On November 3, 2015 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported financial results for the third quarter and nine months ended September 30, 2015 (Press release, Rigel, NOV 3, 2015, View Source;p=RssLanding&cat=news&id=2106100 [SID:1234507934]).

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"We are concentrating our efforts on the timely completion of our two Phase 3 studies with fostamatinib in immune thrombocytopenic purpura (ITP). We expect topline data from the first Phase 3 trial in the middle of 2016 with the second reporting shortly thereafter," said Raul Rodriguez, president and chief executive officer of Rigel. "Also, our new partnership with Aclaris Therapeutics demonstrates our continuing efforts to explore additional partnerships and advance opportunities in areas beyond our therapeutic focus." he added.

For the third quarter of 2015, Rigel reported a net loss of $6.7 million, or $0.08 per share, compared to a net loss of $20.9 million, or $0.24 per share, for the same period of 2014. Weighted average shares outstanding for the third quarters of 2015 and 2014 were 88.5 million and 87.8 million, respectively.

Contract revenues from collaborations of $13.0 million in the third quarter of 2015 were comprised of an $8.0 million upfront payment from Aclaris Therapeutics International Limited pursuant to the license agreement executed in August 2015 for the development and commercialization of certain Rigel JAK inhibitors for the treatment of alopecia areata and other dermatological conditions, as well as $4.8 million from the amortization of the $30.0 million upfront payment from Bristol-Myers Squibb. There were no contract revenues from collaborations in the third quarter of 2014.

Rigel reported costs and expenses of $19.8 million in the third quarter of 2015, compared to $21.0 million for the same period in 2014. The decrease in operating expenses was primarily due to the decrease in facilities costs resulting from the sublease agreement executed in December 2014, partially offset by the increase in research and development costs related to Rigel’s Phase 3 clinical program for fostamatinib in ITP.

For the nine months ended September 30, 2015, Rigel reported a net loss of $38.8 million, or $0.44 per basic and diluted share, compared to a net loss of $68.6 million, or $0.78 per basic and diluted share, for the same period of 2014.

As of September 30, 2015, Rigel had cash, cash equivalents and short-term investments of $134.4 million, compared to $143.2 million as of December 31, 2014. Rigel expects to end 2015 with cash and investments in excess of $115.0 million, which is expected to be sufficient to fund operations into the second quarter of 2017.

(Filing, 10-Q, Rigel, NOV 3, 2015, View Source [SID:1234507933])

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On November 3, 2015 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the third quarter and year-to-date periods ended September 30, 2015 (Filing, 8-K, AMAG Pharmaceuticals, NOV 3, 2015, View Source [SID:1234507909]). Total revenues for the third quarter of 2015 increased to $96.2 million, compared with $25.5 million in the third quarter of 2014. This increase is primarily related to the additions of Makena (hydroxyprogesterone caproate injection) in November 2014 and Cord Blood Registry (CBR) in August 2015 to the company’s portfolio, which contributed revenue of $65.2 million and $7.2 million, respectively, to the third quarter 2015 results. After certain non-cash and one-time costs related to business development activities and acquisitions, the company reported an operating loss of $1.4 million in the third quarter of 2015, compared with operating income of $4.3 million in the same period last year. This resulted in a net loss of $20.6 million, or $0.62 per basic and diluted share, compared with net income of $1.5 million, or $0.07 per basic share and $0.06 per diluted share for the same period last year.

Non-GAAP revenue totaled $103.5 million in the third quarter of 2015, compared with $23.5 million for the same period last year.(1) The company reported adjusted EBITDA of $52.8 million in the third quarter of 2015, compared with adjusted EBITDA of $1.3 million in the third quarter of 2014.(1) Non-GAAP cash earnings for the third quarter of 2015 totaled $42.3 million, or $1.02 per diluted share, compared with $0.3 million, or $0.01 per diluted share, for the same period in 2014.(1),(2)

"While our overall portfolio experienced growth during the third quarter, we believe there is opportunity for even better performance in the future as integration activities are completed and our investments in the next generation development programs for Makena and an expanded label for Feraheme progress toward FDA approvals and launches," said William Heiden, AMAG’s chief executive officer. "With our business continuing to generate strong cash flows, we will maintain our focus on executing on the opportunities we have today, line extension approvals in the future, as well as continued portfolio expansion through acquisitions and licensing transactions."

3Q15 Business Highlights and Recent Developments

· Makena net sales totaled $65.2 million in the third quarter of 2015, representing 36% growth over the corresponding period in the prior year.(3) The growth in sales was driven by a 42% increase in volume partially offset by a decrease in net revenue per injection due to higher growth in the Medicaid versus commercial segment.

· Sales of Feraheme (ferumoxytol) injection returned to growth, increasing 3% to $23.2 million in the third quarter of 2015, compared with $22.5 million in the same period last year. Sales of MuGard grew 16% in the third quarter of 2015 over the same period last year.

· The company closed on the acquisition and financing of CBR, the world’s largest stem cell collection and storage company, on August 17, 2015. The CBR business recorded $14.5 million of non-GAAP revenue for the six-week period between closing and September 30, 2015.(1) On a pro forma basis (as if AMAG had acquired CBR at the beginning of the third quarter of 2015), total CBR revenue was $29.3 million, compared with $33.0 million in the third quarter of 2014, with the decrease being partially attributable to new customer discounts in the third quarter of 2015.(4)

· During the third quarter of 2015, the company announced plans to further expand its growing maternal health portfolio by entering into an exclusive option agreement with Velo Bio, LLC, a privately held life sciences company. The agreement gives the company the option to acquire the global rights to an orphan drug candidate in clinical development for use in the treatment of severe preeclampsia, an area of high unmet need in pregnant women.

· The Company recently announced start-up activities for a head-to-head, Phase 3 clinical trial evaluating Feraheme in adult patients with iron deficiency anemia (IDA). The study marks a step forward on the pathway to potentially broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment. The company expects to begin enrolling patients in the trial in the first quarter of 2016, with potential approval of a supplemental new drug application for a broader IDA indication and launch in 2018.

· The company advanced its next generation development programs for Makena seeking to enhance the product for patients and their healthcare providers. As previously disclosed, the company has filed for approval of a single-dose, preservative-free version of Makena, with anticipated approval in the fourth quarter of 2015. In addition, the company is developing a device for subcutaneous administration of Makena by an auto-injector. The company has an exclusive agreement in place with a device partner whose technologies are covered by multiple issued patents, and has other approved products in its portfolio. AMAG is also developing a longer-acting formulation of Makena.

Third Quarter Ended September 30, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues for the third quarter of 2015 were $96.2 million, compared with $25.5 million for the same period in 2014. Net product sales of Makena, Feraheme and MuGard totaled $88.9 million in the third quarter of

(3) Based on unaudited pro forma sales for the third quarter of 2014. Acquisition of Lumara Health closed in November 2014.
(4) Based on unaudited pro forma sales for the third quarter of 2015 and 2014. Acquisition of CBR closed on August 17, 2015.

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2015, compared with $23.0 million in the third quarter of 2014. Service revenue from CBR totaled $7.2 million in the third quarter of 2015.

Total costs and expenses for the third quarter of 2015 were $97.5 million, compared with $21.2 million for the same period in 2014. The increases in costs and expenses were primarily due to the following: (i) higher costs associated with managing the company’s expanded portfolio and infrastructure following the acquisitions of Lumara Health in November 2014 and CBR in August 2015, (ii) increased cost of goods sold from new product and higher sales volumes for each of the company’s products, (iii) non-cash charges associated with inventory step-up and amortization related to the acquisitions, (iv) a $10.0 million upfront payment for the exclusive option to acquire rights to a development stage asset to treat severe preeclampsia, and (v) $9.2 million in acquisition and restructuring costs related to CBR.

The company reported an operating loss of $1.4 million and a net loss of $20.6 million, or $0.62 per basic and diluted share, for the third quarter of 2015, compared with operating income of $4.3 million and net income of $1.5 million, or $0.07 per basic share and $0.06 per diluted share, for the same period in 2014.

Financial Results (Non-GAAP Basis)(1),(2)

Non-GAAP revenues totaled $103.5 million, up from $23.5 million in the third quarter of 2014. Non-GAAP CBR revenue totaled $14.5 million in the third quarter of 2015. The difference between GAAP and non-GAAP revenue for CBR represents purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $50.6 million resulting in a gross margin of 93% and adjusted EBITDA margin of 51% for the third quarter of 2015. This compares to costs and expenses of $22.3 million in the same period of 2014, which resulted in a gross margin of 90% and adjusted EBITDA margin of 5%. Non-GAAP adjusted EBITDA for the third quarter of 2015 was $52.8 million, compared with $1.3 million for the same period in 2014.

After deducting cash interest expense, the company generated third quarter non-GAAP cash earnings of $42.3 million, or $1.27 per non-GAAP basic share and $1.02 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share for the third quarter of 2015 includes the impact of the convertible debt and related bond hedge and warrants.

Balance Sheet Highlights

As of September 30, 2015, the company’s cash and investments totaled approximately $442.9 million and total debt (face value) was $1.05 billion.

"The two transformative acquisitions that we completed in the past twelve months have allowed us to significantly grow our top line while delivering strong cash flows and profitability for our shareholders," said Frank Thomas, AMAG’s president and chief operating officer. "As we continue to integrate the businesses, we are anticipating even better financial and operating performance, allowing us to serve our patients more effectively and efficiently."

Nine Months Ended September 30, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues for the nine months ended September 30, 2015 were $309.5 million, compared with $71.1 million for the same period in 2014. This increase is primarily related to the addition of Makena in November 2014 and CBR in August 2015, which contributed $184.3 million and $7.2 million, respectively, in product revenue to the year-to-date 2015 results. In addition, the company recognized $39.2 million of collaboration revenue in 2015 related to the termination of the company’s ex-US ferumoxytol marketing agreement with Takeda Pharmaceutical Company Limited.

Net income for the first nine months of 2015 totaled $25.6 million, compared with a net loss of $7.2 million for same period in 2014. Basic net income per share was $0.84, compared with a net loss per basic share of $0.33 in 2014. Diluted net income per share was $0.73 in 2015, compared with a net loss per diluted share of $0.33 in 2014. The weighted average diluted shares used in calculating diluted net income per share for the first nine months of 2015 followed the if-converted method of accounting for the convertible debt.

Financial Results (Non-GAAP Basis)(1),(2)

Non-GAAP adjusted EBITDA for the nine months ended September 30, 2015 was $152.1 million, compared with a loss before interest, taxes, depreciation and amortization of $0.8 million for the same period in 2014. After deducting cash interest expense, the company generated non-GAAP cash earnings of $127.2 million, or $3.31 per non-GAAP diluted share.

Updating 2015 Financial Outlook(6)

The company is updating its full year 2015 guidance to include revenue from CBR and reflect the business performance for the first nine months and the outlook for the remainder of 2015.

On November 3, 2015 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biotechnology company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic disease, and cancer, reported financial results for the third quarter ended September 30, 2015 and provided a review of recent business highlights (Filing, 8-K, Xencor, NOV 3, 2015, View Source [SID:1234507935]).

"The advancements made this quarter for both our internal and partnered XmAb programs represent progress across the full breadth of our Fc engineering technology. For our XmAb bispecific antibody platform, we are working toward the initiation of clinical trials for XmAb14045 and XmAb13676, which are planned for the first half and second half of 2016, respectively and in September we announced our research collaboration with Amgen to apply our bispecific platform to their antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. "In the months ahead, we plan to initiate clinical testing of XmAb5871 in IgG4-Related Disease (IgG4-RD) and report full data results from our ongoing Phase 1a trial of XmAb7195 in the first half of 2016. We are on strong financial footing, with sufficient cash to advance development of our clinical programs and platform through 2019."

Business Highlights

XmAb 5871: A first-in-class monoclonal antibody that targets CD19 with its variable domain and that uses Xencor’s proprietary XmAb immune inhibitory Fc domain to target FcγRIIb, a receptor that inhibits B-cell function.

· Xencor plans to file an investigational new drug (IND) application this year and initiate enrollment in a Phase 2, open-label, pilot study of XmAb5871 in IgG4-RD in early 2016. The trial, designed to assess control of disease activity, will enroll approximately 15 subjects for up to 24 weeks and will utilize the IgG4-RD Responder Index to measure treatment activity (Carruthers 2012, International Journal of Rheumatology). Xencor expects to report preliminary data by the end of 2016.

· Xencor plans in 2016 to initiate clinical development of XmAb5871 in an additional autoimmune disease and initiate a bioequivalence trial with a subcutaneous formulation.

XmAb 7195: A first in class monoclonal antibody that targets IgE with its variable domain and uses Xencor’s XmAb immune inhibitor Fc domain to target FcγRIIb, resulting in three distinct mechanisms of action for reducing IgE levels.

· Xencor plans to report complete IgE reduction and safety data from the ongoing Phase 1a trial of XmAb7195 for the treatment of asthma in the first half of 2016.

· Xencor plans to initiate a Phase 1 trial with a subcutaneous formulation of XmAb7195 in 2016.

Internal Bispecific Oncology Pipeline: Xencor’s initial bispecific programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T cell binding domain (CD3). These bispecific antibodies activate T cells for highly potent and targeted killing of malignant cells. Their XmAb Fc domains confer long circulating half-lives, stability and ease of manufacture.

· Xencor remains on track to initiate clinical trials for its first two bispecific oncology candidates, XmAb14045, for the treatment of acute myeloid leukemia, and XmAb13676, for the treatment of B-cell malignancies, in the first and second half of 2016, respectively.

· Xencor plans to start clinical trials for additional bispecific oncology candidates in 2017.

Partnered XmAb Programs

· In September 2015, Xencor and Amgen entered into a research and license agreement to develop and commercialize five bispecific molecules based on Amgen antibodies against predefined targets, and Xencor’s preclinical T cell engager program directed at CD38 and CD3 for multiple myeloma. Xencor received a $45 million upfront payment, and is eligible to receive up to $1.7 billion in clinical, regulatory and sales milestone payments in total and royalties on sales.

· In September 2015, Xencor reported that its partner, CSL Limited, through its licensee Janssen Biotech Inc., initiated a Phase 2 clinical trial of CSL362 (now called JNJ-56022473), which uses Xencor’s XmAb Cyotoxic Fc Domain, for the potential treatment of patients with acute myeloid leukemia (AML). The trial initiation triggered a milestone payment to Xencor.

Third Quarter Ended September 30, 2015 Financial Results

Cash equivalents and marketable securities totaled $197.6 million as of September 30, 2015, compared to $54.7 million on December 31, 2014. The increase reflects the net proceeds of $115.0 million received from completion of Xencor’s follow-on financing in the first quarter and net proceeds from partners and collaborators during the first three quarters of 2015 including an upfront payment of $45.0 million received from Amgen in the third quarter.

Revenues for the third quarter ended September 30, 2015 were $3.5 million, compared to $0.8 for the same period in 2014. Revenues for the nine months ended September 30, 2015 were $6.0 million, compared to $3.9 million for the same period in 2014. Revenues in the three and nine month period ended September 30, 2015 were earned primarily from the Company’s Novo Nordisk and Alexion collaborations and also reflect a milestone payment received from our CSL collaboration, compared to revenue for the same periods in 2014, which was primarily earned from Xencor’s 2010 Amgen collaboration which terminated in the fourth quarter of 2014.

Research and development expenditures for the third quarter ended September 30, 2015 were $10.6 million, compared to $5.0 million for the same period in 2014. Total research and development expenses for the nine months ended September 30, 2015 were $23.3 million, compared to $13.5 million for the same period in 2014. The increased research and development spending for the three and nine months ended September 30, 2015 over the same periods in 2014 is primarily due to increased spending on Xencor’s bispecific technology and development pipeline, including its initial bispecific oncology candidates, XmAb14045 and XmAb13676.

General and administrative expenses in the third quarter ended September 30, 2015 were $3.2 million, compared to $2.2 million for the same period in 2014. Total general and administrative expenses for the first nine months of 2015 were $8.5 million compared to $5.5 million for the same period in 2014. The increased spending in the general and administrative area is due to increased staffing in Xencor’s legal and accounting departments and additional spending in professional fees for legal and business development activities.

Non-cash, share-based compensation expense for the first nine months of 2015 was $3.4 million compared to $1.1 million in the first nine months of 2014.

Net loss for the third quarter ended September 30, 2015 was $10.0 million, or $(0.25) on a fully diluted per share basis, compared to a net loss of $6.3 million or $(0.20) on a fully diluted per share basis, for the same period in 2014. For the nine months ended September 30, 2015, net loss was $25.3 million, or $(0.66) on a fully diluted per share basis, compared to a net loss of $15.1 million, or $(0.48) on a fully diluted per share basis for the same period in 2014. The increased loss for the three and nine months ended September 30, 2015 over the same periods in 2014 is due to increased spending in both the research and development and general and administrative areas and the increase in stock based compensation charges.

The total shares outstanding as of September 30, 2015 was 40,477,003, which reflects the additional 8,625,000 shares issued in the Company’s follow-on financing in the first quarter of 2015.

Based on current operating plans, Xencor expects to have sufficient cash to fund research and development programs and operations through 2019.

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On November 03, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer, reported consolidated financial results for the third quarter of 2015 and progress in its proprietary and partnered clinical development programs (Press release, NewLink Genetics, NOV 3, 2015, View Source [SID:1234507912]).

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"Our dynamic and experienced team has made significant progress in driving our broad clinical development programs," said Charles Link, M.D., Chairman and Chief Executive Officer. "We look forward to reporting on our strong pipeline of clinical data over the coming year."

Dr. Link added, "GDC-0919, the checkpoint inhibitor program partnered with Genentech continues to make great progress. Both companies are putting substantial resources behind this program, and we continue to be excited about the development plan and the progress of our collaboration."

"As we anticipate the data readout for the IMPRESS trial in 2016, NewLink Genetics continues to advance its investment in manufacturing and pre-commercial activities relating to algenpantucel-L, our HyperAcute Cellular Immunotherapy product candidate for patients with resected pancreatic cancer," said Nicholas Vahanian, M.D., President and Chief Medical Officer. "We await the promise of our cellular immunotherapy agents to educate the immune system to destroy tumor cells in pancreatic and other cancers."

Financial Results for the Three-Month Period Ended September 30, 2015

Cash Position: NewLink Genetics ended the quarter on September 30, 2015, with cash, cash equivalents, and certificates of deposit totaling $200.4 million, compared to $202.8 million for the year ending December 31, 2014 .

R&D Expenses: Research and development expenses in the third quarter of 2015 were $22.5 million, compared to $10.9 million during the comparable period in 2014. The increase is primarily due to clinical trial expenses related to NewLink Genetics’ broad pipeline of product candidates, as well as expenses for manufacturing and research related to the Ebola vaccine candidate. The majority of the Ebola-related expenses are subject to reimbursement under government contracts.

G&A Expenses: General and administrative expenses in the third quarter of 2015 were $7.4 million, compared to $4.9 million during the comparable period in 2014. The increase was primarily due to an increase in share-based compensation expense, consulting and legal fees, and medical affairs and pre-commercial activities.

Net Loss: NewLink Genetics reported a net loss of $15.9 million, or ($0.55) per diluted share, for the third quarter of 2015, compared to a net loss of $5.6 million, or ($0.20) per diluted share, for the comparable period in 2014.

NewLink Genetics ended the quarter with 28,774,911 shares outstanding.

Financial Guidance

NewLink Genetics expects to have more than $160 million in cash and equivalents on December 31, 2015.

Conference Call and Program Updates:

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 business development activities. Dial-in information for the conference call is set forth at the end of this press release. Programs to be discussed include:

IDO Checkpoint Inhibitor Programs

NewLink Genetics entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO checkpoint inhibitor GDC-0919 and an expanded pipeline of potential IDO/TDO inhibitor candidates in 2014. This product candidate is currently in Phase 1 clinical development for patients with advanced solid tumors.

Key preclinical data is being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Bethesda, Maryland on November 6, 2015.

Phase 1 data on GDC-0919 was presented at the ECC/ESMO meeting in Vienna. Key preliminary data showed that GDC-0919 had a favorable safety profile and preliminary evidence of disease stabilization and peripheral pharmacodynamic modulation. Details from the poster presentation are available in the press release found at View Source
The collaboration’s clinical development team has advanced GDC-0919 into a combination study with atezolizumab that is actively enrolling patients. In addition, the collaboration is planning combination studies of GDC-0919 with OX-40 agonists.
NewLink will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.
Indoximod, NewLink Genetics’ proprietary IDO pathway inhibitor, is in multiple Phase 1 and Phase 2 clinical trials for patients with breast, prostate, pancreatic and brain cancers as well as melanoma. We will provide additional details about our trials on the conference call. Additionally, there will be multiple opportunities for the Company to provide further updates during 2015 and 2016 at academic meetings and associated programs.

HyperAcute Cellular Immunotherapy Programs

NewLink Genetics’ proprietary HyperAcute Cellular Immunotherapy programs may prove to have broad potential for patients across a spectrum of cancer indications, including use in combination with checkpoint inhibitors.

Algenpantucel-L is NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with pancreatic cancer. The product is currently being studied in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESectable Cancer Study, in patients with surgically resected pancreatic cancer. The study is powered to show an improvement in overall survival after 442 events, and we continue to expect that final results will be reported in 2016.

PILLAR, or Pancreatic Immunotherapy with Algenpantucel-L for Locally Advanced Non-Resectable Disease, is our Phase 3 clinical trial studying the efficacy of algenpantucel-L for patients with borderline resectable or locally advanced unresectable pancreatic cancer. We expect to complete enrollment in this study in 2015.

Tergenpumatucel-L

Tergenpumatucel-L, NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with non-small cell lung cancer (NSCLC), remains in Phase 2. We are eager to learn more about this product in our recently begun trial evaluating tergenpumatucel-L in combination with indoximod and chemotherapy for patients with advanced NSCLC.

Dorgenmeltucel-L

Dorgenmeltucel-L, NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with melanoma, continues in a trial evaluating efficacy in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab for patients with advanced melanoma.

Ebola Vaccine

During the third quarter, we announced that NewLink Genetics was awarded an $8.1 million base contract with future options totaling $5.2 million by the Defense Threat Reduction Agency of the United States Department of Defense to support various development activities of the investigational rVSV-ZEBOV (Ebola) vaccine candidate. Additionally, the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services exercised an $18 million option on NewLink Genetics’ existing contract.

NewLink has exclusively licensed research, development, manufacturing and commercialization of the rVSV-ZEBOV (Ebola) vaccine to Merck. This vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC).