NLNK-201200510-8K


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): May 10, 2012 (May 10, 2012)


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 May 10, 2012, NewLink Genetics Corporation, a Delaware corporation (the “Company”), issued a press release reporting financial results for the first quarter ended March 31, 2012.
 
The press release is attached hereto as Exhibit 99.1, which 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 it 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.



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Section 9 - Financial Statements and Exhibits
 
Item 9.01.              Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit Number
 
Description
99.1
 
Press Release, dated May 10, 2012, entitled “NewLink Genetics Corporation Reports First Quarter 2012 Financial Results.”



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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:    May 10, 2012


 
NewLink Genetics Corporation
 
 
 
 
By:
/s/ Gordon H. Link, Jr.
 
  Gordon H. Link, Jr.
Its:
  Chief Financial Officer



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INDEX TO EXHIBITS
 
Exhibit Number
 
Description
99.1
 
Press Release, dated May 10, 2012, entitled “NewLink Genetics Corporation Reports First Quarter 2012 Financial Results.”


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NLNK-20120510-8K-EX1


Exhibit 99.1
Contact:
Gordon Link
Chief Financial Officer
515-598-2925
glink@linkp.com
FOR IMMEDIATE RELEASE
NewLink Genetics Corporation Reports First Quarter 2012 Financial Results
AMES, Iowa, May 10, 2012 - NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated financial results for the first quarter of 2012, and provided an update on the progress of its clinical development programs.
“During the first quarter of 2012 we continued to advance our pivotal trial in pancreatic cancer and are also moving forward on a number of other HyperAcute immunotherapy development programs including those to treat melanoma and lung and kidney cancers,” commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. “We also made strides in our IDO pathway inhibitor program and are looking forward to presenting new data for a number of these programs at both DDW and ASCO. We believe that the receipt of patent allowances in both of our core programs will also facilitate our business development activities.”
First quarter 2012 Financial Results
Cash, cash equivalents and certificates of deposit totaled $35.8 million at March 31, 2012.
Total grant revenues for first quarter 2012 were $471,000 compared with $604,000 for first quarter 2011. Grant revenues will vary depending on the level of research funded under grants as well as changes in the overhead rates and profit factors agreed to under the grants. The decrease in revenue was due to reduced research by BPS under various Department of Defense contracts and National Institutes of Health grants.
Research and development (R&D) expense for first quarter 2012 was $3.8 million compared with $3.2 million for first quarter 2011. The increase was primarily due to increases in personnel-related expenses and clinical trial expense.
General and administrative (G&A) expense for first quarter 2012 was $1.5 million compared with $1.3 million for first quarter 2011. The increase was primarily due to increases in personnel-related expenses.
Net loss for first quarter 2012 was $4.8 million or $.23 per common share (based on 20.6 million weighted average shares outstanding), compared with $3.9 million, or $1.07 per common share, for first quarter 2011 (based on 3.6 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from NewLink's initial public offering in November 2011, as well as the conversion of all preferred stock to common stock in connection with the initial public offering.
Financial Guidance
NewLink is maintaining its financial guidance and continues to expect to end 2012 with about $20 million in cash, cash equivalents and marketable securities. NewLink continues to anticipate that that this capital should allow it to fund its operations through 2013 based on its current operating plans.

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2012 Key Accomplishments to Date
Continued to advance our HyperAcute Pancreas Phase 3 clinical trial. Enrollment is matching our anticipated levels and we continue to expect to complete enrollment before the end of 2013. We still expect that our first interval look will occur at the end of 2012 or early 2013. Data from the HyperAcute Pancreas Phase 2 clinical trial will be presented at both the 53rd Annual Meeting of the American Gastroenterological Association in conjunction with Digestive Disease Week (DDW) on May 22, 2012 and the 2012 American Society of Clinical Oncology (ASCO) Annual meeting on June 4, 2012.
Studies with our IDO pathway inhibitor product candidate in combination with a dendritic cell vaccine or Taxotere continue and we anticipate data from these studies will be presented at ASCO in June, 2012.
Entered into a settlement agreement with the Iowa Economic Development Authority ("IEDA") as the successor organization to the Iowa Department of Economic Development. Under the terms of the settlement agreement we agreed to pay a 0.5% royalty on future product sales up to a cap of $6.8 million in exchange for IEDA's release of our job creation and project expenditure obligations and IEDA's release of the security interest in substantially all of our assets.
The Japan Patent Office issued a notice of allowance for a patent entitled "Antitumor Vaccination Using Allogeneic Tumor Cells Expressing Alpha (1,3)-Galactosyltransferase," which contains broad pharmaceutical composition claims covering NewLink's HyperAcute products for the treatment of cancer. NewLink holds exclusive rights to the allowed application as well as to previously issued counterpart patents in the United States, Canada, Mexico, and Europe.
The United States Patent & Trademark Office (USPTO) allowed broad claims to oral pharmaceutical compositions comprising 1-methyl-D-tryptophan (D-1MT) (US Serial No. 12/175,538) and also to oral pharmaceutical compositions comprising 1-methyl-DL-tryptophan (US Serial No. 11/603,291). The company holds exclusive rights to the allowed applications.
We converted our letter of intent with the National Cancer Institute into a cooperative research and development agreement (CRADA).
Upcoming Activities
NewLink expects to present at the following investor conferences:
Jefferies 2012 Global Healthcare Conference, June 4-7, in New York City, NY.
32nd Annual Canaccord Global Growth Conference, August 14-16, in Boston, MA.
Stifel Nicolaus Weisel Healthcare Conference 2012, September 4-7, in Boston, MA.
Robert W Baird Health Care Conference, September 5-6, in New York City, NY.
NewLink expects to present at the following oncology and pharmacology meetings:
53rd Annual Meeting of the American Gastroenterological Association in conjunction with Digestive Disease Week at the San Diego Convention Center in San Diego, CA, May 19-22, 2012.
2012 American Society of Clinical Oncology (ASCO) Annual meeting June 1-5, 2012 at the McCormick Place, Chicago, IL.

About NewLink Genetics Corporation
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed with an objective to harness multiple components of the innate immune system to combat cancer, either as a monotherapy or in

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combination with current treatment regimens, without incremental toxicity. NewLink's lead product candidate, HyperAcute Pancreas cancer immunotherapy is being studied in a Phase 3 clinical trial in surgically resected pancreatic cancer patients (patient information is available at http://www.pancreaticcancer-clinicaltrials.com). This clinical trial is being performed under a Special Protocol Assessment with the U.S. Food and Drug Administration. NewLink and its collaborators have completed patient enrollment for a Phase 1/2 clinical trial evaluating its HyperAcute Lung cancer immunotherapy product candidate for non-small cell lung cancer and a Phase 2 clinical trial for its HyperAcute Melanoma cancer immunotherapy product candidate. NewLink also is developing d-1-methyltryptophan, or D-1MT, a small molecule, orally bioavailable product candidate from NewLink's proprietary indoleamine (2, 3) dioxygenase, or IDO, pathway inhibitor technology. Through NewLink's collaboration with the National Cancer Institute, NewLink is studying D-1MT in various chemotherapy and immunotherapy combinations in two Phase 1B/2 safety and efficacy clinical trials. For more information please visit www.linkp.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 facts, 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's financial guidance for 2012; the timing for completion of enrollment of our Phase 3 clinical trial for our HyperAcute Pancreas cancer immunotherapy; the timing of release of clinical data from ongoing clinical studies; NewLink's future financial performance, results of operations or 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's Annual Report on Form 10-K for the period ended December 31, 2011, in its Quarterly Report on Form 10-Q for the period ended March 31, 2012, and in its other filings with the Securities and Exchange Commission. 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's views as of any date subsequent to the date of this press release.



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NewLink Genetics Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share amounts)
 
 
 
 
 
Quarter Ended
 
March 31,
 
March 31,
 
2012
 
2011
 
 
 
 
Grant revenue
$
471

 
$
604

 
 
 
 
Operating expenses:
 
 
 
Research and development
3,830

 
3,180

General and administrative
1,458

 
1,316

 
 
 
 
Loss from operations
(4,817
)
 
(3,892
)
 
 
 
 
Other (expense) income, net
(25
)
 
(6
)
 
 
 
 
Net loss
$
(4,842
)
 
$
(3,898
)
 
 
 
 
Net loss attributable to NewLink
$
(4,842
)
 
$
(3,897
)
 
 
 
 
Net loss per common share, basic and diluted
$
(0.23
)
 
$
(1.07
)
 
 
 
 
Weighted average number of common shares outstanding
20,613,146

 
3,636,044

 
 
 
 
 
 
 
 

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NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share amounts)
 
 
 
 
 
March 31,
 
December 31,
 
2012
 
2011
 
 
 
 
Assets
 
 
 
Current assets:
 
 
 
Cash, cash equivalents and certificates of deposit
$
35,759

 
$
41,980

Prepaid expenses and other current assets
1,459

 
808

Total current assets
37,218

 
42,788

 
 
 
 
Property and equipment, net
6,229

 
5,591

 
 
 
 
Total assets
$
43,447

 
$
48,379

 
 
 
 
Liabilities and Equity
 
 
 
Current liabilities:
 
 
 
Accounts payable and accrued expenses
$
2,029

 
$
3,537

Deferred rent
65

 
913

Other current liabilities
216

 
6,214

Total current liabilities
2,310

 
10,664

 
 
 
 
Long-term liabilities:
 
 
 
Royalty obligation payable
6,000

 

Notes payable and obligations under capital leases
885

 
942

Deferred rent
1,454

 

Total long-term liabilities
8,339

 
942

Total liabilities
10,649

 
11,606

 
 
 
 
Stockholders’ equity:
 
 
 
Preferred Stock

 

Common stock
207

 
206

Additional paid-in capital, net
118,909

 
118,043

Deficit accumulated during the development stage
(86,318
)
 
(81,476
)
Total NewLink Genetics stockholders’ equity
32,798

 
36,773

Total equity
32,798

 
36,773

Commitments

 

Total liabilities and equity
$
43,447

 
$
48,379

 
 
 
 


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