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): November 1, 2018 (October 31, 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   x
 
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 November 1, 2018, NewLink Genetics Corporation, a Delaware corporation (the “Company”), issued a press release providing an operational update and reporting financial results for the third quarter ended September 30, 2018 ("Press Release").

A copy of the Press Release and the Third Quarter 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 5 - Corporate Governance and Management

Item 5.02.    Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
 
On October 31, 2018, Paolo Pucci notified NewLink Genetics Corporation ("NewLink") that he was resigning his position as a member of the board of directors of NewLink, effective immediately.  Concurrently therewith, Mr. Pucci also resigned as the Chair of the Nominating and Corporate Governance Committee and as a member of the Audit Committee. He explained that he was doing so in light of the guidelines of proxy advisory firms regarding the maximum number of directorships that should be held by a CEO.  Mr. Pucci serves as CEO of ArQule, Inc. and as a director of West Pharmaceutical Services, Inc.  Mr. Pucci served as a director of NewLink since 2015.  His resignation is not due to any disagreement with NewLink regarding any of its operations, policies or practices.









Section 9 - Financial Statements and Exhibits
 
Item 9.01.              Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit Number
 
Description
99.1
 
99.2
 






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:    November 1, 2018


 
NewLink Genetics Corporation
 
 
 
 
By:
/s/ Carl W. Langren
 
  Carl W. Langren
Its:
  Chief Financial Officer



Exhibit
Exhibit 99.1


http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12525511&doc=4
FOR IMMEDIATE RELEASE
NewLink Genetics Reports Third Quarter 2018 Financial Results and Announces Abstracts to Be Presented at Upcoming Medical Meetings
Management to Host Conference Call Today at 4:30 p.m. ET
Ames, Iowa, November 1, 2018 -- NewLink Genetics Corporation (NASDAQ:NLNK) today reported consolidated financial results for the third quarter 2018 and reviewed recent highlights and upcoming milestones.
“NewLink Genetics continues to produce encouraging data supporting indoximod in targeted cancer indications. We remain confident in the advancement of our clinical programs as we strive to develop novel therapies addressing areas of great unmet need,” said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. “We look forward to presenting data at SITC and ASH this fall.”
Data to be Presented at Upcoming Medical Meetings
Abstract accepted for oral presentation at the ASH Annual Meeting, December 1-4, 2018
Abstract 332: Indoximod combined with standard induction chemotherapy is well tolerated and induces a high rate of complete remission with MRD-negativity in patients with newly diagnosed AML: results from a Phase 1 trial, Emadi, A., et al. - to be presented during the oral session, 616 entitled “Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Combination Therapy” Sunday, Dec 2, 2018, 9:30-11:00 AM PT. Data indicate that a high percentage of newly diagnosed AML patients treated with indoximod plus standard-of-care (SOC) chemotherapy achieved complete response (CR) and showed no evidence of minimal residual disease (were MRD-negative). Indoximod was well tolerated.
Abstracts accepted for poster presentation at the SITC Annual Meeting, November 7-11, 2018
Abstract 11213: A phase 1a clinical trial of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, Rixe, O., et al. (Poster #P331)
Abstract 10294: The immunogenomic impact of indoximod on the tumor microenvironment of melanoma patients, Yu, J., et al. (Poster #P142)
Abstract 10304: Effects of indoximod plus gemcitabine/nab-paclitaxel on tumor microenvironment of patients with metastatic pancreatic cancer, Yu, J., et al. (Poster #P706)
Posters are being presented on Friday, November 9th, and Saturday, November 10th, from 8 AM to 8 PM, in Exhibition Hall E of the Walter E. Washington Convention Center.
Outlook for 2019
Updated results from Phase 1 trial of indoximod plus radiotherapy for pediatric patients with recurrent malignant brain tumors including initial survival data expected to be presented 1H 2019
Updated data from Phase 1 trial of indoximod plus radiotherapy in DIPG anticipated in 2019
Data from Phase 2 trial of NLG207 (CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, plus paclitaxel in recurrent ovarian cancer anticipated in 2019



Exhibit 99.1


Clinical Update
NewLink Genetics continues its clinical trials of indoximod in combination therapies for adult patients with newly diagnosed AML, pediatric patients with recurrent brain tumors, and pediatric patients with newly diagnosed DIPG. These targeted indications are those with unmet need where indoximod has produced encouraging early data and where standard-of-care therapy has not changed significantly for decades.
A Phase 2 study evaluating NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin, in combination with paclitaxel for patients with recurrent ovarian cancer is complete, and data analysis is underway. NLG207 is an asset acquired from Cerulean Pharma Inc. in 2017. This trial is being conducted in conjunction with the Gynecological Oncology Group.
Board Changes
Paolo Pucci has resigned his position as a Director on NewLink Genetics’ Board effective October 31, 2018 due to the increasing responsibilities associated with his current position as CEO of ArQule, Inc. and current guidelines of proxy advisors regarding the number of directorships to be held by a CEO. With Mr. Pucci’s departure, NewLink’s Board will consist of seven directors.
Financial Results for the Three-Month Period Ended September 30, 2018
Cash Position: NewLink Genetics ended the quarter on September 30, 2018, with cash and cash equivalents totaling $122.1 million compared to $158.7 million for the year ending December 31, 2017.
R&D Expenses: Research and development expenses for the third quarter of 2018 were $7.6 million, a decrease of $10.9 million from $18.5 million for the same period in 2017. The decrease was due to reductions of $7.3 million in contract research and manufacturing spend, $2.5 million in clinical trial expense, $570,000 in personnel-related and stock compensation expense, $560,000 in supplies and licensing, and $100,000 in restructuring costs. These reductions were offset by an increase of $70,000 in legal and consulting expense.
G&A Expenses: General and administrative expenses for the third quarter of 2018 were $7.6 million, a decrease of $320,000 from $7.9 million for the same period in 2017. The decrease was due to reductions of $300,000 in restructuring costs, $240,000 in legal and consulting expenses, and $10,000 in personnel-related and stock compensation expense. These reductions were offset by an increase of $230,000 in supplies and other expense.
Net Loss: NewLink Genetics reported a net loss of $7.4 million or ($0.20) per diluted share for the third quarter of 2018 compared to a net loss of $20.6 million or ($0.69) per diluted share for the third quarter of 2017.
NewLink Genetics ended the quarter with 37,216,892 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) 235-8286 (U.S.) or (267) 753-2161 (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 10 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 1753698. The replay will be available for two weeks from the date of the call.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan



Exhibit 99.1


with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company focusing on developing 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 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 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; the effects of its organizational realignment; 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, 2017 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 & Media Contact:

Lisa Miller
Director of Investor Relations
NewLink Genetics
515-598-2555
lmiller@linkp.com




Exhibit 99.1


NewLink Genetics Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share amounts)
 
 
 
 
 
 
 
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2018
 
2017
 
2018
 
2017
Grant revenue
$

 
$
5,379

 
$
11,268

 
$
18,279

Licensing and collaboration revenue
120

 
103

 
1,004

 
334

     Total operating revenues
120

 
5,482

 
12,272

 
18,613

Operating expenses:
 
 
 
 
 
 
 
  Research and development
7,570

 
18,480

 
39,972

 
52,405

  General and administrative
7,588

 
7,907

 
23,792

 
25,038

     Total operating expenses
15,158

 
26,387

 
63,764

 
77,443

Loss from operations
(15,038
)
 
(20,905
)
 
(51,492
)
 
(58,830
)
Other income and expense:
 
 
 
 
 
 
 
  Miscellaneous income (expense)
(18
)
 
12

 
16

 
(101
)
  Interest income
664

 
151

 
1,510

 
353

  Interest expense
(2
)
 
(3
)
 
(51
)
 
(116
)
Other income (expense), net
644

 
160

 
1,475

 
136

Net loss before taxes
(14,394
)
 
(20,745
)
 
(50,017
)
 
(58,694
)
Income tax benefit
6,991

 
119

 
6,991

 
429

Net loss
$
(7,403
)
 
$
(20,626
)
 
$
(43,026
)
 
$
(58,265
)
Basic and diluted loss per share
$
(0.20
)
 
$
(0.69
)
 
$
(1.16
)
 
$
(1.98
)
Basic and diluted average shares outstanding
37,214,363

 
29,939,823

 
37,178,542

 
29,462,226






Exhibit 99.1


NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands)
 
Year Ended
 
September 30,
 
December 31,
 
2018
 
2017
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
122,061

 
$
158,708

Prepaid expenses and other current assets
4,920

 
6,226

Income tax receivable
7,398

 
356

Other receivables
700

 
10,176

Total current assets
135,079

 
175,466

Property and equipment, net
4,096

 
5,091

Income tax receivable
140

 
$
140

Total non-current assets
4,236

 
$
5,231

Total assets
$
139,315

 
$
180,697

Liabilities and Stockholders' Equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
1,238

 
$
9,256

Accrued expenses
8,736

 
12,467

Current portion of unearned revenue

 
56

Current portion of deferred rent
84

 
92

  Current portion of notes payable and obligations under capital leases
74

 
160

Total current liabilities
10,132

 
22,031

Long-term liabilities:
 
 
 
Royalty obligation payable to Iowa Economic Development Authority
6,000

 
6,000

Notes payable and obligations under capital leases
59

 
111

Deferred rent
929

 
998

Total long-term liabilities
6,988

 
7,109

     Total liabilities
17,120

 
29,140

Stockholders' equity:
 
 
 
Blank check preferred stock, $0.01 par value: Authorized shares - 5,000,000 at September 30, 2018 and December 31, 2017; issued and outstanding shares - 0 at September 30, 2018 and December 31, 2017

 

Common stock, $0.01 par value: Authorized shares - 75,000,000 at September 30, 2018 and December 31, 2017; issued 37,305,626 and 37,168,122 at September 30, 2018 and December 31, 2017, respectively, and outstanding 37,216,892 and 37,109,556 at September 30, 2018 and December 31, 2017, respectively
373

 
372

Additional paid-in capital
399,018

 
389,786

Treasury stock, at cost: 88,734 and 58,566 shares at September 30, 2018 and December 31, 2017, respectively
(1,405
)
 
(1,142
)
Accumulated deficit
(273,040
)
 
(237,459
)
     Total stockholders' equity
124,946

 
151,557

Total liabilities and stockholders' equity
$
142,066

 
$
180,697

 
 
 
 
 
 
 
 


q32018earningsslidesfina
Third Quarter 2018 Financial Results NewLink Genetics Corporation Nasdaq: NLNK November 1, 2018


 
Introduction •Lisa Miller, Director of Investor Relations Clinical Priorities • Charles J. Link, Jr, MD, Chairman, CEO & CSO Clinical Updates and Guidance on Timing of Data •Eugene Kennedy, MD, Chief Medical Officer Third Quarter 2018 Financial Results • Carl Langren, Chief Financial Officer 2


 
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; the effects of its organizational realignment, 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, 2017 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


 
Indoximod Clinical Programs Front-line diffuse intrinsic pontine glioma (DIPG) Indoximod plus radiotherapy for pediatric patients with DIPG Early data show all patients demonstrated initial symptomatic improvement on therapy Phase 1b trial ongoing with updated data anticipated 2019 Recurrent malignant pediatric brain tumors Indoximod plus radio-chemotherapy for pediatric patients with malignant brain tumors Phase 1b trial ongoing with updated data anticipated 1H 2019 Front-line acute myeloid leukemia (AML) Indoximod plus standard-of-care chemotherapy for patients with front-line AML Updated data July 2018 showed promising MRD-negativity with indoximod Phase 1b trial ongoing with updated data in oral presentation at ASH, December 2018 NLG802, prodrug of indoximod Preclinical data show significantly higher PK levels with NLG802 Phase 1 trial ongoing with updated data at SITC, November 2018 4


 
Indoximod plus Chemotherapy in Acute Myeloid Leukemia (AML) Phase 1b Exploring Minimal Residual Disease as a Surrogate Endpoint Combination with current Data to be presented by Emadi, et al at standard of care (7+3) ASH, December 2018 chemotherapy • Indoximod was well tolerated and does not appear to add significant toxicity • 21/25 (84%) ITT patients achieved morphologic Minimal complete response (CR) residual disease • 15/19 (79%) per protocol patients achieved CR (MRD) evaluated by • 10/12 (83%) patients MRD- at end of induction sensitive flow • 11/11 (100%) patients MRD- at end of cytometry assay consolidation Currently enrolling Phase 1b expansion cohort 5


 
Abstracts Accepted for Upcoming Medical Meetings Abstract accepted for oral presentation at the ASH Annual Meeting, December 1-4, 2018 • Indoximod combined with standard induction chemotherapy is well tolerated and induces a high rate of complete remission with MRD-negativity in patients with newly diagnosed AML: results from a Phase 1 trial, Emadi, A., et al. Abstracts accepted for presentation at the SITC Annual Meeting, November 7-11, 2018 • A phase 1a clinical trial of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, Rixe, O., et al. • The immunogenomic impact of indoximod on the tumor microenvironment of melanoma patients, Yu, J., et al. • Effects of indoximod plus gemcitabine/nab-paclitaxel on tumor microenvironment of patients with metastatic pancreatic cancer, Yu, J., et al. 6


 
Other Opportunities Clinical Programs Under Evaluation . NLG207 (formerly CRLX101) – Nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin – Acquired from Cerulean Pharma – Phase 2 trial to evaluate NLG207 plus weekly paclitaxel in recurrent ovarian cancer – Trial conducted in conjunction with GOG – Phase 2 data anticipated in 2019 . Pursuing additional opportunities to expand our pipeline Multiple clinical opportunities addressing areas of unmet need 7


 
Financial Position Q3 2018 End Cash and Equivalents $122.1 Million Average Quarterly Cash Use Projected ~$10 Million Cash Runway Projected Into 2H 2021 Shares Outstanding as of September 30, 2018 37.2 Million 8


 
NewLink Genetics: Key Takeaways Clinical development plan targeting the most promising programs • Recurrent pediatric brain tumors, front-line DIPG, front-line AML, NLG802, NLG207 Strong cash position • Cash on hand at Q3 end $122.1 million • Estimated cash runway into the second half of 2021 excluding Ebola PRV monetization • Substantial financial interest in Priority Review Voucher (PRV) affiliated with approval of the Ebola vaccine licensed by NewLink Genetics Indoximod data to be presented at upcoming medical conferences in 2018 • December 2018: Updated Phase 1b AML data presented in oral presentation at ASH • November 2018: Initial Phase 1 NLG802 data & Phase 2 indoximod biomarker data from melanoma and pancreatic cancer patients to be presented at SITC 9


 
Q & A 10