<SEC-DOCUMENT>0000000000-21-012584.txt : 20230728
<SEC-HEADER>0000000000-21-012584.hdr.sgml : 20230728
<ACCEPTANCE-DATETIME>20211018163004
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-012584
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20211018

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			INTENSITY THERAPEUTICS, INC.
		CENTRAL INDEX KEY:			0001567264
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				461488089
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		61 WILTON ROAD, 3RD FLOOR
		CITY:			WESTPORT
		STATE:			CT
		ZIP:			06880
		BUSINESS PHONE:		203-221-7381

	MAIL ADDRESS:	
		STREET 1:		61 WILTON ROAD, 3RD FLOOR
		CITY:			WESTPORT
		STATE:			CT
		ZIP:			06880

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Intensity Therapeutics, Inc.
		DATE OF NAME CHANGE:	20130117
PUBLIC REFERENCE ACCESSION NUMBER:		0001213900-21-048854
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                           October 18, 2021

       Lewis Bender
       Chief Executive Officer
       Intensity Therapeutics, Inc.
       61 Wilton Road, 3rd Floor
       Westport, CT 06880

                                                        Re: Intensity
Therapeutics, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted September
20, 2021
                                                            CIK No. 0001567264

       Dear Mr. Bender:

              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 September 20, 2021

       Prospectus Summary
       Our Company, page 1

   1.                                                   We refer to your
disclosure that your product candidate INT230-6 utilizes a combination
                                                        of two proven
anticancer cytotoxic agents, cisplastin and vinblastine. Please revise to
                                                        clarify in the Summary
and elsewhere, if true, that both are generic and FDA-approved
                                                        drugs. Where
appropriate, please also provide a brief overview of the FDA approved uses
                                                        of cisplastin and
vinblastine.
 Lewis Bender
FirstName  LastNameLewis
Intensity Therapeutics, Inc. Bender
Comapany
October  18,NameIntensity
             2021          Therapeutics, Inc.
October
Page 2 18, 2021 Page 2
FirstName LastName
2.       We refer to your disclosure on page 1 and throughout the prospectus
that your lead
         product candidate INT230-6 has an    excellent safety profile    and
has shown    excellent
         safety    in clinical studies. Please note that determinations of
safety and efficacy are solely
         within the authority of the FDA; therefore, please revise the
prospectus to remove all
         references and/or implications of safety and efficacy, including those
cited above.
3.       We note your statement on pages 1 and 51 and elsewhere in the
prospectus that you seek
         to develop and commercialize first and best-in-class medicines to
treat cancer. The term
            first-in-class    and    best-in-class    suggests that your
product candidates are effective and
         likely to be approved as a new class of cancer therapeutics. Given the
early stage of
         development of INT120-6 and your other product candidates, it is not
appropriate to
         suggest that your products are likely to be effective or receive
regulatory approval. Please
         delete these references throughout your registration statement. If
your use of the term was
         intended to convey your believe that the product is based on a novel
technology or
         approach, you may discuss how your technology differs from technology
sued by
         competitors.
The report by our auditors includes a paragraph that states that substantial
doubt exists about the
Company's ability..., page 8

4.       Please quantify the total dollar amount to redeem all of the shares of
Series A Preferred
         Stock.
We purchase components for our products from third parties, some of which may
be sole source
suppliers, page 20

5.       We note your disclosure here that in certain cases, the components
used to manufacture
         your product candidates may be sourced from single-source suppliers.
Please expand
         your disclosure to discuss your sources, the availability of raw
materials and the names of
         any principal suppliers. See Item 101(h)(4)(v) of Regulation S-K.
Cautionary Note Regarding Forward-Looking Statements, page 33

6.       You state on page 33 that investors are cautioned not to    place
undue reliance on
         statements that reflect your intentions and expectations disclosed in
forward-looking
         statements. Please note that you are responsible for the disclosure
contained in your
         registration statement and you may not use language that could be
interpreted as a
         disclaimer of information contained in your filing. Please revise.
 Lewis Bender
FirstName  LastNameLewis
Intensity Therapeutics, Inc. Bender
Comapany
October  18,NameIntensity
             2021          Therapeutics, Inc.
October
Page 3 18, 2021 Page 3
FirstName LastName
Use of Proceeds, page 34

7.       Please revise to identify the specific product candidates (and target
indications, as
         applicable) for which you intend to use the proceeds of the offering.
Please also disclose
         the approximate amount of proceeds you intend to allocate toward each
of the programs
         identified in the pipeline table and how far the proceeds from the
offering will allow you
         to proceed with the continued development of each of your programs.
Refer to Instruction
         3 to Item 504 of Regulation S-K.
Management   s Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 43

8.       Regarding your research and development expenses, please disclose the
costs incurred
         during each period presented for each of your key research and
development projects. If
         you do not track your research and development costs by project,
please disclose that fact
         and explain why you do not maintain and evaluate research and
development costs by
         project. Provide other quantitative or qualitative disclosure that
provides more
         transparency as to the type of research and development expenses
incurred (i.e. by nature
         or type of expense) which should reconcile to total research and
development expense on
         the Statements of Operations.
9.       Regarding your general and administrative expenses, separately
quantify each item noted
         for the change from prior periods.
Our Pipeline, page 48

10.      Please revise your pipeline table to standardize the width of each of
the Phase I, II and III
         columns. Revise the table to eliminate the separate columns for
Preclinical Animal
         Pharmacology TE and GLP Toxicology, as those stages are not
sufficiently distinct.
          Please also clarify the meaning of the abbreviated target indications
included in the first
         column, such as mTNBC, CRC, SCC, PC, BC and HCC, and delete references
to    P3
         and    P2/3   . Please also discuss, where appropriate, the
significance of the different
         colored circles at the end of the first column of your pipeline table.
11.      We refer to your disclosure that that you have designed a Phase 3
study for soft tissue
         sarcoma, for which you have submitted a protocol synthesis to the FDA,
and a Phase 2/3
         development plan for the treatment of metastatic triple negative
breast cancer (mTNBC).
         Please clarify whether you have completed Phase 2 studies, as well as
the status of the
         FDA   s review and approval of (if applicable) your Phase 3 program
for sarcoma and
         Phase 2/3 program for mTNBC. If the FDA has not approved your planned
programs,
         please shorten the bars under the heading    INT230-6 Sarcomas P3
and    INT230-6
         mTNBC P2/3    in your table accordingly.
 Lewis Bender
FirstName  LastNameLewis
Intensity Therapeutics, Inc. Bender
Comapany
October  18,NameIntensity
             2021          Therapeutics, Inc.
October
Page 4 18, 2021 Page 4
FirstName LastName
12.      We note the inclusion of your INT33X (Next Generation) discovery
program in your
         pipeline table. Given the status of development and absence of
disclosure relating to this
         program in the Business section, it seems premature to highlight this
program prominently
         in your pipeline table. Please remove this program from the table or
advise.
Our Strengths, page 49

13.      We refer to your disclosure on page 51 that you have designed and plan
to conduct a
         Phase 3 study of INT230-6 for the treatment of sarcoma based on the
data from your
         metastatic study in sarcoma patients. Please disclose the timeline for
the use of INT230-6
         for the treatment of sarcoma and your prior discussions with the FDA
regarding the
         review of the trial design for your Phase 1, 2 and 3 programs for the
treatment of sarcoma.
INT230-6, Our Lead Product Candidate, page 55

14.      We refer to your disclosure of your collaboration with the National
Cancer Institute
         (NCI). Please expand your disclosure to address related statistical
significance and/or p-
         values in your mouse model showing increased absorption with your
DfuseRx technology
         and the growth inhibition experiments. Please also expand your
disclosure of your growth
         inhibition experiments to include the design and scope of your study
and to discuss the
         data from the results to support the conclusions drawn.
Clinical Collaborations, page 58

15.      You disclose on page 58 that there were no drug-related serious
adverse events in your IT-
         01 cohort combining INT230-6 and Keytruda. We note your disclosure on
page 50 that a
         few low grade immune-related adverse events were reported in the
combination. Please
         expand your disclosure here to discuss the immune-related adverse
events observed,
         including the number of patients who experienced such symptoms.
16.      We note your disclosure on page 59 that Yervoy is a potent drug that
has a relatively high
         percentage of severe side effects. Please expand your disclosure of
the severe side effects
         of Yervoy. You also disclose that the combination of INT230-6 and
Yervoy is being
         evaluated in patients in your Phase 2 cohorts. Please revise to
discuss the design and
         scope of your studies using Yervoy and any immune-related adverse
events that have been
         observed to date. We refer to your disclosure on page 50.
17.      We refer to your collaborations with Merck, Bristol-Myers Squibb (BMS)
and Ottawa
         Hospital Research Institute and note that you have entered into
clinical trial collaboration
         and supply agreements with Merck and BMS, both of which will be filed
as exhibits to the
         registration statement. Please confirm if there is a collaboration
agreement in place with
         the Ottawa Hospital Research Institute, and if so, please provide a
brief description of the
         material terms of the arrangement and file the agreement as an exhibit
to the registration
         statement or explain to us why you believe you are not required to do
so. Please also
         revise to include descriptions of the material terms of your
collaboration agreements with
         Merck and BMS. Refer to Item 601(b)(10) of Regulation S-K.
 Lewis Bender
FirstName  LastNameLewis
Intensity Therapeutics, Inc. Bender
Comapany
October  18,NameIntensity
             2021          Therapeutics, Inc.
October
Page 5 18, 2021 Page 5
FirstName LastName
Clinical Trial Results, page 59

18.      We note your disclosure on pages 50 and 59 that eight patients
experienced grade 3
         related adverse events. Please describe the type of grade 3 adverse
events observed in
         your Phase 1/2 study. You also disclose that the most frequent related
adverse event
         included localized tumor related pain. If distinct from the grade 3
adverse events
         referenced above, please specify the number of patients who
experienced localized tumor
         related pain. Please also include descriptions of the types of grade 1
or 2 adverse events
         that were observed throughout the prospectus, where applicable.
Data shows that INT230-6 may increase survival in refractory cancer patients,
page 60

19.      We refer to the results of your metastatic study disclosed on page 61
and study of different
         markers of cancer proliferation on page 63. Please revise to clarify
whether the studies
         were powered for statistical significance and expand your discussion
of the statistical
         significance and p-values with respect to the survival probability and
reduction in the
         number of tumor cells, respectively (as applicable).
20.      We note your discussion of the marked reduction in the amount of live
cancer following
         the first dose of treatment as depicted in the absence of a blue stain
in Image B shown on
         page 63. Please revise the graphic on page 63 to ensure that the
significant reduction or
         absence of blue stain is clearly visible to the lay reader.
Results from Sarcoma Tissue, page 64

21.      Please expand your disclosure to specify the primary endpoint of the
sarcoma study,
         whether any adverse events were observed, the number of patients with
metastatic soft
         tissue sarcomas enrolled in the study to date and the number of
patients who experienced
         significant reduction of cancer as shown in Images A and B of the
graphic at the bottom of
         page 64. Please clarify whether there is any overlap between the
sarcoma study discussed
         on page 64 and the 18 sarcoma patients treated in your IT-01 study
referenced on page 65.
Competition, page 83

22.      We refer to your disclosure on pages 10 and 84 that some of your
competitors have
         developed products and therapies that are similar to your approach of
intratumoral
         delivery or the activation of the immune system, and may also be
focused on treating the
         same disease indications that your product candidates are focused on
treating. Please
         identify any competitors that to your knowledge are using intratumoral
technology for the
         treatment of cancer, including but not limited to, refractory or
metastatic cancers.
Intellectual Property, page 84

23.      Please revise your disclosure to identify for each issued U.S. patent
and patent application
         the scope of the technology to which each patent or patent application
relates, the patent
         protection and the expiration dates, as applicable.
 Lewis Bender
Intensity Therapeutics, Inc.
October 18, 2021
Page 6
Management, page 86

24.    For your directors, please disclose the specific skills, qualifications
and attributes that led
       you to the conclusion that the person should serve as your director.
Refer to Item 401(e) of
       Regulation S-K.
Principal Stockholders, page 97

25.    Please revise footnote 9 to identify the natural persons who are the
beneficial owners of
       the shares held by Portage Biotech Inc., as well as to list the address
of each such natural
       person.
General

26.    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 Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Jane Park at 202-551-7439 or Christopher Edwards at 202-551-6761 with any other
questions.



                                                              Sincerely,
FirstName LastNameLewis Bender
                                                              Division of
Corporation Finance
Comapany NameIntensity Therapeutics, Inc.
                                                              Office of Life
Sciences
October 18, 2021 Page 6
cc:       Daniel Woodard, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
