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PRECISION BIOSCIENCES INC
Response Received
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PRECISION BIOSCIENCES INC
Response Received
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PRECISION BIOSCIENCES INC
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PRECISION BIOSCIENCES INC
Response Received
4 company response(s)
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SEC wrote to company
2019-03-06
PRECISION BIOSCIENCES INC
Filing - SEC Comment Letter to PRECISION BIOSCIENCES INC
UPLOAD · 2019-03-06
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Company responded
2019-03-08
PRECISION BIOSCIENCES INC
References: November 15, 2018
Filing - Correspondence from PRECISION BIOSCIENCES INC
CORRESP · 2019-03-08
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Company responded
2019-03-13
PRECISION BIOSCIENCES INC
Filing - Correspondence from PRECISION BIOSCIENCES INC
CORRESP · 2019-03-13
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Company responded
2019-03-25
PRECISION BIOSCIENCES INC
Filing - Correspondence from PRECISION BIOSCIENCES INC
CORRESP · 2019-03-25
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Company responded
2019-03-25
PRECISION BIOSCIENCES INC
Filing - Correspondence from PRECISION BIOSCIENCES INC
CORRESP · 2019-03-25
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PRECISION BIOSCIENCES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-03-18
PRECISION BIOSCIENCES INC
Filing - SEC Comment Letter to PRECISION BIOSCIENCES INC
UPLOAD · 2019-03-18
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PRECISION BIOSCIENCES INC
Awaiting Response
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SEC wrote to company
2019-02-22
PRECISION BIOSCIENCES INC
Filing - SEC Comment Letter to PRECISION BIOSCIENCES INC
UPLOAD · 2019-02-22
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PRECISION BIOSCIENCES INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-11-16
PRECISION BIOSCIENCES INC
Filing - SEC Comment Letter to PRECISION BIOSCIENCES INC
UPLOAD · 2018-11-16
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-05 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2026-01-02 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | 333-292478 | Read Filing View |
| 2023-06-13 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2023-06-12 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2020-06-09 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-25 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-25 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-18 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-13 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-08 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-06 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-02-22 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2018-11-16 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-02 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | 333-292478 | Read Filing View |
| 2023-06-12 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2020-06-09 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-18 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-06 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-02-22 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2018-11-16 | SEC Comment Letter | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-05 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2023-06-13 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-25 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-25 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-13 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
| 2019-03-08 | Company Response | PRECISION BIOSCIENCES INC | DE | N/A | Read Filing View |
2026-01-05 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP 1 filename1.htm Document Precision BioSciences, Inc. 302 East Pettigrew St., Suite A-100 Durham, North Carolina 27701 January 5, 2026 VIA EDGAR TRANSMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Christopher Edwards Re: Precision BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-292478) To the addressee set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby respectfully request acceleration of the effective date of the Registration Statement on Form S-3 (File No. 333-292478) (the “Registration Statement”), of Precision BioSciences, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:05 p.m., Eastern Time, on January 7, 2026, 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 Nathan Ajiashvili at (212) 906-2916. If you have any questions regarding the foregoing, please do not hesitate to contact Nathan Ajiashvili of Latham & Watkins LLP at (212) 906-2916. Thank you in advance for your consideration. Very truly yours, Precision BioSciences, Inc. By: /s/ John Alexander Kelly Name: John Alexander Kelly Title: Chief Financial Officer cc: (via email) Peter N. Handrinos, Latham & Watkins LLP Nathan Ajiashvili, Latham & Watkins LLP
2026-01-02 - UPLOAD - PRECISION BIOSCIENCES INC File: 333-292478
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> January 2, 2026 Michael Amoroso President and Chief Executive Officer Precision BioSciences, Inc. 302 East Pettigrew St., Suite A-100 Durham, North Carolina 27701 Re: Precision BioSciences, Inc. Registration Statement on Form S-3 Filed December 30, 2025 File No. 333-292478 Dear Michael Amoroso: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Nathan Ajiashvili, Esq. </TEXT> </DOCUMENT>
2023-06-13 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP
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CORRESP
PRECISION BIOSCIENCES, INC.
302 East Pettigrew St., Suite A-100
Durham, North California 27701
June 13, 2023
Via EDGAR Transmission
Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 3010
100 F Street, N.E.
Washington, D.C. 20549
Attention: Joshua Gorsky
Re: PRECISION BIOSCIENCES, INC.
Registration Statement on Form S-3 (Registration No. 333-272540)
To the addressee set forth above,
In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-272540) (the “Registration Statement”) of Precision BioSciences, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on June 15, 2023, or at such later time as the Company or its counsel may orally request via telephone call to the staff. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Peter Handrinos at (617) 948-6060 or Nathan Ajiashvili at (212) 906-2916.
If you have any questions regarding the foregoing, please do not hesitate to contact Peter Handrinos at (617) 948-6060 or Nathan Ajiashvili at (212) 906-2916, of Latham & Watkins LLP. Thank you in advance for your consideration.
Very truly yours,
Precision BioSciences, Inc.
By: /s/ John Alexander Kelly
Name: John Alexander Kelly
Title: Chief Financial Officer
cc: Peter N. Handrinos, Latham & Watkins LLP
Nathan Ajiashvili, Latham & Watkins LLP
|
2023-06-12 - UPLOAD - PRECISION BIOSCIENCES INC
United States securities and exchange commission logo
June 12, 2023
Michael Amoroso
President and Chief Executive Officer
Precision BioSciences, Inc.
302 East Pettigrew St., Suite A-100
Durham, North Carolina 27701
Re:Precision BioSciences, Inc.
Registration Statement on Form S-3
Filed June 9, 2023
File No. 333-272540
Dear Michael Amoroso:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Peter N. Handrinos, Esq.
2020-06-09 - UPLOAD - PRECISION BIOSCIENCES INC
United States securities and exchange commission logo
June 8, 2020
Matthew Kane
President and Chief Executive Officer
Precision BioSciences, Inc.
302 East Pettigrew St.
Suite A-100
Durham, NC 27701
Re:Precision BioSciences, Inc.
Registration Statement on Form S-3
Filed June 1, 2020
File No. 333-238857
Dear Mr. Kane:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-06-09 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP 1 filename1.htm dtil-corresp.htm PRECISION BIOSCIENCES, INC. 302 East Pettigrew St., Suite A-100 Durham, North Carolina 27701 June 9, 2020 Via EDGAR Transmission Securities and Exchange Commission Division of Corporation Finance Mail Stop 3010 100 F Street, N.E. Washington, D.C. 20549 Attention: Abby Adams Re: PRECISION BIOSCIENCES, INC. Registration Statement on Form S-3 (Registration No. 333-238857) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-238857) (the “Registration Statement”) of Precision BioSciences, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on June 11, 2020, or at such later time as the Company or its counsel may orally request via telephone call to the staff. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Peter Handrinos at (617) 948-6060 or Nathan Ajiashvili at (212) 906-2916. If you have any questions regarding the foregoing, please do not hesitate to contact Peter Handrinos at (617) 948-6060 or Nathan Ajiashvili at (212) 906-2916, of Latham & Watkins LLP. Thank you in advance for your consideration. Very truly yours, Precision BioSciences, Inc. By: /s/Abid Ansari Name: Abid Ansari Title: Chief Financial Officer cc: Peter N. Handrinos, Latham & Watkins LLP Nathan Ajiashvili, Latham & Watkins LLP
2019-03-25 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP 1 filename1.htm CORRESP Precision BioSciences, Inc. 302 East Pettigrew St., Suite A-100 Durham, North Carolina 27701 March 25, 2019 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 3030 Washington, D.C. 20549 Attn: Jeffrey Gabor Re: Precision BioSciences, Inc. Registration Statement on Form S-1 Filed March 1, 2019 Registration No. 333-230034 Dear Mr. Gabor: 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 the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on March 27, 2019, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as Precision BioSciences, Inc. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili at Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or Heyward Armstrong at Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P., counsel to the Company, at (919) 821-6619, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Very truly yours, PRECISION BIOSCIENCES, INC. /s/ Matthew Kane Matthew Kane cc: Michael P. Saber, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. Amy M. Batten, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. Heyward Armstrong, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. Peter N. Handrinos, Latham & Watkins LLP Nathan Ajiashvili, Latham & Watkins LLP
2019-03-25 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP 1 filename1.htm CORRESP March 25, 2019 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Jeffrey Gabor Re: Precision BioSciences, Inc. Registration Statement on Form S-1 File No. 333-230034 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between March 18, 2019 and the date hereof, approximately 1,907 copies of the Preliminary Prospectus dated March 18, 2019 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement. We wish to advise you that the participating underwriters have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on March 27, 2019 or as soon thereafter as practicable. [Signature page follows] Very truly yours, J.P. Morgan Securities LLC Goldman Sachs & Co. LLC Jefferies LLC Barclays Capital Inc. As representatives of the Underwriters J.P. Morgan Securities LLC By: /s/ David Ke Name: David Ke Title: Executive Director Goldman Sachs & Co. LLC By: /s/ Lyla Bibi Name: Lyla Bibi Title: Managing Director Jefferies LLC By: /s/ Charlie Glazer Name: Charlie Glazer Title: Managing Director Barclays Capital Inc. By: /s/ Victoria Hale Name: Victoria Hale Title: Vice President [Signature Page to Underwriters Acceleration Letter]
2019-03-18 - UPLOAD - PRECISION BIOSCIENCES INC
March 15, 2019
Matthew Kane
President and Chief Executive Officer
Precision BioSciences, Inc.
302 East Pettigrew St., Suite A-100
Durham, NC 27701
Re:Precision BioSciences, Inc.
Registration Statement on Form S-1
Response dated March 13, 2019
File No. 333-230034
Dear Mr. Kane:
We have reviewed your March 13, 2019 response to our comment letter and have the
following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing your response to this comment, we may have additional comments.
Unless we note otherwise, our references to prior comments are to comments in our March 6,
2019 letter.
Registration Statement on Form S-1 filed March 1, 2019
Capitalization, page 85
1.We acknowledge your March 13, 2019 response to comment 1 of our March 6, 2019 letter
and your election to account for your 2019 Notes under the fair value option. Please tell
us why the fair value of your 2019 Notes is $39.6 million upon the pro forma completion
of your offering when at least $46.6 million worth of your common stock will be issued to
settle these notes.
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
March 15, 2019 Page 2
FirstName LastName
Matthew Kane
Precision BioSciences, Inc.
March 15, 2019
Page 2
You may contact Mark Brunhofer at 202-551-3638 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Heyward Armstrong
2019-03-13 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP
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CORRESP
SMITH, ANDERSON, BLOUNT,
DORSETT, MITCHELL, & JERNIGAN, L.L.P.
LAWYERS
OFFICES
Wells Fargo Capitol Center
150 Fayetteville Street, Suite 2300
Raleigh, North Carolina 27601
March 13, 2019
MAILING ADDRESS
P.O. Box 2611
Raleigh,
North Carolina
27602-2611
TELEPHONE: (919) 821-1220
FACSIMILE: (919) 821-6800
VIA EDGAR AND HAND DELIVERY
Mr. Jeffrey Gabor
United States Securities and Exchange
Commission
Division of Corporation Finance
Office of
Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549-6010
Re:
Precision BioSciences, Inc.
Registration Statement on Form S-1
Filed on March 1, 2019
File No. 333-230034
Dear Mr. Gabor:
On behalf of Precision
BioSciences, Inc. (the “Company”), we submit this letter in response to the comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter
March 6, 2019 relating to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”). In this letter, we have recited the comment from the Staff in bold type
and have followed the comment with the Company’s response. For the Staff’s convenience, we are also sending, by hand delivery, copies of this letter for the Staff’s review.
Capitalization, page 85
1.
It is apparent from the accumulated deficit amount presented in the pro forma column of your capitalization
table that you do not anticipate a beneficial conversion feature (BCF) charge associated with the issuance and/or conversion of your 2019 Notes. Given the variability of the conversion price as disclosed on page
F-34, please tell us your consideration for any BCF or contingent BCF associated with these notes. Reference for us the authoritative literature you rely upon to support your position.
Response: The Company respectfully advises the Staff that it concluded that the only features in the 2019
Notes that could potentially represent beneficial conversion features (“BCFs”) are nondetachable conversion features in the 2019 Notes that are in the money as of the issuance date. The Company’s determination is consistent
with the definition of BCF in ASC 470-20-20, as well as ASC
470-20-25-8, which indicates that instruments containing continuous reset adjustments to provide a fixed monetary value represent
stock-settled debt. Two conversion options were identified in the 2019 Notes: (1) the second settlement alternative arising from the provision that results in an automatic settlement into common stock in connection with a qualified initial
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 13, 2019
Page
2
public offering at a
settlement price per share equal to the lesser of (a) 85% of the price per share in such offering or (b) $800 million divided by the Company’s fully diluted capitalization as of immediately prior to the closing of such offering and
(2) settlement, at the option of the applicable holder, at the maturity date of the 2019 Notes into Series B-1 Preferred Stock of the Company at a settlement price per share based on the then-outstanding
principal and accrued interest under the 2019 Notes divided by $6.40 per share. The first conversion feature was determined to not be in-the-money at the issuance date
of the 2019 Notes and therefore does not contain an initial active BCF. The second conversion feature would require bifurcation from the host debt instrument and accounting as an embedded derivative because the authorization and issuance of the
Series B-1 Preferred Stock is subject to approval by the Company’s existing holders of Series A and B Preferred Stock and thus outside of the Company’s control. Because the Company does not
control whether it will be permitted to deliver Series B-1 Preferred Stock, the Company is required to presume the monetary value of the Series B-1 Preferred Stock will
be settled in cash. As a result, this feature requires bifurcation as an embedded derivative and cannot represent a BCF.
The remaining
features included in the 2019 Notes consist of the 85% settlement features and automatic settlement upon a liquidation event. The 85% settlement features include (1) optional settlement into common stock in connection with an initial public
offering (other than a qualified initial public offering) at 85% of the initial public offering price per share and (2) automatic settlement into preferred stock at a settlement price equal to 85% of the lowest per share cash purchase price of
preferred stock sold in the financing round. The Company determined that these features represent redemption features. The 85% settlement features and the settlement upon a liquidation event would require bifurcation as embedded derivatives under
ASC 815-15-25-42. In reaching the conclusion that the 85% settlement features are redemption features, the Company determined
them to be share-settled redemption features since the monetary value provided upon settlement is the same regardless of the share price.
The absence of a BCF in the 2019 Notes permits the Company to apply either of the following accounting options for the 2019 Notes:
(1) historical cost accounting, which would require the Company to bifurcate multiple embedded derivatives included in the 2019 Notes, or (2) fair value accounting, which would require the Company to recognize any changes in the fair value
of the 2019 Notes through the statement of operations until settlement. The Company has elected to apply fair value accounting to the 2019 Notes.
The Company plans to update its disclosure regarding the 2019 Notes in the “Capitalization” section in Amendment No. 2 to the
Registration Statement by including the following disclosure:
The pro forma and pro forma as adjusted information below assumes the
Company elects the fair value option to account for the 2019 Notes. Additionally, the Company assumes for purposes of the pro forma and pro forma as adjusted information that the fair value of the 2019 Notes upon conversion is equal to
$39.6 million.
* * * * *
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 13, 2019
Page
3
If we can be of
further assistance in facilitating your review of the above response, please do not hesitate to contact me at (919) 821-6619 or Nathan Ajiashvili at
(212) 906-2916.
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 13, 2019
Page
4
Sincerely yours,
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL & JERNIGAN, L.L.P.
By:
/s/ Heyward D. Armstrong
Heyward D. Armstrong
Enclosures
cc:
Matthew Kane, Precision BioSciences, Inc.
Abid Ansari, Precision BioSciences, Inc.
Michael P. Saber, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P.
Amy M. Batten, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P.
Peter N. Handrinos, Latham & Watkins LLP
Nathan Ajiashvili, Latham & Watkins LLP
Divakar Gupta, Cooley LLP
Darren
DeStefano, Cooley LLP
2019-03-08 - CORRESP - PRECISION BIOSCIENCES INC
CORRESP
1
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CORRESP
SMITH, ANDERSON, BLOUNT,
DORSETT, MITCHELL, & JERNIGAN, L.L.P.
LAWYERS
OFFICES
Wells Fargo Capitol Center
150 Fayetteville Street, Suite 2300
Raleigh, North Carolina 27601
HEYWARD D. ARMSTRONG
DIRECT DIAL: (919) 821-6619
E-Mail: harmstrong@smithlaw.com
March 8, 2019
MAILING ADDRESS
P.O. Box 2611
Raleigh,
North Carolina
27602-2611
TELEPHONE: (919)
821-1220
FACSIMILE: (919)
821-6800
FOIA Confidential Treatment Request
Under 17 C.F.R. § 200.83
Certain confidential information in this letter has been omitted and provided separately to the Securities and Exchange
Commission. Confidential treatment has been requested by Precision BioSciences, Inc. with respect to the omitted portions, which are identified in this letter by the mark “[***].”
VIA EDGAR AND HAND DELIVERY
Mr. Jeffrey
Gabor
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare &
Insurance
100 F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549-6010
Re:
Precision BioSciences, Inc.
Anticipated Price Range and Stock-Based Compensation
Registration Statement on Form S-1 (File No. 333-230034)
Dear Mr. Gabor:
On behalf of Precision BioSciences, Inc. (the “Company”), we submit this letter (this “Letter”) to the staff
(the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company originally submitted the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) to the Commission on October 18, 2018, resubmitted to the Commission on December 28, 2018 and February 21, 2019 and subsequently filed the
Registration Statement with the Commission on March 1, 2019.
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. In particular, the Company references Comment #9 of the Staff’s letter dated November 15, 2018 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.
We are respectfully requesting confidential treatment for certain portions of this Letter pursuant to Rule 83 of the Commission’s Rules
on Information and Requests, 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 letter has been filed on
EDGAR, omitting the confidential information contained in this Letter.
CONFIDENTIAL TREATMENT
REQUESTED BY
PRECISION BIOSCIENCES, INC.
PBS-1
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 8, 2019
Page
2
For the convenience of the Staff, we are providing to the Staff copies of this Letter by hand
delivery. In this Letter, we have recited the prior comment from the Staff in italicized, bold type and have followed the comment with the Company’s response.
9. 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 this offering 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.
The Company 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 lead underwriters (the “Underwriters”) of the
Company’s proposed initial public offering of its common stock (“IPO”), if the Company were to commence marketing of the transaction today, the Company currently anticipates that the estimated price range would be approximately
$[***] to $[***] per share (the “Preliminary IPO Price Range”), with a midpoint 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 of the Company’s common stock that may occur prior to the Commission’s declaration of effectiveness of the Registration Statement. The Company advises the Staff that the final range to be included in a pre-effective amendment to the Registration Statement will include a price range of no more than $2.00, if the maximum price is $10.00 per share or less, or 20% of the high end of the range, if the maximum price is
greater than $10.00 per share, unless otherwise approved by the Staff.
The Company’s final range to be included in a pre-effective amendment to the Registration Statement remains under discussion between the Company and the 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 During the Preceding 12
Months
The following table summarizes by grant date the number of shares of common stock underlying stock options granted during the
past year, as well as the associated per share exercise price, equal to the estimated fair value per share of the Company’s common stock on the date of option grant, and the estimated fair value of options per share used to determine
stock-based compensation expense for financial reporting purposes.
Grant Date
Number of Shares
Underlying Option Grants
Exercise Price Per Share
Estimated Fair Value of
Shares
April 20, 2018
720,000
$
4.21
$
4.21
July 23, 2018
626,250
$
4.76
$
4.76
October 12, 2018
4,484,750
$
5.61
$
5.61
December 5, 2018
915,000
$
6.18
$
6.18
February 19, 2019
1,175,000
$
6.46
$
6.46
CONFIDENTIAL TREATMENT
REQUESTED BY
PRECISION BIOSCIENCES, INC.
PBS-2
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 8, 2019
Page
3
Historical Fair Value Determination and Methodology
As there has been no public market for the Company’s common stock to date, the estimated fair value of the Company’s common stock has
been determined by the Board of Directors as of the date of each option grant, with input from management, taking into account (i) the most recent third-party valuations of the common stock and (ii) the Board of Directors’ assessment
of any additional objective and subjective factors that it believed were relevant and that may have changed from the date of the most recent third-party valuation through the date of the grant.
Third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’
Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation. As described in further detail in the section of the Registration Statement entitled “Management’s Discussion and Analysis
of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates—Stock-Based Compensation” and under “Discussion of Common Stock Valuations and Option Grants” below, the third-party
valuation reports were prepared by determining the Company’s total equity value using from appropriate valuation methodologies and then allocating the value across the Company’s various outstanding securities at the time of valuation using
one of the following valuation methods:
•
OPM. The option pricing allocation method (“OPM”) treats common stock and
preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. The Company factored into the
valuations the likelihood of which the Company would seek an IPO based on the Company’s status as of each valuation date. A discount for lack of marketability of the shares of common stock is then applied to arrive at an indication of value for
the shares of common stock.
•
PWERM. Under the probability-weighted expected return method (“PWERM”) methodology, the
fair value of common stock is estimated based upon an analysis of future values for the Company, assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns considering
each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability
weighted to arrive at an indication of value for the common stock.
•
Hybrid. The hybrid method is a PWERM where the equity value in one of the scenarios is calculated using an
OPM.
CONFIDENTIAL TREATMENT
REQUESTED BY
PRECISION BIOSCIENCES, INC.
PBS-3
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 8, 2019
Page
4
At each grant date, the Board of Directors considered whether any events had occurred that
would trigger any material changes to the business or would require adjustment to the estimated fair value from the previous valuation date. Additional objective and subjective factors considered by the Company’s Board of Directors included the
following:
•
the prices at which the Company sold any shares of preferred stock and the superior rights and preferences of the
preferred stock relative to the Company’s common stock at the time of each grant;
•
the progress of the Company’s research and development programs, including the status and results of
preclinical studies for the Company’s product candidates;
•
the Company’s stage of development and commercialization and its business strategy;
•
external market conditions affecting the life sciences industry and trends within the life sciences industry;
•
the Company’s financial position, including cash on hand, and the Company’s historical and forecasted
performance and operating results;
•
the lack of an active public market for the Company’s common stock and the Company’s preferred stock;
•
the likelihood of achieving a liquidity event, such as an initial public offering or sale of the Company in light
of prevailing market conditions; and
•
the analysis of initial public offerings and the market performance of similar companies in the life sciences
industry.
Discussion of Common Stock Valuations and Stock Option Grants
April 2018 and July 2018
At the close of
the first and second fiscal quarters of 2018, the Company received independent third-party valuation reports of the Company’s common stock as of March 31, 2018, at $4.21 per share, and June 30, 2018, at $4.76 per share (the
“March 2018 Valuation” and “June 2018 Valuation,” respectively). The March 2018 Valuation determined the equity value of the Company using guideline M&A transactions and prior sales of company stock valuation
approaches. The June 2018 Valuation determined the equity value of the Company using a prior sales of company stock valuation approach, taking into account the Company’s arm’s-length May 2018 through
July 2018 sales of Series B Convertible Preferred Stock for a total of approximately $110.0 million. Each of the March 2018 Valuation and June 2018 Valuation allocated total equity value using OPM.
On April 20, 2018, the Company granted options to purchase a total of 720,000 shares of common stock at an exercise price of $4.21 per
share. After consideration of various factors, the Board of Directors determined that the March 2018 Valuation represented the fair market value of the Company’s common stock as of April 20, 2018. Similarly, on July 23, 2018, the
Company granted options to purchase a total of 626,250 shares of common stock at an exercise price of $4.76 per share, and after consideration of various factors, the Board of Directors determined that the June 2018 Valuation represented the fair
market value of the Company’s common stock as of July 23, 2018.
CONFIDENTIAL TREATMENT
REQUESTED BY
PRECISION BIOSCIENCES, INC.
PBS-4
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 8, 2019
Page
5
October 2018
The Company received an independent third-party valuation of the Company’s common stock as of September 12, 2018 at $5.61 per share
(the “September 2018 Valuation”). The September 2018 Valuation used a hybrid valuation method.
In determining the equity
value of the Company, the September 2018 Valuation assigned different probabilities to four future scenarios as follows: (i) the Company completing an IPO in February 2019 was assigned a probability of [***]%; (ii) the Company completing an IPO
in September 2019 was assigned a probability of [***]%; (iii) the Company completing an IPO in December 2019 was assigned a probability of [***]%; and (iv) the Company not completing an IPO was assigned a probability of [***]%.
For each of scenarios (i) through (iii), the equity value of the Company was determined using the PWERM based on an analysis of the post-IPO market capitalizations of comparable public companies that had completed IPOs during the two years prior to the valuation date using guideline public company IPOs and guideline public companies market
approaches. These values were determined based on a qualitative analysis of the Company as of the valuation date relative to the guideline public companies, as of each of their IPO dates, with respect to size, risk, total number of drugs in
development and development progress of those drugs, considering conditions in the overall biopharmaceutical IPO market during the last two years, the expected positioning of the Company at each potential IPO date, and the potential market
environment at each potential IPO date and then discounted to present value.
For scenario (iv), the equity value of the Company was
determined using the OPM based on a prior sales of company stock market approach. This value considered the Company’s arm’s-length June 2018 sale of Series B Convertible Preferred Stock for a total
of approximately $110.0 million and used the backsolve method to account for share class rights and preferences. The backsolve method is a market approach that derives an implied total equity value from the sale price of the Company’s
equity securities in a recent arm’s-length transaction.
The September 2018 Valuation
allocated the equity value of the Company using the hybrid method described above and applied a discount for the lack of marketability of the Company’s common stock. The discount for lack of marketability was determined using two methods: a
group of transactions from a pre-IPO study and a put option analysis, which calculates the cost of put option to protect an investor against risk of an extended holding period. As the Company approaches a
liquidity event that would result in a ready and liquid market for its stock, the discount for lack of marketability decreases.
The
following table displays the summary calculation for the September 2018 Valuation’s determination of weighted average per share value on a minority, non-marketable basis:
Scenario
Present Per
Share Value
– Marketable
Lack of
Marketability
Discount
Present Per
Share Value
Probability
Weighted
Per Share
Value
(i) IPO completed in February 2019
$
6.55
10.0
%
$
5.89
[***]
%
$
4.12
(ii) IPO completed in September 2019
6.04
12.5
%
5.28
[***]
%
0.53
(iii) IPO completed in December 2019
5.87
15.0
%
4.99
[***]
%
0.50
(iv) no IPO completed
4.88
5.0
%
4.63
[***]
%
0.46
5.61
CONFIDENTIAL TREATMENT
REQUESTED BY
PRECISION BIOSCIENCES, INC.
PBS-5
SMITH, ANDERSON, BLOUNT, DORSETT,
MITCHELL, & JERNIGAN, L.L.P.
March 8, 201
2019-03-06 - UPLOAD - PRECISION BIOSCIENCES INC
March 6, 2019
Matthew Kane
President and Chief Executive Officer
Precision BioSciences, Inc.
302 East Pettigrew St., Suite A-100
Durham, NC 27701
Re:Precision BioSciences, Inc.
Registration Statement on Form S-1
Filed on March 1, 2019
File No. 333-230034
Dear Mr. Kane:
We have reviewed your registration statement and have the following comment. 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 comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to the comment, we may have additional comments.
Registration Statement on Form S-1 filed March 1, 2019
Capitalization, page 85
1.It is apparent from the accumulated deficit amount presented in the pro forma column of
your capitalization table that you do not anticipate a beneficial conversion feature (BCF)
charge associated with the issuance and/or conversion of your 2019 Notes. Given the
variability of the conversion price as disclosed on page F-34, please tell us your
consideration for any BCF or contingent BCF associated with these notes. Reference for
us the authoritative literature you rely upon to support your position.
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.
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
March 6, 2019 Page 2
FirstName LastName
Matthew Kane
Precision BioSciences, Inc.
March 6, 2019
Page 2
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 Mark Brunhofer at (202) 551-3638 or Mary Mast at (202) 551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at (202) 551-2544 or Joseph McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-02-22 - UPLOAD - PRECISION BIOSCIENCES INC
February 19, 2019
Matthew Kane
President and Chief Executive Officer
Precision BioSciences, Inc.
302 East Pettigrew St., Suite A-100
Durham, NC 27701
Re:Precision BioSciences, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted on December 28, 2018
CIK No. 0001357874
Dear Mr. Kane:
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
Our Foundation I-Crel, page 1
1.We note revisions in response to prior comment 2 in which you broadly cite "scientific
literature" and "various third-party studies" to support performance claims concerning I-
Crel. Please revise your Business section to identify and discuss the literature and studies
that you highlight in your Summary.
Food and Agriculture, page 4
2.We refer to prior comments 1 and 6 and note your revised disclosure on page 4
indicating that you have "successfully" edited a variety of plant species. Please revise to
clarify how you measure editing success in the context of food and agriculture (e.g.,
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
February 19, 2019 Page 2
FirstName LastNameMatthew Kane
Precision BioSciences, Inc.
February 19, 2019
Page 2
safety, nutrition, flavor). Given that you have not conducted field testing, please tell us
the basis you have to make this performance claim. In addition, please revise this section
of the Summary to clarify that you have not commercialized any food and agriculture
products to date and to explain that you must undertake field testing prior to
commercializing any such products. Also revise to explain briefly the term "pre-breeding
material."
Our amended and restated certificate of incorporation provides that the Court of Chancery...,
page 77
3.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any “derivative
action.” Please disclose whether this provision applies to actions arising under the federal
securities laws. Also ensure that the exclusive forum provision in your proposed
organizational documents states this clearly. In this regard, we note that Section 27 of the
Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any
duty or liability created by the Exchange Act or the rules and regulations thereunder.
Notes to consolidated financial statements
Note 13: Collaboration and license agreements, page F-26
4.We acknowledge your response to the third bullet of prior comment 20. The disclosure of
the potential receipt of an aggregate $1.6 billion in milestones under the Servier
agreement does not provide financial statement users with any information to assess the
likelihood of receipt or the potential timing of receipt. As a result, please revise your
disclosure to aggregate your potential milestones into subcategories based on the nature of
the underlying milestones. For example, aggregation by early-stage development, late-
stage development, regulatory submission, regulatory approval and sales-based milestones
appear to be reasonable and appropriate.
Condensed consolidated statements of changes in stockholders' equity (deficit) (Unaudited), page
F-34
5.Please revise your submission to provide the comparable interim information for 2017 as
required by Rule 8-03(a)(5) of Regulation S-X.
Notes to unaudited condensed consolidated financial statements
Note 9: Collaboration and license agreements
Collaboration and license agreement with Gilead, page F-45
6.Please revise your disclosure to clearly identify each deliverable and separate unit of
accounting, the arrangement consideration allocated to each separate unit of accounting
and how you will account for each. See ASC 605-25-50-2. Also, disclose aggregate
milestone consideration to be received by subcategories based on the nature of the
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
February 19, 2019 Page 3
FirstName LastName
Matthew Kane
Precision BioSciences, Inc.
February 19, 2019
Page 3
underlying milestones consistent with the comment above on your Servier agreement.
Refer to ASC 605-28-50-2.
You may contact Mark Brunhofer at (202) 551-3638 or Mary Mast at (202) 551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at (202) 551-2544 or Joseph McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-11-16 - UPLOAD - PRECISION BIOSCIENCES INC
November 15, 2018
Matthew Kane
President and Chief Executive Officer
Precision BioSciences, Inc.
302 East Pettigrew St., Suite A-100
Durham, NC 27701
Re:Precision BioSciences, Inc.
Draft Registration Statement on Form S-1
Submitted on October 19, 2018
CIK No. 0001357874
Dear Mr. Kane:
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.We note your statements of industry leadership on pages 1 and 3. Given the early stage of
your development and the competition in this space, please tell us the basis for your
leadership claims. Also, revise the "Overview" section on page 1 to clarify that your
operations are preclinical in nature.
2.We note numerous performance claims on pages 1-4, and elsewhere in the prospectus,
concerning I-Crel nucleases generally and your ARCUS neucleases and platform. Given
your risk factor disclosures on page 15 concerning the differences between animal and
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
November 15, 2018 Page 2
FirstName LastNameMatthew Kane
Precision BioSciences, Inc.
November 15, 2018
Page 2
human DNA and on page 31 concerning off-target editing in humans, it is not clear what
basis you have to make these performance claims. For instance, and without limitation,
we refer to your disclosures concerning I-Crel's ability to achieve "a high level of on-
target editing" and your ability to redirect ARCUS nucleases "without compromising its
editing abilities." Accordingly, please revise to clarify the basis for performance claims
and balance the Summary presentation to highlight challenges you face as you advance
into clinical development. To avoid confusion, please also consider placing disclosures
concerning the attributes of I-Crel under a heading separate from one that addresses the
attributes of your proprietary ARCUS nucleases.
3.We refer to your table on page 3 depicting your product development pipeline. Please
revise to remove the unidentified in vivo gene correction platform candidate or tell us why
you believe the inclusion of this unidentified program candidate is appropriate. Also,
revise your presentation so that all text contained in the table is legible.
4.We refer to the final paragraph on page 3 and your disclosure on page 90 concerning the
Servier collaboration agreement. Please revise your Summary discussion on page 3 to
explain briefly your role in the development of each antigen target selected by Servier.
Also clarify here, and elsewhere in the prospectus, whether Servier has selected any
antigen targets in addition to the CD19 target.
5.Please revise the Summary to explain briefly the following terms at first use or in close
proximity thereto: "immunotherapy", "CAR T Cells", "allogeneic", "in vivo" and "base 3'
overhangs".
6.We refer to the second paragraph on page 4 concerning your Food and Agriculture
segment. Please revise to explain briefly how your business model is "differentiated."
With reference to your risk factor discussion on page 12, please revise to briefly discuss
the potential timeline for commercialization of product candidates in this segment.
Risk Factors
We expect to take advantage..., page 15
7.Your risk factor disclosure on page 15 discusses your intention to take advantage of a
research tax incentive program in Australia; however, your Business discussion does not
address any operations or plans concerning Australia. Accordingly, please revise your
Business discussion or advise.
Use of Proceeds, page 80
8.With reference to your product pipeline table on page 3 and your R&D expense table on
page 92, please revise the Use of Proceeds section to identify the approximate amount of
proceeds, if any, intended for each clinical and preclinical candidate. For each candidate,
indicate whether the offering funds are intended to be used to reach a particular stage of
development. To the extent that offering funds will not be sufficient to complete a
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
November 15, 2018 Page 3
FirstName LastNameMatthew Kane
Precision BioSciences, Inc.
November 15, 2018
Page 3
particular stage of development, please also explain the need for additional funding to
complete that stage of development.
Management's discussion and analysis of financial condition and results of operations
Critical accounting policies and use of estimates
Stock-based compensation, page 104
9.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 this offering 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.
Business
Our ARCUS genome editing platform, page 115
10.We refer to the final sentence in the first paragraph under the heading. Please revise to
disclose how many ARCUS nucleases you have patented to date and discuss, as
applicable, any uncertainty concerning whether an engineered nuclease is patentable.
Our product development platform approach , page 117
11.We refer to your disclosures on pages 123 and 124 concerning the four product candidates
in your CAR T cell development pipeline. In this section you disclose conclusions
without providing information concerning the studies or the results that formed the basis
for your conclusions. Accordingly, please substantially revise this section to explain the
studies, including who conducted them, their scope and design, and the primary and
secondary endpoints, if any.
Our food and agriculture program, page 127
12.With reference to your footnote disclosure on page 3, please revise the Business
discussion to discuss the development stages for food and agricultural products. Discuss,
as applicable, whether there is any regulatory significance or implications tied to
achievement of the various field stages. In this regard, we note that your disclosure on
page 149 discusses the process for submitting petitions requesting a determination of non-
regulated status.
Ultra-low saturated fatty acid canola oil..., page 130
13.We note your disclosure here and elsewhere in the prospectus highlighting your
achievement of significantly lower levels of saturated fatty acids in edited canola oil
varieties. Please tell us, and revise, as applicable, to discuss the challenges you face in
development of these canola oil varieties, including, as applicable, whether you have
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
November 15, 2018 Page 4
FirstName LastNameMatthew Kane
Precision BioSciences, Inc.
November 15, 2018
Page 4
observed any less desirable traits. For instance, please tell us whether the optimized
varieties have shown altered levels of other fats or whether the varieties have altered
cooking properties (e.g., a materially different smoke point).
License and Collaboration Agreements, page 132
14.We note your disclosure on F-28 that you entered into a research, collaboration and
license agreement with the University of Pennsylvania that includes three gene knockout
programs and up to three gene knockin or gene repair programs in which the company
will provide funding to the University of Pennsylvania and receive a license to certain
technology invented under the agreement. Please expand your License and Collaboration
Agreement disclosure to describe the material terms of the agreement, including financial
and termination provisions. Additionally, please file this agreement as an exhibit or
provide an analysis supporting a determination that you are not required to file it pursuant
to Item 601(b)(10) of Regulation S-K.
License and Collaboration Agreements
Servier, page 132
15.Please revise to discuss Servier's obligations, if any, to develop and commercialize a
candidate following exercise of a commercial option. Discuss, as applicable, whether the
agreement contains development and commercialization milestones that must be achieved
by specific deadlines.
16.We note your disclosure on page 132 that you are eligible to earn tiered royalties on net
sales of optioned products ranging from mid single-digit to low double-digit percentages.
The upper bound of the range is very broad and therefore does not provide investors with
a meaningful understanding of the potential royalty payments. Accordingly, please revise
so that the range for the upper bound is discernible within 10 percentage points.
Competition, page 135
17.Please revise your discussion of competitive conditions by describing the current
landscape for patent protections in your industry. In this regard, we note that across
several risk factors on pages 52 to 63 you highlight risks stemming from existing third-
party patents and patent applications. We further note your 2014 patent litigation
settlement with Cellectis. In your discussion of the competitive landscape, identify
specific patents and patent applications, if material, as well as their holders/applicants.
Notes to consolidated financial statements
Note 1: Description of business and summary of significant accounting policies
Share-based compensation, page F-12
18.It appears that your policy to recognize the grant-date fair value of stock options granted
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
November 15, 2018 Page 5
FirstName LastNameMatthew Kane
Precision BioSciences, Inc.
November 15, 2018
Page 5
to non-employees over the requisite service period is consistent with the guidance
applicable to employee grants under ASC 718. Please tell us how your policy complies
with the equity-based payments to non-employees guidance in ASC 505-50.
Recent accounting pronouncements not yet adopted, page F-12
19.Please revise your disclosure on page F-13 regarding the new revenue recognition
standards under ASC 606 to specifically discuss your consideration of the transition
method to be applied under ASC 606-10-65-1d.
Note 13: Collaboration and license agreements, page F-26
20.Please address the following comments related to your agreement with Les Laboratories
Servier:
•Tell us why you recognized only $5.8 million and $4.8 million of revenue under this
agreement in 2017 and 2016, respectively, when you disclose on page 94 that you
recognize the $105.0 million upfront fee ratably over the 9.5 year performance period
which would imply recognition of approximately $11.1 million on an annual basis.
•Revise your disclosure to clearly identify each deliverable and separate unit of
accounting, the arrangement consideration allocated to each separate unit of
accounting and how you will account for each. See ASC 605-25-50-2. In this regard,
although you indicate on the top of page F-27 that "certain development milestones
related to early-stage activities" are nonsubtantive and are combined with the
development license into a single unit of accounting, you do not appear to discuss the
accounting for substantive milestones or the option exercise fees under the
arrangement.
•Revise your disclosure to disclose a description and the amount of each milestone
within the $1.6 billion of potential consideration disclosed at the bottom of page F-26
as well as whether each is substantive as required by ACS 605-28-50-2.
Note 15: Subsequent events, page F-28
21.Please revise your disclosure here and in your contractual obligations and commitments
disclosure on page 101 to indicate the magnitude of your commitment under the research,
collaboration and license agreement with the University of Pennsylvania. Otherwise, tell
us why such disclosure is not warranted.
General
22.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.
23.Please supplementally provide us with copies of all written communications, as defined in
FirstName LastNameMatthew Kane
Comapany NamePrecision BioSciences, Inc.
November 15, 2018 Page 6
FirstName LastName
Matthew Kane
Precision BioSciences, Inc.
November 15, 2018
Page 6
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.
You may contact Mark Brunhofer at (202) 551-3638 or Mary Mast at (202) 551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at (202) 551-2544 or Joseph McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
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