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Vaxcyte, Inc.
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Vaxcyte, Inc.
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Vaxcyte, Inc.
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Vaxcyte, Inc.
Response Received
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Medium - date proximity
SEC wrote to company
2020-03-27
Vaxcyte, Inc.
Summary
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Vaxcyte, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-01-21
Vaxcyte, Inc.
Summary
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Vaxcyte, Inc.
Awaiting Response
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Medium
SEC wrote to company
2019-11-08
Vaxcyte, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-14 | SEC Comment Letter | Vaxcyte, Inc. | DE | 001-39323 | Read Filing View |
| 2025-05-07 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2025-04-10 | SEC Comment Letter | Vaxcyte, Inc. | DE | 001-39323 | Read Filing View |
| 2020-06-09 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-05-22 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-03-27 | SEC Comment Letter | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-01-21 | SEC Comment Letter | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2019-11-08 | SEC Comment Letter | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-14 | SEC Comment Letter | Vaxcyte, Inc. | DE | 001-39323 | Read Filing View |
| 2025-04-10 | SEC Comment Letter | Vaxcyte, Inc. | DE | 001-39323 | Read Filing View |
| 2020-03-27 | SEC Comment Letter | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-01-21 | SEC Comment Letter | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2019-11-08 | SEC Comment Letter | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-07 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
| 2020-05-22 | Company Response | Vaxcyte, Inc. | DE | N/A | Read Filing View |
2025-05-14 - UPLOAD - Vaxcyte, Inc. File: 001-39323
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 14, 2025 Andrew Guggenhime President and Chief Financial Officer Vaxcyte, Inc. 825 Industrial Road, Suite 300 San Carlos, California 94070 Re: Vaxcyte, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 Filed February 25, 2025 File No. 001-39323 Dear Andrew Guggenhime: We have completed our review of your filing. 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. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-05-07 - CORRESP - Vaxcyte, Inc.
CORRESP 1 filename1.htm Document May 7, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attention: Jenn Do Vanessa Robertson Re: Vaxcyte, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed February 25, 2025 File No. 001-39323 Dear Ms. Do and Ms. Robertson, Vaxcyte, Inc. (the “Company,” “we,” or “our”) acknowledges receipt of your comment letter (the “Comment Letter”) dated April 10, 2025 from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC” or the “Commission”) regarding the above-referenced Form 10-K, as filed on February 25, 2025. As such, set forth below is the Company’s response to the comment contained in the Comment Letter. To facilitate the Staff’s review, the text of the Staff’s comment is set forth below in bold. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 99 Results of Operations, page 109 1. You disclose on page 106 that do not allocate all of your costs by vaccine candidates, as your research and development expenses include internal costs, such as payroll and other personnel expenses, which are not tracked by vaccine candidate. Please provide revised disclosure to be included in future filings to address the following: • Clarify which expenses you do allocate by project and clarify if you track any expenses by candidate. To the extent you do track any research and development expenses by program, provide a breakdown of the expenses tracked by project. • If you do not track external expenses by program, break out external research and development costs by clinical and preclinical. If you cannot disaggregate these amounts, please disclose that fact and explain why not. • For all other research and development expenses. provide us with other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. by nature or type of expense) which should reconcile to total research and development expense on the Statements of Operations. We note that you included a break out of research and development expenses by type in the 10-K for the year ended December 31, 2023. Response : The Company acknowledges the Staff’s comment and respectfully advises the Staff that we track our research and development (“R&D”) expenses by major types of expense, and we do not have a systematic approach to allocate R&D expenses by candidate, program and/or project. Our R&D expenses include: 1) External costs: a) Product manufacturing costs: This includes costs related to acquiring, developing, and manufacturing supplies for clinical trials and to prepare for potential future commercial launches, including fees paid to contract manufacturing organizations. b) Clinical costs: This includes costs and expenses related to agreements with contract research organizations, investigator sites, and consultants to conduct clinical trials. c) R&D consumables costs, laboratory supplies and equipment costs. d) Facility and allocated costs. e) Other expenses, which primarily include professional and consulting services costs. 2) Internal personnel-related costs: This includes salaries, employee benefits, and stock-based compensation for our personnel in R&D functions. Our pneumococcal conjugate vaccine (“PCV”) programs include VAX-31 and VAX-24, and our non-PCV programs include VAX-A1, VAX-PG, VAX-GI, and other discovery-stage programs. The majority of our external costs relate to our PCV programs, including both VAX-31 and VAX-24, compared to the costs related to VAX-A1 and other non-PCV programs. Most of the external costs associated with our vaccine candidates, particularly our PCV programs, are common in nature, and can be deployed across multiple candidates or redeployed as our vaccine development strategy evolves; as a result, we do not have a systematic approach to track external costs precisely by candidate, program or project, nor are we able to allocate these costs across programs in sufficiently reliable detail for reporting purposes, other than clinical costs that are conducted on a program-by-program basis. However, as clinical costs only account for a small portion of the total R&D expenses, we do not believe providing clinical costs by program would materially enhance an investor’s understanding of our total R&D expenses or provide a more meaningful level of disclosure for investors to understand our results of operations. Further, we do not allocate internal personnel-related costs by program or project because several of our departments support multiple vaccine candidate R&D programs, and the hours are not tracked separately by program. While the Company may have the ability to retrospectively provide the R&D expenses on a program-by-program basis by means of manually allocating the costs with certain assumptions, the allocation could be arbitrary and provide less meaningful or potentially misleading information to investors. Moreover, we are also concerned that public disclosure of the R&D expenses by candidate, program or project would result in competitive harm to the Company in a variety of ways, adversely impacting our competitive position, and as a result, our stockholders. For instance, we believe that such disclosure may weaken our ability to negotiate competitive terms with external vendors with which we may contract from time to time for services in support of our vaccine programs because they may be able to determine the amounts we pay for certain work related to a program and leverage this commercially sensitive information against us in the negotiation of contractual terms. This may negatively impact our ability to secure agreements with such vendors on optimal terms or could even make certain proposed arrangements commercially prohibitive to the Company. Our PCV programs are in the clinical stages, and non-PCV programs are in preclinical stages. The majority of our external costs relate to our PCV programs, including both VAX-31 and VAX-24, compared to the costs related to VAX-A1 and other non-PCV programs. Costs associated with preclinical programs are relatively small and insignificant to the overall financial statements. Further, other than certain clinical trial expenses, the majority of the expenses are shared among various vaccine programs and not tracked separately, and we are not able to disclose such expenses by clinical and preclinical stages in sufficiently reliable detail for reporting purposes. We have determined that the expenses related to preclinical stage programs are not material to an understanding of the Company’s results of operations at this time and therefore do not warrant separate disclosure. If, and to the extent, we determine such expenses are material to the understanding of the Company’s results of operations, such expenses will be tracked and separately disclosed in future periodic reports. The Company does track product manufacturing costs and clinical costs separately. As the Company continues progressing in the clinic to Phase 3 and the clinical costs continue to grow, we believe it is meaningful to present the two types of external expenses separately, in addition to other external costs and internal personnel-related costs, to provide more transparency to investors. Therefore, the Company has revised the disclosure in our Quarterly Report on Form 10-Q filed on May 7, 2025, to present product manufacturing costs, clinical costs, other external costs and internal personnel-related costs separately, as set forth on Exhibit A hereto. The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the disclosure in our Quarterly Report on Form 10-Q filed on May 7, 2025 in response to the Staff’s comment to provide additional qualitative and quantitative disclosure that provides more transparency as to the type of R&D expenses incurred, as set forth on Exhibit A hereto (changes that are in response to the Staff’s comment are marked). We will include disclosure in our future filings that is similar to the disclosure in our Quarterly Report on Form 10-Q filed on May 7, 2025. We believe these revisions reflect the way management views and manages our R&D activities and business. We also believe these revisions will provide further context to enhance an investor’s understanding of our use and expected use of resources in connection with our R&D activities and provide greater clarity and transparency in our financial disclosures. We hope that the foregoing has been responsive to the Staff’s comments. Please do not hesitate to contact the undersigned with any questions or comments regarding this letter. Sincerely, Andrew Guggenhime President and Chief Financial Officer cc: Mikhail Eydelman, Vaxcyte, Inc. Robert Bitman, Vaxcyte, Inc. Raquel Fox, Skadden, Arps, Slate, Meagher & Flom LLP Exhibit A Components of Results of Operations Operating Expenses Research and Development Research and development expenses represent costs incurred in performing research, development and manufacturing activities in support of our own product development efforts. These Our research and development expenses include internal personnel-related costs (including salaries, employee benefits and stock-based compensation) for our personnel in research and development functions, and external costs related to ( including ( i) product manufacturing costs, primarily related to acquiring, developing and manufacturing supplies for preclinical studies, clinical trials and other studies, to prepare for potential future commercial launches, including fees paid to contract manufacturing organizations; ( ii) clinical costs related to agreements with contract research organizations, investigative sites and consultants to conduct non-clinical and preclinical studies and clinical trials; (iii) professional and consulting services; (iv) research and development consumables ; (v) , laboratory supplies and equipment ; and (vi costs; (iv ) facility and other allocated shared services ; and (v) other expenses primarily including professional and consulting services costs. Our pneumococcal conjugate vaccine (“PCV”) programs include VAX-31 and VAX-24, and our non-PCV programs include VAX-A1, VAX-PG, VAX-GI, and other discovery-stage programs. The majority of our external costs relate to our PCV programs, including both VAX-31 and VAX-24, compared to the costs related to VAX-A1 and other non-PCV programs. Most of the external costs associated with our vaccine candidates, particularly our PCV programs, are common in nature, and can be deployed across multiple candidates or redeployed as our vaccine development strategy evolves; as a result, we do not track external costs by candidate, program or project. We do not allocate internal personnel-related costs by program or project because several of our departments support multiple vaccine candidate programs and the hours are not tracked separately by program. We do not allocate all of our costs by vaccine candidates, as our research and development expenses include internal costs, such as payroll and other personnel expenses, which are not tracked by vaccine candidate. In particular, with respect to internal costs, several of our departments support multiple vaccine candidate research and development programs. Our PCV programs are in the clinical stages, and non-PCV programs are in preclinical stages. The majority of our external costs relate to our PCV programs, including both VAX-31 and VAX-24, compared to the costs related to VAX-A1 and other non-PCV programs. Costs associated with preclinical programs are relatively small and insignificant to the overall financial statements. Further, several expenses are shared among various vaccine programs and, as such, we do not separately track external costs by clinical and preclinical stages. Results of Operations Comparison of the Three Months Ended March 31, 2025 and 2024 Operating Expenses Research and Development Expenses Research and development expenses increased by 53.5 million, or 56.6%, during the three months ended March 31, 2025 compared to the corresponding period in 2024. The increase was driven by external costs, which grew by $34.2 million largely due to increased development and manufacturing activities in connection with the adult and infant PCV programs and to support the potential future commercial launches. Product manufacturing costs increased by $27.3 million, research and development consumables, lab supplies and equipment increased by $6.4 million, facility and allocated costs increased by $4.1 million and other external costs increased by $1.7 million, partially offset by a decrease of $5.4 million in clinical costs primarily due to reduced clinical trial activities compared to the prior period. The increase was further driven by internal personnel-related costs, which grew by $19.3 million largely due to headcount growth.
2025-04-10 - UPLOAD - Vaxcyte, Inc. File: 001-39323
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 10, 2025 Andrew Guggenhime President and Chief Financial Officer Vaxcyte, Inc. 825 Industrial Road, Suite 300 San Carlos, California 94070 Re: Vaxcyte, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed February 25, 2025 File No. 001-39323 Dear Andrew Guggenhime: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 99 Results of Operations, page 109 1. You disclose on page 106 that do not allocate all of your costs by vaccine candidates, as your research and development expenses include internal costs, such as payroll and other personnel expenses, which are not tracked by vaccine candidate. Please provide revised disclosure to be included in future filings to address the following: Clarify which expenses you do allocate by project and clarify if you track any expenses by candidate. To the extent you do track any research and development expenses by program, provide a breakdown of the expenses tracked by project. If you do not track external expenses by program, break out external research and development costs by clinical and preclinical. If you cannot disaggregate these April 10, 2025 Page 2 amounts, please disclose that fact and explain why not. For all other research and development expenses. provide us with other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. by nature or type of expense) which should reconcile to total research and development expense on the Statements of Operations. We note that you included a break out of research and development expenses by type in the 10-K for the year ended December 31, 2023. In closing, 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 Jenn Do at 202-551-3743 or Vanessa Robertson at 202-551-3649 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2020-06-09 - CORRESP - Vaxcyte, Inc.
CORRESP 1 filename1.htm CORRESP BofA Securities, Inc. One Bryant Park New York, New York 10036 Jefferies LLC 520 Madison Avenue New York, New York 10022 Evercore Group L.L.C. 55 East 52nd Street New York, New York 10055 June 9, 2020 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Ada D. Sarmento Mary Beth Breslin Michael Fay Al Pavot Re: Vaxcyte, Inc. Registration Statement on Form S-1 File No. 333-238630 Acceleration Request Requested Date: Thursday, June 11, 2020 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 “Act”), we, as representatives of the several underwriters, hereby join in the request of Vaxcyte, Inc. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement, requesting effectiveness as of 4:00 P.M., Eastern Time, on June 11, 2020, or at such later time as the Company or its outside counsel, Cooley LLP, may request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the securities, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Signature Page Follows] Very truly yours, BOFA SECURITIES, INC. By: /s/ Michael Liloia Authorized Signatory JEFFERIES LLC By: /s/ Michael Brinkman Authorized Signatory EVERCORE GROUP L.L.C. By: /s/ Gloria Tang Authorized Signatory [Signature Page to Underwriters’ Acceleration Request]
2020-06-09 - CORRESP - Vaxcyte, Inc.
CORRESP 1 filename1.htm CORRESP VAXCYTE, INC. 353 Hatch Drive Foster City, California 94404 June 9, 2020 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Mary Beth Breslin Michael Fay Al Pavot RE: Vaxcyte, Inc. Registration Statement on Form S-1 File No. 333-238630 Acceleration Request Requested Date: Thursday, June 11, 2020 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Vaxcyte, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1 to become effective on Thursday, June 11, 2020, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant’s counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of Robert W. Phillips and J. Carlton Fleming 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 Robert W. Phillips of Cooley LLP, counsel to the Registrant, at (415) 693-2020, or J. Carlton Fleming at (650) 843-5865. [Signature Page Follows] Very truly yours, VAXCYTE, INC. By: /s/ Jane Wright-Mitchell Name: Jane Wright-Mitchell Title: General Counsel cc: Grant E. Pickering, Vaxcyte, Inc. Robert W. Phillips, Cooley LLP Charles S. Kim, Cooley LLP J. Carlton Fleming, Cooley LLP Peter N. Handrinos, Latham & Watkins LLP Brian J. Cuneo, Latham & Watkins LLP Miles P. Jennings, Latham & Watkins LLP [Company Signature Page to Acceleration Request]
2020-05-22 - CORRESP - Vaxcyte, Inc.
CORRESP 1 filename1.htm CORRESP Robert W. Phillips +1 415 693 2020 rphillips@cooley.com May 22, 2020 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Mary Beth Breslin Michael Fay Al Pavot Re: Vaxcyte, Inc. Amendment No. 3 to Draft Registration Statement on Form S-1 Submitted March 13, 2020 CIK No. 0001649094 Ladies and Gentlemen: On behalf of Vaxcyte, Inc. (“Vaxcyte” or the “Company”), we are submitting this response letter in response to the comment letter, dated March 27, 2020, from the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amendment No. 3 to Draft Registration Statement on Form S-1 (the “DRS”) confidentially submitted to the Commission on March 13, 2020. We are also electronically transmitting for filing a Registration Statement on Form S-1 (the “Registration Statement”) that reflects changes in response to the Staff’s comments, as well as other updates. We are also sending to the Staff a copy of this letter and the Registration Statement in typeset format, including a version that is marked to show changes to the DRS. The numbering of the paragraphs below corresponds to the numbering of the comments in the Staff’s comment letter. For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Page references in the text of this response letter correspond to the page numbers in the Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings ascribed to such terms in the Registration Statement. Amendment No. 3 to Draft Registration Statement on Form S-1 Prospectus Summary, page 1 1. We note your revised disclosure in response to our prior comment 1. Please remove your statements here and elsewhere in the prospectus that you believe that SVX-24, if approved, has the potential to become the most broad-spectrum pneumococcal conjugate vaccine addressing the $7 billion global pneumococcal vaccine market. Please also revise your statements here and elsewhere in the prospectus that you believe that you are developing potentially “best-in-class” vaccines. This language implies that your product candidates will be effective and will be better than competing vaccines, neither of which is appropriate at this stage of development. Cooley LLP 101 California Street 5th Floor San Francisco, CA 94111-5800 t: (415) 693-2000 f: (415) 693-2222 cooley.com U.S. Securities and Exchange Commission May 22, 2020 Page Two In response to the Staff’s comment, the Company has revised the existing disclosure on pages 1, 98, 103 and 111 of the Registration Statement. * * * Please contact me at (415) 693 2020 or J. Carlton Fleming of Cooley LLP at (650) 843 5865 with any questions or further comments regarding our responses to the Staff’s comments. Sincerely, /s/ Robert W. Phillips Robert W. Phillips Cooley LLP cc: Grant E. Pickering, Vaxcyte, Inc. Jane Wright-Mitchell, Vaxcyte, Inc. Charles S. Kim, Cooley LLP J. Carlton Fleming, Cooley LLP Peter N. Handrinos, Latham & Watkins LLP Brian J. Cuneo, Latham & Watkins LLP Miles P. Jennings, Latham & Watkins LLP Cooley LLP 101 California Street 5th Floor San Francisco, CA 94111-5800 t: (415) 693-2000 f: (415) 693-2222 cooley.com
2020-03-27 - UPLOAD - Vaxcyte, Inc.
March 27, 2020
Grant E. Pickering
President and Chief Executive Officer
SutroVax, Inc.
353 Hatch Drive
Foster City, California 94404
Re:SutroVax, Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted March 13, 2020
CIK No. 0001649094
Dear Mr. Pickering:
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.
Amendment No. 3 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.We note your revised disclosure in response to our prior comment 1. Please remove your
statements here and elsewhere in the prospectus that you believe that SVX-24, if
approved, has the potential to become the most broad-spectrum pneumococcal conjugate
vaccine addressing the $7 billion global pneumococcal vaccine market. Please also revise
your statements here and elsewhere in the prospectus that you believe that you
are developing potentially "best-in-class" vaccines. This language implies that your
product candidates will be effective and will be better than competing vaccines, neither of
which is appropriate at this stage of development.
FirstName LastNameGrant E. Pickering
Comapany NameSutroVax, Inc.
March 27, 2020 Page 2
FirstName LastName
Grant E. Pickering
SutroVax, Inc.
March 27, 2020
Page 2
You may contact Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Ada D. Sarmento at 202-551-3798 or Celeste Murphy at 202-551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Robert W. Phillips, Esq.
2020-01-21 - UPLOAD - Vaxcyte, Inc.
January 17, 2020
Grant E. Pickering
President and Chief Executive Officer
SutroVax, Inc.
353 Hatch Drive
Foster City, California 94404
Re:SutroVax, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 31, 2019
CIK No. 0001649094
Dear Mr. Pickering:
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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.We note your response to our prior comment 1 and continue to object to your
characterization of SVX-24 as having "the potential to become the standard of care." The
qualifier, "if approved," does not address our concerns that this language continues to
imply that the product will be effective and will replace the current standard of care before
a competing vaccine does, neither of which is appropriate at this stage of development.
Please revise your registration statement to remove this language.
FirstName LastNameGrant E. Pickering
Comapany NameSutroVax, Inc.
January 17, 2020 Page 2
FirstName LastName
Grant E. Pickering
SutroVax, Inc.
January 17, 2020
Page 2
Risk Factors Summary, page 5
2.We note your response to our prior comment 5 and reissue. The risk that your intended
approach will not be sufficient for regulatory approval or that regulators will require field
efficacy trials or longer trials with more participants than you currently anticipate exists
now. Please add a separate bullet point in this section to discuss that risk.
You may contact Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Robert W. Phillips, Esq.
2019-11-08 - UPLOAD - Vaxcyte, Inc.
November 7, 2019
Grant E. Pickering
President and Chief Executive Officer
SutroVax, Inc.
353 Hatch Drive
Foster City, California 94404
Re:SutroVax, Inc.
Draft Registration Statement on Form S-1
Submitted October 11, 2019
CIK No. 0001649094
Dear Mr. Pickering:
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.
Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.Please revise your statement here and elsewhere in the prospectus that SVX-24 has the
potential to become the "standard of care." This statement implies an expectation of
regulatory approval and is inappropriate given the length of time and uncertainty with
respect to securing marketing approval.
Our Pipeline, page 3
2.Please remove your statement that you believe that your preclinical study results may be
predictive of clinical trial results based on your use of the same rabbit model used to
develop each of the PCVs approved to date. It is not appropriate to imply that success in
FirstName LastNameGrant E. Pickering
Comapany NameSutroVax, Inc.
November 7, 2019 Page 2
FirstName LastName
Grant E. Pickering
SutroVax, Inc.
November 7, 2019
Page 2
animal models may result in success in humans.
3.Please expand to state whether you have received any feedback from the FDA as to
whether they would accept your intended approach of seeking regulatory approval based
on a demonstration of non-inferiority to the standard of care rather than on clinical field
efficacy studies.
Our Strategy, page 4
4.We note your disclosure that your strategy is to "rapidly advance" SVX-24 through IND-
enabling activities, clinical development and regulatory approval. Please revise this
statement and any similar disclosure to remove any implication that you will be successful
in commercializing your product candidates in a rapid or accelerated manner as such
statements are speculative.
Risk Factors Summary, page 5
5.We note several statements in the prospectus, including in a risk factor, regarding
pursuing a streamlined approach to regulatory approval of your vaccines based on how
other vaccines have obtained regulatory approval. Please add a risk factor to this section
to make it clear that there can be no assurance that your intended approach will be
sufficient for regulatory approval or that regulators will not require field efficacy trials
or longer trials with more participants than you currently anticipate.
Implications of Being an Emerging Growth Company, page 7
6.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 investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Use of Proceeds, page 66
7.We note your disclosure that you intend to use a portion of the proceeds to fund the
clinical and ongoing development of your vaccine candidates. Please specifically disclose
how far you expect the proceeds from the offering to allow you to proceed in the
development of each of these candidates.
Business
Drawbacks for Current PCVs, page 102
8.Please make the disclosure under the charts in Figure 4 and Figure 5 on page 103 more
legible.
FirstName LastNameGrant E. Pickering
Comapany NameSutroVax, Inc.
November 7, 2019 Page 3
FirstName LastName
Grant E. Pickering
SutroVax, Inc.
November 7, 2019
Page 3
Intellectual Property, page 118
9.Please specify to which of your product candidates your pending and current patents
relate.
Amended and Restated Agreement with Sutro Biopharma, page 119
10.We note your disclosure that royalties are payable until the later of the expiration of the
last valid claim in the licensed patents or 10 years after the first commercial sale. Please
specify when the licensed patents are expected to expire.
University of California, San Diego License Agreement, page 120
11.We note your disclosure that royalties are payable until expiration of the last licensed
patent. Please specify when the current last licensed patent is expected to expire.
Principal Stockholders, page 156
12.We note your disclosure regarding certain individuals who share or may be deemed to
share investment and dispositive power over the shares held by certain entities. It is not
clear whether those are the sole individuals who have voting and investment control. In
that regard, please revise your disclosure to identify all of the natural person or
persons who have voting and investment control of the shares held by Abingworth
Bioventures VI, LP, Longitude Venture Partners II, L.P., and TPG Growth IV Switcheroo,
L.P.
Description of Capital Stock, page 158
13.We note that you refer shareholders to, in part, the relevant provisions of the Delaware
General Corporation Law. It is not appropriate to qualify your disclosure by reference to
information that is not included in the filing or filed as an exhibit. Please revise
accordingly.
General
14.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
FirstName LastNameGrant E. Pickering
Comapany NameSutroVax, Inc.
November 7, 2019 Page 4
FirstName LastName
Grant E. Pickering
SutroVax, Inc.
November 7, 2019
Page 4
You may contact Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Robert W. Phillips, Esq.