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Sana Biotechnology, Inc.
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2025-08-13
Sana Biotechnology, Inc.
References: July 30, 2025
Sana Biotechnology, Inc.
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3 company response(s)
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2021-01-20
Sana Biotechnology, Inc.
References: December 7, 2020
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SEC wrote to company
2021-01-25
Sana Biotechnology, Inc.
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2021-01-28
Sana Biotechnology, Inc.
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2021-02-01
Sana Biotechnology, Inc.
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Sana Biotechnology, Inc.
Response Received
1 company response(s)
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2021-01-04
Sana Biotechnology, Inc.
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2021-01-12
Sana Biotechnology, Inc.
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Sana Biotechnology, Inc.
Awaiting Response
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2020-12-08
Sana Biotechnology, Inc.
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-10 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | 001-39941 | Read Filing View |
| 2025-08-13 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | 001-39941 | Read Filing View |
| 2021-02-01 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-28 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-25 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-20 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-12 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-04 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2020-12-08 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-10 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | 001-39941 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | 001-39941 | Read Filing View |
| 2021-01-25 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-04 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2020-12-08 | SEC Comment Letter | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-02-01 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-28 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-20 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
| 2021-01-12 | Company Response | Sana Biotechnology, Inc. | DE | N/A | Read Filing View |
2025-09-10 - UPLOAD - Sana Biotechnology, Inc. File: 001-39941
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 10, 2025 Susan Wyrick Acting Chief Financial Officer Sana Biotechnology, Inc. 188 East Blaine Street Suite 400 Seattle, WA 98102 Re: Sana Biotechnology, Inc. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 17, 2025 File No. 001-39941 Dear Susan Wyrick: 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 cc: Jennifer D. Knapp, Esq. </TEXT> </DOCUMENT>
2025-08-13 - CORRESP - Sana Biotechnology, 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: 866.974.7329 August 13, 2025 VIA EDGAR AND OVERNIGHT DELIVERY Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Sasha Parikh Angela Connell Lauren Hamill Tim Buchmiller Re: Sana Biotechnology, Inc. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 17, 2025 File No. 001-39941 Ladies and Gentlemen: On behalf of our client, Sana Biotechnology, Inc. (the “ Company ”), we submit this letter in response to comments from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) contained in its letter dated July 30, 2025 (the “ Comment Letter ”), regarding the above-referenced Annual Report on Form 10-K (File No. 001-39941) of the Company, filed on March 17, 2025. In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. References to “we” or “our” mean the Company. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business Our Pipeline, page 9 1. The pipeline table should graphically demonstrate the current status of your product candidates as well as indicate each of the material stages you will need to complete prior to regulatory approval and commercialization. In this regard: • We note you have one column captioned “Phase 2/3,” which could create the impression of fewer regulatory steps to complete or of further candidate progress. In future filings, please revise to add separate columns of equal width for each of Phase 2 and Phase 3 clinical testing. • We note that you have included a footnote 1 to the pipeline table, which appears to be meant to identify an “investigator sponsored trial;” however, it is unclear as to which row of the pipeline table this footnote pertains to. In future filings, please revise to mark the pipeline table in the appropriate corresponding place in order for investors to better understand this graphic. AUSTIN BOSTON BOULDER BRUSSELS HONG KONG LONDON LOS ANGELES NEW YORK PALO ALTO SALT LAKE CITY SAN DIEGO SAN FRANCISCO SEATTLE SHANGHAI WASHINGTON, DC WILMINGTON, DE Securities and Exchange Commission August 13, 2025 Page 2 The Company acknowledges the Staff’s comment and respectfully advises the Staff that in future filings the Company plans to remove the pipeline table and provide narrative disclosure regarding the Company’s pipeline of product candidates. Intellectual Property, page 48 2. In future filings, please revise your intellectual property disclosure in relation to the company’s material patents as follows: • Clearly describe on an individual or patent family basis the type of patent protection granted for each product or technology (composition of matter, use, or process), whether such patent is owned or licensed, the expiration year of each patent, and the jurisdiction, including any foreign jurisdiction, of each material pending or issued patent, or otherwise advise. • Additionally, in light of your disclosure on page 49, it appears that certain of your patents will expire on dates beginning in 2028. Revise your discussion to identify with greater specificity any material patent(s) that will expire in the near term. Also, as appropriate, please provide additional risk factor disclosure discussing the extent to which you face material risk stemming from the expiration of these patents, or otherwise advise. The Company acknowledges the Staff’s comment and respectfully advises the Staff that in future filings the Company plans to revise its intellectual property disclosure in relation to its material patents to (i) clearly describe on a patent family basis the type of patent protection granted for each product or technology (composition of matter, use, or process), whether such patent is owned or licensed, the expiration year of the last-to-expire patent in that patent family, and the jurisdiction, including any foreign jurisdiction, of each material issued patent and (ii) identify with greater specificity any material patent(s) that will expire in the near term, if any. The Company respectfully advises the Staff that it does not face material risk stemming from the expiration of the patents that will expire in 2028. In the event the Company does, at the time of the applicable filing, face material risk stemming from the expiration of patents that will expire in the near term, it will provide additional risk factor disclosure as appropriate. License Agreement with Beam, page 56 3. Based on your disclosure on page 56, it appears that the Beam Agreement will remain in effect until the expiration of the last-to-expire royalty term. Please revise future filings to clarify when the patents underlying the royalty term are expected to expire. The Company acknowledges the Staff’s comment and respectfully advises the Staff that in future filings the Company plans to revise its disclosure in relation to the Beam Agreement to clarify when the patents underlying the royalty term are expected to expire. Securities and Exchange Commission August 13, 2025 Page 3 License Agreement with the NIH, page 56 4. You state on page 57 that unless earlier terminated by either party, the NIH Agreement will expire upon expiration of the last-to-expire valid claim in the licensed patent rights. Please revise future filings to disclose when you expect such patent expiration to occur. The Company acknowledges the Staff’s comment and respectfully advises the Staff that in future filings the Company plans to revise its disclosure in relation to the NIH Agreement to disclose when it expects such patent expiration to occur. * * * * Please direct any questions with respect to this letter to me at (650) 849-3041 or jknapp@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Jennifer Knapp Jennifer Knapp cc: Steven D. Harr, M.D., Sana Biotechnology, Inc. Susan Wyrick, Sana Biotechnology, Inc. Bernard J. Cassidy, Sana Biotechnology, Inc. Tony Jeffries, Wilson Sonsini Goodrich & Rosati, P.C. Phillip McGill, Wilson Sonsini Goodrich & Rosati, P.C.
2025-07-30 - UPLOAD - Sana Biotechnology, Inc. File: 001-39941
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 30, 2025 Susan Wyrick Acting Chief Financial Officer Sana Biotechnology, Inc. 188 East Blaine Street Suite 400 Seattle, WA 98102 Re: Sana Biotechnology, Inc. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 17, 2025 File No. 001-39941 Dear Susan Wyrick: We have reviewed your filing and have the following comments. 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 a 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. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business Our Pipeline, page 9 1. The pipeline table should graphically demonstrate the current status of your product candidates as well as indicate each of the material stages you will need to complete prior to regulatory approval and commercialization. In this regard: We note you have one column captioned "Phase 2/3," which could create the impression of fewer regulatory steps to complete or of further candidate progress. In future filings, please revise to add separate columns of equal width for each of Phase 2 and Phase 3 clinical testing. We note that you have included a footnote 1 to the pipeline table, which appears to be meant to identify an "investigator sponsored trial;" however, it is unclear as to which row of the pipeline table this footnote pertains to. In future filings, please revise to mark the pipeline table in the appropriate corresponding place in order for investors to better understand this graphic. July 30, 2025 Page 2 Intellectual Property, page 48 2. In future filings, please revise your intellectual property disclosure in relation to the company's material patents as follows: Clearly describe on an individual or patent family basis the type of patent protection granted for each product or technology (composition of matter, use, or process), whether such patent is owned or licensed, the expiration year of each patent, and the jurisdiction, including any foreign jurisdiction, of each material pending or issued patent, or otherwise advise. Additionally, in light of your disclosure on page 49, it appears that certain of your patents will expire on dates beginning in 2028. Revise your discussion to identify with greater specificity any material patent(s) that will expire in the near term. Also, as appropriate, please provide additional risk factor disclosure discussing the extent to which you face material risk stemming from the expiration of these patents, or otherwise advise. License Agreement with Beam, page 56 3. Based on your disclosure on page 56, it appears that the Beam Agreement will remain in effect until the expiration of the last-to-expire royalty term. Please revise future filings to clarify when the patents underlying the royalty term are expected to expire. License Agreement with the NIH, page 56 4. You state on page 57 that unless earlier terminated by either party, the NIH Agreement will expire upon expiration of the last-to-expire valid claim in the licensed patent rights. Please revise future filings to disclose when you expect such patent expiration to occur. 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 Sasha Parikh at 202-551-3627 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Lauren Hamill at 303-844-1008 or Tim Buchmiller at 202-551-3635 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer D. Knapp, Esq. </TEXT> </DOCUMENT>
2021-02-01 - CORRESP - Sana Biotechnology, Inc.
CORRESP 1 filename1.htm Company Acceleration Request Sana Biotechnology, Inc. 188 East Blaine Street, Suite 400 Seattle, WA 98102 February 1, 2021 VIA EDGAR AND E-MAIL United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Tracie Mariner Mary Mast Ada D. Sarmento Mary Beth Breslin Re: Sana Biotechnology, Inc. Registration Statement on Form S-1 (Registration No. 333- 252061) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (Registration No. 333-252061) (the “Registration Statement”) of Sana Biotechnology, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:30 p.m., Washington, D.C. time, on February 3, 2021, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Brian Cuneo at (650) 463-3014 or B. Shayne Kennedy at (714) 755-8181. Thank you for your assistance in this matter. Very truly yours, SANA BIOTECHNOLOGY, INC. By: /s/ Steven D. Harr, M.D. Steven D. Harr, M.D. President and Chief Executive Officer cc: James J. McDonald, Sana Biotechnology, Inc. Brian Cuneo, Latham & Watkins LLP B. Shayne Kennedy, Latham & Watkins LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP
2021-01-28 - CORRESP - Sana Biotechnology, Inc.
CORRESP 1 filename1.htm CORRESP January 28, 2021 VIA EDGAR AND OVERNIGHT DELIVERY United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Tracie Mariner Mary Mast Ada D. Sarmento Mary Beth Breslin Re: Sana Biotechnology, Inc. Registration Statement on Form S-1 Filed January 13, 2021 File No. 333-252061 Ladies and Gentlemen: On behalf of our client, Sana Biotechnology, Inc. (the “Company”), we are hereby submitting to the Securities and Exchange Commission (the “Commission”) Amendment No. 1 (“Amendment No. 1”) to the Company’s Registration Statement on Form S-1 (the “Registration Statement”). The Company previously filed a Registration Statement on Form S-1 on January 13, 2021 (the “First Public Filing”) and submitted draft Registration Statements on Form S-1 on a confidential basis, pursuant to Title I, Section 106 under the Jumpstart Our Business Startups Act, on November 10, 2020 and on December 18, 2020. The Registration Statement filed concurrently with this letter has been revised to reflect the Company’s responses to the comment letter to the First Public Filing dated January 23, 2021 from the staff of the Commission (the “Staff”) as well as other revisions and updates to its disclosure. For your convenience, we are providing by overnight delivery a courtesy package that includes copies of the Registration Statement, including copies which have been marked to show changes from the First Public Filing, as well as copy of this letter. January 28, 2021 Page 2 For ease of review, we have set forth below the numbered comment of your letter in bold type followed by the Company’s response thereto. January 23, 2021 Comment Letter Business Preclinical Development of Hypoimmune Cells, page 156 1. Please remove the reference to “promising” early results from the NHP hypoimmune iPSC transplantation experiments in this section. Response: In response to the Staff’s comment, the Company has revised page 156 of the Registration Statement to remove the reference to “promising” in the identified location. Financial statements for the interim period ended September 30, 2020 17. Subsequent Events, page F-58 2. Please tell us why you have not disclosed any significant equity issuances such as the options granted since September 30, 2020. Response: In response to the Staff’s comment, the Company has revised page F-58 of the Registration Statement. * * * January 28, 2021 Page 3 We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (650) 463-3014 or by email to Brian.Cuneo@lw.com with any questions or comments regarding this correspondence. Very truly yours, Brian J. Cuneo of LATHAM & WATKINS LLP cc: Steven D. Harr, M.D., Sana Biotechnology, Inc. James J. MacDonald, Sana Biotechnology, Inc. B. Shayne Kennedy, Latham & Watkins LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP
2021-01-25 - UPLOAD - Sana Biotechnology, Inc.
United States securities and exchange commission logo
January 23, 2021
Steven D. Harr, M.D.
President and Chief Executive Officer
Sana Biotechnology, Inc.
188 East Blaine Street, Suite 400
Seattle, Washington 98102
Re:Sana Biotechnology, Inc.
Registration Statement on Form S-1
Filed January 13, 2021
File No. 333-252061
Dear Dr. Harr:
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.
Registration Statement on Form S-1
Business
Preclinical Development of Hypoimmune Cells, page 156
1.Please remove the reference to "promising" early results from the NHP hypoimmune iPSC
transplantation experiments in this section.
Financial statements for the interim period ended September 30, 2020
17. Subsequent Events, page F-58
2.Please tell us why you have not disclosed any significant equity issuances such as the
options granted since September 30, 2020.
We remind you that the company and its management are responsible for the accuracy
FirstName LastNameSteven D. Harr, M.D.
Comapany NameSana Biotechnology, Inc.
January 23, 2021 Page 2
FirstName LastName
Steven D. Harr, M.D.
Sana Biotechnology, Inc.
January 23, 2021
Page 2
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 Tracie Mariner at 202-551-3744 or Mary Mast at 202-551-3613 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: Brian J. Cuneo, Esq.
2021-01-20 - CORRESP - Sana Biotechnology, Inc.
CORRESP 1 filename1.htm CORRESP 140 Scott Drive Menlo Park, California 94025 Tel: +1.650.328.4600 Fax: +1.650.463.2600 www.lw.com FIRM / AFFILIATE OFFICES Abu Dhabi Milan Barcelona Moscow Beijing Munich Boston New Jersey Brussels New York Century City Orange County Chicago Paris January 20, 2021 Dubai Riyadh Düsseldorf Rome Frankfurt San Diego Hamburg San Francisco Hong Kong Shanghai Houston Silicon Valley London Singapore Los Angeles Tokyo Madrid Washington, D.C. VIA EDGAR AND HAND DELIVERY United States Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tracie Mariner Mary Mast Ada Sarmento Mary Beth Breslin Re: Sana Biotechnology, Inc. Registration Statement on Form S-1 Filed on January 13, 2021 File No. 333-252061 Ladies and Gentlemen: On behalf of Sana Biotechnology, Inc. (the “Company”), we submit this letter (this “Letter”) to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”). The Company originally filed the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) with the Commission on January 13, 2021. The purpose of this Letter is to provide supplemental information to the Staff with respect to the accounting treatment for stock-based compensation for its consideration during the review cycle so that the Company may be in a position to print a preliminary prospectus as promptly as practicable. In particular, the Company references Comment #13 of the Staff’s letter dated December 7, 2020 with respect to providing an explanation for the determination of the fair value of the common stock underlying the Company’s equity issuances and the reasons for any differences between the recent valuations of its common stock and the estimated offering price. The supplemental response set forth below is based upon information provided to Latham & Watkins LLP by the Company. CONFIDENTIAL TREATMENT REQUESTED BY SANA BIOTECHNOLOGY, INC. January 20, 2021 Page 2 On behalf of the Company, we are respectfully requesting confidential treatment for specified portions of this letter pursuant to Rule 83 promulgated by the Commission (17 C.F.R. § 200.83). This letter is accompanied by such request for confidential treatment because of the commercially sensitive nature of the information discussed in this letter. A redacted version of this letter will be filed with the Commission on EDGAR, omitting the confidential information. The Company’s discussion of its accounting for stock-based compensation is primarily contained within the sections of the Registration Statement entitled “Management’s discussion and analysis of financial condition and results of operations—Critical Accounting Policies and Significant Judgements and Estimates—Stock-Based Compensation” and “—Common Stock Valuations” (the “MD&A”) and appears on pages 120 through 122 of the Registration Statement. The Company supplementally advises the Staff that, while not reflected in the Registration Statement, based on discussions with the Company’s Board of Directors (the “Board of Directors”) and reflecting the input from the underwriters for its initial public offering (“IPO”), the Company currently anticipates an approximate price range of $[***] to $[***] per share for the Company’s common stock (the “Preliminary IPO Price Range”), with a midpoint of the anticipated range of approximately $[***] per share (the “Preliminary Assumed IPO Price”). The Preliminary IPO Price Range and Preliminary Assumed IPO Price do not reflect any stock split that the Company might affect prior to the Commission’s declaration of effectiveness of the Registration Statement. The Company is currently anticipating implementing an approximate [***]-to-1 reverse stock split, which would result in a post-split Preliminary IPO Price Range of $[***] to $[***] per share, with a midpoint of $[***] per share. The post-split price range will be narrowed within the Preliminary IPO Price Range prior to distribution of the preliminary prospectus in connection with the Company’s road show. For consistency with the Registration Statement, all data in this letter is reflected on a pre-split basis, unless otherwise expressly noted. The Company’s final post-split Preliminary IPO Price Range remains under discussion between the Company and the lead underwriters, and a bona fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary prospectus in connection with the Company’s road show. STOCK OPTION GRANTS SINCE SEPTEMBER 30, 2019 The following table summarizes the number of shares of common stock underlying stock options granted since September 30, 2019, as well as the associated per share exercise price and the estimated fair value per share of the Company’s common stock used to determine stock-based compensation expense for financial reporting purposes. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to portions of this letter. CONFIDENTIAL TREATMENT REQUESTED BY SANA BIOTECHNOLOGY, INC. SANA-1002 January 20, 2021 Page 3 Grant Date(s) Number of Shares Underlying Options Grants Exercise Price Per Share Estimated Fair Value – Financial Reporting Purposes October 25 – December 30, 2019 [ ***] $ [ ***] $ [ ***] January 27 – March 16, 2020 [ ***] $ [ ***] $ [ ***] March 30, 2020 [ ***] $ [ ***] $ [ ***](a) April 23 – June 2, 2020 [ ***] $ [ ***] $ [ ***] July 7 – September 24, 2020 [ ***] $ [ ***] $ [ ***] September 28, 2020 [ ***] $ [ ***] $ [ ***](a) October 23 – November 30, 2020 [ ***] $ [ ***] * (b) December 8, 2020 [ ***] $ [ ***] * (b) December 28, 2020 [ ***] $ [ ***] * (b) (a) Represents the fair value per share of the underlying common stock for financial reporting purposes used to calculate the grant date fair value of the stock options issued on March 30, 2020 and September 28, 2020 for which compensation expense is recognized for the nine month period ended September 30, 2020. See “March 31, 2020 Valuation” and “September 30, 2020 Valuation” below for discussion of retrospective review of estimated fair value. (b) The Company has not completed its financial reporting for the three month period ended December 31, 2020. HISTORICAL FAIR VALUE DETERMINATION AND METHODOLOGY The Company has historically determined the fair value of its common stock using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “AICPA Practice Guide”). In addition, the Board of Directors also considered numerous objective and subjective factors, along with input from management and third-party valuations, to determine the fair value of the Company’s common stock as disclosed in the Registration Statement. The Company was incorporated in July 2018 and since February 2019, the Company has obtained independent third-party valuations of its common stock on at least a quarterly basis as well as following events or conditions that the Company determines could cause the assumptions, qualifications or methodologies contained in prior independent third-party valuations to materially change. As described in greater detail in MD&A, (a) for valuations performed prior to September 30, 2020, the Company utilized the option-pricing model (“OPM”) backsolve method for determining the fair value of its common stock, and (b) for valuations on or subsequent to September 30, 2020, the Company utilized a hybrid method (the “Hybrid Method”) of the OPM and the probability-weighted expected return method (“PWERM”), for determining the fair value of the Company’s common stock. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to portions of this letter. CONFIDENTIAL TREATMENT REQUESTED BY SANA BIOTECHNOLOGY, INC. SANA-1003 January 20, 2021 Page 4 In the OPM framework, the backsolve method for inferring the equity value implied by a recent financing transaction involves making assumptions for the expected time to liquidity, volatility, and risk-free rate and then solving for the value of equity by calibrating to the value of the most recent class of preferred stock. A reasonable discount for lack of marketability is then applied to conclude on a per share value of the common stock on a minority, non-marketable basis. The OPM method was selected as management concluded that the financing transactions were negotiated transactions that provided the best indication of the fair value of the preferred stock at each measurement date. Under the PWERM, the per share value of the common stock is estimated based upon the probability-weighted present value of expected future equity values for the common stock, under various possible future liquidity event scenarios, in light of the rights and preferences of each class of equity, and the resulting per share value of the common stock is discounted for a lack of marketability. The Hybrid Method estimates the probability-weighted value across multiple scenarios but uses the OPM to estimate the allocation of value within one or more of the scenarios. The Company determined to incorporate the PWERM into its valuation methodology as values associated with various potential outcomes were considered estimable, in light of the Company’s stage of development, operating results, its prospects for an IPO in the near term, general conditions in the capital markets, including with respect to IPOs, and the relative likelihood of achieving a liquidity event such as an IPO in light of prevailing market conditions. At each grant date, the Board of Directors evaluated any recent events and their potential impact on the estimated per share fair value of the common stock. For grants of stock awards made on dates for which there was no concurrent independent third-party valuation, the Board of Directors determined the fair value of the common stock on the date of grant taking into consideration the immediately preceding valuation report as well as other pertinent information available at the time of the grant. DISCUSSION OF FAIR VALUE DETERMINATIONS OVER THE PAST 12 MONTHS Notably, for the nine months ended September 30, 2020 the Company’s stock compensation expense was $3.0 million, or approximately 1.8% of the Company’s total operating expenses of $172.8 million for the period. The table below sets forth the fair market value determinations of the Company’s common stock as provided by independent third-party valuation reports for periods since September 30, 2019: [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to portions of this letter. CONFIDENTIAL TREATMENT REQUESTED BY SANA BIOTECHNOLOGY, INC. SANA-1004 January 20, 2021 Page 5 Date of Estimated Fair Value as Determined by the Valuation Report Fair Value Per Share September 30, 2019 $[***] December 31, 2019 $[***] March 31, 2020 $[***] June 30, 2020 $[***] September 30, 2020 $[***] December 9, 2020 $[***] Corporate and Financing History and Acquisition of Cobalt Biomedicine, Inc. The Company was incorporated in July 2018, and, in October 2018, the Company completed its Series A-1 convertible preferred stock financing issuing approximately 45.85 million shares of Series A-1 convertible preferred stock at $1.00 per share. In February 2019, the Company entered into a Series A-2/B convertible stock purchase agreement pursuant to which it issued approximately 216.1 million shares of Series A-2 convertible preferred stock at $1.00 per share. The Series A-2/B convertible stock purchase agreement also gave the investors the right and obligation to participate, subject to the satisfaction of certain conditions, in a future Series B convertible preferred stock financing at $4.00 per share. In connection with the entry into the Series A-2/B convertible preferred stock purchase agreement, the Company acquired Cobalt Biomedicine, Inc. issuing approximately 145.8 million shares of Series A-2 convertible preferred stock and approximately 2.8 million shares of restricted common stock in consideration. Subsequently in February and March 2019, pursuant to the Series A-2/B convertible stock purchase agreement, the Company issued an additional approximately 11.9 million shares of Series A-2 convertible preferred stock, and in October 2019, the Company issued an additional approximately 7.9 million shares of Series A-2 convertible preferred stock, in each case, at $1.00 per share. In June 2020, the Company completed the closing of the Series B convertible preferred stock portion of the financing (the “Series B Tranche”) issuing an aggregate of approximately 108.9 million shares of Series B convertible preferred stock at $4.00 per share. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to portions of this letter. CONFIDENTIAL TREATMENT REQUESTED BY SANA BIOTECHNOLOGY, INC. SANA-1005 January 20, 2021 Page 6 September 30, 2019 Valuation and Fair Value Determination Following the completion of the Series A-2 convertible preferred stock financing, the Company obtained an independent third-party valuation of the Company’s common stock as of September 30, 2019 (giving effect to the issuance of the Series A-2 convertible preferred stock issued in early October 2019). Based on its consideration of this valuation and the objective and subjective factors described on page 121 and 122 of the Registration Statement, the Board of Directors determined that the fair value of the Company’s common stock was $[***] per share as of September 30, 2019 (the “September 2019 Valuation”). The independent third-party valuation estimated the equity value of the Company using a market approach that derives an implied total equity value from the per share sale price of the Company’s equity securities in a recent arm’s-length transaction (the “Backsolve Method” of the OPM), specifically the closing of the Company’s Series A-2 convertible preferred stock financing using the equity value derived from an OPM backsolve performed based on the Series A-2 convertible preferred stock financing. The Company determined that the Series A-2 convertible preferred stock financing was a reasonable indication of value as of the September 30, 2019 valuation date and that the terms of the financing were fairly negotiated at arm’s length and reasonably reflected the expected economics of the Company. In addition, at that time progress toward satisfying the conditions to the Series B Tranche was limited and not quantifiable in the OPM. Taking these factors into consideration, the total implied equity value of the Company was determined to be approximately $[***] million. After estimating the Company’s total equity value based on the Backsolve Method, each value was allocated to the various classes of the Company’s equity using the OPM. The independent third-party valuation used the OPM method to establish an estimated value of $[***] per common share, and applied a discount for lack of marketability (“DLOM”) of [***]%, to establish a fair value of $[***] per common share. The Board of Directors utilized the September 2019 Valuation for stock options granted between October 25, 2019 and D
2021-01-12 - CORRESP - Sana Biotechnology, Inc.
CORRESP
1
filename1.htm
CORRESP
140 Scott Drive
Menlo Park, California 94025
Tel: +1.650.328.4600 Fax: +1.650.463.2600
www.lw.com
FIRM / AFFILIATE OFFICES
January 12, 2021
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United States Securities and Exchange Commission
Los Angeles
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Division of Corporation Finance
Madrid
Washington, D.C.
100 F Street, N.E.
Washington, D.C. 20549-6010
Milan
Attention:
Tracie Mariner
Mary Mast
Ada D. Sarmento
Mary Beth Breslin
Re:
Sana Biotechnology, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Confidentially submitted on December 18, 2020
CIK No. 00011770121
Ladies and Gentlemen:
On behalf of our client, Sana Biotechnology, Inc. (the “Company”), we are hereby filing with the Securities and
Exchange Commission (the “Commission”) the Company’s Registration Statement on Form S-1 (the “Registration Statement”). The Company previously submitted
draft Registration Statements on Form S-1 on a confidential basis, pursuant to Title I, Section 106 under the Jumpstart Our Business Startups Act, on November 10, 2020 (the “First
Submission”) and on December 18, 2020 (“Submission No. 2”). The Registration Statement filed concurrently with this letter has been revised to reflect the Company’s
responses to the comment letters to Submission No. 2 dated January 4, 2021 and the First Submission dated December 7, 2020 from the staff of the Commission (the “Staff”). For your convenience, we are providing
by overnight delivery a courtesy package that includes copies of the Registration Statement, including copies which have been marked to show changes from Submission No. 2, as well as copy of this letter.
For ease of review, we have set forth below the numbered comment of your letter in bold type followed by the Company’s response thereto.
January 12, 2021
Page
2
January 4, 2021 Comment Letter
Prospectus Summary
Our in vivo
Cell Engineering Platform and Programs, page 4
1.
We note your revisions in response to prior comment 5. Please revise your statement that you believe success
with any initial therapy targeting a given cell type may meaningfully accelerate lead candidate selection for other indications to remove any implication that you will be able to accelerate the development of your product candidates.
Response: In response to the Staff’s comment, the Company has revised pages 5 and 133 of the
Registration Statement.
Use of Proceeds, page 92
2.
We note your revisions in response to prior comment 11. Based on the next anticipated milestone for each of
your product candidates as described in the S-1, please revise this section to disclose which of those milestones you intend to complete using the proceeds of this offering.
Response: In response to the Staff’s comment, the Company has revised pages 15 and 93 of the Registration Statement.
Allogeneic T Cell Program (SC291, SC225), page 163
3.
We note your revisions in response to prior comment 14. Please revise your statement that your two programs
“should increase the likelihood of success” to remove any predictions or expectations regarding your likelihood of success as such statements are speculative.
Response: In response to the Staff’s comment, the Company has revised page 168 of the Registration Statement.
December 7, 2020 Comment Letter
Implications of Being an Emerging Growth Company, page 12
18.
Please revise your disclosure to identify the natural person or persons who have voting and investment
control of the shares held by F-Prime Fund VI.
Response: In response
to the Staff’s comment, the Company has revised pages 232 and 233 of the Registration Statement.
* * *
January 12, 2021
Page
3
We hope the foregoing answers are responsive to your comments. Please do not hesitate to
contact me by telephone at (650) 463-3014 or by email to Brian.Cuneo@lw.com with any questions or comments regarding this correspondence.
Very truly yours,
/s/ Brian J. Cuneo
Brian J. Cuneo
of LATHAM & WATKINS
LLP
cc:
Steven D. Harr, M.D., Sana Biotechnology, Inc.
James J. MacDonald, Sana Biotechnology, Inc.
B. Shayne Kennedy, Latham & Watkins LLP
Charles S. Kim, Cooley LLP
Kristin VanderPas, Cooley LLP
2021-01-04 - UPLOAD - Sana Biotechnology, Inc.
United States securities and exchange commission logo
January 4, 2021
Steven D. Harr, M.D.
President and Chief Executive Officer
Sana Biotechnology, Inc.
188 East Blaine Street, Suite 400
Seattle, Washington 98102
Re:Sana Biotechnology, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 18, 2020
CIK No. 0001770121
Dear Dr. Harr:
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 December 7, 2020 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Our in vivo Cell Engineering Platform and Programs, page 4
1.We note your revisions in response to prior comment 5. Please revise your statement that
you believe success with any initial therapy targeting a given cell type may meaningfully
accelerate lead candidate selection for other indications to remove any implication
that you will be able to accelerate the development of your product candidates.
Use of Proceeds, page 92
2.We note your revisions in response to prior comment 11. Based on the next anticipated
milestone for each of your product candidates as described in the S-1, please revise this
section to disclose which of those milestones you intend to complete using the proceeds of
FirstName LastNameSteven D. Harr, M.D.
Comapany NameSana Biotechnology, Inc.
January 4, 2021 Page 2
FirstName LastName
Steven D. Harr, M.D.
Sana Biotechnology, Inc.
January 4, 2021
Page 2
this offering.
Allogeneic T Cell Program (SC291, SC255), page 163
3.We note your revisions in response to prior comment 14. Please revise your statement
that your two programs "should increase the likelihood of success" to remove any
predictions or expectations regarding your likelihood of success as such statements are
speculative.
You may contact Tracie Mariner at (202) 551-3744 or Mary Mast at (202) 551-3613 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: Brian J. Cuneo, Esq.
2020-12-08 - UPLOAD - Sana Biotechnology, Inc.
United States securities and exchange commission logo
December 7, 2020
Steven D. Harr, M.D.
President and Chief Executive Officer
Sana Biotechnology, Inc.
188 East Blaine Street, Suite 400
Seattle, Washington 98102
Re:Sana Biotechnology, Inc.
Draft Registration Statement on Form S-1
Submitted November 10, 2020
CIK No. 0001770121
Dear Dr. Harr:
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
Overview, page 1
1.Please tell us the basis for your belief stated in the first paragraph that engineered cells
will have a therapeutic potential that will be "at least as disruptive" as biologics. Please
also tell us why you believe it is appropriate to cite the amount of global revenues for all
branded biologic drugs when you do not have any product candidates in development
beyond the preclinical stage and which address only certain indications.
2.We note your disclosure on page 1 that you "expect to file multiple INDs per year." Given
the unpredictability of drug development, please remove this statement and a similar
FirstName LastNameSteven D. Harr, M.D.
Comapany NameSana Biotechnology, Inc.
December 7, 2020 Page 2
FirstName LastNameSteven D. Harr, M.D.
Sana Biotechnology, Inc.
December 7, 2020
Page 2
statement in the Business section as such statements are speculative.
3.We note your disclosure on page 1 and in the Business section that you have shown that
you can specifically target numerous cell surface receptors that, when combined with
delivery vehicles to form fusosomes, allow cell-specific delivery across multiple different
cell types. Please revise the second paragraph of the Summary and the statements in the
Business section to clarify that you have not conducted clinical development efforts to
date.
4.Please revise your pipeline table on page 2 to include a separate column for
preclinical, Phase 1, Phase 2 and Phase 3 and to provide the indications that you are
actually pursuing as opposed to the "potential" indications. It appears that you have
included every in-house program in your pipeline table. Please explain to us why each
program is sufficiently material to your business to warrant inclusion in your pipeline
table or revise your table as appropriate.
Our in vivo Cell Engineering Platform and Programs, page 4
5.We note your disclosure here and in the Business section that your fusogen technology
should allow you to rapidly create multiple therapies targeting a variety of diseases with
each successful fusogen and accelerate development of subsequent therapies targeting that
same cell type. Please revise these statements and any similar statements to remove any
implication that you will be able to accelerate the development of your product
candidates. Please also revise the statements here and in the Business section that success
with any initial therapy targeting a given cell type meaningfully "de-risks" development of
subsequent therapies targeting that same cell type and any similar statements that imply
that you will be successful in mitigating the risk associated with drug development.
6.We note your disclosure that your preclinical data demonstrate that you can make an
"effective" CAR T cell in vivo with a single intravenous injection. Efficacy is
a determination that is solely within the authority of the FDA or similar foreign regulators.
You may present clinical trial end points and objective data resulting from trials without
concluding efficacy. Please revise this statement accordingly.
Risks Associated with Our Business, page 11
7.Please expand the second to last bullet point in this section or add another bullet point to
address the risks associated with the licensed technology and the related agreements you
have with Harvard, UCSF, Washington University, Cobalt, Oscine and Cytocardia as
discussed in the risk factor on page 61.
Implications of Being an Emerging Growth Company, page 12
8.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
FirstName LastNameSteven D. Harr, M.D.
Comapany NameSana Biotechnology, Inc.
December 7, 2020 Page 3
FirstName LastName
Steven D. Harr, M.D.
Sana Biotechnology, Inc.
December 7, 2020
Page 3
not they retain copies of the communications.
Risk Factors, page 18
9.Given the length of your risk factor section, please revise to comply with Regulation S-K
Item 105 by relocating risks that could generically apply to any registrant or offering to
the end of the section under the caption “General Risk Factors.”
Risks Related to Intellectual Property and Information Technology
We may be dependent on intellectual property licensed or sublicensed to us from..., page 66
10.We note your disclosure that government agencies have provided assistance in connection
with the development of certain intellectual property rights owned by or licensed to you,
and these government agencies may have retained rights in the intellectual property.
Please revise this risk factor to identify the intellectual property or technologies and what
rights in the intellectual property the government agencies have retained.
Use of Proceeds, page 91
11.Please revise to identify the specific product candidates for which you intend to use the
proceeds of this offering and how far in their development you intend to get using the
proceeds of this offering.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Stock Based Compensation, page 118
12.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features. Please discuss with the staff how to submit your response.
13.You state on page 120 that you used the backsolve method for inferring the equity value
implied by a recent financing transaction. Tell us why you believe that the
contemporaneous financing transactions were arms' length transactions.
Business, page 121
14.Please revise the statements in this section that you are uniquely positioned to develop
transformative engineered cells as medicines and that you can increase your likelihood of
success. These statements are not appropriate given the number of companies currently
developing product candidates and the number of product candidates that never receive
FDA approval.
FirstName LastNameSteven D. Harr, M.D.
Comapany NameSana Biotechnology, Inc.
December 7, 2020 Page 4
FirstName LastName
Steven D. Harr, M.D.
Sana Biotechnology, Inc.
December 7, 2020
Page 4
Our T Cell Fusosome Approach, page 138
15.Please remove the reference to potential "first-in-class" product candidates as this
statement implies an expectation of regulatory approval and is inappropriate given the
length of time and uncertainty with respect to securing marketing approval.
Intellectual Property, page 184
16.Please revise to disclose the type of patent protection you have (composition of matter,
use or process) and the material foreign jurisdictions where you have patents or pending
patent applications.
Key Intellectual Property Agreements, page 187
17.Please provide the current expiration date for the last-to-expire licensed patent right under
each of the agreements in this section if the royalty term for such agreement is determined
using such information.
Principal Stockholders, page 235
18.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by F-Prime Fund VI.
2. Summary of significant accounting policies
Acquisitions, page F-8
19.Please clarify that in an asset acquisition, amounts allocated to IPR&D are recorded in
research and development expense if they do not have an alternative future use. Refer to
ASC 730-10-25-2c.
3. Acquisitions, page F-16
20.Please clarify, in Management's Discussion and Analysis and elsewhere in the filing as
appropriate, the amount of any payment expected to be paid upon the IPO or within 12
months after the IPO. In this respect we note the following:
•You state on page F-17 that the valuation measurement dates for the Cobalt Success
payment are triggered by an IPO at a time when at least one company program using
technology acquired from Cobalt is currently in a clinical trial, has been submitted to
the FDA for approval, or has been approved by the FDA. You also state that the
valuation measurement dates are triggered upon a change of control when at least one
of your programs based on fusogen technology is subject of an active research
program.
•For the Harvard College agreement you state on page F-20 that the milestone
payments of up to $76 million would double upon a change of control. In addition,
we note that the success payment measurement dates are triggered by an equity
financing of more than $25.0 million as well as the one year anniversary of an IPO.
FirstName LastNameSteven D. Harr, M.D.
Comapany NameSana Biotechnology, Inc.
December 7, 2020 Page 5
FirstName LastName
Steven D. Harr, M.D.
Sana Biotechnology, Inc.
December 7, 2020
Page 5
21.For the Cobalt Success payments, clarify the triggering points in which Success payments
will be made. For example, clarify if an ongoing clinical trial would trigger a payment or
if the ongoing clinical trial has to also be submitted to the FDA for approval to trigger a
payment. In addition, clarify if you currently are undergoing a program based on the
fusogen technology which is the subject of an active research program, which would
trigger a Success payment and how much. Finally, please clarify for both the Harvard and
Cobalt agreements that a change of control includes an IPO, if such is the case, that could
result in Success payments.
Financial Statements for the Years Ended December 31, 2019
Notes to Consolidated Financial Statements
11. Convertible preferred stock
Rights issued with Series A-1 and Series A-2 convertible preferred stock
Conversion, page F-26
22.You state on page 111 that all outstanding shares of convertible preferred stock will
convert into shares of your common stock. On page F-53 you state that the Series A-1,
Series A-2, and Series B convertible preferred stock will automatically convert into shares
of the Company's common stock upon closing of the sale of shares of common stock to
the public in an underwritten public offering at a price that generates at least $75.0 million
in gross proceeds pursuant to an effective registration statement in which the shares will
be listed on a national securities exchange. You also state on page F-53 that the
convertible preferred stock will automatically convert into shares of common stock upon
the vote or written consent of the holders of at least 61% of the outstanding convertible
preferred stock, voting together as a single class, which must include a majority of the
Series B preferred stock held by the investors that purchased at least $29 million in the
Series B financing. Please clarify in the filing why you believe all convertible preferred
stock will convert into common stock upon the IPO, given the above conditions to
conversion.
You may contact Tracie Mariner at 202-551-3744 or Mary Mast at 202-551-3613 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: Brian J. Cuneo, Esq.