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Erasca, Inc.
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Erasca, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2024-05-14
Erasca, Inc.
Summary
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Erasca, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2022-08-15
Erasca, Inc.
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Erasca, Inc.
Response Received
4 company response(s)
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Company responded
2021-06-28
Erasca, Inc.
References: June 2, 2021
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SEC wrote to company
2021-07-09
Erasca, Inc.
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Company responded
2021-07-12
Erasca, Inc.
References: July 9, 2021
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Erasca, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2021-06-21
Erasca, Inc.
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Company responded
2021-06-25
Erasca, Inc.
References: June 21, 2021
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Erasca, Inc.
Awaiting Response
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SEC wrote to company
2021-06-02
Erasca, Inc.
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-20 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2025-08-18 | SEC Comment Letter | Erasca, Inc. | DE | 333-289537 | Read Filing View |
| 2024-05-14 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2024-05-14 | SEC Comment Letter | Erasca, Inc. | DE | 333-279261 | Read Filing View |
| 2022-08-16 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2022-08-15 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-12 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-09 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-28 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-21 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-02 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-18 | SEC Comment Letter | Erasca, Inc. | DE | 333-289537 | Read Filing View |
| 2024-05-14 | SEC Comment Letter | Erasca, Inc. | DE | 333-279261 | Read Filing View |
| 2022-08-15 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-09 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-21 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-02 | SEC Comment Letter | Erasca, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-20 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2024-05-14 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2022-08-16 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-13 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-07-12 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-28 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | Erasca, Inc. | DE | N/A | Read Filing View |
2025-08-20 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP Erasca, Inc. 3115 Merryfield Row, Suite 300 San Diego, CA 92121 August 20, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Erasca, Inc. Registration Statement on Form S-3 File No. 333-289537 To the addressees set forth above: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, on behalf of Erasca, Inc., respectfully requests that the effective date of the Registration Statement on Form S-3 referred to above be accelerated so that it will become effective at 4:00 P.M. Eastern Time on August 22, 2025, or as soon as practicable thereafter. If you have any questions or require additional information, please contact Matthew T. Bush, Esq. of Latham & Watkins LLP at (858) 523-3962. Thank you for your assistance and cooperation in this matter. Very truly yours, ERASCA, INC. By: /s/ Jonathan E. Lim Jonathan E. Lim, M.D. Chairman, Chief Executive Officer and Co-Founder cc: Ebun S. Garner, Erasca, Inc. Cheston J. Larson, Latham & Watkins LLP Matthew T. Bush, Latham & Watkins LLP
2025-08-18 - UPLOAD - Erasca, Inc. File: 333-289537
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 18, 2025 Dr. Jonathan E. Lim Chairman, Chief Executive Officer and Co-Founder Erasca, Inc. 3115 Merryfield Row, Suite 300 San Diego, CA 92121 Re: Erasca, Inc. Registration Statement on Form S-3 Filed August 12, 2025 File No. 333-289537 Dear Dr. Jonathan E. Lim: 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Matthew T. Bush, Esq. </TEXT> </DOCUMENT>
2024-05-14 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP Erasca, Inc. 3115 Merryfield Row, Suite 300 San Diego, CA 92121 May 14, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Erasca, Inc. Registration Statement on Form S-3 File No. 333-279261 To the addressees set forth above: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, on behalf of Erasca, Inc., respectfully requests that the effective date of the Registration Statement on Form S-3 referred to above be accelerated so that it will become effective at 4:00 P.M. Eastern Time on May 16, 2024, or as soon as practicable thereafter. If you have any questions or require additional information, please contact Matthew T. Bush, Esq. of Latham & Watkins LLP at (858) 523-3962. Thank you for your assistance and cooperation in this matter. Very truly yours, ERASCA, INC. By: /s/ Jonathan E. Lim Jonathan E. Lim, M.D. Chairman, Chief Executive Officer and Co-Founder cc: Ebun S. Garner, Erasca, Inc. Cheston J. Larson, Latham & Watkins LLP Matthew T. Bush, Latham & Watkins LLP
2024-05-14 - UPLOAD - Erasca, Inc. File: 333-279261
United States securities and exchange commission logo
May 14, 2024
Jonathan E. Lim, M.D.
Chairman and Chief Executive Officer
Erasca, Inc.
3115 Merryfield Row, Suite 300
San Diego, California 92121
Re:Erasca, Inc.
Registration Statement on Form S-3
Filed May 9, 2024
File No. 333-279261
Dear Jonathan E. Lim:
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 Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cheston J. Larson, Esq.
2022-08-16 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP Erasca, Inc. 3115 Merryfield Row, Suite 300 San Diego, CA 92121 August 16, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Erasca, Inc. Registration Statement on Form S-3 File No. 333-266802 To the addressees set forth above: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, on behalf of Erasca, Inc., respectfully requests that the effective date of the Registration Statement on Form S-3 referred to above be accelerated so that it will become effective at 4:00 P.M. Eastern Time on August 18, 2022, or as soon as practicable thereafter. If you have any questions or require additional information, please contact Matthew T. Bush, Esq. of Latham & Watkins LLP at (858) 523-3962. Thank you for your assistance and cooperation in this matter. Very truly yours, ERASCA, INC. By: /s/ Jonathan E. Lim Jonathan E. Lim, M.D. Chairman, Chief Executive Officer and Co-Founder cc: Ebun S. Garner, Erasca, Inc. Cheston J. Larson, Latham & Watkins LLP Matthew T. Bush, Latham & Watkins LLP
2022-08-15 - UPLOAD - Erasca, Inc.
United States securities and exchange commission logo
August 15, 2022
Ebun Garner
General Counsel
Erasca, Inc.
3115 Merryfield Row, Suite 300
San Diego, California 92121
Re:Erasca, Inc.
Registration Statement on Form S-3
Filed August 11, 2022
File No. 333-266802
Dear Mr. Garner:
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 Conlon Danberg at 202-551-4466 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew T. Bush, Esq.
2021-07-13 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP July 13, 2021 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Tonya K. Aldave Susan Block Sonia Bednarowski Angela Connell Julie Sherman Re: Erasca, Inc. Registration Statement on Form S-1 (File No. 333-257436) 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 July 12, 2021 and the date hereof, approximately 2,346 copies of the Preliminary Prospectus, dated July 12, 2021, 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 Thursday, July 15, 2021 or as soon thereafter as practicable. [signature page follows] Very truly yours, J.P. MORGAN SECURITIES LLC MORGAN STANLEY & CO. LLC BOFA SECURITIES, INC. As representatives of the Underwriters J.P. MORGAN SECURITIES LLC By: /s/ Benjamin Burdett Name: Benjamin Burdett Title: Managing Director MORGAN STANLEY & CO. LLC By: /s/ Kalli Dircks Name: Kalli Dircks Title: Managing Director, Equity Capital Markets BOFA SECURITIES, INC. By: /s/ Ryan Fisk Name: Ryan Fisk Title: Managing Director [Signature Page to Acceleration Request Letter]
2021-07-13 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP Erasca, Inc. 10835 Road to the Cure, Suite 140 San Diego, CA 92121 July 13, 2021 VIA EDGAR Ms. Tonya K. Aldave Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 Re: Erasca, Inc. Registration Statement on Form S-1 File No. 333-257436 Dear Ms. Aldave: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, on behalf of Erasca, Inc. (the “Company”), respectfully requests that the effective date of the Registration Statement on Form S-1 referred to above be accelerated so that it will become effective at 4:00 P.M. Eastern Time on July 15, 2021, or as soon as practicable thereafter. Please contact Matthew T. Bush of Latham & Watkins LLP, counsel to the Company, at (858) 523-3962, to provide notice of effectiveness, or if you have any questions or require additional information regarding this matter. Thank you for your assistance and cooperation in this matter. Very truly yours, ERASCA, INC. By: /s/ Jonathan E. Lim Jonathan E. Lim, M.D. Chairman and Chief Executive Officer cc: Sonia Bednarowski, Securities and Exchange Commission Angella Connell, Securities and Exchange Commission Julie Sherman, Securities and Exchange Commission David M. Chacko, M.D., Erasca, Inc. Ebun S. Garner, Erasca, Inc. Cheston J. Larson, Latham & Watkins LLP Matthew T. Bush, Latham & Watkins LLP Alaina P. Ellis, Latham & Watkins LLP
2021-07-12 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP 12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Beijing Moscow Boston Munich Brussels New York Century City Orange County Chicago Paris Dubai Riyadh Düsseldorf San Diego Frankfurt San Francisco Hamburg Seoul Hong Kong Shanghai Houston Silicon Valley London Singapore Los Angeles Tokyo Madrid Washington, D.C. Milan July 12, 2021 VIA EDGAR Ms. Tonya K. Aldave Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 Re: Erasca, Inc. Registration Statement on Form S-1 Filed June 25, 2021 File No. 333-257436 Dear Ms. Aldave: We are in receipt of the Staff’s letter dated July 9, 2021 with respect to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”). We are responding to the Staff’s comments on behalf of Erasca, Inc. (“Erasca” or the “Company”) as set forth below. Simultaneously with the submission of this letter, the Company is filing via EDGAR Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”) responding to the Staff’s comments. The Company’s responses set forth in this letter are numbered to correspond to the numbered comments in the Staff’s letter. All terms used but not defined herein have the meanings assigned to such terms in the Amended Registration Statement. For ease of reference, we have set forth the Staff’s comments and the Company’s response for each item below. Registration Statement on Form S-1 Prospectus Summary, page 1 1. We note your response to our prior comment 2 and reissue. Your pipeline table, which indicates that you are currently in Phase 1 of HERKULES-2, HERKULES-3 and HERKULES-4 clinical trials, appears to be inconsistent with your disclosure on pages 4 and 127 that you are planning to begin the dosing of first patients in HERKULES-2, HERKULES-3, and HERKULES-4 in the future. If these trials have not yet begun, please revise your pipeline table here and throughout the registration statement to show the arrows for the HERKULES-2, HERKULES-3 and HERKULES-4 trials in the INDenabling column of the pipeline table. July 12, 2021 Page 2 In the alternative, if the Phase 1 trials have already been completed for these three specific indications, as you state a clinical trial of ERAS-007 may have already been done by Asana, revise throughout your prospectus the apparently inconsistent disclosure that you have not yet dosed any patients in HERKULES-2, HERKULES-3 or HERKULES-4 trials, or clarify how the trials indicated in the table as planned may be differentiated from the trial discussed in the asterisk to the table. Finally, include a detailed and balanced description of the trails completed by Asana as they may relate specifically to HERKULES-2, HERKULES-3 or HERKULES-4. This description should include the number of participants in the trials, the endpoints, the statistical significance and p-values, any serious adverse events experienced by the trail participants, and the trails’ graphs, charts and diagrams, or advise. Erasca’s Response: In response to the Staff’s comment, the Company has revised the pipeline table throughout the Amended Registration Statement to show the arrows for the HERKULES-2, HERKULES-3 and HERKULES-4 trials in the IND-enabling column. In addition, the Company respectfully advises the Staff that the results of the Phase 1 clinical trial conducted by Asana helped inform the design of the Company’s clinical development program and doses to be tested for ERAS-007, which the Company will study in more specific patient populations in the HERKULES clinical trials. The Company has included the detailed results of the Asana trial beginning on page 135 of the Amended Registration Statement. To avoid any confusion of the relationship of the Asana trial to the planned clinical trials, the Company has moved the asterisk footnote from within the arrows of the HERKULES -2, -3 and -4 clinical trials to the product candidate itself, ERAS-007, and has added additional disclosure to such footnote consistent with the foregoing. Finally, the Company has enlarged the font size of the footnote to make it more legible. Risk Factors Our current amended and restated certificate of incorporation provides, page 70 2. We note that you have removed disclosure on page 70 relating to the application of the exclusive forum provision to the claims brought under the Exchange Act. We also note that the forum selection provision in your amended and restated certificate of incorporation identifies a state court located within the State of Delaware (or, if no state court located within the State of Delaware has jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain litigation, including any “derivative action.” Please disclose here whether this provision applies to actions arising under the Exchange Act. If this provision does not apply to actions arising under the Exchange Act, please also ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Exchange Act. Erasca’s Response: The Company has revised the Amended Registration Statement, including on page 71 as well as in Exhibit 3.3, to clarify that the exclusive forum provision does not apply to actions arising under the Exchange Act, in response to the Staff’s comment. ********* July 12, 2021 Page 3 Any comments or questions regarding the foregoing should be directed to the undersigned at (858) 523-3962. Thank you in advance for your cooperation in connection with this matter. Very truly yours, /s/ Matthew T. Bush Matthew T. Bush of LATHAM & WATKINS LLP cc: Susan Block, Securities and Exchange Commission Sonia Bednarowski, Securities and Exchange Commission Angela Connell, Securities and Exchange Commission Julie Sherman, Securities and Exchange Commission Jonathan Lim, M.D., Erasca, Inc. David M. Chacko, M.D., Erasca, Inc. Ebun Garner, Erasca, Inc. Cheston Larson, Latham & Watkins LLP Charles Kim, Cooley LLP Sean Clayton, Cooley LLP
2021-07-09 - UPLOAD - Erasca, Inc.
United States securities and exchange commission logo
July 9, 2021
Jonathan E. Lim
Chief Executive Officer
Erasca, Inc.
10835 Road to the Cure, Suite 140
San Diego, CA 92121
Re:Erasca, Inc.
Registration Statement on Form S-1
Filed on June 25, 2021
File No. 333-257436
Dear Dr. Lim:
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 June 21, 2021 letter.
Registration Statement on Form S-1
Prospectus Summary, page 1
1.We note your response to our prior comment 2 and reissue. Your pipeline table, which
indicates that you are currently in Phase 1 of HERKULES-2, HERKULES-3 and
HERKULES-4 clinical trials, appears to be inconsistent with your disclosure on pages 4
and 127 that you are planning to begin the dosing of first patients in HERKULES-2,
HERKULES-3, and HERKULES-4 in the future. If these trials have not yet begun, please
revise your pipeline table here and throughout the registration statement to show the
arrows for the HERKULES-2, HERKULES-3 and HERKULES-4 trials in the IND-
enabling column of the pipeline table.
FirstName LastNameJonathan E. Lim
Comapany NameErasca, Inc.
July 9, 2021 Page 2
FirstName LastName
Jonathan E. Lim
Erasca, Inc.
July 9, 2021
Page 2
In the alternative, if the Phase 1 trials have already been completed for these three specific
indications, as you state a clinical trial of ERAS-007 may have already been done by
Asana, revise throughout your prospectus the apparently inconsistent disclosure that you
have not yet dosed any patients in HERKULES-2, HERKULES-3 or HERKULES-4 trials,
or clarify how the trials indicated in the table as planned may be differentiated from the
trial discussed in the asterisk to the table. Finally, include a detailed and balanced
description of the trails completed by Asana as they may relate specifically to
HERKULES-2, HERKULES-3 or HERKULES-4. This description should include the
number of participants in the trials, the endpoints, the statistical significance and p-values,
any serious adverse events experienced by the trail participants, and the trails' graphs,
charts and diagrams, or advise.
Risk Factors
Our current amended and restated certificate of incorporation provides, page 70
2.We note that you have removed disclosure on page 70 relating to the application of
the exclusive forum provision to the claims brought under the Exchange Act. We also
note that the forum selection provision in your amended and restated certificate of
incorporation identifies a state court located within the State of Delaware (or, if no state
court located within the State of Delaware has jurisdiction, the federal district court for the
District of Delaware) as the exclusive forum for certain litigation, including any
“derivative action.” Please disclose here whether this provision applies to actions arising
under the Exchange Act. If this provision does not apply to actions arising under the
Exchange Act, please also ensure that the exclusive forum provision in the governing
documents states this clearly, or tell us how you will inform investors in future filings that
the provision does not apply to any actions arising under the Exchange Act.
You may contact Julie Sherman at 202-551-3640 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Tonya Aldave at 202-551-3601 or Susan Block at 202-551-3210 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-06-28 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP 12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Beijing Moscow Boston Munich Brussels New York FOIA CONFIDENTIAL TREATMENT REQUEST Century City Orange County Chicago Paris The entity requesting confidential treatment is: Dubai Riyadh Düsseldorf Rome Frankfurt San Diego Erasca, Inc. Hamburg San Francisco 10835 Road to the Cure, Suite 140 Hong Kong Seoul San Diego, CA 92121 Houston Shanghai Attn: Jonathan E. Lim, M.D., Chairman and Chief Executive Officer London Silicon Valley Los Angeles Singapore Madrid Tokyo Milan Washington, D.C. June 28, 2021 VIA EDGAR Ms. Tonya K. Aldave Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 Re: Erasca, Inc. | Anticipated Price Range Registration Statement on Form S-1 (File No. 333-257436) Dear Ms. Aldave: Rule 83 Confidential Treatment Requested by Erasca, Inc. On behalf of Erasca, Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated June 2, 2021 (the “Comment Letter”), relating to the Company’s draft Registration Statement on Form S-1 confidentially submitted to the Commission on May 7, 2021, and which was subsequently updated by the Company with a Registration Statement on Form S-1 filed with the Commission on June 25, 2021 (the “Registration Statement”), we are submitting this supplemental letter to further address Comment No. 8 of the Comment Letter. This letter is furnished supplementally on behalf of Erasca, Inc. (the “Company”). To assist the Staff in its review, the Company advises the Staff that it presently estimates, based in part on information received by the lead underwriters, that the public offering price per share for the offering pursuant to the Registration Statement will be between $[***] and $[***] (without giving effect to any stock split that the Company will effect prior to the offering, the “Preliminary Price Range”), considering information currently available and current market conditions. For clarity, the Company advises the Staff that, given the volatility of the public trading markets and the uncertainty of the timing of the offering, the Company and the lead underwriters have not yet [* * *] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Erasca, Inc. with respect to this letter. Securities and Exchange Commission FOIA CONFIDENTIAL TREATMENT REQUEST Page 2 finally agreed to a price range for the offering. The Company advises the Staff that the final range to be included in a pre-effective amendment to the Registration Statement, after giving effect to an appropriate stock split, will include a price range of no more than $2.00 or 20% of the low end of the range, unless otherwise approved by the Staff. Recent Stock Option Grants The Company’s grants of stock options during the 12 months preceding the latest balance sheet date presented in the Registration Statement, as well as those made since the latest balance sheet, are set forth below. Grant Date Number of Shares Underlying Options Granted Per Share Exercise Price of Options Estimated Fair Market Value of Shares February 26, 2020 270,000 $ 0.56 $ 0.56 July 13, 2020 1,027,500 $ 1.04 $ 1.04 September 1, 2020 346,250 $ 1.04 $ 1.04 September 23, 2020 4,905,116 $ 1.04 $ 1.04 September 28, 2020 285,000 $ 1.04 $ 1.04 October 30, 2020 710,250 $ 1.04 $ 1.04 January 26, 2021 2,421,652 $ 2.80 $ 2.80 February 26, 2021 1,320,000 $ 2.80 $ 2.80 March 4, 2021 973,000 $ 2.80 $ 2.80 April 12, 2021 1,495,000 $ 4.84 $ 4.84 April 19, 2021 1,034,000 $ 4.84 $ 4.84 April 22, 2021 100,000 $ 4.84 $ 4.84 April 26, 2021 62,000 $ 4.84 $ 4.84 May 17, 2021 804,000 $ 4.84 $ 4.84 June 14, 2021 980,000 $ 7.73 $ 7.73 Common Stock Valuation Methodologies 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 of the Company (the “Board”) 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 further disclosed on pages 101-102 of the Registration Statement. For the options granted in 2020 and 2021, the Company utilized a hybrid method computing the probability-weighted value across varying scenarios: the option-pricing method (“OPM”), current value method (“CVM”) and an initial public offering (“IPO”) of the Company, which are accepted valuation methods under the AICPA Practice Guide for determining the fair value of the Company’s common stock. The OPM treats a Company’s security classes as call options on total equity value, with exercise prices based on the relative seniority of payments among such security classes. The value of junior equity interests under the OPM is based on the value of optionality over-and-above the value of securities that are senior to them in the capital structure. Under the CVM, the enterprise value is calculated based on an assumed asset sale at a current date and the corresponding allocation of proceeds based on the rights and preferences of each class of equity. Securities and Exchange Commission FOIA CONFIDENTIAL TREATMENT REQUEST Page 3 In addition, in April 2020 the Company entered into a Series B preferred stock purchase agreement (“Series B Purchase Agreement”) with third party investors, pursuant to which in April and August 2020 the Company sold an aggregate of 27,481,001 shares of Series B-1 convertible preferred stock at a per share price of $5.00, for aggregate gross proceeds of $137.4 million. The Series B Purchase Agreement also provided for the issuance and sale of an aggregate of 13,175,191 shares of Series B-2 convertible preferred stock at a price of $7.50 per share, in an additional closing to certain purchasers of the Company’s Series B-1 convertible preferred stock, upon the achievement of certain milestones set forth in the Series B Purchase Agreement. The closing of the Series B-2 financing occurred in January 2021. As a result of the closings of the Series B-1 and B-2 financings, in valuations conducted in 2020 and 2021, the Company used the backsolve method to determine equity value in the OPM scenarios. 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. Based on the stage of the Company’s development programs, and utilizing newer, evolving theories for the determination of fair market values for common securities in biotechnology companies, the CVM was introduced in the April 2020 valuation. Under a fair market value standard, a willing buyer and seller transact to a “negotiated price”. This negotiation dynamic is not addressed in the current literature as the literature assumes that optionality is “fully valued” (and likely overvalued) utilizing a Black-Scholes or similar framework. The reality in transaction settings with respect to reaching a “negotiated price” is that optionality is not always paid for in transactions. With platform-based, development stage biotechnology companies such as the Company, much of the underlying value includes real optionality. Black-Scholes is known to overvalue real options and, as such, a CVM based approach was included to adjust for this fact. Further, optionality is only “fully priced” in transactions when the bidding dynamics for buyers and sellers is robust. Given the stage of the Company’s assets at the time of the Series B financing in April 2020, it was apparent that a number of key inflection points needed to occur prior to reaching a level whereby a robust negotiation dynamic could be assumed. As such, a partial optionality model was developed and the CVM approach was included. As biotechnology companies reach key value inflection points and get closer to going public, these bidding dynamics become more robust and optionality does become more fully valued in the valuation of securities. Given that the Company reached a number of key value inflection points later in 2020 which set the Company on a path toward a potential IPO, the CVM approach was removed beginning with the valuations conducted in 2021 to represent a “full optionality” pricing mechanism into the common stock. The Board and management developed estimates based on the application of these approaches and the assumptions underlying these valuations, giving careful consideration to independent third-party valuation reports. At each grant date, the Board considered whether any events occurred that would trigger any material changes to the business or would require adjustment to the estimated fair value from the previous valuation date. Securities and Exchange Commission FOIA CONFIDENTIAL TREATMENT REQUEST Page 4 Grant Date Fair Value Determinations February 2020 Option Grants. The Board, with input from management, determined the fair value of the common stock to be $0.56 per share as of February 26, 2020, after considering a valuation report from an independent third-party valuation firm as of December 31, 2019. In reaching this determination, the Board determined that no material changes had occurred in the business since the date of the third-party valuation report. The December 31, 2019 valuation established the following scenarios and probabilities: Scenario Indicated Value Assigned Weight DLOM* Weighted Value Per Unit/ Share OPM $ 0.93 97.5 % 42 % $ 0.54 IPO $ 1.90 2.5 % 36 % $ 1.21 Concluded Fair Value $ 0.56 * The DLOM was based on the Finnerty and Asian Put Option Analysis and consideration of various restricted stock studies. In determining the estimated equity value for the OPM scenario, the Company applied certain adjustments to the concluded equity value based on a backsolve method to the Company’s most recent equity financing, a Series A convertible preferred stock financing in which shares were sold at $1.667 per share in closings in October 2018, December 2018, and between January 2019 and March 2019. The backsolved equity value was adjusted for delays experienced in program development. The estimated equity value for the IPO scenario was determined based on the pre-IPO equity values for recent IPOs of similarly-situated oncology-focused companies. The Company estimated the average time to a potential liquidity event was 2.75 years in each scenario based on management’s best estimates. July 2020 – October 2020 Option Grants. The Board, with input from management, determined the fair value of the common stock to be $1.04 per share for options granted in July, September and October 2020, after considering a valuation report from an independent third-party valuation firm as of April 30, 2020. In reaching this determination, the Board determined that no material changes had occurred in the business since the date of the third-party valuation report and the dates of the option grants. Securities and Exchange Commission FOIA CONFIDENTIAL TREATMENT REQUEST Page 5 Among the qualitative factors considered by the Board in determining the fair value of the Company’s common stock were the following developments in the Company’s business subsequent to February 26, 2020: • in March 2020, the World Health Organization declared COVID-19 as a worldwide pandemic and the related outbreak had a negative impact on the global economy, trade and business; • in March 2020, the Company entered into a license agreement with Katmai Pharmaceuticals, Inc., pursuant to which the Company in-licensed rights related to ERAS-801; and • in April 2020, the Company entered into the Series B Purchase Agreement. The April 30, 2020 valuation established the following scenarios and probabilities: Scenario Indicated Value Assigned Weight DLOM* Weighted Value Per Unit/ Share OPM $ 2.57 60 % 40 % $ 1.54 IPO $ 2.90 2.5 % 35 % $ 1.88 CVM $ 0.28 37.5 % 40 % $ 0.17 Concluded Fair Value $ 1.04 * The DLOM was based on the Finnerty Put Option Analysis and consideration of various restricted stock studies. In determining the estimated equity value for the OPM scenario, an OPM backsolve was used based on the April Series B-1 financing. The estimated equity value for the IPO scenario was determined based on the pre-IPO equity values for recent IPOs of similarly-situated oncology-focused companies. In determining the estimated equity value for the CVM scenario, the Company considered the total invested capital through the valuation date, and adjusted for a multiple of cash outflows and remaining available capital after such outflows. The Company estimated the average time to a potential liquidity event was 2.50 years in each of the OPM and IPO scenarios based on management’s best estimates. As discussed above, the valuation applied a partial optionality framework based on the stage of the Company’s development programs to determine the weights for each of the scenarios. Given the Company’s programs were in early stages of development, a probability of 37.5% was assigned to the no optionality scenario (CVM), and the residual probability was assigned to the optionality scenarios (OPM and IPO). Furthermore, the earliest a possible IPO was expected at that time was in [***], so the probability of 2.5% remained unchanged, with the residual probability assigned to the OPM scenario. Securities and Exchange Commission FOIA CONFIDENTIAL TREATMENT REQUEST Page 6 January 2021 – March 2021 Option Grants. The Board, with input from management, determined the fair value of the common stock to be $2.80 per share for options granted in January, February and March 2021, after considering a valuation report from an independent third-party valuation firm as of December 31, 2020. In reaching this determination, the Board determined that no material changes had occurred in the business since the date of the third-party valuation report and the dates of the option grants. Among the qualitative factors considered by the Board in determining the fair value of the Company’s common stock were the following developments in the Company’s business subsequent to October 30, 2020: • in November 2020, the Company entered into a merger agreement and license agreement with Asana BioSciences, pursuant to which the Company obtained rights to ERAS-007, one of the Company’s current lead product candidates; and • in December 2020, the Company dosed the first patient in its Phase 1 clinical trial of ERAS-601. The December 31, 2020 valuation established the following scenarios and probabilities: Scenario Per Share Value Assigned Weight DLOM* Weighted Value Per Share OPM $ 4.52 97.5 % 40 % $ 2.71 IPO $ 7.21 2.5 % 15 % $ 6.13 Concluded Fair Value $ 2.80 * The DLOM was based on the Finnerty Put Option Analysis. In determining the estimated equity value for the OPM scenario, an OPM backsolve was used based on the price per share of the Series B-2 financing ($7.50) because as of the December 31, 2020 valuation date, the triggering milestones necessary for the Series B-2 closing had occurred, with the financing ultimately closing in January 2021. The estimated equity value for the IPO scenario was determined based on the pre-IPO equity values for recent IPOs of similar
2021-06-25 - CORRESP - Erasca, Inc.
CORRESP 1 filename1.htm CORRESP 12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com June 25, 2021 VIA EDGAR Ms. Tonya K. Aldave Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 FIRM /AFFILIATE OFFICES Beijing Boston Brussels Century City Chicago Dubai Düsseldorf Frankfurt Hamburg Hong Kong Houston London Los Angeles Madrid Milan Moscow Munich New York Orange County Paris Riyadh San Diego San Francisco Seoul Shanghai Silicon Valley Singapore Tokyo Washington, D.C. Re: Erasca, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted June 9, 2021 CIK No. 0001761918 Dear Ms. Aldave: We are in receipt of the Staff’s letter dated June 21, 2021 with respect to the above-referenced confidential Amendment No. 1 to the draft Registration Statement (the “DRS”). We are responding to the Staff’s comments on behalf of Erasca, Inc. (“Erasca” or the “Company”) as set forth below. Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR a revised Registration Statement on Form S-1 (the “Registration Statement”) responding to the Staff’s comments and updating the DRS. The Company’s responses set forth in this letter are numbered to correspond to the numbered comments in the Staff’s letter. All terms used but not defined herein have the meanings assigned to such terms in the Registration Statement. For ease of reference, we have set forth the Staff’s comments and the Company’s response for each item below. Prospectus summary, page 1 1. We note your response to our prior comment 4 and reissue. For each of the nine programs in the discovery and the IND-enabling stages, please provide us with a detailed analysis of why each of those programs is sufficiently material to your business to warrant inclusion in your pipeline table or revise your table to remove programs that are not sufficiently material. In this regard we note, as examples only, that you do not list the programs currently in discovery or in the IND-enabling stage on your website, you do not appear to discuss them in your Management’s Discussion and Analysis of Financial Condition section, and you do not appear to have plans to use the proceeds of this offering to advance all of these programs. Erasca’s Response: In light of the Staff’s comment, the Company has reconsidered the materiality of each of the discovery and IND-enabling stage programs described in the pipeline table. After careful consideration, the Company has removed two of the discovery programs from the table: ERAS-9 and ERAS-11. However, the Company strongly believes that the remaining seven programs are material to its June 25, 2021 Page 2 development strategy and essential to an understanding of the investment opportunity and has provided a detailed analysis below. In addition, the Company advises the Staff that the Company is in the process of updating its website to conform to the disclosure in the Registration Statement. As background before addressing each program individually, Erasca would like to remind the Staff that since the Company’s founding, Erasca has focused on discovering and developing new product candidates based on differentiated approaches to shut down RAS-driven cancers. The Company realized early on that RAS may evade direct inhibition via multiple mechanisms—both in-pathway and beyond. To combat this, the Company has internally developed its own research programs, which have been complemented by a parallel corporate development strategy to in-license or acquire assets with the goal of comprehensively shutting down the RAS/MAPK pathway with single agents and rational combinations. As indicated in the Registration Statement, the Company’s efforts are rooted in a deep understanding of the biology of the RAS/MAPK pathway and are focused on finding the right molecules in a modality-agnostic manner rather than relying on a single, platform-specific approach. The Company’s development programs have been designed to allow it to target not just individual signaling nodes in the RAS/MAPK pathway, but multiple nodes and cooperative mechanisms in concert. As described further below, the Company’s strategy is focused on targeting multiple nodes and cooperative mechanisms of the RAS/MAPK pathway in parallel, rather than targeting a single node. When viewed in totality, the development programs that the Company presents in the pipeline table target every critical node in the RAS/MAPK pathway, which the Company believes is essential to a prospective investor’s understanding of the Company’s strategy, capabilities and development efforts to-date. The Company addresses below each of the seven discovery and IND-enabling stage programs included in the pipeline table of the Registration Statement with specificity so the Staff will have the benefit of the Company’s detailed analysis: ERAS-801 – Approved EGFR inhibitors do not effectively target primary brain tumors (e.g., glioblastoma multiforme (“GBM”)). The Company believes this is because of (1) the molecules’ inability to adequately penetrate the central nervous system (“CNS”) and (2) the molecules being weak inhibitors of EGFR mutations observed in GBM, which are distinct from EGFR mutations observed in non-small lung cancer. As described in the Registration Statement, ERAS-801 was specifically designed to address these key limitations, including having enhanced CNS penetration (~4x greater penetration than approved EGFR inhibitors) and the ability to target clinically relevant EGFR alterations in GBM, such as EGFR amplification and EGFRvIII mutations. The Company entered into an exclusive worldwide license agreement in 2020 with Katmai Pharmaceuticals for this program, and the license agreement is described in the Registration Statement (“Business—Our acquisition and license agreements—Katmai Pharmaceuticals” as well as throughout MD&A) and filed as a material agreement (Exhibit 10.17). The Company anticipates filing an IND in the first quarter of 2022, as disclosed in the Registration Statement. ERAS-1 – The historic discovery by Dr. Kevan Shokat, one of the Company’s co-founders, of the switch II pocket (S-IIP) has spurred the development of multiple KRAS G12C inhibitors, including one from Amgen that recently received FDA approval. However, current inhibitors of which the Company is aware do not adequately address the propensity for certain tumors (e.g., non-small cell lung cancer) to metastasize to the brain. The Company specifically designed and optimized the ERAS-1 program to have comparable or superior activity as compared to other KRAS G12C inhibitors in development plus a robust ability to cross the blood-brain barrier (“BBB”) in order to address this key limitation of other KRAS G12C inhibitors. The Company believes its ERAS-1 pre-candidates are the only KRAS G12C inhibitors specifically designed to cross the BBB and have the potential to be the only candidates to be able to do so. The Company expects to nominate a development candidate (“DevCan”) from one of its pre-candidates in the second half of 2021 and file an IND in the second half of 2022. June 25, 2021 Page 3 ERAS-2/3 – Targeting non-G12C RAS mutations (the focus of the Company’s RAS-GTP franchise, including ERAS-4 and ERAS-2/3) is more challenging than targeting KRAS G12C. Dr. Shokat, who is a professor at UCSF, identified a novel region on RAS called the switch II groove (S-IIG), which is present in the RAS-GTP state. This novel finding and the associated 2018 exclusive worldwide license agreement with UCSF for Dr. Shokat’s work related to RAS-GTP were the foundation for forming the Company and for Dr. Shokat being a co-founder of the Company. No RAS-GTP inhibitor has been approved to date, so the Company believes this program is material to disclose to investors based on its potential groundbreaking nature. The license agreement with UCSF is described in the Registration Statement (“Business—Our acquisition and license agreements—University of California, San Francisco”) and filed as a material agreement (Exhibit 10.15). ERAS-4 – The focus of the ERAS-4 program is developing small molecules that potently and selectively bind to KRAS G12D. This mutation, which is even more common than KRAS G12C, is difficult to target for several reasons described in the Registration Statement, including that non-G12C mutations do not have a mutant-specific site for irreversible inhibitor binding. As such, there are very few companies of which the Company is aware that have been able to discover tractable starting points and none of which the Company is aware that have entered clinical trials. Therefore, the Company believes that its recent breakthrough of potent and selective compounds (described in the Registration Statement (in particular, “Business—Our pipeline—ERAS-4: our KRAS G12D program”)), positions the Company favorably relative to other companies in this space to be able to nominate and advance a DevCan that could become a meaningful therapy for patients with tumors driven by this mutation. MAPKlamp combinations involving KRAS G12D inhibitors support the Company’s strategy of targeting colorectal cancer and pancreatic ductal adenocarcinoma since the G12D mutation is the most frequent KRAS mutation observed in both cancer types. ERAS-5 – Autophagy is a key escape route mechanism in tumor cells where RAS/MAPK pathway signaling is inhibited. The ULK1 and ULK2 kinases are key regulators of autophagy. Thus, developing inhibitor(s) of these kinases is a key aspect of targeting escape routes (the Company’s third therapeutic strategy). The Company entered into an exclusive worldwide license agreement in 2020 with LifeArc for this program, and the license agreement is described in the Registration Statement (“Business—Our acquisition and license agreements—LifeArc”) and filed as a material agreement (Exhibit 10.18). The Company has identified a promising ERAS-5 compound that showed strong potency, target engagement, inhibition of autophagy, and selectivity. ERAS-10 – The Company’s modality-agnostic approach aims to allow the Company to selectively and potently inhibit or degrade critical signaling nodes with small molecule therapeutics, large molecule therapeutics, and protein degraders. A key differentiator of the Company’s strategy has been to assemble a robust pipeline, irrespective of modality – this is a material aspect of the Company’s strategy to disclose to investors. The Company’s goal has been to start with the biology of the RAS/MAPK pathway and then find the best modality and asset to shut it down, alone and in combination. ERAS-10, the Company’s protein degrader program, is thus an important component of the Company’s modality-agnostic strategy, and the Company has strong in-house capabilities and expertise with its development team in this area. As the main component of its protein degrader strategy, the Company strongly believes this program represents a material part of its development strategy and pipeline. ERAS-12 – All approved anti-EGFR antibodies target domain III (D3) only, which is accessible for antibody binding only in the inactive conformation of wildtype EGFR, and no approved antibodies June 25, 2021 Page 4 target domain II (D2), which is accessible for antibody binding only in the active, ligand-bound conformation of wildtype EGFR. Antibodies targeting D2 are expected to be more effective when epidermal growth factor (EGF) or other members of the EGF family are overexpressed. The Company is developing a bispecific antibody that is active against both the inactive and active conformations of wildtype EGFR, and the Company anticipates filing an IND for this program by 2024. Achieving a higher level of EGFR inhibition may better control tumor growth and delay the emergence of resistance mechanisms that drive EGFR into the active conformation, thereby addressing a key limitation of approved anti-EGFR antibodies. The Company acquired this program in 2021 from Emerge Life Sciences, and the asset purchase agreement is described in the Registration Statement (“Business—Our acquisition and license agreements—Emerge LifeSciences”) and filed as a material agreement (Exhibit 10.21). Based on the foregoing, coupled with the existing disclosure in the Registration Statement (including the filing of acquisition/license agreements for the applicable programs as material agreement exhibits and the separate bullet in “Use of Proceeds” setting forth expected proceeds to be used for the discovery and pre-IND stage programs), the Company strongly believes that each of the foregoing programs is sufficiently material to its business to warrant inclusion in the pipeline. 2. Refer to your response to our prior comment 5. Your pipeline table, which indicates that you are currently in Phase 1 of HERKULES-2, HERKULES-3 and HERKULES-4 clinical trials, appears to be inconsistent with your disclosure on pages 4 and 127 that you are planning to begin the dosing of first patients in HERKULES-2, HERKULES-3, and HERKULES-4 in the future. If these trials have not yet begun, please revise your pipeline table here and throughout the registration statement accordingly. Erasca’s Response: The Company has revised the pipeline table on pages 4, 110 and 125 of the Registration Statement in response to the Staff’s comment, to clarify that the HERKULES-2, HERKULES-3, and HERKULES-4 trials are planned and that the HERKULES-1 trial is ongoing. In addition, the Company has updated the pipeline table to indicate that a Phase 1 trial for ERAS-007 was previously completed by Asana, to further clarify why the applicable rows of the pipeline table for ERAS-007 are shown in the Phase 1 stage, while acknowledging that for such rows the relevant HERKULES trials have not yet commenced. The Company respectfully advises the Staff that this presentation is consistent with the disclosure throughout the Registration Statement that the dosing of such HERKULES trials is expected on the timelines indicated therein. Business Patient lives at stake annually with RAS/MAPK pathway alterations, page 120 3. Please provide support for your statement here as it relates to your belief that “[y]our deep and focused pipeline has the potential to target 100% of CRC, ~90% of pancreatic cancer, ~70% of head and neck squamous cell carcinoma (HNSCC), ~65% of melanoma, ~55% of GBM, ~40% of NSCLC, and ~40% of AML, and also the potential to provide targeted therapy options for many patients with RAS/MAPK pathway-driven tumors in a wide range of less common histologies.” In this regard, we note that you appear to have only one product candidate in Phase 1 and one product candidate in Phase 2 of clinical trials and that all remaining product candidates are still either in discovery or pre-clinical trials. In addition, none of the types of cancers you reference in this statement appear to be included as specific indications in your pipeline table. Erasca’s Response: The Company has removed the statement on page 120 of the Registration Statement in response to the Staff’s comment. June 25, 2021 Page 5 ERAS-601: our SHP2 inhibitor, page 147 4. We note your response to our prior comment 11 and reissue in part. Please identify the four serious adverse events (SAEs) observed in the clinical trial referenced on pages 152 and 153. The Company has revised the disclosure on page 154 of the Registration Statement in response to the Staff’s comment to identify the four serious adverse events. Our acquisition and license agreements University of California, San Francisco, page 176 5. We note your response to our prior comment 13 and reissue in part. On page 177, you state that you are obligated to pay tiered s
2021-06-21 - UPLOAD - Erasca, Inc.
United States securities and exchange commission logo
June 21, 2021
Jonathan E. Lim
Chief Executive Officer
Erasca, Inc.
10835 Road to the Cure, Suite 140
San Diego, CA 92121
Re:Erasca, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted June 9, 2021
CIK No. 0001761918
Dear Dr. Lim:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus summary, page 1
1.We note your response to our prior comment 4 and reissue. For each of the nine programs
in the discovery and the IND-enabling stages, please provide us with a detailed analysis of
why each of those programs is sufficiently material to your business to warrant inclusion
in your pipeline table or revise your table to remove programs that are not sufficiently
material. In this regard we note, as examples only, that you do not list the programs
currently in discovery or in the IND-enabling stage on your website, you do not appear to
discuss them in your Management's Discussion and Analysis of Financial Condition
section, and you do not appear to have plans to use the proceeds of this offering to
advance all of these programs.
FirstName LastNameJonathan E. Lim
Comapany NameErasca, Inc.
June 21, 2021 Page 2
FirstName LastName
Jonathan E. Lim
Erasca, Inc.
June 21, 2021
Page 2
2.Refer to your response to our prior comment 5. Your pipeline table, which indicates that
you are currently in Phase 1 of HERKULES-2, HERKULES-3 and HERKULES-4
clinical trials, appears to be inconsistent with your disclosure on pages 4 and 127 that you
are planning to begin the dosing of first patients in HERKULES-2, HERKULES-3, and
HERKULES-4 in the future. If these trials have not yet begun, please revise your pipeline
table here and throughout the registration statement accordingly.
Business
Patient lives at stake annually with RAS/MAPK pathway alterations, page 120
3.Please provide support for your statement here as it relates to your belief that "[y]our deep
and focused pipeline has the potential to target 100% of CRC, ~90% of pancreatic cancer,
~70% of head and neck squamous cell carcinoma (HNSCC), ~65% of melanoma, ~55%
of GBM, ~40% of NSCLC, and ~40% of AML, and also the potential to provide targeted
therapy options for many patients with RAS/MAPK pathway-driven tumors in a wide
range of less common histologies." In this regard, we note that you appear to have only
one product candidate in Phase 1 and one product candidate in Phase 2 of clinical trials
and that all remaining product candidates are still either in discovery or pre-clinical trials.
In addition, none of the types of cancers you reference in this statement appear to be
included as specific indications in your pipeline table.
ERAS-601: our SHP2 inhibitor, page 147
4.We note your response to our prior comment 11 and reissue in part. Please identify the
four serious adverse events (SAEs) observed in the clinical trial referenced on pages 152
and 153.
Our acquisition and license agreements
University of California, San Francisco, page 176
5.We note your response to our prior comment 13 and reissue in part. On page 177, you
state that you are obligated to pay tiered sublicensing fees ranging from "low double digit
percentages to up to 30%." Please revise to clarify what you mean by “low double digit
percentages” so that investors understand the potential range of royalty payments in a
range not to exceed ten percent. If the range is more than ten percent, please provide a
range within ten percent for each tier or disclose the number of tiers.
Government Regulation
Foreign Regulation, page 191
6.We note your response to our prior comment 12 and reissue. Please revise this section to
describe the approval process in China and Japan.
FirstName LastNameJonathan E. Lim
Comapany NameErasca, Inc.
June 21, 2021 Page 3
FirstName LastName
Jonathan E. Lim
Erasca, Inc.
June 21, 2021
Page 3
You may contact Julie Sherman at 202-551-3640 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Tonya Aldave at 202-551-3601 or Sonia Bednarowski at 202-551-3666 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matt Bush, Esq.
2021-06-02 - UPLOAD - Erasca, Inc.
United States securities and exchange commission logo
June 2, 2021
Jonathan E. Lim
Chief Executive Officer
Erasca, Inc.
10835 Road to the Cure, Suite 140
San Diego, CA 92121
Re:Erasca, Inc.
Draft Registration Statement on Form S-1
Submitted May 7, 2021
CIK No. 0001761918
Dear Dr. Lim:
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
General
1.Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications. Please contact Tonya K. Aldave at (202) 551-3601 to discuss how to
submit the materials, if any, to us for our review.
2.We note your disclosure on page 171 that the "key competitive factors affecting the
success of all of [your] programs are likely to be efficacy, safety, and convenience of each
product candidate." Please revise throughout the prospectus to remove any implication
FirstName LastNameJonathan E. Lim
Comapany NameErasca, Inc.
June 2, 2021 Page 2
FirstName LastNameJonathan E. Lim
Erasca, Inc.
June 2, 2021
Page 2
that your product candidates are more likely than others to receive FDA approval or
explain to us why these statements are appropriate given the stage of your product
candidates.
Prospectus Summary, page 1
3.Please revise your pipeline table on page 4 to show separate columns for Phases 1, 2 and 3
or tell us the basis for your belief that you will be able to conduct Phase 1b/2 trials and
Phase 2/3 trials for all of your product candidates.
4.We note that you have nine programs in the discovery and the IND-enabling stage. Please
explain to us why each of those programs is sufficiently material to your business to
warrant inclusion in your pipeline table or revise your table as appropriate.
5.Your pipeline table, which indicates that you have completed Phase 1 of HERKULES-2,
HERKULES-3 and HERKULES-4, appears to be inconsistent with your disclosure on
page 109 that you "are planning to initiate HERKULES-2, HERKULES-3, and
HERKULES-4 in the future. If these trials have not yet begun, please revise your
pipeline table here and throughout the registration statement accordingly.
6.We note your disclosure on page 4 that you in-licensed ERAS-007 based in part on
preclinical studies that demonstrated the highest potency and longest target residence time
of ERK inhibitors of which you are aware. Please disclose here the ranges of the
potency and target residence time observed in the preclinical studies.
Use of Proceeds, page 78
7.We note your disclosure that you intend to use net proceeds to fund the clinical
development of ERAS-007 in your HERKULES series of clinical trials, fund the clinical
development of ERAS-601, and fund the ongoing discovery and development of your
other current RAS/MAPK pathway-focused pipeline programs. Please specify how far in
the development of each of the listed clinical trials you expect to reach with the proceeds
of the offering. If any material amounts of other funds are necessary to accomplish the
specified purposes, state the amount and sources of other funds needed for each specified
purpose. Refer to Instruction 3 to Item 504 of Regulation S-K.
Managements Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Estimates
Common Stock Valuations, page 99
8.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.
FirstName LastNameJonathan E. Lim
Comapany NameErasca, Inc.
June 2, 2021 Page 3
FirstName LastNameJonathan E. Lim
Erasca, Inc.
June 2, 2021
Page 3
Business
Our innovation model, page 121
9.Please remove the reference to potential "first-in-class/best-in-class" targeted therapies
because this description implies an expectation of regulatory approval and is inappropriate
given the length of time and uncertainly with respect to securing marketing approval.
ERAS-007: our ERK inhibitor, page 125
10.Please disclose the endpoints for your ERAS-007 clinical trial.
ERAS-601: our SHP2 inhibitor, page 144
11.Please disclose the endpoints and any serious adverse events encountered during your
ERAS-601 clinical trial.
Our acquisition and license agreements
Asana BioSciences, page 165
12.We note your disclosure on page 165 that you are required to use commercially
reasonable efforts to develop and obtain regulatory approval for ERAS-007 in the United
States, at least one major market country in Europe, and either China or Japan. Please
revise your government regulation section to address the approval process in China and
Japan.
NiKang Therapeutics, page 166
13.We note your reference to tiered royalties on net sales and sublicensing revenue sharing
fees "in the mid double-digit percentages." Please revise your disclosure to narrow the
royalty range to no more than ten percentage points (for example, between twenty and
thirty percent). In addition, revise your disclosure on page 170 in the description of the
licensing agreement with the University of California, San Francisco, where you describe
the sublicensing fees to be "in the low to low-mid double-digit percentages."
Executive and director compensation
Summary compensation table, page 196
14.We note that your named executive officers received compensation that appears in the
"non-equity incentive plan compensation" column of the summary compensation table.
Please add a footnote to describe generally these compensatory payments.
Note 7. Asset Acquisition, page F-20
15.We see that you entered into an agreement and plan of merger with Asana and ASN
Product Development, Inc., pursuant to which ASN became its wholly-owned subsidiary,
in November 2020. It appears that you have accounted for this transaction as an asset
acquisition. Please revise your disclosure to clarify this fact and explain how you
FirstName LastNameJonathan E. Lim
Comapany NameErasca, Inc.
June 2, 2021 Page 4
FirstName LastName
Jonathan E. Lim
Erasca, Inc.
June 2, 2021
Page 4
determined that the assets acquired did not meet the definition of a business. Please also
revise to disclose the nature of the development milestone whereby you will be required to
issue 4,666,667 shares of its common stock to Asana and explain how this differs from the
$90 million in development and regulatory milestones. Lastly, please explain your
reference to a carve-out for a specific milestone payment that may or may not occur and
what specifically this disclosure refers to with regards to the acquisition.
You may contact Julie Sherman at 202-551-3640 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Tonya Aldave at 202-551-3601 or Sonia Bednarowski at 202-551-3666 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences