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| EX-99.1 - PRESS RELEASE - LUMOS PHARMA, INC. | nlnk-20171102x8kxex991.htm |
| 8-K - 8-K - LUMOS PHARMA, INC. | nlnk-20171102x8k.htm |
NewLink Genetics Corporation
Nasdaq: NLNK
November 2, 2017
Third Quarter 2017 Results
Agenda
2
Introduction
Jack Henneman, Executive Vice President & CFO
IDO Pathway Program Developments & Outlook
Charles J. Link, Jr., M.D., Chairman, CEO & CSO
Clinical Updates & Guidance on Timing of Data
Eugene P. Kennedy, M.D., Vice President Clinical & Medical Affairs
Third Quarter 2017 Financial Results & Financing
Mr. Henneman
Cautionary Note Regarding Forward-Looking Statements
This presentation contains forward-looking statements of NewLink Genetics 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 any 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 Genetics 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 in this presentation represent NewLink'
Genetics' views as of the date of this presentation. NewLink Genetics 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.
3
Recent Highlights
Progression toward Pivotal trial in advanced melanoma achieved with parameters of trial design
established and reviewed by FDA
Updated Phase 2 data for indoximod plus PD-1 checkpoint inhibitor KEYTRUDA® suggest
substantial improvement of response rate for advanced melanoma patients
Entered clinical collaboration with AstraZeneca to evaluate indoximod plus durvalumab plus
standard-of-care chemotherapy in Phase 2 trial for patients with metastatic pancreatic cancer
Indoximod granted Orphan Drug Designation by the FDA for Stage IIb-IV melanoma
First patients dosed with novel salt formulation of indoximod
First patients dosed with NLG802, prodrug of indoximod
Financial position secured with ~$55MM raised from Bank of America Merrill Lynch & Stifel led
underwritten offering and $19MM from “at the market” offering through Cantor Fitzgerald
4
Indoximod program has made substantial progress in 2017
Best Response by Patient with Advanced Melanoma
5
Significant Depth of Response
*Patients that progressed due to new non-target lesions.
Note: 1 patient was unevaluable for response due to pleural effusion/collapsed left lung; the patient progressed based on several new non-target lesions.
Zakharia Y, et al. Oral presentation at: Third International Cancer Immunology Conference; September 6-9, 2017; Frankfurt, Germany.
Progressive Disease
Threshold for progression
Threshold for partial response
P
er
ce
n
t
ch
an
ge
in
t
u
m
o
r
vo
lu
m
e
80%
100%
40%
60%
0%
20%
–40%
–20%
–60%
–80%
–100%
*
* *
Stable Disease
Partial Response
Complete Response
Indoximod Pivotal Phase 3 Study Design
Two-Arm, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study
Randomization via an interactive web system
Stratified by:
̶ Checkpoint inhibitor (pembro or nivo)
̶ Prior BRAF treatment
̶ Advanced stage disease at randomization
Investigator choice for PD-1
̶ Pembrolizumab 200mg IV Q3 weeks
̶ Nivolumab 240mg IV Q2 weeks
Treatment until disease progression or unacceptable toxicity
BRAF, B-Raf proto-oncogene, serine-threonine kinase; IV, intravenous; Q2W, every 2 weeks; Q3W, every 3 weeks; PO, orally; Q12h, every 12 hours.
1:1
Randomization
PD-1 checkpoint inhibitor
+ placebo PO Q12h
N=300
PD-1 checkpoint inhibitor
+ indoximod PO Q12h
N=300
6
Clinical Collaboration between AstraZeneca and NewLink
Phase 2 Randomized, Placebo Controlled Trial of IDO plus anti-PDL-1
Statistically powered to compare 4 drug
regimen to Standard of Care (SOC)
Primary Endpoint: Overall Response
Secondary Endpoints:
̶ Overall Survival
̶ Progression Free Survival
̶ Safety
Status and Milestones
̶ FPI 1H18
̶ Protocol being finalized by Joint Committee
Placebo (I) + Durvalumab +
Gemcitabine + nab-Paclitaxel
N=50
Indoximod (I) + Durvalumab (D)
+ Gemcitabine + nab-Paclitaxel
N=100
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VS
Trial design informed by P2 indoximod plus SOC
Placebo (I) + Placebo (D) +
Gemcitabine + nab-Paclitaxel
N=50
Randomiz
a
tio
n
2
1
1
Third Quarter 2017 Financial Results
Cash and Equivalents $120.7 million
Debt ~$0.3 million
YE 2017 Cash (Projected)1 ~$150 million
Forecast Quarterly Negative Cash-Flow ~$14-$16 million
Shares Outstanding as of October 31,20171 37.1 million
8
1 Includes ~$55 million from an underwritten offering of 5.75 million shares of stock and proceeds from 1.9 million shares of stock sold under the company’s ATM
Financially well positioned to proceed with indoximod development program
NewLink Genetics
The Phase 3 Pivotal trial for patients with advanced melanoma is our top priority and we
continue to work toward our goal of completing accrual by the end of 2018.
The AstraZeneca collaboration represents a significant step in our effort to expand the
clinical program and differentiate indoximod from other IDO pathway inhibitors.
The opportunity for indoximod has the potential to go well beyond these initial indications.
9
Key Takeaways
10
Q & A