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“BioTime’s management team has sharpened its focus on our high priority
programs,” said Dr.
Through the second quarter,
Cell Cure Neurosciences, Ltd.(Cell Cure Neurosciences) is currently enrolling patients at Hadassah University Medical Centerin Jerusalem, Israel, in a clinical Phase I/IIa dose-escalation study evaluating the safety and efficacy of OpRegen® for geographic atrophy (GA), the severe stage of the dry form of age-related macular degeneration (dry-AMD). Dry-AMD represents nearly 90% of AMD prevalence and currently has no FDA-approved therapy. The Phase I/IIa clinical trial is designed with four cohorts and allows for interim data readouts.
Cell Cure Neurosciences presented preclinical efficacy data for its lead
product candidate, OpRegen® at the annual
meeting of the
Association for Research in Vision and Ophthalmology(ARVO) in May. The findings demonstrated the product’s potential to preserve vision and retinal structure when transplanted into the leading animal model of retinal disease.
In May, Cell Cure Neurosciences was awarded a grant for 2015 of
6.24 million shekels(approximately $1.61 million) from Israel’s Office of the Chief Scientist(OCS) to help finance the development of OpRegen®. The OCS has previously supported Cell Cure Neurosciences, providing grants totaling approximately $8.0 millionto date in non-dilutive funding.
Asterias Biotherapeutics, Inc.(Asterias) promoted Edward Wirth, M.D., Ph.D. to Chief Medical Officer.
In June, Asterias announced that the first patient had been dosed at
Atlanta-based Shepherd Center in a Phase I/IIa clinical trial evaluating the activity of escalating amounts of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The Phase I/IIa trial is part of the planned registration program for AST-OPC1, with neurologically complete cervical SCI as the first targeted indication.
Also in June, Asterias announced positive long-term follow-up data
from a Phase II clinical trial of AST-VAC1 in patients with acute
myelogenous leukemia (AML). The results showed that more than 50% of
those who received AST-VAC1 had prolonged relapse-free survival, even
patients with high-risk AML, including those over 60 years of age and
patients in second remission. The data were presented during an oral
presentation at the annual meeting of the
American Society of Clinical Oncology( ASCO) in May.
Asterias was added to the Russell 3000®, Russell Global,
and Russell Microcap® Indexes on
June 26, 2015as part of Russell Investments’ annual reconstitution of its comprehensive set of U.S. and global equity indexes. The Russell indexes are widely used by investment managers and institutional investors for index funds and they serve as benchmarks for passive and active investment strategies.
During the second quarter, Asterias raised a total of
$14.5 millionin aggregate gross proceeds through various private and public offerings, as well as receiving $1.1 millionfrom the California Institute of Regenerative Medicine(CIRM) in accordance with a quarterly disbursement schedule under the $14.3 milliongrant award related to the AST-OPC1 development program. Year-to-date payments from CIRM total $3.3 millionin non-dilutive funding.
Cell Delivery Matrices
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, which was chosen as the clearest regulatory pathway as the first indication. Patient enrollment is ongoing with completion of enrollment in the trial expected by early next year. Renevia™, BioTime’s proprietary cell delivery matrix, is specifically designed to facilitate the stable engraftment and proliferation of transplanted cells.
The results of the Renevia™ trial could ultimately lead to a
submission in 2016 for CE Mark approval in
Europefor the treatment of HIV-associated facial lipoatrophy. Positive outcomes of this trial could greatly accelerate the potential development of future therapeutics for other lipoatrophy-related conditions, as well as the potential to expand the use of BioTime’s cell delivery matrices for a number of additional cell types.
Cancer Diagnostics Platform
William Annettwas named Chief Executive Officer of OncoCyte Corporation(OncoCyte) on June 16, 2015. Bill has extensive experience as a CEO of diagnostics companies and as an executive with Genentech and Accenture, among other companies. His deep experience with product commercialization at leading companies is of particular importance as OncoCyte prepares to launch its first liquid biopsy cancer diagnostic test, currently scheduled for 2016.
OncoCyte also reported positive results from its proprietary,
non-invasive, liquid biopsies diagnostics at the
American Association for Cancer Research(AACR) for bladder and breast cancer and the American Thoracic Society(ATS) for lung cancer diagnostics.
OncoCyte announced the appointment of
Andrew Arnoto its Board of Directors on July 15, 2015. Mr. Arno’s depth of experience in the capital markets, as well as advising emerging companies is expected to greatly benefit the company.
LifeMap Solutions, Inc.(LifeMap Solutions) continues to extend its lead as the premier commercial entity building on the new ResearchKit software framework developed by Apple, Inc.As previously announced in the first quarter, LifeMap Solutions launched the Asthma Healthapp. Asthma Healthserves as the interface for participants in a large-scale medical asthma research study with the Icahn School of Medicineat Mount Sinai. In the second quarter, the Company posted initial user-behavior findings to the official ResearchKit blog; these initial findings showed the app's user-retention numbers to be comparable to those of top-charting apps like social networks.
In collaboration with the
Mount Sinai- National Jewish Health Respiratory Institute, the Company has also developed a clinical-care app that empowers Chronic Obstructive Pulmonary Disease (COPD) patients to manage their condition under the oversight of a physician. This app, COPD Navigator, continues in its pilot program at Mount Sinai. The company has announced that it will build additional clinical-care apps to manage different chronic conditions.
In the first half of 2015,
BioTimewas notified of the issuance of 27 new patents that add to over 700 patents and patent applications filed world wide and licensed or owned by the BioTimefamily of companies in the field of regenerative medicine. The new patents, either issued or licensed to BioTimeor certain of its subsidiaries, includes seven U.S. patents, as well as twenty additional patents issued in Europe, Japan, Canadaand Singapore.
BioTime’s operating revenues are currently generated from research grants, licensing fees and royalties from the sale of Hextend®, and advertising from the marketing of the LifeMap Sciences, Inc.’s (LifeMap Sciences) online database products, and from the sale of hydrogels and stem cell products for research.
Total consolidated revenues for the six months ended
Consolidated operating expenses for the second quarter were
Operating expenses for the six months ended
Net loss attributable to
Net loss attributable to
Net losses attributable to
Balance Sheet and Subsequent Financing Events
Cash and cash equivalents totaled
During the six months ended
$2.8 milliongross proceeds from the sale of Asterias AST common stock in “at-the-market” transactions;
$5.5 millionin aggregate gross proceeds from the public offering and concurrent private placement of Asterias’ common stock;
$11.7 millionfrom the exercise of 5,000,000 outstanding Asterias common share purchase warrants originally issued in June 2014;
$3.3 millionin non-dilutive funding from CIRM.
$621,000from the exercise of BioTimeoptions by employees.
Cell Cure Neurosciences
$1.9 millionin non-dilutive funding from the OCS.
$3.3 millionfrom the sale of 3,000,000 of OncoCyte common stock to long-term OncoCyte investors.
BioTime’s subsidiaries include the publicly traded
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for
To receive ongoing
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30, 2015||
|Cash and cash equivalents||$||31,465||$||29,487|
|Trade accounts and grants receivable, net||979||1,042|
|Prepaid expenses and other current assets||1,492||1,232|
|Total current assets||37,004||32,405|
|Equipment, net and construction in progress||5,652||2,858|
|Deferred license fees||282||337|
|Other long-term assets||6||10|
|Intangible assets, net||36,220||38,848|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||6,604||$||6,803|
|Capital lease liability, current portion||58||58|
|Related party convertible debt, net of discount||238||60|
|Deferred grant income||1,932||
|Deferred license and subscription revenue, current portion||360||208|
|Total current liabilities||9,192||7,129|
|Deferred tax liabilities, net||
|Deferred rent liabilities, net of current portion||36||97|
|Capital lease liability, net of current portion||3||31|
|Other long-term liabilities||30||28|
|Total long-term liabilities||
|Commitments and contingencies|
|Series A Convertible Preferred Stock, no par value, authorized 2,000 shares as of June 30, 2015 and December 31, 2014; 70 issued and outstanding as of June 30, 2015 and December 31, 2014||3,500||3,500|
|Common shares, no par value, authorized 125,000 shares as of June 30, 2015 and December 31, 2014; 83,281 issued and 78,387 outstanding as of June 30, 2015 and 83,122 issued and 78,228 outstanding at December 31, 2014||235,555||234,850|
|Accumulated other comprehensive income/(loss)||(131||)||186|
|Treasury stock at cost: 4,894 shares at June 30, 2015 and at December 31, 2014||(19,890||)||(19,890||)|
|BioTime, Inc. shareholders' equity||
|Total shareholders' equity||
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||79,610||$||74,901|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(IN THOUSANDS, EXCEPT PER SHARE DATA)|
Three Months Ended
Six Months Ended
|Royalties from product sales||117||76||274||174|
|Sale of research products and services||98||91||188||189|
|Cost of sales||(260||)||(252||)||(525||)||(383||)|
|Research and development||(9,059||)||(9,081||)||(18,383||)||(17,470||)|
|General and administrative||(6,186||)||(4,836||)||(11,365||)||(8,503||)|
|Total operating expenses||(15,245||)||(13,917||)||(29,748||)||(25,973||)|
|Loss from operations||(13,496||)||(13,062||)||(27,005||)||(24,183||)|
Interest income/(expenses), net
|Other income, net||225||165||35||234|
|Total other income/(expenses), net||229||155||(44||)||216|
|LOSS BEFORE INCOME TAX BENEFIT||(13,267||)||(12,907||)||(27,049||)||(23,967||)|
|Deferred income tax benefit||1,271||1,513||2,448||
|Net loss attributable to noncontrolling interest||2,305||1,874||4,736||3,496|
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC.||(9,691||)||(9,520||)||(19,865||)||(17,609||)|
|Dividends on preferred shares||(52||)||(34||)||(52||)||(34||)|
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS (1)||$||(9,743||)||$||(9,554||)||$||(19,917||)||$||(17,643||)|
BASIC AND DILUTED NET LOSS PER COMMON SHARE (1)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED
|(1) Basic and diluted loss per common share is calculated using "Net loss attributable to BioTime, Inc. common shareholders."|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
Three Months Ended
Six Months Ended
|Other comprehensive loss, net of tax:|
|Change in foreign currency translation and other comprehensive income/(loss) from equity investments:|
|Foreign currency translation loss||(317||)||(41||)||(318||)||(148||)|
|Unrealized gain/(loss) on available-for-sale securities, net of taxes||-||1||1||(1||)|
|Less: Comprehensive loss attributable to noncontrolling interest||(2,305||)||(1,874||)||(4,736||)||(3,496||)|
|COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS BEFORE PREFERRED STOCK DIVIDEND||(10,008||)||(9,560||)||(20,182||)||(17,758||)|
|Preferred stock dividend||(52||)||(34||)||(52||)||(34||)|
|COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS(1)||$||(10,060||)||$||(9,594||)||$||(20,234||)||$||(17,792||)|
(1) Comprehensive loss includes foreign currency translation loss of