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United States securities and exchange commission logo
June 9, 2021
Mehesh Karande
Chief Financial Officer
Omega Therapeutics, Inc.
20 Acorn Park Dive
Cambridge, MA 02140
Re: Omega Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Filed may 10, 2021
CIK No. 0001850838
Dear Mr. Karande:
We have reviewed your draft 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 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 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 the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1 submitted May 10, 2021
Overview, page 1
1. Please revise the
opening paragraph to provide context and balance to your disclosure that
you are an
early-stage biopharmaceutical company and to highlight that your operations
are preclinical in
nature.
2. We note your statement
on page 1 that you believe your platform will fundamentally
transform human
medicine and has broad potential applicability across a range of
diseases and
conditions. Please place this selected disclosure in its proper context by
revising your Summary
disclosure to make it clear, per your disclosure of your intellectual
property, that your
in-licensed patents relate to specific diseases and conditions, such as
HCC and NSCLC.
Mehesh Karande
FirstName LastNameMehesh Karande
Omega Therapeutics, Inc.
Comapany
June 9, 2021NameOmega Therapeutics, Inc.
June 9,
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3. Please clarify the meaning or scientific or technical terms the first
time they are used in
the Summary and the Business sections or in close proximity thereto in
order to ensure
that lay readers will understand the disclosure. For example, please
briefly explain what
you mean by oncogenes, HCC xenograts, lipid excipients, effector
proteins and cationic
and ionizable LNPs.
4. Please replace your statement that you have achieved in vivo proof of
concept with an
objective description of your preclinical results and remove the
prediction that you expect
to achieve in vivo preclinical proof-of-concept for multiple
additional programs in ___.
You may indicate when you expect to complete in vivo studies but not
the results of such
studies.
Advantages of Omega Platform, page 3
5. Please balance your disclosure with equally prominent disclosure of
the disadvantages of
your platform, including clinical data relating to novel products can
be difficult to analyze
and approval of novel products can be more expensive and take longer.
Our Portfolio, page 4
6. Please revise your pipeline table on pages 4 and 113 to limit the
preclincal phases
presented as separate columns to two, discovery and preclinical
trials, and to include
separate columns for each of the Phase 1, 2 and 3 trials. We also note
that your Summary
pipeline table contains text that is difficult to read. Please revise
to increase the font size
and clarify which candidate(s) the text relates to.
7. We note the inclusion of several product candidates relating to the
treatment of relating to
the corneal regeneration, idiopathic pulmonary fibrosis and small cell
lung cancer diseases
with undisclosed targets in the second, fourth and seventh rows in
your Summary pipeline
table. Given the lack of disclosure
related to these programs, please explain why these programs are
sufficiently material to
your business to warrant inclusion in your pipeline table. If they are
material, please
expand your disclosure in your Business section to provide a more
fulsome discussion of
these programs, including a description of preclinical studies or
development activities
conducted. Alternatively, remove any programs that not currently
material from your
pipeline table on pages 4 and 113.
Developments by competitors may render our products or technologies
obsolete..., page 47
8. We note your disclosure on page 48 and 133 that several of your
competitors are
developing technologies focused on gene-expression control using
various technologies.
Please disclose whether any of your competitors are developing
gene-expression therapies
for the treatment of diseases such as HCC, NSCLC and ARDS.
Our restated certificate of incorporation will designate specific courts as the
exclusive forum...,
Mehesh Karande
FirstName LastNameMehesh Karande
Omega Therapeutics, Inc.
Comapany
June 9, 2021NameOmega Therapeutics, Inc.
June 9,
Page 3 2021 Page 3
FirstName LastName
page 85
9. We note your disclosure that your forum selection provision in your
restated certificate of
incorporation may limit a shareholder s ability to bring a claim in
a judicial forum that it
finds favorable for disputes with you and may discourage such
lawsuits. Please revise this
risk factor and your disclosure on page 179 to discuss that there is
also a risk that your
forum selection provision may result in increased costs for investors
to bring a claim.
Use of Proceeds, page 90
10. Please revise to identify the specific product candidates for which
you intend to use the
proceeds of the offering, quantify the approximate
amount of proceeds you intend to allocate toward each and indicate how
far the proceeds
from the offering will allow you to proceed with the continued
development of
each programs.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 103
11. We note your disclosure on page 102 that you do not track research and
development
expenses on a program by program basis. In light of the significant
increase in research
and development expenses, please revise to provide a breakdown of your
research and
development expenses by type of expense.
Hepatocellular Carcinoma, page 125
12. We refer to your disclosure on pages 126 and 127 regarding your
preclinical
studies comparing your product candidate OTX-2002 with sorafenib.
Please expand your
disclosure to the disclose any observed adverse side effects and the
primary and secondary
endpoints, as applicable.
Manufacturing, page 131
13. We refer to your disclosure on page 132 regarding a third-party
provider with extensive
LNP intellectual property and a highly experienced CDMO that will
manufacture your
product candidates that you will rely on for your delivery technology.
To the extent you
are dependent on the third-party provider with extensive LNP
intellectual property, please
identify the party and file any agreements as exhibits to the
registration statement. See
Item 101(h)(4)(v) and Item 601(b)(10) of Regulation S-K.
Alternatively, provide an
analysis supporting your degermation that such information is not
required.
Intellectual Property, page 133
14. We refer to your disclosure on pages 134 and 135 regarding your patent
portfolio for
specified products and technologies. For each of the product and
technology areas
identified, please clarify your disclosure to specify the number of
patents and/or patent
Mehesh Karande
FirstName LastNameMehesh Karande
Omega Therapeutics, Inc.
Comapany
June 9, 2021NameOmega Therapeutics, Inc.
June 9,
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applications, whether such patents or patent applications are owned or
licensed, as well as
the applicable jurisdiction for each group of patents or patent
applications. You also
disclose on page 133 that all patents and patent applications in your
patent portfolio will
expire between 2035 and 2042. Please specify when you expect the
patents issuing from
patent applications in each category of your patent portfolio to
expire.
15. We note your disclosure on page 135 regarding other patent
applications relating to novel
OEC compositions and their use for treating additional disorders,
including other cancers,
inflammatory disorders, neurological and metabolic disorders. Please
specify the number
of patent applications, whether they are owned or licensed, and
applicable jurisdiction of
such patent applications.
License Agreement with Flagship, page 135
16. You disclose on page 135 that you assigned to Flagship certain
foundational intellectual
property ("Foundational IP") and obtained an exclusive,
royalty-bearing license from
Flagship under such Foundational IP to develop any product thereof.
Please expand your
disclosure to describe the nature, scope and expiration of
intellectual property comprising
the Foundational IP. Additionally describe your obligations under the
Flagship agreement.
17. We note your disclosure on page 136 regarding the Flagship license
agreement. Please
expand your disclosure of the type of product or technology that the
licensed patents relate
to and when the last-to-expire licensed patent is scheduled to expire.
18. Please expand your disclosure on page 136 of the intellectual property
that is jointly
conceived by you and Flagship, including who is responsible for the
clinical development
of such intellectual property included within the scope of the
license.
Exclusive and Co-Exclusive License Agreements with WIBR, page 136
19. Please revise your disclosure to specify the aggregate amounts paid to
date (including the
payment of any upfront or execution fees), when the last-to-expire
patent is scheduled to
expire and the royalty term, as applicable, under your exclusive
license agreement with
WIBR.
20. We refer to your disclosure on page 136 regarding your co-exclusive
license agreement
with WIBR. Please revise your disclosure to disclose when the last-to
expire licensed
patent is scheduled to expire, the royalty term and the aggregate
amounts paid to date
under the license agreement (including payment of any upfront or
execution fees). We
also note your disclosure on page 136 that your co-exclusive rights
under the WIBR Co-
Exclusive Agreement will become exclusive if the co-exclusive license
agreement
between WIBR and the co-exclusive licensee is terminated. Please
expand your
disclosure of the termination provisions of your co-exclusive license
agreement with
WIBR.
21. Please describe the nature of an invention that would result in the
third party to the SRA
Mehesh Karande
FirstName LastNameMehesh Karande
Omega Therapeutics, Inc.
Comapany
June 9, 2021NameOmega Therapeutics, Inc.
June 9,
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FirstName LastName
obtaining non-exclusive rights to the licensed patents.
22. You disclose on page 136 that your co-exclusive rights under the WIBR
Co-Exclusive
Agreement will become exclusive if the co-exclusive license agreement
between WIBR
and the co-exclusive licensee is terminated. Please expand your
disclosure of the
termination provisions of your Co-Exclusive Agreement with WIBR.
Agreements with Acuitas, page 138
23. We refer to your disclosure on page 138 regarding your development and
option
agreement with Acuitas. Please disclose when the last-to-expire
licensed patent under the
second option are scheduled to expire. With respect to your disclosure
of the Acuitas
license agreement, please revise to disclose the aggregate amounts
paid to date and when
the last-to-expire licensed patent is scheduled to expire. We also
note your disclosure on
page 66 that you depend substantially on your license agreements,
including your Acuitas
license agreement. Please file the Acuitas option and license
agreements as exhibits to the
registration statement or provide analysis as to why it would not be
required under Item
601(b)(10) of Regulation S-K.
Note 2 - Summary of Significant Accounting Policies
Stock-based Compensation, page F-11
24. Once you have an estimated offering price or range, please provide us
an analysis
explaining the reasons for the differences between 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 the stock options, warrants and other stock-based
compensation, as well as
beneficial conversion features. Please discuss with the staff how to
submit your response.
General
25. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
communications.
You may contact David Burton at 202-551-3626 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Suzanne Hayes at 202-551-3675 with any
other questions.
Sincerely,
Division of
Corporation Finance
Mehesh Karande
Omega Therapeutics, Inc.
FirstName
June LastNameMehesh Karande
9, 2021
Page 6
Comapany NameOmega Therapeutics, Inc.
June 9, 2021 Page 6 Office of Life Sciences
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