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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
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.
FirstName LastNameCarmine Stengone
Risks Related to Our Business, page 6
Comapany NameContineum Therapeutics, Inc.
JanuaryPlease
7. revise
11, 2024 your
Page 2 Summary Risk Factors to quantify your accumulated
deficit.
FirstName LastName
Carmine Stengone
FirstName
ContineumLastNameCarmine
Therapeutics, Inc. Stengone
Comapany
January 11,NameContineum
2024 Therapeutics, Inc.
January
Page 3 11, 2024 Page 3
FirstName LastName
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.
Carmine Stengone
FirstName
ContineumLastNameCarmine
Therapeutics, Inc. Stengone
Comapany
January 11,NameContineum
2024 Therapeutics, Inc.
January
Page 4 11, 2024 Page 4
FirstName LastName
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.