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December 13, 2019
Maurizio Chiriva Internati, DBSc., Ph.Ds.
Chief Executive Officer
Kiromic, Inc.
7707 Fannin, Suite 140
Houston, TX 77054
Re: Kiromic, Inc.
Draft Registration Statement on Form S-1
Submitted November 15, 2019
CIK No. 0001792581
Dear Dr. Internati:
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
Cover Page
1. We note that you intend to apply to list your common shares on the
Nasdaq Global Select
Market but no assurance can be given that your application will be
approved. Please tell
us whether you will continue your offering if your listing is not
approved. If you intend to
proceed with your offering before receiving approval of your listing
application, please
revise your disclosure to clarify that the listing of the common shares
on the Nasdaq
Global Select Market is not a condition to the offering.
Maurizio Chiriva Internati, DBSc., Ph.Ds.
FirstName LastNameMaurizio Chiriva Internati, DBSc., Ph.Ds.
Kiromic, Inc.
Comapany13, 2019
December NameKiromic, Inc.
Page 2
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FirstName LastName
Prospectus Summary
Overview, page 1
2. Please tell us the basis for your statement that you are a clinical
stage company, given that
your product candidates appear to be in the preclinical stage and you
have not yet
completed an IND-enabling study for your most advanced product
candidate.
Alternatively, revise your disclosure. In addition, revise to describe
more specifically the
preclinical stage of your product candidates where you state in the
second paragraph that
they are "in the early stages" of the FDA's clinical trial process.
Our Approach, page 2
3. Please revise to briefly define the term "refractory CAR T patients."
4. Please revise to clarify, as you do at page 74, that you are still
developing your delivery
vehicle, ABBIE, and describe the current stage of its development.
Our Product Pipeline and Development, page 5
5. We note from disclosure at pages 76 through 79 that you have not yet
commenced Phase 1
clinical trials with respect to any of your products. Please revise
your chart to include a
"Preclinical" column for your three products, and relocate the bar to
this column so that
the chart more accurately reflects the current developmental stage of
the product
candidates. Please similarly revise at page 75 in your Business
section. In addition, please
remove the references to dates in the table, as it is unclear to what
they relate and you
have not actually begun the Phase 1 trials where these dates are shown
in the table.
Alexis Isoform Mesothelin MPM, page 6
6. Please revise paragraph three to accurately reflect the number
resulting from multiplying
80% of 3000 U.S. patients diagnosed with MPM each year.
Our Risks and Challenges, page 6
7. We note your statement that you have entered into "significant
arrangements with
collaborators and expect to depend on collaborations with third
parties for certain
research, development, and commercialization activities," but are
unable to determine that
you have filed these agreements as exhibits to your registration
statement. Please advise or
revise. We note similar language at page 24, "We have entered into
significant
arrangements with collaborators...and if such collaborations are not
successful, it may
harm our business and prospects."
If we fail to comply with our obligations in the agreements under which we
license intellectual
property rights...., page 40
8. We note your statement that you "are a party to a number of
intellectual property license
agreements that are important to your business." Please revise to file
these agreements as
Maurizio Chiriva Internati, DBSc., Ph.Ds.
Kiromic, Inc.
December 13, 2019
Page 3
exhibits to your filing, or tell us why you do not believe they are
material. Refer to Item
601(b)(10) of Regulation S-K. Likewise, please discuss the material
terms of these
agreements at "Our Intellectual Property" at page 80 of your
registration statement.
Use of Proceeds, page 50
9. Please revise to describe how far in the Phase 1/2 clinical trials the
45% of the proceeds
will enable you to reach. You should provide this disclosure for a
reasonable range of
potential outcomes regarding the number of securities that you might
sell. In addition, if a
material amount of other funds is necessary to complete Phase I/II
clinical trials, please
revise your disclosure to state the amount necessary to complete the
clinical trial, and the
sources of such other funds. Please refer to Instruction 3 to Item 504
of Regulation S-K.
Finally, please also specify the product candidate or candidates to
which the proceeds for
IND applications and IND enabling trials will be applied.
Managements Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Estimates, Stock Based Compensation, page 65
10. We reference the disclosure about the valuation of your common stock
in determining the
grant-date fair value of stock options. Provide us the estimated
offering price or range
when it is available and explain to us the reasons for significant
differences between
recent valuations of your common stock and the estimated offering
price.
Business, page 70
11. We note your reference to "preclinical animal studies" you have
conducted in paragraph
two of the risk factor titled "Our tumor-specific cancer immunotherapy
approach is based
on novel ideas..." on page 18. Please revise your Business section to
briefly describe the
preclinical studies you have conducted related to your products.
Alexis Isoform CD19, page 77
12. We note your statement that CD19 targeting CAR T therapies have shown
"preliminary
efficacy" in chronic lymphocytic leukemia. Please revise your
disclosure to remove any
suggestion that your product candidate is safe or effective, insofar
as determinations as to
safety and efficacy are within the sole authority of the FDA or
comparable foreign
regulatory authorities.
Our Intellectual Property, page 80
13. Please revise to discuss in more detail the patents held in your patent
portfolio. Please
FirstName LastNameMaurizio Chiriva Internati, DBSc., Ph.Ds.
indicate in each instance the expiration date of your material patents,
and also the type of
Comapany NameKiromic, Inc.
each patent held, composition of matter, use, or process. Likewise,
please identify the
December 13, 2019 Page 3instance.
jurisdiction in each
FirstName LastName
Maurizio Chiriva Internati, DBSc., Ph.Ds.
FirstName LastNameMaurizio Chiriva Internati, DBSc., Ph.Ds.
Kiromic, Inc.
Comapany13, 2019
December NameKiromic, Inc.
Page 4
December 13, 2019 Page 4
FirstName LastName
Our Research and Development Collaborations, page 81
14. Please revise to describe the material terms of your collaboration
agreement with the
Anderson Cancer Center. Likewise, please file the agreement as an
exhibit to your filing.
General
15. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405, that you, or anyone else 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.
You may contact Kristin Lochhead at 202-551-3664 or Al Pavot at
3202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Paul Fischer at 202-551-3415 or Mary Beth Breslin at 202-551-3625 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Louis Bevilacqua