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United States securities and exchange commission logo
December 29, 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.
Amendment No. 1 to
Registration Statement on Form S-4
Filed December 19,
2022
File No. 333-268300
Dear Rahul Ballal:
We have reviewed your amended 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.
Unless we note
otherwise, our references to prior comments are to comments in our
December 7, 2022 letter.
Amendment No. 1 to Registration Statement on Form S-4
Litigation Related to the Merger, page 25
1. We have the following
comments with respect to the litigation you disclose in this section.
In an appropriate
place, please revise to describe the relief sought.
Please tell us your
consideration of adding a risk factor discussing
the litigation
related to the Merger, including whether such litigation could prevent
the merger from
becoming effective, or from becoming effective within the intended
timeframe.
Background of the Merger, page 168
2. We note your response
to prior comment 11, which we reissue with respect to the third
Rahul Ballal, Ph.D.
FirstName
Imara Inc. LastNameRahul Ballal, Ph.D.
Comapany29,
December NameImara
2022 Inc.
December
Page 2 29, 2022 Page 2
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bullet. Please further revise this section to discuss how Imara's
management and advisors
conducted corporate, technical, scientific and industry due diligence
on Enliven and other
companies.
Other Factors, page 187
3. We note your response to prior comment 14, which we reissue in part.
Your disclsoure in the penultimate paragraph in this section
states that SVB
Securities compared adjusted equity valuations to the proposed
Enliven valuation of
$324.6 million and also compared the resulting implied exchange
ratio of 0.5885x-
3.1924x to the exchange ratio. Please revise to state any
conclusions SVB Securities
reached regarding Enliven's valuation and the exchange ratio based
on the results of
these comparisons.
Additionally, please further revise to specify the number of
companies that SVB
Securities excluded from its comparable company analysis that
generally met the
selection criteria.
Certain Unaudited Financial Projections, page 189
4. We acknowledge the additional information provided in your response to
prior comment
15 but continue to believe that your presentation could provide
investors with additional
material disclosure in order to evaluate the reasonableness of the
Financial Projections.
.
Refer to bullet 2 of the prior comment, which we reissue in part.
In regard to the net
sales and operating income projected amounts, please specifically
address the growth
rates underlying your projections. In regard to the length of the
projections, please
disclose whether, and if so how, the forecasts reflect more than
simple assumptions
about growth rates. Additionally, revise your narrative disclosure
to describe and
quantify key factors underlying significant year-to-year changes
in revenues.
Refer to bullet 3 of the prior comment, which we reissue in part.
Specifically explain
how management and the Board determined that the projections are
reasonable,
particularly in light of the extensive length of the forecasts and
since Enliven is a
clinical stage company with limited operations and no approved
products.
We note you assume U.S. regulatory approval of ELVN-001 and
ELVN-002 in 2027
and 2028, respectively. You also appear to assume foreign
regulatory approval.
Please revise to explain how you arrived at the probability of
regulatory approval in
the U.S. and in any foreign jurisdiction and why you applied the
same regulatory
success rate for each of the pre-commercialization products.
We note that the Financial Projections assume net sales of
ELVN-001 and ELVN-
002 both in the U.S. and "outside of the United States." Please
revise to identify the
other principal target markets where you have assumed regulatory
approval,
including the assumed approval date in each jurisdiction. Provide
a breakdown of
forecasted non-U.S. revenues by product for each principal market.
You now state on page 191 that Imara management did not
independently incorporate
Rahul Ballal, Ph.D.
Imara Inc.
December 29, 2022
Page 3
specific assumptions regarding the market opportunity for the
product candidates.
Notwithstanding, for each product candidate, please revise to
disclose whether the
financial forecasts prepared by Enliven included assumptions
related to the length of
time from regulatory approval to commercial availability of each
product in each
principal target market, assumptions about market
acceptance/penetration rates,
specific market growth rates, the impact of competition, and any
other factors or
contingencies that would affect the projections. Explain how any
such assumptions
were determined, and explain the basis for assuming growth rates
over an extended
period of time.
We note the Financial Projections "reflect a blended
probability of success" for both
ELVN-001 and ELVN-002. Explain to us the extent to which you have
considered
providing separate forecasted financial information for each
product candidate based
on their stage of development, particularly since actual results
will differ materially if
one or both of the product candidates are not approved.
Our Team and Investors, page 294
5. We note your response to prior comment 19. Please further revise this
section to discuss
in greater detail the material terms of the consulting agreements with
your scientific
advisors referenced on page 295. Describe the parties rights and
obligations, payment
terms, including the amounts of equity and cash compensation paid or
to be paid, and
termination provisions. In addition, please file the agreements as
exhibits or provide an
analysis explaining why they should not be filed pursuant to
Regulation S-K, Item
601(b)(10).
Our Programs, page 299
6. We note your response to prior comment 20, which we reissue with
respect to the first
bullet. We note that there are still numerous instances throughout
this section where
information presented in your tables and figures appears to be printed
in much smaller
type than the surrounding text. Even with enhanced pixilation, such
text is not easily
legible. Please revise the formatting in your graphics to use font
size that is clearly
readable without the need for magnification.
Summary of Our Preclinical Results, page 310
7. We reissue the second bullet of prior comment 22 to the extent that you
have not disclosed
all serious adverse events that were deemed study related. In this
regard, we note that you
FirstName LastNameRahul Ballal, Ph.D.
have disclosed a non-exhaustive list of adverse findings from toxicity
studies of ELVN-
Comapany NameImara
001 and Inc.on pages 316 and 335. It may be useful to provide
this disclsoure in
ELVN-002
tabular
December 29, form.
2022 Page 3
FirstName LastName
Rahul Ballal, Ph.D.
FirstName
Imara Inc. LastNameRahul Ballal, Ph.D.
Comapany29,
December NameImara
2022 Inc.
December
Page 4 29, 2022 Page 4
FirstName LastName
You may contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494
if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Hamill at 303-844-1008 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Stephanie L. Leopold, Esq.