Attached files
| file | filename |
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| EX-99.1 - PRESS RELEASE - LUMOS PHARMA, INC. | nlnk-20170608x8kxex991.htm |
| 8-K - 8-K - LUMOS PHARMA, INC. | nlnk-20170608x8k.htm |
NewLink Genetics Corporation
Nasdaq: NLNK
June 8, 2017
Conference Call on GDC-0919 Program
Zakharia Y, et al. Oral presentation at: 107th Annual Meeting of the American Association for Cancer Research (AACR); April 1-5, 2017; Washington, DC. Abstract CT117.
Forward-Looking Disclaimer
This presentation contains forward-looking statements of NewLink that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this presentation are forward-looking
statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “will,” “could,” “should,” “seek” or the
negative of these terms or other similar expressions are intended to identify forward-looking statements, although
not all forward-looking statements contain these identifying words. These forward-looking statements include,
among others, statements about NewLink Genetics’ financial guidance for 2017; results of its clinical trials for
product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional
indications into clinical development; NewLink Genetics’ future financial performance, results of operations, cash
position and sufficiency of capital resources to fund its operating requirements; and any other statements other
than statements of historical fact. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that NewLink makes due to a number of important
factors, including those risks discussed in “Risk Factors” and elsewhere in NewLink Genetics’ Annual Report on
Form 10-K for the year ended December 31, 2016 and other reports filed with the U.S. Securities and Exchange
Commission (SEC). The forward-looking statements represent NewLink's views as of the date of this
presentation. NewLink anticipates that subsequent events and developments will cause its views to change.
However, while it may elect to update these forward-looking statements at some point in the future, it specifically
disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as
representing NewLink Genetics’ views as of any date subsequent to the date of this presentation.
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Zakharia Y, et al. Oral presentation at: 107th Annual Meeting of the American Association for Cancer Research (AACR); April 1-5, 2017; Washington, DC. Abstract CT117.
NewLink Participants and Agenda
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Introduction
Jack Henneman, Executive Vice President & CFO
GDC-0919 Decision Review
Charles J. Link, Jr., M.D., Chairman, CEO & CSO
IDO Pathway Program Update
Nicholas N. Vahanian, M.D., President & CMO
Financial Update
Mr. Henneman
Zakharia Y, et al. Oral presentation at: 107th Annual Meeting of the American Association for Cancer Research (AACR); April 1-5, 2017; Washington, DC. Abstract CT117.
Indoximod plus Pembrolizumab (PD-1)
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Best Response by RECIST Criteria
n (%) n = 51 †
Overall Response Rate 30 (59)
Complete Response 6 (12)
Partial Response 24 (47)
Stable Disease 11 (22)
Disease Control Rate 41 (80)
Progressive Disease 10 (20)
*Based RECIST guidelines version 1.1, †Non-ocular and cutaneous patients
Interim data support decision to initiate Pivotal Phase 3 vs single agent PD-1
Advanced/ Metastatic Melanoma
Zakharia Y, et al. Oral presentation at: 107th Annual Meeting of the American Association for Cancer Research (AACR); April 1-5, 2017; Washington, DC. Abstract CT117.
Indoximod plus Pembrolizumab (PD-1)
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Impressive Clinical Benefit and Disease Control Rate
*SD of primary lesion; new non-target lesions classified patients as PD, *Based RECIST guidelines version 1.1, †Non-ocular and cutaneous patients
Interim data support decision to initiate Pivotal Phase 3 vs single agent PD-1
Advanced/ Metastatic Melanoma
P
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Ch
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80%
40%
60%
0%
20%
–40%
–20%
–60%
–80%
–100%
Threshold for Progression
Threshold for Partial Response
Zakharia Y, et al. Oral presentation at: 107th Annual Meeting of the American Association for Cancer Research (AACR); April 1-5, 2017; Washington, DC. Abstract CT117.
Indoximod plus Provenge (sipuleucel-T) Vaccine
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Randomized, Double Blind, Placebo Controlled Phase 2 Study
Abstract 3066 Jha et al. 2017 ASCO Annual Meeting
Metastatic Castration Resistant Prostate Cancer
Median rPFS of 10.3 months for indoximod vs 4.1* months in placebo (p=0.011)
*Median time to objective progression for pivotal IMPACT trial of sipuleucel-T was 3.7 mo