On May 10, 2017 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported financial results for the first quarter ended March 31, 2017 and provided an overview of certain corporate developments (Press release, Verastem, MAY 10, 2017, View Source;p=RssLanding&cat=news&id=2272006 [SID1234519086]).

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"Following the presentation of positive data from the DYNAMO study of duvelisib in indolent non-Hodgkins Lymphoma (iNHL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December 2016, we are focused on executing against the important milestones that lie ahead, beginning with reporting top-line duvelisib data from the Phase 3 DUO study in chronic lymphocytic leukemia (CLL), which is expected mid-year 2017," said Robert Forrester, President and Chief Executive Officer of Verastem. "We continue to believe duvelisib has significant potential as a convenient, oral monotherapy for patients with relapsed CLL and possibly other lymphomas, where there remains an unmet medical need."

Mr. Forrester continued, "For defactinib, the program continues to advance across three ongoing clinical collaborations evaluating focal adhesion kinase (FAK) inhibition in combination with immuno-oncology agents."
First Quarter 2017 and Recent Highlights:

Duvelisib
Long Term Follow Up Data from the DYNAMO Study Selected for Oral Presentation at the 14th International Conference on Malignant Lymphoma (ICML) – In early May, Verastem announced that an abstract highlighting long term follow up data from the ongoing Phase 2 DYNAMO study was selected for oral presentation at ICML 2017 in Lugano, Switzerland. The presentation, titled "DYNAMO: A Phase 2 Study Demonstrating the Clinical Activity of Duvelisib in Patients with Double-Refractory Indolent Non-Hodgkin Lymphoma," will be presented by Pier Luigi Zinzani, M.D., Ph.D., of the University of Bologna Institute of Hematology, on Thursday, June 15, 2017 at 15:40 CET in Room A, Cinema Corso and Aula Magna (Lugano University).

Ongoing Phase 3 DUO Study in Relapsed or Refractory CLL – The efficacy and safety of duvelisib is currently being evaluated in the randomized Phase 3 DUO study in patients with relapsed or refractory CLL. In the DUO study, approximately 300 patients were randomized 1:1 to receive duvelisib (25mg BID) or ofatumumab (8 weekly infusions, starting with an initial intravenous dose of 300mg on day 1 followed by 7 weekly doses of 2,000mg, then 2,000mg monthly for 4 cycles). The trial was fully enrolled in November 2015. The primary endpoint of this study is progression free survival (PFS). Key secondary endpoints include overall response rate (ORR), overall survival, duration of response (DOR) and safety. Verastem expects to report top-line data from the DUO study in mid-year 2017.

Published Scientific Research Demonstrating the Potential of Duvelisib in Combination with Venetoclax – A recent publication1 in Leukemia by Patel and colleagues provides scientific rationale for the combination of duvelisib with the BCL2 inhibitor venetoclax for the treatment of CLL. Using samples from duvelisib-treated CLL patients, this group at the University of Texas MD Anderson Cancer Center found that duvelisib-treatment increased expression of several pro-apoptotic proteins such that the CLL cells were poised for apoptosis. They went on to show that CLL cells from patients after duvelisib treatment were killed more effectively by venetoclax than CLL cells taken from the same patients before duvelisib treatment.

Defactinib (VS-6063)
Presented Defactinib Data at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting – In an oral presentation titled, "Reprogramming the tumor microenvironment to improve responses to therapy," Verastem scientific collaborator David G. DeNardo, Ph.D., Assistant Professor of Medicine, Division of Oncology, Department of Immunology, Washington University School of Medicine in St. Louis, described data demonstrating that FAK inhibition can enable efficacy of PD-1 inhibition in preclinical models of pancreatic cancer that, like the clinical disease, are otherwise refractory to checkpoint inhibition. Verastem’s FAK inhibitor, defactinib, is currently being evaluated in combination with Merck’s PD-1 inhibitor, pembrolizumab, and gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC). Initial analysis of immune biomarkers from matched pairs of metastatic biopsies, taken either pre- or post-treatment, from patients with PDAC showed an increase in activated proliferating cytotoxic T-cells together with a reduction in tumor-associated macrophages (TAMs).

Dosed the First Patient in Combination Trial of Defactinib and Avelumab in Patients with Ovarian Cancer – As announced in January 2017, the first patient was dosed in a new clinical trial evaluating avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with defactinib in patients with advanced ovarian cancer. This multicenter, open-label, dose-escalation and dose-expansion Phase 1/2 clinical trial is designed to assess the safety, pharmacokinetics, pharmacodynamics, and initial observations of clinical activity of the avelumab/defactinib combination in patients with recurrent or refractory stage III-IV ovarian cancer. The study is being conducted in collaboration with the alliance between Merck KGaA, Darmstadt, Germany, which in the U.S. and Canada operates as EMD Serono, and Pfizer, and is expected to enroll approximately 100 patients at up to 15 sites across the U.S.
Updated Data from the Window of Opportunity Study in Mesothelioma Selected for Poster Presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting – An abstract highlighting updated data from the ongoing Phase 2 Window of Opportunity study was selected for a poster presentation at ASCO (Free ASCO Whitepaper) 2017 in Chicago. The presentation, titled "Effect of FAK inhibitor defactinib on tumor immune changes and tumor reductions in a phase II window of opportunity study in malignant pleural mesothelioma (MPM)," will be presented by Raphael Bueno, M.D., of the Brigham and Women’s Hospital and Harvard Medical School, on Saturday, June 3, 2017 from 8:00-11:30am CT in Hall A at McCormick Place.

Corporate and Financial
Eric K. Rowinsky Appointed to the Board of Directors – Verastem announced the appointment of Eric K. Rowinsky, M.D., to its Board of Directors. Dr. Rowinsky brings to Verastem nearly 30 years of experience in the development of cancer treatments, such as cetuximab (Erbitux) when he was Chief Medical Officer of ImClone Systems, as well as Cyramza, Portrazza, Taxol, Taxotere, Hycamtin, Tarceva, Camptosar, Tykerb, and cixutumumab, among others. Dr. Rowinsky is a member of the board of directors of Biogen, Navidea, and Fortress Biotech, all public life sciences companies, and has served on the board of directors of BIND Therapeutics, a life-science company acquired by Pfizer. Dr. Rowinsky is replacing Paul A. Friedman, M.D. who is transitioning from his role as Director to become a member of Verastem’s Clinical and Scientific Advisory Board.

Hagop Youssoufian, MSc, M.D., Named Head of Hematology and Oncology Development – In January 2017, Dr. Youssoufian assumed this leadership role at Verastem to oversee the clinical and regulatory development of Verastem’s pipeline, including duvelisib, and provide overall strategic and tactical leadership to its hematology-oncology clinical programs. Dr. Youssoufian brings over 25 years of product development and commercialization experience to Verastem, having served as Chief Medical Officer at BIND Therapeutics, Ziopharm Oncology and Imclone Systems, and other senior roles at Progenics, Sanofi Aventis and Bristol-Myers Squibb where he was involved in the development of Sprycel, Taxotere Erbitux, Cyramza, Portrazza and Lartruvo.

Additional Key Personnel Appointments – Michael Ferraresso joined Verastem as Vice President, Commercial Operations, and Verastem also appointed several highly experienced individuals to its Clinical and Scientific Advisory Board, including Lori Kunkel, M.D., former Chief Medical Officer at Pharmacyclics, Edmund J. Pezalla, M.D., MPH, Former Vice President, Pharmaceutical Policy and Strategy at Aetna, Greg Berk, M.D., former Chief Medical Officer at Verastem, Inc., Cheryl Cohen, former Chief Commercial Officer at Medivation, Inc., and Brian Stuglik, R.Ph, former Vice President and Chief Marketing Officer, Oncology Global Marketing at Eli Lilly.

Secured $25 Million Loan Facility – In March 2017, Verastem entered into a Loan and Security Agreement with Hercules Capital, Inc. for up to $25.0 million in financing. Verastem received the first $2.5 million of financing under the Loan and Security Agreement when the transaction closed. The proceeds will be used for Verastem’s ongoing research and development programs and for general corporate purposes. Additional tranches of up to $22.5 million in aggregate will be available subject to certain conditions, including positive data from the Phase 3 DUO clinical trial evaluating duvelisib in patients with relapsed or refractory CLL.

First Quarter 2017 Financial Results
Net loss for the three months ended March 31, 2017 (2017 Quarter) was $13.0 million, or $0.35 per share, as compared to a net loss of $8.3 million, or $0.22 per share, for the three months ended March 31, 2016 (2016 Quarter). Net loss includes non-cash stock-based compensation expense of $1.2 million and $1.6 million for the 2017 Quarter and 2016 Quarter, respectively.

Research and development expense for the 2017 Quarter was $8.4 million compared to $4.2 million for the 2016 Quarter. The $4.2 million increase from the 2016 Quarter to the 2017 Quarter was primarily related to an increase of $2.8 million in contract research organization expense for outsourced biology, chemistry, development and clinical services, which includes clinical trial costs, an increase in personnel related costs of approximately $965,000, and an increase of approximately $554,000 in consulting fees. These increases were offset by a decrease in stock-based compensation and other expenses of approximately $86,000.

General and administrative expense for the 2017 Quarter was $4.8 million compared to $4.3 million for the 2016 Quarter. The increase of approximately $508,000 from the 2016 Quarter to the 2017 Quarter primarily resulted from an increase in consulting and professional fees of approximately $922,000, partially offset by a decrease in stock-based compensation expense of approximately $397,000.

As of March 31, 2017, Verastem had cash, cash equivalents and investments of $72.6 million compared to $80.9 million as of December 31, 2016. Verastem used $10.7 million for operating activities during the 2017 Quarter.
The number of outstanding common shares as of March 31, 2017, was 36,992,418.

Financial Guidance
Based on our current operating plans, we expect to have sufficient cash, cash equivalents and investments to fund our research and development programs and operations into 2018.

About the Tumor Microenvironment
The tumor microenvironment encompasses various cellular populations and extracellular matrices within the tumor or cancer niche that support cancer cell survival. This includes immunosuppressive cell populations such as regulatory T-cells, myeloid-derived suppressor cells, M2 tumor-associated macrophages, as well as tumor-associated fibroblasts and extracellular matrix proteins, which can hamper the entry and therapeutic benefit of cytotoxic immune cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s product candidates, including duvelisib and defactinib, also target the tumor microenvironment as a mechanism of action to potentially improve a patient’s response to therapy.

About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.2,3,4 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory CLL5, and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory iNHL that achieved its primary endpoint of ORR upon top-line analysis of efficacy data6. Duvelisib is also being evaluated for the treatment of hematologic malignancies through investigator-sponsored studies, including T-cell lymphoma.7 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib
Defactinib is an investigational inhibitor of FAK, a non-receptor tyrosine kinase encoded by the PTK-2 gene that mediates oncogenic signaling in response to cellular adhesion and growth factors.8 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment, enhancement of anti-tumor immunity, and reduction of cancer stem cells.9,10 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer, and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.11,12,13 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.

On May 10, 2017 Magenta Therapeutics, a biotechnology company developing therapies to improve and expand the use of curative blood stem cell transplantation for more patients, reported the presentation of new clinical data on its lead expansion program, MGTA-456, at the American Society of Gene and Cell Therapy (ASCGT) Annual Meeting in Washington, D.C (Press release, Magenta Therapeutics, MAY 10, 2017, View Source [SID1234520732]).

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The presentation by John E. Wagner, M.D., executive medical director of the Bone Marrow Transplantation Program at the University of Minnesota, highlights results from three clinical trials involving a total of 36 patients, which evaluated the use of MGTA-456 to expand the number of umbilical cord blood stem cells in a variety of transplant settings, including single cord transplant in older patients undergoing non-myeloablative conditioning.

The presentation, Hematopoetic Stem Cell Expansion with Stem Regenin-1, will begin at 8:35 am in the Thurgood Marshall East room at the Marriott Wardman Park Hotel. The abstract is available online at: View Source!/4399/presentation/927

About MGTA-456

MGTA-456 (formerly HSC835), aims to expand the number of cord blood stem cells used in transplants to achieve superior clinical outcomes compared to standard transplant procedures, and to enable more patients to benefit from a transplant. Early results published in Science1 demonstrated the ability of MGTA-456 to significantly increase the number of umbilical cord blood stem cells. Clinical results reported in Cell Stem Cell2 demonstrated that this approach yielded an increased expansion of stem cells. Magenta is developing MGTA-456 in multiple diseases, including immune and blood diseases.

XBiotech has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, XBiotech, 2017, MAY 10, 2017, View Source [SID1234521568]).

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On May 10, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported an update on the ADAPT trial, a randomized, active controlled, open-label, multi-center Phase 3 trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC), following a meeting with the FDA (Press release, Argos Therapeutics, MAY 10, 2017, View Source [SID1234518972]).

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As previously reported, the Company has continued to conduct the ADAPT trial notwithstanding the recommendation by the Independent Data Monitoring Committee in February 2017 to terminate the trial for futility. In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC’s assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC’s February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive.

The Company submitted information related to its analysis of the interim data to the FDA and met with the FDA to discuss the future direction of the ADAPT trial and the Rocapuldencel-T development program. Participating in the meeting along with representatives from the Company were Robert Figlin, MD, Chairman of Hematology Oncology and Professor of Medicine, Cedars Sinai Medical Center; Nizar Tannir, MD, Professor and Deputy Chairman, Department of Genitourinary Medical Oncology, MD Anderson Cancer Center; and Gary Koch, PhD, Professor of Biostatistics, University of North Carolina.

The FDA agreed with the Company’s plan to continue the trial in accordance with the current protocol to 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. The Company believes that 290 events will have occurred by late 2017 or early 2018. The Company also proposed to submit, and the FDA agreed to review, a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival beyond 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect. The Company can extend the study past 290 events without needing to enroll additional patients.

As previously reported, the Company has analyzed interim data from a predefined subset of patients who demonstrated an immune response to Rocapuldencel-T at 48 weeks, whose immune response is consistent with the mechanism of action of the therapy and correlates with survival, suggesting that the treatment is biologically active. Analysis of the data from the ADAPT trial, including immune response data, remains ongoing. The Company expects to provide further updates on the future direction of the ADAPT trial and the Rocapuldencel-T program following further analysis of the data from the trial and further discussions with the FDA.

"We are pleased to be able to continue the ADAPT trial," noted Robert Figlin, MD, principal investigator for the trial. "We believe that Rocapuldencel-T may offer patients and their physicians an important new option for the treatment of mRCC, a disease that remains an area of high unmet medical need. By amending the protocol to extend the ADAPT trial, we believe we can potentially increase the likelihood of detecting a treatment effect, if one exists, given that immunotherapy is expected to result in a delayed treatment effect. We appreciate the collaborative efforts of the FDA as we seek to determine the potential utility of Rocapuldencel-T in the treatment of this difficult disease."

"We remain committed to the clinical development of Rocapuldencel-T, and look forward to providing additional updates on the ADAPT trial and the Rocapuldencel-T development program moving forward," noted Jeff Abbey, CEO of Argos. "We appreciate the continued commitment of the investigators and patients in the ADAPT trial as we continue to explore the potential benefit of this unique therapy."

About the Arcelis Technology Platform

Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

On May 10, 2017 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, reported financial results for the first quarter ended March 31, 2017 (Press release, BioTime, MAY 10, 2017, View Source;p=RssLanding&cat=news&id=2271990 [SID1234519038]).

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"At BioTime we are continuing to make meaningful clinical progress with our core development programs in Ophthalmology, Aesthetics and Therapeutics Delivery. We are generating an increasing amount of positive human data from our clinical trials that provide a solid foundation for our optimism," said Adi Mohanty, Co-Chief Executive Officer. "We are excited to be announcing top line safety and efficacy data next month from our Renevia pivotal trial in Europe. This week, we are presenting encouraging ophthalmic clinical trial data at ARVO from the OpRegen trial in dry-AMD. Separately at ARVO, tomorrow we are presenting promising pre-clinical data in retinal restoration."

"Our strategies for Simplification and Unlocking Value are moving forward with the formation of AgeX Therapeutics last month. AgeX is a new subsidiary that is doing exciting work in the field of Aging. BioTime has already successfully demonstrated its ability to create value by building subsidiary companies. Our publicly-traded affiliates Asterias and OncoCyte continue to report encouraging positive clinical data as they move their therapies for spinal cord injury and lung cancer diagnostics forward," concluded Mr. Mohanty.

Highlights

Clinical Progress

Renevia (adipose cells + cell delivery matrix)

The schedule to read-out the Renevia top-line pivotal trial results was accelerated to June 2017. If the data are positive the Company plans to submit an application for CE Mark approval in Europe by year end, which could lead to approval and commercial launch in about a year.
The ongoing pivotal clinical trial in Europe is assessing the efficacy and safety of Renevia in treating HIV-associated lipoatrophy (facial fat loss). The Company intends to conduct additional trials in the U.S. that target a broader $7 billion aesthetics market opportunity, which is consistent with the previously stated goal of indication and geographic expansion for Renevia.
The trial in Europe is fully enrolled and continues to progress well with no safety related issues to date.
OpRegen (retinal pigment epithelial cells)

New positive clinical data on OpRegen were reported at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) this week. The data show OpRegen cells engraft (remain in place) and possible evidence of a biological response. Should the data establish that OpRegen cells safely engraft and remain alive in the patient, then the Company believes OpRegen may have a higher probability of success when compared to molecular therapeutics. The treatment continues to be well-tolerated, which includes some patients with more than one year of follow-up.
The data presented at ARVO is from the first and second cohorts of the ongoing Phase I/IIa clinical trial in the advanced form of dry-AMD. Patients from the second cohort, in which patients are receiving a higher and more clinically meaningful 200,000 cell dose, were included in the data.
The Company anticipates DSMB review of cohort 2 by the end of the second quarter and, upon approval, to begin enrolling cohort 3 immediately, thereafter. Cohort 3 is expected to enroll more quickly due to reduced patient staggering requirements. The trial is being expanded to U.S. sites as previously announced.
AST-OPC1 (oligodendrocyte progenitor cells)

In April, BioTime’s affiliate, Asterias (NYSE MKT: AST) announced that the Data Monitoring Committee (DMC) unanimously recommended continuation of the SCiStar Phase I/IIa clinical trial for AST-OPC1 following a review of the accumulated safety data. AST-OPC1 is for patients with spinal cord injury. Following positive results earlier this year in January, Asterias plans to initiate discussions with the FDA in mid-2017 to determine the most appropriate clinical and regulatory path forward for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)

BioTime’s affiliate, OncoCyte (NYSE MKT: OCX) is on track to be first to market with a lung cancer confirmatory liquid biopsy diagnostic test in the second half of this year. The test targets a market opportunity believed to exceed $4 billion annually.
In preparation for commercialization, OncoCyte submitted its application for CLIA lab certification in late March. Earlier is month, OncoCyte established a Medical Advisory Committee to provide guidance and advice in several areas including commercialization, unmet clinical needs and future pipeline products. The committee is comprised of four recognized lung cancer experts.
On May 22, 2017, results from OncoCyte’s 300-patient R&D validation study will be presented at the American Thoracic Society 2017 International Conference (ATS) in Washington, D.C. by Dr. Anil Vachani, and will be discussed on an investor call later that day.
Simplification and Unlocking Value

New Subsidiary AgeX Therapeutics, Inc.

In April, BioTime announced the formation of AgeX Therapeutics, Inc. as a new subsidiary. AgeX will consolidate certain BioTime subsidiaries and programs in the field of interventional gerontology. Two of the objectives in forming AgeX are to: 1) quickly establish leadership in the emerging biotechnology field of Aging by accelerating development of its pluripotent cell and iTR assets; and 2) continue the implementation of BioTime’s strategy to simplify its corporate structure and operations as well as focus its resources on continued clinical development and product commercialization in Ophthalmology; Aesthetics and Delivery.
Value of Holdings in Public Affiliates

At March 31, 2017, BioTime held common stock in publicly-traded affiliates valued at $161.3 million. This amount was the market value of BioTime’s 21.7 million shares in Asterias (NYSE MKT: AST) and 14.7 million shares in OncoCyte (NYSE MKT: OCX).
First Quarter Financial Results

Cash Position and Marketable Securities: Cash and cash equivalents totaled $23.8 million as of March 31, 2017, compared to $22.1 million as of December 31, 2016, which included OncoCyte’s cash and cash equivalents of $10.2 million.

Revenues: BioTime’s revenues are generated primarily from research grants, licensing fees and royalties, and subscription and advertising from the marketing of online database products. Total revenues were $0.4 million for the first quarter, compared to $2.1 million in the first quarter of 2016. Asterias’ total revenues included in 2016 were $1.6 million compared to no revenues in the first quarter of 2017 due to the deconsolidation in May 2016.

R&D Expenses: Research and development expenses were $6.5 million for the first quarter, compared to $13.7 million for the comparable period in 2016, a decrease of $7.2 million. This decrease was primarily attributable to the deconsolidation of Asterias in May 2016 and OncoCyte in February 2017. Asterias and OncoCyte combined, contributed to $7.4 million of the decrease in research and development expenses in the first quarter of 2017 as compared to 2016. This decrease was offset to some extent by an increase of $1.0 million in BioTime’s research and development programs, including OpRegen, Renevia, PureStem progenitor and pluripotent cell lines, and orthopedic therapy.

G&A Expenses: General and administrative expenses were $5.1 million for the first quarter compared to $11.9 million for the comparable period in 2016. The $6.8 million decrease was primarily due to the deconsolidation of financial statements of Asterias and OncoCyte. The deconsolidation of these former subsidiaries contributed to $7.4 million of the total decrease. This decrease in our general and administrative expenses was offset by increases in BioTime’s general and administrative expenses amounting to $0.9 million primarily due to: an increase of $0.3 million in compensation and related expenses due to additional key personnel hires.

Cash used by BioTime tends to be higher in the first quarter due to payments of annual bonuses and other compensation related costs.

Net Income (loss) attributable to BioTime: Net income attributable to BioTime was $49.3 million, or $0.46 per basic and diluted common share for the three months ended March 31, 2017, compared to net loss of $17.1 million, or ($0.19) per basic and diluted common share. The 2017 net income attributable to BioTime was primarily due to the $71.7 million gain on deconsolidation of OncoCyte and $16.1 million gain recognized from the increase in the market value of the OncoCyte shares owned by BioTime from February 17, 2017, the date of deconsolidation, through the end of the quarter. These gains were offset by the $11.3 million loss in operations, $3.9 million in deferred income tax expenses, and $26.1 million loss recognized from the decrease in the market value of the Asterias shares owned by BioTime from December 31, 2016 to the end of the quarter. BioTime deconsolidated Asterias in May 2016.