United States securities and exchange commission logo

                             February 19, 2021

       Garo Armen
       President and Chairman of the Board of Directors
       AgenTus Therapeutics, Inc.
       3 Forbes Road
       Lexington, MA 02421

                                                        Re: AgenTus
Therapeutics, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted January
22, 2021
                                                            CIK No. 0001840229

       Dear Dr. Armen:

              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

             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

       Draft Registration Statement on Form S-1 submitted on January 22, 2021

       Prospectus Summary , page 1

   1.                                                   With reference to your
glossary of Industry Terms, please revise the Summary to explain
                                                        each of the terms at
first use in the Summary. Also, revise to explain the terms "off-the-
                                                        shelf" on page 1 and
"unmodified" and "targeted" on page 2.
   2.                                                   With reference to your
disclosures on page 39, please revise to discuss your currents plans
                                                        for separating your
resources and functions from those of Agenus.
       Overview , page 2

   3.                                                   We refer to the bottom
three rows of your pipeline table under the heading "Targeted
 Garo Armen
FirstName LastNameGaro
AgenTus Therapeutics, Inc.Armen
February  NameAgenTus
            2021          Therapeutics, Inc.
Page 2 19, 2021 Page 2
FirstName LastName
         INTELLIGENT iNKT Cells." We note that your Business section disclosure
does not
         discuss any preclinical work that you have conducted to date relating
to any of the
         candidates. In addition, we note that you do not appear to have
identified specific targets
         or have milestones related to future work. Accordingly, it does not
appear appropriate to
         highlight these programs prominently in your prospectus Summary.
Please revise to
         remove these programs from the table.
Strategy , page 2

4.       We note your disclosure referencing your plans to "rapidly advance"
your lead product
         candidate, AGENT-797, through clinical development. With reference to
your risk
         disclosures on pages 15 and 17-18, please balance the Summary
disclosure by
         highlighting that it takes many years to develop a new medicine and
that no allogeneic
         iNKT cell therapy has been approved for commercial use by any
regulatory authority.
Potential Advantages of Allogeneic iNKT Cell Therapy Compared to Current CAR-T
Therapy, page 6

5.       Please tell us your basis for highlighting a    more favorable safety
and relapse rate profile
         relative to the current standard of care given your disclosure on page
17 that no allogeneic
         iNKT cell therapy has been approved for commercial use by any
regulatory authority. In
         addition, we note that it is not clear (i) that your INTELLIGENT iNKT
cells are
         comparable to the autologous iNKT cells used in the referenced trials
or (ii) what is the
         basis for your expectation that your INTELLIGENT iNKT cells will have
a higher level
         of batch homogeneity and consistency than the autologous iNKT cells
used in the clinic to
         date. Please note that we have similar concerns regarding you
disclosures under the
         heading "Key Features of Our INTELLIGENT iNKT Cells." Please revise
Key Features of Our INTELLIGENT iNKT Cells, page 7

6.       Please discuss briefly here or on page 93 the basis for your statement
that "allogeneic
         iNKT cells may engraft better than other allogeneic cell types and
thus require less
Implications of Being an Emerging Growth Company and Smaller Reporting Company,
page 8

7.       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,
         present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
         not they retain copies of the communications.
Implications of Being a Controlled Company, page 9

8.       We note that you are a "controlled company" as defined under the
relevant Nasdaq listing
         rules. Please disclose your status as a controlled company in the
prospectus cover page.
         Also, revise the Summary to indicate the equity stake that your parent
entity and affiliates
 Garo Armen
FirstName LastNameGaro
AgenTus Therapeutics, Inc.Armen
February  NameAgenTus
            2021          Therapeutics, Inc.
Page 3 19, 2021 Page 3
FirstName LastName
         will hold following the offering.

Use of proceeds , page 10

9.       You note that you will use a portion of the proceeds to    fund the
IND submission and
         development of AGENT-797 through completion of our planned Phase 1
clinical trial for
         the treatment of patients with multiple myeloma and B cell lymphoma.
 This appears to
         contradict your statement that you will have already commenced your
Phase I clinical trial
         in January of 2021, under which the IND should already have been
submitted. Please
         revise or advise.
Summary Consolidated Financial Data, page 11

10.      Please clearly show in the notes how you computed each pro forma
amount, including a
         discussion of any significant assumptions and estimates used to arrive
at the amounts. For
         example, please address the following:
             Please specifically show in your disclosures how you computed the
number of basic
              and diluted weighted average shares to use in determining pro
forma earnings per
              share amounts; and
             Your disclosures on page 81 indicate your outstanding convertible
note is payable in
              cash or equity shares at Agenus    election. In this regard,
please clarify your basis for
              assuming that the notes will be settled in shares of your common
stock rather than
         In a similar manner, please expand your disclosures related to the pro
forma amounts
         presented in the Capitalization table on page 75.
Use of Proceeds, page 73

11.      We note your disclosure that you may find it necessary or advisable to
use the net
         proceeds for other purposes. We also note your risk factor disclosure
indicating that you
         may experience difficulty in separating your resources from Agenus.
Accordingly, please
         tell us and, revise as applicable, to discuss whether the proceeds
could be used to fund
         Agenus operations.
Capitalization, page 75

12.      It is not clear why you have not presented any debt amounts in your
capitalization table.
         Please advise or revise your table accordingly.
13.      You disclose that your pro forma amounts reflect the effectiveness of
your amended and
         restated certificate of incorporation. Please better clarify in your
disclosures the specific
         terms in the amended and restated certificate of incorporation that
you are referring to and
         how they will impact your financial statements. It is also not clear
whether you intend to
         give effect to the conversion of your convertible affiliated note in
your pro forma amounts
         in a similar manner to the pro forma amounts presented on page 12.
 Garo Armen
FirstName LastNameGaro
AgenTus Therapeutics, Inc.Armen
February  NameAgenTus
            2021          Therapeutics, Inc.
Page 4 19, 2021 Page 4
FirstName LastName
Historical Results of Operations Year Ended December 31, 2019
Research and Development Programs, page 81

14.      Please disclose your research and development expenses by product
candidate for each
         period presented. To the extent that you do not track expenses by
product candidate,
         please disclose as such, and provide a breakdown by nature of type of
Critical Accounting Policies and Estimates, page 82

15.      You disclosures on page F-13 indicate that share-based compensation
was issued under
         your 2018 Plan as well as under the Agenus 2019 Equity Incentive Plan.
Given it would
         appear that there would be significant judgment related to share-based
         including how you determined the fair value of your shares in valuing
         compensation issued under your 2018 Plan, please include share-based
compensation as
         part of your critical accounting policies and estimates disclosures
and specifically address
         the following:
             the methods that management used to determine the fair value of
your shares and the
              nature of the material assumptions involved;
             the extent to which the estimates are considered highly complex
and subjective; and
             the estimates will not be necessary to determine the fair value of
new awards once the
              underlying shares begin trading.
         Alternatively, please advise why you do not think additional
disclosures are necessary.
16.      Once you have an estimated offering price or range, please explain to
us how you
         determined the fair value of your common stock underlying equity
issuances and the
         reasons for any differences between the recent valuations of your
common stock leading
         up to the IPO and the estimated offering price. This information will
help facilitate our
         review of your accounting for equity issuances including stock
Preclinical Efficacy Data for iNKT Cell Therapy, page 94

17.      Please revise to clarify whether this data relates to generic iNKT
cell therapies or your
         INTELLIGENT iNKT cell therapy, AGENT-797. Also, revise to clarify
whether you or
         your patent conducted or sponsored any of these trials. As applicable,
please revise your
         disclosure on pages 96-97 to present the pre-clinical work and results
or revise to indicate
         that such work has not been conducted.
Investigator-Initiated Clinical Data for iNKT Cell Therapy, page 95

18.      You state that "[m]ultiple investigator-initiated clinical trials
using autologous iNKT cells
         have demonstrated safety and efficacy across multiple cancer
indications, with clinical
         trials for three different cancers published to date: melanoma,
non-small cell lung cancer
         (NSCLC), and HNSCC." Please remove the implication that autologous
iNKT cell have
         been proven to be safe and effective, as these determinations are the
exclusive authority of
         the FDA or other regulators.
 Garo Armen
FirstName LastNameGaro
AgenTus Therapeutics, Inc.Armen
February  NameAgenTus
            2021          Therapeutics, Inc.
Page 5 19, 2021 Page 5
FirstName LastName
19.      Please clarify whether the tables you have included on page 96 refer
to the four
         investigator-initiated clinical trials that you mention in this
section. If so, please revise
         your narrative description to make this more clear, as it appears
there are only three
         clinical trials listed and there is no way to determine which, if any,
of the images of the
         iNKT treatments correspond to each trial.
Additional Product Development
T-Rx, page 98

20.      You state that, under your TCR platform, "[s]afety is ensured by using
         proprietary off-target profiling." Please delete this sentence, as
safety determinations are
         in the purview of the FDA.
Immuno-Oncology Combination Therapy Collaboration with Agenus, page 100

21.      It is not clear why you have provided the pipeline table for two of
Agenus' products.
         Please provide an explanation for why the stage of Agenus' clinical
development is
         material to your investors or remove this pipeline table.
Intellectual Property, page 100

22.      You disclose that you own "one issued patent and had 23 pending patent
         applications." For the issued patent, please amend this disclosure to
include the type of
         patent protection granted (i.e., composition of matter, use, or
process), its expiration date,
         and its the jurisdiction. For the pending patent applications, amend
this disclosure to
         include the date that these patent applications were submitted, their
jurisdiction, and their
         expected expiration date.
Competition , page 112

23.      Please revise to clarify whether any of your competitors are testing
their therapies
         on COVID-19-related pneumonia and/or multiple myeloma/B cell lymphoma
         clinical trials.

Certain Relationships and Related Party Transactions
Relationship with Agenus, page 129

24.      Please disclose the material terms of your Intercompany Agreement with
Agenus. For
         instance, and without limitation, discuss the term and termination
provisions and the
         (i) duration and the applicable markup percentages in your "cost plus
basis" agreements.
         Also, tell us whether the "new services agreement" referenced on page
39 will be executed
         prior to effectiveness of the registration statement.
Note 2. Summary of Significant Accounting Policies
(h) Revenue Recognition , page F-9
 Garo Armen
AgenTus Therapeutics, Inc.
February 19, 2021
Page 6
25.   You disclose that revenue includes grant income recognized in accordance
with ASC 958-
      605, Not-for-Profit Entities, Revenue Recognition. Please help us
understand how you
      determined it was appropriate to follow the guidance of ASC 985 rather
than ASC 606 in
      regards to revenue recognition. Based on the appropriate guidance, please
disclose how
      you determined the appropriate amount of revenue to record related to the
agreement with
      the Belgium Walloon Region Government as discussed on page F-13. Please
also expand
      your disclosures to discuss the impact of terminating this agreement in
Financial Statements
Note 10. Related Party Transactions, page F-14

26.   Pursuant to SAB Topic 1:B.1, please address the following:
          Please clearly disclose, if true, that the financial statements
provided reflect all of the
          costs of doing business related to these operations, including
expenses incurred by
          other entities on your behalf;
          Please specifically disclose the allocation method used for each
material type of cost
          allocated and your assertion that the methods used are reasonable.
Your disclosures
          indicate that costs were allocated primarily based on time devoted to
activities and
          headcount-based allocations; however, it is not clear what specific
allocation method
          was used for each significant cost; and
          Please disclose management  s estimates of what expenses would have
been on a
          stand-alone basis, if practicable.

       You may contact Nudrat Salik at (202) 551-3692 or Daniel Gordon at (202)
551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at (202) 551-7976 or Joe McCann at (202) 551-6262 with
any other

FirstName LastNameGaro Armen
                                                             Division of
Corporation Finance
Comapany NameAgenTus Therapeutics, Inc.
                                                             Office of Life
February 19, 2021 Page 6
cc:       Zachary Blume
FirstName LastName