- The ongoing Phase I/IIa clinical trial is evaluating the safety of three different dosage regimens of OpRegen ® in the advanced form of dry age-related macular degeneration (Dry-AMD). Dry-AMD is a condition for which there is currently no FDA-approved therapy. Preliminary data from the first cohort of patients treated in this trial of OpRegen ® resulted in no serious adverse events. Imaging data from the first patient who completed one-year of post-treatment clinical assessment may indicate that the graft can survive for at least 12 months. These and other data will be presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT), on December 2, in Rome, Italy.
- Enrollment in the second cohort, in which patients are receiving a higher and more clinically meaningful 200,000 cell dose, is expected to be complete by year end 2016, and data are expected early in 2017.
- Additional data, from the third cohort, which is expected to commence before year end, is anticipated by the end of 2017.
- US clinical trial sites are expected to be announced in early 2017.
- The Renevia ® pivotal clinical trial for HIV-related facial lipoatrophy continues to enroll new patients and is on track to complete patient enrollment by the end of 2016. The objective of the trial is to assess the safety and efficacy of Renevia ® in restoring normal skin contours in patients whose subcutaneous fat has been lost due to antiviral drug treatment for HIV. BioTime expects top-line efficacy data in the first half of 2017. If the data are positive, the company plans to submit an application for CE mark approval in Europe shortly thereafter.
- Positive data from the pivotal trial could provide support for future studies of Renevia ® in certain broader applications of fat tissue deficits. These include various medical aesthetics applications, such as age-related and trauma-related facial fat loss.
- In September, BioTime's affiliate Asterias Biotherapeutics, Inc. (NYSE MKT: AST), announced positive data from the AST-OPC1 SCiSTAR Phase 1/2a clinical study in patients with complete cervical spinal cord injuries. All patients in the initial cohort who received 10 million AST-OPC1 cells showed at least one motor level of improvement (regaining some function in their arms), while two of five patients achieved two motor levels of improvement (regaining some function in their arms, hands and fingers) on at least one side of their body. The data were presented at the Annual Scientific Meeting of the International Spinal Cord Society (ISCoS) in Vienna, Austria.
- Six-month efficacy data on this first cohort are expected to be announced in January 2017. Enrollment is also ongoing in a new cohort in which patients are receiving a higher dose of 20 million cells.
- In August, BioTime's subsidiary OncoCyte Corporation (NYSE MKT: OCX) closed a financing with both new and existing investors, providing OncoCyte with gross proceeds of $10.55 million, before deducting placement agent fees and offering expenses.
- Data was presented related to OncoCyte's lead product, a confirmatory diagnostic for lung cancer screening. OncoCyte expects to complete the study by year end and, if successful, could launch the product by mid-year 2017.
- In August, BioTime strengthened its regenerative medicine intellectual property portfolio with the issuance of 31 new patents. This included nine in the U.S. and 22 in Australia, Canada, China, India, Israel, and Japan. The new patents supplement the existing portfolio of more than 700 patents and patent applications owned or licensed by the BioTime family of companies worldwide.
- In October, BioTime strengthened its senior management team with the appointment of Jim Knight as Senior Vice President, Head of Corporate Development. Mr. Knight is a highly accomplished professional with an extensive skill set and knowledge that is applicable immediately, as the company has started reporting encouraging early clinical data on its key programs.
|Three months ended September 30, 2016||Three months ended September 30, 2015|
|Consolidated Results of Operations||Asterias||Consolidated Results less Asterias||Consolidated Results of Operations||Asterias||Consolidated Results less Asterias|
|BIOTIME, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS)|
|September 30, 2016 (Unaudited)||December 31, 2015|
|Cash and cash equivalents||$||30,451||$||42,229|
|Available for sale securities||903||753|
|Trade accounts and grants receivable, net||1,604||1,078|
|Prepaid expenses and other current assets||2,079||2,610|
|Total current assets||35,152||47,237|
|Property, plant and equipment, net and construction in progress||4,726||7,539|
|Deferred license fees||145||322|
|Deposits and other long-term assets||1,011||1,299|
|Equity method investment in Asterias, at fair value||92,210||-|
|Equity method investment in Ascendance||3,482||4,671|
|Intangible assets, net||10,848||33,592|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||7,176||$||9,377|
|Capital lease liability, current portion||173||38|
|Promissory notes, current portion||95||95|
|Related party convertible debt, net of discount, current portion||357||-|
|Deferred grant income||-||2,513|
|Deferred license and subscription revenue, current portion||537||439|
|Total current liabilities||8,338||12,462|
|Deferred revenues, net of current portion||385||615|
|Deferred rent liabilities, net of current portion||46||158|
|Related party convertible debt, net of discount, net of current portion||954||324|
|Promissory notes, net of current portion||173||220|
|Capital lease, net of current and other liabilities||89||34|
|Commitments and contingencies|
|Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding||-||-|
|Common shares, no par value, 150,000 shares authorized; 103,392 shares issued and 102,772 shares outstanding at September 30, 2016; 94,894 issued and 90,421 outstanding at December 31, 2015||313,506||274,342|
|Accumulated other comprehensive loss||(690||)||(237||)|
|Treasury stock at cost: 620 shares at September 30, 2016 and 4,473 shares at December 31, 2015||(2,891||)||(18,033||)|
|BioTime, Inc. shareholders' equity||119,391||26,891|
|Total shareholders' equity||136,241||76,447|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||147,574||$||94,660|
|BIOTIME, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Royalties from product sales and license fees||177||357||463||631|
|Subscription and advertisement revenues||69||343||700||1,020|
|Sale of research products and services||144||140||331||328|
|Cost of sales||(58||)||(432||)||(378||)||(957||)|
|Research and development||(6,422||)||(11,433||)||(29,093||)||(29,816||)|
|General and administrative||(4,574||)||(7,545||)||(23,083||)||(18,911||)|
|Total operating expenses||(10,996||)||(18,978||)||(52,176||)||(48,727||)|
|Loss from operations||(9,555||)||(17,104||)||(47,714||)||(44,109||)|
|Interest income/(expense), net||(167||)||(12)||(513||)||(207||)|
|BioTime's share of losses in equity method investment in Ascendance||(855||)||-||(1,189||)||-|
|Gain on deconsolidation of Asterias||-||-||49,048||-|
|Gain on equity method investment in Asterias at fair value||40,015||-||26,532||-|
|Other income/(expense), net||(173||)||(573||)||197||(408||)|
|Total other income/(expense), net||38,820||(585||)||74,075||(615||)|
|INCOME (LOSS) BEFORE INCOME TAX BENEFIT||29,265||(17,689||)||26,361||(44,724||)|
|Deferred income tax benefit||-||948||-||3,395|
|NET INCOME (LOSS)||29,265||(16,741||)||26,361||(41,329||)|
|Net loss attributable to non-controlling interest||1,934||3,115||12,286||7,762|
|NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.||31,199||(13,626||)||38,647||(33,567||)|
|Dividends on preferred shares||-||(363||)||-||(415||)|
|NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS||31,199||(13,989||)||38,647||(33,982||)|
|NET INCOME (LOSS) PER COMMON SHARE:|
|WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:|