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Zymeworks Receives Second Orphan Drug Designation for ZW25 in Gastric Cancer

On February 16, 2017 Zymeworks Inc. ("Zymeworks"), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, reported that its lead product candidate, ZW25, has been granted orphan drug designation from the U.S. Food and Drug Administration (the "FDA") in the treatment of gastric cancer, including cancer of the gastroesophageal junction ("GEJ") (Press release, Zymeworks, FEB 16, 2017, View Source [SID1234517741]).

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"Gastric Cancer represents ZW25’s second orphan drug designation, in addition to ovarian cancer, which was granted last year," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Gastric cancer is the fifth most common cancer in the world, and we believe ZW25 has the potential to address the significant unmet medical need that exists for patients with this disease."

Dr. Diana Hausman, Zymeworks’ Chief Medical Officer, added, "ZW25 demonstrated encouraging anti-tumor activity in preclinical models of gastric cancer. We are excited about the opportunity to advance the development of ZW25, which is currently being evaluated in a first in human Phase 1 clinical trial in the US in patients with advanced HER2 expressing cancers, including gastric/GEJ tumors."

The FDA grants orphan drug designation to biological products that are intended to treat a rare disease or condition, which is generally defined as affecting a patient population of fewer than 200,000 people in the United States. Orphan drug designation provides the sponsor certain financial incentives, including tax credits, the waiver of associated application fees, and a period of marketing exclusivity if the product candidate receives the first marketing approval for the indication for which it has such designation.

About ZW25

ZW25 is Zymeworks’ lead product candidate currently being evaluated in an adaptive Phase 1 clinical trial in the United States, based on our Azymetric platform. It is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models. We are developing ZW25 as a best-in-class HER2-targeting antibody intended as a treatment option for patients with any solid tumor that expresses HER2.

Genocea Reports Fourth Quarter and Year-End 2016 Financial Results

On February 16, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, reported corporate highlights and financial results for the fourth quarter and year ended December 31, 2016 (Press release, Genocea Biosciences, FEB 16, 2017, View Source [SID1234517735]). Genocea is developing GEN-003, a therapeutic vaccine candidate for the treatment of genital herpes expected to enter Phase 3 development in 2017, and is applying its unique and proprietary T cell antigen identification platform, ATLAS, to immuno-oncology and cancer vaccine development.

"We are proud to report on our 2016 achievements, as we made important advances in both our GEN-003 and immuno-oncology programs," said Chip Clark, president and chief executive officer of Genocea. "With the announcements of positive virologic and clinical data for GEN-003 from our ongoing Phase 2b trial, we believe we have confirmed a highly attractive clinical profile for GEN-003, which has the potential to be the first new treatment for patients with genital herpes in more than 20 years. We are encouraged by market research indicating that the GEN-003 clinical profile is attractive to both physicians and payers, and, most importantly, to patients, many of whom are dissatisfied with their current treatment options."

Mr. Clark continued: "In addition to the progress on GEN-003, we announced last fall that we are now focusing our early stage development resources on our immuno-oncology programs. We believe there is a significant opportunity to use our ATLAS platform in immuno-oncology to comprehensively profile T cell responses to cancer. We believe that we can create value by developing novel therapeutic neoantigen cancer vaccines and by developing non-invasive assays to define patient selection for clinical trials and clinical practice. As we presented at our first-ever R&D Day in December, we are making significant progress in both areas and remain on track to file an IND for our first cancer vaccine (GEN-009) by the end of this year."

Program Highlights

GEN-003 Program Milestones

March 2016: Announced positive efficacy data from the Phase 2 dose-optimization trial, demonstrating sustained reductions in the rate of viral shedding and clinical efficacy across secondary clinical endpoints 12 months after dosing
June 2016: Presented detailed 6- and 12-month clinical and viral shedding data from the Phase 2 dose-optimization trial at the American Society for Microbiology annual general meeting, ASM Microbe 2016
September 2016: Announced the first data from the placebo-controlled Phase 2b trial evaluating a new Phase 3-ready formulation, with GEN-003 demonstrating significant reduction in viral shedding immediately after dosing
October 2016: Presented 12-month immunogenicity data from the Phase 2 dose-optimization trial at the Infectious Disease Society of America (IDSA) annual meeting, IDWeek 2016, demonstrating GEN-003 effects clear and robust T and B cell responses
January 2017: Announced positive 6-month results from the Phase 2b clinical trial showing statistical significance vs. placebo for multiple clinical endpoints
Immuno-Oncology Program Milestones

November 2016: Announced new findings supporting the potential of the proprietary ATLAS technology to identify clinically meaningful neoantigens compared to those identified by predictive algorithms and presented the results at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 31st Annual Meeting & Associated Programs, SITC (Free SITC Whitepaper) 2016
December 2016: Announced two immuno-oncology collaborations, Checkmate Pharmaceuticals, Inc. and US Oncology, each employing ATLAS to characterize T cell responses to optimize clinical development and to discover new antigens, respectively
Anticipated Upcoming Milestones and Events

Milestones

1Q 2017: GEN-003 end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected; will confirm the design of the GEN-003 Phase 3 program
2H 2017: GEN-003 24-month Phase 2 data expected; will inform likely timing of maintenance dosing for GEN-003
2H 2017: GEN-003 12-month Phase 2b data anticipated; expected to reconfirm clinical profile of GEN-003 at 1 year post dosing
4Q 2017: GEN-003 Phase 3 program start expected
4Q 2017: GEN-009 neoantigen cancer vaccine Investigational New Drug (IND) application filing expected
Events

March 2017: Presentation at the Cowen 37th Annual Health Care Conference in Boston
April 2017: Presentation at the Needham & Company 16th Annual Healthcare Conference in NYC
Financial Guidance

Genocea expects that its existing cash, cash equivalents and investments are sufficient to support its operating expenses and capital expenditure requirements into the first quarter of 2018, without assuming any receipt of proceeds from potential business development partnerships, equity financings or debt drawdowns. This guidance assumes commencing Phase 3 trials for GEN-003 for genital herpes in the fourth quarter of 2017 and filing an IND for GEN-009 for cancer by the end of the year, however it is Genocea’s strategy to secure additional sources of financing in advance of starting GEN-003 Phase 3 clinical trials.

Fourth Quarter and Year-End 2016 Financial Results

Cash Position: Cash, cash equivalents and investments as of December 31, 2016 were $63.4 million compared to $75.5 million as of September 30, 2016.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2016 increased $5.3 million, to $11.8 million, from the same period in 2015, driven by higher manufacturing and clinical costs for GEN-003 together with higher personnel and lab-related costs related to Genocea’s immuno-oncology programs. These increases were partially offset by reduced spending on early stage infectious disease programs.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2016 were $3.9 million, compared to $3.8 million for the same period in 2015. The slight increase reflects higher personnel costs to support Genocea’s expanding R&D operations.
Net Loss: Net loss was $16.0 million for the quarter ended December 31, 2016, compared to a net loss of $10.3 million for the same period in 2015.
Full Year 2016 Financial Results

Cash Position: Cash, cash equivalents and investments as of December 31, 2016 were $63.4 million, compared to $106.4 million as of December 31, 2015.
R&D Expenses: R&D expenses for the year ended December 31, 2016 were $34.6 million, compared to $28.0 million for the same period in 2015, reflecting higher personnel costs, consulting and professional services costs, clinical costs, and lab-related costs to support the continued advancement of GEN-003. These increased costs were partially offset by lower GEN-003 manufacturing costs in 2016 compared to 2015. Increases in personnel and lab related costs across early stage research programs were offset by a reduction in GEN-004 costs for which a clinical trial was completed in late 2015 and further development of this program was suspended.
G&A Expenses: G&A expenses were $15.4 million for the year ended December 31, 2016, compared to $14.0 million for the same period in 2015, reflecting an increase in market research costs to support GEN-003 and higher depreciation costs from facility expansion in late 2015.
Refund of Research and Development Expense: A gain of $1.6 million for the quarter ended March 31, 2016 resulted from cash received pursuant to contractual obligations under a collaboration agreement with Isconova AB ("Isconova") (since acquired by Novavax, Inc.) to refund R&D expenses paid by Genocea to Isconova between 2009 and 2011 relating to the development of the Matrix-M adjuvant technology.
Net Loss: Net loss was $49.6 million for the year ended December 31, 2016, compared to a net loss of $42.5 million for the same period in 2015.

Takeda Completes Acquisition of ARIAD Pharmaceuticals, Inc.

On February 16, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") reported the completion of its acquisition of ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) ("ARIAD") for $24.00 per share in cash (Press release, Ariad, FEB 16, 2017, View Source;p=RssLanding&cat=news&id=2246696 [SID1234517733]).

"We are very pleased to have completed the acquisition of ARIAD Pharmaceuticals. The addition of ARIAD’s innovative targeted therapies and research and development capabilities strengthens and diversifies our oncology business, positioning Takeda for sustainable long-term growth in this priority therapeutic area," said Christophe Weber, president and chief executive officer of Takeda. "We are particularly excited by the global potential of brigatinib, an investigational drug product, which we believe will become a best-in-class ALK inhibitor for non-small cell lung cancer with the potential to achieve peak annual sales of over $1 billion. We are also impressed with the swiftness and agility of Takeda and ARIAD employees as they have planned for a successful integration while remaining focused on strategic goals. This bodes very well for the future of our combined business, and we look forward to building on this strong start to maximize the benefit of Iclusig (ponatinib) and potential of brigatinib for cancer patients."

"The acquisition of ARIAD is transformational for Takeda Oncology. Iclusig enhances our strong position in hematology in the U.S., and brigatinib has the potential to broaden our solid tumor franchise globally," said Christophe Bianchi, president of Takeda Oncology. "There is a strong cultural fit between our two companies, with a shared mission to advance innovative therapies to improve the lives of patients with cancer. We have been working together over the past month to plan for a smooth integration of our businesses and we will work closely with regulatory authorities on our brigatinib market authorization submissions."

Takeda continues to expect the transaction to be accretive to Underlying Core Earnings by FY2018. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the anticipated brigatinib launch.

Tender Offer Details

Takeda completed the acquisition through a tender offer and subsequent merger of ARIAD with Kiku Merger Co., Inc., a wholly owned subsidiary of Takeda Pharmaceuticals U.S.A. ARIAD is now an indirect wholly owned subsidiary of Takeda.

The tender offer for all of the outstanding shares of ARIAD common stock expired as scheduled, immediately following the offer’s expiration time of 11:59 p.m., Eastern Time, on February 15, 2017. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Takeda that 158,558,628 shares of ARIAD common stock were tendered, representing approximately 81.4% of the shares outstanding. All of the conditions to the tender offer having been satisfied, Takeda’s indirect wholly owned subsidiary Kiku Merger Co., Inc. has accepted for payment and will promptly pay for all shares tendered. The transaction will be funded by approximately $3.5 billion of new debt and the remainder from existing cash. Takeda is expected to remain investment grade and the transaction has no impact on Takeda’s dividend policy.

On February 16, 2017, Takeda completed its acquisition of ARIAD through the merger of Kiku Merger Co., Inc. with ARIAD without a vote of ARIAD’s shareholders pursuant to Section 251(h) if the Delaware General Corporation Law. As a result of the merger, ARIAD became an indirect wholly owned subsidiary of Takeda. In connection with the merger, all ARIAD shares not purchased in the tender offer have been converted into the right to receive $24.00 per share in cash, without interest (less any required withholding taxes), the same amount paid for all shares validly tendered and not validly withdrawn in the tender offer. ARIAD common stock will cease to be traded on the NASDAQ Global Select Market.

Evercore Partners acted as financial advisor and Cleary Gottlieb Steen & Hamilton LLP acted as legal advisor to Takeda. J.P. Morgan Securities LLC, Goldman, Sachs & Co. and Lazard acted as financial advisors and Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal advisor to ARIAD.

Cellceutix Reports on Q2 Fiscal 2017, Prepares for Important Clinical Milestones

On February 16, 2017 Cellceutix Corporation, (OTCQB: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, reported a general business update, corporate outlook for on upcoming clinical milestones for its first-in-class drug candidates and select financial results for the second quarter of the fiscal year 2017 ended December 31, 2016 (Press release, CellCeutix, FEB 16, 2017, View Source [SID1234517730]). A comprehensive review of the latest quarter reported is available through Cellceutix’s recently submitted Form 10-Q with the Securities and Exchange Commission at www.sec.gov and on the Cellceutix website.

Portfolio Development

The second quarter of fiscal 2017 and the start of our third quarter proved very positive for Cellceutix’s three lead compounds, Brilacidin, Prurisol and Kevetrin. The past few months laid the groundwork for some fast-approaching milestones that represent pivotal moments for Cellceutix. As mentioned by management in previous news releases, a primary focus for the 2017 calendar year is completing work necessary to forge partnerships with larger pharmaceutical companies presently engaged with Cellceutix, some under Confidential Disclosure Agreements (CDAs). Should outcomes from ongoing clinical studies yield favorable results, the Company is optimistic that it will be able to capitalize on the data with respect to a partnership. Securing partnerships would generate substantial shareholder value, while also helping to advance the Company’s innovative drug candidates toward market approval, benefiting patients in need of additional safe and effective treatment options.

· Brilacidin—Oral Mucositis (Phase 2 Trial)

· Enrolling 60 patients, the study is evaluating Brilacidin as an oral rinse, 3 times daily for 7 weeks, to prevent and control Oral Mucositis (OM) in patients receiving chemoradiation therapy for head and neck cancer. Even though over 400,000 patients in the U.S. suffer from this condition, presently there are no approved drugs for the treatment of OM in this population, with only limited palliative care options available. Cellceutix’s goal with this trial is to show that Brilacidin has dual functionality in not only shortening the duration and intensity of OM in patients with head and neck cancers, but also preventing the onset of the condition, an accomplishment no other pharmaceutical company has achieved.

· Upcoming Milestone: Interim analysis of the Phase 2 trial is expected in approximately 6 to 8 weeks.

· Brilacidin—Inflammatory Bowel Diseases Ulcerative Proctitis/Proctosigmoiditis (Phase 2a Trial)

· This Proof-of-Concept trial includes enrolling 18 patients divided evenly into three cohorts. Review of safety data from the first 6 patients revealed that Brilacidin, administered for 6 weeks as a retention enema, at 50 mg once daily, appeared well-tolerated, with no measurable systemic absorption detected. Clinically meaningful improvements in symptoms were also demonstrated, as measured by physician assessments and patient reported outcomes, further supported with endoscopic evaluation. Brilacidin may show greater efficacy at higher dosing levels in the trial, which are comprised of 100 mg for the current cohort and 200 mg for the third cohort. Cellceutix believes that a successful trial creates an opportunity to explore Brilacidin for an array of other hard-to-treat Inflammatory Bowel Diseases that current lack effective therapeutics.

· Upcoming Milestone: Cellceutix projects that an interim analysis of the second cohort will be completed in approximately two weeks. The trial is anticipated to be completed in 2Q2017.

Over the next month to two months, Cellceutix expects to have interim data from both Brilacidin trials. This is particularly important for the development of Brilacidin and pursuit of partnerships as the data can provide clinical evidence of the immunomodulatory and anti-inflammatory properties of Brilacidin for indications that represent areas of unmet medical needs.

· Prurisol – Chronic Plaque Psoriasis (Phase 2b Trial)

· Subject recruitment is now ongoing across the United States. The study increases the total daily oral dosing of Prurisol from a previous high of 200 mg, which was shown to be well-tolerated in a successfully completed Phase 2a trial, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization). Enrolling approximately 189 patients with moderate to severe chronic plaque psoriasis, treatment duration is 12 weeks (84 days). Primary efficacy is being evaluated using the Psoriasis Area and Severity Index (PASI). The Company believes now is an opportune time to develop an oral treatment for psoriasis given that currently available treatment options are limited, with many not easily administered and often associated with undesirable side effects.

· Kevetrin – Advanced Ovarian Cancer (Phase 2a Trial)

· As disclosed on February 10, 2017, a Phase 2a trial of Kevetrin (CTIX-KEV-201) has commenced. This is an open-label study evaluating the safety, tolerability, and pharmacokinetics of Kevetrin, as well as changes in select biomarkers and objective tumor response when administered to patients with platinum-resistant/refractory ovarian cancer. The clinical trial comprises two different short-term treatment regimens and will enroll an estimated 10 patients. The trial will directly inform how Kevetrin modulates the p53 signaling pathway. Cellceutix is consulting with a world renowned expert on p53 and a member of the National Academy of Sciences who helped design the study, which is intended to provide potential partners key information on the mechanism of action of the novel compound.

"I think it is pretty easy to see why we are thrilled at our prospects with four different mid-stage trials ongoing," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. "Each study has a valuable component in demonstrating the robustness and potential of our pipeline and I greatly look forward to what I suspect will be a 2017 with a steady flow of information across all four trials."

"Success in any one of our mid-phase trials could instantly transform the Company overnight," commented Cellceutix Chief Executive Officer Leo Ehrlich. "Having already engaged in productive discussions with large pharmaceutical companies, Cellceutix remains partnership-focused in 2017. Potentially life-saving drugs and tremendous value creation await patients and shareholders alike as we strive to deliver compelling trial results."

2

Select Financial Results for the Second Quarter of Fiscal 2017

The current primary potential source of cash available to the Company are equity investments through its $30.0 million equity purchase agreement with Aspire Capital signed in March 2015. The Company has financed its operations to date through the sale of its common stock. The Company had raised approximately $11.0 million from initiation of the equity purchase agreement with Aspire Capital through the three months ended December 31, 2016, leaving approximately $19.0 million available. Additionally, as of December 31, 2016, Cellceutix had approximately $3.9 million in cash on hand.

For the three months ended December 31, 2016, the Company’s net loss was approximately $3.36 million, or $0.03 per share, compared to a net loss of $3.32 million, or $0.03 per share, for the three months ended December 31, 2015.

Agios Reports Fourth Quarter and Full Year 2016 Financial Results and Highlights Key 2017 Milestones

On February 16, 2017 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2016 (Press release, Agios Pharmaceuticals, FEB 16, 2017, View Source [SID1234517729]). In addition, Agios highlighted select corporate milestones and data presentations for its preclinical and clinical development programs.

"Our 2016 accomplishments, including the enasidenib NDA submission with our collaboration partner Celgene and clear proof-of-concept data for our PK deficiency program, demonstrate our ability to transform our scientific discoveries into important precision medicines," said David Schenkein, M.D., chief executive officer at Agios. "In 2017, we are focused on making the transition to a commercial stage company by delivering our lead cancer programs to patients, bringing our first rare genetic disease program into pivotal development and advancing our next research program, focused on MTAP-deleted cancers, into the clinic."

KEY UPCOMING MILESTONES

The company expects to achieve the following key milestones:

IDH Mutant Inhibitors in Hematologic Malignancies

Potential approval of enasidenib in the United States for IDH2m positive relapsed/refractory (R/R) acute myeloid leukemia (AML) in collaboration with Celgene by the end of 2017.
Submit a new drug application (NDA) to the U.S. FDA for ivosidenib (AG-120) for IDH1m positive R/R AML by the end of 2017.
Initiate a global, registration-enabling Phase 3 study (AGILE) combining ivosidenib (AG-120) and VIDAZA in newly diagnosed AML patients with an IDH1 mutation ineligible for intensive chemotherapy in the first half of 2017.
IDH Mutant Inhibitors in Solid Tumors

Complete the dose-escalation phase of the ongoing Phase 1 study of AG-881 in IDHm positive glioma in the first half of 2017.
Rare Genetic Diseases

Finalize design for a global pivotal trial of AG-348 in pyruvate kinase (PK) deficiency in the third quarter of 2017.
Initiate a global pivotal trial of AG-348 in PK deficiency in the first half of 2018.
Cancer Metabolism Research:

Submit an Investigational New Drug (IND) application for the development candidate targeting methylthioadenosine phosphorylase (MTAP)-deleted tumors by the end of 2017. MTAP is a metabolic enzyme that is deleted in approximately 15 percent of all cancers.
ANTICIPATED 2017 DATA PRESENTATIONS

First data from the expansion phase of the ongoing Phase 1 study of ivosidenib (AG-120) in R/R AML in the second half of 2017
First data from the ongoing Phase 1b combination study of enasidenib or ivosidenib (AG-120) with standard-of-care intensive chemotherapy in newly diagnosed AML in the second half of 2017
First data from the cholangiocarcinoma expansion cohort of the ongoing Phase 1 study of ivosidenib (AG-120) in advanced IDH1m positive solid tumors in the first half of 2017
Updated data from the glioma expansion of the ongoing Phase 1 study of ivosidenib (AG-120) in advanced IDH1m positive solid tumors in the second half of 2017
Updated data from AG-348 Phase 2 DRIVE PK study in PK deficiency in both the first and second half of 2017
Updated preclinical data for the program targeting MTAP-deleted tumors at the Keystone Tumor Metabolism Meeting taking place March 5-9, 2017 in Whistler, British Columbia
FOURTH QUARTER 2016 HIGHLIGHTS

Supported Celgene’s submission of an NDA for enasidenib in IDH2m positive R/R AML.
Initiated a global, registration-enabling randomized Phase 3 study (ClarIDHy) for ivosidenib (AG-120) in IDH1m positive advanced cholangiocarcinoma. The FDA also granted ivosidenib Fast Track Designation for the treatment of patients with previously treated, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation.
Completed the dose-escalation phase of the Phase 1 study of AG-881 in IDHm positive hematologic malignancies. The study is now closed for enrollment.
Selected a development candidate targeting MTAP-deleted tumors to enter IND-enabling studies.
FULL YEAR 2016 FINANCIAL RESULTS

Cash, cash equivalents and marketable securities as of December 31, 2016 were $573.6 million, compared to $375.9 million as of December 31, 2015. This increase was driven by cash received under our collaboration agreements with Celgene totaling $258.2 million, which includes a $200 million upfront payment from the May 2016 collaboration agreement, $25 million related to initiation of the enasidenib Phase 3 IDHENTIFY study and $33.2 million of program funding, net proceeds of $162.1 million received from the company’s September 2016 public offering, and $7.9 million from stock award activities. These items were offset by a decrease in cash related to expenditures to fund operating activities and purchases of fixed assets of $230.6 million during the year ended December 31, 2016.

Collaboration revenue was $69.9 million for the year ended December 31, 2016, compared to $59.1 million for the prior year.

Research and development (R&D) expenses were $220.2 million, including $25.4 million of stock-based compensation expense, for the year ended December 31, 2016, compared to $141.8 million, including $17.4 million in stock-based compensation expense, for the year ended December 31, 2015. The increase in R&D expenses was primarily due to increased costs to support advancement of the company’s lead investigational medicines toward later-stage development. Celgene is responsible for all development costs for enasidenib and certain development costs for AG-881 and reimburses the company for development costs incurred for these investigational medicines.

General and administrative (G&A) expenses were $50.7 million, including $16.7 million of stock-based compensation expense, for the year ended December 31, 2016, compared to $36.0 million, including $14.5 million of stock-based compensation expense, for the year ended December 31, 2015. The increase in G&A expense was largely due to increased headcount and other professional expenses to support growing operations.

Net loss for the year ended December 31, 2016 was $198.5 million, compared to a net loss of $117.7 million for the year ended December 31, 2015.

CASH GUIDANCE

Based on its current operating plans, the company expects that its existing cash, cash equivalents and marketable securities as of December 31, 2016, together with anticipated interest income, and anticipated payments from Celgene under our collaboration agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2018.