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LB PHARMACEUTICALS INC
Response Received
4 company response(s)
Medium - date proximity
↓
Company responded
2025-08-22
LB PHARMACEUTICALS INC
References: August 12, 2025
↓
Company responded
2025-09-03
LB PHARMACEUTICALS INC
References: June 17, 2024
↓
↓
LB PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
LB PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-09 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-09-09 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-09-03 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-08-22 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-08-12 | SEC Comment Letter | LB PHARMACEUTICALS INC | DE | 377-07237 | Read Filing View |
| 2024-07-02 | SEC Comment Letter | LB PHARMACEUTICALS INC | DE | 377-07237 | Read Filing View |
| 2024-06-17 | SEC Comment Letter | LB PHARMACEUTICALS INC | DE | 377-07237 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-12 | SEC Comment Letter | LB PHARMACEUTICALS INC | DE | 377-07237 | Read Filing View |
| 2024-07-02 | SEC Comment Letter | LB PHARMACEUTICALS INC | DE | 377-07237 | Read Filing View |
| 2024-06-17 | SEC Comment Letter | LB PHARMACEUTICALS INC | DE | 377-07237 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-09 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-09-09 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-09-03 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2025-08-22 | Company Response | LB PHARMACEUTICALS INC | DE | N/A | Read Filing View |
2025-09-09 - CORRESP - LB PHARMACEUTICALS INC
CORRESP 1 filename1.htm CORRESP September 9, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Christine Torney Mary Mast Doris Stacey Gama Laura Crotty Re: LB Pharmaceuticals Inc Registration Statement on Form S-1, as amended (Registration No. 333-289812) Ladies and Gentlemen: In connection with the above-referenced Registration Statement, as amended, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), we hereby join in the request of LB Pharmaceuticals Inc that the effective date of the Registration Statement, as amended, be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on September 10, 2025, or as soon thereafter as practicable. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that we will take reasonable steps to secure adequate distribution of the preliminary prospectus to underwriters, dealers, institutions and others prior to the requested effective time of the Registration Statement. In connection with the preliminary prospectus distribution for the above-referenced issue, the prospective underwriters have confirmed that they are complying with the 48-hour requirement in Rule 15c2-8(b) under the Securities Exchange Act of 1934, as amended. Very truly yours, LEERINK PARTNERS LLC PIPER SANDLER & CO. STIFEL, NICOLAUS & COMPANY, INCORPORATED As Representatives of the several underwriters [SIGNATURE PAGE FOLLOWS] LEERINK PARTNERS LLC By: /s/ Rahul Chaudhary Name: Rahul Chaudhary Title: Senior Managing Director, Head of Equity Capital Markets PIPER SANDLER & CO. By: /s/ Chad Huber Name: Chad Huber Title: Managing Director STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Ken Clausman Name: Ken Clausman Title: Managing Director As representatives of the several underwriters. [Signature Page to Acceleration Request Letter]
2025-09-09 - CORRESP - LB PHARMACEUTICALS INC
CORRESP 1 filename1.htm CORRESP LB Pharmaceuticals Inc One Pennsylvania Plaza, Suite 1025 New York, NY 10119 September 9, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Christine Torney, Mary Mast, Doris Stacey Gama, and Laura Crotty Re: LB Pharmaceuticals Inc Registration Statement on Form S-1, as amended (File No. 333-289812) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, LB Pharmaceuticals Inc (the “ Company ”) hereby requests that the U.S. Securities and Exchange Commission (the “ Commission ”) accelerate the effective date of the above-referenced Registration Statement on Form S-1 (as amended to date, the “ Registration Statement ”) and declare the Registration Statement effective as of 4:00 p.m. Eastern time, on September 10, 2025, or as soon thereafter as possible, or at such other time as its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. Once the Registration Statement has been declared effective, please orally confirm that event with Divakar Gupta of Cooley LLP at (212) 479-6474 or, in his absence, Brandon Fenn of Cooley LLP at (212) 479-6626. Under separate cover, you will receive today a letter from the managing underwriters of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. Very truly yours, LB Pharmaceuticals Inc /s/ Heather Turner By: Heather Turner Title: Chief Executive Officer cc: Gad Soffer, LB Pharmaceuticals Inc Marc Panoff, LB Pharmaceuticals Inc Divakar Gupta, Cooley LLP Brandon Fenn, Cooley LLP Marc Recht, Cooley LLP Minkyu Park, Cooley LLP William C. Hicks, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. John T. Rudy, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Alok A. Choksi, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2025-09-03 - CORRESP - LB PHARMACEUTICALS INC
CORRESP 1 filename1.htm CORRESP Divakar Gupta VIA EDGAR +1 212 479 6474 dgupta@cooley.com *FOIA Confidential Treatment Request* Confidential Treatment Requested by LB Pharmaceuticals Inc in connection with its Registration Statement on Form S-1 (File No. 333-289812) September 3, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Christine Torney Mary Mast Doris Stacey Gama Laura Crotty Re: LB Pharmaceuticals Inc Registration Statement on Form S-1 August 22, 2025 File No. 333-289812 Ladies and Gentlemen: On behalf of LB Pharmaceuticals Inc (the “ Company ”), in response to comments from the staff (the “ Staff ”) of the U.S. Securities and Exchange Commission (the “ Commission ”) received by letter dated June 17, 2024 (the “ Comment Letter ”), relating to the Company’s draft Registration Statement on Form S-1 confidentially submitted to the Commission on May 20, 2024 (the “ DRS ”), and which was subsequently updated by the Company with Amendment No. 1 to the DRS confidentially submitted with the Commission on June 24, 2024, Amendment No. 2 to the DRS confidentially submitted with the Commission on July 23, 2025 and the Registration Statement on Form S-1 publicly filed with the Commission on August 22, 2025 (Registration No. 333-289812) (the “ Registration Statement ”), we are submitting this supplemental letter to further address Comment No. 7 of the Comment Letter. For the convenience of the Staff, we have incorporated the text of Comment No. 7 into this letter. Due to the commercially sensitive nature of information contained in this letter, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has 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). Cooley LLP 55 Hudson Yards New York, NY 10001 T:+1 212 479 6000 f:+1 212 479 6275 cooley.com U.S. Securities and Exchange Commission September 3, 2025 Page Two Staff Comment Management’s Discussion and Analysis and Financial Condition and Results of Operations Critical Accounting Estimates Determination of the Fair Value of Common Stock, page 103 7. 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. Response: Preliminary Price Range The Company respectfully advises the Staff that the Company currently expects a price range of approximately $[***] to $[***] per share (the “ Preliminary Price Range ”) for the planned initial public offering (“ IPO ”) of the Company’s common stock, par value $0.0001 per share (the “ Common Stock ”), which Preliminary Price Range does not reflect the impact of a reverse stock split of the Common Stock that the Company anticipates may be effected prior to the filing of, and reflected in, an amendment to the Registration Statement to be filed prior to the commencement of the Company’s road show (the “ Reverse Stock Split ”). The share and per share numbers in this letter are presented on a pre-Reverse Stock Split basis. This Preliminary Price Range implies a pre-money equity valuation for the Company of $[***] million to $[***] million. The Preliminary Price Range is based in part upon the Company’s prospects, prospects for the biopharmaceutical industry generally, the general condition of the securities markets and the recent market prices of, and the demand for, publicly traded shares of generally comparable companies in the biopharmaceutical industry, as well as input received from Leerink Partners LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated, the representatives of the several underwriters for the IPO (the “ Representatives ”). The Company notes that, as is typical in initial public offerings, the Preliminary Price Range for the Company’s IPO was not derived using a formal determination of fair value or single valuation methodology but was determined by discussions among the Company and the Representatives based on a variety of considerations and methodologies, including the assessment of the aforementioned factors. The Company will include a narrower bona fide price range of the Common Stock, as adjusted for the Reverse Stock Split, in an amendment to the Registration Statement that will be filed prior to the commencement of the Company’s road show. However, the parameters of the bona fide price range will be subject to then-current market conditions, continuing discussions with the Representatives and material business developments impacting the Company, and, due to the volatility in the securities markets, in particular the volatility experienced in the market by recent initial public offering issuers, there is a possibility that the bona fide price range for the IPO may fall outside of the Preliminary Price Range. In any event, the Company confirms to the Staff that the bona fide price range will comply with Item 501(b)(3) of Regulation S-K and Compliance & Disclosure Interpretation 134.04. FOIA Confidential Treatment Requested by LB Pharmaceuticals Inc [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Cooley LLP 55 Hudson Yards New York, NY 10001 T:+1 212 479 6000 f:+1 212 479 6275 cooley.com U.S. Securities and Exchange Commission September 3, 2025 Page Three Common Stock Valuation Methodologies As there has been no public market for the Common Stock to date, the Company’s board of directors (the “ Board ”) has determined the estimated fair value of the Common Stock for purposes of granting equity awards, as of the date of each option grant, with input from management, considering (i) the Company’s most recent arm’s length sales of its redeemable convertible preferred stock, (ii) the most recent third-party valuation of its Common Stock, and (iii) the Board’s assessment of additional objective and subjective factors that the Board believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the grant. The Board considered various objective and subjective factors to determine the estimated fair value of the Common Stock as of each grant date, including: • the prices of the Company’s redeemable convertible preferred stock sold to outside investors in arm’s length transactions and the rights, preferences, and privileges of the Company’s redeemable convertible preferred stock as compared to those of the Common Stock, including liquidation and redemption preferences of the Company’s redeemable convertible preferred stock; • the progress of the Company’s research and development programs, including the status and results of clinical trials for LB-102, the Company’s lead product candidate, and progress of the Company’s development and manufacturing processes; • the Company’s stage of development and business strategy, and material risks related to the Company’s business; • the hiring of key personnel and management; • external market conditions affecting the biopharmaceutical industry, and trends within the biopharmaceutical industry; • the Company’s financial position, including cash on hand, and historical and forecasted performance and results of operations; • the lack of an active public market for the Common Stock and the Company’s redeemable convertible preferred stock; • 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; • the achievement of enterprise milestones, including entering into collaboration and license agreements; • the analysis of initial public offerings and the market performance of similar companies in the biopharmaceutical industry; and • the economy in general. The third-party valuations of the Common Stock that the Board considered in making its determinations were prepared in accordance with the American Institute of Certified Public Accountants’ Accounting and Valuation Guide , Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “ Practice Aid ”), which prescribes several valuation approaches for determining the value of an enterprise, such as the cost, market and income approaches, and various methodologies for allocating the value of an enterprise to its capital structure and specifically its common stock. FOIA Confidential Treatment Requested by LB Pharmaceuticals Inc [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Cooley LLP 55 Hudson Yards New York, NY 10001 T:+1 212 479 6000 f:+1 212 479 6275 cooley.com U.S. Securities and Exchange Commission September 3, 2025 Page Four In accordance with the Practice Aid, the Company considered the following methods for allocating the enterprise value across its classes and series of capital stock to determine the estimated fair value of the Common Stock at each valuation date. • Current Value Method (“ CVM ”). The CVM estimates the fair market value of the enterprise by subtracting the liquidation preference of any preferred stock considering all rights and assumed conversion behavior associated with those shares. • Option Pricing Method (“ OPM ”). The OPM estimates the value of the Common Stock using the various inputs in the Black-Scholes option pricing model. The OPM treats the rights of the holders of Common Stock as equivalent to that of call options on any value of the enterprise above certain break points of value based upon the liquidation preferences of the holders of the Company’s redeemable convertible preferred stock, as well as their rights to participation, and the stock prices of the outstanding options. Thus, the value of the Common Stock can be determined by estimating the value of its portion of each of these call option rights. Under this method, the Common Stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preference at the time of a liquidity event, such as a merger or sale. • Probability-Weighted Expected Return Method (“ PWERM ”). The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes considered by the Company, as well as the economic and control rights of each share class. • Hybrid Method (“ Hybrid Method ”) . The Hybrid Method is a weighted-average method that combines both OPM and PWERM. Weighting allocations are assigned to the OPM and PWERM factoring in possible future liquidity events. To support the Board in determining the estimated fair value of the Common Stock as the Company sought to obtain better visibility into the timing of the potential IPO, but accounting for uncertainty around the Company’s value should the IPO not occur, the Hybrid Method was utilized for the independent third party valuation of the Common Stock as of September 30, 2024 (the “ September 2024 Valuation ”). The OPM and Hybrid Method are commonly used in these situations, and such use is consistent with guidance from the Practice Aid. In the Company’s case, the Hybrid Method incorporated two scenarios: (1) a stay private scenario where the allocation of total equity value was performed using the OPM and (2) an IPO scenario where all outstanding shares of the Company’s redeemable convertible preferred stock were assumed to be mandatorily converted into shares of Common Stock. In addition, given the Common Stock represents a non-marketable equity interest in a private enterprise, an adjustment to the preliminary value estimates was made in each of the sale and IPO scenario to account for the lack of liquidity. This adjustment is commonly referred to as a discount for lack of marketability (“ DLOM ”). At each grant date, the Board evaluated any recent events and their potential impact on the estimated fair value per share of the Common Stock. For grants of awards made on dates for which there was no contemporaneous independent third-party valuation, the Board determined the estimated fair value of the Common Stock on the date of grant taking into consideration the most recent valuation report as well as other pertinent information available to it at the time of the grant. FOIA Confidential Treatment Requested by LB Pharmaceuticals Inc [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Cooley LLP 55 Hudson Yards New York, NY 10001 T:+1 212 479 6000 f:+1 212 479 6275 cooley.com U.S. Securities and Exchange Commission September 3, 2025 Page Five Common Stock Valuations and Stock Option Grants The Company granted the following stock option awards since July 1, 2024, which remained outstanding as of the date hereof: Date of Grant Numbers of Shares Subject to Stock Options Granted Exercise Price Per Share of Common Stock Estimated Fair Value Per Share of Common Stock at Grant Date November 18, 2024 4,935,000 $ 1.50 $ [ ***] January 7, 2025 219,138 $ 1.50 $ [ ***] February 11, 2025 1,000,000 $ 1.50 $ [ ***] September 2024 Valuation—November 18, 2024, January 7, 2025 and February 11, 2025 Stock Option Grants On November 18, 2024, the Company granted stock options to purchase a total of 4,935,000 shares of Common Stock at an exercise price of $1.50 per share. The Board determined the fair value of the Common Stock at the time of the grant to be $[***] per share based on a number of factors, including the September 2024 Valuation. On January 7, 2025, the Company granted stock options to purchase a total of 219,138 shares of Common Stock at an exercise price of $1.50 per share. The Board determined the fair value of the Common Stock at the time of the grant to be $[***] per share based on a number of factors, including the September 2024 Valuation. On February 11, 2025, the Company granted stock options to purchase a total of 1,000,000 shares of Common Stock at an exercise price of $1.50 per share. The Board determined the fair value of the Common Stock at the time of the grant to be $[***] per share based on a number of factors, including the September 2024 Valuation. For the September 2024 Valuation, the total equity value was considered and adjusted for the changes in the market environment using a combination of the cost-based approach and market-based approach. Based on an analysis of the market, the selected guideline public companies suggested a [***]% decrease (based on mean and median) in the enterprise value since the prior valuation. The observed market change was applied to the June 30, 2024 enterprise value to arrive at an adjusted enterprise value of approximately $[***] million. Further, the total productive expenses incurred by the Company since June 30, 2024, through the valuation date, was approximately $[***] million. The Company also factored in a [***]% return on the productive expenses considering that it had completed its Phase 2 trials and was awaiting trial results. FOIA Confidential Treatment Requested by LB Pharmaceuticals Inc [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commis
2025-08-22 - CORRESP - LB PHARMACEUTICALS INC
CORRESP 1 filename1.htm CORRESP Divakar Gupta T: (212) 479-6474 dgupta@cooley.com August 22, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Christine Torney Mary Mast Doris Stacey Gama Laura Crotty Re: LB Pharmaceuticals Inc Amendment No.2 to Draft Registration Statement on Form S-1 Submitted on July 23, 2025 CIK No. 0001691082 Ladies and Gentlemen: On behalf of LB Pharmaceuticals Inc (the “ Company ”), the following information is submitted in response to the comments received from the staff (the “ Staff ”) of the U.S. Securities and Exchange Commission (the “ Commission ”) by letter dated August 12, 2025 (the “ Comment Letter ”) regarding the above-referenced Amendment No.2 to the draft Registration Statement on Form S-1, as confidentially submitted to the Commission on July 23, 2025. Concurrently with the submission of this response letter, the Company is filing a revised Registration Statement on Form S-1 (the “ Registration Statement ”) with the Commission. In addition to addressing the comments raised by the Staff in the Comment Letter, the Company has included other revisions and updates to its disclosure in the Registration Statement. For the convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the respective comment in the Comment Letter, the text of which we have incorporated into this response letter for convenience in italicized type and which is followed by the Company’s response. In the responses below, page number references are to the Registration Statement. Amendment No. 2 to Draft Registration Statement on Form S-1 Prospectus Summary Overview, page 1: 1. You state that based on positive end-of-Phase 2 feedback from the FDA, as well as historical precedent, you believe that your Phase 2 acute schizophrenia trial may serve as one of the two pivotal trials required for approval of a new drug application and therefore would only need a single, six-week Phase 3 trial alongside other planned NDA-enabling studies for approval. Please balance this disclosure by also stating that there is no guarantee that your Phase 2 trial may serve as one of the two pivotal trials required which in such case you may be required to conduct two pivotal trials for NDA approval. Response: In response to the Staff’s comment, the Company has revised the disclosures on pages 2, 113 and 137 of the Registration Statement. Cooley LLP 55 Hudson Yards, New York, NY 10001-2157 t: (212) 479-6000 f: (212) 479-6275 cooley.com U.S. Securities and Exchange Commission August 22, 2025 Page Two Business, page 110: 2. We note your use of p-values throughout this section regarding your product candidate LB-102. At first use, please provide a brief explanation of the disclosed p-value and how it is used to measure statistical significance. Response: In response to the Staff’s comment, the Company has revised the disclosures on page 128 of the Registration Statement. * * * Please contact me at (212) 479-6474 with any questions or further comments regarding our responses to the Staff’s comments. Sincerely, /s/ Divakar Gupta Divakar Gupta cc: Heather Turner, LB Pharmaceuticals Inc Gad Soffer, LB Pharmaceuticals Inc Marc Panoff, LB Pharmaceuticals Inc Brandon Fenn, Cooley LLP Marc Recht, Cooley LLP Minkyu Park, Cooley LLP Cooley LLP 55 Hudson Yards, New York, NY 10001-2157 t: (212) 479-6000 f: (212) 479-6275 cooley.com
2025-08-12 - UPLOAD - LB PHARMACEUTICALS INC File: 377-07237
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 12, 2025 Heather Turner Chief Executive Officer LB Pharmaceuticals Inc One Pennsylvania Plaza, Suite 1025 New York, NY 10119 Re: LB Pharmaceuticals Inc Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted July 23, 2025 CIK No. 0001691082 Dear Heather Turner: 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 and non-public draft submissions 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. Amendment No. 2 to Draft Registration Statement on Form S-1 Prospectus Summary Overview, page 1 1. You state that based on positive end-of-Phase 2 feedback from the FDA, as well as historical precedent, you believe that your Phase 2 acute schizophrenia trial may serve as one of the two pivotal trials required for approval of a new drug application and therefore would only need a single, six-week Phase 3 trial alongside other planned NDA-enabling studies for approval. Please balance this disclosure by also stating that there is no guarantee that your Phase 2 trial may serve as one of the two pivotal trials required which in such case you may be required to conduct two pivotal trials for NDA approval. August 12, 2025 Page 2 Business, page 110 2. We note your use of p-values throughout this section regarding your product candidate LB-102. At first use, please provide a brief explanation of the disclosed p- value and how it is used to measure statistical significance. 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 Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Brandon Fenn, Esq. </TEXT> </DOCUMENT>
2024-07-02 - UPLOAD - LB PHARMACEUTICALS INC File: 377-07237
July 2, 2024
Zachary Prensky
Chief Executive Officer
LB Pharmaceuticals Inc
575 Madison Avenue
New York, NY 10022
Re:LB Pharmaceuticals Inc
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted June 24, 2024
CIK No. 0001691082
Dear Zachary Prensky:
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
June 27, 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. Please further revise your disclosure to
include the date the company first submitted the IND to the FDA.
Business
Our Solution: LB-102 for the Treatment of Schizophrenia, page 112
2.In response to prior comment 15 you discuss a 2014 study of 30 psychiatric drugs. If true,
please clarify that this study was conducted by a third party.
July 2, 2024
Page 2
Please contact Christine Torney at 202-551-3652 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Minkyu Park, Esq.
2024-06-17 - UPLOAD - LB PHARMACEUTICALS INC File: 377-07237
United States securities and exchange commission logo
June 17, 2024
Zachary Prensky
Chief Executive Officer
LB Pharmaceuticals Inc
575 Madison Avenue
New York, NY 10022
Re:LB Pharmaceuticals Inc
Draft Registration Statement on Form S-1
Submitted May 20, 2024
CIK No. 0001691082
Dear Zachary Prensky:
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 the cover page to disclose whether your offering is contingent on final
approval of your NASDAQ listing. Please also ensure this disclosure is consistent with
your underwriting agreement.
Prospectus Summary
Overview, page 1
2.We note your statement that amisulpride has received regulatory approvals and has been
commercialized outside of the US for the treatment of schizophrenia. Please include
disclosure similar to that on page 112 which provides information on the countries where
amisulpride has been approved. Please also explain the company's understanding of why it
has not received regulatory approval in the US to date.
FirstName LastNameZachary Prensky
Comapany NameLB Pharmaceuticals Inc
June 17, 2024 Page 2
FirstName LastNameZachary Prensky
LB Pharmaceuticals Inc
June 17, 2024
Page 2
3.Please revise this section to include a brief description of the interactions the company has
had to date with the FDA in relation to LB-102, including the timing of regulatory
submissions.
4.Please revise the Summary to include a brief overview of the data collected in the
company's Phase 1 clinical trial for LB-102 for schizophrenia.
Our Team and History, page 2
5.You state here and on page 109 that since your inception you have raised $121.7 million
from a leading syndicate of investors including Deep Track Capital, Pontifax, TCGX, and
Vida Ventures. Please advise whether TCGX is a related party or affiliate of TCG
Crossover Fund, which is listed in the principal stockholder table on page 179 as a greater
than 5% stockholder. If it is not, please remove the reference to TCGX as a previous
investor in the Summary. Please also revise this disclosure to indicate that prospective
investors should not rely on the other named investors’ previous investment decision, that
these investors may have different risk tolerances to investors in the offering and, if true,
the offering(s) pursuant to which the named investors acquired their shares was conducted
at a discount to the IPO price.
Use of Proceeds, page 82
6.You state that you intend to use a certain amount of money to "advance the clinical
development of LB-102 to treat acute schizophrenia[.]" Please describe how far in the
development process you estimate that the allocated proceeds from the offering will
enable you to reach.
Management's Discussion and Analysis and Financial Condition and Results of Operations
Critical Accounting Estimates
Determination of the Fair Value of Common Stock, page 103
7.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.
Business
Overview, page 107
8.We note various statements throughout the prospectus related to the potential safety
and/or efficacy of LB-102. For example, you state that "preclinical studies in models of
schizophrenia demonstrated the LB-102 had the potential to show efficacy results superior
to those of amisulpride" and that "LB-102 provided consistent dopamine receptor
occupancy in the brain at levels [you] believe will effectively treat schizophrenia at doses
lower than amisulpride, potentially allowing efficacy benefits and once-daily dosing."
FirstName LastNameZachary Prensky
Comapany NameLB Pharmaceuticals Inc
June 17, 2024 Page 3
FirstName LastName
Zachary Prensky
LB Pharmaceuticals Inc
June 17, 2024
Page 3
Please revise your disclosure throughout the document, including but not limited to these
statements, to eliminate the implication that your product candidate has been or will
ultimately be determined safe and/or effective or has demonstrated safety and/or efficacy,
as such determinations are within the sole purview of the FDA or similar foreign
regulators. Note that you may state your product candidate has been well tolerated, if
accurate, and include data observed in clinical trials but should not draw conclusions from
such data.
9.You state that amisulpride is one of the most effective antipsychotic medications currently
in use. Please clarify that amisulpride is not approved in the US as an antipsychotic
medication, if true.
10.You state that your Phase 1 clinical trials achieved a level of dopamine receptor
occupancy in the brain comparable to amisulpride and that in your Phase 1 imaging trial
you observed dopamine receptor occupancy at levels that other treatments have shown to
be effective in treating schizophrenia. Please revise this disclosure to clarify that there is
no guarantee that LB-102 will be approved.
Our Strategy, page 109
11.You state that amisulpride is approved for treatment of dysthymia in Brazil, Italy, Latvia,
and Slovakia and refer to various studies conducted in 2022, 1997, and 2006. Please
clarify, if true, that these studies were conducted by third parties. Further, you state that a
2006 trial also found amisulpride to be as clinically effective as sertraline. Please clarify if
the trials were conducted as head-to-head studies.
12.You state that a 2018 clinical trial studied the efficacy of amisulpride in the treatment of
elderly patients with very late-onset schizophrenia-like psychosis and showed
significantly improved results and that because of amisulpride's efficacy results you
believe that LB-102 could be developed for the treatment of Alzheimer's psychosis. Please
clarify if amisulpride has been approved by the FDA or a comparable foreign regulator for
the treatment of elderly patients with very late-onset schizophrenia-like psychosis. We
remind you that safety and efficacy determinations are solely within the authority of the
FDA or applicable foreign regulator. If amisulpride has not been approved by the FDA or
comparable foreign regulator, please remove statements regarding efficacy in this
context.
13.You state that due to the results of amisulpride in the treatment of elderly patients with
very late-onset schizophrenia-like psychosis in a 2018 clinical trial you believe you can
develop LB-102 for the treatment of other neuropsychiatric diseases, such as Alzheimer's
psychosis. Please discuss how the use of amisulpride for very late-onset schizophrenia-
like psychosis relates to the use of LB-102 for the different indication of Alzheimer's
psychosis.
FirstName LastNameZachary Prensky
Comapany NameLB Pharmaceuticals Inc
June 17, 2024 Page 4
FirstName LastName
Zachary Prensky
LB Pharmaceuticals Inc
June 17, 2024
Page 4
Limitations of Current Treatments for Schizophrenia, page 110
14.We note your chart on page 111 disclosing the reduction in PANSS vs Baseline scores.
Please include a discussion of the significance of the scores listed. Also, please disclose
that PANNS is a subjective assessment which requires patients or examiners to undertake
a questionnaire regarding symptoms at the beginning and end of the trial, which can
increase the variability of clinical results across clinical trials and create a significant
degree of uncertainty in determining overall clinical benefit, as you do on page 14.
Our Solution: LB-102 for the Treatment of Schizophrenia, page 112
15.We note your disclosure here that LB-102 was generally well-tolerated and demonstrated
a safety profile consistent with amisulpride, on page 118 that the effects and results from
treatment with LB-102 were on par with and, in some instances, better than
amisulpride, and similar statements throughout your document comparing your LB-102
candidate to the safety and efficacy results of other drugs that have reached
commercialization. Please clarify whether you have conducted head-to-head trials
between LB-102 and amisulpride or other approved products to support such statements.
If you have not conducted head-to-head trials, please remove all direct comparisons from
the prospectus.
Our Lead Product Candidate, LB-102, page 116
16.You state that LB-102 is a patented benzamide designed to improve upon the safety and
efficacy of amisulpride and that in creating LB-102 you added a methyl group to the
chemical structure of amisulpride with the intention of improving its permeability of the
blood-drain barrier. You also state on page 18 that LB-102 is an N-methylated version of
amisulpride and that LB-102 is structurally similar to amisulpride. We note that
amisulpride has not received regulatory approval in the US. Please revise your disclosure
to clarify whether you are relying on clinical trial results for amisulpride in other
jurisdictions in advancing LB-102 through US clinical trials.
LB-102 Clinical Data
Completed Phase 1 Clinical Trial of LB-102 in Healthy Volunteers, page 119
17.You state that you conducted a Phase 1 clinical trial for LB-102. Please disclose
where these trials were conducted.
Intellectual Property
Overview, page 127
18.You state that as of April 18, 2024, you owned approximately 42 patents and pending
patent applications in the US and foreign jurisdiction. You also state that as of April 18,
2024, you owned approximately 39 patents and pending patent applications in the US and
foreign jurisdictions relating to LB-102. Please include a discussion of the other three
FirstName LastNameZachary Prensky
Comapany NameLB Pharmaceuticals Inc
June 17, 2024 Page 5
FirstName LastNameZachary Prensky
LB Pharmaceuticals Inc
June 17, 2024
Page 5
patents not accounted for, including the type of patent protection (for example,
composition of matter, use or process), the specific product(s) to which the patents relate,
whether the patents are owned or licensed, the patent expiration dates, and the applicable
jurisdictions.
19.We note the table on page 128 relating to patents and pending patent applications directed
to LB-102. For each of the two line items, please clarify how many issued or pending
patent applications are captured and the applicable jurisdiction of each.
License and Other Agreements
LB-102, page 127
20.You state that in August 2023 you entered into several Amended and Restated Royalty
Agreements with certain of your investors, co-founders, former directors, and executive
officers. Please include a complete description of each parties' rights and obligations
under the agreements.
13. Related Party Transactions, page F-33
21.You disclose that in August 2023 you entered into several amended and restated royalty
participation agreements with certain of your investors, co-founders, former directors, and
executive officers. Please address the following:
•Clarify the terms of the original and amended agreements.
•If there was any consideration received in connection with either the original or
amended agreements, please disclose the accounting treatment and tell us your
consideration of ASC 470-10-25.
•If the amended agreements were entered into contemporaneously with the preferred
stock offering, tell us your consideration of whether any of the proceeds received
from the preferred stock offering should have been allocated to the amended royalty
agreements. In this regard, tell us if the parties in the royalty agreements were also
parties in the preferred stock offering.
General
22.Please 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 the staff member associated with the
review of this filing to discuss how to submit such copies.
Please contact Christine Torney at 202-551-3652 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with any other
questions.
FirstName LastNameZachary Prensky
Comapany NameLB Pharmaceuticals Inc
June 17, 2024 Page 6
FirstName LastName
Zachary Prensky
LB Pharmaceuticals Inc
June 17, 2024
Page 6
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Minkyu Park, Esq.