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Asterias Biotherapeuticsapproved for listing on NYSE MKT
Asterias’ AST-OPC1 cleared by
FDAfor Phase 1/2a dose escalation clinical trial for spinal cord injury
Cell Cure Neuroscience’s OpRegen®
FDAfor Phase 1/2a dose escalation clinical trial for the dry form of age-related macular degeneration
Renevia™ cleared for pivotal trial in
Europefor treatment of HIV-related lipoatrophy
Premvia™ cleared by
FDAas Class II medical device for wound management
BioTimeand its subsidiaries end October with $35 millionin cash to fund additional milestone achievements in 2015
“BioTime and its subsidiaries set in motion a rapid cadence of milestone
achievements in our clinical development of therapeutic and diagnostic
products during the third quarter,” said Dr.
“On the financial front, we raised
Third Quarter and Recent Highlights
BioTimereceived authorization to begin its pivotal human clinical trial of Renevia™ in Europeto treat HIV patients with premature facial aging caused by lipoatrophy. In the trial, Renevia™ will be used to deliver fat-derived cells to the patient’s face where there has been a loss of subdermal fat. Lipoatrophy is estimated to occur in 35-50% of the 10 million HIV patients worldwide on antiretroviral therapy.
Premvia™ was cleared for marketing by the
FDAas a Class II medical device for the management of wounds. Premvia™ is the first FDA-cleared member of BioTime’s HyStem® family of hydrogels, which are designed to mimic the natural structures of the human body’s extracellular matrix.
Michael H. Mulroyand Stephen L. Carttjoined BioTime’s Board of Directors. Mr. Mulroy and Mr. Cartt both had successful careers in senior management at Questcor Pharmaceuticals, Inc.where Mr. Mulroy served as Executive Vice President – Strategic Affairs and General Counsel and Mr. Cartt served as Chief Operating Officer.
BioTimeand certain of its subsidiaries raised $31 millionthrough sales of BioTimecommon shares in a registered direct offering.
AST-OPC1 was cleared by the
FDAfor the initiation of a dose escalation Phase 1/2a clinical trial in patients with complete cervical spinal cord injury. A large portion of the cost of this trial will be paid by grant support from the California Institute for Regenerative Medicine(CIRM).
AST-VAC2, an immunotherapy treatment, will be the subject of a
Phase 1/2a clinical trial in patients with non-small cell lung cancer
UK, contingent on regulatory approval, through an agreement entered into by Asterias and Cancer Research UK(CRUK) under which CRUK will pay for the cost of the trial.
- Asterias became the first of BioTime’s subsidiaries to be publicly traded. Asterias common stock now trades on the NYSE MKT under the ticker symbol AST.
OpRegen®, a therapy designed for patients with the
severe form of age-related macular degeneration (AMD) called
geographic atrophy, was cleared by the
FDAfor a Phase 1/2a clinical trial. AMD is the leading cause of blindness in the aging US population and many other developed countries around the world. There is currently no FDA-approved therapy for the dry form of AMD.
OncoCyte Corporationand The Wistar Institutecontinued their collaboration on a large, multi-site clinical study of blood-based lung cancer diagnostic markers. Over 600 blood samples were obtained from patients with a high-risk profile for development of lung cancer at six clinical sites. Wistar investigators are currently assessing gene expression patterns in blood cells of patients with malignant versus non-malignant lung disease. The performance of gene markers tested in the study in determining the presence or the progression of disease in various categories of patients may determine the specific nature of the lung cancer test that OncoCyte will develop.
OncoCyte expanded the clinical development of its urine-based bladder
cancer diagnostic test by initiating a multi-site clinical trial. The
trial will involve up to 1,200 patient samples obtained from at least
four large urology clinics located throughout
the United States. The multi-site clinical trial has been initiated in part due to positive interim data from the ongoing study in pathology specimens.
OncoCyte entered into a collaboration with
Abcodia Ltd.to develop OncoCyte’s blood-based PanC-Dx™, a test for early detection of breast cancer. OncoCyte will test the performance of PanC-Dx™ cancer markers in detecting breast cancer in a set of blood samples taken from study subjects both before and after they developed breast cancer. If the outcome of this initial study is promising, future studies could proceed and expand into the use of a larger cohort to assess PanC-Dx™ cancer markers in a case-controlled longitudinal design.
LifeMap Solutions strengthened its management team with the
Rafhael Cedenoas Chief Technology Officer and Head of Product. Mr. Cedeno will be responsible for overseeing all aspects of product development, including the integration of Mount Sinai’s expertise and data into LifeMap Solutions’ products. In addition, Joel Dudley, PhD, Rong Chen, PhD, and Elissa Levinfrom Mount Sinai’s Icahn School of Medicinewill work with LifeMap Solutions science team to develop LifeMap Solutions’ mobile health products and services.
Third Quarter Financial Results
For the three months ended
Operating expenses for the three months ended
Net loss attributable to
Year-to-Date Financial Results
For the nine months ended
Operating expenses for the first nine months of 2014, on a consolidated
Net loss attributable to
Balance Sheet and Subsequent Financing Events
Cash and cash equivalents, on a consolidated basis, totaled
During the nine months ended
In addition to the above capital raise, during early
Asterias Biotherapeutics, Inc. is developing pluripotent stem-cell based therapies in neurology and oncology, including AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury, multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based cancer vaccine. Asterias trades publicly on the NYSE MKT under the symbol AST.
BioTime Asia, Ltd., a Hong Kongcompany, may offer and sell products for research use for BioTime’s ESI BIO Division.
Cure Neurosciences Ltd. is an
Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders. OpRegen® is currently in a Phase I/IIa clinical trial for the treatment of the dry-form of age-related macular degeneration.
ESI BIOis the research and product marketing division of BioTime, providing stem cell researchers with products and technologies to enable them to translate their work into the clinic, including PureStem® progenitors and HyStem® hydrogels.
- LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®, the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery® database of embryonic development, stem cell research, and regenerative medicine, and MalaCards, the human disease database.
- LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on developing mobile health (mHealth) products.
- OncoCyte Corporation is developing products and technologies to diagnose and treat cancer, including PanC-Dx™, with four clinical studies currently underway.
- OrthoCyte Corporation is developing therapies to treat orthopedic disorders, diseases and injuries.
- ReCyte Therapeutics, Inc. is developing therapies to treat a variety of cardiovascular and related ischemic disorders, as well as products for research using cell reprogramming technology.
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|
|September 30, 2014||December 31,|
|Cash and cash equivalents||$||7,416,235||$||5,495,478|
|Trade accounts and grants receivable, net||1,014,183||998,393|
|Prepaid expenses and other current assets||1,255,479||1,277,405|
|Total current assets||9,939,464||7,949,970|
|Deferred license and consulting fees||364,208||444,833|
|Other long-term assets||53,127||-|
|Intangible assets, net||42,104,092||46,208,085|
|LIABILITIES AND EQUITY|
|Accounts payable and accrued liabilities||$||5,550,698||$||6,722,624|
|Capital lease liability, current portion||57,500||-|
|Related party convertible debt, net of discount||3,088||-|
|Deferred license and subscription revenue, current portion||177,574||235,276|
|Total current liabilities||5,788,860||6,957,900|
|Capital lease, net of current portion||44,963||-|
|Deferred tax liability, net||10,787,141||8,277,548|
|Other long-term liabilities||79,108||231,981|
|Total long-term liabilities||10,911,212||8,509,529|
|Commitments and contingencies|
|Preferred shares, no par value, authorized 2,000,000 shares as of September 30, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of September 30, 2014 and December 31, 2013, respectively||3,500,000||-|
|Common shares, no par value, authorized 125,000,000 shares as of September 30, 2014 and December 31, 2013; 73,690,302 issued and 68,291,760 outstanding as of September 30, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013||201,298,235||203,456,401|
|Accumulated other comprehensive (loss)/income||(150,691)||62,899|
|Treasury stock at cost: 5,398,542 and 10,697,715 shares at September 30, 2014 and at December 31, 2013, respectively||(22,119,467)||(43,033,957)|
|BioTime stockholders' equity||10,981,369||14,800,768|
|Total stockholders' equity||38,954,592||42,262,321|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||55,654,664||$||57,729,750|
BIOTIME, INC. AND SUBSIDIARIES
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
Three Months Ended
Nine Months Ended
|Royalties from product sales||147,811||80,592||321,806||291,505|
|Sale of research products and services||110,555||90,272||299,615||214,277|
|Cost of sales||(230,901)||(206,678)||(614,080)||(570,237)|
|Research and development||(8,836,341)||(6,441,462)||(26,267,792)||(17,389,409)|
|General and administrative||(4,261,450)||(4,267,875)||(12,764,324)||(11,273,948)|
|Total operating expenses||(13,097,791)||(10,709,337)||(39,032,116)||(28,663,357)|
|Loss from operations||(12,137,589)||(10,201,953)||(36,280,725)||(26,691,743)|
|Interest (expense)/income, net||(7,632)||509||(29,786)||2,033|
|(Loss)/gain on sale or write off of fixed assets||(133)||5,830||(8,709)||5,120|
|Other (expense)/income, net||(118,796)||(60,704)||165,135||(169,512)|
|Total other (expenses)/income, net||(126,561)||(54,365)||126,640||(162,359)|
|LOSS BEFORE INCOME TAX BENEFIT||(12,264,150)||(10,256,318)||(36,154,085)||(26,854,102)|
|Deferred income tax benefit||
|Net loss attributable to non-controlling interest||1,683,532||1,253,150||5,151,013||2,583,581|
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC.||(8,267,925)||(9,003,168)||(25,828,095)||(24,270,521)|
|Dividends on preferred shares||(34,038)||-||(34,038)||-|
|Net loss attributable to common shareholders||(8,301,963)||(9,003,168)||(25,862,133)||(24,270,521)|
|Unrealized loss on available-for-sale assets||(1,210)||-||(2,740)||-|
|Foreign currency translation (loss)/gain||(66,768)||7,016||(216,330)||184,310|
|TOTAL COMPREHENSIVE LOSS||$||(8,335,903)||$||(8,996,152)||$||(26,047,165)||$||(24,086,211)|
|BASIC AND DILUTED NET LOSS PER COMMON SHARE||$||(0.12)||$||(0.16)||$||(0.41)||$||(0.45)|
|WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC AND DILUTED||67,920,853||55,621,564||62,594,212||53,545,834|
Judith Segall, 510-521-3390 ext. 301
EVC Group, Inc.
Brian Moore, 310-579-6199
Gregory Gin, 862-236-0673
Doug Sherk, 415-652-9100