1stOncology™: Cancer Intelligence Service – Page 16119 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Halozyme Reports Second Quarter 2016 Financial Results

Aug. 9, 2016 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results and recent highlights for the second quarter ended June 30 (Press release, Halozyme, AUG 9, 2016, View Source [SID:1234514466]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"I am very pleased with the strong momentum in our ENHANZE platform leading to today’s increase in our 2016 revenue guidance, driven by continued royalty revenue growth and expansion of the addressable patient population through the approval of two new indications," said Dr. Helen Torley, president and chief executive officer. "With a range of new targets being tested in phase 1 trials, ENHANZE remains a growing value driver for the company.

"We also continue to see strong, ongoing interest and support from investigators for PEGPH20 as we initiated sites in our phase 3 study in pancreatic cancer, dosed the first metastatic breast cancer patient in our clinical trial with Eisai and resumed our trial in combination with KEYTRUDA (pembrolizumab) in lung and gastric cancer patients."

Second Quarter 2016 and Recent Highlights include:

Presenting key efficacy and safety data from stage 1 of its phase 2 clinical study in metastatic pancreatic cancer patients treated with PEGPH20 at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Conference. The results continued to show clinically meaningful efficacy for HA-high patients treated with PEGPH20 plus gemcitabine and ABRAXANE (nab-paclitaxel) versus gemcitabine and ABRAXANE alone, including median progression free survival of 9.2 months versus 6.0 months. Safety data presented from stage 2 of the study continued to show a reduction in the rate of thromboembolic events in both treatment arms as compared to stage 1.
The company expects to report mature response rate and progression free survival data from stage 2 of the study in the fourth quarter.
Progressing with site initiations in the HALO-301 | Pancreatic study towards the goal of approximately 90 percent of centers ready to screen patients by the end of 2016.
After assessing recruitment and the enrollment of increasingly later line patients, Halozyme has decided to discontinue the PRIMAL study of PEGPH20 with docetaxel in non-small cell lung cancer patients and focus on immuno-oncology therapy in its ongoing phase 1b study of PEGPH20 in combination with KEYTRUDA.
Resuming patient enrollment and dosing in its ongoing phase 1b clinical study evaluating PEGPH20 in combination with KEYTRUDA (pembrolizumab) in relapsed lung and gastric cancer patients under a revised clinical protocol. The revised protocol has been submitted to all institutional review boards (IRB) and is pending feedback from the FDA. The majority of IRBs have approved the amended protocol allowing the study to resume. The company continues to project that the study will move into the dose expansion phase by the end of 2016, pending feedback from the FDA.
Dosing of first patient in its phase 1b/2 clinical collaboration with Eisai evaluating eribulin in combination with PEGPH20 in women with advanced or metastatic, HER2-negative, HA-high breast cancer.
Shire launching the pediatric indication of HYQVIA in eight European countries to treat primary and certain secondary immunodeficiencies, following a marketing authorization granted by the European Commission in May. HYQVIA is co-administered with Halozyme’s ENHANZE technology.
Pfizer completing a phase 1 study of rivipansel with rHuPH20, demonstrating the feasibility of large volume subcutaneous administration in combination with Halozyme’s ENHANZE technology.
Roche receiving approval by the European Medicines Agency for an indication of Mabthera SC to treat patients with chronic lymphocytic leukemia.
Refinancing existing debt, increasing expected cash balances by $22 million in 2016 and 2017, with the option to borrow an additional $15 million in 2017.
Second Quarter 2016 Financial Highlights

Revenue for the second quarter was $33.3 million compared to $43.4 million for the second quarter of 2015. Revenue in the prior year period included $23 million for the initiation of the company’s partnership with AbbVie. Excluding the $23 million payment, revenue grew 64 percent year-on-year. Revenue for the second quarter included $12.3 million in royalties, $9.5 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $4.2 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Research and development expenses for the second quarter were $35.5 million, compared to $21.2 million for the second quarter of 2015. The planned increases were primarily due to a ramp in spending associated with PEGPH20 study HALO-301, the investment in studies to explore the pan-tumor potential of PEGPH20 and manufacturing and clinical supply expenses that are reimbursed by ENHANZE partners.
Selling, general and administrative expenses for the second quarter were $11.2 million, compared to $9.8 million for the second quarter of 2015. The increase was primarily due to personnel expenses, including stock compensation, for the period.
Net loss for the second quarter was $26.9 million, or $0.21 per share, compared to net income in the second quarter of 2015 of $3 million, or $0.02 per share.
Cash, cash equivalents and marketable securities were $230 million at June 30 compared to $238.6 million at March 31, 2016.
Financial Outlook for 2016

For the full year 2016, the company updated its prior guidance and now expects:

Net revenues to be in the range of $140 million to $150 million, an increase from the prior range of $130 million to $145 million;
Operating expenses to continue to be in the range of $245 million to $260 million;
Cash flow to be in the range of $65 million to $85 million, an increase from the prior range of $45 million to $65 million; and
Year-end cash balance to be in the range of $170 million to $190 million from the prior range of $150 million to $170 million, which was increased on June 8 when the company announced a debt refinancing agreement
– See more at: View Source#sthash.dbGsP3hr.dpuf.

FUJIFILM TO HOST FREE EDUCATIONAL LUNG CANCER WEBINAR FEATURING JOHNS HOPKINS EXPERT DAVID FELLER-KOPMAN, MD

On August 9, 2016The Endoscopy Division of FUJIFILM Medical Systems U.S.A., Inc. reported that it will sponsor a complimentary online educational webinar for thoracic surgeons, interventional pulmonologists, pulmonologists, nurse practitioners and physician assistants entitled "Lung Cancer: The State of the Disease" on Thursday, August 25th from 2PM-3PM EST (Press release, Fujifilm, AUG 9, 2016, View Source [SID:1234514465]). David Feller-Kopman, MD, Director of Bronchoscopy & Interventional Pulmonology at Johns Hopkins Hospital and Associate Professor of Medicine & Otolaryngology–Head and Neck Surgery, Johns Hopkins University will deliver the presentation and also participate in a Q&A session.

More people die every year from lung cancer than from colon, breast and prostate cancer combined. Dr. Feller-Kopman’s presentation will focus on the epidemiology of lung cancer, as well as the very latest on screening trends, diagnosis, staging, and treatment.

"Lung cancer is an epidemic, and physicians and healthcare professionals must take the lead in improving outcomes for patients," said Dr. Feller-Kopman. "During this webinar, I will cover research, trends and ways to improve the quality of life for patients with lung cancer, including the use of EBUS, a highly valuable tool in the staging of lung cancer."

Dr. Feller-Kopman’s research over the years has focused on pleural pathophysiology and the evaluation and management of patients with lung cancer. He regularly uses Fujifilm’s Endobronchial Ultrasound System (EBUS) in his lab work as well as with patients. He has published more than 150 original investigations and review articles and has trained 13 fellows in interventional pulmonology. He is the immediate past president of the American Association for Bronchology and Interventional Pulmonology (AABIP), the past chair of the Interventional Chest / Diagnostic Procedure Network of the American College of Clinical Pharmacy (ACCP) and an active member of the American Thoracic Society (ATS) Thoracic Oncology Assembly.

Medical professionals in the field of pulmonology have recognized Fujifilm’s innovative Endobronchial Ultrasound System (EBUS)—specifically designed for supporting advanced diagnosis and staging within the lungs—for its performance and high-quality imaging.

Aeterna Zentaris Reports Second Quarter 2016 Financial and Operating Results

On August 9, 2016 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health, reported financial and operating results for the second quarter ended June 30, 2016.

Commenting on recent key developments, David A. Dodd, President and Chief Executive Officer of the Company, stated, "After the end of Q2, we concluded two important out-license agreements for Zoptrex, confirming the market’s interest in our lead oncology compound, Zoptrex (zoptarelin doxorubicin). Zoptrex is a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE). Based on recent information regarding the survival of patients in the Phase 3 clinical trial of Zoptrex, we expect to complete the trial by year-end. If the results of the trial warrant doing so, we intend to file a new drug application for Zoptrex in the first half of 2017."

Mr. Dodd continued his commentary with an update on the development of Macrilen (macimorelin), "We are pleased to announce that we should complete enrollment in our confirmatory Phase 3 study of Macrilen for the evaluation of adult growth hormone deficiency by the end of August. As a result, we are very confident that the study of Macrilen will be concluded in 2016. If our expectations for completion of the confirmatory Phase 3 study are realized and if the top-line results indicate that the product attained the primary endpoint of the Phase 3 study, we expect to file an NDA for Macrilen during the first half of 2017. Since the regulatory review period for the Macrilen confirmatory study is six months, we could begin commercializing the product late in 2017."

Second Quarter 2016 Financial Highlights

R&D costs were $3.7 million for the three-month period ended June 30, 2016 and $7.4 million for the six-month period then ended, compared to $4.5 million and $8.9 million, respectively, for the three-month and six-month periods ended June 30, 2015. The decrease for the three-month and six-month periods ended June 30, 2016, as compared to the same period in 2015, is mainly attributable to lower comparative third-party costs. Third-party costs attributable to Zoptrex decreased considerably during the three-month and six-month periods ended June 30, 2016, as compared to the same periods in 2015, mainly due to the fact that dosing of patients in the ZoptEC trial was completed in February 2016. This is consistent with our expectations as we are approaching the end of the clinical trials. In addition, during 2015, we started the confirmatory Phase 3 clinical trial of Macrilen, which explains the increase in costs for this product candidate. The overall decrease in R&D costs is also explained by lower employee compensation and benefits costs, lower facilities rent and maintenance as well as lower other costs. A substantial portion of this decrease is due to the realization of cost savings in connection with our effort to streamline our R&D activities and to increase our commercial operations and flexibility by reducing our R&D staff, which was started in 2014, and for which a provision was recorded in the third quarter of 2014.

G&A expenses were $1.9 million for the three-month period ended June 30, 2016, and $3.8 million for the six-month period then ended, compared to $2.0 million and $5.4 million, respectively, for the three-month and six-month periods ended June 30, 2015. The comparative decrease for the six-month period is mainly attributable to the recording, in the prior year quarter, of certain transaction costs allocated to warrants in connection with the completion of the March 2015 Offering.

Selling expenses were $1.7 million for the three-month period ended June 30, 2016 and $3.4 million for the six-month period then ended, essentially unchanged as compared to the three-month and six-month periods ended June 30, 2015. The selling expenses for the three- and six-month periods ended June 30, 2016 and 2015 represent the costs of our contracted sales force related to the co-promotion activities as well as our internal sales management team. Those activities were launched during the fourth quarter of 2014.

Net loss for the three-month and six-month periods ended June 30, 2016 were $7.0 million and $10.7 million, respectively, or $0.71 and $1.08, respectively, both per basic and diluted share. During the same three-month and six-month periods in 2015, our net loss was $15.1 million and $24.8 million, respectively, or $13.65 and $27.22, respectively, per basic and diluted share for the same period in 2015. The decrease in net loss for the three-month and six- month periods ended June 30, 2016, as compared to the same periods in 2015, is due largely to lower operating expenses and higher comparative net finance income.

Cash and cash equivalents were approximately $26.2 million as at June 30, 2016, compared to approximately $33.0 million as at March 31, 2016.

Puma Biotechnology Reports Second Quarter 2016 Financial Results

On August 9, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2016 (Press release, Puma Biotechnology, AUG 9, 2016, View Source [SID:1234514457]).

Unless otherwise stated, all comparisons are for the second quarter and six months ended June 30, 2016, compared to the second quarter and six months ended June 30, 2015.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $66.6 million, or $2.05 per share, for the second quarter of 2016, compared to a net loss applicable to common stock of $64.7 million, or $2.01 per share, for the second quarter of 2015. Net loss applicable to common stock for the first half of 2016 was $137.6 million, or $4.23 per share, compared to $117.1 million, or $3.68 per share, for the first half of 2015.

Non-GAAP adjusted net loss was $37.9 million, or $1.17 per share, for the second quarter of 2016, compared to non-GAAP adjusted net loss of $36.5 million, or $1.13 per share, for the second quarter of 2015. Non-GAAP adjusted net loss for the first half of 2016 was $79.3 million, or $2.44 per share, compared to $68.8 million, or $2.16 per share, for the first half of 2015. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release. The Company anticipates that non-GAAP net loss will continue to decrease in subsequent quarters due to a continued reduction in clinical trial expenses and due to a reduction in expenses associated with the completion of the regulatory filings for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in Europe and the United States, which were submitted in June and July, respectively.

Net cash used in operating activities for the second quarter of 2016 was $30.8 million. Net cash used in operating activities for the first half of 2016 was $65.8 million. At June 30, 2016, Puma had cash and cash equivalents of $57.8 million and marketable securities of $85.9 million, compared to cash and cash equivalents of $31.6 million and marketable securities of $184.3 million at December 31, 2015. The Company anticipates that net cash used in operating activities will continue to decrease in subsequent quarters due to a reduction in the expenses described above.

"We are very pleased with the accomplishments of the Company," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "These milestones include the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in June and the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in July for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer based on the positive ExteNET Phase III trial. We also reported positive Phase II data from an investigator sponsored trial of neratinib in patients with HER2 mutated, non-amplified breast cancer in June. In addition, our Phase II trial of neratinib in the front-line treatment of HER2-positive metastatic breast cancer (NEfERT-T trial) was published in JAMA Oncology in April, and positive results from the I-SPY 2 Phase II clinical trial of neratinib for the neoadjuvant treatment of breast cancer was published in the July 7 issue of The New England Journal of Medicine.

"In the second half of 2016, we look forward to several regulatory and clinical milestones with neratinib. From the regulatory perspective, we look forward to working with the EMA and FDA as they review our MAA and NDA submission, respectively. We also look forward to continuing our development of neratinib in the second half of 2016 and beyond. We anticipate (i) reporting additional data from the Phase II trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using loperamide prophylaxis in the fourth quarter of 2016; (ii) reporting additional Phase II data from the FB-7 neoadjuvant HER2-positive breast cancer trial in the subgroup of patients who are MammaPrint High in the fourth quarter of 2016; (iii) reporting data from the Phase II trial of neratinib plus fulvestrant in patients with HER2 non-amplified breast cancer that has a HER2 mutation during the fourth quarter of 2016; (iv) reporting data from the Phase III trial of neratinib in third-line HER2-positive metastatic breast cancer patients in either the fourth quarter of 2016 or the first quarter of 2017; and (v) reporting data from the Phase II trial of neratinib in metastatic breast cancer patients with brain metastases during the fourth quarter of 2016."

Operating Expenses

Operating expenses were $66.5 million for the second quarter of 2016, compared to $64.9 million for the second quarter of 2015. Operating expenses for the first half of 2016 were $137.7 million compared to $117.5 million for the first half of 2015.

General and Administrative Expenses:

General and administrative expenses were $12.3 million for the second quarter of 2016, compared to $5.5 million for the second quarter of 2015. General and administrative expenses for the first half of 2016 were $23.3 million compared to $13.4 million for the first half of 2015. The increase of approximately $9.9 million resulted primarily from increases of approximately $4.6 million in stock-based compensation, $2.9 million in professional fees and expenses, $1.3 million in payroll and related costs, and $1.0 million in facility and equipment costs. These increases reflect higher legal and compliance expenses, as well as overall corporate growth.

Research and Development Expenses:

Research and development expenses were $54.2 million for the second quarter of 2016, compared to $59.4 million for the second quarter of 2015. Research and development expenses for the first half of 2016 were $114.4 million, compared to $104.1 million for the first half of 2015. The increase of approximately $10.3 million resulted primarily from increases of approximately $5.3 million in stock-based compensation and $4.3 million for internal clinical development, regulatory and quality assurance expenses. We expect research and development expenses to decrease in subsequent quarters as we complete clinical trials and as our regulatory filings for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer have been submitted in the United States and European Union.

BioTime, Inc. Reports Second Quarter Results and Recent Corporate Accomplishments

On August 9, 2016 BioTime, Inc. (NYSE MKT:BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported financial results for the second quarter ended June 30, 2016 and provided a corporate update (Press release, BioTime, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194367 [SID:1234514456]).

"During the second quarter, we continued to sharpen our focus on clinical progress and simplifying our corporate structure," said Adi Mohanty, Co-Chief Executive Officer. "Our key therapeutic programs, Renevia in medical aesthetics and OpRegen in dry AMD, continue to advance in the clinic, and we expect additional meaningful milestones from these programs in the second half of 2016. Meanwhile, our public subsidiaries continue to demonstrate their ability to make solid clinical progress. We strengthened our balance sheet by completing a successful public equity offering with gross proceeds of approximately $20.1 million from new and existing investors. Additionally, as we previously announced in May, we have deconsolidated Asterias Biotherapeutics, Inc. from our financial statements as result of its recent financing. We continue to see Asterias playing an important role in furthering therapies based on pluripotent stem cell technology. Asterias will continue to file its own financial statements with the SEC, allowing our shareholders to continue to follow its financial progress."

Second Quarter and Recent Highlights

Clinical Progress

Renevia (adipose cells + cell delivery matrix)

The Renevia pivotal clinical trial for HIV-related facial lipoatrophy continues to enroll new patients and is on track to complete patient enrollment by the second half of 2016. The objective of the trial is to assess the efficacy of Renevia in restoring normal skin contours in patients whose subcutaneous fat has been lost due to antiviral drug treatment for HIV. The Company expects top-line efficacy data in the first half of 2017, and plans to submit an application for CE Mark approval in Europe in the first half of 2017 if the data are positive. Positive data from the pivotal trial could provide support for future studies of Renevia in certain broader applications of fat tissue deficits in various medical aesthetics applications, such as age-related and trauma-related facial fat loss.
OpRegen (retinal pigment epithelial cells)

In June, the Data Safety Monitoring Board (DSMB) for the OpRegen Phase I/IIa clinical trial for the treatment of the advanced form of dry age-related macular degeneration (AMD) completed its review of the initial safety data from the first cohort and recommended dose escalation to the second cohort. Enrollment has begun for the second patient cohort, which is receiving a higher, more clinically significant, dose of OpRegen cells. The Company expects completion of enrollment for the second cohort in 2016 and, if the data are positive, anticipates DSMB approval to proceed to the third cohort by the end of 2016. OpRegen has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of dry AMD, which occurs in approximately 90% of those afflicted with AMD.
AST-OPC1 (oligodendrocyte progenitor cells)

In July, enrollment and dosing of the first efficacy cohort was completed in the AST-OPC1 SCiSTAR Phase 1/2a clinical trial in complete cervical spinal cord injury. This is the second of three cohorts in the study and it represents the first cohort in which patients have been administered a dose high enough to fall within the potentially efficacious range predicted by preclinical studies conducted by Asterias. Top-line six-month efficacy and safety results from this patient cohort are expected in January 2017. As of May 13, 2016, BioTime owned approximately 49% of the common shares outstanding of Asterias Biotherapeutics (NYSE MKT:AST).
Cancer Diagnostics

OncoCyte Corporation (NYSE MKT:OCX), the cancer diagnostics subsidiary of BioTime and developer of novel, non-invasive blood and urine based tests for the early detection of cancer, presented positive data from a clinical study for the non-invasive detection of bladder cancer at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Interim data from the clinical study, which was first reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2015 Annual Meeting, demonstrated a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer.
Corporate Developments

In June, BioTime closed a public offering of shares of its common stock. In July, the underwriters exercised in full their over-allotment option. Gross proceeds of the offering and full exercise of the over-allotment option totaled approximately $20.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by BioTime.
On May 13, 2016, BioTime deconsolidated its former majority-owned subsidiary, Asterias Biotherapeutics, Inc. As result, Asterias’ financial statements for periods after May 12, 2016 are no longer included in BioTime’s consolidated financial statements, and BioTime is now accounting for its investment in Asterias at fair value based on the closing stock price of Asterias common stock on the NYSE MKT and the number of shares held by BioTime. Changes in the fair value of Asterias common stock are reflected as unrealized gains or losses in BioTime’s consolidated statements of operations, as a non-operating item. See Second Quarter Financial results below.
Second Quarter Financial Results

Note on deconsolidation of Asterias and comparability of results:

BioTime’s consolidated balance sheet at December 31, 2015, as reported, included Asterias’ assets and liabilities. However, Asterias’ assets and liabilities are not included in BioTime’s consolidated balance sheet at June 30, 2016 due to the deconsolidation of Asterias on May 13, 2016. Furthermore, BioTime’s consolidated statements of operations for the three and six months ended June 30, 2016 include Asterias’ results for the period through May 12, 2016, the day immediately preceding the deconsolidation. For the three and six months ended June 30, 2015, BioTime’s consolidated results include Asterias’ results for the full periods presented.

All discussions about the results of operations, or balance sheet amounts that follow, as appropriate and indicated, include both the actual results and amounts pertaining to Asterias.

Cash Position and investments: Cash and cash equivalents totaled $27.7 million as of June 30, 2016, compared to $42.2 million as of December 31, 2015, which included Asterias’ cash and cash equivalents of $11.2 million. The cash on hand as of June 30, 2016 includes $7.0 million held by subsidiaries and excludes Asterias due to the deconsolidation. As of June 30, 2016, BioTime owned 21.7 million shares of Asterias common stock and 14.7 million shares of OncoCyte common stock, which represented an aggregate market value of approximately $104 million as of that date. On June 21, 2016, BioTime closed a $17.5 million public offering of shares of its common stock. On July 5, 2016, BioTime announced the exercise in full of the underwriters’ over-allotment option to purchase an additional 1,098,326 shares of BioTime common stock. The gross proceeds of the offering, including the over-allotment option were approximately $20.1 million before deducting underwriting discounts and commissions and other offering expenses payable by BioTime.

Revenues: BioTime’s operating revenues are currently primarily generated from research grants, licensing fees and advertising from the marketing of online database products. Total consolidated revenues were $1.3 million for the second quarter, compared to $2.0 million in the second quarter of 2015. Asterias’ total revenues included in the second quarter of 2016 and 2015 were $0.8 million in each respective period as shown in the table below (in thousands).

Three months ended June 30, 2016

Three months ended June 30, 2015
Consolidated
Results of
Operations

Less: Asterias
(42 days)

Consolidated
Results less
Asterias

Consolidated
Results of
Operations

Less: Asterias
(3 months)

Consolidated
Results less
Asterias

Total revenues $ 1,266 $ 760 $ 506 $ 2,009 $ 772 $ 1,237

The decrease in BioTime’s total revenues was mainly due to less grant revenue recorded in 2016 due to expiration of a National Institutes of Health (NIH) grant in August 2015.

Operating Expenses (in thousands)

Three months ended June 30, 2016

Three months ended June 30, 2015
Consolidated
Results of
Operations

Less: Asterias
(42 days)

Consolidated
Results less
Asterias

Consolidated
Results of
Operations

Less: Asterias
(3 months)

Consolidated
Results less
Asterias

Research and development $ 8,938 $ 2,343 $ 6,595 $ 9,059 $ 3,696 $ 5,363
General and administrative 6,636 1,357 5,279 6,186 1,845 4,341

R&D Expenses: Research and development expenses were $8.9 million for the second quarter, compared to $9.1 million for the comparable period in 2015, including $2.3 million and $3.7 million attributable to Asterias’ research and development for the respective periods.

The increase in R&D of approximately $1.2 million is in part a result of increased expenses primarily related to regulatory and clinical trials of BioTime’s Renevia program and OncoCyte’s cancer diagnostics, offset by a decrease of approximately $1.3 million principally due to the deconsolidation of Asterias.

G&A Expenses: General and administrative expenses were $6.6 million for the second quarter, compared to $6.2 million for the second quarter of 2015, including $1.4 million and $1.8 million attributable to Asterias for the same periods, respectively. The $0.9 million increase is in part a result of increased staffing needed to advance programs under development at BioTime, including non-cash stock-based compensation from BioTime and OncoCyte, offset by a $0.5 million decrease due to the deconsolidation of Asterias.

Net Income attributable to BioTime: Net income attributable to BioTime was $24.5 million for the three months ended June 30, 2016, or $0.26 per share primarily due to the $49.0 million noncash gain on deconsolidation of Asterias, offset by unrealized losses of $13.5 million from the decline in the fair value of the Asterias shares owned by BioTime that occurred during the period May 13 through June 30, 2016. There was no deferred income tax provision or benefit recorded in the three months ended June 30, 2016. For the second quarter of 2015, net loss attributable to BioTime was $9.7 million, or ($0.12) per share. Net income (loss) attributable to BioTime includes losses from BioTime’s majority owned and consolidated subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.