United States securities and exchange commission logo
September 26, 2022
Richard Peters, M.D.
Chief Executive Officer
Yumanity Therapeutics, Inc.
40 Guest Street, Suite 4410
Boston, MA 02135
Re: Yumanity
Therapeutics, Inc.
Registration
Statement on Form S-4
Filed August 29,
2022
File No. 333-267127
Dear Dr. Peters:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4 filed August 29, 2022
Prospectus Summary
Kineta, Inc., page 16
1. Please remove all
"best-in-class" and "first-in-class" references throughout the prospectus
as these statements are
speculative in light of the current regulatory status of your product
candidates.
2. Please balance
disclosure of a "$48 billion market opportunity" with Kineta's current
market share and any
steps that must be taken before commercializing Kineta's product
candidates.
Richard Peters, M.D.
FirstName LastNameRichard
Yumanity Therapeutics, Inc. Peters, M.D.
Comapany 26,
September NameYumanity
2022 Therapeutics, Inc.
September
Page 2 26, 2022 Page 2
FirstName LastName
Risk Factors
Yumanity may be sued for infringing the intellectual property rights of
others..., page 79
3. We note disclosure stating Yumanity is "aware" of patents owned by
third parties expiring
in 2031 and contemplating defenses to potential claims of
infringement. Please clarify if
Yumanity is currently party to any material ongoing litigation related
to intellectual
property infringement.
The Transactions
Background of the Transaction, page 174
4. We note that H.C. Wainwright & Co. acted as a financial advisor to
both Yumanity
Therapeutics, Inc. and Kineta, Inc. for this transaction. Please
revise to clarify at what
point the parties were made aware of the potential conflict of
interest and whether the
same individuals were engaged to perform the advisory services. To the
extent you have
not done so, please also describe the steps Yumanity and Kineta took
to mitigate the risks
resulting from the engagements and if applicable, how potential
conflicts of interest were
considered by the Yumanity board in determining the Exchange Ratio and
other terms of
the merger. Additionally, please include a risk factor in the risk
factors section discussing
the risks to investors related to this potential conflict of interest.
Tax Treatment of the Transactions, page 210
5. We note your disclosure that the parties intend for this transaction
to qualify as
a reorganization within the meaning of Section 368(a) of the Internal
Revenue
Code. Please have counsel provide a tax opinion addressing the
material tax
consequences to shareholders or provide us your analysis as to why you
do not believe
such an opinion is required. The tax opinion should address and
express a conclusion for
each material federal tax consequence. For additional guidance
concerning assumptions
and opinions subject to uncertainty, refer to Staff Legal Bulletin No.
19.
The Merger Agreement
Conditions to the Merger Agreement, page 220
6. Please revise to identify the conditions that the parties may waive.
Yumanity's Business
Yumanity's Pipeline, page 266
7. We note your statement here and elsewhere that the FDA's partial
clinical hold suspends
initiation of multiple dose clinical trials for YTX-7739 in the U.S.
until the FDA's
concerns have been addressed. Revise to explain the concerns
identified by the FDA.
Expedited Development and Review Programs, page 283
8. Please revise to explicitly state that these accelerated approval
designations do not grant
Richard Peters, M.D.
FirstName LastNameRichard
Yumanity Therapeutics, Inc. Peters, M.D.
Comapany 26,
September NameYumanity
2022 Therapeutics, Inc.
September
Page 3 26, 2022 Page 3
FirstName LastName
any advantages in the regulatory approval process or guarantee
eventual approval by the
FDA.
Kineta's Business
Kineta's Product Candidate Pipeline, page 301
9. Please separate the Phase 2 and Phase 3 columns in your pipeline table
or tell us the basis
for your belief that Kineta will be able to conduct Phase 2/3 trials
for all of their product
candidates. In addition, please explain what is involved in "lead
selection" and why you
believe this is a separate and distinct development phase, as opposed
to part of discovery
and/or IND-enabling studies, or revise.
10. We note the inclusion of aCD24 mAb for the indication of advanced
solid tumors in your
pipeline table. Given the limited disclosure related to this program,
please explain why it
is sufficiently material to your business to warrant inclusion in your
pipeline table. If it is
material, please expand your disclosure in the Business section to
provide a more fulsome
discussion of this program, including a description of preclinical
studies or development
activities conducted. Alternatively, remove any programs that are not
currently material
from your pipeline table on page 302.
KVA12.1: Potential first-in-class VISTA blocking immunotherapy, page 301
11. Please revise your disclosure to present objective information about
trial results, rather
than conclusions as to the safety or efficacy of your product
candidates. For example, on
page 303 you state that KVA12.1 showed strong "single agent efficacy"
in cold tumors.
Please revise this statement, and any others like it, to remove
conclusions of safety and
efficacy, as these conclusions are within the sole authority of the
FDA and
comparable foreign regulators.
12. Please increase the size of the graphics appearing in this section so
that the text is legible.
License Agreements, page 308
13. Please expand your discussion of each agreement that appears in this
section to disclose
up-front payments received or paid, aggregate amounts paid or received
to date, aggregate
future potential milestone payments, segregated by development and
commercial
milestone payments, and royalty rate or range that does not exceed ten
percentage points.
Strategic Partnerships, page 308
14. For each of the partnerships disclosed in this section, please revise
to include the nature
and scope of intellectual property transferred, each parties rights
and obligations, the
duration of agreement and royalty term, up-front or execution payments
received or paid,
aggregate amounts paid or received to date under agreement, aggregate
future potential
milestone payments to be paid or received, segregated by development
and commercial
milestone payments, and royalty rates or a royalty range not to exceed
ten percentage
Richard Peters, M.D.
Yumanity Therapeutics, Inc.
September 26, 2022
Page 4
points.
Intellectual Property, page 311
15. Please revise this section to disclose the applicable jurisdictions of
protection and
expiration dates or potential expiration dates, if granted, for each
material patent or patent
application.
Management Following the Merger
Summary Compensation Table, page 370
16. Please revise your Summary Compensation table to include compensation
information for
each of your last two completed fiscal years. Refer to Item 402(n) of
Regulation S-K for
guidance.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Michael Fay at 202-551-3812 or Sasha Parikh at
202-551-3627 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Christine Westbrook at 202-551-5019 with
any other
questions.
Sincerely,
FirstName LastNameRichard Peters, M.D.
Division of
Corporation Finance
Comapany NameYumanity Therapeutics, Inc.
Office of Life
Sciences
September 26, 2022 Page 4
cc: John Haggerty, Esq.
FirstName LastName