UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 8, 2018
NewLink Genetics Corporation | ||
(Exact name of registrant as specified in its charter) | ||
Delaware | 001-35342 | 42-1491350 |
(State or other jurisdiction | (Commission | (IRS Employer |
of incorporation) | File Number) | Identification No.) |
2503 South Loop Drive Ames, IA | 50010 | |
(Address of principal executive offices) | (Zip Code) | |
Registrant's telephone number, including area code: (515) 296-5555 | ||
Not applicable | ||
(Former name or former address, if changed since last report.) | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act o
Section 8 - Other Events
Item 8.01. Other Events.
On January 8, 2018, NewLink Genetics Corporation, a Delaware corporation, or the Company, issued a press release titled "NewLink Genetics Outlines 2018 Business Priorities to Support Phase 3 Pivotal Trial of Indoximod Plus PD-1 Inhibitors."
A copy of the press release and the related presentation are attached hereto as Exhibit 99.1 and 99.2, respectively, and are incorporated herein by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | Description | |
99.1 | Press Release, dated January 8, 2018, entitled “NewLink Genetics Outlines 2018 Business Priorities to Support Phase 3 Pivotal Trial of Indoximod Plus PD-1 Inhibitors” | |
99.2 | J.P. Morgan Healthcare Conference Presentation | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: January 8, 2018
NewLink Genetics Corporation | |
By: | /s/ John B. Henneman III |
John B. Henneman III | |
Its: | Chief Financial Officer |
INDEX TO EXHIBITS
Exhibit Number | Description | |
99.1 | Press Release, dated January 8, 2018, entitled “NewLink Genetics Outlines 2018 Business Priorities to Support Phase 3 Pivotal Trial of Indoximod Plus PD-1 Inhibitors” | |
99.2 | ||
Exhibit 99.1
NewLink Genetics Outlines 2018 Business Priorities to Support Phase 3 Pivotal Trial of Indoximod Plus PD-1 Inhibitors
NewLink Genetics updates financial and clinical guidance
AMES, Iowa, January 8, 2018 -- NewLink Genetics Corporation (NASDAQ: NLNK) today announced Indigo301, the name of its upcoming Phase 3 trial of indoximod plus PD-1 inhibitors for patients with advanced melanoma, and outlined 2018 business priorities to support this trial. In addition, the company updated clinical and financial guidance and provided preliminary unaudited financial information for year-end 2017.
These updates were made in conjunction with the 36th Annual JP Morgan Healthcare Conference that begins today in San Francisco. NewLink Genetics’ Chairman and Chief Executive Officer, Charles J. Link, Jr., M.D., will discuss the Company’s continued execution of its corporate strategy and 2018 priorities as part of a live presentation on Thursday, January 11, 2018, at 11:00 AM PT/2:00 PM ET. The slide presentation with updated guidance has been posted on the Company’s website and may be found here. The oral presentation will be webcast and available on the NewLink Genetics website under the Investors & Media tab under Events & Presentations.
Indigo301 is a randomized Phase 3 study of indoximod or placebo plus KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab) for patients with unresectable or metastatic melanoma. The choice of PD-1 inhibitors will be at the physician’s discretion, mirroring the general clinical setting. The study will consist of a planned 624 patients enrolled at approximately 100 sites in multiple countries and will include co-primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS), with a secondary endpoint of Objective Response Rate (ORR).
“NewLink has focused its business priorities on the execution of Indigo301 for patients with advanced melanoma,” said Dr. Link. “We will also initiate a randomized Phase 2 trial in collaboration with AstraZeneca for patients with metastatic pancreatic cancer, and we anticipate clinical data from additional development programs.”
To expedite the enrollment of Indigo301, NewLink Genetics has expanded the planned number of trial sites both within and outside of the US and plans several clinical recruitment initiatives to engage with the oncology community with the goal to enroll the majority of patients in 2018. As a result of these clinical planning efforts, NewLink Genetics is accordingly updating its guidance for clinical trials as follows:
Clinical Guidance and Milestones
• | Enroll the majority of Indigo301 trial by the end of 2018 |
• | Phase 2 results for indoximod + PD-1 blockade in advanced melanoma expected in 2018 |
• | Phase 2 results for indoximod + gem/nab-paclitaxel in pancreatic cancer expected 1H 2018 |
• | Phase 2 randomized AstraZeneca collaboration in pancreatic cancer to initiate 1H 2018 |
Exhibit 99.1
Financial Guidance and Outlook
“Entering 2018, we have aligned our business and investments to drive Indigo301 and other high-potential development programs,” said Jack Henneman, Executive Vice President and Chief Financial Officer for NewLink Genetics. “As we continue to progress, we remain committed to maintaining the strength of our balance sheet in support of our most promising clinical programs.”
NewLink Genetics ended 2017 with approximately $158 million in cash and cash equivalents. Updated guidance for use of cash is provided in the slide presentation available on the company’s website.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape. NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, pancreatic cancer and other malignancies.
About NewLink Genetics Corporation
NewLink Genetics is a late-stage biopharmaceutical company focusing on discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics’ IDO pathway inhibitors are designed to harness multiple components of the immune system to combat cancer. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies. For more information, please visit www.newlinkgenetics.com and follow us on Twitter @NLNKGenetics.
KEYTRUDA® is a registered trademark of Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “guidance,” “upcoming,” “will,” “plan,” "anticipate," "approximate," "expect," 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 2018; 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 in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events
Exhibit 99.1
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 press release.
###
Investor Contact:
Lisa Miller
Director of Investor Relations
NewLink Genetics
515-598-2555
lmiller@linkp.com
Media Contact:
Vivian Ni
Public & Media Relations
LaVoieHealthScience
617-374-8800, ext. 109
vni@lavoiehealthscience.com
NewLink Genetics Corporation
NASDAQ: NLNK
January 8-11, 2018
36th Annual J.P. Morgan Healthcare Conference
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 and 2018; results of its clinical
trials for product candidates; its timing of enrollment of patients and 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.
2
NewLink Genetics
Focused on Indoximod, an IDO Pathway Inhibitor
Indoleamine 2,3-dioxygenase (IDO) pathway is a key immuno-oncology target
Our leading IDO pathway inhibitor, indoximod, has a differentiated mechanism of action (MOA)
Indoximod’s unique MOA may allow effectiveness in different combinations and therapeutic
settings than direct enzymatic inhibitors
Clinical data suggest indoximod combinations may enhance multiple therapeutic modalities
– PD-1 checkpoint inhibitors (advanced melanoma)
– Cancer vaccine (metastatic prostate cancer)
– Chemotherapy (pancreatic cancer and acute myeloid leukemia)
Indoximod has the potential to improve patient outcomes across a broad range of cancers
including both hematologic and solid tumor indications
3
Indoximod has been studied in more than 700 patients
Launching pivotal trial (Indigo301) of indoximod plus PD-1 inhibitors for patients with advanced
melanoma
Phase 2 data for indoximod (IDO) plus pembrolizumab (PD-1) suggest potential for
improvement of both response rate and PFS for patients with advanced melanoma
Indoximod granted Orphan Drug Designation by the FDA for Stage IIb-IV melanoma
Phase 2 clinical collaboration with AstraZeneca to evaluate indoximod plus durvalumab plus
standard-of-care chemotherapy for patients with metastatic pancreatic cancer
First patients dosed with novel salt formulation of indoximod
First patients dosed with NLG802, prodrug of indoximod
Cash and equivalents of approximately $158 million at YE 2017
4
Indoximod program made substantial progress in 2017
NewLink Genetics
Highlights
Targeting the IDO Pathway
Indoximod
– Acts directly on immune cells to reverse IDO
pathway-mediated suppression
Other IDO inhibitors
– Direct IDO enzymatic inhibitors such as
NLG919, epacadostat and BMS-986205
block tryptophan metabolism1,2
5
Indoximod - A Unique Approach To Inhibiting the IDO Pathway
IDO, indoleamine 2,3-dioxygenase; Treg, regulatory T cell; MDSC, myeloid-derived suppressor cell; CTL, cytotoxic T lymphocyte.
1Mautino M. AACR 2013. Abstract 491. 2Jochems C. Oncotarget. 2016;7(25):37762-37772.
Indoximod has a differentiated mechanism of action
IDO Pathway Mediated Immuno-Suppression
6
Treg Activation and Effector Cell Reduction
Combination data show potential to enhance multiple different treatment modalities Immuno-suppressive feedback loop dependent on multiple components
Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
KYN KYN
TRP
Effector
T cell
Regulatory
T cell
Effector cell
suppression/anergy/death
Treg activation
IDO-expressing cell
(DC, Mo, etc)
AhR
GCN2
AhR
GCN2
mTOR mTOR
Indoximod is an IDO Pathway Inhibitor with a Differentiated MOA
7
A Proposed Mechanism with a Broad Spectrum of Potential Clinical Utility
Combination data show potential to enhance multiple different treatment modalities Indoximod interrupts the IDO mediated immuno-suppressive feedback loop
Indoximod MOA
1Metz R. Oncoimmunology. 2012;1(9):1460-1468; 2Holmgaard RB, et al. Cell Reports. 2015;13(2):412-424;
3Sharma MD, et al. Immunity. 2010;33(6):942-954; 4Adapted from Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
KYN KYN
TRP
Effector
T cell
IDO-expressing cell
(DC, Mo, etc)
Regulatory
T cell
Indoximod
Orally available tryptophan mimetic1
Counteracts immunosuppressive effects of kynurenine1
Activates multiple immune cells (effector cells)2
Prevents activation of regulatory T cells (Tregs)3
Reprograms Tregs into helper T cells3
GCN2
mTOR
GCN2
mTOR
4
Indoximod is an IDO Pathway Inhibitor with a Differentiated MOA
Orally available tryptophan mimetic1
Counteracts immunosuppressive effects of kynurenine1
Activates multiple immune cells (effector cells)2
Prevents activation of regulatory T cells (Tregs)3
Reprograms Tregs into helper T cells3
8
A Proposed Mechanism with a Broad Spectrum of Potential Clinical Utility
Combination data show potential to enhance multiple different treatment modalities Indoximod interrupts the IDO mediated immuno-suppressive feedback loop
Indoximod MOA
1Metz R. Oncoimmunology. 2012;1(9):1460-1468; 2Holmgaard RB, et al. Cell Reports. 2015;13(2):412-424;
3Sharma MD, et al. Immunity. 2010;33(6):942-954; 4Adapted from Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
KYN KYN
TRP
Effector
T cell
Regulatory
T cell
Effector cell
suppression/anergy/death
IDO-expressing cell
(DC, Mo, etc)
AhR
GCN2
AhR
GCN2
mTOR mTOR
4
Indoximod is an IDO Pathway Inhibitor with a Differentiated MOA
Orally available tryptophan mimetic1
Counteracts immunosuppressive effects of kynurenine1
Activates multiple immune cells (effector cells)2
Prevents activation of regulatory T cells (Tregs)3
Reprograms Tregs into helper T cells3
9
A Proposed Mechanism with a Broad Spectrum of Potential Clinical Utility
Combination data show potential to enhance multiple different treatment modalities Indoximod interrupts the IDO mediated immuno-suppressive feedback loop
Indoximod MOA
1Metz R. Oncoimmunology. 2012;1(9):1460-1468; 2Holmgaard RB, et al. Cell Reports. 2015;13(2):412-424;
3Sharma MD, et al. Immunity. 2010;33(6):942-954; 4Adapted from Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
KYN
TRP
Effector
T cell
IDO-expressing cell
(DC, Mo, etc)
AhR
GCN2
mTOR
4
Indoximod is an IDO Pathway Inhibitor with a Differentiated MOA
Orally available tryptophan mimetic1
Counteracts immunosuppressive effects of kynurenine1
Activates multiple immune cells (effector cells)2
Prevents activation of regulatory T cells (Tregs)3
Reprograms Tregs into helper T cells3
10
A Proposed Mechanism with a Broad Spectrum of Potential Clinical Utility
Combination data show potential to enhance multiple different treatment modalities Indoximod interrupts the IDO mediated immuno-suppressive feedback loop
Indoximod MOA
1Metz R. Oncoimmunology. 2012;1(9):1460-1468; 2Holmgaard RB, et al. Cell Reports. 2015;13(2):412-424;
3Sharma MD, et al. Immunity. 2010;33(6):942-954; 4Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
TRP
Regulatory
T cell
Treg activation
IDO-expressing cell
(DC, Mo, etc)
AhR
GCN2
mTOR
4
Indoximod is an IDO Pathway Inhibitor with a Differentiated MOA
Orally available tryptophan mimetic1
Counteracts immunosuppressive effects of kynurenine1
Activates multiple immune cells (effector cells)2
Prevents activation of regulatory T cells (Tregs)3
Reprograms Tregs into helper T cells3
11
A Proposed Mechanism with a Broad Spectrum of Potential Clinical Utility
Combination data show potential to enhance multiple different treatment modalities Indoximod interrupts the IDO mediated immuno-suppressive feedback loop
Indoximod MOA
1Metz R. Oncoimmunology. 2012;1(9):1460-1468; 2Holmgaard RB, et al. Cell Reports. 2015;13(2):412-424;
3Sharma MD, et al. Immunity. 2010;33(6):942-954; 4Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
TRP
Regulatory
T cell
IDO-expressing cell
(DC, Mo, etc)
Helper
T cell
KYN
AhR
GCN2
4
Indoximod is an IDO Pathway Inhibitor with a Differentiated MOA
Orally available tryptophan mimetic1
Counteracts immunosuppressive effects of kynurenine1
Activates multiple immune cells (effector cells)2
Prevents activation of regulatory T cells (Tregs)3
Reprograms Tregs into helper T cells3
12
A Proposed Mechanism with a Broad Spectrum of Potential Clinical Utility
Combination data show potential to enhance multiple different treatment modalities Indoximod interrupts the IDO mediated immuno-suppressive feedback loop
Indoximod MOA
1Metz R. Oncoimmunology. 2012;1(9):1460-1468; 2Holmgaard RB, et al. Cell Reports. 2015;13(2):412-424;
3Sharma MD, et al. Immunity. 2010;33(6):942-954; 4Adapated from Munn, D et al. Trends in Immunology. Page 12, Figure 1, March 2012.
IDO
KYN KYN
TRP
Effector
T cell
Regulatory
T cell
Effector cell
suppression/anergy/death
Treg activation
IDO-expressing cell
(DC, Mo, etc)
AhR
GCN2
AhR
GCN2
mTOR mTOR
Helper
T cell
4
13
Characteristic n = 51*
Median age (range), yr 62.9 (27–88)
Male, n (%) 34 (67)
Race/Ethnicity, n (%)
White, non-Hispanic† 50 (98)
LDH above ULN, n (%) 12 (24)
Disease stage, n (%)
III 8 (16)
IV 43 (84)
M1a 9 (18)
M1b 13 (25)
M1c 21 (41)
Phase 2: Baseline Demographics and Clinical Characteristics
ECOG PS, Eastern Cooperative Oncology Group performance status;
LDH, lactate dehydrogenase; ULN, upper limit of normal.
*Excludes uveal melanoma patients.
†One patient declined to answer.
Characteristic n = 51*
ECOG PS, n (%)
0 38 (75)
1 13 (25)
Primary site, n (%)
Cutaneous 40 (78)
Mucosal or primary unknown 11 (22)
Prior therapy, n (%)
Radiation 9 (18)
Systemic therapy 14 (27)
None 28 (55)
Indoximod (IDO) plus Pembrolizumab (PD-1) in Advanced Melanoma
Zakharia Y, et al. Oral presentation at: Third International Cancer Immunology Conference; September 6-9, 2017; Frankfurt, Germany.
14
Phase 2: Impressive Response Rate and Progression Free Survival (N=51)
*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.
Response N (%)
ORR 31 (61)
CR 10 (20)
PR 21 (41)
SD 10 (20)
DCR 41 (80)
PD 10 (20)
Significant depth of response observed in a large number of patients
Survival
Median PFS 12.9 months
PFS at 12 months 56%
Indoximod (IDO) plus Pembrolizumab (PD-1) in Advanced Melanoma
0
10
20
30
40
50
60
70
80
90
15
Nivolumab1 Pembrolizumab2* Ipilimumab+Nivolumab3 Indoximod+Pembrolizumab4
0
2
4
6
8
10
12
14
ORR PFS CR DCR
Comparative anti-PD-1 monotherapy & anti-PD-1 + anti-PD-1 combination data provided for illustrative purposes only; no head-to-head trials conducted.
*Data are for Q2W regimen. ORR, overall response rate; CR, complete response; DCR, disease control rate; PFS, progression-free survival.
1Robert C, et al. N Engl J Med. 2015;372(4): 320-330. 2Robert C, et al. N Engl J Med. 2015;372(26): 2521-2532. 3Larkin J, et al. N Engl J Med. 2015;373(1):23-34.
4Zakharia Y. Oral presentation at: Third International Cancer Immunotherapy Conference, September 6-9, 2017; Frankfurt, Germany.
P
e
rc
entag
e
of patient
s
Mo
n
th
s
Indoximod Plus PD-1 Response and Survival in Advanced Melanoma
Potential to Improve Outcomes Without Added Toxicity of Ipilimumab + Nivolumab
16
Indoximod plus Pembrolizumab Phase 2 Patient
Complete Response in Advanced Melanoma
Zakharia Y, et al. Oral presentation at: Third International Cancer Immunology Conference; September 6-9, 2017; Frankfurt, Germany.
After Treatment
(July 2017)
Before Treatment
(October 2015)
17
Adverse Event Profile Appears Comparable to Pembrolizumab Alone
Full dose combination generally well tolerated
Combination was generally well tolerated
No treatment-related Grade 4/5 adverse events reported to date
Serious Adverse Events (SAEs) led to discontinuation in only 3 patients
SAEs labelled as possibly related to indoximod reported in 4 patients
Limited immune-mediated adverse events reported regardless of attribution to treatment
No treatment-related deaths were reported
Indoximod (IDO) plus Pembrolizumab (PD-1) in Advanced Melanoma
Zakharia Y, et al. Oral presentation at: Third International Cancer Immunology Conference; September 6-9, 2017; Frankfurt, Germany.
18
• Adults ≥18 years of age with unresectable
stage III or IV advanced melanoma
• No prior melanoma therapy, except
– BRAF/MEK inhibitor
– Prior adjuvant or neoadjuvant therapy
≥4 weeks before randomization
– Prior adjuvant immunotherapy
(no relapse during treatment or
≤6 months of treatment
discontinuation)
• Stable brain metastases allowed
Co-primary endpoints
• Progression-free survival
• Overall survival
Secondary endpoint
• Objective response rate
• Total planned enrollment: 624 patients
• ~100 sites in multiple countries
• Randomization (via an interactive web
randomization system) stratified by:
– Choice of checkpoint inhibitor
(pembrolizumab or nivolumab)
– Prior BRAF/MEK therapy
– M stage at randomization
• Treatment until disease progression
or unacceptable toxicity
*Standard-of-care dosing per country.
1
:1
R
a
n
d
o
m
iz
a
tio
n
PD-1 checkpoint inhibitor*
+ indoximod orally every 12 hours
PD-1 checkpoint inhibitor*
+ placebo orally every 12 hours
A Phase 3 Study of Indoximod or Placebo Plus Pembrolizumab
or Nivolumab For Patients With Unresectable or Metastatic
Melanoma
PATIENT POPULATION EFFICACY ENDPOINTS
ENROLLMENT
Trial Support
19
Broad Set of Initiatives to Drive Enrollment and Expand Awareness
Launching clinical trials initiative
– Physician and patient information website
– Targeted online and print advertising
– Patient advocacy partnerships
Deploying field based medical affairs team in Q1:18
– Work directly with trial sites to accelerate enrollment
– Facilitate patient recruitment activities at local and regional levels
– Engage Key Opinion Leaders
Enlisting support from multiple industry leading experts
– Additional clinical trial specialists targeting Ex US sites
– Specialty accrual programs tailored to individual site needs and requirements
Phase 2 Randomized, Placebo Controlled Trial* of IDO
plus anti-PD-L1 and Chemotherapy for Patients with
Metastatic Pancreatic Cancer
Objective: Evaluate 4 drug regimen vs SOC
Planned enrollment of 200 patients
Primary Endpoint: Overall Response
Secondary Endpoints:
̶ Overall Survival
̶ Progression-Free Survival
̶ Safety
Status and Milestones
̶ First Patient 1H:18
̶ 50/50 Cost Sharing
̶ NewLink to be study sponsor
20 * Clinical collaboration with AstraZeneca
Indoximod plus Standard of Care Chemotherapy
Phase 1/2 for Indoximod plus Standard of Care Chemotherapy for Patients with
Acute Myeloid Leukemia
21
Strong preclinical data and significant unmet need
Patients with newly diagnosed Acute Myeloid Leukemia (AML)
Surrogate efficacy endpoint being explored as potential fast to market strategy
Currently completing initial Phase 1b dose escalation
EHA ’17 Abstract E-912, Emadi, et al June 23rd 2017
15 patients enrolled as of June 1, 2017
Indoximod does not appear to add significant toxicity
7/9 patients who completed treatment per protocol (>80% compliance) achieved morphologic CR
7/7 patients with CR had no evidence of minimal residual disease
* Burris, H et al. ASCO, June 2017. Abstract 105.
** Mautino, M et al. AACR, October 2013. Abstract 491. 22
Direct IDO1 Enzymatic Inhibitor
Significant retained value and clinical development opportunity
NLG919
Phase 2 ready asset
Favorable safety profile with no appreciable increase in AEs in combination with PD-L1 blockade*
Peripheral PD showed dose-dependent decreases in plasma kynurenine, consistent with systemic
modulation of IDO1*
NLG919 + indoximod preclinical data showed synergistic anti-tumor activity**
NewLink Genetics has worldwide rights to NLG919
Potential for development or licensing opportunities
NLG919 & Indoximod
23
NLG919 & Indoximod - Antitumor Activity Alone & Synergy in Combination
Control Indoximod
NLG919 Indoximod + NLG919
Control: pmel1 cells + gp100 vaccine + CpG + IFA
Mautino, M et al; AACR Annual Meeting Poster Presentation, Abstract 491, April 7th, 2013
Indoximod differentiated MOA may demonstrate synergistic activity with direct IDO1 inhibitors
NewLink Genetics
Enroll the majority of Indigo301 trial by the end of 2018
Phase 2 results for indoximod + checkpoint blockade in melanoma expected in 2018
Phase 2 results indoximod + gem/nab-paclitaxel in pancreatic cancer expected 1H 2018
AstraZeneca randomized Phase 2 collaboration in pancreatic cancer to initiate 1H 2018
24
Near and Medium Term Catalysts
Indoximod offers opportunity to address unmet need in multiple indications
Financial Position
YE 2017 Cash and Equivalents1 $158 million
Debt ~$0.3 million
YE 2018 Cash (Projected)2 ~$75 million
Forecast Quarterly Cash Use ~$20-22 million
Shares Outstanding as of October 31,2017 37.1 million
25
1 Preliminary unaudited cash position at year-end 2017
2 Excludes projections of proceeds, if any, from financings not yet completed
Financially well-positioned to execute our business strategy