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“BioTime continues to advance its strategic product development
programs. We are currently enrolling patients in a pivotal trial of Renevia™
for the treatment of HIV-associated lipoatrophy,” said Dr.
First Quarter and Recent Highlights
Renevia™, BioTime’s proprietary cell delivery matrix, is
designed to facilitate the stable engraftment of transplanted cells.
Earlier this year,
BioTimeannounced the successful treatment of the first patient in the Company’s pivotal clinical trial in Europeof Renevia™ for HIV-associated lipoatrophy. These results could lead to submission for CE Mark approval for the treatment of HIV-associated facial atrophy. Potential implications of this trial also include the development of future therapeutics for other lipoatrophy-related conditions as well as potential use of Renevia™ to deliver other types of cells.
- Results from two prospective clinical validation studies of PanC-Dx™, OncoCyte’s class of proprietary tests for the non-invasive diagnosis of cancer, were presented at the annual meeting of the AACR in April of this year. PanC-Dx™ demonstrated a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer.
- Initial data from a large, prospective clinical validation study showed the potential of PanC-Dx™ as a non-invasive, blood-based diagnostic test to screen for multiple types of human cancers, including breast cancer. The clinical data were also presented in April at the annual meeting of the AACR.
OncoCyte expects that interim clinical validation data on markers for
lung cancer will be presented at the
American Thoracic Societymeeting later this month.
Preclinical data demonstrated that Cell Cure’s product candidate, OpRegen®,
preserved vision and retinal structure when transplanted into the
leading animal model of retinal disease. These findings were presented
at the annual meeting of the
Association for Research in Vision and Ophthalmology(ARVO) in May. OpRegen® consists of high-purity retinal pigment epithelial cells derived from human embryonic stem cells using a proprietary directed differentiation method.
- Cell Cure is initiating a Phase I/IIa dose escalation study of OpRegen® to evaluate its safety and efficacy when transplanted sub-retinally in patients who are in an advanced stage of the dry form of age-related macular degeneration.
The long-term follow-up of AML patients enrolled in the Phase II
clinical trial of AST-VAC1, Asterias’s autologous
telomerase-based dendritic cell cancer vaccine, was selected for oral
presentation at the annual meeting of the
American Society of Clinical Oncology( ASCO) to be held in Chicago, Illinoisfrom May 29 to June 2, 2015.
ES Cell International Pte Ltd(ESI) and Beckman Research Institute of the City of Hope(BRICOH) signed a nonexclusive license agreement under which ESI’s good manufacturing practice (GMP)-compliant, clinical-grade human embryonic stem (hES) cells will be manufactured and provided to BRICOH’s collaborators for use in the pre-clinical development of therapeutic products to treat human disease. The agreement is an important part of BioTime’s strategy to leverage third-party funding and potentially generate future revenues by placing its hES cells in a wide array of therapeutic programs and medical applications that are not being developed by BioTimeor its subsidiaries.
ESI’s hES cell lines will be used by
University of California, Irvinescientist Dr. Leslie Thompsonto continue her research on the use of stem cells to treat Huntington’s disease under a $5 milliongrant from the California Institute for Regenerative Medicine(CIRM). The CIRM grant will further support a collaboration between ESI and University of California, Davis’s GMP laboratory for the creation of the GMP-grade cells needed in Dr. Thompson’s preclinical and potentially subsequent clinical studies.
First Quarter 2015 Financial Results
Total consolidated revenues for the first quarter 2015 were
Consolidated operating expenses for the first quarter were
Net loss attributable to
Cash and cash equivalents totaled
BioTime’s subsidiaries include the publicly traded
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for
To receive ongoing
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended|
|March 31,||March 31,|
|Royalties from product sales||156,550||97,886|
|Sale of research products and services||89,919||98,586|
|Cost of sales||(264,167||)||(131,914||)|
|Research and development||9,323,510||8,405,393|
|General and administrative||5,178,800||3,667,171|
|Total operating expenses||14,502,310||12,072,564|
|Loss from operations||(13,502,023||)||(11,137,843||)|
|Interest expense, net||(25,461||)||(8,384||)|
|Other income/(expense), net||(239,453||)||69,170|
|Total other income/(expenses), net||(264,914||)||60,786|
|LOSS BEFORE INCOME TAX BENEFITS||(13,766,937||)||(11,077,057||)|
|Deferred income tax benefit||1,176,882||1,349,026|
|Net loss attributable to non-controlling interest||2,422,687||1,629,017|
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC.||$||(10,167,368||)||$||(8,099,014||)|
|BASIC AND DILUTED NET LOSS PER COMMON SHARE||$||(0.13||)||$||(0.14||)|
|WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING:|
|BASIC AND DILUTED||78,261,788||58,257,427|
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||25,829,533||$||29,486,909|
|Trade accounts and grants receivable, net||866,180||1,041,856|
|Prepaid expenses and other current assets||1,271,895||1,231,789|
|Total current assets||28,544,122||32,404,557|
Equipment, net and construction in progress
|Deferred license and consulting fees||309,458||336,833|
|Other long-term assets||7,916||9,985|
|Intangible assets, net||37,534,302||38,848,396|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||6,322,407||$||6,803,173|
|Capital lease liability, current portion||57,500||57,500|
|Related party convertible debt, net of discount||169,908||60,237|
|Deferred grant income||1,474,300||-|
|Deferred license and subscription revenue, current portion||178,546||208,357|
|Total current liabilities||8,202,661||7,129,267|
|Deferred tax liabilities, net||3,337,662||4,514,362|
|Deferred rent liabilities, net of current portion||34,967||97,280|
|Capital lease, net of current portion||17,307||31,290|
|Other long-term liabilities||38,119||27,961|
|Total long-term liabilities||3,989,025||5,048,874|
|Commitments and contingencies|
Series A Convertible Preferred Stock, no par value, authorized 2,000,000 shares as of March 31, 2015 and December 31, 2014; 70,000 issued and outstanding as of March 31, 2015 and December 31, 2014
|Common shares, no par value, authorized 125,000,000 shares as of March 31, 2015 and December 31, 2014; 83,210,775 issued and 78,316,833 outstanding as of March 31, 2015 and 83,121,698 issued and 78,227,756 outstanding as of December 31, 2014||234,751,802||234,842,998|
|Accumulated other comprehensive income||238,820||185,835|
|Treasury stock at cost: 4,893,942 shares at March 31, 2015 and December 31, 2014||(19,889,788||)||(19,889,788||)|
|BioTime, Inc. shareholders' equity||26,250,404||36,455,983|
|Total shareholders' equity||57,511,784||62,722,765|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||69,703,470||$||74,900,906|