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Asterias Biotherapeutics Reports First Quarter Financial Results and Recent Development Progress
-Continued positive interim efficacy and safety results reported during the quarter; multiple data readouts on the efficacy and safety of AST-OPC1 anticipated during 2017-
- Conference Call and Webcast Today, May 11, at 4:30 p.m. ET -

FREMONT, Calif., May 11, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today reported financial and operational results for the quarter ended March 31, 2017, as well as recent corporate progress.

"We are making good progress so far in 2017," said Steve Cartt, President and Chief Executive Officer. "In January and March, we reported positive clinical results from the SCiStar study for the AIS-A patients who received 10 million AST-OPC1 cells (Cohort 2), highlighting the potential of AST-OPC1 to help patients with complete paralysis regain arm, hand and finger function, and thus greater independence. We also recently reported encouraging MRI results from the study that indicated no spinal cord lesion cavities were forming in any patient treated with AST-OPC1."  Mr. Cartt continued, "Our clinical team continues to enroll patients in our SCiStar study, and we expect to complete enrollment in 2017 as well as initiate discussions with the FDA around mid-year to determine the next stage of this important clinical program. Finally, we look forward to reporting 12-month efficacy and safety data from Cohort 2, as well as additional data from other cohorts, later this year."

First Quarter 2017 and Recent Key Achievements

  • Reported efficacy results in January for the first five AIS-A spinal cord injury patients in Cohort 2. The results showed that each of the patients in this cohort, who had previously shown improvement in upper extremity motor function at 3-months following administration of AST-OPC1, maintained or showed additional motor function improvement as of their most recent follow-up (6-months or 9-months following administration of AST-OPC1). Asterias subsequently reported that the sixth, and final, patient in Cohort 2 showed additional motor function improvement at 6-months following administration of AST-OPC1. The results suggest a meaningful and favorable improvement to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 compared to the level of expected rates of spontaneous recovery based on the historical control data of a closely matched patient population.
  • Reported new MRI data from the SCiStar study that indicates AST-OPC1 cells have durably engrafted in patients post-implantation, and have the potential to prevent lesion cavity formation, possibly reducing spinal cord tissue deterioration after spinal cord injury.
  • Received recommendation from the Data Monitoring Committee for the SCiStar clinical trial to continue enrollment for the 10 million cell and 20 million cell dose cohorts in the SCiStar study, as planned.
  • Successfully completed the validation and start-up of its internal current Good Manufacturing Practices manufacturing facility in preparation for late-stage clinical trials of AST-OPC1.
  • Published positive AST-VAC1 Phase 2 clinical data in Acute Myeloid Leukemia in 'Cancer,' a leading peer-reviewed journal of the American Cancer Society.
  • Presented a clinical update on the SCiStar study during the American Spinal Cord Association 2017 Annual Scientific Meeting in Albuquerque, New Mexico.
  • Asterias' President of Research and Development and Chief Scientific Officer will be presenting a clinical update on AST-OPC1 during the Presidential Symposium at the American Society of Gene and Cell Therapy 20th Annual Meeting on May 12, 2017.

Financial Results

Cash and cash equivalents as of March 31, 2017 were $18.1 million, while available-for-sale securities were $14.4 million.  The combined total of cash, cash equivalents, and available-for-sale securities totaled $32.5 million.

Total revenues were $2.0 million for the first quarter. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $6.6 million in the first quarter, with the primary driver being expenses associated with the Company's AST-OPC1 program. General and administrative expenses were $4.5 million in the first quarter.  

Net loss was $6.3 million, or $0.13 per share, for the first quarter.  For the quarter ended March 31, 2017, net cash used in operating activities was $7.2 million and net cash provided from financing activities was $5.4 million.

Conference Call and Webcast Details

Asterias will host a conference call and webcast today, May 11, 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 800-533-7619 (U.S./Canada) or 785-830-1923 (international) five minutes prior to the start of the call and providing the Conference ID 7610291. To access the live webcast, go to http://asteriasbiotherapeutics.com/inv_events_presentations.php.

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 7610291. Additionally, the archived webcast will be available at http://asteriasbiotherapeutics.com/inv_events_presentations.php.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's 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 company's 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)
(UNAUDITED)




Three Months Ended

March 31,




2017



2016


REVENUES:







Grant income


$

1,894



$

1,487


Royalties from product sales



116




107


Total revenues



2,010




1,594


Cost of sales



(53)




(53)


Gross profit



1,957




1,541











EXPENSES









Research and development



(6,598)




(6,343)


General and administrative



(4,466)




(6,290)


Total operating expenses



(11,064)




(12,633)











Loss from operations



(9,107)




(11,092)











OTHER INCOME/(EXPENSE)









Gain from change in fair value of warrant liability



2,954




-


Interest expense, net



(134)




(147)


Total other expenses, net



2,820




(147)











LOSS BEFORE INCOME TAX BENEFIT



(6,287)




(11,239)











Deferred income tax benefit



-




902











NET LOSS


$

(6,287)



$

(10,337)











BASIC AND DILUTED NET LOSS PER SHARE


$

(0.13)



$

(0.27)











WEIGHTED AVERAGE SHARES OUTSTANDING: BASIC AND DILUTED



48,357




38,304


 

ASTERIAS BIOTHERAPEUTICS, INC.
BALANCE SHEET
(IN THOUSANDS EXCEPT PAR VALUE AMOUNTS)




March 31,

2017

(unaudited)



December 31,

2016

 


ASSETS







CURRENT ASSETS







Cash and cash equivalents


$

18,059



$

19,800


Available-for-sale securities, at fair value



14,441




15,269


Prepaid expenses and other current assets



1,664




1,921


Total current assets



34,164




36,990











NONCURRENT ASSETS









Intangible assets, net



17,458




18,130


Property, plant and equipment, net



5,210




5,475


Other assets



389




415


TOTAL ASSETS


$

57,221



$

61,010











LIABILITIES AND STOCKHOLDERS' EQUITY









CURRENT LIABILITIES









Amount due to BioTime, Inc.


$

-



$

288


Accounts payable



737




1,076


Accrued expenses



1,848




2,495


Capital lease liability, current



7




7


Deferred grant income



291




2,185


Total current liabilities



2,883




6,051











LONG-TERM LIABILITIES









Warrant liability



5,711




8,665


Capital lease liability, noncurrent



18




20


Deferred rent liability



281




266


Lease liability



3,866




3,980


TOTAL LIABILITIES



12,759




18,982











STOCKHOLDERS' EQUITY









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; 49,099 and 47,567 shares Series A Common Stock issued and outstanding at March 31, 2017 and December 31, 2016, respectively; no Series B Common Stock issued and outstanding at March 31, 2017 and December 31, 2016



5




5


Additional paid-in capital



136,379




126,829


Accumulated other comprehensive loss



(1,907)




(1,078)


Accumulated deficit



(90,015)




(83,728)


Total stockholders' equity



44,462




42,028


TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY


$

57,221



$

61,010


 

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SOURCE Asterias Biotherapeutics, Inc.

Investor Relations, (510) 456-3892, InvestorRelations@asteriasbio.com, or EVC Group, Inc., Michael Polyviou/Greg Gin, (646) 445-4800, mpolyviou@evcgroup.com; Media, Thomas D. Gibson, GIBSON Communications, LLC, (201) 476-0322 - Main, (201) 264-3646 - Mobile, tom@tomgibsoncommunications.com