Document


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): March 1, 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 2 - Financial Information
 
Item 2.02.              Results of Operations and Financial Condition.
 
On March 1, 2018, NewLink Genetics Corporation, a Delaware corporation (the “Company”), issued a press release providing an operational update and reporting financial results for the fourth quarter and year-ended December 31, 2017 ("Press Release"). A copy of the Press Release and the Fourth Quarter and Year End Financial Results Presentation are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.
 
The information in this Current Report, including Exhibits 99.1 and 99.2 attached hereto is furnished under Item 2.02 of this report and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.






Section 9 - Financial Statements and Exhibits
 
Item 9.01.              Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit Number
 
Description
99.1
 
Press Release, dated March 1, 2018, entitled “NewLink Genetics Reports Fourth Quarter, Year-End 2017 Financial Results and Provides Clinical Update for Indoximod Programs”
99.2
 
Fourth Quarter and Year-End 2017 Financial Results 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:    March 1, 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
 
99.2
 









Exhibit
Exhibit 99.1


http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12099424&doc=4
FOR IMMEDIATE RELEASE

NewLink Genetics Reports Fourth Quarter, Year-End 2017 Financial Results and Provides Update for Indoximod Programs
- Management to Host Conference Call Today at 4:30 p.m. ET
Ames, Iowa, March 1, 2018 -- NewLink Genetics Corporation (NASDAQ:NLNK) today reported consolidated financial results for the fourth quarter and year ended 2017, as well as progress in its clinical development programs. The Company also outlined key 2018 business priorities related to the clinical programs for indoximod, its IDO pathway inhibitor drug candidate.
“NewLink Genetics has produced encouraging data supporting indoximod in several indications and looks forward to presenting additional data in 2018, further validating IDO pathway inhibition as a key target in immuno-oncology,” said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. “In addition, Indigo301, our pivotal trial for patients with metastatic melanoma, and Indigo201, our randomized Phase 2 trial in collaboration with AstraZeneca for patients with metastatic pancreatic cancer, are our core clinical priorities for 2018.”
Anticipated 2018 Highlights
Initiate randomization portion of Indigo301, a pivotal Phase 3 trial for patients with advanced melanoma, in Q2-Q3 2018
Full Phase 2 results of indoximod plus checkpoint inhibitors in metastatic melanoma in 1H:2018
Initiate Indigo201, a randomized Phase 2 trial for patients with metastatic pancreatic cancer, in 1H:2018
Full Phase 2 results from the single-arm trial of indoximod plus gemcitabine nab-paclitaxel in metastatic pancreatic cancer in 1H:2018
Two abstract presentations at AACR Annual Meeting 2018 include data from a Phase 1 study of indoximod for pediatric patients with malignant brain tumors and data providing additional characterization of the differentiated mechanism of action of indoximod
Continued evaluation of indoximod in additional oncology indications
2017 Highlights
Presented updated Phase 2 data of indoximod plus pembrolizumab in advanced melanoma at the Third Annual International Cancer Immunotherapy Conference with encouraging overall and complete response rates and progression-free survival
Commenced dose determination portion of Indigo301
Entered into a collaboration with AstraZeneca on Indigo201
Presented Phase 2 data from a randomized, double-blind study of indoximod plus cancer vaccine for patients with metastatic castration-resistant prostate cancer at ASCO Annual Meeting, indicating statistically significant improvement in median progression-free survival compared to monotherapy



Exhibit 99.1


Presented Phase 1b data of indoximod plus chemotherapy in newly diagnosed AML suggesting the potential for indoximod in treatment regimens beyond PD-1
Successfully raised $74.3 million, net of offering costs, and ended 2017 with $158.7 million cash and equivalents
Update on Current Clinical Timeline and Financial Guidance
NewLink Genetics reported an update of its clinical timeline and now expects to initiate Indigo301 randomization in Q2 to Q3 2018 and complete enrollment in 2019. The Company expects to end this year with approximately $75 million in cash. The shift in the timeline arises from an increased number of trial sites planned for Indigo301 and additional work related to manufacturing.
Financial Results
Cash Position: NewLink Genetics ended the year on December 31, 2017, with cash and cash equivalents totaling $158.7 million compared to $131.5 million for the year ending December 31, 2016. The Company's cash position is sufficient to fund operations in the near and medium term.
R&D Expenses: Research and development expenses were $17.5 million and $69.9 million in the fourth quarter and year ended December 31, 2017 compared to $19.5 million and $93.3 million during the comparable periods in 2016. The decrease year-over-year was due primarily to higher restructuring charges of $11.1 million incurred in 2016, including a non-cash charge of $4.0 million related to impaired assets, as compared to $600,000 of charges incurred in 2017. Remainder of the decrease was due to decreases of $6.2 million in clinical trial costs, $4.4 million in supplies, equipment and licensing, $3.6 million in personnel-related expense, and $200,000 in manufacturing expense. Decreases were offset by increases of $1.0 million in stock compensation expense and $600,000 in legal and consulting.
G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2017 were $6.7 million and $31.7 million compared to $7.2 million and $33.2 million during the comparable periods in 2016. The decrease was primarily due to a $2.3 million reduction in personnel-related spend and $1.2 million reduction in legal and consulting, offset by increases of $700,000 in stock compensation expense, $700,000 in supplies and equipment, and $600,000 in restructuring charges incurred in 2017.
Net Loss: NewLink Genetics reported a net loss of $13.7 million or $0.37 per diluted share for the fourth quarter of 2017 and a net loss of $72.0 million or $2.30 per diluted share for the year ended December 31, 2017, compared to a net loss of $13.5 million or $0.46 per diluted share for the fourth quarter of 2016 and a net loss of $85.2 million or $2.94 per diluted share for the year ended December 31, 2016.
NewLink Genetics ended 2017 with 37,109,556 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics' senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations" or by clicking here. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.  A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9466627. The replay will be available for two weeks from the date of the call.



Exhibit 99.1


About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. 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.
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. For more information, please visit www.NewLinkGenetics.com and follow us on Twitter @NLNKGenetics.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink Genetics 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," “intend,” "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 execution of clinical trials; 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 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:
Sharon Correia
VP, Integrated Communications
LaVoieHealthScience
617-374-8800, ext. 105
scorreia@lavoiehealthscience.com

Source: NewLink Genetics Corporation




Exhibit 99.1


NewLink Genetics Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share amounts)
 
 
 
 
 
 
 
 
 
 
Three Months Ended December 31,
 
Year Ended December 31,
 
 
2017
 
2016
 
2017
 
2016
 
Grant revenue
$
10,042

 
$
12,185

 
$
28,321

 
$
32,242

 
Licensing and collaboration revenue
56

 
518

 
390

 
3,526

 
Total operating revenues
10,098

 
12,703

 
28,711

 
35,768

 
Operating expenses:
 
 
 
 
 
 
 
 
Research and development
17,461

 
19,490

 
69,866

 
93,300

 
General and administrative
6,688

 
7,183

 
31,726

 
33,226

 
Loss from operations
(14,051
)
 
(13,970
)
 
(72,881
)
 
(90,758
)
 
Other income, net
235

 
129

 
371

 
247

 
Net loss before taxes
(13,816
)
 
(13,841
)
 
(72,510
)
 
(90,511
)
 
Income tax benefit
130

 
335

 
559

 
5,356

 
Net loss
$
(13,686
)
 
$
(13,506
)
 
$
(71,951
)
 
$
(85,155
)
 
Basic and diluted loss per share
$
(0.37
)
 
$
(0.46
)
 
$
(2.30
)
 
$
(2.94
)
 
Basic and diluted average shares outstanding
36,770,490

 
29,147,247

 
31,304,309

 
28,979,327

 





Exhibit 99.1


NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands)
 
Year Ended
 
December 31,
 
December 31,
 
2017
 
2016
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
158,708

 
$
131,490

Prepaid expenses and other current assets
6,226

 
5,921

Income tax receivable
356

 
5,975

Other receivables
10,176

 
24,526

Total current assets
175,466

 
167,912

Non-current Assets
 
 
 
Property and equipment, net
5,091

 
6,835

Income Tax Receivable
140

 

Total non-current assets
5,231

 
6,835

Total assets
$
180,697

 
$
174,747

 
 
 
 
Liabilities and Stockholders' Equity
 
 
 
Current liabilities:
 
 
 
Accounts payable and accrued expenses
$
21,723

 
$
37,192

Unearned revenue
56

 
391

Other current liabilities
252

 
322

Total current liabilities
22,031

 
37,905

Long-term liabilities:
 
 
 
Royalty obligation payable
6,000

 
6,000

Notes payable and obligations under capital leases
111

 
285

Deferred rent
998

 
1,091

Total long-term liabilities
7,109

 
7,376

Total liabilities
29,140

 
45,281

Stockholders' equity:
 
 
 
Common stock
372

 
292

Additional paid-in capital
389,786

 
295,535

Treasury stock, at cost
(1,142
)
 
(853
)
Accumulated deficit
(237,459
)
 
(165,508
)
Total stockholders' equity
151,557

 
129,466

Total liabilities and stockholders' equity
$
180,697

 
$
174,747

 
 
 
 
 
 
 
 




nlnkq42017slidesfinal
NewLink Genetics Corporation Nasdaq: NLNK March 1, 2018 Fourth Quarter and Year-End 2017 Financial 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., Chief Medical Officer Fourth Quarter and Year-End 2017 Financial Results  Jack 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, 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 execution of clinical trials; 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 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


 
2017 Highlights  Presented updated Phase 2 data of indoximod plus pembrolizumab indicating encouraging overall and complete responses and progression-free survival  Commenced dose determination portion of Indigo301, a pivotal Phase 3 trial for patients with advanced melanoma  Entered into a collaboration with AstraZeneca on Indigo201, a randomized Phase 2 trial for patients with metastatic pancreatic cancer  Presented Phase 2 data at ASCO from a randomized double-blind study of indoximod plus cancer vaccine for patients with metastatic castration-resistant prostate cancer indicating statistically significant improvement in PFS compared to monotherapy  Presented Phase 1b data of indoximod plus chemotherapy in acute myeloid leukemia suggesting the potential for indoximod in treatment regimens beyond PD-1  Successfully raised $74.3 million, net of offering costs, and ended 2017 with $158.7 million cash and equivalents 4


 
2018 Highlights  Initiate randomization of Indigo301, a pivotal Phase 3 in advanced melanoma in Q2-Q3 2018  Full Phase 2 results of indoximod plus checkpoint inhibitors in metastatic melanoma 1H:2018  Initiate Indigo201, a randomized Phase 2 in metastatic pancreatic cancer in 1H:2018  Full Phase 2 results of indoximod plus gemcitabine nab-paclitaxel in metastatic pancreatic cancer in 1H:2018  Two abstracts to be presented at AACR Annual Meeting in April 2018 – Phase 1 study of indoximod for pediatric patients with malignant brain tumors – Additional characterization of the differentiated mechanism of action of indoximod  Continued evaluation of indoximod in additional oncology indications 5


 
6 • 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 Clinicaltrials.gov NCT03301636


 
Financial Position YE 2017 Cash and Equivalents $158.7 million Debt ~$0.3 million YE 2018 Cash (Projected)1 ~$75 million Forecast Quarterly Cash Use ~$20-22 million Shares Outstanding as of December 31,2017 37.1 million 7 1 Excludes projections of proceeds, if any, from potential future financings Financially well-positioned to execute our business strategy


 
NewLink Genetics  Initiation of two key randomized trials with indoximod plus checkpoint inhibition – Indigo301 for patients with advanced melanoma – Indigo201 in collaboration with AstraZeneca for patients with metastatic pancreatic cancer  Presentation of results from two Phase 2 trials – Full Phase 2 results of indoximod plus checkpoint inhibitors for patients with advanced melanoma – Full Phase 2 results of indoximod plus chemotherapy for patients with metastatic pancreatic cancer  Additional data supporting the opportunity for indoximod to improve the lives of patients with cancer across a range of indications 8 Key Takeaways for 2018


 
9 Q & A