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Conference Call and Webcast Today at
“I’m happy with the tremendous progress we made last year in all three of our strategic objectives, clinical development, simplification and unlocking value of non-core programs,” said Adi Mohanty, Co-Chief Executive Officer. “We still have more to do, and are well on our way to transforming the company in 2017.”
“This year is shaping up to be the year of data with top line data from
our registrational trial for Renevia® in
Renevia® (adipose cells + cell delivery matrix)
Positive early Renevia data presented at the
International Federation for Adipose Therapeutics and Sciencemeeting (IFATS) meeting in November. The data related to the treatment of the initial 9 run-in patients for BioTime’s ongoing pivotal clinical trial in Europeassessing the efficacy of Renevia for the treatment of HIV-associated lipoatrophy. In December, achieved the recruitment milestone of 50 patients enrolled in the trial. Data from the run-in portion of the study (N=9) indicated that adipose progenitor cells (fat cells), obtained from a liposuction aspirate, remained viable and were observed to proliferate when combined with Renevia hydrogel. Analysis suggests that the grafts retain volume over the assessment period, and the treating physician observed incremental volume was retained in patients who had progressed to the one-year follow-up evaluation. In addition, there were encouraging signs of new tissue regeneration observed. No serious adverse events were noted during the run-in portion of the study.
- Additional positive data from the pivotal trial would allow the Company to launch a commercial product in about a year and provide support for future studies of Renevia in certain broader indications of fat tissue deficits in various medical aesthetics applications, such as age-related and trauma-related facial fat loss.
- Top-line clinical trial results are expected to be read out mid-2017. If the data are positive, the Company plans to submit an application for CE Mark approval in Europe at the end of 2017.
OpRegen® (retinal pigment epithelial cells)
- Presented positive early OpRegen data at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) in December. The data from the first cohort in the Phase I/IIa clinical trial of OpRegen in the advanced form of dry age-related macular degeneration (dry-AMD). The data suggest that OpRegen is safe and well tolerated. Imaging data from a patient who completed one-year of post-treatment clinical assessment suggests that the graft can survive for at least 12 months.
- Enrollment in the second cohort, in which patients are receiving a higher and more clinically meaningful 200,000 cell dose started in 2016. The Company intends to approach the DSMB in the second quarter of this year for approval to begin administering the next higher 500,000 cell dose to the third cohort, and if approved, also begin the fourth cohort before year end.
An abstract with data from the first and second cohorts in the ongoing
trial has been accepted for poster presentation at the annual meeting
Association for Research in Vision and Ophthalmology(ARVO), which will take place in Baltimore, MD, May 7- 11.
- The Company is expanding the trial to U.S. sites and recently announced that two of the top retinal surgeons will be enrolling patients at their centers of excellence.
AST-OPC1 (oligodendrocyte progenitor cells)
In November, BioTime’s affiliate, Asterias (NYSE MKT: AST) reported
the successful administration of the highest dose of 20 million cells
of AST-OPC1 to a patient with complete cervical spinal cord injury
(SCI) as part of the SCiStar Phase I/IIa clinical trial. In
January 2017, they announced positive efficacy results that showed additional motor function improvement at 6-months and 9-months following administration of 10 million AST-OPC1 cells in 6 AIS-A patients with complete cervical SCIAsterias plans to initiate discussions with the FDAin mid-2017 to determine the most appropriate clinical and regulatory path forward for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)
In early March, BioTime’s affiliate,
OncoCyte(NYSE MKT: OCX) reported successful completion of a critical step in the development of its lung cancer diagnostic test by locking the prediction algorithm. The cancer diagnostic, has been selected for presentation in a poster discussion session at the 2017 American Thoracic Society (ATS) International Conferencethat will take place May 19-24in Washington, D.C.
The lung cancer diagnostic test targets a multi-billion dollar market
March 6, 2017, OncoCyteannounced the successful completion of the study and that it has locked the prediction algorithm of the test. Based on the study results, OncoCyteannounced that it will begin ramping-up its commercial capabilities in anticipation of the potential commercial launch of the test. OncoCytewill initiate a clinical validation phase for the diagnostic. During this phase, OncoCytewill also continue to carry out analytical validation studies to refine its operational stage laboratory processes, and will apply for certification of its CLIA diagnostic testing lab. Upon CLIA certification, OncoCytewill conduct a small CLIA lab validation study to demonstrate that the full assay system utilized in the CLIA lab provides the same results on clinical samples as those obtained in the R&D lab. OncoCytewill then begin a clinical validation study on a new set of at least 300 blinded prospectively collected blood samples to confirm whether the sensitivity and specificity of the test remain within commercial parameters in a CLIA operational setting. Assuming successful completion of these steps, OncoCyteanticipates launching the test commercially in the second half of 2017.
Simplification and Unlocking Value
OncoCytefinancials were deconsolidated from BioTime’s consolidated financial statements. This will be reflected in BioTime’s future quarterly and annual consolidated financial statements, beginning February 18, 2017.
BioTimeannounced that it expanded its ophthalmology portfolio with the acquisition of a world-wide license to ophthalmology-related intellectual (IP) property assets from University of Pittsburgh. The technology was developed in part in collaboration with BioTimescientists. The IP includes composition and methodologies to develop 3-D retinal tissue constructs from pluripotent cells for their implantation in patients with advanced stages of retinal degeneration.
BioTimecontinues to leverage and develop its delivery technology platforms. The Company’s Hystem® technology is being used to deliver Renevia. ReGylde™ is in preclinical development as a device for viscosupplementation and a combination product for drug delivery in osteoarthritis. Delivery is a third area of focus for the Company, in addition to aesthetics and ophthalmology.
BioTimeexpanded its senior management team with the appointments of Jim Knightas Senior Vice President of Corporate Development, in October, and Stephana Patton, Ph.D., J.D., as General Counsel, in February. These industry veterans further strengthen the BioTimemanagement team, complementing other management team additions, such as Oscar Cuzzani, M.D., Ph.D., Vice President of Clinical Development. Dr. Cuzzani joined in February 2016.
In January, the Company announced the opening of a new, state-of-the
art, cGMP manufacturing facility in
Jerusalem Bio Parkon the campus of Hadassah University Hospitalin Jerusalem. This facility has the capabilities to produce multiple cell therapy products.
In February, the Company successfully completed a public equity
offering raising net proceeds of approximately
$18.7 million. The raise was completed on attractive terms involving modest discounts and no warrants. It followed a similarly successful raise in June of 2016.
Cash and cash equivalents totaled
Revenues: Total revenues were $1.1 million for the fourth
quarter, compared to $1.5 million in the fourth quarter of 2015.
Asterias’ total revenues included in the fourth quarter of 2015
were $0.6 million as compared to none in 2016 due to the deconsolidation
R&D Expenses: Research and development expenses were $7.0
million for the fourth quarter, compared to $12.8 million for the
comparable period in 2015. For 2016, research and development expenses
The tables below show BioTime’s research and development expenses, by
program and by company, for the three months ended
Three Months Ended December 31
|BioTime and ESI||PureStem® progenitor and pluripotent cell lines, and related research products||$||1,427||$||1,609|
Hydrogel products, Renevia® and other HyStem ® products and research
|ReCyte Therapeutics||Cardiovascular therapy||262||231|
|Subtotal therapeutic projects||4,509||4,610|
|Asterias||Pluripotent cell therapy programs||-||5,483|
|LifeMap Sciences||Databases and mobile health products||1,099||1,459|
|Subtotal non-therapeutic projects||2,504||2,695|
|Total research and development expenses||$||7,013||$||12,788|
Year Ended December 31
|BioTime and ESI||PureStem® progenitor and pluripotent cell lines, and related research products||$||6,060||$||5,196|
|BioTime||Renevia® and other HyStem ® products and research||3,856||4,047|
|ReCyte Therapeutics||Cardiovascular therapy||949||1,142|
|Subtotal therapeutic projects||16,328||15,120|
|Asterias||Pluripotent cell therapy programs||8,684||17,322|
|LifeMap Sciences||Databases and mobile health products||5,348||5,251|
|Subtotal non-therapeutic projects||11,094||10,162|
|Total research and development expenses||$||36,106||$||42,604|
G&A Expenses: The tables below show BioTime’s general and
administrative expenses, by program and by company, for the three months
Three Months Ended December 31
|Subtotal therapeutic entities||3,025||4,619|
|Subtotal non-therapeutic entities||2,318||2,662|
|Total general and administrative expenses||$||5,343||$||10,223|
Year Ended December 31
|Subtotal therapeutic entities||11,570||
|Subtotal non-therapeutic entities||9,295||
|Total general and administrative expenses||$||28,426||$||29,134|
Net Income (loss) attributable to BioTime: Net loss
attributable to BioTime was $5.1 million, or
Conference Call and Webcast Details
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BioTime common stock is traded on the NYSE MKT and TASE under the symbol
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Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries and affiliates, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries and affiliates, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
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BIOTIME, INC. AND SUBSIDIARIES
|Three Months Ended||Years Ended|
|Royalties from product sales and license fees||81||88||544||719|
|Subscription and advertisement revenues||272||337||972||1,357|
|Sale of research products and services||405||130||736||458|
|Cost of sales||20||(155||)||(358||)||(1,107||)|
|Research and development||(7,013||)||(12,788||)||(36,106||)||(42,604||)|
|General and administrative||(5,343||)||(10,223||)||(28,426||)||(29,134||)|
|Total operating expenses||(12,356||)||(23,011||)||(64,532||)||(71,738||)|
|Loss from operations||(11,253||)||(21,705||)||(58,967||)||(65,809||)|
|Interest expense, net||(234||)||(133||)||(747||)||(340||)|
|BioTime’s share of losses and impairment in equity method investment in Ascendance||(3,482||)||(35||)||(4,671||)||(35||)|
|Gain on deconsolidation of Asterias||-||-||49,048||-|
|Gain on equity method investment in Asterias at fair value||7,829||-||34,361||-|
|Gain on investment||-||3,694||-||3,694|
|Other income/(expense), net||(601||)||245||(403||)||(160||)|
|Total other income/(expense), net||3,512||3,771||77,588||3,159|
|INCOME (LOSS) BEFORE INCOME TAX BENEFIT||(7,741||)||(17,934||)||18,621||(62,650||)|
|Deferred income tax benefit||-||1,120||-||4,516|
|NET INCOME (LOSS)||(7,741||)||(16,814||)||18,621||(58,134||)|
|Net loss attributable to non-controlling interest||2,665||3,382||14,951||11,143|
|NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.||(5,076||)||(13,432||)||33,572||(46,991||)|
|Dividends on preferred shares||-||-||-||(415||)|
|NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS||(5,076||)||(13,432||)||33,572||(47,406||)|
|NET INCOME (LOSS) PER COMMON SHARE:|
|WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:|
BIOTIME, INC. AND SUBSIDIARIES
|December 31,||December 31,|
|Cash and cash equivalents||$||22,088||$||42,229|
|Available for sale securities||627||753|
|Trade accounts and grants receivable, net||446||1,078|
Receivable from affiliates
|Prepaid expenses and other current assets||1,777||2,610|
|Total current assets||25,649||47,237|
|Property, plant and equipment, net and construction in progress||5,529||7,539|
|Deferred license fees||118||322|
|Deposits and other long-term assets||1,031||1,299|
|Equity method investment in Asterias, at fair value||100,039||
Equity method investment in Ascendance
|Intangible assets, net||10,206||33,592|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||7,144||$||9,377|
|Capital lease liability, current portion||202||38|
|Promissory notes, current portion||99||95|
Related party convertible debt, net of discount, current portion
|Deferred grant income||-||2,513|
|Deferred license and subscription revenue, current portion||572||439|
|Total current liabilities||8,850||12,462|
|Deferred revenues, net of current portion||308||615|
|Deferred rent liabilities, net of current portion||50||158|
Capital lease liability, net of current portion
|Related party convertible debt, net of discount||1,032||324|
|Promissory notes, net of current portion||120||220|
|Other long term liabilities||8||8|
|Commitments and contingencies|
Series A Convertible preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of December 31, 2016 and 2015, respectively
|Common stock, no par value, authorized 150,000 shares; issued and outstanding shares; 103,396 shares issued and 102,776 outstanding as of December 31, 2016 and 94,894 issued and 90,421 outstanding as of December 31, 2015||
|Accumulated other comprehensive loss||(738)||(237)|
|Treasury stock at cost: 620 and 4,473 shares at December 31, 2016 and 2015, respectively||(2,891)||(18,033)|
|BioTime, Inc. shareholders' equity||
|Total shareholders' equity||130,508||76,447|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||142,572||$||94,660|