BioTime, Inc. (NYSE MKT:BTX) today reported financial results for the first quarter ended March 31, 2015 and provided a corporate update. "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. Michael D. West, BioTime's Chief Executive Officer. "At this year's annual meeting of the American Association for Cancer Research (AACR), our subsidiary OncoCyte reported interim clinical validation data on its PanC-Dx™ cancer diagnostic tool for the non-invasive detection of bladder and breast cancers. Our subsidiary Cell Cure Neurosciences presented data on its product candidate, OpRegen ®, at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). Preclinical study showed that OpRegen ® preserved vision and retinal structure when it was transplanted into the leading animal model of retinal disease. A Phase I/IIa trial of the product has been initiated for the treatment of the dry form of age-related macular degeneration, a condition for which there is currently no FDA-approved therapy. In addition, we are pleased that the findings regarding our subsidiary Asterias's cancer vaccine AST-VAC1 were selected for presentation at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO). The presentation will focus on the long-term follow-up data from a Phase II immunotherapy trial for patients with acute myelogenous leukemia (AML). Taken together, the results presented at these conferences highlight the BioTime family of companies' leading role in the field of regenerative medicine." First Quarter and Recent Highlights Since BioTime reported fourth-quarter and full-year 2014 results in March 2015, the Company and its subsidiaries have reported the following progress. BioTime, Inc.
- Renevia™, BioTime's proprietary cell delivery matrix, is designed to facilitate the stable engraftment of transplanted cells. Earlier this year, BioTime announced the successful treatment of the first patient in the Company's pivotal clinical trial in Europe of 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 Society meeting later this month.
Cell Cure Neurosciences Ltd.
- 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, Illinois from 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 BioTime or its subsidiaries.
- ESI's hES cell lines will be used by University of California, Irvine scientist Dr. Leslie Thompson to continue her research on the use of stem cells to treat Huntington's disease under a $5 million grant 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 ResultsTotal consolidated revenues for the first quarter 2015 were $1.3 million, compared to $1.1 million in the first quarter 2014. BioTime's operating revenues are currently generated primarily from research grants, licensing fees, and advertising from the marketing of the LifeMap Sciences's online database products, and from the sale of hydrogels and stem cell products for research. Consolidated operating expenses for the first quarter were $14.5 million, compared to $12.1 million for the same period in 2014. Research and development (R&D) expenses for the first quarter were $9.3 million, compared to $8.4 million in the year-ago quarter. The increase in R&D expenses is largely due to the continued ramp-up of the Asterias and LifeMap Solutions product development programs, OncoCyte's clinical trial work to develop its PanC-Dx™ cancer diagnostics, and increased activity of the ESI BIO division. General and administrative (G&A) expenses for the first quarter were $5.2 million, compared to $3.7 million in the first quarter a year ago. This increase was primarily due to the ramp-up of the Asterias and LifeMap Sciences development programs. Net loss attributable to BioTime for the three months ended March 31, 2015 was $10.2 million, including deferred income tax benefits of $1.2 million. For the first quarter of 2014, net loss was $8.1 million, including deferred income tax benefits of $1.3 million. On a per share basis, net loss for the first quarter was $0.13 per share, compared to $0.14 per share for the first quarter of 2014. Net loss attributable to BioTime includes losses from BioTime majority-owned subsidiaries based upon BioTime's percentage ownership of those subsidiaries. Cash and cash equivalents totaled $25.8 million as of March 31, 2015, compared to $29.5 million as of December 31, 2014. The cash on hand as of March 31, 2015 includes $9.0 million held by Asterias and other subsidiaries. During February 2015, Asterias raised $5.5 million in aggregate gross proceeds from the public offering and concurrent private placement of its Series A common stock. In the first quarter 2015, Asterias received $2.3 million from CIRM under the grant award related to the AST-OPC1 development program. About BioTime BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company. BioTime and its subsidiaries are leveraging their industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures. The lead clinical programs of BioTime and its subsidiaries include OpRegen ®, currently in a Phase I/IIa trial for the treatment of the dry form of age-related macular degeneration; AST-OPC1, currently in a Phase I/IIa trial for spinal cord injuries; Renevia™, currently in a pivotal trial in Europe as an injectable matrix for the engraftment of transplanted cells to treat HIV-related lipoatrophy; and PanC-Dx™ cancer diagnostics, nearing the completion of initial clinical studies for the detection of bladder, breast, and lung cancers. AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage. BioTime's subsidiaries include the publicly traded Asterias Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem cell-based therapies in neurology and oncology, including AST- OPC1 and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem cell-based therapies for retinal and neurological disorders, including OpRegen ®; OncoCyte Corporation, developing PanC-Dx™ cancer diagnostics; LifeMap Sciences, Inc., developing and marketing an integrated on-line database resource for biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile health (mHealth) products; ES Cell International Pte Ltd, which has developed cGMP-compliant human embryonic stem cell lines that are being marketed by BioTime for research purposes under the ESI BIO branding program; OrthoCyte Corporation, developing therapies to treat orthopedic disorders, diseases and injuries; and ReCyte Therapeutics, Inc., developing therapies to treat a variety of cardiovascular and related ischemic disorders. BioTime common stock is traded on the NYSE MKT under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+. FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com .
|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||$||29,486,909|
|Trade accounts and grants receivable, net||866,180||1,041,856|
|Prepaid expenses and other current assets||1,271,895||1,231,789|
|Total current assets||28,544,122||32,404,557|
|Equipment, net and construction in progress||2,864,669||2,857,846|
|Deferred license and consulting fees||309,458||336,833|
|Other long-term assets||7,916||9,985|
|Intangible assets, net||37,534,302||38,848,396|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||6,322,407||$||6,803,173|
|Capital lease liability, current portion||57,500||57,500|
|Related party convertible debt, net of discount||169,908||60,237|
|Deferred grant income||1,474,300||-|
|Deferred license and subscription revenue, current portion||178,546||208,357|
|Total current liabilities||8,202,661||7,129,267|
|Deferred tax liabilities, net||3,337,662||4,514,362|
|Deferred rent liabilities, net of current portion||34,967||97,280|
|Capital lease, net of current portion||17,307||31,290|
|Other long-term liabilities||38,119||27,961|
|Total long-term liabilities||3,989,025||5,048,874|
|Commitments and contingencies|
|Series A Convertible Preferred Stock, no par value, authorized 2,000,000 shares as of March 31, 2015 and December 31, 2014; 70,000 issued and outstanding as of March 31, 2015 and December 31, 2014||3,500,000||3,500,000|
|Common shares, no par value, authorized 125,000,000 shares as of March 31, 2015 and December 31, 2014; 83,210,775 issued and 78,316,833 outstanding as of March 31, 2015 and 83,121,698 issued and 78,227,756 outstanding as of December 31, 2014||234,751,802||234,842,998|
|Accumulated other comprehensive income||238,820||185,835|
|Treasury stock at cost: 4,893,942 shares at March 31, 2015 and December 31, 2014||(19,889,788||)||(19,889,788||)|
|BioTime, Inc. shareholders' equity||26,250,404||36,455,983|
|Total shareholders' equity||57,511,784||62,722,765|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||69,703,470||$||74,900,906|