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, 2016
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))
Section 2 - Financial Information
Item 2.02. Results of Operations and Financial Condition.
On November 1, 2016, 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, 2016 ("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 9 - Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | Description | |
99.1 | Press Release, dated November 1, 2016, entitled “NewLink Genetics Reports Third Quarter 2016 Financial Results” | |
99.2 | Third Quarter 2016 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: November 1, 2016
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 November 1, 2016, entitled “NewLink Genetics Reports Third Quarter 2016 Financial Results” | |
99.2 | Third Quarter 2016 Financial Results Presentation | |
Exhibit 99.1
FOR IMMEDIATE RELEASE
NewLink Genetics Corporation Provides Operational Update and Reports Third Quarter 2016 Financial Results
-Management to Host Conference Call Today at 8:30 a.m. ET-
AMES, Iowa - November 1, 2016 -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, today reported consolidated financial results for the third quarter of 2016 and progress in its clinical and pipeline development programs.
“We continue to focus our clinical developmental efforts targeting the IDO pathway. We have two distinct IDO pathway inhibitors advancing in the clinic, GDC-0919 with our partner Genentech and indoximod, our proprietary IDO pathway inhibitor,” said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer. “We are also encouraged by recent clinical data that increasingly validate the IDO pathway as an important target in immuno-oncology.”
The Company hosted an investor day on October 25, outlining its vision and execution plans for the future. A webcast of the Company’s presentations can be found at http://investors.linkp.com/events.cfm.
“As described at our investor day, we believe 2017 will be an important year in the development of both GDC-0919 and indoximod and we look forward to providing further updates and results,” added Nicholas N. Vahanian, MD, President and Chief Medical Officer.
The program featured leaders in the field of immuno-oncology and pioneers in the science of IDO: George C. Prendergast, PhD, President & CEO, Lankenau Institute for Medical Research (LIMR) and Editor in Chief, Cancer Research; David H. Munn, MD, Professor of Pediatric Hematology-Oncology, Medical College of Georgia, Augusta University; Montaser Shaheen MD, Associate Professor, University of New Mexico Cancer Center; and Ashkan Emadi, MD, PhD, Associate Professor, University of Maryland.
Key takeaways from the Investor Day included:
1. | Validation of IDO as a Target. The IDO pathway can allow cancer to escape the immune system. Many cancers have developed the ability to employ IDO to evade immune attack. We believe clinical results are increasingly validating the IDO pathway as a target for cancer therapies. Just as scientists discovered the role of PD-1/PD-L1 expression and the usefulness of PD-1/PD-L1 blockade, there is an increasing body of research into the role of the IDO pathway in cancer. |
2. | NewLink's Two IDO Pathway Inhibitor Clinical Candidates. NewLink Genetics is engaged in clinical trials for two IDO pathway inhibitor product candidates, each with its own distinct mechanism of action. |
Exhibit 99.1
• | GDC-0919, a direct IDO enzymatic inhibitor, is being developed in partnership with Genentech. GDC-0919 is currently in a Phase 1b trial, in combination with atezolizumab in solid tumors. In October, 2014, NewLink and Genentech entered in to a license and collaboration agreement with an upfront payment of $150 million, more than $1 billion in potential milestones, and substantial royalties. |
• | Indoximod, an IDO pathway inhibitor, is proprietary to NewLink Genetics. Indoximod is being tested in the clinic in multiple indications including melanoma, pancreatic cancer, malignant brain tumors, breast cancer, acute myeloid leukemia, and non-small cell lung cancer. |
3. | Indoximod Clinical Development. The Company reported that it will evaluate the data and report on several clinical trials underway in 2017. Furthermore, our clinical development strategy for indoximod includes formulation optimization intended to improve the candidate's clinical and commercial potential. |
4. | Future R&D. NewLink also discussed its program targeting the PTEN pathway in regulatory T cells (Treg cells) as a central driver of tumor immunosuppression. NewLink Genetics is an early leader in the field of PTEN research, just as it was in developing IDO as a potential pathway for immune suppression in cancer. |
Financial Results for the Three-Month Period Ended September 30, 2016
Cash Position: NewLink Genetics ended the quarter on September 30, 2016, with cash and equivalents totaling $148.3 million, compared to $197.8 million for the year ending December 31, 2015.
R&D Expenses: Research and development expenses in the third quarter of 2016 were $24.5 million, compared to $22.5 million during the comparable period in 2015. The increase was primarily due to a $3.2 million increase in contract manufacturing costs, a $340,000 increase in stock compensation expense, and a $400,000 increase in clinical trial expenses, offset by a decrease in equipment and supplies of $1.3 million, wages of $490,000 and a $160,000 decrease in consulting.
G&A Expenses: General and administrative expenses in the third quarter of 2016 were $7.7 million compared to $7.4 million during the comparable period in 2015. The increase was due primarily to an increase of $300,000 in consulting and personnel-related expenses.
Net Income/Loss: NewLink Genetics reported a net loss of $15.5 million, or a loss of $0.54 per diluted share, for the third quarter of 2016, compared to a net loss of $15.9 million, or a loss of $0.55 per diluted share, for the comparable period in 2015.
NewLink Genetics ended the quarter with 29,091,652 shares outstanding.
Financial Guidance and Upcoming Investor Meetings
NewLink Genetics expects to have approximately $132 million in cash and equivalents on December 31, 2016.
We have presented at seven investor meetings and conferences since the beginning of the year, including our own investor day held last week. We expect to present at three upcoming conferences in New York City,
Exhibit 99.1
including the Global Mizuho Investor Conference on November 14, the Stifel 2016 Healthcare Conference on November 15, and the Piper Jaffray 28th Annual Healthcare Conference on November 29.
Conference Call
The Company has scheduled a conference call for 8:30 a.m. ET today to discuss these results and to provide an update on clinical and pipeline development programs. NewLink Genetics’ senior management team will host the conference 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 call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. 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 5960440.
About NewLink Genetics Corporation
NewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer. For more information, please visit http://www.newlinkgenetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release 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 2016; 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, 2015 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.
******
Corporate Contact:
Jack Henneman
Chief Financial Officer, NewLink Genetics
515-598-2561
Investor@linkp.com
Exhibit 99.1
Investors:
Donna LaVoie
LaVoieHealthScience
617-374-8800, ext. 107
dlavoie@lavoiehealthscience.com
Media:
David Connolly
LaVoieHealthScience
617-374-8800, ext. 108
dconnolly@lavoiehealthscience.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, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Grant revenue | $ | 14,457 | $ | 13,365 | $ | 20,057 | $ | 26,294 | |||||||
Licensing and collaboration revenue | 888 | 844 | 3,008 | 34,555 | |||||||||||
Total revenue | 15,345 | 14,209 | 23,065 | 60,849 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 24,463 | 22,508 | 73,810 | 56,619 | |||||||||||
General and administrative | 7,749 | 7,384 | 26,043 | 23,007 | |||||||||||
Loss from operations | (16,867 | ) | (15,683 | ) | (76,788 | ) | (18,777 | ) | |||||||
Other income (expense), net | 19 | (63 | ) | 118 | (30 | ) | |||||||||
Net loss before taxes | (16,848 | ) | (15,746 | ) | (76,670 | ) | (18,807 | ) | |||||||
Income tax benefit (expense) | 1,308 | (160 | ) | 5,021 | — | ||||||||||
Net loss | $ | (15,540 | ) | $ | (15,906 | ) | $ | (71,649 | ) | $ | (18,807 | ) | |||
Basic and diluted loss per share | $ | (0.54 | ) | $ | (0.55 | ) | $ | (2.48 | ) | $ | (0.66 | ) | |||
Basic and diluted average shares outstanding | 28,983,561 | 28,734,768 | 28,911,042 | 28,518,503 | |||||||||||
Exhibit 99.1
NewLink Genetics Corporation | |||||||
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(In thousands) | |||||||
September 30, | December 31, | ||||||
2016 | 2015 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash, cash equivalents and certificates of deposit | $ | 148,276 | $ | 197,800 | |||
Prepaid expenses and other current assets | 25,683 | 10,342 | |||||
Income tax receivable | 5,197 | — | |||||
Total current assets | 179,156 | 208,142 | |||||
Property and equipment, net | 7,188 | 10,400 | |||||
Total assets | $ | 186,344 | $ | 218,542 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 39,626 | $ | 12,422 | |||
Unearned revenue | 693 | 892 | |||||
Other current liabilities | 326 | 667 | |||||
Income taxes payable | — | 859 | |||||
Total current liabilities | 40,645 | 14,840 | |||||
Long-term liabilities: | |||||||
Royalty obligation payable | 6,000 | 6,000 | |||||
Notes payable and obligations under capital leases | 333 | 368 | |||||
Deferred rent | 1,089 | 1,153 | |||||
Unearned revenue | — | 407 | |||||
Total long-term liabilities | 7,422 | 7,928 | |||||
Total liabilities | 48,067 | 22,768 | |||||
Stockholders' equity: | |||||||
Common stock | 291 | 288 | |||||
Additional paid-in capital | 290,772 | 276,610 | |||||
Treasury stock, at cost | (784 | ) | (771 | ) | |||
Accumulated deficit | (152,002 | ) | (80,353 | ) | |||
Total stockholders' equity | 138,277 | 195,774 | |||||
Total liabilities and stockholders' equity | $ | 186,344 | $ | 218,542 | |||
NewLink Genetics Corporation
Nasdaq: NLNK
November 1, 2016
Third Quarter 2016 Financial Results
Cautionary Note Regarding Forward Looking Statements
This presentation contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All
statements, other than statements of historical fact, contained in this press release 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 2016; 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, 2015 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
Investor Day – Distinguished Speakers
IDO Combinations with Checkpoint Inhibitors
George C. Prendergast, PhD, President & Chief Executive Officer, Lankenau Institute for Medical Research
(LIMR), Editor-in-Chief, Cancer Research
3
Immunoregulatory Role of Tryptophan Metabolism
David H. Munn, MD, Medical College of Georgia, Augusta University
Understanding Current Melanoma Clinical Data
Montaser Shaheen MD, Associate Professor, University of New Mexico Cancer Center
Indoximod in Treatment of Patients with Acute Myeloid Leukemia (AML)
Ashkan Emadi, MD, PhD, Associate Professor of Medicine, Pharmacology & Experimental Therapeutics,
University of Maryland
4
NewLink Genetics
Investor Day Takeaways
IDO pathway is central to immune escape
IDO pathway is becoming increasingly validated as a target for drugs
Two promising candidates that target the IDO pathway, with distinct mechanisms of action
GDC-0919, which targets the enzyme directly (partnered with Genentech)
Indoximod, which inhibits the effects of IDO by supplying a “tryptophan-sufficiency” signal
Proven track record in both in-and-out licensing
Strong balance sheet to advance current clinical programs
Indoximod Strategy
5
Optimize Formulation, Enhance Commercial Opportunity and Extend Lifecycle
*Includes indoximod, epacadostat and GDC-0919
Next 6-12 Months
Updated clinical data for
indoximod in melanoma, brain
and pancreas cancers
Formulation improvements to
optimize clinical and commercial
potential
Emerging IDO data may provide
additional validation
2018 and Beyond
Potential for large scale
indoximod trials
Commercial formulation
established
Potential for regulatory
exclusivity
IDO combination data may support
multiple indications
Current State
IDO target increasingly validated
with early clinical data*
Clinical results support preclinical
combination data
Promising data in melanoma,
brain and pancreatic cancers
Distinct mechanism of action
Potential for IP extension
Financial Position
Cash and Equivalents $148 million (September 30, 2016)
Debt ~$0.6 million
YE 2016 Cash (Projected) ~$132 million
Quarterly Negative Cash-Flow ~$13 million
Shares Outstanding 29.1 million
Market Capitalization $450 million*
Headcount 130
6
*As of October 5, 2016