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Bicara Therapeutics Inc.
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Bicara Therapeutics Inc.
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Company responded
2024-08-27
Bicara Therapeutics Inc.
References: July 5, 2024
Filing - Correspondence from Bicara Therapeutics Inc.
CORRESP · 2024-08-27
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SEC wrote to company
2024-08-29
Bicara Therapeutics Inc.
References: July 5, 2024
Filing - SEC Comment Letter to Bicara Therapeutics Inc.
UPLOAD · 2024-08-29
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Company responded
2024-09-03
Bicara Therapeutics Inc.
References: August 29, 2024 | July 5, 2024
Filing - Correspondence from Bicara Therapeutics Inc.
CORRESP · 2024-09-03
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Company responded
2024-09-10
Bicara Therapeutics Inc.
Filing - Correspondence from Bicara Therapeutics Inc.
CORRESP · 2024-09-10
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Bicara Therapeutics Inc.
Response Received
1 company response(s)
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SEC wrote to company
2024-08-06
Bicara Therapeutics Inc.
Filing - SEC Comment Letter to Bicara Therapeutics Inc.
UPLOAD · 2024-08-06
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Company responded
2024-08-22
Bicara Therapeutics Inc.
References: August 6, 2024
Filing - Correspondence from Bicara Therapeutics Inc.
CORRESP · 2024-08-22
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Bicara Therapeutics Inc.
Awaiting Response
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SEC wrote to company
2024-07-05
Bicara Therapeutics Inc.
Filing - SEC Comment Letter to Bicara Therapeutics Inc.
UPLOAD · 2024-07-05
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-24 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-09-03 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-08-29 | SEC Comment Letter | Bicara Therapeutics Inc. | DE | 377-07267 | Read Filing View |
| 2024-08-27 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-08-22 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-08-06 | SEC Comment Letter | Bicara Therapeutics Inc. | DE | 377-07267 | Read Filing View |
| 2024-07-05 | SEC Comment Letter | Bicara Therapeutics Inc. | DE | 377-07267 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2024-08-29 | SEC Comment Letter | Bicara Therapeutics Inc. | DE | 377-07267 | Read Filing View |
| 2024-08-06 | SEC Comment Letter | Bicara Therapeutics Inc. | DE | 377-07267 | Read Filing View |
| 2024-07-05 | SEC Comment Letter | Bicara Therapeutics Inc. | DE | 377-07267 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-24 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-09-03 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-08-27 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
| 2024-08-22 | Company Response | Bicara Therapeutics Inc. | DE | N/A | Read Filing View |
2025-11-24 - CORRESP - Bicara Therapeutics Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR November 24, 2025 United States Securities and Exchange Commission Office of Life Sciences Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Bicara Therapeutics Inc. Acceleration Request for Registration Statement on Form S-3 Filed October 3, 2025 File No. 333-290707 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Bicara Therapeutics Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to November 26, 2025, at 4:01 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Kathryn W. Clerici at (617) 570-1363. If you have any questions regarding this request, please contact Kathryn W. Clerici of Goodwin Procter LLP at (617) 570-1363. Sincerely, Bicara Therapeutics Inc. /s/ Claire Mazumdar Claire Mazumdar, Ph.D. Chief Executive Officer cc: Ivan Hyep, Bicara Therapeutics Inc. Lara Meisner, Esq., Bicara Therapeutics Inc. Kingsley L. Taft, Esq. Goodwin Procter LLP Gabriela Morales-Rivera, Esq. Goodwin Procter LLP Kathryn W. Clerici, Esq., Goodwin Procter LLP
2024-09-10 - CORRESP - Bicara Therapeutics Inc.
CORRESP 1 filename1.htm CORRESP September 10, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, D.C. 20549 Attn: Tara Harkins, Vanessa Robertson, Daniel Crawford and Tim Buchmiller Re: Bicara Therapeutics Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-281722) Ladies and Gentleman: In connection with the above-referenced Registration Statement, we wish to advise you that between September 6, 2024 and the date hereof, we effected the distribution of approximately 5,125 copies of the Company’s Preliminary Prospectus dated September 6, 2024 to prospective underwriters, institutional investors, dealers, brokers, individuals and others. 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 Company that the effectiveness of the above-referenced Registration Statement be accelerated to 4:01 p.m. Eastern Time on September 12, 2024 or as soon thereafter as practicable. [Remainder of page intentionally left blank] Very truly yours, MORGAN STANLEY & CO. LLC TD SECURITIES (USA) LLC CANTOR FITZGERALD & CO. STIFEL, NICOLAUS & COMPANY, INCORPORATED As representatives of the several underwriters MORGAN STANLEY & CO. LLC By: /s/ Chris Rigoli Name: Chris Rigoli Title: Executive Director TD SECURITIES (USA) LLC By: /s/ Brian Hagerty Name: Brian Hagerty Title: Managing Director CANTOR FITZGERALD & CO. By: /s/ Asif Ahmed Name: Asif Ahmed Title: Co-Head of Equity Capital Markets, Managing Director STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Ken Clausman Name: Ken Clausman Title: Managing Director [Signature Page to Request for Acceleration of Effectiveness]
2024-09-10 - CORRESP - Bicara Therapeutics Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR September 10, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Tara Harkins, Vanessa Robertson, Daniel Crawford and Tim Buchmiller Re: Bicara Therapeutics Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-281722 Dear Ladies and Gentlemen, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Bicara Therapeutics Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to September 12, 2024 at 4:01 p.m. Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Gabriela Morales-Rivera at (617) 570-1329. If you have any questions regarding this request, please contact Gabriela Morales-Rivera of Goodwin Procter LLP at (617) 570-1329. Sincerely, BICARA THERAPEUTICS INC. /s/ Claire Mazumdar Claire Mazumdar Chief Executive Officer cc: Ivan Hyep, Bicara Therapeutics Inc. Ryan Cohlhepp, Bicara Therapeutics Inc. Lara Meisner, Bicara Therapeutics Inc Kingsley L. Taft, Goodwin Procter LLP Christopher Huntsman, Goodwin Procter LLP
2024-09-03 - CORRESP - Bicara Therapeutics Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 September 3, 2024 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Tara Harkins, Vanessa Robertson, Daniel Crawford and Tim Buchmiller CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” Re: Bicara Therapeutics Inc. Registration Statement on Form S-1 Filed August 22, 2024 File No. 333-281722 Dear Ladies and Gentlemen: This letter is confidentially submitted on behalf of Bicara Therapeutics Inc. (the “Company”), in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1, filed on August 22, 2024 (the “Registration Statement”), as set forth in the Staff’s letter, dated August 29, 2024, addressed to Claire Mazumdar (the “Comment Letter”). The Company is filing Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which includes changes to reflect responses to the Staff’s comments and other updates. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1. Registration Statement on Form S-1 filed August 22, 2024 Capitalization, page 82 1. Please reconcile the $164,064,000 of Series C redeemable convertible preferred stock as of June 30, 2024 presented in your capitalization table to the $164,604,000 of Series C redeemable convertible preferred stock presented within your consolidated balance sheet as of June 30, 2024 on page F-26. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 82 and 83 of Amendment No. 1 in response to the Staff’s comment. FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. September 3, 2024 Page 2 Critical Accounting Polices and Estimates Common Stock Valuation, page 100 2. We note your updated disclosure that no stock options were granted using common stock valuations prepared under PWERM. Please revise your disclosure to address the significant stock options granted in August 2024. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 100, 101 and 102 of Amendment No. 1 in response to the Staff’s comment. 3. We note your response to comment 12 from our letter dated July 5, 2024. We note that you utilized your June 28, 2024 common stock valuation to value your 30.0 million stock options granted during August 2024. We further acknowledge the factors that you outlined related to the significant increase from your June 28, 2024 fair market value of your stock to the initial preliminary offering price range. Please explain to us in more detail and disclose the continued positive developments that you considered and provide us with an analysis of whether potential additional stock compensation expense would be material since there was a short period of time from your fair value determination on August 19th and the determination of your preliminary IPO range. RESPONSE: The Company respectfully submits to the Staff the below additional detail regarding the grant of approximately 30.0 million stock options in August 2024 (the “August 2024 Option Grants”) and continued positive developments with respect to the Company’s business that occurred subsequent to June 28, 2024, the date of the Company’s most recent determination of the fair value of its Common Stock (the “June 2024 Valuation”). First, the Company respectfully notes that the board of directors of the Company (the “Board”) approved the June 2024 Valuation on August 6, 2024. On that date, the Board also approved options to purchase 29,250,000 shares of common stock, subject to the approval of a certificate of amendment to the fourth amended and restated certificate of incorporation (the “Charter Amendment”) by the appropriate stockholders of the Company to increase the number of shares of common stock authorized. The requisite stockholders voted to approve the Charter Amendment on August 13, 2024, and, once the Charter Amendment was declared effective by the state of Delaware on that date, the options were declared effective as of that date. Given the uncertainty around whether the Company would proceed with an IPO given the factors detailed below, the options were granted contingent on the closing of the IPO and if the IPO was not to close by December 31, 2024, the options would be forfeited. FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. September 3, 2024 Page 3 • The Company respectfully notes that if the Company had applied a weighting of 100% to the short term IPO scenario in the third-party valuation as of June 28, 2024, the estimated fair value of the Common Stock would have been $1.69 per share, before giving effect to any discount for lack of marketability (“DLOM”), which is merely $[***] below the lower end of the range and $[***] below the mid-point of the range currently contemplated in the offering. As further detailed below, the Company does not believe that the potential additional stock compensation expense would be material. • The Company respectfully notes that it did not receive the final preliminary price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) until August 27, 2024, twenty-one (21) days after the Board approved the August 2024 Option Grants on August 6, 2024. The Company had received an initial preliminary price range on August 9, 2024 and continued to receive revised ranges until the final range was determined on August 27, 2024. Prior to receiving the Preliminary Price Range, we relied on the probability-weighted expected return method (“PWERM”) reflected in the June 2024 Valuation, with an IPO scenario probability weighting of 50% and continued operation as a private company scenario of 50% for valuation purposes. • Furthermore, the Company respectfully notes that the Company continued to conduct testing-the-water meetings throughout August 2024, up until August 21, 2024, when the Company concluded its final meeting and received blinded investor feedback from the Company’s investment banking syndicate. This feedback gave the Company the necessary information to proceed with publicly filing the Registration Statement with the Commission on August 22, 2024. • The Company also continued critical hires in August 2024 to prepare for a potential IPO and continued business and clinical operations as a public company, including hiring (i) a Vice President, of Commercial Operations, (ii) Medical Director, (iii) a Senior Director of Clinical Operations, (iv) a head of Investor Relations and Corporate Communications and (v) a Chief of Staff & Director of Corporate Development. The latter two individuals began their employments on August 19, 2024, and were granted collectively the remaining amount of the August 2024 Option Grants, options to purchase 700,000 shares of common stock. • During mid to late August 2024, the Company also completed and progressed several clinical and operational milestones, including receiving commitments from major enrollment sites across Europe, Latin America and from notable organizations, and finalizing the statement of work for the Phase 2/3 clinical trial with the Company’s primary contract research organization. FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. September 3, 2024 Page 4 • The Company respectfully reiterates the recent relevant macroeconomic factors which contributed to significant volatility and uncertainty around the potential timing for the IPO that contributed to the Company’s determination that the June 2024 Valuation was still appropriate as of August 6, 2024, August 13, 2024 and August 19, 2024, including the (i) volatile market conditions, as illustrated by the significant drop on August 5, 2024 through all three major indexes (Dow industrials, S&P 500 and Nasdaq Composite) and (ii) general weakness of the IPO market for biotechnology IPOs, as illustrated by the two biotechnology IPOs that were completed from June 27, 2024 through August 22, 2024, Alumis Inc. and Artiva Biotherapeutics Inc., with (a) Alumis pricing at the low end of the price range included in the preliminary prospectus, (b) Artiva Biotherapeutics Inc. pricing $2 below the price range included in the preliminary prospectus, and (c) both securities trading significantly below issue since pricing. • Between August 19, 2024, and August 22, 2024, the three major indexes showed signs of strengthening and since the Company’s filing of the S-1 on August 22, 2024, approximately two other biotechnology companies have publicly filed an S-1 registration statement for their initial public offering, signaling increasing strength in the IPO market as well. The Company respectfully advises the Staff that it does not believe that using the midpoint of the Preliminary Price Range ([$***])would be material to the financial statements. Based on the June 2024 Valuation, the fair value of common stock would be $1.10 per share after taking into consideration the PWERM approach with a 50% probability of an IPO scenario and a 50% probability of continuing operations as a private company scenario and applying a 15% DLOM adjustment consistent with the third-party valuation approach. The fair value of the stock options using Black-Scholes option pricing model would be $0.84 per share. Taking into account the fact the Company issued 30.0 million shares, this would result in an additional $2.3 million stock compensation expense over a four-year vesting period, or $0.6 million per year. The Company is expecting to incur approximately $[***] in expenses for the year ended December 31, 2024. As a result, the potential additional stock compensation expense would only increase expected annual expenses by 0.7%. Since the potential additional stock compensation would increase expected annual expenses by 0.7%, the Company would not consider it to be material. FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. September 3, 2024 Page 5 Principal Stockholders, page 186 4. For your new board members, Dr. Powell and Dr. Bowden, please update the beneficial ownership information to show the ownership of these directors in accordance with Item 403(b) of Regulation S-K. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 189 and 191 of Amendment No. 1 in response to the Staff’s comment. Notes to Unaudited Condensed Consolidated Financial Statements 12. Subsequent Events, page F-45 5. Please quantify the amount of the stock compensation expense you expect to recognize for the option grants issued subsequent to June 30, 2024. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on page F-45 of Amendment No. 1 in response to the Staff’s comment. As noted in the revised disclosure, compensation cost will not be recognized until it is probable that such performance condition will be achieved and must be reevaluated each reporting period. Management will go through the probability assessment during their normal close process in preparing the books and records of the Company for their next quarterly filing and determine if the probability threshold has been met. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1329. Sincerely, /s/ Gabriela Morales-Rivera Gabriela Morales Rivera Enclosures cc: Claire Mazumdar, Bicara Therapeutics Inc. Ryan Cohlhepp, Bicara Therapeutics, Inc. Ivan Hyep, Bicara Therapeutics, Inc. Lara Meisner, Bicara Therapeutics, Inc. Kingsley L. Taft, Goodwin Procter LLP FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC.
2024-08-29 - UPLOAD - Bicara Therapeutics Inc. File: 377-07267
August 29, 2024
Claire Mazumdar
Chief Executive Officer
Bicara Therapeutics Inc.
116 Huntington Avenue, Suite 703
Boston, MA 02116
Re:Bicara Therapeutics Inc.
Registration Statement on Form S-1
Filed August 22, 2024
File No. 333-281722
Dear Claire Mazumdar:
We have reviewed your registration statement and have the following comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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 this letter, we may have additional comments.
Registration Statement on Form S-1 filed August 22, 2024
Capitalization, page 82
1.Please reconcile the $164,064,000 of Series C redeemable convertible preferred stock as
of June 30, 2024 presented in your capitalization table to the $164,604,000 of Series C
redeemable convertible preferred stock presented within your consolidated balance sheet
as of June 30, 2024 on page F-26.
Critical Accounting Polices and Estimates
Common Stock Valuation, page 100
2.We note your updated disclosure that no stock options were granted using common stock
valuations prepared under PWERM. Please revise your disclosure to address the
significant stock options granted in August 2024.
We note your response to comment 12 from our letter dated July 5, 2024. We note that
you utilized your June 28, 2024 common stock valuation to value your 30.0 million stock
options granted during August 2024. We further acknowledge the factors that you 3.
August 29, 2024
Page 2
outlined related to the significant increase from your June 28, 2024 fair market value of
your stock to the initial preliminary offering price range. Please explain to us in more
detail and disclose the continued positive developments that you considered and provide
us with an analysis of whether potential additional stock compensation expense would be
material since there was a short period of time from your fair value determination on
August 19th and the determination of your preliminary IPO range.
Principal Stockholders, page 186
4.For your new board members, Dr. Powell and Dr. Bowden, please update the beneficial
ownership information to show the ownership of these directors in accordance with Item
403(b) of Regulation S-K.
Notes to Unaudited Condensed Consolidated Financial Statements
12. Subsequent Events, page F-45
5.Please quantify the amount of the stock compensation expense you expect to recognize
for the option grants issued subsequent to June 30, 2024.
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.
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.
Please contact Tara Harkins at 202-551-3639 or Vanessa Robertson at 202-551-3649 if
you have questions regarding comments on the financial statements and related matters. Please
contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gabriela Morales-Rivera, Esq.
2024-08-27 - CORRESP - Bicara Therapeutics Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 August 27, 2024 FOIA CONFIDENTIAL TREATMENT REQUESTED The entity requesting confidential treatment is Bicara Therapeutics Inc. 116 Huntington Avenue, Suite 703 Boston, MA 02116 Telephone: (617) 468-4219 CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” VIA EDGAR, FACSIMILE AND FEDERAL EXPRESS U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tara Harkins, Vanessa Robertson, Daniel Crawford and Tim Buchmiller RE: Bicara Therapeutics Inc. Registration Statement on Form S-1 File No. 333-281722 CIK No. 0002023658 Rule 83 Confidential Treatment Request by Bicara Therapeutics Inc. Dear Ladies and Gentlemen: On behalf of Bicara Therapeutics Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated July 5, 2024 (the “Comment Letter”) relating to the Company’s Registration Statement on Form S-1, originally confidentially submitted to the Commission on June 10, 2024, and subsequently publicly filed by the Company with the Commission on August 22, 2024 (File No. 333-281722) (the “Registration Statement”), we submit this supplemental letter to address comment 12 of the Comment Letter. FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission August 27, 2024 Page 2 Because of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has concurrently filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations. We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the offering, the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the final price range to be included in such amendment which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range. Prior to the effectiveness of the Registration Statement, the Company intends to implement a reverse stock split of its Common Stock (the “Stock Split”). The Company expects to reflect the Stock Split in a pre-effective amendment to the Registration Statement that includes the actual price range. For purposes of this letter, we have presented all dollar and per share amounts without giving effect to the Stock Split to be consistent with the current presentation in the Registration Statement. The Company respectfully requests that the bracketed information contained in this letter be treated as confidential information pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.8, and that the Commission provide timely notice to Claire Mazumdar before it permits any disclosure of the bracketed information in this letter. For the convenience of the Staff, we have recited the prior comment from the Staff in the Comment Letter in italicized type and have followed the comment with the Company’s response. 12. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock lead in up to the initial public offering and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation. Please discuss with the staff how to submit your response. The Company respectfully submits the below additional information to assist the Staff in its review of the Company’s position with respect to its determination of the fair value of the Company’s common stock, par value $0.0001 per share (“Common Stock”), underlying its outstanding equity awards and the reasons for the differences between the recent valuation of its Common Stock and the estimated offering price for its initial public offering (“IPO”). 2 FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission August 27, 2024 Page 3 Preliminary IPO Price Range The Company advises the Staff that it estimates a preliminary price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) for its IPO, before giving effect to the Stock Split, resulting in a midpoint of the Preliminary Price Range of $[***] per share. The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing Preliminary Price Range will not be subject to significant change. Determining the Fair Value of Common Stock Prior to the IPO As there has been no public market for the Common Stock to date, the estimated fair value of its Common Stock has been determined by the Company’s board of directors (the “Board”) as of the date of each equity award, with input from management, considering the Company’s most recently available third-party valuations of its Common Stock, and the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant. The Company’s most recent third-party valuations of its Common Stock utilized by the Board in determining exercise prices at the time of each equity award were as follows: Date of Third-Party Valuation Date of Board Approval Estimated Fair Market Value of Common Stock per Share September 30, 2022 October 4, 2022 $0.48 March 31, 2023 April 5, 2023 $0.41 November 20, 2023 December 14, 2023 $0.59 June 1, 2024 N/A $0.90 June 28, 2024 August 6, 2024 $1.00 3 FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission August 27, 2024 Page 4 Equity Awards Between January 1, 2023 and August 19, 2024 The following table summarizes by grant date the number of shares subject to awards granted between January 1, 2023 and August 19, 2024, the per share exercise price of the awards and the fair value of Common Stock underlying the awards on each grant date: Grant Date Type of Award Number of Shares Subject to Award Per Share Exercise Price of Award Per Share Fair Market Value of Common Stock on Grant Date Per Share Estimated Fair Value of Award on Grant Date(1) 1/01/2023 Option 100,000 $0.48 $0.48 $0.35 04/05/2023 Option 4,845,000 $0.41 $0.41 $0.30 08/08/2023 Option 13,472,075 $0.41 $0.41 $0.30 09/22/2023 Option 2,000,000 $0.41 $0.41 $0.30 12/14/2023 Option 18,278,630 $0.59 $0.59 $0.43 03/26/2024 Option 1,950,000 $0.59 $0.59 $0.44 04/23/2024 Option 250,000 $0.59 $0.59 $0.44 08/13/2024 Option 29,250,000 $1.00 $1.00 $0.77 08/19/2024 Option 700,000 $1.00 $1.00 $0.77 (1) The per share estimated fair value of options reflects the fair value of options granted on each grant date determined using the Black-Scholes option-pricing model. Valuation Methodologies The 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 (“Practice Aid”). As disclosed in the Registration Statement, the Company’s enterprise value valuations were prepared using either an option pricing method (“OPM”) market-adjusted backsolve approach based on a recent arms-length transaction, or the probability-weighted expected return method (“PWERM”), with an IPO scenario and continued operation as a private company scenario. The 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. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. 4 FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission August 27, 2024 Page 5 The PWERM is a scenario-based methodology that estimates the fair value of common stock 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. A discount for lack of marketability (“DLOM”) of the common stock is then applied to arrive at an indication of value for the common stock. September 30, 2022 Valuation The fair value of the Common Stock of $0.48 per share at September 30, 2022 was determined with the assistance of an independent third-party valuation firm and approved by the Board on October 4, 2022. This valuation was used to support the fair market value of the Common Stock in accordance with Section 409A of the IRC with respect to options granted on January 1, 2023, along with other factors determined by the Board to be relevant at the time of the grant of such options. The September 30, 2022 valuation applied the OPM method to allocate the fair value of the Company’s equity to various securities within the Company’s capital structure. Under this method, the OPM model was built based on the Company’s capital structure and reasonable option model inputs. The equity value of the Company was determined such that the implied value per share of Series Seed preferred stock was equal to its original issue price to third party investors at the closing of the Series Seed preferred stock financing on September 2, 2022. The 35.0% DLOM applied to the fair value of Common Stock was estimated using a put option analysis. Between September 30, 2022 and January 1, 2023, the Company continued to operate its business in the ordinary course and there were no significant developments in its business. As a result, the Company determined that the fair value of the Company’s Common Stock remained $0.48 per share from September 30, 2022 and January 1, 2023. The principal factors contributing to the decrease in the fair value of Common Stock from the September 30, 2022 valuation to the March 15, 2023 valuation, include the following: • The Company continued to operate its business in the ordinary course and there were no significant developments in its business. • The closing of the Series B preferred stock financing at a purchase price of $1.025 per share. Given the proximity of the closing of the Series B preferred stock financing on March 2, 2023, the valuation firm considered the OPM back-solve approach to estimate the implied total equity value of the Company. Under this method, an OPM allocation model was built based on the Company’s capital structure and reasonable option model inputs. • The departure of Liviu Niculescu, Chief Medical Officer on November 4, 2022. 5 FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission August 27, 2024 Page 6 • Macroeconomic volatility when Silicon Valley Bank, where the Company kept its operating cash, failed on March 10, 2023 after a bank run. March 15, 2023 Valuation The fair value of the Common Stock of $0.41 per share at March 15, 2023 was determined with the assistance of an independent third-party valuation firm and approved by the Board on April 5, 2023. This valuation was used to support the fair market value of the Common Stock in accordance with Section 409A of the IRC with respect to options granted on April 5, 2023 through September 22, 2023, along with other factors determined by the Board to be relevant at the time of each such grant of options. The March 15, 2023 valuation applied the OPM method to allocate the fair value of the Company’s equity to various securities within the Company’s capital structure. Under this method, the OPM model was built based on the Company’s capital structure and reasonable option model inputs. The equity value of the Company was determined such that the implied value per share of Series B preferred stock was equal to its original price issued to third party investors at the closing of the Series B preferred stock financing on March 2, 2023 The 35.0% DLOM applied to the fair value of Common Stock was estimated using a put option analysis. Between March 15, 2023 and September 22, 2023, the Company continued to operate its business in the ordinary course and there were no significant developments in its business. As a result, the Company determined that the fair value of the Company’s Common Stock remained $0.41 per share from March 15, 2023 to September 22, 2023. November 20, 2023 Valuation The fair value of the Common Stock of $0.59 per share at November 20, 2023 was determined with the assistance of an independent third-party valuation firm and approved by the Board on December 14, 2023. This valuation was used to support the fair market value of the Common Stock in accordance with Section 409A of the IRC with respect to options granted on December 14, 2023, March 26, 2024 and April 23, 2024, along with other factors determined by the Board to be relevant at the time of such grant of options. The December 14, 2023 valuation applied the OPM method to allocate the fair value of the Company’s equity to various securities within the Company’s capital structure. Under this method, the OPM model was built based on the Company’s capital structure and reasonable option model inputs. The equity value of the Company was determined such that the implied value per share of Series C preferred stock was equal to its original price issued to third party investors at the closing of the Series C preferred stock financing on December 5, 2023. The 32.5% DLOM applied to the fair value of Common Stock was estimated using a put option analysis. 6 FOIA CONFIDENTIAL TREATMENT REQUESTED BY BICARA THERAPEUTICS INC. Division of Corporation Finance Office of Life Science
2024-08-22 - CORRESP - Bicara Therapeutics Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 August 22, 2024 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Tara Harkins, Vanessa Robertson, Daniel Crawford and Tim Buchmiller Re: Bicara Therapeutics Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted July 22, 2024 CIK No. 0002023658 Dear Ladies and Gentlemen: This letter is submitted on behalf of Bicara Therapeutics Inc. (the “Company”), in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amendment No. 1 to Draft Registration Statement on Form S-1, confidentially submitted on July 22, 2024 (the “Amendment No. 1”), as set forth in the Staff’s letter, dated August 6, 2024, addressed to Claire Mazumdar (the “Comment Letter”). The Company is concurrently publicly filing the Registration Statement on Form S-1 (the “Registration Statement”), which includes changes that reflect responses to the Staff’s comments and other updates. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to Amendment No. 1, and page references in the responses refer to the Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Registration Statement. Amendment No. 1 to Draft Registration Statement on Form S-1 Prospectus Summary Ficerafusp alfa clinical results, page 3 August 22, 2024 Page 2 1. We note your response to prior comment 3 and reissue in part. Please revise where you discuss obtaining accelerated approval to include balancing disclosure that an accelerated approval pathway may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that your product candidate will receive marketing approval. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on page 4 of the Registration Statement in response to the Staff’s comment. 2. We note your response to prior comment 6 and reissue in part. Please revise this section to disclose, as indicated in your response, that you cannot derive statistical significance from this phase of your clinical trials. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 3, 118 and 119 of the Registration Statement in response to the Staff’s comment. Risk Factors Risks Related to Our Dependence on and Work with Third Parties, page 33 3. We note your revised disclosure in response to prior comment 21. Please revise your Risk Factors section to disclose the risks relating to the Biocon Agreement’s termination provision permitting termination upon reasonable advance notification by either party, how it may disrupt the development of ficerafusp alfa, or otherwise advise. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 34 and 126 of the Registration Statement in response to the Staff’s comment. Business Ficerafusp alfa synergizes with anti-PD-1 therapies, with anti-tumor activity superior to other anti-EGFR therapies in preclinical models, page 110 4. We note your response to prior comment 15 and reissue. Please revise to disclose the design, data and results of the two preclinical cancer mouse models whose data were published in Cancer Research. Regarding design, revise to disclose the number of mice receiving each treatment and the number of mice in control groups, whether the tests were powered for statistical significance and if so, state whether the results were statistically significant. Provide the data relied on for your conclusion that “the relapse rate of tumors in ficerafusp alfa-treated mice were minimal compared with cetuximab treated mice;” that “treatment with ficerafusp alfa led to an improved response as compared to cetuximab combination;” and that you “believe this August 22, 2024 Page 3 data supports the ability of BCA101ficerafusp alfa to prevent TGF-B from inducing resistance to EGFR-directed therapy and TGF-B-driven immunosuppression.” RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on page 114 of the Registration Statement in response to the Staff’s comment to add additional disclosure regarding the design of the preclinical mouse model published in Cancer Research (the “Model”), including the number of mice in the test and control groups and the statistical significance of the Model. We have also indicated on page 114 that we have relied on the clinical data from this Model to support the statements made in this section around the improved anti-tumor activity of ficerafusp alfa in combination with pembrolizumab as compared to pembrolizumab alone. With respect to the statements referenced in the Staff’s comment, the Company respectfully advises the Staff that it has removed these statements that draw comparisons to cetuximab and EGFR therapies as they are no longer the focus of this section. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1329. August 22, 2024 Page 4 Sincerely, /s/ Gabriela Morales-Rivera Gabriela Morales Rivera Enclosures cc: Claire Mazumdar, Bicara Therapeutics Inc. Ryan Cohlhepp, Bicara Therapeutics, Inc. Ivan Hyep, Bicara Therapeutics, Inc. Lara Meisner, Bicara Therapeutics, Inc. Kingsley L. Taft, Goodwin Procter LLP Christopher W. Huntsman, Goodwin Procter LLP
2024-08-06 - UPLOAD - Bicara Therapeutics Inc. File: 377-07267
August 6, 2024
Claire Mazumdar
Chief Executive Officer
Bicara Therapeutics Inc.
116 Huntington Avenue, Suite 703
Boston, MA 02116
Re:Bicara Therapeutics Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted July 22, 2024
CIK No. 0002023658
Dear Claire Mazumdar:
We have reviewed your amended draft registration statement and have the following
comments.
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 a comment applies 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 this letter and your amended
draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in our
July 5, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Ficerafusp alfa clinical results, page 3
1.We note your response to prior comment 3 and reissue in part. Please revise where you
discuss obtaining accelerated approval to include balancing disclosure that an accelerated
approval pathway may not lead to a faster development or regulatory review or approval
process and does not increase the likelihood that your product candidate will receive
marketing approval.
2.We note your response to prior comment 6 and reissue in part. Please revise this section to
disclose, as indicated in your response, that you cannot derive statistical significance from
this phase of your clinical trials.
August 6, 2024
Page 2
Risk Factors
Risks Related to Our Dependence on and Work with Third Parties, page 33
3.We note your revised disclosure in response to prior comment 21. Please revise your Risk
Factors section to disclose the risks relating to the Biocon Agreement's termination
provision permitting termination upon reasonable advance notification by either party,
how it may disrupt the development of ficerafusp alfa, or otherwise advise.
Business
Ficerafusp alfa synergizes with anti-PD-1 therapies, with anti-tumor activity superior to other
anti-EGFR therapies in preclinical models, page 110
4.We note your response to prior comment 15 and reissue. Please revise to disclose the
design, data and results of the two preclinical cancer mouse models whose data were
published in Cancer Research. Regarding design, revise to disclose the number of mice
receiving each treatment and the number of mice in control groups, whether the the tests
were powered for statistical significance and if so, state whether the results were
statistically significant. Provide the data relied on for your conclusion that "the relapse
rate of tumors in ficerafusp alfa-treated mice were minimal compared with cetuximab-
treated mice;" that "treatment with ficerafusp alfa led to an improved response as
compared to cetuximab combination;" and that you "believe this data supports the ability
of BCA101ficerafusp alfa to prevent TGF-B from inducing resistance to EGFR-directed
therapy and TGF-B-driven immunosuppression."
Please contact Tara Harkins at 202-551-3639 or Vanessa Robertson at 202-551-3649 if
you have questions regarding comments on the financial statements and related matters. Please
contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gabriela Morales-Rivera, Esq.
2024-07-05 - UPLOAD - Bicara Therapeutics Inc. File: 377-07267
July 5, 2024
Claire Mazumdar
Chief Executive Officer
Bicara Therapeutics Inc.
116 Huntington Avenue, Suite 703
Boston, MA 02116
Re:Bicara Therapeutics Inc.
Draft Registration Statement on Form S-1
Submitted June 10, 2024
CIK No. 0002023658
Dear Claire Mazumdar:
We have reviewed your draft registration statement and have the following comments.
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 a comment applies 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 this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-1
Cover Page
1.Please revise your cover page to clarify whether the offering is contingent upon final
approval of your Nasdaq listing. Please ensure that the disclosure is consistent with your
underwriting agreement.
BCA101 Clinical results, page 3
We note your disclosure here and elsewhere throughout your Prospectus comparing data
from your clinical trials with other therapeutics. To the extent that these comparisons were
not the result of head-to-head clinical trials, revise to remove the comparisons. As a non-
exhaustive list, we note the following:
"The CR rate we observed in this cohort appears to be significantly higher compared
to those previously reported in investigator-sponsored trials, or ISTs, of cetuximab in
combination with pembrolizumab or nivolumab, as well as the KEYNOTE-048 study •2.
July 5, 2024
Page 2
with pembrolizumab, of approximately 3%" on pages 3 and 113;
•"the mPFS in HPV-negative subjects was 9.8 months, a threefold increase in PFS
benefit when compared to published historical data for pembrolizumab monotherapy,
and superior to the data published for cetuximab and anti-PD-1 combination ISTs" on
page 113; and
•"treatment-related adverse events, or TRAEs, leading to discontinuation of BCA101
and/or pembrolizumab was 12%, markedly lower than historical pembrolizumab
combinations, including lenvatinib or chemotherapy, which showed TRAEs leading
to discontinuation rates of 28% and 33%, respectively" on page 114.
3.Revise page 4 and where else you state you believe you may use the accelerated approval
pathway for BCA101 to briefly describe the feedback received from the FDA that
supports your belief. Please also revise to include balancing disclosure that an accelerated
approval pathway may not lead to a faster development or regulatory review or approval
process and does not increase the likelihood that your product candidate will receive
marketing approval.
4.Please revise to remove the statements appearing on pages 4 and 113 that you "believe
BCA101 in combination with pembrolizumab could be established as the new
chemotherapy-free standard of care for HPV-negative first-line R/M HNSCC" as it is
speculative given your current stage of development.
5.Please revise pages 4, 112 and 113 to state what "PD" abbreviates in the graphics.
6.Discuss whether the results presented in this section were statistically significant. Include
the associated p-values, if appropriate.
Our Team, page 6
7.We note you disclose the names of your investors on pages 6 and 101. Please limit the
disclosure of specific investors to those identified in the Principal Stockholders table on
page 174. Additionally, indicate that prospective investors should not rely on the named
investors’ investment decision, that these investors may have different risk tolerances and
that the shares purchased in the referenced financings were conducted at a significant
discount to the IPO price, if true.
Summary of Material Risks Associated with our Business, page 6
8.Please expand your summary of material risks to further provide balancing disclosure by
discussing if you are substantially dependent on any license agreements for BCA101, that
you have never generated revenue and never commercialized a product.
The Offering, page 9
9.Please revise pages 9 and 78 to clearly state for your Phase 2/3 trial whether proceeds are
intended to fund some but not all of the clinical trial work that would be necessary for you
to file a Biologics License Application. Disclose the additional head and neck squamous
cell carcinoma patient populations you plan to expand your BCA101 program to using
proceeds from this offering.
July 5, 2024
Page 3
Risk Factors
The operations of our suppliers, many of which are located outside of the United States, are
subject to additional risks . . ., page 37
10.Please revise to state why "[i]f approved, the BIOSECURE Act in its current form would
not prevent [you] from sourcing drug product from WuXi Bio for clinical use."
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Research and Development Expenses (including Research and Development (Related Party),
page 90
11.We note your disclosure that you have not reported program costs since your inception
because you have not historically tracked or recorded your research and development
expenses on a program-by-program basis. Please break out your external research and
development costs separately and clarify if they relate to more than the BCA101 program.
Critical Accounting Policies and Estimates
Common Stock Valuation, page 95
12.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the initial public offering and the estimated offering price. This information will
help facilitate our review of your accounting for equity issuances including stock
compensation. Please discuss with the staff how to submit your response.
Business
Overview, page 98
13.We note your disclosure on page 28 that you are currently conducting a clinical trial in
Canada. Please revise your Business section where appropriate to disclose all the
jurisdictions where you are currently conducting clinical trials.
Our Solution: BCA101, a Novel Bifunctional Antibody, page 105
14.Please revise your graphic on page 105 to remove "[i]mproved efficacy" as efficacy
determinations are within the sole discretion of the FDA or similar foreign regulators.
BCA101 synergizes with anti-PD-1 therapies, with anti-tumor activity superior to other anti-
EGFR therapies in preclinical models, page 108
15.Please revise to disclose the design, data and results of the two preclinical cancer mouse
models whose data were published in Cancer Research .
Preclinical in vivo models demonstrate BCA101 may have an enhanced ability to prevent tumor
relapse compared to cetuximab, page 108
16.Please revise to state whether your preclinical experiments in patient derived xenograft
models of EGFR-expressing treatment-naïve HNSCC tumors were powered for statistical
significance and if so, provide the p-values.
July 5, 2024
Page 4
Ongoing Phase 1/1b Trial, page 111
17.Please revise your graphic on page 111 so all of the text is legible.
18.Please revise page 111 to state the number of patients you expect to enroll in the multiple
dose expansion cohorts.
BCA101 has been generally well-tolerated with a favorable tolerability profile, page 114
19.Please disclose the number of patients that experienced treatment-related severe adverse
events due to dermatitis acneiform and the number of patients with treatment-related
adverse events that discontinued BCA101 and/or pembrolizumab. Also revise to clarify if
the Grade 3 or 4 adverse events were considered treatment-related severe adverse events.
20.We note your disclosure in the second paragraph of this section of the EGFR-related
adverse events and note that your first paragraph indicates that there may also be adverse
events associated with TGF-B inhibition. Please revise to clarify if you have observed any
adverse events related to TGF-B inhibition in your trials of BCA101 to date.
Contract Transfer And License Agreement with Biocon, page 117
21.Please revise to clarify how you use the technology licensed from Biocon. Revise to state
how each party may terminate the Biocon Agreement, the aggregate amount paid to date,
the aggregate amount of any future milestone payments, whether there is a royalty term
and if so, disclose the royalty rate. Please also file the Assumed Contracts as exhibits, or
tell us why they are not required to be filed, and disclose when the ownership of
the Assumed Contracts will be transferred to you.
Intellectual Property, page 118
22.Please revise to disclose the jurisdictions for each patent family where you have pending
patents. Revise to describe the patent family with "pending patent applications that, if
issued, may provide additional intellectual property protection for BCA101."
Manufacturing, page 120
23.Please disclose the names of your principal suppliers. Refer to Item 101(h)(4)(v) of
Regulation S-K.
Certain Relations and Related Party Transactions
Policies for approval of related party transactions, page 173
24.Please disclose the standards to be applied in deciding whether to approve or ratify any
related party transaction. Refer to Regulation S-K Item 404(b)(1)(ii).
Exhibits
25.Please file the Director Engagement Letters, Scientific Advisory Board Letter with Dr.
Hodi, Ivan Hyep Promissory Note, Syngene Master Manufacturing Services Agreement,
and Syngene Master Contract Services Agreement as exhibits or otherwise advise.
General
Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, 26.
July 5, 2024
Page 5
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Please contact Tara Harkins at 202-551-3639 or Vanessa Robertson at 202-551-3649 if
you have questions regarding comments on the financial statements and related matters. Please
contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gabriela Morales-Rivera, Esq.
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