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United States securities and exchange commission logo
October 1, 2020
Nima M. Farzan
President and Chief Executive Officer
Kinnate Biopharma Inc.
11875 El Camino Real, Suite 101
San Diego, California 92130
Re: Kinnate Biopharma
Inc.
Draft Registration
Statement on Form S-1
Submitted September
4, 2020
CIK No. 0001797768
Dear Ms. Farzan:
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.
DRS filed September 4, 2020
Prospectus Summary
Overview, page 1
1. Revise the summary to
briefly describe the following terms at their first use:
Class I, II and III
BRAF mutations;
Intrahepatic
cholangiocarcinoma (ICC);
urothelial
carcinoma (UC);
oncogenic kinases;
and
oncogenic drivers.
Nima M. Farzan
FirstName LastNameNima
Kinnate Biopharma Inc. M. Farzan
Comapany
October NameKinnate Biopharma Inc.
1, 2020
October
Page 2 1, 2020 Page 2
FirstName LastName
Our Programs, page 4
2. Your pipeline table includes three separate pre-clinical phases, each
of which are wider
than the three clinical phases, which gives the impression that your
product candidates are
farther along in the clinical process. You also name the target,
rather than your potential
candidates. Revise the table to eliminate the separate columns for
lead identification and
optimization, as those stages are not sufficiently distinct. Also
revise to name your
particular product candidates and delete the rows for any product
candidate that is not
currently material. To this end, we note you should identify your
multiple FGFR
candidates to the extent they are material and delete the row for
"undisclosed targets," as
they are not sufficiently advanced to be material to your business. To
the extent they are
material, you should revise the prospectus to identify and describe
them. Finally, please
tell us why you believe your CDK12 targeted research is material and
should remain in
the pipeline. We note the focus on your RAF and FGFR programs from the
disclosure on
page 6 and in the risk factors on pages 13-16 and 19.
3. On pages 4, 5 and throughout the document, to more accurately describe
the potential
timing, revise to disclose when you plan to submit the INDs for
KIN002787 and your
FGFR-targeting candidates, rather than stating the potential start
date of your phase 1
trials "subject to our planned IND submission taking effect."
4. On pages 4 and 108, you discuss preclinical studies in which you have
observed that your
RAF product candidate is effective in addressing tumors and in doing
so in comparison to
current products. On pages 4, 105 and 108, you also discuss the
"demonstrated potent
inhibition of RAF dimer signaling" and state, with respect to FGFR,
you "have observed
potency across a broad range of clinically-relevant genomic
alterations in FGFR2 and
FGFR3 that drive resistance to current therapies." As safety and
efficacy determinations
are solely within the FDA's authority and they continue to be
evaluated throughout all
phases of clinical trials, please remove these and any similar
references in your
prospectus. In the Business section, you may present objective data
resulting from your
trials without including conclusions related to efficacy.
Our Team and Investors, page 5
5. At the top of page 6 you refer to your scientific advisory board as
"leaders" and your
investors as "world-class," and on page 107 you use the terms
"world-class" and "thought
leaders." Revise to clarify what you mean by these descriptors.
Use of Proceeds, page 81
6. To the extent that the proceeds are intended to complete only a
particular phase of
clinical development for each particular product candidate, please
identify the relevant
clinical phase. Refer to Instruction 3 to Item 504 of Regulation S-K.
Nima M. Farzan
FirstName LastNameNima
Kinnate Biopharma Inc. M. Farzan
Comapany
October NameKinnate Biopharma Inc.
1, 2020
October
Page 3 1, 2020 Page 3
FirstName LastName
Management s Discussion and Analysis of Financial Condition and Results of
Operations
Determination of the Fair Value of Common Stock, page 101
7. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your 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
compensation and
beneficial conversion features.
Business
Overview, page 105
8. On page 105, and other areas of the business section, particularly
when discussing your
program and strategy, you emphasize your strategy to, among other
things, "reduce the
time . . . of drug development" and that you "expect to engage with
regulatory authorities
to discuss expedited regulatory approval strategies." Clarify whether
these expedited
strategies are outside the expedited pathways to approval currently
available. Disclose on
what basis you place your expectations. For example, if the FDA has
indicated they will
meet with you in this regard, please disclose as much. If not, revise
your disclosure to
clarify. In any event, revise this discussion to balance your desire
to accelerate the drug
approval process with the reality that you have no control over the
procedures or length of
time needed for FDA review.
Our Programs, page 107
9. On page 109, you discuss studies reporting that only 10% of drug
candidates that enter
Phase 1 are ultimately approved; and then distinguish your
methodology, including that
"small molecule kinase inhibitors are a proven modality with many
approved drugs in the
class." Because there are many approved drugs in the class does not
establish that these
types of drugs obtain approval at rates higher than the 10% you have
cited. Tell us what
support you have for the assertion that small molecule kinase
inhibitors are, as a class,
materially more likely to obtain FDA approval than other drugs.
Our Strategy, page 109
10. Revise to clarify your meaning of "deep collaborations." We note the
disclosure of your
collaborations with Massachusetts General Hospital Cancer Center and
"global CROs" on
pages 135-36. For your collaborations and your "network of global
external partners,"
revise to clarify if you have binding agreements with these
counterparts and, in the
appropriate section of the document, identify them, summarize the
material terms of the
agreements and file them as exhibits. Refer to Item 601(b)(10) of
Regulation S-K.
Nima M. Farzan
FirstName LastNameNima
Kinnate Biopharma Inc. M. Farzan
Comapany
October NameKinnate Biopharma Inc.
1, 2020
October
Page 4 1, 2020 Page 4
FirstName LastName
Intellectual Property, page 136
11. Revise to disclose in what foreign jurisdictions you have pending
patent applications.
Clarify how many "other patent applications" you own with respect to
your various
programs and explain the significance of the "various compounds" to
which they are
directed.
Manufacturing, page 138
12. Identify the single-source third party CMOs on whom you rely, and file
their contracts as
exhibits. Refer to Item 601(b)(1) of Regulation S-K.
Executive Compensation, page 160
13. We note your employment agreements are not finalized. Once finalized,
please revise to
summarize the material terms of each of the employment agreements with
your
executives. Refer to Item 402(l), (m), (o) and (q) of Regulation S-K.
Certain Relationships and Related Party Transactions, page 171
14. Please identify the natural person or persons who directly or
indirectly exercise sole or
shared voting and/or dispositive power with respect to the convertible
preferred stock
disclosed in the tables in this section. Refer to Item 403 of
Regulation S-K.
Description of Capital Stock, page 177
15. According to the risk factor disclosure on page 77, the exclusive
forum provision will not
apply to "suits brought to enforce a duty or liability created by the
Exchange Act or any
other claim for which the U.S. federal courts have exclusive
jurisdiction." If correct,
revise the Exclusive Jurisdiction disclosure on page 181 to clarify.
In addition, on page
181 you state, "Our amended and restated bylaws further provide that
the federal district
courts of the United States of America will be the exclusive forum for
resolving any
complaint asserting a cause of action arising under the Securities
Act. Any person or
entity purchasing or otherwise acquiring any interest in our
securities shall be deemed to
have notice of and consented to these provisions." We note that
Section 27 of
the Exchange Act creates exclusive federal jurisdiction over all suits
brought to enforce
any duty or liability created by the Exchange Act or the rules and
regulations thereunder,
and Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state
courts over all suits brought to enforce any duty or liability created
by the Securities Act
or the rules and regulations thereunder. If the provision applies to
Securities Act claims,
please also revise your prospectus to state that there is uncertainty
as to whether a court
would enforce such provision and that investors cannot waive
compliance (or consent to
noncompliance) with the federal securities laws and the rules and
regulations thereunder.
If the exclusive forum provisions do not apply to actions arising
under the Securities Act
or Exchange Act, please also ensure that the exclusive forum provision
in the governing
Nima M. Farzan
Kinnate Biopharma Inc.
October 1, 2020
Page 5
documents state this clearly, or tell us how you will inform investors in
future filings that
the provision does not apply to actions arising under the Securities Act
or Exchange Act.
16. Revise this section disclose the current dividend and liquidation
preferences of your
convertible preferred stock as disclosed on F-15, as well as any
differential voting rights
to be included in your amended charter and bylaws.
Financial Statements
Note 6. Stockholders Equity, page F-14
17. We see that you repriced certain of your Series A Preferred Shares and
also issued an
additional 2.3 million shares for no consideration. Please clarify your
accounting for
repricing these shares, including the accounting guidance upon which you
based your
accounting and how you calculated the related gain.
You may contact Julie Sherman at (202) 551-3640 or Angela Connell at
(202) 551-
3426 if you have questions regarding comments on the financial statements and
related
matters. Please contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202)
551-
3257 with any other questions.
Sincerely,
FirstName LastNameNima M. Farzan
Division of
Corporation Finance
Comapany NameKinnate Biopharma Inc.
Office of Life
Sciences
October 1, 2020 Page 5
cc: Tony Jeffries, Esq.
FirstName LastName