On May 2, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported new results from 19 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 3rd – 7th June in Chicago, United States (Press release, Hoffmann-La Roche , MAY 2, 2016, View Source [SID:1234511800]). More than 200 abstracts have been accepted across eight cancer types, including four "late breakers" and nearly 30 oral presentations.

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"The confluence of new medicines, sophisticated diagnostics and advanced technologies has created an unprecedented opportunity to improve outcomes for patients today and in the future," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. "At this year’s ASCO (Free ASCO Whitepaper) meeting, we look forward to presenting results from studies that have the potential to define new treatment approaches for cancers that have not seen significant progress in decades."

New trial results for atezolizumab include data from a study in which people received the medicine as an initial treatment for metastatic bladder cancer (first-line). These data will be highlighted as part of ASCO (Free ASCO Whitepaper)’s official press program. New overall survival and diagnostic results will be presented in recurrent metastatic bladder and lung cancer, and results from early combination studies of atezolizumab with targeted medicines and the investigational cancer immunotherapy MOXR0916, an OX40 agonist, will also be featured.

Roche will be presenting data from the J-ALEX trial, an open-label, randomised phase III study that compared Alecensa and crizotinib in people with ALK-positive advanced or recurrent NSCLC who had not previously received an ALK inhibitor and who had a maximum of one prior treatment with a chemotherapy.

Results for Roche’s haematology medicines include data from a study of MabThera/Rituxan in children with high risk B-cell non-Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL). Results from Phase I/II studies of Venclexta (venetoclax) in acute myeloid leukemia (AML), as well as the first data from a phase 1b study of Venclexta in B-cell NHL in combination with either MabThera/Rituxan and CHOP chemotherapy or Gazyva/Gazyvaro and CHOP chemotherapy, will also be presented. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

An analyst briefing to discuss key data presented on the Roche Group’s oncology products and pipeline at ASCO (Free ASCO Whitepaper) 2016 will take place on Sunday 5 June from 6:30 -8:00 pm CDT at the Marriott Downtown Chicago Magnificent Mile. This event, independently organized by Roche, is open to analysts and investors who have registered for the event. To register for the event, please follow the link (Password: Analyst2016)

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) 2016 Annual Meeting news and updates by using the hashtag #ASCO16.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2016

Medicine Abstract title Abstract number
Atezolizumab (investigational use) Atezolizumab (atezo) as first-line (1L) therapy in cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (mUC): Primary analysis of IMvigor210 cohort 1. Abstract LBA4500 (oral)
Sunday, 5 June
08:00-11:00 CDT

Updated efficacy and > 1-y follow up from IMvigor210: Atezolizumab (atezo) in platinum (plat) treated locally advanced/metastatic urothelial carcinoma (mUC). Abstract 4515 (oral)
Sunday, 5 June
08:00-11:00 CDT

Updated survival and biomarker analyses of a randomized phase II study of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR). Abstract 9028 (poster)
Saturday, 4th June
08:00-11:30 CDT

Correlation of peripheral and intratumoral T-cell receptor (TCR) clonality with clinical outcomes in patients with metastatic urothelial cancer (mUC) treated with atezolizumab. Abstract 3005 (oral)
Saturday, 4 June
13:15-16:15 CDT

A phase Ib dose escalation study of the OX40 agonist MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors. Abstract 101 (oral)
Saturday, 4 June
08:00-09:30 CDT

Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC). Abstract 3502 (oral)
Sunday, 5 June
08:00-11:00 CDT

Phase Ib trial of atezolizumab in combination with nab-paclitaxel in patients with metastatic triple negative breast cancer (mTNBC) Abstract 1009 (poster discussion)
Sunday, 5 June
16:45-18:00 CDT

Alecensa (alectinib) (investigational use) Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC): primary results from the J-ALEX study Abstract 9008 (oral)
Monday, 6 June
9:45-12:45 CDT

Avastin (bevacizumab) Overall survival of patients with HER2-negative metastatic breast cancer treated with a first-line paclitaxel with or without bevacizumab in real-life setting: Results of a multicenter national observational study Abstract 1013 (poster discussion)
Sunday, 5 June
16:45-18:00 CDT

ipatasertib (investigational use) Randomized phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study) Abstract 5017 (poster discussion)
Saturday, 4 June
13:00 – 16:30 CDT

MabThera / Rituxan (rituximab) (investigational use) Results of the randomized Intergroup trial Inter-B-NHL Ritux 2010 for children and adolescents with high risk B-cell non Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL): Evaluation of rituximab (R) efficacy in addition to standard LMB chemotherapy (CT) regimen Abstract 10507 (oral)
Friday, 3 June
15:00-18:00 CDT

Venclexta (venetoclax) (investigational use) Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ≥65 years ineligible for standard induction therapy Abstract 7009 (poster discussion)
Monday, 6 June
11:30-12:45 CDT

Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged ≥65 years with acute myelogenous leukemia Abstract 7007 (oral)
Saturday, 4 June
15:00-18:00 CDT

Phase 1b study of venetoclax plus R- or G-CHOP in patients with B-cell non-Hodgkin lymphoma Abstract 7566 (poster)
Monday, 6 June
8:00-11:30 CDT

About personalised cancer immunotherapy
The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab, PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent versus those who may benefit more from combination approaches; the purpose is to inform treatment strategies which will give the greatest number of patients a chance for transformative benefit. The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.
Personalised Cancer Immunotherapy is an essential component of how Roche delivers on the broader commitment to personalised healthcare.

On May 2, 2016 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that data on its engineered allogeneic CAR T-cell programs will be featured in three poster presentations at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 19th Annual Meeting (Filing, 6-K, Cellectis, MAY 2, 2016, View Source [SID:1234511835]).

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The meeting will be held from May 4 to May 7, 2016 in Washington, DC, USA.

Allogeneic CAR T-Cells Targeting CD123 Effectively Eliminate Myeloid Leukemia Cells

Presentation by Julianne Smith, Ph.D., Vice President CART Development at Cellectis
Poster Session: Cancer-Immunotherapy, Cancer Vaccines II
Session Time: Thursday, May 5, 2016, 5:45 PM
Room: Exhibit Hall C & B South
Final abstract number: 397

An Engineered CAR T-Cell Platform for Allogeneic Combination Immunotherapy

Presentation by Philippe Duchateau, Ph.D., Chief Scientific Officer of Cellectis
Poster Session: Cancer-Targeted Gene and Cell Therapy II
Session Time: Friday, May 6, 2016, 6:00 PM – 8:00 PM
Room: Exhibit Hall C & B South
Final abstract number: 676

Integration of Dual Signal Input Strategies in Novel Chimeric Antigen Receptors to Control the CAR T-Cell Functions

Presentation by Alexandre Juillerat, Ph.D., Senior Scientist at Cellectis
Poster Session: Cancer-Immunotherapy, Cancer Vaccines III
Session Time: Friday May 6, 2016 6:00 PM – 8:00 PM
Room: Exhibit Hall C & B South
Final abstract number: 651

Posters will be posted on Cellectis’ website on May 7, 2016.

On May 2, 2016 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported financial results for the first quarter ended March 31, 2016 and provided a review of pipeline and corporate highlights (Filing, Q1, Xencor, 2016, MAY 2, 2016, View Source [SID:1234511837]).

"During the quarter we initiated Phase 2 trials with XmAb5871 in both IgG4-Related Disease (IgG4-RD) and systemic lupus erythematosus (SLE), two diseases with high unmet need and a strong rationale for B-cell inhibition," said Bassil Dahiyat, Ph.D., President and Chief Executive Officer of Xencor. "We also continued to advance our broad pipeline of wholly-owned and partnered programs. We remain on track to report the full results from our Phase 1a trial of XmAb7195 in the coming months and to initiate four additional clinical trials in 2016, including human trials evaluating our initial bispecific oncology product candidates, XmAb14045 for acute myeloid leukemia and XmAb13676 for B-cell malignances."

Pipeline Highlights:

XmAb5871: A first-in-class monoclonal antibody that targets CD19 with its variable domain and that uses Xencor’s proprietary XmAb immune inhibitor Fc domain to target FcgRIIb, a receptor that inhibits B-cell function. In March 2016, Xencor initiated a Phase 2 clinical study for the treatment of IgG4-Related Disease (IgG4-RD) and a Phase 2 clinical study for the treatment of systemic lupus erythematosus (SLE).

· Initiation of Phase 1 trial with a subcutaneous formulation expected in 2016
· Initial data from IgG4-RD Phase 2 trial expected in 1H 2017
· Initial data from subcutaneous formulation Phase 1 trial expected in 2017
· Initial data from SLE Phase 2 trial expected in 2018

The primary objective of the Phase 2, open-label, pilot study of XmAb5871 in patients with IgG4-RD is to evaluate the effect of every other week intravenous (IV) administration of XmAb5871 on the IgG4-RD Responder Index in patients with active IgG4-RD. Secondary and exploratory objectives are to determine the safety and tolerability profile, to characterize the pharmacokinetics and pharmacodynamics and to characterize immunogenicity of every other week IV administration of XmAb5871 in patients with IgG4-RD. The trial will enroll approximately 15 subjects for up to 24 weeks of treatment.

The primary endpoint for the Phase 2 randomized, double-blind, placebo-controlled study of XmAb5871 in patients with SLE is maintenance of disease activity improvement achieved by a brief course of disease-suppressing IM steroid therapy. Secondary and exploratory endpoints are to evaluate the time to loss of SLE disease activity improvement, to determine the safety and tolerability profile, to characterize the pharmacokinetics and pharmacodynamics, and to characterize immunogenicity of every other week IV administration of XmAb5871 in patients with SLE. The trial will enroll approximately 90 subjects for up to 24 weeks of treatment.

XmAb7195: A first in class monoclonal antibody that targets IgE with its variable domain and uses Xencor’s XmAb immune inhibitor Fc domain to target FcgRIIb, resulting in three distinct mechanisms of action for reducing IgE levels. XmAb7195 is being developed for the treatment of severe asthma and allergic diseases.

· Full results from Phase 1a trial expected in 2Q 2016
· Initiation of Phase 1 trial with a subcutaneous formulation expected in 2016
· Initial data from subcutaneous formulation Phase 1 trial expected in 1H 2017

In 2015, Xencor announced interim data from Part 1 of this trial, which showed a rapid reduction of free IgE levels to below the limit of detection in 90% of treated subjects, including those treated at the lowest dose evaluated of 0.3 mg/kg, with parallel reductions in total IgE. A dose limiting toxicity of transient, asymptomatic thrombocytopenia was observed at the 3.0 mg/kg dose. Moderate urticaria was also reported in some treated subjects with an apparent correlation of dose with frequency of occurrence. The Phase 1 trial with a subcutaneous formulation in healthy volunteers will evaluate safety, tolerability and immunogenicity, and will measure IgE levels.

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.

· Initiate clinical trial for XmAb14045 in 2016
· Initiate clinical trial for XmAb13676 in 2016
· Initial data for XmAb14045 expected in 2017
· Begin clinical trials for additional bispecific oncology candidates in 2017

Xencor plans to initiate clinical trials for its first two bispecific oncology candidates, XmAb14045, for the treatment of acute myeloid leukemia (AML), and XmAb13676, for the treatment of B-cell malignancies, in 2016. Xencor has multiple additional bispecific oncology candidates, both tumor targeting bispecifics and dual T-cell checkpoint inhibitor bispecifics in pre-clinical development.

Partnered XmAb Programs: Xencor’s partners currently have seven programs in clinical testing that were either discovered at Xencor or that rely on Xencor’s proprietary XmAb technology.

In January 2016, Xencor announced that the National Institutes of Health (NIH) initiated a Phase 1 clinical trial of VRC01LS, a therapeutic antibody for the treatment of HIV that uses Xencor’s Xtend antibody half-life extension technology.

MorphoSys announced that in 2017 it plans to begin a Phase 3 clinical trial of XmAb5574/MOR208 in diffuse large B-cell lymphoma (DLBCL).

First Quarter Ended March 31, 2016 Financial Results

Cash, cash equivalents and marketable securities totaled $178.7 million as of March 31, 2016, compared to $193.3 million on December 31, 2015. The decrease reflects net spending on operations in the first quarter of 2016.

Revenues for the first quarter ended March 31, 2016 were $7.3 million, compared to $1.5 million in the same period of 2015. Increased revenue for the first quarter of 2016 over revenue for the same period in 2015 is primarily the result of revenue recognized under our 2015 Amgen collaboration.

Research and development expenditures for the first quarter ended March 31, 2016 were $10.0 million, compared to $5.2 million for the same period in 2015. Increased research and development spending in the first quarter of 2016 over the same period in 2015 reflects additional spending on our XmAb5871 clinical programs and our initial bispecific development candidates, XmAb14045 and XmAb13676.

General and administrative expenses in the first quarter ended March 31, 2016 were $4.0 million compared to $2.8 million for the same period in 2015. Increased spending on general and administration in the first quarter of 2016 over the comparable period in 2015 reflects additional spending on professional fees including legal fees.

Non-cash, share based compensation expense for the first quarter ended March 31, 2016 was $2.0 million, compared to $1.1 million for same period in 2015.

Net loss for the first quarter ended March 31, 2016 was $6.40 million, or $(0.16) on a fully diluted per share basis, compared to a net loss of $6.44 million, or $(0.19) on a fully diluted per share basis, for the same period in 2015. Increased revenue in the first quarter of 2016 over the same period of 2015 was offset by increased expenditures of a similar amount such that the net loss for both periods is comparable. The lower loss per share amount in the first quarter of 2016 over the amount reported in the first quarter 2015 reflects the additional shares outstanding at the end of the first quarter of 2016.

The weighted-average shares outstanding used to compute loss per share was 40,626,729 for the quarter ended March 31, 2016, compared to 34,297,782 for the quarter ended March 31, 2015.

Financial Guidance

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

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On May 2, 2016 Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, reported its first quarter 2016 financial results and accomplishments (Press release, Sangamo BioSciences, MAY 2, 2016, View Source [SID:1234511807]).

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Sangamo BioSciences, Inc. (PRNewsFoto/Sangamo BioSciences, Inc.)
"During the first quarter of 2016 we focused on activities to enable initiation of the first clinical trials of our IVPRP approach in hemophilia B and MPS I, and I am pleased to report that we will meet our stated timelines for the opening of both trials," said Edward Lanphier, Sangamo’s president and chief executive officer. "We look forward to generating and presenting clinical data that support the application of this highly leverageable platform while continuing to progress our programs in hemophilia A and several lysosomal storage disorders toward clinical development."

Recent Highlights

Presentation of new data from Sangamo’s proprietary In Vivo Protein Replacement Platform (IVPRP) programs for MPS I and MPS II at the 12TH Annual WORLDSymposium Meeting. Sangamo scientists and academic collaborators from the University of Minnesota presented new preclinical data in disease models of the Company’s IVPRP-based MPS I (Hurler syndrome) and MPS II (Hunter syndrome) programs at the 2016 WORLDSymposium Annual Meeting. In animal models of disease, the data demonstrated the production of stable, therapeutic levels of replacement enzyme from the liver into the circulation and secondary tissues, including the brain, resulting in significant reduction in biomarkers of the disease, and notably, statistically significant improvements in cognitive function in treated animals.
Publication in the New England Journal of Medicine (NEJM) highlighting Sangamo’s IVPRP approach for hemophilia B. In March, NEJM published a review authored by Dr. Amit Nathwani, a key opinion leader in the field of gene therapy approaches to hemophilia, highlighting Sangamo’s IVPRP-based SB-FIX program for the one-time, permanent treatment of hemophilia B. The article details the significant advantages of Sangamo’s ZFN-mediated, targeted integration of the Factor IX (FIX) gene at the albumin locus over conventional non-integrating gene therapy approaches that use adeno-associated virus (AAV) to deliver the FIX gene and other therapeutic genes to liver cells.
Sangamo augments clinical expertise with the appointment of Matthew Spear, M.D. as Vice President and Head of Clinical Development. Dr. Spear joins Sangamo with more than 20 years of experience in all stages of biopharmaceutical research and development and has led the development of over 15 therapeutic products. Most recently, Dr. Spear served as a Vice President in Clinical Development at Incyte Corp.
Presentation of immunological data from Sangamo’s SB-728-T Phase 2 clinical program in HIV/AIDS at the 2016 Annual Conference on Retroviral and Opportunistic Infections (CROI 2016). Sangamo’s collaborators from Case Western Reserve University presented analyses of immunological data from the Company’s clinical trials of SB-728-T, a ZFP Therapeutic designed to provide functional control of HIV/AIDS. The presentation outlined potentially interrelated mechanisms for viral load (VL) control in SB-728-T-treated subjects during a treatment interruption (TI) from their antiretroviral therapy. This suggests a model mechanism of action for SB-728-T and enables identification of patients who will most benefit from Sangamo’s ZFN-mediated CCR5 knock-out approach.
Upcoming Events in 2016

Initiation of IVPRP-based Phase 1/2 clinical trials SB-FIX-1501 (hemophilia B) and SB-318-1502 (MPS I / Hurler syndrome) by the end of the second quarter and mid-2016, respectively.
Presentation of data from several ZFP Therapeutic programs by Sangamo scientists and collaborators at the upcoming 19TH Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), which will be held in Washington D.C. from May 4-7, 2016.
Submission of investigational new drug (IND) applications in the first half of 2016 for Sangamo’s IVPRP-based SB-913 program for MPS II (Hunter syndrome), and beta-thalassemia program in collaboration with Biogen Inc. (Biogen).
Presentation of new clinical data from Cohort 3* of Sangamo’s SB-728-1101 Phase 1/2 trial in T-cells for the functional control of HIV/AIDS in the second half of 2016.
First Quarter 2016 Results
For the first quarter ended March 31, 2016, Sangamo reported a consolidated net loss of $16.5 million, or $0.23 per share, compared to a net loss of $5.3 million, or $0.08 per share, for the same period in 2015. As of March 31, 2016, the Company had cash, cash equivalents, marketable securities and interest receivable of $189.0 million.

Revenues for the first quarter of 2016 were $3.9 million, compared to $13.5 million for the same period in 2015. First quarter 2016 revenues were generated from the Company’s collaboration agreements with Biogen and Shire International GmbH (Shire), enabling technology agreements and research grants. The revenues recognized for the first quarter of 2016 consisted of $3.7 million from collaboration agreements and $0.2 million from research grants, compared to $12.7 million and $0.8 million, respectively, for the same period in 2015.

The decrease in collaboration agreement revenues was primarily a result of an amendment to the Company’s collaboration and license agreement with Shire in the third quarter of 2015, which returned the rights to the hemophilia programs to Sangamo, and a decrease in revenue under the Company’s collaboration agreement with Sigma.

In the first quarter of 2016, Sangamo recognized $2.0 million of revenues related to research services performed under the collaboration agreement with Biogen, and $0.4 million of revenues related to research services performed under the collaboration agreement with Shire. In addition, Sangamo received upfront payments of $13.0 million and $20.0 million pursuant to the agreements entered into with Shire in 2012 and Biogen in 2014, respectively. The Shire payment is being recognized as revenue on a straight-line basis over the initial six-year research term. Beginning in January 2016, the Biogen payment will be recognized over approximately 42 months which reflects the revised service period related to Sangamo’s deliverables under the Biogen agreement. The Company recognized $0.5 million of the Shire upfront payment and $0.6 million of the Biogen upfront payment as revenue for the first quarter of 2016.

Research and development expenses were $15.3 million for the first quarter of 2016, compared to $15.0 million for the same period in 2015. Research and development expenses were primarily comprised of manufacturing expenses, research expenses associated with Sangamo’s clinical and preclinical programs, and personnel-related expenses, including stock-based compensation.

General and administrative expenses were $5.4 million for the first quarter of 2016, compared to $4.7 million for the same period in 2015.

Total operating expenses for the first quarter of 2016 were $20.6 million, compared to $19.7 million for the same period in 2015.

Financial Guidance for 2016
The Company reiterates its earlier guidance as follows:

Cash and Investments: Sangamo expects that its cash, cash equivalents and marketable securities will be at least $150 million at the end of 2016, inclusive of research funding from existing collaborators but exclusive of funds arising from any additional new collaborations or partnerships, equity financings or other new sources.
Revenues: Sangamo expects that revenues will be in the range of $20 million to $25 million in 2016, inclusive of research funding from existing collaborations.
Operating Expenses: Sangamo expects that operating expenses will be in the range of $85 million to $95 million for 2016

On May 02, 2016 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) provided updates on EXPAREL (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the first quarter ended March 31, 2016 (Press release, Pacira Pharmaceuticals, MAY 2, 2016, View Source;p=RssLanding&cat=news&id=2163649 [SID:1234511733]).

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"With immense leverage across our organization from manufacturing to financials, we began our aggressive investment in the future growth of Pacira in the first quarter of 2016," said Dave Stack, Chief Executive Officer and Chairman. "In this short amount of time, we were able to enhance our executive team with two important hires, initiate two Phase 3 studies for the EXPAREL nerve block indication and initiate a randomized controlled trial in total knee arthroplasty to establish best practice for best outcomes with EXPAREL. As we prepare for our oral surgery launch later this year, we look forward to further investments in the expanded use of EXPAREL and development of pipeline opportunities."

Recent Highlights

Key Executive Appointments to Support Company’s Future Growth: Pacira recently announced the appointment of two key executives to the Pacira management team. As Chief Financial Officer, Charles A. Reinhart III will be responsible for all financial and capital market activities, including accounting, financial reporting, financial planning and analysis and investor relations. He will succeed former Chief Financial Officer Jim Scibetta, who will continue to serve as President, and will report to Dave Stack. As Chief Commercial Officer, Robert Weiland will oversee commercial activities for EXPAREL, which include marketing, sales, national accounts, training and commercial operations and analytics. He will report to Jim Scibetta.

Initiation of Important Clinical Studies for EXPAREL: Pacira initiated two Phase 3 clinical trials that will serve as the basis of the supplemental New Drug Application (sNDA) to be filed for EXPAREL use in nerve block to provide postsurgical analgesia. One study will assess brachial plexus block with EXPAREL in patients undergoing total shoulder arthroplasty or rotator cuff repair. The second study will evaluate femoral nerve block with EXPAREL for patients undergoing total knee arthroplasty. Pacira also initiated a randomized controlled trial comparing local infiltration analgesia with EXPAREL to local infiltration analgesia without EXPAREL in total knee arthroplasty. This study is intended to provide a procedure-specific protocol on appropriate technique and administration for producing optimal outcomes with EXPAREL.

First Quarter 2016 Financial Results

EXPAREL net product revenues were $63.8 million in the first quarter of 2016, compared to $56.0 million in the first quarter of 2015.

Total revenues were $65.5 million in the first quarter of 2016, compared to $58.3 million in the first quarter of 2015.

Total operating expenses were $67.7 million in the first quarter of 2016, compared to $55.0 million in the first quarter of 2015.

GAAP net loss was $3.9 million, or $(0.10) per share (basic and diluted), in the first quarter of 2016, compared to GAAP net income of $1.3 million, or $0.03 per share (basic and diluted), in the first quarter of 2015.

Non-GAAP net income was $5.7 million, or $0.15 per share (basic) and $0.14 per share (diluted), in the first quarter of 2016, compared to non-GAAP net income of $9.8 million, or $0.27 per share (basic) and $0.23 per share (diluted), in the first quarter of 2015.

Pacira ended the first quarter of 2016 with cash and cash equivalents, short-term investments and long-term investments ("cash") of $163.5 million.

Pacira had 37.0 million basic and 41.1 million diluted weighted average shares of common stock outstanding in the first quarter of 2016.

2016 Outlook

Pacira affirms that it expects the following operating expenses for 2016:

Non-GAAP research and development (R&D) expense of $60 million to $70 million.

Non-GAAP selling, general and administrative (SG&A) expense of $125 million to $135 million.

Stock-based compensation expense of $35 million to $40 million.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Monday, May 2, 2016, at 9 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 54803652.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 54803652. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), non-GAAP net income, because such measures exclude stock-based compensation and amortization of debt discount. These measures supplement our financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future R&D, SG&A and stock-based compensation outlook for 2016 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP net income measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See a reconciliation of non-GAAP net income to GAAP net income (loss) below.