SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2019
NewLink Genetics Corporation
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
2503 South Loop Drive
(Address of principal executive offices)
Registrant's telephone number, including area code: (515) 296-5555
(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 February 27, 2019, 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, 2018 ("Press Release").
A copy of the Press Release and the Fourth Quarter and Year-end 2018 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.
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: February 27, 2019
NewLink Genetics Corporation
/s/ Carl W. Langren
Carl W. Langren
Chief Financial Officer
FOR IMMEDIATE RELEASE
NewLink Genetics Reports Fourth Quarter, Year-End 2018 Financial Results and Provides Update for Clinical Programs
- Management to Host Conference Call Today at 4:30 p.m. ET
Ames, Iowa, February 27, 2019 -- NewLink Genetics Corporation (NASDAQ:NLNK) today reported consolidated financial results for the fourth quarter and year ended 2018, as well as progress in its clinical development programs. The Company also outlined key 2019 priorities related to its clinical pipeline.
“In 2018, we published further clinical results on indoximod that suggest it has significant activity in combination therapy for a variety of cancer indications,” said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. “As we enter 2019 with a strong cash position, our intention is to focus on developing the best potential registration strategy for bringing indoximod forward and further developing our pipeline assets, especially NLG207. We would like to thank the investigators and patients who support our clinical trials year after year, and we remain committed to your care.”
Anticipated 2019 Outlook
Updated results on the cohort of patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), from the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors, are anticipated in 2019
Results from a Phase 2 study of NLG207 (formerly CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, conducted by the Gynecological Oncology Group (GOG) for patients with recurrent ovarian cancer, has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019, at the Georgia World Conference Center, in Atlanta, March 29 - April 3, 2019
Updated results from a Phase 1 study of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, are anticipated in 2019
Updated results from a Phase 1b study of indoximod for pediatric patients with recurrent malignant brain tumors are anticipated in 2019
Completion by Merck of the rolling Biologics License Application (BLA) filing for V920 (rVSV∆G-ZEBOV-GP), our partnered Ebola vaccine candidate, is expected in 2019
Presented Phase 1 results of indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed DIPG at the American Association of Clinical Research (AACR) Annual Meeting, April 2018, and updated Phase 1 results at the International Symposium of Pediatric Neuro-Oncology (ISPNO) Annual Meeting, July 2018, showing symptomatic improvement and marked radiographic improvement in DIPG patients.
Presented updated Phase 1 results for indoximod plus standard of care chemotherapy for younger, healthy patients with newly diagnosed acute myeloid leukemia (AML) in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting, December 2018
Presented final results from two Phase 2 studies of indoximod at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting with results for indoximod plus checkpoint inhibition in advanced melanoma which we believe showed encouraging overall and complete response rates which compared favorably to historical PD-1 monotherapy results and results for indoximod plus gemcitabine / nab-paclitaxel in metastatic pancreatic cancer demonstrating potentially promising activity that correlated with a measurable immune response
At the Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting, we presented correlative immunologic assay results from biopsies obtained during both the advanced melanoma and the metastatic pancreatic cancer trials previously presented at ASCO 2018, illustrating indoximod’s impact on the tumor microenvironment as well as first-in-human results showing significantly enhanced pharmacokinetic properties of our indoximod prodrug, NLG802
November 13, 2018, our partner, Merck, announced that it had begun the rolling submission of licensure application for Ebola vaccine, V920 (rVSV∆G-ZEBOV-GP), to the FDA
Cash Position: NewLink Genetics ended the year on December 31, 2018, with cash and cash equivalents totaling $120.7 million compared to $158.7 million for the year ending December 31, 2017. The Company projects its cash position is sufficient to fund planned operations through the end of 2021.
R&D Expenses: Research and development expenses were $5.7 million and $45.7 million in the fourth quarter and year ended December 31, 2018 compared to $17.5 million and $69.9 million during the comparable periods in 2017. The decrease year-over-year was due primarily to a $15.2 million reduction in contract research and manufacturing expense, $3.0 million in personnel-related expense, $3.3 million in supplies and equipment, $1.8 million in clinical trial costs, $1.3 million in technology and licensing, and reduction in restructuring expenses of $100,000, offset by a $500,000 increase in consulting and other costs.
G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2018 were $5.4 million and $29.2 million compared to $6.7 million and $31.7 million during the comparable periods in 2017. The year-over-year decrease of $2.5 million was due to a reduction of $2.5 million in personnel-related spend, $550,000 reduction in consulting and other costs, reduction in restructuring expenses of $300,000, offset by an $850,000 increase in supplies and other expense.
Net Loss: NewLink Genetics reported a net loss of $10.6 million or a loss of $0.28 per diluted share for the fourth quarter of 2018 and a net loss of $53.6 million or a loss of $1.44 per diluted share for the year ended December 31, 2018, compared to 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.
NewLink Genetics ended 2018 with 37,251,220 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 through this link: https://edge.media-server.com/m6/p/dqg32drc. 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 1279102. The replay will be available for two weeks from the date of the call.
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 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.
NLG207 (formerly CRLX101) is an investigational nanoparticle-drug conjugate (NDC) composed of a cyclodextrin-based polymer backbone conjugated to camptothecin, a topoisomerase-1 inhibitor. NDCs enhance drug delivery to tumors where gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. Topoisomerase 1 inhibitors are a class of drugs that modify DNA damage responses in cancer cells. NewLink Genetics is evaluating NLG207 in a series of clinical trials in advanced refractory ovarian cancer patients.
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company focusing on developing novel oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' IDO pathway inhibitors are immuno-oncology drug candidates designed to harness multiple components of the immune system to combat cancer. NewLink Genetics’ nanoparticle drug candidate, NLG207, conjugated to camptothecin, a topoisomerase 1 inhibitor, is under development to combat refractory malignancies. 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 2019 and beyond; 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, 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 & Media Contact:
Director of Investor Relations
NewLink Genetics Corporation
Consolidated Statements of Operations
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NewLink Genetics Corporation
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Blank check preferred stock, $0.01 par value: Authorized shares - 5,000,000 at December 31, 2018 and 2017; issued and outstanding shares - 0 at December 31, 2018 and 2017
Common stock, $0.01 par value: Authorized shares - 75,000,000 at December 31, 2018 and 2017; issued 37,343,547 and 37,168,122 at December 31, 2018 and 2017, respectively, and outstanding 37,251,220 and 37,109,556 at December 31, 2018 and 2017, respectively
Additional paid-in capital
Treasury stock, at cost: 92,327 and 58,566 shares at December 31, 2018 and 2017, respectively
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Fourth Quarter and Full Year 2018 Financial Results NewLink Genetics Corporation Nasdaq: NLNK February 27, 2019
•Lisa Miller, Director of Investor Relations Agenda • Charles J. Link, Jr, MD, Chairman, CEO & CSO •Eugene Kennedy, MD, Chief Medical Officer • 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 2019 and beyond; 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
NLG207 plus paclitaxel in recurrent ovarian cancer Recurrent . NLG207 is a nanoparticle formulation of topoisomerase 1 ovarian cancer inhibitor, camptothecin . Phase 2 results accepted for presentation at AACR in April 2019 NLG207 Front-line diffuse Indoximod plus radiotherapy for pediatric patients with DIPG intrinsic pontine . Early data show all patients demonstrated initial symptomatic improvement on therapy with evidence of radiographic responses glioma (DIPG) . Phase 1b trial ongoing with updated data anticipated 2019 NewLink NLG802, prodrug NLG802 in patients with advanced solid tumors of indoximod . Early Phase 1 data showed significantly improved PK properties Genetics . Updated Phase 1 trial data anticipated 2019 Clinical Recurrent Indoximod plus radio-chemotherapy for pediatric patients with recurrent Programs malignant malignant brain tumors Indoximod . Phase 1b trial ongoing with updated data anticipated 2019 pediatric brain tumors Front-line acute Indoximod plus standard-of-care chemotherapy for patients with front-line AML myeloid leukemia . Updated Phase 1 data December 2018 showed promising (AML) MRD-negativity with indoximod . Phase 1b trial ongoing 4
Other Opportunities Ebola VSV-ZEBOV (V920) vaccine . Merck has announced they began rolling BLA submission process . NewLink holds substantial interest in potential Priority Review Voucher (PRV) Continue to pursue additional opportunities to expand our pipeline 5
NLG207 NLG207 (formerly CRLX101) Ovarian Cancer . Nanoparticle formulation of the Approximately topoisomerase 1 inhibitor camptothecin Roughly 70 percent . Originally acquired from Cerulean Pharma 22,530 of patients diagnosed with ovarian cancer in 2017 women will be diagnosed 3 1 . Phase 2 trial to evaluate NLG207 plus with ovarian cancer in 2018 will have a recurrence weekly paclitaxel in recurrent ovarian Woman have a cancer completed, conducted in 1 in 78 conjunction with GOG Majority chance to have diagnosed at . Data will be presented at upcoming AACR 2 ovarian cancer advanced stage meeting in April 2019 during her lifetime1 . Initial focus on our Phase 2 ovarian cancer trial, and reviewing other potential opportunities in multiple malignancies References: 1. American Cancer Society. Cancer Facts & Figures 2018. Atlanta, GA: American Cancer Society; 2018. 2. National Cancer Institute. http://seer.cancer.gov/statfacts/html/ovary.html 3. Ovarian Cancer Research Alliance. https://ocrahope.org/patients/about-ovarian-cancer/recurrence/ 6
Front-line Indoximod plus radiotherapy for pediatric patients with DIPG diffuse intrinsic . Early data show all patients demonstrated initial symptomatic improvement on pontine therapy with evidence of deep radiographic responses glioma (DIPG) . Phase 1b trial ongoing with updated data anticipated 2019 NLG802, NLG802 in patients with advanced solid tumors prodrug of . Early Phase 1 data show significantly improved PK properties Indoximod indoximod . Updated Phase 1 trial data anticipated 2019 Pipeline Recurrent malignant Indoximod plus radio-chemotherapy for pediatric patients with recurrent malignant brain tumors pediatric . Phase 1b trial ongoing with updated data anticipated 2019 brain tumors Front-line acute Indoximod plus standard-of-care chemotherapy for patients with front-line AML myeloid . Updated data December 2018 showed promising MRD-negativity with indoximod leukemia (AML) . Phase 1b trial ongoing 7
Financial Position Q4 2018 End Cash and Equivalents $120.7 Million Average Quarterly Cash Use Projected ~$10 Million Cash Runway Projected Through 2021 Shares Outstanding as of December 31, 2018 37.25 Million 8
NewLink Genetics: Key Takeaways Targeting Indications of Need Strong Cash Position Upcoming Presentations . Current clinical development Cash on hand at Q4 end April 2019: Phase 2 results for programs include: $120.7 million NLG207 in recurrent refractory ovarian, fallopian tube, or primary NLG207 Estimated cash runway to year peritoneal cancer to be presented at • Ovarian cancer end 2021 excluding Ebola PRV AACR Indoximod monetization • Frontline DIPG 2019: Updated Phase 1 data for indoximod plus radiotherapy in DIPG • Recurrent pediatric Substantial financial interest in brain tumors Priority Review Voucher (PRV) issued if approval of the Ebola 2019: Updated Phase 1 data for • Frontline AML vaccine licensed by NewLink NLG802, indoximod prodrug NLG802 Genetics . 2019: Updated Phase 1 data for Continue to pursue opportunities indoximod plus radio-chemotherapy to expand pipeline in recurrent pediatric brain tumors 9
Q & A 10