James C. T. Linfield
+1 720 566 4010
linfieldjct@cooley.com
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VIA EDGAR AND OVERNIGHT MAIL
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Re:
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NewLink Genetics Corporation
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Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A
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Filed on January 9, 2020
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File No. 001-35342
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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.
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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.
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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 endpoints were met.
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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.
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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.
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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.
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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 FDA's specified threshold for statistical significance for a clinical trial, please revise your disclosure to clarify the p-value
that the FDA uses in evaluating the results of a clinical trial and whether the results of the post-hoc analysis would meet such threshold.
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cc:
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Brad J. Powers, Esq., NewLink Genetics Corporation
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Matthew P. Dubofsky, Cooley LLP
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Robert Suffoletta, Wilson Sonsini Goodrich & Rosati
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