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MBX Biosciences, Inc.
Response Received
2 company response(s)
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MBX Biosciences, Inc.
Response Received
4 company response(s)
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Company responded
2024-08-26
MBX Biosciences, Inc.
References: April 17, 2024
Summary
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SEC wrote to company
2024-08-30
MBX Biosciences, Inc.
Summary
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Company responded
2024-08-30
MBX Biosciences, Inc.
References: August 30, 2024
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Company responded
2024-09-10
MBX Biosciences, Inc.
Summary
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Company responded
2024-09-10
MBX Biosciences, Inc.
Summary
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MBX Biosciences, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2024-07-22
MBX Biosciences, Inc.
Summary
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Company responded
2024-08-23
MBX Biosciences, Inc.
References: July 22, 2024
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MBX Biosciences, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-05-07
MBX Biosciences, Inc.
Summary
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MBX Biosciences, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-04-17
MBX Biosciences, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-22 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-09-22 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-08-13 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-08307 | Read Filing View |
| 2024-09-10 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-08-30 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| 2024-08-30 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-08-26 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-08-23 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-07-22 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| 2024-05-07 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-08307 | Read Filing View |
| 2024-08-30 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| 2024-07-22 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| 2024-05-07 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | MBX Biosciences, Inc. | DE | 377-07147 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-22 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-09-22 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-09-10 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-08-30 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-08-26 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
| 2024-08-23 | Company Response | MBX Biosciences, Inc. | DE | N/A | Read Filing View |
2025-09-22 - CORRESP - MBX Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR September 22, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: MBX Biosciences, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-290447 Dear Ladies and Gentlemen, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), MBX Biosciences, Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to September 24, 2024 at 4:00 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 Edwin M. O’Connor at (212) 813-8853. If you have any questions regarding this request, please contact Edwin M. O’Connor of Goodwin Procter LLP at (212) 813-8853. Sincerely, MBX BIOSCIENCES, INC. /s/ P. Kent Hawryluk P. Kent Hawryluk Chief Executive Officer cc: Richard Bartram, MBX Biosciences, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Edwin M. O’Connor, Esq., Goodwin Procter LLP
2025-09-22 - CORRESP - MBX Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 Jefferies LLC 520 Madison Avenue New York, New York 10022 September 22, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: MBX Biosciences, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-290447 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), we, as representatives of the several underwriters, hereby join in the request of MBX Biosciences, Inc. (the “ Company ”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended, so that it becomes effective at 4:00 p.m. Eastern time on September 24, 2025, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, J.P. MORGAN SECURITIES LLC JEFFERIES LLC As representatives of the several underwriters listed in Schedule 1 to the Underwriting Agreement J.P. MORGAN SECURITIES LLC By: /s/ David Ke Name: David Ke Title: Managing Director JEFFERIES LLC By: /s/ Matthew Kim Name: Matthew Kim Title: Managing Director [ Signature Page to Underwriters’ Acceleration Request ]
2025-08-13 - UPLOAD - MBX Biosciences, Inc. File: 377-08307
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 13, 2025 P. Kent Hawryluk Chief Executive Officer MBX Biosciences, Inc. 11711 N. Meridian Street, Suite 300 Carmel, IN 46032 Re: MBX Biosciences, Inc. Draft Registration Statement on Form S-1 Submitted August 8, 2025 CIK No. 0001776111 Dear P. Kent Hawryluk: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. 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 Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Edwin O Connor, Esq. </TEXT> </DOCUMENT>
2024-09-10 - CORRESP - MBX Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 Jefferies LLC 520 Madison Avenue New York, New York 10022 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: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell Re: MBX Biosciences, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-281764 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of MBX Biosciences, Inc. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended, so that it becomes effective at 4:00 p.m. Eastern time on September 12, 2024, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, J.P. MORGAN SECURITIES LLC JEFFERIES LLC As representatives of the several underwriters listed in Schedule 1 to the Underwriting Agreement J.P. MORGAN SECURITIES LLC By: /s/ David Ke Name: David Ke Title: Managing Director JEFFERIES LLC By: /s/ Matthew Kim Name: Matthew Kim Title: Managing Director [Signature Page to Underwriters’ Acceleration Request]
2024-09-10 - CORRESP - MBX Biosciences, 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: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell Re: MBX Biosciences, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-281764 Dear Ladies and Gentlemen, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), MBX Biosciences, 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 4:00 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 Edwin M. O’Connor at (212) 813-8853. If you have any questions regarding this request, please contact Edwin M. O’Connor of Goodwin Procter LLP at (212) 813-8853. Sincerely, MBX BIOSCIENCES, INC. /s/ P. Kent Hawryluk P. Kent Hawryluk Chief Executive Officer cc: Richard Bartram, MBX Biosciences, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Edwin M. O’Connor, Esq., Goodwin Procter LLP Daniel Hughes, Esq., Goodwin Procter LLP
2024-08-30 - UPLOAD - MBX Biosciences, Inc. File: 377-07147
August 30, 2024
P. Kent Hawryluk
President and Chief Executive Officer
MBX Biosciences, Inc.
11711 N. Meridian Street, Suite 300
Carmel, Indiana 46032
Re:MBX Biosciences, Inc.
Registration Statement on Form S-1
Filed August 23, 2024
File No. 333-281764
Dear P. Kent Hawryluk:
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
Prospectus summary
MBX 2109: Potential treatment for chronic hypoparathyroidism, page 4
1.Please revise the second paragraph of this section discussing treatments for HP to reflect
your disclosure elsewhere in the prospectus that Yorvipath has been approved by the FDA
for the treatment of HP. Please similarly revise your risk factor discussion of
Yorvipath and the left column of the graphic on page 132, as needed.
Our company and team, page 6
2.Please limit the discussion of your existing stockholders to those stockholders who appear
in your Principal Stockholders section.
August 30, 2024
Page 2
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 Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Edwin O’Connor
2024-08-30 - CORRESP - MBX Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 August 30, 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: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell Re: MBX Biosciences, Inc. Registration Statement on Form S-1 Filed August 23, 2024 File No. 333-281764 Dear Ladies and Gentlemen: This letter is submitted on behalf of MBX Biosciences, 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 23, 2024 (the “Registration Statement”), as set forth in the Staff’s letter, dated August 30, 2024, addressed to P. Kent Hawryluk (the “Comment Letter”). The Company is concurrently publicly filing Amendment No. 1 to the Registration Statement on Form S-1 (the “Amendment No. 1”), which includes changes to reflect the response to the Staff’s comment 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 the Amendment No. 1. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Amendment No. 1. Registration Statement on Form S-1 Business Prospectus summary MBX 2109: Potential treatment for chronic hypoparathyroidism, page 4 1. Please revise the second paragraph of this section discussing treatments for HP to reflect your disclosure elsewhere in the prospectus that Yorvipath has been approved by the FDA for the treatment of HP. Please similarly revise your risk factor discussion of Yorvipath and the left column of the graphic on page 132, as needed. RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosure on pages 4, 36 and 132 of the Amendment No. 1 in response to the Staff’s comment. Our company and team, page 6 2. Please limit the discussion of your existing stockholders to those stockholders who appear in your Principal Stockholders section. RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosure on pages 7 and 127 of the Amendment No. 1 in response to the Staff’s comment. [Signature Page Follows] Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission August 30, 2024 Page 2 If you should have any questions concerning the enclosed matters, please contact the undersigned at (212) 813-8853. Sincerely, /s/ Edwin M. O’Connor Edwin M. O’Connor, Esq. Enclosures cc: P. Kent Hawryluk, MBX Biosciences, Inc. Richard Bartram, MBX Biosciences, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Daniel Hughes, Esq., Goodwin Procter LLP
2024-08-26 - CORRESP - MBX Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 August 26, 2024 FOIA CONFIDENTIAL TREATMENT REQUEST The entity requesting confidential treatment is MBX Biosciences, Inc. 11711 N. Meridian Street, Suite 300 Carmel, Indiana 46032 Telephone: (317) 659-0200 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 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell RE: MBX Biosciences, Inc. Registration Statement on Form S-1 File No. 333-281764 CIK No. 0001776111 Rule 83 Confidential Treatment Request by MBX Biosciences, Inc. Dear Ladies and Gentlemen: On behalf of MBX Biosciences, Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated April 17, 2024 (the “Comment Letter”) relating to the Company’s Registration Statement on Form S-1, originally confidentially submitted to the Commission on March 22, 2024, amended by way of confidential submission on April 26, 2024, further amended by way of confidential submission on July 11, 2024, and subsequently publicly filed by the Company with the Commission on August 23, 2024 (File No. 333-281764) (the “Registration Statement”), we submit this supplemental letter to address comment 14 of the Comment Letter. 1 CONFIDENTIAL TREATMENT REQUESTED BY MBX BIOSCIENCES, INC. Securities and Exchange Commission August 26, 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 actual 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. The Company expects to reflect the Stock Split (as defined below) in a pre-effective amendment to the Registration Statement that includes the actual price range; however, all dollar amounts and per share amounts in this letter are pre-Stock Split, and therefore, consistent with 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 Richard Bartram 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. 14. 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. Please discuss with the staff how to submit your response. 2 CONFIDENTIAL TREATMENT REQUESTED BY MBX BIOSCIENCES, INC. Securities and Exchange Commission August 26, 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 initial public offering (“IPO”), before giving effect to a reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement (the “Stock Split”) resulting in a midpoint of the Preliminary Price Range of $[***] per share (the “Midpoint Price”). 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 Company’s common stock, par value $0.0001 (“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 affected the fair value from the date of the most recent valuation through the date of the grant. These 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 (the “Practice Aid”). The Company’s most recent third-party valuations of its Common Stock estimated fair value were as follows: Date of Third-Party Valuation Date of Board Approval Estimated Fair Market Value of Common Stock per Share November 7, 2022 November 7, 2022 $ 0.27 (1) August 15, 2023 August 15, 2023 $ 0.65 January 31, 2024 January 31, 2024 $ 0.76 March 22, 2024 April 24, 2024 $ 0.87 August 2, 2024 August 2, 2024 $ 0.87 (1) On November 7, 2022, the Board, with the assistance of a third-party valuation firm, determined the fair market value of the Common Stock to be $0.27. The fair market value of the Common Stock was subsequently reassessed as of November 7, 2022, solely for financial reporting purposes, to appropriately bifurcate upside and downside scenarios in accordance with the Practice Aid. As a result, the fair value of the Common Stock as of November 7, 2022 was determined to be $0.34, as compared to the $0.27 determined by the originally performed valuation for tax reporting purposes. This revaluation resulted in recognition of additional stock-based compensation expense. The exercise price for stock options granted from November 7, 2022 through April 19, 2023 was derived from the originally performed valuation. 3 CONFIDENTIAL TREATMENT REQUESTED BY MBX BIOSCIENCES, INC. Securities and Exchange Commission August 26, 2024 Page 4 The following table summarizes by grant date the number of shares subject to awards granted between January 18, 2023 through the date of this letter, the per share exercise price of the awards and the fair value of Common Stock underlying the awards on each grant date: Grant date Number of shares subject options granted Per share exercise price of options Fair value per common share on grant date Estimated fair value per option January 18, 2023 35,000 $ 0.27 $ 0.34 (1) $ 0.25 (2) April 19, 2023 1,404,250 $ 0.27 $ 0.34 (1) $ 0.25 (2) August 15, 2023 17,057,250 $ 0.65 $ 0.65 $ 0.50 (2) November 2, 2023 2,571,360 $ 0.65 $ 0.65 $ 0.50 (2) January 31, 2024 3,675,056 $ 0.76 $ 0.76 $ 0.58 (2) April 24, 2024 2,205,455 $ 0.87 $ 0.87 $ 0.71 (2) August 2, 2024 4,298,500 $ 0.87 $ 0.87 $ 0.73 (2) (1) On November 7, 2022, the Board, with the assistance of a third-party valuation firm, determined the fair market value of the Common Stock to be $0.27. The fair market value of the Common Stock was subsequently reassessed as of November 7, 2022, solely for financial reporting purposes, to appropriately bifurcate upside and downside scenarios in accordance with the Practice Aid. As a result, the fair value of the Common Stock as of November 7, 2022 was determined to be $0.34, as compared to the $0.27 determined by the originally performed valuation for tax reporting purposes. This revaluation resulted in recognition of additional stock-based compensation expense. The exercise price for stock options granted from November 7, 2022 through April 19, 2023 was derived from the originally performed valuation. (2) The per share estimated fair value of options reflects the weighted-average fair value of options granted on each grant date determined using the Black-Scholes option-pricing model. The third-party valuations were performed in accordance with the guidance outlined in the Practice Aid. The Common Stock valuations were prepared using an option pricing method (“OPM”), a hybrid method of OPM and probability-weighted expected return method (“PWERM”) or the current value method (the “Current Value Method”). The OPM, the hybrid method and the Current Value method use market approaches to estimate the Company’s enterprise value. 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 CONFIDENTIAL TREATMENT REQUESTED BY MBX BIOSCIENCES, INC. Securities and Exchange Commission August 26, 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. The hybrid method is a hybrid between the PWERM and OPM, estimating the probability-weighted value across multiple scenarios, but using the OPM to estimate the allocation of value within one or more of those scenarios. When using the hybrid method, the third party valuations considered two future-event scenarios: an IPO scenario and an alternative exit scenario. The IPO scenario estimated an equity value based on the guideline public company method under a market approach. The guideline public companies considered for this scenario consist of biopharmaceutical companies with recently completed initial public offerings. The value of the shares under an initial public offering event scenario was determined according to the PWERM and the OPM scenario, using an appropriate time to a liquidity event, was used to estimate the fair value of the share class assuming the initial public offering event does not occur. In certain instances, the Precedent Transaction (“Backsolve”) Method was used to determine value of shares under an IPO scenario. The resulting share values under each scenario are weighted by their respective probabilities. The equity value for the alternative exit scenario was estimated using an enterprise value based on the price of a recently issued preferred securities and using the OPM method for allocation of value. The valuation utilized an option pricing model to quantify or attribute value to the economic rights of convertible preferred stock as compared to the common stock, such as liquidation preferences, dividend provisions, and participation rights after liquidation preferences. This method was determined to be the most appropriate valuation methodology based on the Company’s stage of development and other relevant factors. In determining the estimated fair value of the Common Stock, the Board also considered the fact that the Company’s stockholders could not freely trade the Common Stock in the public markets. Accordingly, discounts were applied to reflect the lack of marketability of the Common Stock based on the weighted-average expected time to liquidity. The current value method, once the fair value of the enterprise is established, allocates value to the various series of preferred and common stock based on their respective seniority, liquidation preferences or conversion values, whichever is greatest. 5 CONFIDENTIAL TREATMENT REQUESTED BY MBX BIOSCIENCES, INC. Securities and Exchange Commission August 26, 2024 Page 6 In addition to considering the results of independent third-party valuations, the Committee considered various objective and subjective factors to determine the thresholds for the options of common stock as of each grant date, including: • the prices of the Company’s convertible preferred stock sold to investors in arm’s length transactions and the rights, preferences and privileges of the convertible preferred stock relative to those of the Common Stock; • the Company’s stage of development and business strategy and the material risks related to the business and industry; • the progress of the Company’s research and development programs, including the status of preclinical studies and clinical trials for its drug candidates; • the Company’s results of operations and financial position, including levels of available capital resources; • the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies; • the lack of marketability of the Common Stock as a private company; • the likelihood of achieving a liquidity event for the holders of Common Stock, such as an initial public offering or a sale of the Company, given prevailing market conditions; • trends and developments in the industry; • external market conditions affecting the life sciences and biotechnology industry sectors; and • the economy in general. The assumptions underlying these valuations are highly complex and subjective, and represent management’s best estimates, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company uses significantly different assumptions or estimates, the fair value of the Common Stock and the Company’s stock-based compensation expense could be materially different. Once a public trading market for the Common Stock has been established in connection with the completion of this offering, it will no longer be necessary for the Board or the Committee to estimate the fair value
2024-08-23 - CORRESP - MBX Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 August 23, 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: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell Re: MBX Biosciences, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted July 11, 2024 CIK 0001776111 Dear Ladies and Gentlemen: This letter is submitted on behalf of MBX Biosciences, 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 Draft Registration Statement on Form S-1, originally confidentially submitted on March 22, 2024 (the “Draft Registration Statement”), and resubmitted on April 26, 2024 ( “Amendment No. 1 to the Draft Registration Statement”) and July 11, 2024 (“Amendment No. 2 to the Draft Registration Statement”), as set forth in the Staff’s letter, dated July 22, 2024, addressed to P. Kent Hawryluk (the “Comment Letter”). The Company is concurrently publicly filing the Registration Statement on Form S-1 (the “Registration Statement”), which includes changes to reflect the response to the Staff’s comment 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. 2 to the Draft Registration Statement, 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. 2 to Draft Registration Statement on Form S-1 Business Phase 1 clinical development and results, page 135 1. We note your discussion of the results of your Phase 1 trial of MBX 2109 and the separate Phase 1 trial of TransCon PTH. Please revise your disclosure to briefly describe the limitations of cross-study comparisons as opposed to head-to-head comparisons. RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosure on page 136 of the Registration Statement in response to the Staff’s comment. If you should have any questions concerning the enclosed matters, please contact the undersigned at (212) 813-8853. Sincerely, /s/ Edwin M. O’Connor Edwin M. O’Connor, Esq. Enclosures cc: P. Kent Hawryluk, MBX Biosciences, Inc. Richard Bartram, MBX Biosciences, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Daniel Hughes, Esq., Goodwin Procter LLP
2024-07-22 - UPLOAD - MBX Biosciences, Inc. File: 377-07147
July 22, 2024
P. Kent Hawryluk
President and Chief Executive Officer
MBX Biosciences, Inc.
11711 N. Meridian Street, Suite 300
Carmel, Indiana 46032
Re:MBX Biosciences, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted July 11, 2024
CIK No. 0001776111
Dear P. Kent Hawryluk:
We have reviewed your amended draft registration statement and have the following
comment.
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 this 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.
Amendment No. 2 to Draft Registration Statement on Form S-1
Business
Phase 1 clinical development and results, page 135
1.We note your discussion of the results of your Phase 1 trial of MBX 2109 and the separate
Phase 1 trial of TransCon PTH. Please revise your disclosure to briefly describe the
limitations of cross-study comparisons as opposed to head-to-head comparisons.
Please contact Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Alan Campbell at 202-551-4224 with any other
questions.
July 22, 2024
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Edwin O’Connor
2024-05-07 - UPLOAD - MBX Biosciences, Inc. File: 377-07147
United States securities and exchange commission logo
May 7, 2024
P. Kent Hawryluk
President and Chief Executive Officer
MBX Biosciences, Inc.
11711 N. Meridian Street, Suite 300
Carmel, Indiana 46032
Re:MBX Biosciences, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted April 26, 2024
CIK No. 0001776111
Dear P. Kent Hawryluk:
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
April 17, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your response to prior comment 3 and re-issue in part. Please revise the
Overview section of the Prospectus Summary to clarify that developing drug candidates is
an "uncertain process" and that you have not yet demonstrated the ability to gain
regulatory approvals.
2.We note your response to comment 5 and re-issue in part. Please revise your comparison
of the preclinical results of MBX 4291 and tirzepatide to clarify that MBX 4291’s results
in clinical trials may not reflect your findings in preclinical studies.
FirstName LastNameP. Kent Hawryluk
Comapany NameMBX Biosciences, Inc.
May 7, 2024 Page 2
FirstName LastName
P. Kent Hawryluk
MBX Biosciences, Inc.
May 7, 2024
Page 2
3.We note your response to prior comment 17 and revised disclosure. Please further revise
your Summary disclosure comparing MBX 4291 and tirzepatide to reflect (i) your
statements on page 144 indicating that it appears that less frequent dosing of MBX 4291
would require a higher dose than tirzepatide; (ii) the content of the graphic on page 144
showing that the concentration of the active component of MBX 4291 was significantly
lower than the concentration of tirzepatide in the duration comparison; and (iii) that the
study supporting the potential duration of MBX 4291 was conducted separately from
studies evaluating its effects.
MBX 2109: Potential best-in-class treatment for chronic hypoparathyroidism, page 3
4.We note your response to comment 9 and re-issue in part. Please provide balancing
disclosure when Orphan Drug Designation is first introduced in the prospectus that it does
not shorten the development time or regulatory review time of a product candidate and
does not provide any guarantee of approval in the regulatory review or approval process.
Our company and team, page 6
5.We note your response to comment 8 and re-issue in part. Please revise to clarify, if
true, Dr. DiMarchi is not an employee of your company. Please also disclose the number
of hours per week, if any, that Dr. DiMarchi is required to devote to your company. Please
also revise your disclosure on page 2 to clearly state whether you currently have any
independent discovery capabilities or whether you are currently reliant on Dr. DiMarchi's
discovery capabilities.
Business
Our solution: MBX 4291, page 141
6.Please revise your narrative description of the graphic at the top of page 144 to disclose
the range of concentrations of the (i) active component of MBX 4291 and (ii) tirzepatide,
respectfully.
Please contact Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Edwin O’Connor
2024-04-17 - UPLOAD - MBX Biosciences, Inc. File: 377-07147
United States securities and exchange commission logo
April 17, 2024
P. Kent Hawryluk
President and Chief Executive Officer
MBX Biosciences, Inc.
11711 N. Meridian Street, Suite 300
Carmel, Indiana 46032
Re:MBX Biosciences, Inc.
Draft Registration Statement on Form S-1
Submitted March 22, 2024
CIK No. 0001776111
Dear P. Kent Hawryluk:
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 disclose, if accurate, that the closing of this offering is contingent upon a Nasdaq
listing, or otherwise advise. Please ensure the disclosure is consistent with your
underwriting agreement.
Prospectus Summary
Overview, page 1
2.Please revise your Prospectus Summary to define or explain briefly scientific or technical
terms. By way of example, we note the following terms:
•Peak-to-trough
•Prodrug
•Receptor antagonist
•Fatty acylation
FirstName LastNameP. Kent Hawryluk
Comapany NameMBX Biosciences, Inc.
April 17, 2024 Page 2
FirstName LastName
P. Kent Hawryluk
MBX Biosciences, Inc.
April 17, 2024
Page 2
•Hypercalcemic
•Hypocalcemic
3.We note your disclosure regarding your pipeline of novel candidates with "defined
regulatory pathways" and "large market opportunities." Please revise to reflect your
statements (i) on page 17 that developing product candidates is an “uncertain process”, (ii)
on page 16 that you have not yet demonstrated an ability to obtain regulatory approvals
and (iii) on page 30 that your estimates as to prevalence may not be accurate and that
published literature includes estimates which are lower than your estimates.
4.Please remove references throughout your prospectus to potential "best-in-class" and
“first-in-class” when describing your product candidates as these descriptions imply an
expectation of regulatory approval and are inappropriate given the length of time and
uncertainty with respect to securing such approval. In addition, please remove claims that
you are able to design and develop novel peptide therapeutics that have high or enhanced
"potency" and you can improve efficacy and tolerability. Please also remove any similar
disclosures regarding the current potency or efficacy of your product candidates as these
statements appear to be premature given your current stage of development.
5.We note your disclosure here and elsewhere stating that preclinical studies demonstrated
that MBX 4291 showed a “similar efficacy profile” as tirzepatide. As safety and efficacy
determinations are solely within the FDA’s authority, please remove these references to
efficacy. You may compare the performances of MBX 4291 and tirzepatide in preclinical
studies without concluding as to efficacy. Please also clarify that MBX 4291's results in
clinical trials may not reflect your findings in preclinical studies.
6.Please revise your Prospectus Summary, where appropriate, to reflect your disclosure
elsewhere in the prospectus that TransCon PTH was granted a marketing authorization in
the EU in November 2023 and that you could potentially be precluded from gaining
approval for MBX 2109 in the EU until 2035. Please also revise to reflect that an NDA for
TransCon PTH is currently under review by the FDA.
Our Platform, page 2
7.We note that you characterize your PEP platform as "leading" and "world-class." Please
revise to provide the basis for these statements.
8.We note your disclosure here, and elsewhere, regarding your co-founder Dr. DiMarchi’s
global recognition. Please revise to clarify, if true, Dr. DiMarchi is not a director or
employee of your company. Please also disclose the number of hours per week, if any,
that Dr. DiMarchi is required to devote to your company. With reference to your
disclosure on page 22, please also revise to state whether you have any independent
discovery capabilities or whether you are reliant on Dr. DiMarchi's discovery capabilities.
FirstName LastNameP. Kent Hawryluk
Comapany NameMBX Biosciences, Inc.
April 17, 2024 Page 3
FirstName LastName
P. Kent Hawryluk
MBX Biosciences, Inc.
April 17, 2024
Page 3
MBX 2109: Potential best-in-class treatment for chronic hypoparathyroidism, page 3
9.We note your disclosure on page 4 that the FDA has granted Orphan Drug Designation to
MBX 2109 for the treatment of HP. Please briefly describe the significance of having
obtained orphan drug designation. In addition, please revise your reference to orphan drug
designation to clarify that such a designation neither shortens the development time or
regulatory review time of a product candidate, nor does it provide any guarantee of
approval in the regulatory review or approval process.
Our Pipeline, page 3
10.We note your inclusion of a row in your pipeline table for "Additional Obesity Programs."
However, none of these programs appear to be discussed in your prospectus. Accordingly,
please remove this row from your pipeline table.
Our company and team, page 6
11.We note your disclosure regarding raising funding from “leading” healthcare investors.
Please clarify that prospective investors should not rely on the named investors’
investment decisions, that these investors may have different risk tolerances and, if true,
that the shares purchased by these investors were acquired at a discount to the IPO price.
Our Strategy, page 7
12.We note your disclosure here, and elsewhere, regarding your strategy to “rapidly advance”
MBX 2109 and MBX 1416 through clinical development. Please revise these statements
and any other similar statements to remove any implication that you will be successful in
advancing your product candidates in a rapid or accelerated manner, as such statements
are speculative. In this regard, we note your disclosure on page 17 that developing product
candidates, including conducting preclinical studies and clinical trials, is a very time-
consuming, expensive and uncertain process that takes years to complete.
Critical Accounting Policies and Significant Judgments and Estimates
Determination of the Fair Value of Common Stock, page 114
13.Please revise disclosures to explain the specific event(s) or factor(s) that resulted in an
increase in the initial valuation of the common stock fair value from $0.27 per share to
$0.34 per share.
14.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. Please
discuss with the staff how to submit your response.
FirstName LastNameP. Kent Hawryluk
Comapany NameMBX Biosciences, Inc.
April 17, 2024 Page 4
FirstName LastNameP. Kent Hawryluk
MBX Biosciences, Inc.
April 17, 2024
Page 4
Business
Ongoing Avail Phase 2 clinical trial, page 134
15.Please revise this section to reflect your disclosure on pages 29-30 indicating that you
have added new sites to this trial following slow enrollment at the originally selected sites
and that you were unable to enroll sites in the EU.
Our solution: MBX 4291
Preclinical studies, page 141
16.Please define CPS in the graphic on page 141.
17.Please revise to clarify the number of mice dosed with the MBX 4291 active drug and
tirzepatide, as well as the number of non-human primates used to assess the conversion of
MBX 4191. We also note your claims here and throughout the prospectus indicating that
MBX 4291 demonstrated extended duration as compared to tirzepatide in a preclinical
study that may support once-monthly dosing. However, the preclinical study on page 142
appears to indicate that observation of the concentration of tirzepatide ceased after one
week. In addition, it appears that you are relying on the results of MBX 4291 active drug
to support your claim that the decline in exposure is flatter than the more rapid reduction
in tirzepatide exposure. However, your disclosure elsewhere in the prospectus indicates
that you are developing MBX 4291 as a prodrug and the prodrug decline in exposure
appears to track tirzepatide's. Please advise and revise your disclosure accordingly. To the
extent observation of tirzepatide ceased after one week, please remove or revise your
claims that MBX 4291 has demonstrated an extended duration as compared to tirzepatide.
License agreement
Indiana University Research and Technology Corporation Exclusive License Agreement, page
145
18.Please revise to provide the percentage of the sublicensing revenue, or a range not
exceeding 10 percentage points.
Exhibits
19.Please revise to either (i) clearly disclose that Exhibit 10.6 also contains amendments to
the original agreement or (ii) separately number the amendments to the license agreement.
20.When available, please file the Senior Executive Cash Incentive Bonus Plan as an exhibit
to your registration statement.
General
21.Please ensure the writing is legible in the visual depictions throughout your draft
registration statement. For example only, certain text on the y-axis on pages 127 and 133
is not legible.
FirstName LastNameP. Kent Hawryluk
Comapany NameMBX Biosciences, Inc.
April 17, 2024 Page 5
FirstName LastName
P. Kent Hawryluk
MBX Biosciences, Inc.
April 17, 2024
Page 5
22.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Please contact Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Edwin O’Connor