SEC Comment Letter 0000000000-22-013203 to Enliven Therapeutics, Inc. (ELVN) (CIK 0001672619) (ELVN)
Enliven Therapeutics, Inc. (ELVN) (CIK 0001672619)
Date: Dec. 7, 2022 · CIK: 0001672619 · Accession: 0000000000-22-013203
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File numbers found in text: 333-268300
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United States securities and exchange commission logo
December 7, 2022
Rahul Ballal, Ph.D.
President and Chief Executive Officer
Imara Inc.
1309 Beacon Street, Suite 300, Office 341
Brookline, MA 02446
Re:Imara Inc.
Registration Statement on Form S-4
Filed November 10, 2022
File No. 333-268300
Dear Rahul Ballal:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments.
Registration Statement on Form S-4 filed November 10, 2022
Questions and Answers about the Merger
Will the common stock of the combined company trade on an exchange?, page 4
1.Please revise your disclosure as follows:
•Disclose, as you have on page 197, that Imara has agreed to cause the shares of Imara
common stock being issued in the Merger to be approved for listing on Nasdaq at or
prior to the effective time. State both here, on page 197 and elsewhere as appropriate,
as you have in Article VII of the Merger Agreement, that the approval for listing
these shares on Nasdaq, subject to official notice of issuance, is a closing condition of
the Merger. Also disclose whether the terms of the merger agreement permit that this
closing condition could be waived without recirculation or resolicitation. In this
regard, we note that disclosure on page 197 and 212 seems to indicate that this
FirstName LastNameRahul Ballal, Ph.D.
Comapany NameImara Inc.
December 7, 2022 Page 2
FirstName LastNameRahul Ballal, Ph.D.
Imara Inc.
December 7, 2022
Page 2
condition is waivable.
•You disclose that Enliven has filed a listing application for the combined company’s
common stock with Nasdaq and that it is "expected" that the common stock of the
combined company will trade on The Nasdaq Stock Market. Please revise here and
on pages 23 and 197, and elsewhere as appropriate, to make clear whether the merger
is conditioned upon receiving Nasdaq listing approval for the combined company,
and if so, whether such condition is waivable. State whether Nasdaq's determination
in this regard will be known at the time that stockholders are asked to vote to approve
the business combination. Please also include a cross-reference to your risk factor
disclosure stating that the potential reverse stock split may not result in an increase in
the combined company’s stock price necessary to satisfy Nasdaq’s initial or
continued listing requirements for the combined company.
•Disclose here, in your risk factor disclosure on page 32, and elsewhere as appropriate,
whether or not you satisfy the objective Nasdaq listing criteria, and if not, explain
which requirement(s) your stock does not currently meet for listing and describe your
plan to remedy. In your risk factor disclosure, explain how the reverse stock split is
intended to cause you to be in compliance.
What are the material U.S. federal income tax consequences of the Merger to Enliven U.S.
holders?, page 7
2.We note your representation here and beginning on page 195 that Imara and Enliven
"intend" the merger to qualify as a reorganization within the meaning of Section 368(a) of
the U.S. Internal Revenue Code of 1986, as amended (the "Code"), and/or a non-taxable
exchange transaction governed by Section 351(a) of the Code. Please revise your
disclosure here and throughout to provide counsel’s firm opinion for each material tax
consequence, including whether the Merger will qualify as a reorganization and/or a non-
taxable exchange transaction, or to explain why such opinion cannot be given. If the
opinion is subject to uncertainty, please (1) provide an opinion that reflects the degree of
uncertainty (e.g., "should" or "more likely than not") and explains the facts or
circumstances giving rise to the uncertainty, and (2) provide disclosure of the possible
alternative tax consequences including risk factor and/or other appropriate disclosure
setting forth the risks of uncertain tax treatment to investors. Please refer to Item
601(b)(8) of Regulation S-K and Section III.A. of Staff Legal Bulletin 19, Legality and
Tax Opinions in Registered Offerings.
Prospectus Summary
The Companies, page 9
3.We note your statement that Enliven's goal is to design best-in-class or first-in-class
therapies, and other similar statements throughout such as those indicating that "Enliven’s
product candidates will be aimed to be best-in-class and first-in-class." Given the
development stage of Enliven's product candidates and length of the drug approval
process, it is premature and inappropriate to speculate or imply that any Enliven product
FirstName LastNameRahul Ballal, Ph.D.
Comapany NameImara Inc.
December 7, 2022 Page 3
FirstName LastNameRahul Ballal, Ph.D.
Imara Inc.
December 7, 2022
Page 3
candidates will ultimately be approved or become best-in-class or first-in-class. Please
remove these statements.
Enliven's Pipeline, page 11
4.Please clarify what the "Differentiation" column in the pipeline table is intended to
convey. In addition, we note you have created a distinction between "lead optimization"
and "IND-enabling." Please explain what is involved in "lead optimization" and why you
believe this is a separate and distinct development phase, as opposed to part of discovery
and/or IND-enabling studies, or revise.
Support Agreements, page 17
5.We note your discussion of the support agreements beginning on pages 17 and 219.
•Please tell us with specificity who signed the support agreements, and show us how
the percentages of securities covered are reconcilable to the beneficial ownership
disclosure on pages 415-423.
•We also note the discussion of irrevocable proxies in the disclosure and in section 7
of Exhibit 2.3, which is incorporated by reference to your Form 8-K filed October 13,
2022. Please provide us your analysis supporting your conclusions regarding
whether offers and sales of the securities registered for sale have already been made
and completed. For guidance, see the Division of Corporation Finance's Securities
Act Sections Compliance and Disclosure Interpretation 239.13 available on the
Commission's website.
Common Stock Purchase Agreement, page 18
6.We note your description of the Common Stock Purchase Agreement here and on page
220. In your description of the agreement, please identify each shareholder who is
purchasing shares pursuant to such agreement and who is expected to be a beneficial
owner of 5% or more of the outstanding shares of Enliven following the financing.
Risk Factors
Risks Related to the Proposed Reverse Stock Split, page 32
7.We note your disclosure that the principal purpose of the reverse stock split is to increase
Imara's common stock price so that the combined company is able to meet initial listing
requirements and the shares of Imara common stock being issued in the merger will be
approved for listing. In your risk factors and elsewhere as appropriate:
•Please disclose the minimum size of the reverse split that will be necessary for listing.
•Please expand the discussion to indicate the criteria, if any, for the ratio to be used for
the reverse stock split. For example, indicate whether you intend to use the minimum
ratio or a larger ratio in an attempt for a higher price per share subsequent to the
reverse stock split.
•You state at the top of page 33 that the reverse stock split may not result in an
increase in the combined company’s stock price necessary to satisfy Nasdaq’s initial
FirstName LastNameRahul Ballal, Ph.D.
Comapany NameImara Inc.
December 7, 2022 Page 4
FirstName LastNameRahul Ballal, Ph.D.
Imara Inc.
December 7, 2022
Page 4
listing requirements for the combined company. Please enhance your risk factor
disclosure, page 197, and elsewhere as appropriate, to explain the effects on the
proposed transaction and/or the combined company of a failure to comply with the
initial listing requirements of Nasdaq. If the Nasdaq listing approval of the combined
company is a condition that can be waived, please include a discussion of the
potential consequences to investors, including the ability of investors to buy and sell
shares of common stock, if the Nasdaq does not approve the listing application of the
combined company, but the election is made to waive the closing condition and
proceed with the merger.
•You state on page 32 that there can be no assurance that the stock price of the
combined company will meet the listing requirements for any meaningful period of
time. Please enhance your risk factor disclosure, page 197, and elsewhere as
appropriate, to explain the effects on the combined company and its shareholders of a
failure to comply with the continued listing requirements of Nasdaq, including the
potential delisting of its common stock and its impact.
•Please similarly revise your summary risk factor on the reverse stock split on page
22 to explain the effect on the proposed merger transaction or the combined company
if the reverse stock split does not increase the combined company's stock price over
the short- or long-term so as to qualify for Nasdaq listing.
Risks Related to Imara's Intellectual Property, page 52
8.We note your disclosure on page 52 that Imara is party to license agreements with the
UAB Research Foundation and the University of Pittsburgh with respect to IMR-261, and
that this statement appears to conflict with your statement on page 49 that Imara is "not
currently party to any sales, marketing, distribution, development, licensing or broader
collaboration agreements." In this regard:
•Please revise to reconcile your statements regarding Imara's current license
agreements or advise.
•To the extent material, please revise your disclosure to discuss the terms of any
licensing agreements still in effect between Imara and any other party. Include a
discussion of all material payment terms, including quantification of any annual
maintenance fees, upfront payments, amounts paid to date, and the applicable royalty
rates to be paid by each party. In the event a range is provided in place of the actual
royalty rate, such range should be within ten percentage points.
•Additionally, please file Imara's current license agreements as exhibits or provide an
analysis explaining why they should not be filed pursuant to Regulation S-K, Item
601(b)(10).
The FDA, EMA and other comparable foreign regulatory authorities may not accept data..., page
103
9.Please expand this risk factor and elsewhere as appropriate to disclose the location(s) of
the clinical trials of ELVN-001 conducted internationally, and the planned location(s)
FirstName LastNameRahul Ballal, Ph.D.
Comapany NameImara Inc.
December 7, 2022 Page 5
FirstName LastNameRahul Ballal, Ph.D.
Imara Inc.
December 7, 2022
Page 5
for international trials of ELVN-002. In this regard, we note that on page 129 you state
that Enliven uses Pharmaron, located in China, to conduct preclinical studies and clinical
trials.
The certificate of incorporation and bylaws of the combined company will provide..., page 152
10.We note your disclosure that the certificate of incorporation and the bylaws of the
combined company will provide that the Court of Chancery of the State of Delaware is the
sole and exclusive forum for certain litigation, including any derivative action.
•Please disclose whether this provision applies to actions arising under the Securities
Act or Exchange Act. In this regard, we note that Section 27 of the Exchange Act
creates exclusive federal jurisdiction over all suits brought to enforce any duty or
liability created by the Exchange Act or the rules and regulations thereunder, and
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state
courts over all suits brought to enforce any duty or liability created by the Securities
Act or the rules and regulations thereunder. If the provision applies to Securities Act
claims, please also revise your prospectus to state that there is uncertainty as to
whether a court would enforce such provision and that investors cannot waive
compliance with the federal securities laws and the rules and regulations thereunder.
•Please revise this risk factor to disclose that there is also a risk that your exclusive
forum provision may result in increased costs for investors to bring a claim in the
chosen forum.
•If this provision does not apply to actions arising under the Securities Act or
Exchange Act, please ensure that the exclusive forum provision in the governing
documents states this clearly, or tell us how you will inform investors in future filings
that the provision does not apply to any actions arising under the Securities Act or
Exchange Act.
Background of the Merger, page 165
11.With reference to your description of the timeline of the proposed business combination
that begins on page 165:
•With respect to the negotiations between Imara and Enliven, please revise your
disclosure throughout this section to provide greater detail as to how the material
terms of the transaction structure and consideration evolved during the negotiations
through proposals and counter-proposals. For example, with regard to the initial
negotiations, please revise to explain the reason(s) for the inclusion of, and any
revisions to, the material terms from the initial non-binding indication of interest
Imara received from Enliven on July 28, 2022 to the August 12, 2022 updated non-
binding indication of interest, including why Enliven increased the valuation of
Imara's Nasdaq listing.
•Revise your disclosure of any individual meetings to include discussion regarding the
material topics, views, and positions that were discussed at the meetings, and by
whom.
FirstName LastNameRahul Ballal, Ph.D.
Comapany NameImara Inc.
December 7, 2022 Page 6
FirstName LastNameRahul Ballal, Ph.D.
Imara Inc.
December 7, 2022
Page 6
•Revise this section to discuss how Imara's management and board conducted
corporate, technical scientific and industry due diligence on Enliven and other
companies.
•Explain how the key deal terms of the Merger Agreement listed on page 171 were
negotiated by the parties between the initial draft of the Merger Agreement provided
to Enliven on August 25, 2022 and the executed version of October 13, 2022.
Additionally, please ensure that your disclosure addresses other material aspects of
the transaction to the extent discussed in negotiation. By way of example and not
limitation, discuss how the exchange ratio was determined; any discussions of the
support agreements; and negotiations of material terms of the merger agreement such
as termination rights and fees and the structure of the combined company board of
directors and management. The disclosure should provide shareholders with an
understanding of how, when, and why the material terms of your proposed
transaction evolved and why this transaction is being recommended as opposed to
any alternatives.
•We note that OrbiMed is a significant stockholder of Imara and of Enliven and
designates a member to each company’s board of directors. Please disclose whether
the boards had any policies or procedures in place to address any potential conflicts
of interest in the search process and in the negotiation and approval of the Merger.
•Briefly describe in more detail any discussions about the need to obtain additional
financing for the combined company, such as the concurrent Pre-Closing Financing,
and the negotiation process with respect to the terms of the financing.
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