View:
United States securities and exchange commission logo
September 9, 2022
Laura Shawver, Ph.D.
Chief Executive Officer
Silverback Therapeutics, Inc.
500 Fairview Ave. N, Suite 600
Seattle, Washington 98109
Re: Silverback
Therapeutics, Inc.
Preliminary Proxy
Statement on Schedule 14A
Filed August 11,
2022
File No. 001-39756
Dear Dr. Shawver:
We have reviewed your filing 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 these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your
response to these comments, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A filed August 11, 2022
Summary, page 11
1. We note various
statements throughout the filing based on the assumption that "neffy is
approved by the FDA
within ARS Pharma's expected timeframe". However, we also note
that ARS Pharma has not
yet submitted a NDA to the FDA in relation to neffy. Please
revise your disclosure
in all places where such assumption appears to make clear that the
timing of regulatory
approvals is outside of the companies' control, may be delayed, and is
uncertain.
2. We note your disclosure
that "[d]ata from ARS Pharma's studies of neffy in more than 500
subjects demonstrated
epinephrine was delivered at doses that are considered
efficacious[.]" We also
note your disclosure on page 171 that your product demonstrates
a "[p]otentially
improved safety profile compared to injection products[.]" Please revise
these and similar
statements indicating or implying that your product is, or will be
determined to be, safe
and effective. Safety and efficacy determinations are solely within
Laura Shawver, Ph.D.
FirstName
Silverback LastNameLaura Shawver, Ph.D.
Therapeutics, Inc.
Comapany 9,
September NameSilverback
2022 Therapeutics, Inc.
September
Page 2 9, 2022 Page 2
FirstName LastName
the authority of the FDA or similar regulators.
Risk Factors, page 25
3. We note your disclosure on page 175 that in 2020 ARS Pharma signed an
exclusive
licensing agreement with Recordati to commercialize neffy in Russia
and the
Commonwealth of Independent States. Please discuss here or elsewhere
in your proxy
statement the direct or indirect impact of Russia's invasion of
Ukraine on this licensing
agreement. In addition, please also consider any impact:
resulting from sanctions, limitations on obtaining relevant
government approvals,
currency exchange limitations, or export or capital controls,
including the impact of
any risks that may impede your ability to sell assets located in
Russia or Belarus,
including due to sanctions affecting potential purchasers;
resulting from the reaction of your investors, employees,
customers, and/or other
stakeholders to any action or inaction arising from or relating
to the invasion,
including the payment of taxes to the Russian Federation; and
that may result if Russia or another government nationalizes
your assets or operations
in Russia or Belarus.
Additionally, to the extent material, please disclose the risk that
you may suffer
reputational damage from your potential operations in Russia during
the ongoing conflict
between Russia and Ukraine, which could negatively impact the overall
demand for your
products or services, including your operations or your results of
operations.
Risks Related to the Combined Company
The market price of the combined company's common stock is expected to be
volatile..., page 94
4. We note your disclosure that following a decline in Silverback's stock
price, a
federal securities class action complaint was filed against Silverback
and certain of its
officers and directors in the U.S. District for the Western District
of Washington. Please
revise this disclosure to explain when this litigation began and the
current status of the
litigation.
The combined company's amended and restated certificate of incorporation will
designate...the
exclusive forums..., page 98
5. Please revise your disclosure here to also note that such an exclusive
forum provision may
make it more expensive for stockholders to bring a claim against you.
The Merger
Background of the Merger, page 110
6. We note your disclosure that following scientific due diligence,
"Silverback's senior
management made the decision not to move forward with Company D in the
process due
to it meeting fewer Criteria than the other reverse merger targets
Silverback continued to
Laura Shawver, Ph.D.
FirstName
Silverback LastNameLaura Shawver, Ph.D.
Therapeutics, Inc.
Comapany 9,
September NameSilverback
2022 Therapeutics, Inc.
September
Page 3 9, 2022 Page 3
FirstName LastName
advance[.]" Please explain which of the Criteria Company D did not
meet.
7. We note your disclosure that Silverback's senior management
"determined, based upon
a[n] assessment of the Criteria, that ARS Pharma was the most
promising reverse merger
candidate[.]" Please provide further disclosure regarding Silverback's
senior
management's assessment of the Criteria when it determined that ARS
Pharma was the
most promising reverse merger candidate. For example, please explain
which criterion
weighed in favor of ARS Pharma as opposed to Company B or any of the
other merger
candidates.
8. We note your disclosure that "[t]he Transaction Committee recommended
to the
Silverback Board that Silverback pursue a reverse merger with ARS
Pharma based on
scientific evaluation, competitive differentiation, regulatory risk,
potential valuation
consideration relative to the opportunity, commercial potential and
commercial launch
plan feasibility, meaningful near-term catalysts to achieve value
appreciation using
Silverback s cash contribution, in addition to ARS Pharma s own
cash, estimated to be
approximately $40 million as of May 17, 2022, including based on input
from an
experienced commercial advisor engaged to assess the market
opportunity." Please clarify
whether the experienced commercial advisor referenced here was a
separate advisor from
SVB Securities. If so, please disclose the identity of that commercial
advisor and describe
its role in this process.
9. We note your disclosure that on July 1, 2022 and on July 11, 2022,
there were outstanding
issues in the merger agreement. Please describe which terms remained
at issue during
these times.
Opinion of Silverback's Financial Advisor
Additional Factors Observed by SVB Securities - ARS Pharma Valuation Analysis -
Selected
Companies, page 128
10. In relation to the Selected Companies, please revise your disclosure
to explain the "certain
financial and operating characteristics that could be considered
similar to those of ARS
Pharma" that were considered in selecting the companies, as well as
any other criteria
used in selecting the companies for analysis. In this regard, we note
that the statement
that each of the companies either has a lead product being marketed or
in regulatory
development is quite broad and provides little insight into the
reasons for selection.
Please also disclose whether, and if so why, SVB Securities excluded
any companies
meeting the selection criteria from the analyses.
Certain Unaudited Financial Projections, page 129
11. We note your disclosure that the financial projections prepared by ARS
Pharma and
supplied to Silverback assumed, among other things, that neffy will
launch in the third
quarter of 2023. However, we note that ARS Pharma has not yet
submitted a NDA to the
FDA. Please explain how this timing was considered, as the launch of
neffy is central to
Laura Shawver, Ph.D.
Silverback Therapeutics, Inc.
September 9, 2022
Page 4
the projection calculations, and why such assumption was deemed
appropriate.
Description of ARS Pharma's Business
Our Pipeline: Suite of neffy Programs, page 173
12. Please remove the statements on page 173 that you "anticipate approval
in 2023" for neffy,
as the timing of regulatory approvals is outside of the company's
control, may be delayed,
and is uncertain.
Our Strategy, page 174
13. Please revise your disclosure to provide more information regarding
the feedback received
by ARS Pharma from the FDA in a pre-NDA meeting held in mid-2021 as
well as prior
FDA interactions, referenced on page 174.
Clinical Development of neffy, page 179
14. Please provide further details regarding the clinical trials conducted
by ARS Pharma,
including, but not limited to, how many trials were conducted, where
they were
conducted, how patients were selected, whether the trials were
conducted by third parties,
and if so, the identities of those third parties.
Legal Proceedings, page 195
15. Please provide further detail regarding the subject of the 414 patent
(i.e., the intellectual
property underlying the 414 patent).
Unaudited Condensed Combined Financial Statements , page 247
16. Please state that the information in the pro forma financial
statements are presented in
thousands, to be consistent with the financial statements of
Silverback and ARS
Pharmaceuticals Inc.
17. With respect to Note 3, you indicated on page 143 that the exchange
ratio and the post-
Merger equity ownership may change if Silverback Net Cash is between
$210 million and
$255 million. Please state how this will change the estimated shares
of Silverback
common stock to be issued to ARS Pharma stockholders upon closing and
the transaction
accounting adjustments.
General
18. Please supplementally provide us with copies of all materials prepared
by SVB Securities
LLC and shared with your board of directors and their representatives,
including any
FirstName LastNameLaura Shawver, Ph.D.
board books, transcripts and summaries of oral presentations, that were
material to the
Comapany NameSilverback
board's Therapeutics,
decision to approve Inc.and the transactions
contemplated thereby. We
the merger
may9,have
September additional
2022 Page 4 comments after we review those materials
FirstName LastName
Laura Shawver, Ph.D.
FirstName
Silverback LastNameLaura Shawver, Ph.D.
Therapeutics, Inc.
Comapany 9,
September NameSilverback
2022 Therapeutics, Inc.
September
Page 5 9, 2022 Page 5
FirstName LastName
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.
You may contact Christie Wong at 202-551-3684 or Al Pavot at
202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Joshua Gorsky at 202-551-7836 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Kenneth J. Rollins, Esq.