On May 5, 2016 Neurocrine Biosciences, Inc. (NASDAQ:NBIX) reported its financial results for the quarter ended March 31, 2016 (Press release, Neurocrine Biosciences, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165670 [SID:1234512030]). For the first quarter of 2016, the Company reported a net loss of $19.3 million, or $0.22 loss per share, compared to a net loss of $1.2 million, or $0.01 loss per share, for the same period in 2015.

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The Company’s balance sheet at March 31, 2016 reflected cash, cash equivalents, investments and receivables of $448.6 million compared to $464.3 million at December 31, 2015.

"2015 was a very successful year for Neurocrine and we have carried this momentum into the first quarter of 2016 beginning with positive top-line data from the second Phase III study of elagolix in endometriosis, the initiation of two Phase III studies of elagolix in uterine fibroids, the start of our Phase II T-Force GREEN study of valbenazine in children and adolescents with Tourette syndrome, as well as the acceptance of seven valbenazine abstracts at the American Academy of Neurology and American Psychiatric Association Annual Meetings" said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences. "Our focus for the coming months is to continue to execute across all aspects of our business; advancing compounds from research into the clinic, executing on clinical trials, filing the valbenazine NDA, and interacting with providers and payers as we prepare for the commercial launch of valbenazine for tardive dyskinesia upon FDA approval."

The $15.0 million of revenue for the first quarter of 2016 represents a milestone payment from AbbVie related to the commencement of Phase III studies of elagolix in uterine fibroids. The $19.8 million of revenue for the first quarter of 2015 represents recognized revenue in the form of license fees from the NBI-98854 (valbenazine) collaboration and license agreement with Mitsubishi Tanabe.

Research and development expenses increased to $23.9 million during the first quarter of 2016 from $16.6 million during the same period in 2015. This increase was primarily due to higher external clinical development expenses and associated internal costs related to the Company’s VMAT2 inhibitor, valbenazine, which is being evaluated in both tardive dyskinesia and Tourette syndrome. Additionally, expenses related to the Company’s preparation of the New Drug Application for valbenazine in tardive dyskinesia accounted for a portion of the increase in expenses quarter over quarter.

General and administrative expenses increased from $5.5 million in the first quarter of 2015 to $12.0 million for the first quarter of 2016, primarily due to pre-commercialization activities for valbenazine. Personnel related costs increased by $3.9 million quarter over quarter primarily due to the expansion of sales and marketing and medical affairs personnel. This increase in personnel related costs includes a $2.4 million increase in share-based compensation expense. Additionally, a significant increase in other pre-commercialization activities contributed to the overall growth in general and administrative expenses.

Pipeline Highlights

Valbenazine Update

During the fourth quarter of 2015, the Company announced positive efficacy results from the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder who underwent six weeks of placebo controlled assessment. Subsequent to the initial six weeks of treatment, subjects were eligible to continue in the Kinect 3 study for an additional 42 week open-label safety assessment. The open-label safety evaluation is anticipated to complete dosing in mid-2016.

In addition to the ongoing safety assessment of Kinect 3, during the first quarter of 2016 the Company completed enrollment in a separate one-year open-label safety study of valbenazine, Kinect 4, to support the anticipated 2016 filing of a New Drug Application of valbenazine in tardive dyskinesia.

The Company also recently initiated a valbenazine roll-over study for those patients who complete the one year of dosing in either the Kinect 3 or Kinect 4 studies. This roll-over study is designed to permit open-label access to valbenazine for up to an additional 72 weeks of treatment.

As announced previously, Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.

The Company is also exploring valbenazine in Tourette syndrome. The Company recently announced the initiation of two Phase II Tourette syndrome studies evaluating valbenazine in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively.

The T-Forward study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 adults. Subjects will receive once-daily dosing of valbenazine during an eight-week treatment period to assess the safety, tolerability and efficacy of valbenazine in adult Tourette patients. The primary endpoint of this study is a change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8.

The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group study of up to 90 children and adolescents. Subjects will receive once-daily dosing of valbenazine during a six-week treatment period to assess the safety, tolerability and efficacy of valbenazine in pediatric Tourette patients. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of Week 6.

Data from both of these Tourette studies is expected around year-end 2016.

The Company has submitted and had accepted seven valbenazine abstracts at two major medical conferences during the second quarter. Valbenazine data from all three Kinect clinical trials were presented at podium and plenary sessions at the American Academy of Neurology Annual Meeting in April. In addition, four valbenazine scientific abstracts were submitted and accepted for the American Psychiatric Association Annual Meeting in May.

Elagolix Update

During the first quarter of 2016, AbbVie announced positive top-line results from the second of two Phase III clinical trials, the Solstice Study, a multinational study designed to evaluate the efficacy and safety of elagolix in 815 premenopausal women with endometriosis. The top-line results from this trial were consistent with those of the initial Phase III clinical trial, the Violet Petal Study, where after six months of treatment, both doses of elagolix (150 mg once-daily and 200 mg twice-daily) met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea) associated with endometriosis at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale. The observed safety profile of elagolix in the Solstice study was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, and nausea. While most AEs were similar across treatment groups some, such as hot flush and bone mineral density loss, were dose-dependent. AbbVie is targeting a 2017 New Drug Application filing with the FDA for elagolix in endometriosis.

In early 2016, AbbVie announced the initiation of the Phase III uterine fibroids program consisting of two replicate randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with add-back therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies are expected to enroll approximately 400 subjects each for an initial six-month placebo-controlled dosing period. At the end of the six-months of placebo-controlled evaluation, subjects are eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing, and six months post-dosing.

Essential Tremor Program (NBI-640756) Update

NBI-640756 for patients with essential tremor was discovered in the Neurocrine laboratories. The Company has completed dosing in a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers. The study was conducted in multiple sequential cohorts of eight subjects per cohort. Data from this initial Phase I study is expected in the second quarter of 2016.

On May 5, 2016 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients through the biology of hypoxia-inducible factor (HIF), reported financial results for the first quarter ended March 31, 2016 (Press release, Akebia , MAY 5, 2016, View Source [SID:1234512062]). Akebia also provided an update on its Phase 3 INNO2VATE program for vadadustat in dialysis-dependent chronic kidney disease (DD-CKD), and reported data from an ethnobridging study for vadadustat.

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"We continue to execute our strategy designed to position vadadustat as a best-in-class treatment for renal anemia, define a clear path to registration and establish strong commercial support in key markets," said John P. Butler, President and Chief Executive Officer of Akebia. "With the recent European Patent Office decision, we have preserved our access to an important region and are well-positioned to pursue a European collaboration that would provide funding for the balance of our Phase 3 program."

Mr. Butler continued, "On the clinical front, we have now reached alignment with regulators regarding our global Phase 3 program. We are advancing our ongoing global Phase 3 PRO2TECT program in non-dialysis dependent patients (NDD-CKD), and look forward to initiating the INNO2VATE program in DD-CKD patients in the third quarter of 2016. We are also expanding our experience with HIF-PH inhibitors, and plan to begin a Phase 1 trial with our second clinical candidate, AKB-6899, this year."

INNO2VATE Program

Akebia announced today that it has reached alignment with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding key elements of the Phase 3 INNO2VATE program and expects to launch the program in the third quarter of 2016. The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 DD-CKD patients globally. The correction study will enroll approximately 400 patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The conversion study will enroll approximately 2,200 patients currently receiving rESA who will be converted to either vadadustat or the active control with the goal of maintaining their baseline hemoglobin levels. Both studies will include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety measured by major adverse cardiovascular events.

Ethnobridging Study Results

The company announced today that data from its recent ethnobridging study demonstrated that the pharmacokinetics of vadadustat in Japanese volunteers is similar to that in Caucasians at all doses studied. The double-blind study was designed to assess the pharmacokinetics and pharmacodynamics of vadadustat following the administration of multiple ascending doses (150 mg, 300 mg and 600 mg) once daily for 10 days in Japanese and Caucasian healthy volunteers. At all doses studied, the pharmacokinetics and pharmacodynamics of vadadustat in the Japanese population were similar to that observed in Caucasians.

"As we anticipated, these results demonstrate that ethnicity has no effect on the clearance of vadadustat, an important finding that further supports our global development and commercialization strategy in Japan and other Asian markets," stated Brad Maroni, Chief Medical Officer of Akebia. "Together with our partner in Asia, Mitsubishi Tanabe, we look forward to incorporating these results into our plans for vadadustat in the region."

First Quarter 2016 Corporate Highlights

Preserved access to the European market for vadadustat by prevailing in a patent dispute in which the European Patent Office confirmed that none of FibroGen, Inc.’s patent claims met the requirements for patentability and, as a result, revoked the patent in its entirety; and,
Raised approximately $61.0 million, net, in a public offering of approximately 7.3 million shares of common stock in January 2016.
Financial Results

Akebia reported a net loss of ($25.8) million, or ($0.70) per share, for the first quarter of 2016. Net loss for the first quarter of 2015 was ($10.7) million or ($0.53) per share.

Research and development expenses were $20.2 million for the first quarter of 2016 compared to $6.7 million for the first quarter of 2015. The increase is primarily attributable to costs related to the initiation of the PRO2TECT Phase 3 program. Research and development expenses were further increased by personnel-related costs due to additional headcount.

General and administrative expenses were $5.8 million for the first quarter of 2016 compared to $4.2 million for the first quarter of 2015. The increase is primarily due to the following expense increases: $0.8 million due to increased headcount and compensation related costs and $0.8 million in commercial planning costs as well as legal costs.

The Company’s cash provided by operations during the first quarter of 2016 was $17.4 million, an increase of $25.8 million from $8.3 million used in operations for the same period of 2015. The increase is primarily related to the upfront payment of $40.0 million received in January 2016 from Mitsubishi Tanabe in connection with our collaboration agreement. The Company ended the first quarter of 2016 with cash, cash equivalents and available for sale securities of $217.0 million and expects its cash resources to fund its current operating plan through at least the second quarter of 2017.

On May 5, 2016 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery and development of novel therapeutic candidates that engage the body’s ability to rebuild and repair its own cells and tissues, reported a corporate update and reported financial results for the first quarter ended March 31, 2016 (Press release, Acceleron Pharma, MAY 5, 2016, View Source [SID:1234511968]).

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"In the first quarter, we continued to build momentum across our entire clinical pipeline, including the start of patient recruitment into our Phase 3 trials of luspatercept in MDS and beta-thalassemia with our partner Celgene," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "Receipt of the $15 million luspatercept milestone payment and the $140.3 million in net proceeds from our equity follow-on offering in January secured our ability to accelerate the pace of development of our wholly owned programs. To that end, we made significant progress toward the planned Phase 2 trial initiation of ACE-083 in facioscapulohumeral muscular dystrophy in the second half of 2016 and advancing our preclinical work in the area of fibrosis as well as the generation of new product candidates with our IntelliTrap platform."

FIRST QUARTER 2016 HIGHLIGHTS

Development Programs

Hematology

Acceleron received a $15 million milestone payment from collaboration partner Celgene related to the initiation of the luspatercept Phase 3 clinical trials. Luspatercept is being studied in two Phase 3 clinical trials in patients with myelodysplastic syndromes (MDS) or beta-thalassemia, both rare hematologic diseases.
Enrollment is ongoing for both of the Celgene-partnered Phase 3 studies of luspatercept. The MEDALIST trial in MDS is evaluating the efficacy and safety of luspatercept versus placebo in patients with anemia due to very low, low, or intermediate-risk MDS with ring sideroblasts (≥ 15%) who require red blood cell transfusions. The BELIEVE trial in beta-thalassemia is evaluating the efficacy and safety of luspatercept versus placebo in adults who require regular red blood cell transfusions. Luspatercept increases hemoglobin levels and is being developed to help patients reduce or eliminate their need for red blood cell (RBC) transfusions. Luspatercept has been granted Fast Track Designation from the FDA in both indications.
Ongoing Phase 2 trials of luspatercept in MDS and beta-thalassemia continue to generate longer-term safety and efficacy data. The Company expects to report updated results for these trials at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2016.
Enrollment is underway in two additional Phase 2 patient cohorts evaluating luspatercept in low- or intermediate-risk MDS patients who are ring sideroblast negative or are eligible but have not yet received an erythropoietin-stimulating agent (ESA). Initial data from these additional MDS patient cohorts are expected by year-end.
Musculoskeletal Diseases

ACE-083 advancing toward the initiation of a Phase 2 trial in facioscapulohumeral muscular dystrophy (FSHD), a neuromuscular disorder, in the second half of 2016. ACE-083 is a locally acting agent designed to increase muscle mass and strength in the muscles in which it is administered.
We continue to make progress with ACE-2494 toward IND submission. ACE-2494, Acceleron’s first IntelliTrap molecule, is a systemic therapeutic designed to increase muscle mass and strength across a range of musculoskeletal diseases. Preclinical data in mice presented in 2015 showed that after 4 weeks of treatment, ACE-2494 generated substantial dose-dependent mean increases in muscle mass: 41% in rectus femoris, 53% in gastrocnemius, and 87% in pectoralis.
Oncology

Enrollment continues in Part 2 of the Phase 2 DART study, a randomized, double-blind study of dalantercept plus axitinib, compared to placebo plus axitinib in patients with advanced renal cell carcinoma. Dalantercept has been granted FDA Fast Track Designation for this indication.
Nephrology

Acceleron and Celgene assessing the opportunity for the development of sotatercept in the pre-dialysis chronic kidney disease (CKD) setting, and expect to provide an update in the second half of the year.
Corporate Updates

Raised $140.3 million of net proceeds in a follow-on public offering of common stock in January 2016 to advance wholly owned programs.
Financial Results

Cash position – Cash, cash equivalents and investments as of March 31, 2016 were $278.7 million. Net cash provided by operating activities in first quarter 2016 was $0.9 million. As of December 31, 2015 the Company had cash, cash equivalents and investments of $136.0 million. We believe that our existing cash, cash equivalents and investments, including the net proceeds of $140.3 million from our January 2016 common stock offering and the receipt of the $15.0 million Celgene milestone, will be sufficient to fund our projected operating requirements into the second half of 2019.
Revenue – Collaboration revenue for the first quarter was $18.2 million. License and milestone revenue was $15.1 million and includes the $15 million milestone payment received from Celgene related to luspatercept. Cost sharing reimbursement revenue from our Celgene partnership was $3.1 million and is related to expenses incurred by the Company in support of our partnered programs.
Costs and expenses – Total costs and expenses for the first quarter were $22.1 million. This includes R&D expenses of $16.2 million and G&A expenses of $5.9 million.
Other income, net – Other income for the first quarter was $9.0 million and includes an $8.7 million, non-cash, gain on marking our common stock warrant liability to market.
Net income – The Company posted a net income for the first quarter ended March 31, 2016 of $5.1 million.

On May 05, 2016 Geron Corporation (Nasdaq:GERN) reported financial results for the first quarter ended March 31, 2016 and recent events (Press release, Geron, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165745 [SID:1234512001]).

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First Quarter 2016 Results

For the first quarter of 2016, the company reported operating revenues of $749,000 and operating expenses of $9.8 million compared to $537,000 and $10.0 million, respectively, for the comparable 2015 period. Revenues for the first quarter of 2016 and 2015 included royalty and license fee revenues under various non-imetelstat agreements. Operating expenses in the first quarter of 2015 included restructuring charges of $406,000 in connection with the company’s organizational resizing announced in March 2015. Net loss for the first quarter of 2016 was $8.8 million, or $0.06 per share, compared to $9.3 million, or $0.06 per share, for the comparable 2015 period. The company ended the first quarter of 2016 with $141.9 million in cash and investments.

Research and development expenses for the first quarter of 2016 and 2015 were $5.0 million for each period. Research and development expenses for 2016 primarily reflect the net result of higher costs for the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen), partially offset by lower personnel related expenses as a result of the 2015 organizational resizing. The company expects research and development expenses to increase during the remainder of the year as the clinical development of imetelstat continues in collaboration with Janssen.

General and administrative expenses for the first quarter of 2016 were $4.8 million compared to $4.6 million for the comparable 2015 period. The increase in general and administrative expenses primarily reflects the net result of higher non-cash stock-based compensation expense, partially offset by lower personnel related costs due to the 2015 organizational resizing.

Interest and other income for the first quarter of 2016 was $256,000 compared to $149,000 for the comparable 2015 period. The increase in interest and other income in 2016 compared to 2015 primarily reflects higher yields on the company’s marketable securities portfolio.

Recent Company Events

Clinical Development by Janssen

In January 2016, the first patient was dosed in a Phase 2/3 clinical trial to evaluate imetelstat in patients with myelodysplastic syndromes (MDS). The trial, referred to as IMergeTM, will evaluate imetelstat in transfusion dependent patients with International Prognostic Scoring System (IPSS) Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA).

This is the second clinical study to be initiated under the terms of the exclusive worldwide imetelstat license and collaboration agreement between Geron and Janssen. Further information about the trial can be found at View Source

Presentations and Publications

Clinical data on imetelstat safety and efficacy from patients with a form of MDS known as refractory anemia with ring sideroblasts (MDS-RARS) enrolled as part of the Mayo Clinic Pilot Study were published online in the Blood Cancer Journal in March. The full text paper is available online at View Source

The data, previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2015, included nine patients enrolled in the study cohort, classified as having either IPSS intermediate-1 or intermediate-2 risk disease. Six of nine (66.7%) patients had prior treatment with ESAs. Three of the eight (37.5%) patients who were dependent on red blood cell transfusions at study entry became transfusion independent, defined as not requiring transfusions for at least eight weeks. The median duration of transfusion independence was 28 weeks (range: nine weeks to 37 weeks).

Two poster presentations by Janssen and academic collaborators describing non-clinical data on imetelstat were made at the 2016 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April:

Impact of hypomethylating agents on hTERT expression and synergistic effect in combination with imetelstat, a telomerase inhibitor, in AML cell lines (Abstract #2731)

Data presented described non-clinical results that treating acute myeloid leukemia (AML) cell lines with imetelstat enhanced the effects of agents currently used for the treatment of AML. These data extend the rationale from prior non-clinical studies for the potential use of imetelstat in hematologic myeloid malignancies, such as AML, including in combination with standard therapies.

Myelosuppression in patients treated with the telomerase inhibitor imetelstat is not mediated through activation of toll-like receptors (Abstract #2732)

Data presented described results from non-clinical studies that provide further evidence for potential on-target mechanisms of telomerase inhibition by imetelstat underlying the reduction in platelets observed in previously conducted imetelstat clinical trials.

On May 05, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel anti-cancer stem cell (CSC) and immuno-oncology therapeutics, reported first quarter financial results (Press release, OncoMed, MAY 5, 2016, View Source [SID:1234512033]). The company also highlighted data presentations related to six oncology drug candidates, including robust preclinical anti-tumor activity data presented at the AACR (Free AACR Whitepaper) Annual Meeting for its wholly owned GITRL-Fc candidate and upcoming presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting from clinical trials of vantictumab, ipafricept, demcizumab and tarextumab. As of March 31, 2016, cash, cash equivalents and short-term investments totaled $193.5 million.

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"Recent highlights include the presentation of new and compelling data at the AACR (Free AACR Whitepaper) Annual Meeting for our proprietary GITRL-Fc immuno-oncology therapeutic. We observed highly differentiated preclinical data including robust single-agent activity for GITRL-Fc compared to an alternate GITR agonist antibody strategy. We look forward to filing INDs on two distinct IO agents, GITRL-Fc and an undisclosed agent, termed ‘IO#2′, with the first of these IND filings by year-end." said Paul J. Hastings, Chairman and Chief Executive Officer. "Looking ahead, we have a steady stream of data presentations planned, starting with several at the ASCO (Free ASCO Whitepaper) Annual Meeting for ongoing clinical trials, including new data from two of our Phase 1b combination studies for Wnt inhibitors vantictumab and ipafricept, as well as updated Phase 1b survival data for demcizumab in NSCLC."

Corporate Update and Recent Highlights

Initiated a Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) plus anti-PD-1 (pembrolizumab) in solid tumor patients

Presented five posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
Preclinical data comparing efficacy and immune system activation of OncoMed’s wholly owned GITRL-Fc to GITR agonist antibodies and evaluating GITRL-Fc alone and in combination with anti-PDL1 and anti-PD1
Predictive biomarker assays for anti-RSPO3 (OMP-131R10) in solid tumors and vantictumab (anti-Fzd7, OMP-18R5) in pancreatic cancer
Preclinical data detailing anti-DLL4’s activity in non-small cell lung cancer, including immunomodulatory mechanism

Announced acceptance of several clinical abstracts for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting being held June 3-7, 2016 in Chicago, IL. Presentations include:
The first clinical data from Phase 1b trials of the company’s Wnt pathway inhibitors, vantictumab and ipafricept (FZD8-Fc, OMP-54F28), in combination therapy in breast cancer and ovarian cancer, respectively
Updated survival data from OncoMed’s Phase 1b clinical trials of demcizumab (OMP-21M18, anti-DLL4) in non-small cell lung cancer (NSCLC) and of tarextumab (anti-Notch2/3, OMP-59R5) in small cell lung cancer

First Quarter 2016 Financial Results
Cash, cash equivalents and short-term investments totaled $193.5 million as of March 31, 2016, compared to $157.3 million as of December 31, 2015. During the quarter, OncoMed received a $70 million payment from Celgene related to the demcizumab safety milestone achieved in the fourth quarter of 2015. This milestone was recorded as deferred revenue and will be amortized over the performance period.

Revenues for the first quarter 2016 totaled $6.4 million, as compared to $9.7 million in the first quarter of 2015. The decrease in revenue over the same period in 2015 was primarily due to achievement in 2015 of a $5.0 million milestone from GlaxoSmithKline related to brontictuzumab, partially offset by increased amortization of revenue from Celgene related to the demcizumab safety milestone.

Research and development (R&D) expenses for the first quarter 2016 were $28.4 million compared with $19.4 million for the same period in 2015. Higher R&D expenditures during the first quarter 2016 compared to the first quarter of 2015 were attributable to increased Phase 2 costs for the demcizumab and tarextumab programs as well as IND-enabling manufacturing and toxicology costs for the GITRL-Fc and IO#2 programs.

General and administrative (G&A) expenses for the quarter ended March 31, 2016 were $5.2 million, compared to $4.8 million for the same period in 2015. Increased costs during the first quarter 2016 were due to higher employee-related costs including stock-based compensation expenses.

Net loss for the first quarter 2016 was $27.2 million ($0.90 per share), compared to $14.5 million ($0.49 per share) for the same period of 2015. The change in net loss from the prior year quarter was due to an increase in operational expenses, primarily research and development costs, and lower collaboration revenues.

2016 Financial Guidance
OncoMed reiterated financial guidance for the full year 2016. Based on its current plans and expectations, OncoMed anticipates:

Cash expenses in the range of approximately $110-$120 million
2016 year-end cash balance of more than $100 million, without taking into account potential future milestones or payments from partners
Existing cash is anticipated to fund company operations through the first quarter of 2018, without taking into account potential future milestones or payments from partners

Potential milestone and opt-in payments from partners GSK, Bayer and Celgene over the course of 2016, 2017, and 2018 total over $270 million.