Ratio for such investment was contemplated by the Merger Agreement. Additionally, we note that the Amendment will be revised to include an estimated Exchange Ratio of 2.5923, which has been revised based on the an assumed Tocagen Net Cash at Closing of $3.0 million and a Reverse Split of 15-for-1. As noted on page 2, Tocagen, Forte and Merger Sub agreed to a revised reverse split range of 8-for-1 and 15-for-1 on April 14, 2020. Each of these assumptions has been described in the Amendment to show that the initial assumed Exchange Ratio of 1.7514, based on certain assumptions made at the time of signing the Merger Agreement, has been revised to 2.5923 based on more current assumptions. Tocagen has also added an additional Q&A to pages 2 and 3 of the Amendment disclosing the reasons that the Exchange Ratio changed from 1.7514 to 2.5923. The final Exchange Ratio will be disclosed in a Form 8-K five (5) business days prior to the meeting of the Tocagen stockholders to consider the merger. Opinion of the Tocagen Financial Adviser, page 117 13. We note that at the time you received your fairness opinion that certain assumptions were based on an exchange ratio of 1.7514 and that the most recent transaction assumptions are based on an exchange ratio of 1.8149. Discuss any material changes that occurred since the delivery of the opinion or that are anticipated to occur before the stockholder meeting. If the change was not deemed material, please so state in your disclosure. Response: Tocagen respectfully acknowledges the Staff’s comment and refers to Tocagen’s response in comment 12 above. Additionally, no material changes are expected to occur before the stockholder meeting and the final Exchange Ratio to be used at the Closing of the Merger will be determined in accordance with the Merger Agreement, as disclosed. The final Exchange Ratio will be disclosed in a Form 8-K five (5) business days prior to the meeting of the Tocagen stockholders to consider the merger. April 27, 2020 Page 6 Opinion of the Tocagen Financial Advisor Analysis of Selected Publicly Traded Companies, page 121 14. Please disclose how Ladenburg selected the six publicly traded companies for the selected publicly traded companies analysis. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 122 and 123 of the Amendment to disclose how Ladenburg selected the six publicly traded companies for the selected publicly traded companies analysis. Material U.S. Federal Income Tax Consequences of the Merger, page 131 15. Please revise your prospectus disclosure to provide a firm conclusion regarding treatment of the transaction under Section 368(a) and remove language stating that it is intended that, or generally, certain material tax consequences will apply. In addition, please clearly state that the conclusion is the opinion of counsel. Please also remove any statement that assumes the material tax consequences at issue (e.g., “Assuming the Merger qualifies as a reorganization within the meaning of Section 368(a) of the Code”). Refer to Section III of Staff Legal Bulletin No. 19 for guidance. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised pages 6, 7, 21, 133, 134 and 135 of the Amendment to provide a firm conclusion regarding the treatment of the transaction under Section 368(a) and to remove any statement that assumes the material tax consequences at issue. Description of Tocagen’s Business License and Collaboration Agreements, page 173 16. Please disclose, where appropriate, if and how your agreements with ApolloBio, Siemens and USC are impacted by your suspension of research and development activities. Please also discuss the impact of an asset sale or merger on these agreements. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 175 of the Amendment to disclose that the agreements with ApolloBio, Siemens and USC are not impacted by its suspension of research and development activities. Each of these contracts will be assigned to Denovo after Closing as part of the sale of the RRV Platform Assets to Denovo. The sale of the RRV Platform Assets is described in the Background of the Merger on pages 104-112. April 27, 2020 Page 7 17. Please revise your description of the ApolloBio License Agreement to narrow the royalty range from “low double digits” to no more than ten percentage points (for example, between twenty and thirty percent). Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 176 of the Amendment to narrow the royalty range to between 10% and 15%. Description of Forte’s Business Manufacturing, page 183 18. With reference to your disclosure on page 88 regarding your reliance on a sole contract manufacturing organization for materials to be used in clinical trials, please describe the material terms of your services agreement with this contract manufacturing organization and file it as an exhibit to your registration statement. See Item 601(b)(10) of Regulation S-K. Response: Tocagen respectfully acknowledges the Staff’s comment and has revised page 186 of the Amendment to
2020-04-22 - UPLOAD - Forte Biosciences, Inc.
April 21, 2020
Martin J. Duvall
Chief Executive Officer
Tocagen Inc.
4445 Eastgate Mall, Suite 200
San Diego, CA 92121
Re:Tocagen Inc.
Registration Statement on Form S-4
Filed March 25, 2020
File No. 333-237371
Dear Mr. Duvall:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-4 filed March 25, 2020
Cover Page
1.With reference to your disclosure on page 11, where you disclose the 76.7% ownership
percentage of Forte equity holders in the combined company, please revise to clarify that
the equity holders of Forte prior to the Pre-Closing Financing are expected to hold
approximately 46.7% of the combined company.
Questions and Answers About the Merger
What is the Merger?, page 1
2.Disclose here, or provide a cross-reference to, the reasons why Forte entered into the
security purchase agreements.
FirstName LastNameMartin J. Duvall
Comapany NameTocagen Inc.
April 21, 2020 Page 2
FirstName LastNameMartin J. Duvall
Tocagen Inc.
April 21, 2020
Page 2
Prospectus Summary
Forte Biosciences, Inc., page 10
3.We note your statement here and elsewhere in your prospectus that "Forte's clinical data
validates safety," FB-401 demonstrated a "clean safety profile," "the first adult cohort
study established that FB-401 is safe for use," and "FB-401 demonstrated efficacy
improvements." Because FDA approval is dependent on the agency making a formal
determination that a drug is safe and effective, it is premature for you to describe your
clinical stage product as safe and effective, or that the results of any of your trials
demonstrated or established safety or efficacy. Please remove or revise these statements.
Overview of the Merger Agreement and Agreements Related to the Merger Agreement
Merger Consideration and Exchange Ratio, page 14
4.Please clearly disclose Tocagen's current level of net cash and whether you anticipate net
cash to be outside of the range of $7.5 million to $10 million for purposes of calculating
the Exchange Ratio. To the extent this is a possibility, please also provide examples
of estimated percentage ownership, including the estimated percentage ownership of
each company if Tocagen were to have net cash at closing of $3 million. Please also
clearly disclose here and elsewhere that you discuss adjustments to the Exchange Ratio
based on Net Cash that Tocagen having net cash of $3.0 million is a condition to closing.
Termination and Termination Fees, page 17
5.You state that in the event of a "Forte Triggering Event" certain Forte stockholder's
obligations to, among other things, vote their shares in favor of the merger agreement
would be modified. Please define here, or provide a direct cross-reference to, the
definition of a "Forte Triggering Event."
Interests of Certain Directors, Officers and Affiliates of Tocagen and Forte, page 18
6.State here and throughout your registration statement, where you deem appropriate, the
amount of shares that would be covered by vested stock options owned by current
Tocagen named executive officers and directors after giving effect to the terms of the
merger agreement (i.e., options with an exercise price greater than $0.64 will be
cancelled).
Because the Merger will result in an ownership change under Section 382 of the Code for
Tocagen..., page 27
7.Please quantify the NOLs and other tax attributes that are subject to limitation and clarify
the factors that will determine the extent of the limitation.
FirstName LastNameMartin J. Duvall
Comapany NameTocagen Inc.
April 21, 2020 Page 3
FirstName LastNameMartin J. Duvall
Tocagen Inc.
April 21, 2020
Page 3
If Tocagen fails to comply with its obligations in the agreement under which Tocagen licenses
intellectual property rights from the [USC]..., page 36
8.Please revise this risk factor to specify how Tocagen may "[fail] to comply with its
obligations in the agreement."
Cautionary Note Concerning Forward-Looking Statements, page 98
9.Please revise the last sentence of this section to indicate that you will update or revise
forward-looking statements to the extent required by applicable law.
Background of the Merger, page 104
10.We note you disclose that on October 22, 2019, Tocagen selected Ladenburg to serve as a
financial advisor. Provide more details regarding the selection process for financial
advisors, including the qualifications considered.
11.Discuss, where you deem appropriate, why Tocagen decided to sell the RNV Platform
Assets as a separate transaction, rather than, for example, retaining them for the combined
company. Please also provide a description of what is included in the RNV Platform
Assets and provide any update on the plans to sell the RNV Platform Assets.
12.We note that in earlier stages of negotiations that certain assumptions were based on an
exchange ratio of 1.7514 and that the most recent transaction assumptions are based on an
exchange ratio of 1.8149. If material, expand your disclosure here to discuss this change
and how the parties arrived at the exchange ratio.
Opinion of the Tocagen FInancial Adviser, page 117
13.We note that at the time you received your fairness opinion that certain assumptions were
based on an exchange ratio of 1.7514 and that the most recent transaction assumptions are
based on an exchange ratio of 1.8149. Discuss any material changes that occurred since
the delivery of the opinion or that are anticipated to occur before the stockholder meeting.
If the change was not deemed material, please so state in your disclosure.
Opinion of the Tocagen Financial Advisor
Analysis of Selected Publicly Traded Companies, page 121
14.Please disclose how Ladenburg selected the six publicly traded companies for the selected
publicly traded companies analysis.
Material U.S. Federal Income Tax Consequences of the Merger, page 131
15.Please revise your prospectus disclosure to provide a firm conclusion regarding treatment
of the transaction under Section 368(a) and remove language stating that it is intended
that, or generally, certain material tax consequences will apply. In addition, please clearly
state that the conclusion is the opinion of counsel. Please also remove any statement that
FirstName LastNameMartin J. Duvall
Comapany NameTocagen Inc.
April 21, 2020 Page 4
FirstName LastNameMartin J. Duvall
Tocagen Inc.
April 21, 2020
Page 4
assumes the material tax consequences at issue (e.g., "Assuming the Merger qualifies as a
reorganization within the meaning of Section 368(a) of the Code"). Refer to Section III of
Staff Legal Bulletin No. 19 for guidance.
Description of Tocagen's Business
License and Collaboration Agreements, page 173
16.Please disclose, where appropriate, if and how your agreements with ApolloBio, Siemens
and USC are impacted by your suspension of research and development activities. Please
also discuss the impact of an asset sale or merger on these agreements.
17.Please revise your description of the ApolloBio License Agreement to narrow
the royalty range from "low double digits" to no more than ten percentage points (for
example, between twenty and thirty percent).
Description of Forte's Business
Manufacturing, page 183
18.With reference to your disclosure on page 88 regarding your reliance on a sole contract
manufacturing organization for materials to be used in clinical trials, please describe the
material terms of your services agreement with this contract manufacturing organization
and file it as an exhibit to your registration statement. See Item 601(b)(10) of Regulation
S-K.
Intellectual Property, page 184
19.Please revise your disclosure to narrow the royalty range from "low double digits" to no
more than ten percentage points (for example, between twenty and thirty percent). Please
also disclose aggregate payments made to date and the duration of the royalty period. In
addition, please file as an exhibit the license agreement with DHHS. Refer to Item
601(b)(10) of Regulation S-K.
Executive Compensation of Forte
Agreements with Forte’s Named Executive Officers , page 243
20.Please file as exhibits to the registration statement the offer letters with named executive
officers and the 2018 Equity Incentive Plan. See Item 601(b)(10) of Regulation S-K.
Unaudited Pro Forma Condensed Combined Financial Information
Note 3. Preliminary Estimate of Consideration Expected to be Transferred, page PF-7
21.Please revise to disclose how you determined Tocagen's pro forma net assets of $4.2
million as of December 31, 2019. We note that net assets at December 31, 2019 were
approximately $10.8 million.
FirstName LastNameMartin J. Duvall
Comapany NameTocagen Inc.
April 21, 2020 Page 5
FirstName LastName
Martin J. Duvall
Tocagen Inc.
April 21, 2020
Page 5
Note 5. Pro forma Adjustments, page PF-9
22.Please revise to disclose how you determined the amount of the pro forma adjustment to
common stock in Note E.
23.With regards to Note G, please revise to separately state each pro forma adjustment
related to the elimination of Tocagen’s historical accumulated deficit.
24.We refer to Note H. Please reconcile your adjustment to record the conversion of Forte
preferred stock into common stock with the amount in Note D. In addition, revise to
provide your calculation of the fair value of the estimated number of shares of the
combined company to be owned by Tocagen stockholders.
25.We refer you to Note J. Please tell us how you compute total shares of 45,705,701 from
the amounts in the table.
Forte Biosciences Financial Statements
Note 4. License to Patented Technology , page RX-12
26.Please revise to disclose the specific development, regulatory and commercial milestones
under the DHHS license that could require up to $105.5 million in milestone payments. In
addition, disclose the minimum annual royalty payments.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Julie Sherman at 202-551-3640 and Brian Cascio at 202-551-3676 if
you have questions regarding comments on the financial statements and related matters. Please
contact Courtney Lindsay at 202-551-7237 or Irene Paik at 202-551-6553 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Karen Deschaine
2018-05-22 - UPLOAD - Forte Biosciences, Inc.
May 21, 2018
Martin J. Duvall
Chief Executive Officer
Tocagen Inc.
3030 Bunker Hill Street, Suite 230
San Diego, CA 92109
Re:Tocagen Inc.
Registration Statement on Form S-3
Filed May 11, 2018
File No. 333-224880
Dear Mr. Duvall:
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 Christine Westbrook at (202) 551-5019 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Karen Deschaine Anderson, Esq.
2018-05-21 - CORRESP - Forte Biosciences, Inc.
CORRESP
1
filename1.htm
CORRESP
Tocagen Inc.
3030 Bunker Hill Street
Suite 230
San Diego, CA 92109
(858) 412-8400
May 21, 2018
VIA EDGAR
United States
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Christine Westbrook
Re:
Tocagen Inc.
Registration Statement on Form
S-3
Filed: May 11, 2018
File No. 333-224880
Ladies and Gentlemen:
Pursuant to Rule 461 under the
Securities Act of 1933, as amended, Tocagen Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced
Registration Statement on Form S-3 to become effective at 4:30 p.m. Eastern Time on Wednesday, May 23, 2018, or as soon thereafter as is practicable.
In connection with this request, the Registrant hereby acknowledges that:
•
should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any
action with respect to the filing;
•
the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and
•
the Registrant 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.
If you have any questions regarding this request, please contact Karen E. Anderson of Cooley LLP at (858) 550-6088.
Sincerely,
TOCAGEN INC.
By:
/s/ Mark Foletta
Mark Foletta
Chief Financial Officer
2017-04-10 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP April 10, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549-3628 Attn: Ms. Suzanne Hayes Re: Tocagen Inc. (the “Company”) – Request for Acceleration Registration Statement on Form S-1 (File No. 333-216574) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), and as representatives of the several underwriters of the Company’s proposed public offering of common shares, we hereby join the Company’s request for acceleration of the above-referenced Registration Statement, as amended, requesting effectiveness for 4:00 p.m. Eastern Time on April 12, 2017, or as soon thereafter as is practicable. Pursuant to Rule 460 of the Act, we wish to advise you that we have distributed approximately 870 copies of the Company’s Preliminary Prospectus dated April 3, 2017 through the date hereof to underwriters, dealers, institutions and others. We, the undersigned, as representatives of the several underwriters, have complied and will continue to comply, and we have been informed by the participating underwriters that they have complied and will continue to comply, with the provisions of Rule 15c2-8 of the Securities Exchange Act of 1934, as amended. [Signature Page Follows] Very truly yours, Leerink Partners LLC Evercore Group L.L.C. As representatives of the several Underwriters By: Leerink Partners LLC By: /s/ Bryan Giraudo Name: Bryan Giraudo Title: Managing Director By: Evercore Group L.L.C. By: /s/ Jeffrey B. Rosichan Name: Jeffrey B. Rosichan Title: Senior Managing Director [Signature Page to Acceleration Request Letter]
2017-04-10 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP April 10, 2017 United States Securities and Exchange Commission VIA EDGAR Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Ms. Suzanne Hayes Re: Tocagen Inc. Registration Statement on Form S-1 File No. 333-216574 Acceleration Request Requested Date: Wednesday, April 12, 2017 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) to become effective on April 12, 2017, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the staff (the “Staff”). This request for acceleration is subject, however, to your receiving a telephone call prior to such time from our legal counsel, Cooley LLP, confirming this request. The Registrant hereby authorizes each of Karen Deschaine and Wade Andrews of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Karen Deschaine of Cooley LLP, counsel to the Registrant, at (858) 550-6088, or in her absence, Wade Andrews at (858) 550-6042. In connection with this request, the Registrant acknowledges that: • should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and • the Registrant 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. Very truly yours, Tocagen Inc. By: /s/ Martin J. Duvall Martin J. Duvall Chief Executive Officer
2017-03-28 - CORRESP - Forte Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP *FOIA Confidential Treatment Request* Confidential Treatment Requested by Tocagen Inc. in connection with its Registration Statement on Form S-1 filed March 9, 2017 Karen E. Deschaine VIA EDGAR AND FEDEX T: +1 858 550-6088 kdeschaine@cooley.com March 28, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Mary Mast Johnny Gharib Re: Tocagen Inc. Registration Statement on Form S-1 Filed March 9, 2017 File No. 333-216574 Dear Ms. Hayes: On behalf of our client, Tocagen Inc. (the “Company”), we are submitting this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letters dated November 16, 2015 (the “November 2015 Comment Letter”) and March 23, 2017 (the “March 2017 Comment Letter”), relating to the Company’s confidential draft registration statement on Form S-1 submitted to the Commission on October 23, 2015, which was subsequently amended on June 28, 2016 and February 9, 2017 and filed with the Commission on March 9, 2017 (as amended, the “Registration Statement”). In this letter, we are responding (i) only to comment number 5 in the November 2015 Comment Letter and (ii) to the March 2017 Comment Letter, the text of each of which we have incorporated into this response letter for convenience. Confidential Treatment Request Due to the commercially sensitive nature of information contained herein, the Company hereby requests, pursuant to 17 C.F.R. § 200.83, that certain portions of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person as they contain confidential information. The Company has filed a separate copy of this letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. § 200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least […***…] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND SUBMITTED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 4401 EASTGATE MALL, SAN DIEGO, CA 92121 T: (858) 550-6000 F: (858) 550-6420 WWW.COOLEY.COM March 28, 2017 Page 2 of 7 CONFIDENTIAL ten business days advance notice of any intended release so that the Company may, if deemed necessary or appropriate, pursue any remedies available to it. In such an event, we request that you telephone the undersigned rather than rely upon the U.S. mail for such notice. The address and telephone number for Karen E. Deschaine, the responsible representative, is c/o Cooley LLP, 4401 Eastgate Mall, San Diego, California 92121-1909, telephone number (858) 550-6088. Staff Comments and Company Responses November 2015 Comment Letter Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Stock-Based Compensation, page 62 5. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences between recent valuations of your common stock leading up to the IPO and the estimated offering price. Response: First, we respectfully request that the Staff review the disclosure regarding stock based compensation in the Registration Statement on pages 67 – 71, which includes details regarding the Company’s historical practices and valuation approaches that apply to the grant of stock-based awards. Historically, the fair value of the common stock underlying the Company’s stock-based awards has been determined on each grant date by the Company’s board of directors (the “Board”), with input from management. All options to purchase shares of the Company’s common stock were intended to be granted with an exercise price per share no less than the fair value per share of the Company’s common stock underlying those options on the date of grant, determined in good faith and based on the information known to the Board on the date of grant. In the absence of a public trading market for the Company’s common stock, on each grant date, the Board considered various objective and subjective factors described in detail in the Registration Statement, along with input from management, to determine the fair value of the Company’s common stock. In addition to the above factors, as part of its assessment of the fair value of the Company’s common stock for purposes of making stock option grants, the Board also considered appraisals of the fair value of the Company’s common stock from independent third-party valuation specialists using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants’ Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation (the “Practice Aid”). […***…] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND SUBMITTED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 4401 EASTGATE MALL, SAN DIEGO, CA 92121 T: (858) 550-6000 F: (858) 550-6420 WWW.COOLEY.COM March 28, 2017 Page 3 of 7 CONFIDENTIAL The following is a summary of recent valuations: August 31, 2016 Valuation In accordance with the Practice Aid, the August 31, 2016 valuation used a hybrid method of an option pricing method (“OPM”) and the probability-weighted expected return method (“PWERM”) to allocate enterprise value. The enterprise value for the OPM arm of the analysis (the Stay Private Scenario) was determined using a market method, in which the Company’s fair value of equity on a marketable basis was determined by choosing pharmaceutical/gene therapy companies in various stages of clinical development in the oncology space and extrapolating the market value of invested capital (“MVIC”) based upon publicly available information. From this, a preliminary equity value was selected by the average cash-free MVIC indications of the guideline companies. After adding back the Company’s cash balance, net of interest-bearing debt, an equity value on a marketable basis was determined. A per share value from the OPM was determined using an assumption of a liquidity period of 1.2 years and a discount for lack of marketability (“DLOM”) of 23%. The enterprise value for the PWERM arm of the analysis (the IPO Scenario) was determined using a market method, in which the Company’s fair value of equity on a marketable basis was determined by choosing a group of comparable companies that recently conducted an initial public offering (“IPO”). An analysis was performed for two potential IPO scenarios: (1) a near-term IPO scenario and (2) a longer-term IPO scenario. In each case, the comparable companies’ cash-free, pre-IPO valuations were used as a proxy for the Company’s MVIC. A preliminary MVIC was selected using the mean cash-free, pre-IPO valuations of the comparable companies. After adjusting for the Company’s cash balance and interest-bearing debt as of the liquidity event, the equity value on a marketable basis was determined. A per share value from the PWERM is determined using an assumption of a liquidity period of 0.3 years and a DLOM of 9% for the near-term IPO scenario, and a liquidity period of 0.5 years and a DLOM of 11% for the longer-term IPO scenario. The hybrid model weighted the PWERM arm at 21% and 49% for the near-term IPO and longer-term IPO scenarios, respectively, and the OPM arm at 30%. The resulting fair value of the Company’s common stock was $2.40 per share. November 30, 2016 Valuation In accordance with the Practice Aid, the November 30, 2016 valuation used a hybrid method of an OPM and PWERM to allocate enterprise value. The enterprise value for the OPM arm of the analysis (the Stay Private Scenario) was determined using a market method, in which the Company’s fair value of equity on a marketable basis was determined by choosing pharmaceutical/gene therapy companies in various stages of clinical development in the oncology space and extrapolating the MVIC based upon publicly available information. From this, a preliminary equity value was selected by the average cash-free MVIC indications of the guideline companies. After adding back the Company’s cash balance, net of interest-bearing debt, an equity value on a marketable basis was determined. A per share value from the OPM was [...***...] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND SUBMITTED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 4401 EASTGATE MALL, SAN DIEGO, CA 92121 T: (858) 550-6000 F: (858) 550-6420 WWW.COOLEY.COM March 28, 2017 Page 4 of 7 CONFIDENTIAL determined using an assumption of a liquidity period of 0.9 years and a DLOM of 23%. The enterprise value for the PWERM arm of the analysis (the IPO Scenario) was determined using a market method, in which the Company’s fair value of equity on a marketable basis was determined by choosing a group of comparable companies that recently conducted an IPO. Those comparable companies’ cash-free, pre-IPO valuations were used as a proxy for the Company’s MVIC. A preliminary MVIC was selected using the mean cash-free, pre-IPO valuations of the comparable companies. After adjusting for the Company’s cash balance and interest-bearing debt as of the liquidity event, the equity value on a marketable basis was determined. A per share value from the PWERM is determined using an assumption of a liquidity period of 0.4 years and a DLOM of 10%. The hybrid model weighted the PWERM arm at 85% and the OPM arm at 15%. The resulting fair value of the Company’s common stock was $2.19 per share. November 2016 Grants On November 16, 2016, the Board granted options to purchase 3,195,112 shares of common stock. At the grant date, the Board granted the awards with an exercise price of $2.40 per share. The exercise price was based on the valuation analysis as of August 31, 2016 and the other objective and subjective factors described in the Registration Statement. Subsequent to the issuance of the awards, the Company reassessed the common stock fair value related to the options granted in November 2016 in light of the November 30, 2016 valuation. The Company’s reassessed fair value was based on a straight-line method between the August 31, 2016 valuation and the November 30, 2016 valuation which resulted in a grant date estimated fair value of $2.22 per share. The vesting of one-third of the options granted on November 16, 2016 is performance-based. At the time of grant (and as of December 31, 2016), the performance conditions of the awards were not known and as a result the awards were not deemed granted for financial accounting purposes until the Board specified the performance conditions in February 2017. The Company will determine the grant date fair value for the 1,065,037 performance-based options in the first quarter of 2017. Once it has been determined, the Company will use the midpoint of the bona fide initial offering price range as the grant date fair value of the performance-based options and expects to include related stock-based compensation charges, if any, in the first quarter of 2017 and over the related vesting period of the options. March 2017 Grants On March 6, 2017, the Board granted options to purchase 717,154 shares of common stock. At the grant date, the Board determined that the fair value of the Company’s common stock was $2.19 per share in connection with the grant of stock options based on the valuation analysis as of November 30, 2016 and the other objective and subjective factors described in the Registration Statement. Importantly, the Board determined that, as of March 6, 2017, no significant business or market developments had occurred since the valuation date of November 30, 2016. However, the Company also advises the Staff that once the bona fide initial offering price range has been determined, the Company anticipates retrospectively reassessing, solely […***…] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND SUBMITTED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 4401 EASTGATE MALL, SAN DIEGO, CA 92121 T: (858) 550-6000 F: (858) 550-6420 WWW.COOLEY.COM March 28, 2017 Page 5 of 7 CONFIDENTIAL for financial accounting purposes, the common stock fair value related to the options granted in March 2017. The Company advises the Staff that the fair value for financial accounting purposes of the options granted in March 2017 will be the midpoint of the bona fide initial offering price range and that it expects to include related stock-based compensation charges, if any, in the first quarter of 2017 and over the related vesting period of the options. Preliminary IPO Price Range In March 2017, the Company had meetings with potential investors in reliance on Section 5(d) of the Securities Act of 1933, as amended (the “Act”). In connection with such meetings, the Company received feedback from potential investors which caused the underwriters and the Board to increase its expectations regarding the anticipated probability of a near-term IPO but tempered expectations with respect to the value of the Company. The Company respectfully advises the Staff that on March 27, 2017, representatives of the joint book-running managers of its IPO advised the Company that, based on then-current market conditions, they anticipated that the underwriters would recommend to the Company a preliminary estimated IPO price range to be included on the cover of the Company’s preliminary prospectus of $[…***…] to $[…***…] per share, before the implementation of any reverse stock split effected prior to the IPO (the “Preliminary IPO Price Range”). The Company advises the Staff that it will set forth a bona fide initial offering price range in a pre-effective amendment to the Registration Statement prior to the distribution of any preliminary prospectus, which price range will be narrower than but within the Preliminary IPO Price Range (it is anticipated to be a $2.00 range after the implementation of a yet-to-be-determined reverse stock split). The parameters of that narrower price range will be subject to then-current market conditions, continuing discussions with the underwriters, and any further business, market or other developments impacting the Company. The Company respectfully submits to the Staff that the Preliminary IPO Price Range is, at all points within the range, less than the recent valuations of the Company’s common stock used for granting stock-based awards. […***…] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND SUBMITTED SEPARATELY WITH THE COMMISSION PURSUANT TO 17 CFR §200.83 4401 EASTGATE MALL, SAN DIEGO, CA 92121 T: (858) 550-6000 F: (858) 550-6420 WWW.COOLEY.COM March 28, 2017 Page 6 of 7 CONFIDENTIAL March 2017 Comment Letter Management Executive Officers, page 133 1. Please revise Mr. Foletta’s background to describe his business experience during the past five years. Please see Item 401(e) of Regulation S-K for guidance. Response: The Company acknowledges the Staff’s comment and resp
2017-03-23 - UPLOAD - Forte Biosciences, Inc.
Mailstop 4546 March 23, 2017 Martin J. Duvall Chief Executive Officer Tocagen Inc. 3030 Bunker Hill Street, Suite 230 San Diego, CA 92109 Re: Tocagen Inc. Registration Statement on Form S -1 Filed March 9, 2017 File No. 333 -216574 Dear Mr. Duvall: We have reviewed your registration statement 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 in formation you provide in response to our comment , we may have additional comments. Management Executive Officers, page 133 1. Please revise Mr. Foletta’s background to describe his business experience during the past five years. Please see Item 401(e) of Regulation S -K for guidance. 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. Martin J. Duvall Tocagen , Inc. March 23 , 2017 Page 2 You may contact Mary Mast at (202) 551 -3613 or Sharon Blume at (202) 551 -3474 if you have questions regarding comments on the financial statements and related matters. Please contact Johnny Gharib at (202) 551 -3170 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Karen E. Deschaine, Esq. Cooley LLP
2017-03-09 - CORRESP - Forte Biosciences, Inc.
CORRESP
1
filename1.htm
CORRESP
Karen E. Deschaine
+1 858 550 6088
kdeschaine@cooley.com
VIA EDGAR AND FEDEX
March 9, 2017
United
States Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4546
100 F Street, N.E.
Washington, D.C. 20549
Attn: Suzanne
Hayes
Re:
Tocagen Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted February 9, 2017
CIK No. 0001419041
Dear
Ms. Hayes:
Enclosed on behalf of our client, Tocagen Inc. (the “Company”), is a registration statement on Form S-1 (the “Registration Statement”). The Registration Statement updates the Company’s confidential draft registration statement on Form S-1
originally submitted to the Securities and Exchange Commission (the “Commission”) on October 23, 2015 and amended on November 20, 2015, June 28, 2016 and February 9, 2017 (the “Amended
Confidential Draft Registration Statement”). The copy of the Registration Statement that is enclosed with the paper copy of this letter is marked to show changes from the Amended Confidential Draft Registration Statement.
The Registration Statement is being submitted in response to comments received from the staff of the Commission (the “Staff”) by
letter dated March 6, 2017 with respect to the Amended Confidential Draft Registration Statement (the “Comment Letter”) as well as to generally update the disclosure. The numbering of the paragraphs below corresponds to
the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the
Registration Statement.
Staff Comments and Company Responses
Prospectus Summary
Our Pipeline, page 4
1.
Please revise your pipeline table on pages 4 and 83 to identify the specific pipeline programs in preclinical trials. If no specific program has been identified to evaluate RRV with anti-PD-L1 for development, please remove this row from your pipeline table as it is premature to include such information in your table.
Response: The Company has revised the pipeline table on pages 4 and 82 of the Registration Statement to remove the row regarding pipeline programs.
Cooley LLP
4401 Eastgate Mall San Diego, CA 92121
t: (858) 550-6000
f: (858) 550-6420 cooley.com
United States Securities and Exchange Commission
March 9, 2017
Page Two
Our Strategy, page 4
2.
Please provide the meaning and significance of the term “statistical significance” in the first bullet point of this section. In doing so, please refrain from referencing p-values as such disclosure should be reserved for the Business Section where more context can be provided.
Response: The Company has revised the disclosure on pages 4 and 83 of the Registration Statement to delete the references to “statistical
significance”.
Business
Our Lead Product
Candidate: Toca 511 & Toca FC, page 88
3.
When you first reference p-values on page 90 of this section, please explain the meaning and significance of p-values and how
they relate to the FDA’s evidentiary standards of efficacy. In addition, please explain the relationship between p-values and statistical significance on page 96 when you state that with Toca 511 &
Toca FC the risk of death was reduced by 55% compared to lomustine, which is a statistically significant difference.
Response:
The Company has revised the disclosure on page 95 of the Registration Statement to explain the meaning and significance of p-values, including how they relate to the FDA’s evidentiary standards of
efficacy. In addition, the Company has revised the disclosure on page 97 of the Registration Statement to delete the reference to a “statistically significant difference” and to explain the purpose of statistical analysis.
Pooled Safety Date, page 100
4.
Please revise your disclosure in this section and in the table on page 101 to describe the serious adverse events reported in 4.8% of patients treated with Toca 511 and 2.5% of patients treated with Toca
FC.
Response: The Company has revised the disclosure on page 101 of the Registration Statement and in the table on page 102 of
the Registration Statement to include specifics regarding the serious adverse events reported for Toca 511 and Toca FC in the applicable clinical trials.
Cooley LLP
4401 Eastgate Mall San Diego, CA 92121
t: (858) 550-6000
f: (858) 550-6420 cooley.com
Karen E. Deschaine
+1 858 550 6088
kdeschaine@cooley.com
VIA EDGAR AND FEDEX
The Company respectfully requests the Staff’s assistance in completing the review of the Registration
Statement as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Registration Statement or this response letter to me at
(858) 550-6088.
Sincerely,
Cooley LLP
/s/ Karen E. Deschaine
Karen E. Deschaine
cc:
Martin J. Duvall, Tocagen Inc.
Cheston J. Larson, Latham & Watkins LLP
Cooley LLP
4401 Eastgate Mall San Diego, CA 92121
t: (858) 550-6000
f: (858) 550-6420 cooley.com
2017-03-06 - UPLOAD - Forte Biosciences, Inc.
Mailstop 4546 March 6, 2017 Martin J. Duvall Chief Executive Officer Tocagen Inc. 3030 Bunker Hill Street, Suite 230 San Diego, CA 92109 Re: Tocagen Inc. Amendment No. 3 to Draft Registration Statement on Form S -1 Submitted February 9, 2017 CIK No. 0001419041 Dear Mr. Duvall: We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If y ou do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft reg istration statement or filed registration statement, we may have additional comments. Prospectus Summary Our Pipeline, page 4 1. Please revise your pipeline table on pages 4 and 83 to identify the specific pipeline programs in preclinical trials. If no s pecific program has been identified to evaluate RRV with anti -PD-L1 for development, please remove this row from your pipeline table as it is premature to include such information in your table. Our Strategy, page 4 2. Please provide the meaning and signifi cance of the term “statistical significance” in the first bullet point of this section. In doing so, please refrain from referencing p -values as Martin J. Duvall Tocagen , Inc. March 6, 2017 Page 2 such disclosure should be reserved for the Business section where more context can be provided. Business Our Lead Product Candidate: Toca 511 & Toca FC, page 88 3. When you first reference p -values on page 90 of this section, please explain the meaning and significance of p -values and how they relate to the FDA’s evidentiary standards of efficacy. In addition, ple ase explain the relationship between p -values and statistical significance on page 96 when you state that with Toca 511 & Toca FC the risk of death was reduced by 55% compared to lomustine, which is a statistically significant difference. Pooled Safety Date, page 100 4. Please revise your disclosure in this section and in the table on page 101 to describe the serious adverse events reported in 4.8% of patients treated with Toca 511 and 2.5% of patients treated with Toca FC. You may contact Mary Mast at (202) 551 -3613 or Sharon Blume at (202) 551 -3474 if you have questions regarding comments on the financial statements and related matters. Please contact Johnny Gharib at (202) 551 -3170 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Karen E. Deschaine, Esq. Cooley LLP
2016-07-21 - UPLOAD - Forte Biosciences, Inc.
Mail Stop 4720 July 20 , 2016 Harry E. Gruber, M.D. President and Chief Executive Officer Tocagen Inc. 3030 Bunker Hill Street, Suite 230 San Diego, CA 92109 Re: Tocagen Inc. Amendment No. 2 to Draft Registration Statement on Form S -1 Submitted June 28, 2016 CIK No. 0001419041 Dear Dr. Gruber : We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either su bmitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your re sponse. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Clinical Development of Toca 511 & Toca FC, page 87 1. We note your response to comment 3 and continue to believe the statement “The hazard ratio for overall survival was 0.45 (95% C I 0.27, 0.77; p=0.0028) …” is unclear. Please explain what “0.45 (95% C I 0.27, 0.77; p=0.0028) ” is intended to convey. Risk Factors, page 11 2. We note that your Amended and Restated Certificate of Incorporation includes an exclusive forum provision at Article VII. Please include a separate risk factor to disclos e that such a provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds Harry E. Gruber, M.D. Tocagen Inc. July 20 , 2016 Page 2 favorable for disputes, and may discourage lawsuits with respect to such claims against the company and its officers, directors or other employees. You may contact Mary Mast at (202) 551 -3613 or Sharon Blume at (202) 551 -3474 if you have questions regarding comments on the financial s tatements and related matters. Please contact Christina Thomas at (202) 551 -3577 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Karen E. Deschaine, Esq. Cooley LLP
2015-12-02 - UPLOAD - Forte Biosciences, Inc.
Mailstop 4720 December 1, 2015 Via E -mail Harry E. Gruber, M.D. President and Chief Executive Officer Tocagen Inc. 3030 Bunker Hill Street, Suite 230 San Diego, CA 92109 Re: Tocagen Inc. Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted November 20, 2015 CIK No. 0001419041 Dear Dr. Gruber : We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary Overview, page 2 1. We note your response to our prior comment 1. Please revise your disclosure to state that you cannot find reliable incidence data for recurrent HGG. Harry E. Gruber, M.D. Tocagen Inc. December 1, 2015 Page 2 Business, page 76 Overview, page 76 2. We note your response to our prior comment 9. We do not agree with your analysis that it is inappropriate to provide a brief explanation of the terms Fast Track designation and orphan drug designation at first use in order for any potential lay investors to understand the significance of such FDA designations. At first use, please provide a brief explanation of the requirements for and benefits of Fast Track designation and orphan drug designation. Please also include an estimate of the number of people in the United States currently diagnosed with glioblastoma (“GBM”) , since you intend to rely on such information to receive orphan drug designation . Lastly, please provide a brief explanation of how orphan drug designation for GBM may affect the approval and marketing of a product candidate for HGG. Please make corresponding changes to the Prospectus Summary. Clinical Development of Toca 511 & Toca FC Ongoing Phase 1 Clinical Trials , page 87 Ongoing Resection Injection Trial , page 88 3. At first use, plea se explain the term “hazard ratio” for a lay investor to understand. Ongoing Resection Injection Trial Compared to Lomustine External Control , page 91 4. Please provide a brief explanation of the term “Karnofsky performance status ” and what it measures. Please contact Christina Thomas at (202) 551 -3577, Michael Clampitt at (202) 551 -3434 or me at (202) 551 -3675 with any questions. Sincerely, p.p./s/ Mi chael Clampitt Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Via E -mail Karen E. Deschaine, Esq. Cooley LLP 4401 Eastgate Mall San Diego, California 92121
2015-11-17 - UPLOAD - Forte Biosciences, Inc.
Mailstop 4720 November 16, 2015 Via E -mail Harry E. Gruber, M.D. President and Chief Executive Officer Tocagen Inc. 3030 Bunker Hill Street, Suite 230 San Diego, CA 92109 Re: Tocagen Inc. Draft Registration Statement on Form S -1 Submitted October 23, 2015 CIK No. 0001419041 Dear Dr. Gruber : We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary Overview, page 2 1. Please revise your discussion starting with the first full paragraph on page 2 to briefly describe the annual number of cases of recurrent high grade glioma. Please revise the following paragraph to briefly discuss the number of competitors developing immunotherapies. 2. Please revise your disclosure to briefly discuss the FDA regime for trials , i.e., numbe r needed. In addition, please disclose your timeframe for completion of the Phase 3 trials and the additional anticipated costs for Phase 2 and Phase 3. Harry E. Gruber, M.D. Tocagen Inc. November 16, 2015 Page 2 Risk Factors “Our clinical trials may fail to demonstrate safety…,” page 16 3. Please disclose any seri ous adverse events reported in your clinical trials to date. Use of Proceeds, page 50 4. For each product candidate that you intend to develop with the proceeds from this offering, please state the anticipated stage of development that you expect to reach u sing the proceeds of the offering. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Stock -Based Compensation, page 62 5. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences between recent valuations of your common stock leading up to the IPO and the estimated offering price. Business, page 74 Overview, page 74 6. Please disclose all investigational new drug applications (“INDs”) that you have submitted to the FDA as well as the indication(s) and spons or(s) for any active INDs related to your product candidates. 7. At first use, please provide an explanation of your “two preferred delivery methods.” Please make corresponding changes to the Prospectus Summary. 8. At first use, please provide a brief explana tion for each of the following scientific terms to enable a lay investor to understand: “resection injection trial;” “first and second recurrent HGG;” and “systemically administered antibody drug conjugates.” Please make corresponding changes to the Prospectus Summary. 9. At first use, please provide a brief explanation of the requirements for and benefits of Fast Track designation and orphan drug designation. Please also include an estimate of the number of people in the United States currently diagno sed with recurrent high grade Harry E. Gruber, M.D. Tocagen Inc. November 16, 2015 Page 3 glioma (“HGG”) as well as glioblastoma (“GBM”). Lastly, please provide a brief explanation of how orphan drug designation for GBM may affect the approval and marketing of a product candidate for HGG. Please make correspondin g changes to the Prospectus Summary. Our RRV Platform, page 79 10. At first use, please provide a brief explanation of the term “Type 1 interferon” for a lay investor to understand. 11. Please expand your explanations of the graphics on page 81 to provide more context. For example, please explain the significance of “Day 1” to “Day 7” in the top graphic. In the bottom graphic, please explain the significance of base pairs and what they measure. Clinical Development of Toca 511 & Toca FC Ongoing Phase 1 Clinic al Trials , page 85 Ongoing Resection Injection Trial , page 85 12. At first use, please provide brief explanations of the terms “confidence interval” and “stable disease” for a lay investor to understand. 13. Please expand the discussion of your graphic on page 87 to provide a brief description of the logrank test. Please also include a brief explanation of the term “censored.” Pooled Efficacy Data for Ongoing Resection and Intratumoral Injection Trials , page 88 14. Please define the term “Clarke 2011.” Pooled Sa fety Data, page 90 15. Please disclose all treatment -related serious adverse events. Intellectual Property, page 101 16. Please revise your patent -related disclosure to clarify which of your material patents are owned and which are licensed from third parties. 17. Please distinguish which of your material patents and patent applications are granted or pending in the U nited States and identify other applicable jurisdictions in which you have patents granted or patent applications pending . Harry E. Gruber, M.D. Tocagen Inc. November 16, 2015 Page 4 Competition, page 101 18. To the extent known, please disclose the stages of development for the competing product candidates listed. Management Non-Employee Directors, page 118 19. Please describe the business experience of Franklin Berger during the past five years. General 20. Please confirm that the images included in your draft registration statement are all of the graphic, visual or photographic information you will be including. If you intend to use any additional images, please provide us proofs of such materials. Please note t hat we may have comments regarding this material. 21. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential inv estors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. You may contact Mary Mast at (202) 551 -3613 or Sharon Blume at (202) 551 -3474 if you have questions regarding comments on the financial s tatements and related matters. Please contact Christina De Rosa at (202) 551 -3577, Michael Clampitt at (202) 551 -3434 or me at (202) 551-3675 with any other questions. Sincerely, p.p. /s/ Michael Clampitt Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Via E -mail Karen E. Deschaine, Esq. Cooley LLP 4401 Eastgate Mall San Diego, California 92121