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- Four products currently in clinical development
- Three therapeutic products currently in late-stage preparation for clinical development
- Shares of Asterias subsidiary scheduled to trade publicly in near term
- LifeMap Solutions subsidiary launched to develop mobile health products
“BioTime’s efforts in the first quarter of 2014 were focused on
advancing near-term products through clinical trials while also
preparing certain novel stem cell-based therapeutics for clinical trials
later this year. Enrollment in three diagnostic clinical studies has
remained rapid, with completion expected later in 2014. Following the
successful safety trial of ReneviaTM, we have
made rapid progress in preparing for the pivotal ReneviaTM
trial during the second half of the year,” said
“We have continued to develop our subsidiaries’ businesses,” commented
Dr. West. “Shares of the Series A common stock of our subsidiary
“As the industry leader in regenerative medicine with over 600 patents
and patent applications worldwide,
First Quarter and Recent Highlighted Corporate Accomplishments
BioTimeannounced the successful completion of its ReneviaTM-01 safety study. ReneviaTM is being developed as a platform product with a wide array of potential therapeutic applications. The product is a biocompatible and injectable hyaluronan and collagen-based matrix designed to promote the stable engraftment of cells into the body. In the 10-patient study in Europe, ReneviaTM was injected subcutaneously without cells and all responses were localized, minor, and transient. Completion of this trial paves the way for a pivotal clinical efficacy trial planned for the second half of 2014 in which the matrix will be tested in combination with adipose stromal fraction for the treatment of lipoatrophy. The pivotal trial, if successful, could lead to an application for CE Mark approval for marketing in Europeand other markets outside the United States.
BioTimehas submitted to the United States Food and Drug Administration( FDA) a 510(k) premarket notification for Premvia™ as a Class II wound management medical device, and the FDAhas informed BioTimethat the 510(k) notification has been accepted for review. Premvia™, like ReneviaTM, is a member of BioTime’s HyStem® family of hydrogels. The product is being developed for use in the management of wounds, including partial and full-thickness wounds, tunneling wounds, pressure ulcers, diabetic ulcers, second degree burns, skin tears and draining wounds where a hydrating tissue matrix is needed.
OncoCyte Corporationinitiated clinical development of PanC-Dx™, its cancer diagnostic product, in both the United Statesand Chinafor use in detecting bladder cancer. In the United States, OncoCyte entered into a Clinical Trial Agreement with a leading medical institution with an international reputation for excellence and discovery, while in China, OncoCyte entered into a Fee-for-Service Agreement with China Medicine Inc., a contract research organization serving nine major medical institutions, including top-ranked university hospitals in Shanghaiand Wuhan. The goal of these clinical development initiatives is to determine the overall relative performance of OncoCyte’s PanC-Dx™ markers in bladder cancer. Enrollment is continuing at multiple clinical sites in two additional clinical studies that are collecting samples from patients undergoing screening for either breast or lung cancer. These patient samples will be used for the detection of lung and breast cancer.
May 6, 2014, LifeMap Solutions, Inc., a newly formed subsidiary of LifeMap Sciences, Inc., entered into an agreement with a major medical institution to work cooperatively to develop internet, web-based, mobile user or consumer software products to provide users with information that may aid them in improving lifestyle and healthcare decisions and outcomes.
In 2014 to date,
BioTime, and certain of its subsidiaries, have successfully raised additional financing totaling nearly $19 million. During the first quarter, BioTimeraised $3.5 millionthrough the sale of 70,000 shares of Series A Convertible Preferred Stock and also raised $8.8 millionof additional equity capital through the sale of BioTimecommon shares in “at-the-market” transactions. On May 1, 2014, BioTimereceived approximately $6.4 millionin additional equity financing. The funds were raised from current long-term investors in the company and will be used for funding product development, including this year's anticipated pivotal Renevia™ clinical trial, LifeMap Solutions’ mobile health applications, as well as other general operating expenses.
BioTimewas awarded three SBIR Phase 1 Small Business Grants totaling $787,434from the National Institute of General Medical Sciences(NIGMS) at the National Institutes of Health(NIH). Under the first grant entitled “Reagents for Targeted Ablation of Residual Contaminating Pluripotent Stem Cells” BioTimewill work to develop reagents that selectively identify and kill residual pluripotent cells while leaving the intended therapeutic stem cells unharmed. Under the second grant entitled “Rapid Multiplexed Nanoprobe Assays for Pluripotent Stem Cell Differentiation” BioTimewill use the funds for developing improved assays for monitoring stem cell differentiation. Under the third grant entitled “Cell Targeting Peptides for Isolating Patient Specific Stem Cells” BioTimewill work on streamlining PureStem® cell line development.
For the quarter ended
Operating expenses for the three months ended
Net loss attributable to
Balance Sheet and Subsequent Financing Events
Cash and cash equivalents, on a consolidated basis, totaled
During the three months ended
Asterias Biotherapeutics, Inc.is a subsidiary focused on developing cell therapies. Included in its portfolio are two clinical stage cell therapy product candidates for use in neurology and oncology. OPC1 is a formulation of human embryonic stem (hES) cell-derived oligodendrocyte progenitors for the treatment of spinal cord injury and other neurodegenerative disease. VAC2 is a formulation of hES cell-derived dendritic cells intended to function as a vaccine to train a patient’s immune system to destroy telomerase positive cancer cells. Telomerase is a protein abnormally expressed in over 95% of all human cancers.
OncoCyte Corporationis developing products and technologies to diagnose and treat cancer.
Cell Cure Neurosciences Ltd.(“Cell Cure Neurosciences”) is an Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders, including the development of retinal pigment epithelial cells for the treatment of macular degeneration, and treatments for multiple sclerosis.
LifeMap Sciences, Inc.(“LifeMap Sciences”) 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 products.
ES Cell International Pte Ltd., a Singaporeprivate limited company, developed clinical and research grade hES cell lines and plans to market those cell lines and other BioTimeresearch products in over-seas markets as part of BioTime’s ESI BIO Division.
BioTime Asia, Limited, a Hong Kongcompany, may offer and sell products for research use for BioTime’s ESI BIO Division.
OrthoCyte Corporationis 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|
March 31, 2014
|Cash and cash equivalents||$||6,637,834||$||5,495,478|
|Trade accounts and grants receivable, net||818,275||998,393|
|Prepaid expenses and other current assets||1,554,114||1,277,405|
|Total current assets||9,246,811||7,949,970|
|Deferred license and consulting fees||418,958||444,833|
|Other long-term assets||56,062||-|
|Intangible assets, net||44,840,087||46,208,085|
|LIABILITIES AND EQUITY|
|Accounts payable and accrued liabilities||$||5,443,063||$||6,722,624|
|Deferred license and subscription revenue, current portion||177,594||235,276|
|Total current liabilities||5,620,657||6,957,900|
|Deferred rent, net of current portion||28,054||35,997|
|Deferred tax liability, net||6,928,522||8,277,548|
|Other long-term liabilities||8,441||195,984|
|Total long-term liabilities||6,965,017||8,509,529|
|Commitments and contingencies|
|Preferred Shares, no par value, authorized 2,000,000 shares as of March 31, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of March 31, 2014 and December 31, 2013, respectively||3,500,000||-|
|Common shares, no par value, authorized 125,000,000 shares as of March 31, 2014 and December 31, 2013; 69,617,329 issued and 59,071,192 outstanding as of March 31, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013||211,943,421||203,456,401|
|Accumulated other comprehensive income/(loss)||(44,341||)||62,899|
|Treasury stock at cost: 10,546,137 and 10,697,715 shares at March 31, 2014 and at December 31, 2013, respectively||(42,372,546||)||(43,033,957||)|
|Total shareholders' equity||19,242,945||14,800,768|
TOTAL LIABILITIES AND EQUITY
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
Three Months Ended
March 31, 2014
March 31, 2013
|Royalties from product sales||97,886||107,599|
|Sale of research products||98,586||66,724|
|Cost of sales||(131,914||)||(182,749||)|
|Total revenues, net||934,721||431,724|
|Research and development||(8,405,393||)||(5,395,488||)|
|General and administrative||(3,667,171||)||(3,416,145||)|
|Loss from operations||(11,137,843||)||(8,379,909||)|
|Interest (expense)/income, net||(8,384||)||943|
|Loss on sale of fixed assets||(8,576||)||(1,523||)|
|Other income/(expense), net||77,746||(28,056||)|
|Total other income/(expenses), net||60,786||(28,636||)|
|LOSS BEFORE INCOME TAX BENEFIT||(11,077,057||)||(8,408,545||)|
|Income tax benefit||1,349,026||-|
Net loss attributable to noncontrolling interest
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC.||(8,099,014||)||(7,719,263||)|
|Foreign currency translation (loss)/gain||(104,590||)||148,437|
|Unrealized loss on available-for-sale securities, net||(2,650||)||-|
|BASIC AND DILUTED LOSS PER COMMON SHARE||$||(0.14||)||$||(0.15||)|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
Judith Segall, 510-521-3390, ext 301