SEC Comment Letter for Forte Biosciences, Inc. (FBRX) (CIK 0001419041) (FBRX) — Nov 17, 2015
Forte Biosciences, Inc. (FBRX) (CIK 0001419041)
Date: Nov. 17, 2015 · CIK: 0001419041 · Accession: 0000000000-15-054319
AI Filing Summary & Sentiment
Letter
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
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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