SEC Comment Letter 0000000000-24-000410 to Contineum Therapeutics, Inc. (CTNM)
Contineum Therapeutics, Inc.
Date: Jan. 11, 2024 · CIK: 0001855175 · Accession: 0000000000-24-000410
AI Filing Summary & Sentiment
Show Raw Text
United States securities and exchange commission logo
January 11, 2024
Carmine Stengone
Chief Executive Officer and President
Contineum Therapeutics, Inc.
10578 Science Center Drive, Suite 200
San Diego, California 92121
Re:Contineum Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted December 13, 2023
CIK No. 0001855175
Dear Carmine Stengone:
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.We note you applied “for the quotation of the common stock on the Nasdaq Global Select
Market.” Please revise to clarify whether the offering is contingent upon final approval of
your Nasdaq listing. Please ensure that the disclosure is consistent with your underwriting
agreement.
Our Clinical Pipeline, page 1
2.We note the inclusion of the LPA1R DC and Discovery rows in the pipeline tables on
pages 2 and 113. Please explain why you believe these product candidates are material to
the company's operations at this time. In the event the company does consider each
material, please provide more detailed disclosure in both the Summary and Business
sections regarding each candidate. In the event these candidates are not material at this
time, please revise the pipeline table to remove each row. Note that the "Mechanism" and
FirstName LastNameCarmine Stengone
Comapany NameContineum Therapeutics, Inc.
January 11, 2024 Page 2
FirstName LastName
Carmine Stengone
Contineum Therapeutics, Inc.
January 11, 2024
Page 2
"Program" columns for the Discovery row should be revised to include substantive
information if such row remains in the table.
Prospectus Summary
Company Overview, page 1
3.We note various statements throughout the Prospectus that imply the efficacy of your
product candidates. For example, you state that certain candidates are “potent,” that you
“believe that PIPE-791, through its optimized preclinical selectivity, potency and dosing
profile, has the potential to become a highly differentiated therapeutic for both IPF and
Progressive MS,” that you “believe PIPE-791 has the potential to demonstrate
differentiated efficacy and an improved dosing profile versus other LPA1R assets in
development” and that you have "demonstrated" certain improvements in disease in
preclinical studies and trials to date. Because none of your product candidates have been
approved, please revise to remove these and similar statements, as efficacy determinations
are within the sole jurisdiction of the FDA and other similar foreign regulators. You may
include information regarding data observed in studies and trials but may not include the
company's conclusions based on such data.
4.We note your disclosure in the Summary and elsewhere that PIPE-307 is a potentially
"first-in-class” M1R inhibitor and that PIPE-791 has the potential to be a "best-in-class"
treatment for IPF. These terms suggest that your product candidates are effective and
likely to be approved. Given the stage of development of each, the terms
appear speculative. Please revise to delete these references here and throughout your
registration statement.
PIPE-307, page 3
5.Please revise your disclosure on page 4 to disclose that J&J has the right, in its sole
discretion, to further develop or to elect not to develop PIPE-307 for RRMS.
Our Team, page 6
6.We note you disclose the names of your investors on pages 6 and 118. Please limit the
disclosure of specific investors to those identified in the Principal Shareholder table on
page 196. Additionally, indicate that prospective investors should not rely on the named
investors’ investment decision, that these investors may have different risk tolerances and
that the shares purchased in the referenced financings were conducted at a significant
discount to the IPO price, if true.
Risks Related to Our Business, page 6
7.Please revise your Summary Risk Factors to quantify your accumulated deficit.
FirstName LastNameCarmine Stengone
Comapany NameContineum Therapeutics, Inc.
January 11, 2024 Page 3
FirstName LastName
Carmine Stengone
Contineum Therapeutics, Inc.
January 11, 2024
Page 3
Risk Factors
We do not intend to pay cash dividends for the foreseeable future., page 75
8.We note your risk factor on page 75 states your Loan Agreement with First Citizens Bank
“contains a negative covenant which prohibits [you] from paying dividends subject to
limited exceptions.” We also note your disclosure on page 100 which states that you
repaid all of the outstanding principal, the final payment fee and all outstanding and
accrued interest on the loan as of June 2023. Please revise your disclosure to clarify
whether the agreement is still in place and whether the negative covenant is still
applicable.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Collaboration, page 93
9.We note your disclosure that the J&J License Agreement expires on a "country-by-
country basis upon expiration of all royalty payment obligations for all products in such
country". Please revise to provide more specificity regarding the term of the agreement, as
such disclosure does not provide investors with a clear understanding of the duration.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation Expense and Common Stock Valuation, page 108
10.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the initial public offering and the estimated offering price. This information will help
facilitate our review of your accounting for equity issuances including stock
compensation. Please discuss with the staff how to submit your response.
Business, page 112
11.We note your discussion of statistical significance throughout the Business section. Please
revise your disclosure to provide p-values for the results of each study that was powered
for statistical significance. In addition, please disclose the primary and secondary
endpoints for each trial, to the extent applicable, adverse events and whether the trials met
the designated endpoints if the trial has concluded.
Preclinical Data Comparison Between PIPE-791 and Other LPA1R Antagonists, page 127
12.Please revise your table on page 128 to remove comparisons that were not the result of
head-to-head preclinical studies and revise to disclose the designs of the preclinical in
vitro and in vivo studies you conducted comparing PIPE-791 and third-party compounds.
FirstName LastNameCarmine Stengone
Comapany NameContineum Therapeutics, Inc.
January 11, 2024 Page 4
FirstName LastName
Carmine Stengone
Contineum Therapeutics, Inc.
January 11, 2024
Page 4
Clinical Development Plan of PIPE-791 in IPF, page 128
13.Please revise page 128 to remove the statement that you will submit a CTA “[f]ollowing
favorable safety results from [y]our Phase 1 healthy volunteer trial” as it assumes your
Phase 1 trial will be successful.
Intellectual Property, page 150
14.Please revise your disclosure to clarify the jurisdictions where you have patents and
pending patent applications for each of your patent families covering PIPE-791.
Notes to Audited Financial Statements
2. Summary of Significant Accounting Policies, page F-8
15.Please revise to disclose your revenue recognition policy within the audited financial
statements including your policy for contract modifications in accordance with ASC 606-
10-25-10 through 25-13, as set forth in ASC 606-10-50-1. Provide us with your
comprehensive analysis for the accounting treatment applied to the August 2023 contract
modification discussed on page F-52, including specific references to the supporting
authoritative accounting guidance. Also, revise the disclosure of your revenue
recognition policies and estimates within MD&A to discuss your policy for contract
modifications, focusing on the assumptions and uncertainties underlying this critical
accounting estimate. Refer to SEC Release No. 33-8350.
General
16. 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 Ibolya Ignat at 202-551-3636 or Kevin Kuhar at 202-551-3662 if you have
questions regarding comments on the financial statements and related matters. Please contact
Daniel Crawford at 202-551-7767 or Laura Crotty at 202-551-7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Thacker, Esq.