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“During the third quarter,
“BioTime continues to strengthen its leadership position in regenerative medicine on many fronts,” said Dr.
Third Quarter and Recent Highlights
November 5, 2015, BioTimeand Hepregen Corporationformed Ascendance Biotechnology, Inc., a new self-funding company that combines Hepregen’s cellular micro-patterning drug and chemical screening technologies with BioTime’s ESI-BIO research products and proprietary stem cell technologies.
- BioTime’s Board of Directors appointed
Adi Mohantyto serve with Michael D. Westas co-Chief Executive Officer. Dr. West will lead BioTime’s science, technology development, and intellectual property activities with a particular focus on growing the Company’s discovery and pre-clinical product development programs. Mr. Mohanty will lead the Company’s advanced clinical development programs and commercialization strategies, as well as assume leadership of its corporate and administrative activities. Mr. Mohanty has served as BioTime’s Chief Operating Officer since December 2014. BioTimeraised approximately $34.0 millionduring the third quarter and early October through sales of common shares to a select group of U.S. investors, and certain investment funds in Israelthat hold shares of companies that are included within Tel Aviv Stock Exchangeindexes.
- BioTime’s subsidiary
OncoCyte Corporationfiled a Form 10 Registration Statement with the Securities and Exchange Commissionfor BioTime’s planned distribution of OncoCyte common stock to BioTimecommon shareholders. BioTimeexpects that the distribution will provide OncoCyte with greater access to capital markets in order to obtain its own financing for its operations, separately from BioTimefinancings. The distribution will also allow BioTimeand OncoCyte to each focus on its own strategic priorities relating to its own management, capital structure, business model, and financial goals. BioTime’s plan is to effect the distribution to BioTimeshareholders in late 2015, subject to certain conditions. BioTimeexpects to continue to own a majority of the outstanding common stock in OncoCyte immediately after the distribution. OncoCyte Corporationappointed Cavan Redmond, former CEO of WebMD Health Corp.and Group President of Pfizer, as an independent member of its Board of Directors. Mr. Redmond is a seasoned healthcare strategist who has held a number of global leadership positions and has over 25 years of corporate strategy experience.
November 2, 2015, BioTime’s subsidiary Asterias Biotherapeutics, Inc.(NYSE MKT: AST) announced the appointment of Georgia Erbezas Chief Financial Officer, effective November 9, 2015. Ms. Erbez is a seasoned financial executive with experience in the areas of capital resource development and business development. Previously, Ms. Erbez served as a financial consultant to numerous biotechnology companies. Prior to that, she served as Chief Financial Officer, Secretary, and Treasurer of Raptor Pharmaceutical Corp. BioTime'scommon shares began trading on the Tel Aviv Stock Exchange(TASE) under the ticker symbol BTX on September 8, 2015. BioTime’s shares were included in six major TASE equity indexes: TA-75, TA-100, TA-BlueTech, TA-Composite, TA-Tech-Elite, and TA-Biomed. BioTime’s shares will continue to be listed on the NYSE MKT, subject to the rules and regulations of the NYSE MKT applicable to listed companies.
Cell Cure Neurosciences Ltd.received Fast Track designation from the U.S. Food and Drug Administration( FDA) for OpRegen® for the treatment of the dry form of age-related macular degeneration (AMD), a leading cause of blindness in an aging population. The Fast Track designation confers benefits to a drug sponsor, including more frequent communication with FDAon the drug development plan, clinical trial design, potential eligibility for Accelerated Approval and Priority Review, and a rolling regulatory review. OpRegen® is a cell-based therapeutic product consisting of retinal pigment epithelial (RPE) cells.
- In August,
Asterias Biotherapeutics, Inc.concluded recruitment of the initial safety cohort of the SCiStar Phase 1/2a dose-escalation clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) for complete cervical spinal cord injury (SCI), in which three patients were administered a low dose of 2 million AST-OPC1 cells. The results of the study continue to support a robust safety profile for AST-OPC1, with no serious adverse events observed in any of the three treated patients to date.
- In October, following review of the 30-day post-injection safety data from the initial safety cohort, the Data Monitoring Committee recommended dose escalation of AST-OPC1 to the second cohort in the Phase 1/2a clinical trial. Recruitment for the second cohort has commenced, with a planned enrollment of five patients who will each receive 10 million cells of AST-OPC1.
- Asterias announced the publication of preclinical data in Regenerative Medicine that supports the safety and use of AST-OPC1 as a treatment for SCI. The preclinical results showed that AST-OPC1 cells did not cause any adverse clinical observations, toxicities, allodynia, or tumors. AST-OPC1 exhibited robust persistence and limited migration within the thoracic and cervical spinal cord. In addition, AST-OPC1 demonstrated nerve growth-stimulating properties and remyelinating properties that supported restoration of function in animal models.
- Asterias announced a collaboration with the
UK-based Cell Therapy Catapult to advance the development of large-scale manufacturing processes for AST-VAC2, Asterias’ allogeneic dendritic cell immunotherapy. Under the agreement, the Cell Therapy Catapult will streamline and scale manufacturing processes for AST-VAC2 to support advanced clinical trials and eventual commercialization of AST-VAC2. Asterias has an ongoing partnership with Cancer Research UKto execute the first stage of AST-VAC2 clinical development, under which Cancer Research UKwill sponsor and manage a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung carcinoma.
- BioTime’s subsidiary
OrthoCyte Corporationand Heraeus Medical entered into exclusive development and worldwide licensing agreements for the development of innovative bone grafting therapies to address orthopedic unmet needs based on the use of BioTime’s proprietary PureStem® human embryonic progenitor cell technology.
Cell Delivery Technology
- Patient enrollment is ongoing in BioTime’s pivotal clinical trial in
Europeof Renevia™ for HIV-associated lipoatrophy. As planned, an additional clinical trial site in Barcelonawas recently opened. BioTimecurrently expects completion of trial enrollment in the first half of 2016. There have been no serious adverse events observed in any of the treated patients to date.
Cancer Diagnostics Platform
The Wistar Instituteand BioTimesubsidiary OncoCyte Corporationexpanded their collaboration to continue to develop a simple, non-invasive, highly sensitive and specific, blood-based diagnostic test designed to aid physicians in the early detection of lung cancer. The expanded collaboration follows the presentation at the American Thoracic Society International Conferencein May 2015of interim results from a large clinical trial, which showed that OncoCyte’s blood-based diagnostic test for non-invasive detection of lung cancer demonstrated a high level of observed sensitivity and specificity. Dependent on achieving successful scientific and technical results at this stage of development, OncoCyte and Wistar will conduct final validation of the diagnostic test with the goal of completing that work in 2016 to enable OncoCyte to commercially launch the lung diagnostic test.
- ESI-BIO, the stem cell products division of
BioTime, Inc., launched its new technology platform, VascuNet™ Pericyte Co-Culture Assay, designed to give pharmaceutical drug screeners and researchers new standardized in vitro assays that provide a stable, clinically relevant angiogenesis model with greater physiological relevance and accuracy not currently obtainable by other vascular network systems. The Icahn School of Medicineat Mount Sinaiand LifeMap Solutions, a digital-health subsidiary of BioTime, Inc., announced initial results and new features to enhance clinical impact for their free Asthma Healthapp. The app enables individuals with asthma to participate in a large-scale medical research study by simply using their AppleiPhones. The app’s newest features will help enable Asthma Healthstudy participants to use the app with their physicians. LifeMap Sciences, Inc.announced that its next-generation sequencing (NGS) analysis and interpretation tools, VarElect, the NGS phenotyper, and GeneAnalytics™, a novel gene set analysis tool, have been licensed by SciLifeLab. The LifeMap NGS tools will be used by SciLifeLab, a leading provider of molecular biosciences services to leading biomedical research institutions and companies, to enhance the bioinformatics analysis services that it provides across Sweden.
BioTime’s operating revenues are currently generated from the following sources: research grants, licensing fees, and royalties from the sale of Hextend®; advertising from the marketing of the LifeMap Sciences online database products; and from the sale of hydrogels and stem cell products for research.
Total consolidated revenues for the third quarter were
Consolidated operating expenses for the third quarter were
Operating expenses for the nine months ended
Net loss attributable to
Net loss attributable to
Net losses 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
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Three Months Ended
|Nine Months Ended|
|September 30,||September 30,|
|Subscription and advertisement revenues||$||343||$||285||$||1,020||$||880|
|Royalties from product sales||357||148||631||322|
|Sale of research products and services||140||110||328||300|
|Cost of sales||(432||)||(231||)||(957||)||(614||)|
|Research and development||(11,433||)||(8,836||)||(29,816||)||(26,268||)|
General and administrative
|Total operating expenses||(18,978||)||(13,098||)||(48,727||)||(39,032||)|
|Loss from operations||(17,104||)||(12,138||)||(44,109||)||(36,281||)|
|Interest expense, net||(12||)||(7||)||(207||)||(30||)|
|Other income/(expense), net||(573||)||(119||)||(408||)||157|
|Total other income/(expense), net||(585||)||(126||)||(615||)||127|
LOSS BEFORE INCOME TAX BENEFIT
|Deferred income tax benefit||948||2,313||3,395||5,175|
|Net loss attributable to non-controlling interest||3,115||1,683||7,762||5,151|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|Dividends on preferred shares||(363||)||(34||)||(415||)||(34||)|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
BASIC AND DILUTED NET LOSS PER COMMON SHARE
|WEIGHTED AVERAGE NUMBER OF COMMON STOCK|
OUTSTANDING: BASIC AND DILUTED
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$||29,378||$||29,487|
|Trade accounts and grants receivable, net||944||1,042|
|Prepaid expenses and other current assets||1,752||1,232|
|Total current assets||34,365||32,405|
|Equipment, net and construction in progress||6,781||2,858|
|Deferred license fees||352||337|
|Deposits and other long-term assets||455||453|
|Intangible assets, net||34,906||38,848|
LIABILITIES AND SHAREHOLDERS' EQUITY
|Accounts payable and accrued liabilities||$||7,793||$||6,803|
|Capital lease liability, current portion||46||58|
|Promissory notes, current portion||95||
|Related party convertible debt, net of discount||255||60|
|Deferred grant income||1,869||-|
|Deferred license and subscription revenue, current portion||278||208|
|Total current liabilities||10,336||7,129|
|Deferred tax liabilities, net||1,119||4,515|
|Deferred rent liabilities, net of current portion||95||97|
|Capital lease liability, net of current portion||-||31|
|Promissory notes, net of current portion||268||
|Other long-term liabilities||18||28|
|Total long-term liabilities||5,589||5,049|
|Commitments and contingencies|
Series A Convertible Preferred Stock, no par value, authorized 2,000 shares as of September 30, 2015 and December 31, 2014; none and 70 issued and outstanding as of September 30, 2015 and December 31, 2014, respectively
Common stock, no par value, authorized 125,000 shares as of September 30, 2015 and December 31, 2014; 86,764 issued and 82,045 outstanding as of September 30, 2015 and 83,122 issued and 78,228 outstanding at December 31, 2014
|Accumulated other comprehensive income/(loss)||(87||)||186|
Treasury stock at cost: 4,719 and 4,894 shares at September 30, 2015 and at December 31, 2014, respectively
|BioTime, Inc. shareholders' equity||13,043||36,456|
|Total shareholders' equity||60,934||62,723|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||76,859||$||74,901|
Dan L. Lawrence, 510-775-0510
EVC Group, Inc.
Michael Polyviou, 646-445-4800
Gotham Communications, LLC
Bill Douglass, 646-504-0890
Gelbart-Kahana Investor Relations
Zeev Gelbart, +972-3-6074717