Asterias Biotherapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Highlights Recent Development Progress
Tuesday, March 28, 2017 4:01:00 PM ET
Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today reported financial and operational results for the fourth quarter and year ended December 31, 2016 as well as recent corporate progress.
"Asterias has achieved substantial progress over the last year, highlighted by previously announced positive interim efficacy and safety results from our ongoing SCiStar Phase 1/2a clinical trial, as well as initiation of operations at our new cGMP manufacturing facility for AST-OPC1," said Steve Cartt, President and Chief Executive Officer. "We are particularly encouraged by the results we have seen to date in the SCiStar trial, which we believe provide solid evidence of the potential for AST-OPC1 to help patients with complete paralysis recover arm, hand and finger function. Such recovery is critically important to increasing both independence and quality of life in patients who suffer complete cervical spinal cord injuries. In 2017, we look forward to completing study enrollment, engaging in discussions with the FDA to determine our optimal clinical path forward, and reporting more efficacy and safety data later in the year as it becomes available."
As of February 28, 2017, Asterias cash and cash equivalents totaled $19.9 million and combined with its available-for-sale securities totaled $33.5 million.
"Our cash position is significantly improved from the same time last year, which allows us to continue to advance our programs towards important development milestones," said Ryan Chavez, Chief Financial Officer. "We believe we currently have sufficient capital to fund operations through at least the first quarter of 2018."
2016 and Recent Key Achievements
-- Presented positive early efficacy data from the first cohort of the SCiStar study testing a dose of AST-OPC1 within the predicted efficacious dose range. In this cohort, 10 million AST-OPC1 cells were delivered to patients with neurologically complete (AIS-A 10) cervical injuries. Patients from this cohort showed improvement in upper extremity motor function at 3-months following administration of AST-OPC1. Asterias subsequently reported efficacy results for five patients from this cohort that showed additional motor function improvement at 6-months and 9-months following administration of AST-OPC1. Earlier this month, Asterias reported that the sixth, and final, patient in this cohort showed additional motor function improvement at 6-months following administration of AST-OPC1. The results suggest a meaningful and favorable difference to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 versus the level of expected rates of spontaneous recovery shown from historical control data of a closely matched patient population.
-- Received FDA clearance to expand the SCiStar study to include two additional cohorts of subjects with less severe AIS-B (motor complete, sensory incomplete) injuries.
-- Commenced dosing of two additional cohorts in the SCiStar study: AIS-B patients treated with 10 million AST-OPC1 cells; and, following clearance by the studys Data Monitoring Committee, AIS-A patients treated with the higher dose of 20 million AST-OPC1 cells.
-- Successfully completed the validation and start-up of its internal current Good Manufacturing Practices (cGMP) manufacturing facility at Asterias headquarters in Fremont, CA in preparation for late-stage clinical trials of AST-OPC1.
-- Reported positive long-term follow-up results from the Phase 1 clinical trial of AST-OPC1.
-- Received Orphan Drug Designation from FDA for AST-OPC1 for the treatment of acute spinal cord injury.
-- Successfully completed an End-of-Phase 2 meeting with the FDA for AST-VAC1 in Acute Myeloid Leukemia (AML).
-- Completed clinical protocol development and the transfer of the manufacturing processes to produce AST-VAC2 to Cancer Research UK (CRUK) as part of the companys ongoing partnership with CRUK to conduct a Phase 1/2a study for AST-VAC2 in non-small cell lung cancer.
Total revenues were $1.8 million for the fourth quarter and $7.0 million for the year ended December 31, 2016. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $7.9 million in the fourth quarter and $25.5 million in the year ended December 31, 2016, with the primary driver being expenses associated with our AST-OPC1 program. General and administrative expenses were $2.4 million in the fourth quarter and $15.5 million in the year ended December 31, 2016. Non-cash expenses related to warrants distributed to shareholders other than BioTime earlier in the year, which were included in general and administrative expenses, were $5.3 million.
Net loss was $9.3 million, or $0.20 per share, for the fourth quarter and $35.5 million, or $0.83 per share, for the year ended December 31, 2016. For the year ended December 31, 2016, net cash used in operating activities was $19.0 million and net cash provided from financing activities was $28.5 million.
As of December 31, 2016, Asterias cash and cash equivalents totaled $19.8 million and combined with its available-for-sale securities totaled $35.1 million.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today, March 28, 2017, at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the results and corporate developments. For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 888-417-8525 (U.S./Canada) or 719-457-2731 (international) five minutes prior to the start of the call and providing the Conference ID 8401481. To access the live webcast, go to http://asteriasbiotherapeutics.com/events-presentations/ .
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 dialing 888-203-1112 (U.S./Canada) or 719-457-0820 (international) and providing the Conference ID 8401481. Additionally, the archived webcast will be available at http://asteriasbiotherapeutics.com/events-presentations/ .
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The companys proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The companys research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
Forward Looking Statements
Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, 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 businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.
ASTERIAS BIOTHERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Three months ended December Year ended
31, December 31,
2016 2015 2016 2015
Grant income $ 1,707 $ 600 $ 6,572 $ 3,007
Sale of cell lines - - - 40
License revenues - - 125 -
Royalties from product sales 44 8 257 535
Total revenues 1,751 608 6,954 3,582
Cost of sales (9) (3) (128) (268)
Total gross profit 1,742 605 6,826 3,314
Research and development (7,874) (5,403) (25,467) (17,321)
General and administrative (2,400) (2,830) (15,482) (7,901)
Total operating expenses (10,274) (8,233) (40,949) (25,222)
Loss from operations (8,532) (7,628) (34,123) (21,908)
Loss from change in fair value of warrant liability (740) - (3,108) -
Interest expense, net (134) (145) (546) (341)
Other income (expense), net (9) 2 (37) (6)
Total other expenses, net (883) (143) (3,691) (347)
LOSS BEFORE INCOME TAX BENEFIT (9,415) (7,771) (37,814) (22,255)
Deferred income tax benefit 69 2,867 2,325 7,252
NET LOSS $ (9,346) $ (4,904) $ (35,489) $ (15,003)
Basic and diluted net loss per common share $ (0.20) $ (0.13) $ (0.83) $ (0.42)
Weighted average common shares outstanding: basic and diluted 45,957 37,818 42,943 35,443
ASTERIAS BIOTHERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)
December 31, December 31,
Cash and cash equivalents $ 19,800 $ 11,183
Available-for-sale securities, at fair value 15,269 17,006
Landlord receivable - 567
Prepaid expenses and other current assets 1,921 1,033
Total current assets 36,990 29,789
Intangible assets, net 18,130 20,816
Property, plant and equipment, net 5,475 5,756
Investment in affiliates - 416
Other assets 415 457
Total noncurrent assets 24,020 27,445
TOTAL ASSETS $ 61,010 $ 57,234
LIABILITIES AND STOCKHOLDERS EQUITY
Amount due to BioTime, Inc. $ 288 $ 530
Accounts payable 1,076 747
Accrued expenses and other current liabilities 2,495 1,183
Capital lease liability, current 7 7
Deferred grant income 2,185 2,513
Total current liabilities 6,051 4,980
Warrant liability 8,665 -
Capital lease liability, noncurrent 20 26
Deferred tax liabilities, net - 2,550
Deferred rent liability 266 179
Lease liability 3,980 4,400
TOTAL LIABILITIES 18,982 12,135
Preferred Stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding - -
Common Stock, $0.0001 par value, authorized 75,000 Series A Common Stock and 75,000 Series B Common Stock; 47,567 and 38,228 shares Series A Common Stock issued and outstanding at December 31, 2016 and 2015, respectively; no Series B Common Stock issued and outstanding at December 31, 2016 and 2015 5 4
Additional paid-in capital 126,829 92,900
Accumulated other comprehensive income (loss) (1,078) 434
Accumulated deficit (83,728) (48,239)
Total stockholders equity 42,028 45,099
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY $ 61,010 $ 57,234
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SOURCE Asterias Biotherapeutics, Inc.