January 23, 2020
Brad J. Powers, Esq.
General Counsel
NewLink Genetics Corporation
2503 South Loop Drive
Ames, IA 50010
Re: NewLink Genetics Corporation
Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A
Filed January 9, 2020
File No. 001-35342
Dear Mr. Powers:
We have reviewed your amended 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.
Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A
Summary, page 2
1. Please revise the first full paragraph on page 2 to disclose the reason
that you believe
NewLink is entitled to a substantial share of the value of the PRV.
2. As requested by prior comment 2, please indicate in your summary that
LUM-201 is in
the public domain and provide a summary in this section of the potential
effects this could
have on Lumos' business.
3. We note your revised disclosure on page 2 that LUM-201 has the potential
to lead to
"efficacious results." Please revise this and any other similar
statements throughout the
proxy statement that state or imply that your product candidates are safe
or effective as
these determinations are solely within the authority of the U.S. Food and
Drug
Administration and comparable regulatory bodies. We will not object to a
discussion of
whether your product candidates were well-tolerated or discussion of
whether trial
Brad J. Powers, Esq.
NewLink Genetics Corporation
January 23, 2020
Page 2
endpoints were met.
Background of the Merger, page 60
4. We note from the disclosure you have added in response to prior
comment 6 that between
August and September 2019, NewLink received several other inquiries or
proposals that
NewLink's management analyzed, and based on that review, NewLink's
management did
not recommend that the NewLink board consider any of the additional
inquiries or
proposals. Please revise to make clear whether the board was made
aware of these
inquiries or proposals and what conclusions the board made with
respect to those inquiries
or proposals.
Evercel Proposals, page 65
5. We note your reference to an analysis of both Evercel proposals made
by Stifel. Please
provide us supplementally with copies of all materials prepared by
Stifel and shared with
the NewLink board, including copies of all board books and all
transcripts and summaries,
that were material to the board's decision with respect to these
proposals.
NewLink Projections, page 82
6. We note your revised disclosure in response to prior comment 6 that
certain information
referred to in this section is "subject to a confidential treatment
order issued by the SEC."
Notwithstanding the prior confidential treatment requests made by the
company, the
confidential treatment process does not take precedence over a
registrant's obligations to
disclose material information in its public filings. If, under the
specific facts and
circumstances at this time, disclosure of the information referred to
in this section is
necessary for the protection of investors, please disclose the terms
of the Merck
Agreement that would be material to an informed voting decision with
respect to the
proposals in your proxy statement or revise your disclosure as
appropriate.
Post-hoc analysis and using a predictive enrichment marker strategy to select
appropriate
patients, page 114
7. Although we note the revisions in response to prior comment 10, given
the disclosed p-
value, please revise to further clarify the basis for the conclusions in
this section. If you
do not have a scientific basis to state that it is unlikely that your
conclusions regarding the
results were due to chance, please explain that because the results were
not statistically
significant, you cannot exclude the probability that such observations
were due to chance
alone. Also, as requested by our prior comment, if the disclosed p-value
does not meet the
FirstName LastNameBrad J. Powers, Esq.
FDA's specified threshold for statistical significance for a clinical
trial, please revise your
Comapany NameNewLink Genetics Corporation
disclosure to clarify the p-value that the FDA uses in evaluating the
results of a clinical
January 23, and whether the results of the post-hoc analysis would meet such
threshold.
trial 2020 Page 2
FirstName LastName
Brad J. Powers, Esq.
FirstNameGenetics Corporation
NewLink LastNameBrad J. Powers, Esq.
Comapany NameNewLink Genetics Corporation
January 23, 2020
Page 3
January 23, 2020 Page 3
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 David Burton at (202) 551-3626 or Brian Cascio at (202)
551-3676 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tim Buchmiller at (202) 551-3635 or Celeste Murphy at (202) 551-3257
with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: James C.T. Linfield, Esq.
