On May 4, 2016 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2016 and provided an update on progress toward delivering upon its key 2016 corporate objectives and clinical development milestones (Press release, Exelixis, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2165093 [SID:1234511947]).

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Corporate Updates and Key Priorities for 2016

On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets as a treatment for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. With approval granted, Exelixis is highly focused on the U.S. commercial launch for CABOMETYX. CABOMETYX was shipped to wholesalers and pharmacies within three days of approval, with the first prescription filled on April 28, 2016. The European Medicines Agency (EMA) is reviewing the company’s Marketing Authorization Application (MAA) for cabozantinib for advanced RCC; assuming approval, the product would be marketed in the EU by the company’s corporate partner, Ipsen Pharma SAS (Ipsen).

Exelixis continues to work with its partner Genentech, a member of the Roche Group, to co-promote COTELLIC (cobimetinib) in the United States as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma, in combination with vemurafenib, also known as Zelboraf. COTELLIC is also approved in multiple other territories including the EU and Canada.

Corporate Highlights

Exclusive Licensing Agreement with Ipsen for Cabozantinib in Regions Outside the United States, Canada and Japan. On February 29, 2016, Exelixis announced an exclusive licensing agreement with Ipsen for the commercialization and further development of cabozantinib for its current and potential future indications, including COMETRIQ (cabozantinib) capsules, outside the United States, Canada and Japan. Pursuant to the parties’ agreement, Exelixis received an upfront payment from Ipsen of $200.0 million in the first quarter of 2016. The company is also eligible to receive regulatory milestones, including $60.0 million upon the approval of cabozantinib in Europe for advanced RCC and $50.0 million upon the filing and approval of cabozantinib in Europe for advanced hepatocellular carcinoma (HCC), as well as additional development and regulatory milestones for potential further indications. The agreement includes up to $545.0 million of potential commercial milestones and provides for Exelixis to receive tiered royalties up to 26% on Ipsen’s net sales of cabozantinib in its territories. Exelixis and Ipsen have agreed to collaborate on the global development of cabozantinib for current and potential future indications as well.

Cabozantinib Highlights

FDA Approval of CABOMETYX, the Third Approved Medicine to Have Been Discovered by Exelixis. On April 25, 2016, the U.S. FDA approved CABOMETYX for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. CABOMETYX is the first therapy to demonstrate robust and clinically meaningful improvements in all three key efficacy parameters – overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) – in a phase 3 trial (METEOR) for patients with advanced RCC.

The CABOMETYX label includes data from the second interim analysis of the METEOR trial’s OS secondary endpoint. In February 2016, Exelixis announced that CABOMETYX demonstrated a highly statistically significant and clinically meaningful improvement in OS as compared to everolimus. These results have been accepted as an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting, June 3-7, in Chicago, and will be presented in detail on Sunday, June 5, during the Oral Abstract Session: Genitourinary (Nonprostate) Cancer, 10:12 – 10:24 a.m.

Progress on EU Regulatory Filing for Cabozantinib in Advanced RCC. In January 2016, Exelixis submitted, and the EMA subsequently validated, the company’s regulatory application for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy. In validating the MAA, the EMA granted accelerated assessment, making the application eligible for a shortened 150-day review excluding clock-stops when information is requested from Exelixis. Exelixis intends to transfer the MAA to Ipsen later this year.

Continued Enrollment in CELESTIAL; Data Anticipated in 2017. Exelixis continues to make progress with enrollment of CELESTIAL, the phase 3 pivotal trial comparing cabozantinib to placebo in patients with advanced HCC who have previously been treated with sorafenib. Initiated in September 2013, the trial is designed to enroll 760 patients at approximately 200 sites. Patients are being randomized 2:1 to receive 60 mg of cabozantinib daily or placebo. The primary endpoint for CELESTIAL is OS, and the secondary endpoints include PFS and ORR. Exelixis continues to anticipate top-line results from CELESTIAL in 2017. At this time, there is no approved treatment for HCC patients who progress following sorafenib treatment, the current standard of care.

Broad Cabozantinib Development Program Updates. While Exelixis pursues cabozantinib’s late-stage development in advanced RCC and advanced HCC, earlier-stage investigation of the compound continues through the company’s collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP), and its ongoing Investigator-Sponsored Trial (IST) program. Through these two programs, there are more than 45 ongoing or planned studies including trials in advanced RCC, bladder cancer, colorectal cancer, non-small cell lung cancer, and endometrial cancer.

Cabozantinib, Cobimetinib and XL888 Data Presentations at ASCO (Free ASCO Whitepaper) 2016. Exelixis-discovered compounds will be the subject of 18 presentations at the meeting. In addition to the OS results from the METEOR study in advanced RCC, there will be a poster presentation from the same trial on outcomes based on prior therapy. Additional presentations will highlight results from early and mid-stage trials of cabozantinib in other disease settings, including metastatic colorectal cancer, endometrial cancer and metastatic urothelial carcinomas. Cobimetinib data will include updates on combination trials of the compound in metastatic melanoma, triple-negative breast cancer, and colorectal cancer. Exelixis will also host an investor/analyst briefing at the meeting on Sunday, June 5, 2016; see the Investors & Media section of www.exelixis.com for more details when available.

Cobimetinib Highlights

Additional Regulatory Approvals for COTELLIC. In April and May 2016, Australia’s Therapeutic Goods Administration and Brazil’s ANVISA, respectively, approved COTELLIC for use in combination with Zelboraf for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. As previously announced, in February 2016 Health Canada approved COTELLIC in combination with Zelboraf for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

2016 Financial Guidance

The Company is maintaining its guidance that operating expenses for the full year 2016 will be between $240 million and $270 million, including approximately $30 million of non-cash items primarily related to stock-based compensation expense.

"The first quarter of 2016, and the time period following it, was marked by important advances not only for our company, but for the patients we serve," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Most notably, just a little over a week ago we announced that the FDA approved CABOMETYX for advanced RCC, a major milestone for the company. We are especially pleased that the label includes the robust overall survival data from the METEOR trial. CABOMETYX is now the first and only therapy to have demonstrated improvements in the three key efficacy parameters in a phase 3 trial of advanced renal cell carcinoma, one of the most common forms of cancer for men and women in the United States. We are moving quickly to introduce this new and important medicine to the medical community, with our experienced U.S. commercial team already in the field and meeting with healthcare providers. With our partner Ipsen, we are also well positioned to advance the process of seeking approval and potentially commercializing CABOMETYX in markets beyond the U.S., Canada and Japan."

First Quarter 2016 Financial Results

Net revenues for the quarter ended March 31, 2016 were $15.4 million, compared to $9.4 million for the comparable period in 2015. Net revenues for the first quarter of 2016 consisted of $9.1 million of net product revenue related to the sale of COMETRIQ, $5.0 million of contract revenues for a milestone earned from Merck in the first quarter of 2016 related to their worldwide license of our PI3K-delta program and $1.2 million of license revenues recognized from the upfront payment we received from Ipsen under our collaboration and license agreement.

Research and development expenses for the quarter ended March 31, 2016 were $28.9 million, compared to $22.3 million for the comparable period in 2015. The increase was primarily related to an increase in stock-based compensation expense for performance-based stock-options and an annual bonus to our employees in the form of fully-vested restricted stock units, an increase in personnel related expenses resulting from an increase in headcount and an increase in consulting and outside services for medical affairs and drug safety.

Selling, general and administrative expenses for the quarter ended March 31, 2016 were $34.9 million, compared to $9.5 million for the comparable period in 2015. The increase was primarily related to an increase in personnel related expenses resulting from an increase in headcount, predominantly connected to the expansion of our U.S. sales force, higher marketing expenses which includes a portion of commercialization expenses from COTELLIC under our collaboration agreement with Genentech, consulting and outside services expenses which includes an accrual for the estimated termination fee due to Sobi, and stock-based compensation expense for performance-based stock-options and an annual bonus to our employees in the form of fully-vested restricted stock units.

Other income (expense), net for the quarter ended March 31, 2016 was a net expense of ($12.2) million compared to ($12.4) million for the comparable period in 2015. The net expense is comprised primarily of interest expense which includes $7.2 million of non-cash expense related to the accretion of the discounts on both the 4.25% Convertible Senior Subordinated Notes due 2019 and the Company’s indebtedness under our Secured Convertible Notes due June 2018 held by entities associated with Deerfield for the quarter ended March 31, 2016, as compared to $7.7 million for the comparable period in 2015.

Net loss for the quarter ended March 31, 2016 was ($61.3) million, or ($0.27) per share, basic, compared to ($35.2) million, or ($0.18) per share, basic, for the comparable period in 2015. The increased net loss for the quarter was primarily due to increases in selling, general and administrative expenses and research and development expenses, partially offset by an increase in net revenues.

Cash and cash equivalents, short- and long-term investments and long-term restricted cash and investments totaled $407.6 million at March 31, 2016, which increased from $253.3 million at December 31, 2015 as a result of the $200.0 million upfront payment we received from Ipsen in connection with our February 29, 2016 licensing agreement.

Basis of Presentation

Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended April 1, 2016, January 1, 2016 and March 28, 2015 are indicated as being as of and for the periods ended March 31, 2016, December 31, 2015 and March 31, 2015, respectively.

Human telomerase reverse transcriptase (hTERT) is overexpressed in more than 85% of human cancers regardless of their cellular origin. As immunological tolerance to hTERT can be overcome not only spontaneously but also by vaccination, it represents a relevant universal tumor associated antigen (TAA). Indeed, hTERT specific cytotoxic T lymphocyte (CTL) precursors are present within the peripheral T-cell repertoire. Consequently, hTERT vaccine represents an attractive candidate for antitumor immunotherapy. Here, an optimized DNA plasmid encoding an inactivated form of hTERT, named INVAC-1, was designed in order to trigger cellular immunity against tumors. Intradermal injection of INVAC-1 followed by electrogene transfer (EGT) in a variety of mouse models elicited broad hTERT specific cellular immune responses including high CD4(+) Th1 effector and memory CD8(+) T‑cells. Furthermore, therapeutic INVAC‑1 immunization in a HLA-A2 spontaneous and aggressive mouse sarcoma model slows tumor growth and increases survival rate of 50% of tumor-bearing mice. These results emphasize that INVAC-1 based immunotherapy represents a relevant cancer vaccine candidate.

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On May 4, 2016 Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, reported that the first patient has been enrolled into one of the two new arms of its expanded Lymrit 37-01 clinical study with Betalutin (Press release, Nordic Nanovector, MAY 4, 2016, View Source [SID:1234511950]).

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Betalutin is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin’s lymphoma (NHL), including Follicular Lymphoma (FL).

The new arm (Arm 3) is designed to investigate the safety and efficacy of Betalutin in up to 12 patients with relapsed FL pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a few hours prior to the administration of Betalutin.

Luigi Costa, Nordic Nanovector CEO, commented: "We are pleased to initiate the first of the two new cohorts in our ongoing clinical study, which represents a significant step forward in Betalutin’s development plan. Data we have seen to date suggest that we can achieve strong clinical efficacy with a regimen that controls haematological side effects. The two new arms are investigating if different pre-dosing regimens will allow the use of higher doses of Betalutin to potentially achieve even higher efficacy than that so far observed, and therefore an even more compelling product profile."

The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin and different dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.

Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus 50mg/ml unconjugated "cold" HH1 anti-CD37 antibody) is progressing as planned with dose-escalation expected to begin in 2H 2016. Patient screening is also underway for the final arm in the expanded Lymrit 37-01 study (Arm 4), in which escalating doses of Betalutin plus pre-treatment with a higher dose of cold anti-CD37 antibody than in Arm 1 will be evaluated in relapsed FL patients.

A decision to increase the dose of Betalutin to 17.5 MBq/kg in Arm 1 can be made based on the evaluation of the safety and efficacy data observed in the 15 patients treated with 15 MBq/kg. A decision to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or the other of Arms 3 and 4 can be made based on the evaluation of the safety and efficacy data observed in the first three patients of both cohorts.

Data and analysis recently published at the American Association of Cancer Research annual meeting (16-20 April) confirmed that Betalutin was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) and a 31.6% Complete Response (CR) in evaluable patients. Clinical responses observed were sustained, with Duration of Response exceeding 12 months in most responders in the 15 MBq/kg group who have been followed up for at least 12 months.

On May 4, 2016 Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women’s health therapeutics company, reported financial results for the three-month period ended March 31, 2016 (Press release, Juniper Pharmaceuticals, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2164732 [SID:1234511899]). Highlights include:

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Phase 2b trial of COL-1077 10% lidocaine vaginal gel in women undergoing a minimally invasive pipelle-directed endometrial biopsy on track for Q3 2016 data readout;
Pre-IND meeting with the U.S. Food and Drug Administration (FDA) confirmed development pathway for JNP-0101, an oxybutynin intra-vaginal ring (IVR) for the treatment of overactive bladder in women;
Management team, Board of Directors, and Scientific Advisory Board (SAB) strengthened with several key additions;
Product revenue increased 63% and service revenue increased 32% versus 2015; and,
Balance sheet remains strong.

Juniper Pharmaceuticals, Inc. (PRNewsFoto/Juniper Pharmaceuticals, Inc.)
"This was an exceptionally strong quarter for Juniper, with advances in our pipeline of proprietary products supported by solid revenue growth from both our product and service businesses," stated Frank Condella, Chief Executive Officer. "We continue to deliver on our strategy of growing our core business revenues and advancing our product pipeline through clinical development to create long-term shareholder value.

"We look forward to reporting results of our Phase 2b trial of COL-1077 this summer. There are over seven million minimally-invasive gynecologic procedures performed annually in the U.S. alone, and currently available analgesics do not adequately address the pain and cramping experienced by these women. Assuming positive results of the current study, we expect to initiate a pivotal Phase 3 trial of COL-1077 in 2017.

"During the quarter we completed a collaborative pre-IND meeting with the FDA for our first IVR program, JNP-0101 for the treatment of overactive bladder in women. We believe our oxybutynin IVR holds great potential to effectively treat this common condition while improving systemic side effects and health outcomes with improved compliance. We look forward to filing our IND application later this year, and plan to initiate a Phase 2 bioavailability and dose finding study once the IND is active," Condella concluded.

First Quarter Financial Results
First quarter total revenues increased 45% to $12.1 million, compared with $8.3 million for the quarter ended March 31, 2015.

Product revenues were $7.9 million, an increase of $3.1 million, or 63%, versus the first quarter of last year, driven by continued in-market growth and new market sales of CRINONE (progesterone gel) by Merck KGaA, Darmstadt, Germany.

Service revenues from Juniper Pharma Services were $3.3 million, an increase of $0.8 million, or 32%, versus the first quarter of last year, as we experienced strong growth in customer volumes. Royalty revenues, based on Allergan’s sales of CRINONE, were $0.9 million, a 9% decrease versus the first quarter of last year.

Gross profit increased to $5.8 million as compared with $3.4 million in the prior year quarter.

Total operating expenses were $5.5 million in the first quarter of 2016, a $1.2 million increase as compared to the prior year quarter.

The $0.9 million increase in general and administrative costs as compared to the prior year quarter was primarily driven by creation of an internal business development function that was not in place in 2015, in addition to non-recurring legal and professional service costs.

The $0.4 million increase in R&D spending as compared to the prior year quarter was driven by costs associated with our ongoing Phase 2b clinical trial of COL-1077 and the advancement of our IVR pipeline product candidates: JNP-0101 (oxybutynin IVR), JNP-0201 (estrogen + progesterone IVR for symptoms of menopause), and JNP-0301 (progesterone IVR for the prevention of preterm birth).

Juniper recorded net income of $0.4 million, or $0.03 per diluted share, in the first quarter of 2016, compared to a net loss of $0.7 million, or ($0.06) per diluted share, in the same period of 2015.

Additional Business Highlights

Herman Weiss, MD, MBA, FACOG, was appointed Vice President, Medical Affairs and Clinical Development. He was previously Global Medical Director of Women’s Health and Bone Health at Teva Pharmaceutical Industries, Ltd.
Mary Ann Gray, Ph.D., joined Juniper’s Board of Directors as Audit Committee Chair. Dr. Gray’s 20+ years in the biotechnology and biopharmaceutical industry includes Wall Street, financial, and scientific experience.
Prominent physicians Linda Giudice, MD, PhD, and Marianne Mann, MD, joined Juniper’s Scientific Advisory Board.
Liquidity
Cash and cash equivalents were $13.5 million as of March 31, 2016, versus $13.9 million at December 31, 2015. The decrease in cash and cash equivalents was primarily the result of capital expenditures and the timing of certain payments related to revenues recorded in the current quarter.

Conference Call
As previously announced, Juniper’s management will hold a conference call to discuss financial results for the first quarter ended March 31, 2016, as follows:

Date:
Wednesday, May 4, 2016
Time:
8:30 a.m. EDT
Dial-in numbers:
Toll free: (866) 374-4635 (U.S.), (855) 669-9657 (Canada), or

International: (412) 902-4218
Webcast (live & archive):
www.juniperpharma.com, under ‘Investors’ or click here
The teleconference replay will be available at approximately one hour after completion through Thursday, May 12, 2016, at (877) 344-7529 (U.S.), (855) 669-9658 (Canada) or (412) 317-0088 (International). The conference ID for the replay is 10083822.

The archived webcast will be available for one year via the aforementioned URLs.

On May 04, 2016 ArQule, Inc. (Nasdaq:ARQL) reported its financial results for the first quarter of 2016 (Press release, ArQule, MAY 4, 2016, View Source [SID:1234511911]).

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For the quarter ended March 31, 2016, the Company reported a net loss of $4,981,000 or $0.08 per share, compared with a net loss of $4,551,000 or $0.07 per share, for the quarter ended March 31, 2015.

At March 31, 2016, the Company had a total of approximately $47,642,000 in cash, equivalents and marketable securities.

Key Highlights

ARQ 092, our proprietary AKT inhibitor in phase 1 for Proteus syndrome, has demonstrated AKT knockdown in the first three patients dosed: Our collaborators, the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH), have completed the safety, pharmacokinetics and biomarker evaluation of the first cohort of three patients in the phase 1 trial for ARQ 092 in Proteus syndrome. In all of these patients, ARQ 092 was well tolerated and successfully achieved the pre-specified decrease in AKT signaling. The NIH has opened enrollment to patients ages 12 to 18.
ARQ 092 phase 1b trial in oncology has completed enrollment: The final cohort of patients with AKT1/PI3K mutations has completed enrollment. In total, 10 patients with AKT1 mutations have been enrolled in the phase 1b portion of the trial. We anticipate presenting data from the study by year-end.
ARQ 087, our proprietary FGFR inhibitor in phase 2 portion of the trial for intrahepatic cholangiocarcinoma (iCCA), is expected to complete enrollment in the third quarter of 2016: ArQule recently received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) on orphan drug designation for ARQ 087 for biliary tract cancer. The phase 2 portion of the study continues as planned and preliminary data will be available this summer.
ARQ 761, our NQO1 inhibitor, in phase 1b/2 for pancreatic cancer completed enrollment of the first cohort: Our collaborators at the University of Texas Southwestern Medical Center have enrolled the first cohort of patients in combination with gemcitabine and abraxane.
ARQ 531, our proprietary BTK inhibitor, proceeds into Good Laboratory Practice (GLP) toxicology studies: Pre-clinical experiments, including toxicity studies, for ARQ 531 are proceeding as planned.
Tivantinib phase 3 trial in second-line hepatocellular carcinoma, METIV-HCC, completed its planned interim assessment and will continue to the final analysis: The independent data monitoring committee conducted the planned interim assessment and it was determined that the trial will continue to its final analysis. The biomarker-driven phase 3 trial is expected to be completed by year end. The METIV-HCC trial is randomized 2:1 against best supportive care and enrolled approximately 300 MET-high patients with the primary end-point of overall survival.
"We were particularly pleased to report progress with our proprietary pipeline this quarter, and we remain on track for additional data read-outs this year," said Paolo Pucci, Chief Executive Officer of ArQule. "The completion of enrollment for the oncology trial with ARQ 092 and the anticipated completion of the ARQ 087 trial in iCCA next quarter set us up nicely to achieve our 2016 goals. With the METIV-HCC interim analysis behind us, we look forward to concluding the trial by year-end."

"We are pleased to hear from our collaborators at the NIH that the data collected from the first cohort of patients provides compelling in vivo evidence of the effect of ARQ 092 in Proteus syndrome," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "The opportunity for ArQule to add rare diseases to its established oncology clinical development program is a significant step forward in our efforts in precision medicine."

Revenues and Expenses

Revenues for the quarter ended March 31, 2016, were $1,227,000 compared with revenues of $2,785,000 for the quarter ended March 31, 2015. Research and development revenue in 2016 and 2015 includes revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement. The revenue decreases in the quarter ended March 31, 2016 of $0.6 million from our Daiichi Sankyo METIV-HCC trial and $1.0 million from our Kyowa Hakko Kirin JET-HCC trial were due to the extension of the development period through December 31, 2016 for both programs.

Research and development expenses in the first quarter of 2016 were $4,198,000, compared with $4,413,000 for the first quarter of 2015. The $0.2 million decrease in research and development expense in the first quarter of 2016 was primarily due to lower facility costs of $0.3 million and lower labor related costs of $0.2 million from reduced headcount. These decreases were partially offset by increased outsourced clinical and product development costs of $0.3 million.

General and administrative costs were $2,044,000 in the first quarter of 2016 compared with $3,187,000 for the first quarter of 2015. General and administrative expense decreased by $1.2 million in the first quarter of 2016 primarily due to lower facility costs of $0.9 million and labor related cost of $0.2 million.

2016 Financial Guidance

For 2016, ArQule expects net use of cash to range between $23 and $25 million. Revenues are expected to range between $4 and $5 million. Net loss is expected to range between $24 and $27 million, and net loss per share to range between $(0.34) and $(0.39) for the year. ArQule expects to end 2016 with between $29 and $31 million in cash and marketable securities. Our guidance has been updated to include the issuance of 8,027,900 shares of common stock related to the stock offering completed during the quarter.