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- First Cohort in OpRegen® Trial Completed
- Management to Host Investor Conference Call on
“We are off to a strong start in 2016 as we continue to make progress with BioTime’s key clinical therapeutic programs, Renevia® in medical aesthetics and OpRegen® in dry AMD,” said
First Quarter and Recent Highlights
OpRegen® (retinal pigment epithelial cells)
- The first cohort was successfully dosed earlier this year in a Phase I/IIa clinical trial evaluating the safety and efficacy of OpRegen® for the treatment of the advanced form of dry age-related macular degeneration (AMD). The trial is evaluating three different dose regimens.
BioTimeexpects the Data Safety Monitoring Board (DSMB), an independent group of experts established for the Phase I/IIa trial, will complete its review of the initial safety data from the first cohort and recommend dose escalation to the second cohort during the second quarter of 2016. The second cohort will receive a higher, more clinically significant, dose of OpRegen®. The Company expects to complete enrollment in the second cohort in 2016 and, if the data are positive, anticipates DSMB approval to proceed to the third cohort by the end of 2016. OpRegen® has received Fast Track designation from the U.S. Food and Drug Administrationfor the treatment of dry AMD, which occurs in approximately 90% of those afflicted with AMD.
Renevia® (adipose cells + cell delivery matrix)
- The Company expects to complete enrollment for its Renevia® pivotal clinical trial in
Europein the second half of 2016 with top line data availability in early 2017. If the data are positive, BioTimeplans to submit an application for CE Mark approval in the first half of 2017. The objective of the trial is to assess the efficacy of Renevia®, which consists of BioTime’s HyStem® hydrogel cell-transplantation delivery matrix combined with the patient’s own adipose cells, in restoring normal skin contours in patients whose subcutaneous fat, or adipose tissue, has been lost due to antiviral drug treatment for HIV. Positive data from the pivotal trial is expected to provide the foundation for studying Renevia® in the much broader applications of fat tissue deficits in various medical aesthetics applications, such as for age-related and trauma related facial fat loss.
AST-VAC1 (antigen-presenting autologous dendritic cells)
- In February, BioTime’s subsidiary
Asterias Biotherapeutics, Inc.completed the End-of-Phase 2 meeting with the U.S. Food and Drug Administration( FDA) for AST-VAC1, the company's lead clinical program targeting maintenance of relapse-free-survival in acute myeloid leukemia (AML) patients. Asterias is planning for the initiation of a single pivotal Phase 3 trial that could support an accelerated development pathway towards a potential future biologic license application (BLA) filing.
- Asterias presented data from the Phase II clinical trial of its cancer immunotherapy AST-VAC1 in acute myeloid leukemia (AML) at the
American Society of Gene and Cell Therapy(ASGCT) 19th Annual Meeting on May 5, 2016.
AST-OPC1 (oligodendrocyte progenitor cells)
Asterias Biotherapeuticspresented an overview of the AST-OPC1 therapeutic development program that is currently in a Phase I/IIa dose escalation clinical trial in spinal cord injury at the Stem Cell Summit 2016 meeting on April 27, 2016.
OncoCyte Corporation, the cancer diagnostics subsidiary of BioTimeand developer of novel, non-invasive blood and urine based tests for the early detection of cancer, announced that its bladder cancer abstract has been selected for presentation in a poster session, including a live panel discussion on the results, at the 2016 American Society of Clinical Oncology( ASCO) Annual Meeting in Chicago, Illinoisto be held on June 3-7, 2016. The study to be presented at the upcoming ASCOannual meeting is based on the continued development of the diagnostic first reported at the American Association for Cancer Research(AACR) 2015 Annual Meeting. At AACR, OncoCytepresented interim clinical study data for the non-invasive detection of bladder cancer that demonstrated a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer.
April 4, 2016, OncoCyteand the Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, announced positive research results for a lung cancer diagnostic test being developed at Wistar. This study of 620 subjects replicates a previous study that was carried out at Wistar, which was presented at the American Thoracic Societyconference in May 2015. The results of this study are being further evaluated by OncoCyteand mark a successful transition of the assay platform from Illuminamicroarrays to a NanostringnCounter® machine, which is the platform that OncoCyteintends to use for commercialization. OncoCytehas exclusive commercial rights to the lung cancer diagnostic test developed by Wistar. OncoCytemust now independently validate these results in its own follow-up study based on the results of Wistar’s latest study. OncoCytewill attempt to finalize and lock down both the assay and the classifier or algorithm that interprets test results, and if successful, will initiate an internal analytical validation study.
- LifeMap Solutions, the digital health subsidiary of
BioTimeand co-developer of ResearchKit-enabled app Asthma Health, launched its new mobile health app design and development service to help research institutions and health companies worldwide develop custom smartphone apps and research studies. Through the new service, LifeMap offers clients its deep expertise in medical science, consumer behavior, app analytics, and design. LifeMap’s innovative, data-driven mobile health (mHealth) apps are designed to recruit clinical study participants, obtain patient consent through the iPhone, and passively collect participants’ health information. LifeMap Solutions has developed innovative digital health apps in collaboration with leading research institutions including the Icahn School of Medicineat Mount Sinai, Stanford University School of Medicine, and National Jewish Health, as well as with strategic partners like 23andMe.
May 10, 2016, Asterias finalized the pricing of an underwritten public offering of 5,147,059 units at a public offering price of $3.40per unit. Each unit consists of one share of common stock and 0.5 of a warrant to purchase a share of common stock at an exercise price of $4.37per share. The warrants are immediately exercisable and expire on the fifth anniversary of the date of issuance. The offering is expected to close on May 13, 2016, subject to customary closing conditions. If completed, Asterias would receive net proceeds of $16,275,000after underwriting discounts but before paying other costs of the offering. Asterias has granted the underwriters a 30-day option to purchase up to an additional 772,059 shares of common stock and/or additional warrants to purchase up to 386,029 shares of common stock to cover over-allotments, if any. If the over-allotment option is exercised in full, net proceeds of the offering after underwriting discounts but before other expenses are expected to be approximately $18.7 million.
April 28, 2016, Howard I. Scher, M.D., one of the world's leading oncology experts, was appointed to the Board of Directors of Asterias Biotherapeutics.
- In February, pharmaceutical industry veteran
Stephen L. Carttwas appointed as President and Chief Executive Officer of Asterias, and member of the company's Board of Directors. Mr. Cartt previously served as Chief Operating Officer of Questcor Pharmaceuticals Inc.until its sale in 2014 to Mallinckrodt, plcfor $5.6 billion. In addition, Don M. Baileywas appointed to Asterias' Board of Directors and named Chairman of the Board of Directors. Mr. Bailey previously served as President and Chief Executive Officer of Questcor until its sale in 2014 to Mallinckrodt.
First Quarter Financial Results
Cash (and available-for-sale securities) Position: Cash and cash equivalents totaled
Revenues: BioTime’s operating revenues are currently generated from research grants, licensing fees and advertising from the marketing of online database products. Total consolidated revenues were
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss attributable to
Conference Call and Webcast Details
The conference call dial-in number in the U.S./
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./
In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for
To receive ongoing
BIOTIME, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
|Three Months Ended|
|March 31,||March 31,|
|Subscription and advertisement revenues||$||420||$||319|
|Royalties from product sales||123||156|
|Sale of research products and services||43||90|
|Cost of sales||(225||)||(264||)|
|Research and development||13,734||9,323|
|General and administrative||11,872||5,179|
|Total operating expenses||25,606||14,502|
|Loss from operations||(23,758||)||(13,502||)|
|Interest income/(expense), net||(132||)||(25||)|
|BioTime’s share of losses in equity method investment in Ascendance||(235||)||-|
|Other income/(expense), net||128||(240||)|
|Total other income/(expense), net||(239||)||(265||)|
|LOSS BEFORE INCOME TAX BENEFIT||(23,997||)||(13,767||)|
|Deferred income tax benefit||-||1,177|
|Net loss attributable to non-controlling interest||6,885||2,423|
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC.||$||(17,112||)||$||(10,167||)|
|BASIC AND DILUTED NET LOSS PER COMMON SHARE||$||(0.19||)||$||(0.13||)|
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING:
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||27,132||$||42,229|
|Available for sale securities||829||753|
|Trade accounts and grants receivable, net||1,125||1,078|
|Prepaid expenses and other current assets||2,878||2,610|
|Total current assets||32,907||47,237|
|Property, plant and equipment, net and construction in progress||8,932||7,539|
|Deferred license fees||293||322|
|Deposits and other long-term assets||1,268||1,299|
|Equity method investment||4,436||4,671|
|Intangible assets, net||32,278||33,592|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||10,674||$||9,377|
|Capital lease liability, current portion||22||38|
|Promissory notes, current portion||95||95|
|Deferred grant income||2,269||2,513|
|Deferred license and subscription revenue, current portion||609||439|
|Total current liabilities||13,669||12,462|
|Deferred revenues, net of current portion||538||615|
|Deferred rent liabilities, net of current portion||261||158|
|Related party convertible debt, net of discount||394||324|
|Promissory notes, net of current portion||220||220|
|Capital lease, net of current and other liabilities||32||34|
|Commitments and contingencies|
|Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding||-||-|
|Common shares, no par value, 125,000 shares authorized; 94,894 issued and 90,421 outstanding as of March 31, 2016 and December 31, 2015||275,238||274,342|
|Accumulated other comprehensive loss||(60||)||(237||)|
|Treasury stock at cost: 4,473 shares as of March 31, 2016 and December 31, 2015||(18,033||)||(18,033||)|
|BioTime, Inc. shareholders' equity||10,852||26,891|
|Total shareholders' equity||59,592||76,447|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||80,114||$||94,660|
Dan L. Lawrence, 510-775-0510
EVC Group, Inc.
Michael Polyviou, 646-445-4800
Gotham Communications, LLC
Bill Douglass, 646-504-0890