Correspondence 0001193125-23-183590 from Poseida Therapeutics, Inc. (CIK 0001661460)
Poseida Therapeutics, Inc. (CIK 0001661460)
Date: July 7, 2023 · CIK: 0001661460 · Accession: 0001193125-23-183590
AI Filing Summary & Sentiment
File numbers found in text: 001-39376
Referenced dates: June 22, 2023, May 27, 2020
Letter
VIA EDGAR Division of Corporation Finance Office of Life Sciences Re: Poseida Therapeutics, Inc. Form 10-K for the fiscal year ended December 31, 2022 Filed March 9, 2023 File No. 001-39376
Dear Ms. Do and Mr. Vaughn:
Poseida Therapeutics, Inc. (the “Company”, “we”, “our”) sets forth below its response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) in your letter dated June 22, 2023, relating to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed on March 9, 2023. To facilitate the Staff’s review, we have included in bold italics below the Staff’s comments.
Form 10-K for the fiscal year ended December 31, 2022
Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 111
Results of Operations, page 119
We note from page 119 that research and development (R&D) expenses attributable to Clinical stage programs accounts for approximately one-third of total R&D expense for the two annual periods presented. These clinical stage programs are represented by two programs in 2021 and four programs in 2022. We also note the following from your response letter dated May 27, 2020: “Going forward as the Company’s other programs, such as its Allogeneic program, Dual CAR Allogenic program or Gene Therapy program enter the clinic, the Company respectfully advises the Staff that it plans on further breaking out its external clinical stage program costs for investors by program at that time.” Accordingly, please provide us with your proposed disclosure revisions to break out such clinical stage program costs by program in your next Form 10-Q as committed to in your earlier response letter.
Response
The Company acknowledges the Staff’s comments and in future filings with the SEC the Company intends to provide additional specificity regarding research and development expenses attributable to its clinical stage programs incurred during each period presented. The Company initially anticipates providing research and development expenses on a program-by-program basis. However, as we continue advancing our allogeneic programs and wind-down our autologous programs and the aggregate amount of expenses for such autologous programs becomes immaterial, we plan to present research and development expenses attributable to such autologous programs on a consolidated basis. We believe this format of presentation will be consistent with the manner in which our board of directors and management evaluates our financial and operating results and will enable investors to evaluate our financial and operating results similarly.
9390 Towne Centre Drive, Suite 200 • San Diego, CA 92121 • www.poseida.com
The Company will include tables similar to the following in the section entitled Management’s Discussion and Analysis of Financial Condition and Results of Operations in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. As we have not finalized the quarter ended June 30, 2023, we have omitted the form of the narrative disclosures accompanying the research and development expenses tables from this letter but the narrative disclosures we include in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 to be filed with the SEC will separately quantify research and development expenses on a program-by-program basis.
Research and Development Expenses
The following table summarizes our research and development expenses (in thousands):
Three Months Ended June 30,
Change
External costs:
Clinical stage programs:
Allogeneic programs:
P-BCMA-ALLO1
$
$
$
P-MUC1C-ALLO1
Total allogeneic programs
Autologous programs:
P-BCMA-101
P-PSMA-101
Total autologous programs
Total clinical stage programs
$
$ 8,628
$
Preclinical stage programs and other unallocated expenses
7,759
Internal costs:
Personnel
14,844
Facilities and other
3,777
Total research and development expenses
$
$ 35,008
$
Research and Development Expenses
The following table summarizes our research and development expenses (in thousands):
Six Months Ended June 30,
Change
External costs:
Clinical stage programs:
Allogeneic programs:
P-BCMA-ALLO1
$
$
$
P-MUC1C-ALLO1
Total allogeneic programs
Autologous programs:
P-BCMA-101
P-PSMA-101
Total autologous programs
Total clinical stage programs
$
$ 31,656
$
Preclinical stage programs and other unallocated expenses
15,822
Internal costs:
Personnel
29,409
Facilities and other
6,971
Total research and development expenses
$
$ 83,858
$
9390 Towne Centre Drive, Suite 200 • San Diego, CA 92121 • www.poseida.com
Please advise us if we can provide any further information or assistance to facilitate your review. Please also direct any further comments or questions regarding this letter to the undersigned at (858) 779-3104 or jmylet@poseida.com.
Very truly yours,
/s/ Johanna Mylet
Show Raw Text
CORRESP 1 filename1.htm CORRESP VIA EDGAR July 7, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Jenn Do Kevin Vaughn Re: Poseida Therapeutics, Inc. Form 10-K for the fiscal year ended December 31, 2022 Filed March 9, 2023 File No. 001-39376 Dear Ms. Do and Mr. Vaughn: Poseida Therapeutics, Inc. (the “Company”, “we”, “our”) sets forth below its response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) in your letter dated June 22, 2023, relating to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed on March 9, 2023. To facilitate the Staff’s review, we have included in bold italics below the Staff’s comments. Form 10-K for the fiscal year ended December 31, 2022 Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 111 Results of Operations, page 119 We note from page 119 that research and development (R&D) expenses attributable to Clinical stage programs accounts for approximately one-third of total R&D expense for the two annual periods presented. These clinical stage programs are represented by two programs in 2021 and four programs in 2022. We also note the following from your response letter dated May 27, 2020: “Going forward as the Company’s other programs, such as its Allogeneic program, Dual CAR Allogenic program or Gene Therapy program enter the clinic, the Company respectfully advises the Staff that it plans on further breaking out its external clinical stage program costs for investors by program at that time.” Accordingly, please provide us with your proposed disclosure revisions to break out such clinical stage program costs by program in your next Form 10-Q as committed to in your earlier response letter. Response The Company acknowledges the Staff’s comments and in future filings with the SEC the Company intends to provide additional specificity regarding research and development expenses attributable to its clinical stage programs incurred during each period presented. The Company initially anticipates providing research and development expenses on a program-by-program basis. However, as we continue advancing our allogeneic programs and wind-down our autologous programs and the aggregate amount of expenses for such autologous programs becomes immaterial, we plan to present research and development expenses attributable to such autologous programs on a consolidated basis. We believe this format of presentation will be consistent with the manner in which our board of directors and management evaluates our financial and operating results and will enable investors to evaluate our financial and operating results similarly. 9390 Towne Centre Drive, Suite 200 • San Diego, CA 92121 • www.poseida.com The Company will include tables similar to the following in the section entitled Management’s Discussion and Analysis of Financial Condition and Results of Operations in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. As we have not finalized the quarter ended June 30, 2023, we have omitted the form of the narrative disclosures accompanying the research and development expenses tables from this letter but the narrative disclosures we include in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 to be filed with the SEC will separately quantify research and development expenses on a program-by-program basis. Research and Development Expenses The following table summarizes our research and development expenses (in thousands): Three Months Ended June 30, 2023 2022 Change External costs: Clinical stage programs: Allogeneic programs: P-BCMA-ALLO1 $ $ $ P-MUC1C-ALLO1 Total allogeneic programs Autologous programs: P-BCMA-101 P-PSMA-101 Total autologous programs Total clinical stage programs $ $ 8,628 $ Preclinical stage programs and other unallocated expenses 7,759 Internal costs: Personnel 14,844 Facilities and other 3,777 Total research and development expenses $ $ 35,008 $ Research and Development Expenses The following table summarizes our research and development expenses (in thousands): Six Months Ended June 30, 2023 2022 Change External costs: Clinical stage programs: Allogeneic programs: P-BCMA-ALLO1 $ $ $ P-MUC1C-ALLO1 Total allogeneic programs Autologous programs: P-BCMA-101 P-PSMA-101 Total autologous programs Total clinical stage programs $ $ 31,656 $ Preclinical stage programs and other unallocated expenses 15,822 Internal costs: Personnel 29,409 Facilities and other 6,971 Total research and development expenses $ $ 83,858 $ 9390 Towne Centre Drive, Suite 200 • San Diego, CA 92121 • www.poseida.com Please advise us if we can provide any further information or assistance to facilitate your review. Please also direct any further comments or questions regarding this letter to the undersigned at (858) 779-3104 or jmylet@poseida.com. Very truly yours, /s/ Johanna Mylet Johanna Mylet Chief Financial Officer cc: Mark J. Gergen, President and Chief Executive Officer, Poseida Therapeutics, Inc. Harry J. Leonhardt, General Counsel and Chief Compliance Officer, Poseida Therapeutics, Inc. Thomas A. Coll, Cooley LLP Edmond J. Lay, Cooley LLP 9390 Towne Centre Drive, Suite 200 • San Diego, CA 92121 • www.poseida.com