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November 10, 2014
Asterias Biotherapeutics Reports Third Quarter Financial and Operating Results

MENLO PARK, Calif., Nov. 10, 2014 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, today reported financial results for the third quarter and nine months ended September 30, 2014.

"Asterias made substantial progress in the third quarter with respect to our two key development programs that have the potential to address significant unmet medical needs using our pluripotent stem cell technology platform," stated Pedro Lichtinger, President and CEO of Asterias. "We have partnered with leading scientific institutions, and are poised to initiate a dose-escalation Phase 1/2a clinical trial for AST-OPC1 in spinal cord injury and to progress AST-VAC2 into a Phase 1/2a dose-escalation clinical trial in lung cancer in collaboration with our partner, Cancer Research UK. Regarding our AST-OPC1 clinical program, we have decided to accelerate the current timelines by approximately 6 months in order to obtain safety and efficacy readouts more rapidly. To enable this acceleration, we plan to double the number of clinical trial sites and to expand our patient recruitment efforts. In addition, we intend to seek U.S. Food and Drug Administration (FDA) approval to increase the robustness of the proof of concept that we will establish in this Phase 1/2a clinical trial by expanding enrollment from 13 patients to up to 40 patients. We believe these changes will increase the statistical confidence of the safety and efficacy readouts, reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals."

Third Quarter and Recent Events

  • Asterias received clearance from the FDA to initiate a dose-escalation Phase 1/2a clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in patients with complete cervical spinal cord injury (SCI). The dose escalation will start with three patients being dosed 2 million cells and escalate into two five-patient cohorts at 10 million and 20 million cells, respectively.
  • Asterias signed a Notice of Grant Award (NGA) with the California Institute of Regenerative Medicine (CIRM). The NGA provides for the immediate release of clinical development payments and the release of additional grant funds pursuant to the previously announced $14.3 million CIRM grant award for clinical development of AST-OPC1. The grant provides non-dilutive funding to initiate the Phase 1/2a clinical trial of AST-OPC1 for complete cervical SCI and other product development activities for AST-OPC1.
  • Asterias, Cancer Research UK (CRUK) and Cancer Research Technology, the development and commercialization arm of CRUK, entered into an agreement to advance Asterias' novel immunotherapy treatment, AST-VAC2, into clinical trials in subjects with non-small cell lung cancer. Under the agreement, Asterias will transfer the manufacturing process for AST-VAC2 to CRUK, after which CRUK will, at its own cost, manufacture clinical grade AST-VAC2 and conduct the Phase 1/2a clinical trial in the UK, subject to regulatory approval.
  • Successfully distributed 8,000,000 warrants to purchase common shares of BioTime, Inc. at a purchase price of $5.00 per common share until the warrant expires on October 1, 2018.
  • Simplified the Company's capital structure with the conversion of all of its outstanding Series B common stock into Series A common stock. After the automatic conversion of the Series B common stock, the Series A common stock is now the only outstanding class of common stock of Asterias.
  • Strengthened the Company's Board of Directors by adding financial expertise and biopharmaceutical leadership experience with the respective appointments of two additional independent directors, Andrew Arno and Natale Ricciardi.
  • Asterias Series A common stock commenced trading on the NYSE MKT under the ticker symbol "AST."

Third Quarter Financial Results

For the three months ended September 30, 2014, total revenue was $84,515, and was comprised of royalty revenues on product sales by licensees. Operating expenses for the three months ended September 30, 2014 were $4.0 million, compared to $2.7 million in the same period in 2013, and were primarily related to the preparation and commencement of planned research and development operations. Research and development expenses in the third quarter 2014 were $2.6 million, compared to $1.1 million in the year ago quarter. Net loss for the three months ended September 30, 2014 was $1.7 million, compared to a net loss of $2.7 million for the same period in 2013. The reduction in net loss is primarily attributed to the deferred income tax benefit of approximately $2.3 million that was recorded as of September 30, 2014. There was no deferred income tax benefit recorded in the three months ended September 30, 2013. On a per share basis, net loss for the third quarter 2014 was $0.05 per share, compared to $51.62 per share for the year ago quarter. The decrease in the net loss per share primarily reflects the increased share count resulting from the issuance of 21.8 million shares of Asterias Series B common stock to BioTime, Inc. and 6.5 million shares of Asterias Series A common stock to Geron Corporation under the previously announced Asset Contribution Agreement that was executed on October 1, 2013.

Year-to-Date Financial Results

For the nine months ended September 30, 2014, total revenue was $167,207, and was comprised of royalty revenues on product sales by licensees. Operating expenses for the nine months ended September 30, 2014 were $12.0 million, compared to $4.8 million in the same period in 2013, and were primarily attributed to increased research and development related activity and increased staffing and operations. Research and development expenses for the first nine months of 2014 were $7.9 million, compared to $1.9 million in the year ago period. General and administrative expenses for the first nine months of 2014 were $4.1 million, compared to $2.9 million in the year ago period. Net loss for the nine months ended September 30, 2014 was $6.8 million, compared to a net loss of $4.8 million for the same period in 2013. The increase in net loss is offset to some extent by the $5.2 million deferred income tax benefit recorded as of September 30, 2014. There was no deferred income tax benefit recorded in the nine months ended September 30, 2013. On a per share basis, net loss for the nine months ended September 30, 2014 was $0.22 per share, compared to $93.13 per share for the year ago period. The decrease in the net loss per share primarily reflects the increased share count resulting from the issuance of 21.8 million shares of Asterias Series B common stock to BioTime, Inc. and 6.5 million shares of Asterias Series A common stock to Geron Corporation under the previously announced Asset Contribution Agreement that was completed on October 1, 2013.

Cash and cash equivalents totaled $5.0 million at September 30, 2014, and the Company held 3,852,880 BioTime common shares, with a market value of approximately $12.1 million on that date. For the third quarter, cash burn was $2.8 million. In the fourth quarter, the Company anticipates a payment from CIRM under the grant award related to the AST-OPC1 development program. With the CIRM funding, the Company continues to expect cash burn for the second half of 2014 will total approximately $4.4 million.

Conference Call and Webcast Details

The Company will host a conference call and webcast today, November 10, 2014, at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the quarter's results and recent corporate developments.

For both "listen-only" participants and those participants who wish to participate in the question-and-answer portion of the call, the dial-in number in the U.S. is 877-407-8291. For participants outside the U.S., the dial-in number is 201-689-8345. To access the live webcast, go to http://www.wsw.com/webcast/cc/astb3.

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call. The telephone dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. To access the replay for all callers, refer to Conference ID 13594488. An archived webcast will also be available for 30 days, and may be accessed at http://www.wsw.com/webcast/cc/astb3.

About Asterias Biotherapeutics

Asterias' core technologies center on stem cells capable of becoming all of the cell types in the human body, a property called pluripotency. Asterias plans to develop therapies based on pluripotent stem cells to treat diseases or injuries in a variety of medical fields having major unmet needs and without adequate therapies available. Asterias initial focus is on two clinical stage programs including oligodendrocyte progenitor cells (AST-OPC1) for spinal cord injuries and antigen-presenting allogeneic dendritic cells (AST-VAC2) for lung cancer.

In October 2013, Asterias acquired the cell therapy assets of Geron Corporation. These assets included INDs for the clinical stage AST-OPC1 and AST-VAC1 programs, banks of cGMP-manufactured AST-OPC1 drug product, cGMP master and working cell banks of human embryonic stem cells, over 400 patents and patent applications filed worldwide including broad issued claims to fundamental platform technologies for the scalable growth of pluripotent stem cells and compositions of matter for several hESC-derived therapeutic cell types, research cell banks, customized reagents and equipment, and various assets relating to the AST-VAC2 program and preclinical programs in cardiology, and orthopedics.

Asterias is a majority-owned subsidiary of BioTime, Inc., (NYSE MKT: BTX), a biotechnology company engaged in research and product development in the field of regenerative medicine. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating 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.

(a company in the development stage)


CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)













Three Months Ended

September 30,



Nine Months Ended

September 30,



Period from Inception
(September 24, 2012)




2014



2013



2014



2013



to September 30,
2014


REVENUE
















Royalties from product sales


$

84,515



$

-



$

167,207



$

-



$

167,207


Cost of sales



(42,258)




-




(83,603)




-




(83,603)


Total gross profit



42,257




-




83,604




-




83,604























EXPENSES





















Research and development



(2,568,214)




(1,149,059)




(7,910,097)




(1,931,048)




(12,229,592)


Acquired in-process research and development



-




-




-




-




(17,458,766)


General and administrative



(1,468,754)




(1,523,732)




(4,107,888)




(2,888,028)




(8,749,636)


Total operating expenses



(4,036,968)




(2,672,791)




(12,017,985)




(4,819,076)




(38,437,994)























Loss from operations



(3,994,711)




(2,672,791)




(11,934,381)




(4,819,076)




(38,354,390)























OTHER INCOME/(EXPENSE)





















Interest expense, net



(291)




-




(9,827)




-




(11,564)


Gain on sale of fixed assets



-




2,430




-




2,430




2,430


Other income (expense), net



26




1,833




(1,559)




1,924




(1,575)


Total other income (expense), net



(265)




4,263




(11,386)




4,354




(10,709)























LOSS BEFORE DEFERRED INCOME TAX BENEFIT



(3,994,976)




(2,668,528)




(11,945,767)




(4,814,722)




(38,365,099)























Deferred income tax benefit



2,312,693




-




5,174,977




-




8,455,672























NET LOSS



(1,682,283)




(2,668,528)




(6,770,790)




(4,814,722)




(29,909,427)























Unrealized gain (loss) on available-for-sale securities, net



345,549




-




(108,829)




-




(3,043,515)























COMPREHENSIVE LOSS


$

(1,336,734)



$

(2,668,528)



$

(6,879,619)



$

(4,814,722)



$

(32,952,942)























Basic and diluted net loss per common share


$

(0.05)



$

(51.62)



$

(0.22)



$

(93.13)



























Weighted average shares of common stock outstanding — basic and diluted



30,898,819




51,700




30,659,259




51,700






 

ASTERIAS BIOTHERAPEUTICS, INC.

(a company in the development stage)


CONDENSED BALANCE SHEETS




September 30, 2014

(Unaudited)



December 31,

2013


ASSETS







CURRENT ASSETS







Cash and cash equivalents


$

5,025,499



$

2,171,113


Available-for-sale securities, at fair value



12,100,043




32,052,217


BioTime warrants to be distributed to holders of Series A common stock



7,572,089




15,568,307


Prepaid expenses and other current assets



352,502




340,092


Total current assets



25,050,133




50,131,729











NONCURRENT ASSETS









Intangible assets, net



26,115,308




28,291,584


Equipment and furniture, net



1,252,158




1,460,518


Investment in affiliates



415,543




415,543


Other assets



360,983




54,423


Total noncurrent assets



28,143,992




30,222,068


TOTAL ASSETS


$

53,194,125



$

80,353,797











LIABILITIES AND STOCKHOLDERS' EQUITY









CURRENT LIABILITIES









Obligation to distribute BioTime warrants to holders of Series A common stock


$

7,572,089



$

15,568,307


Amount due to BioTime



406,379




2,064,432


Accounts payable



386,064




567,140


Accrued liabilities



140,400




95,885


Total current liabilities



8,504,932




18,295,764











Long-term liabilities, net deferred tax liability



10,787,141




8,277,548


TOTAL LIABILITIES



19,292,073




26,573,312











Commitments and contingencies


















STOCKHOLDERS' EQUITY









Preferred Stock, $0.0001 par value, authorized 5,000,000 shares; none issued and outstanding



-




-


Common Stock, $0.0001 par value, authorized 75,000,000 shares Series A, $0.0001 par value, and 75,000,000 shares Series B, $0.0001 par value; 6,537,779 shares Series A common stock and 24,361,040 shares Series B common stock issued and outstanding at September 30, 2014, and 6,537,779 shares Series A common stock and 23,961,040 shares Series B common stock issued and outstanding at December 31, 2013



3,075




3,050


Additional paid-in capital



66,851,919




79,850,758


Accumulated other comprehensive loss on available-for-sale investments



(3,043,515)




(2,934,686)


Deficit accumulated during the development stage



(29,909,427)




(23,138,637)


Total stockholders' equity



33,902,052




53,780,485


TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY


$

53,194,125



$

80,353,797


 

ASTERIAS BIOTHERAPEUTICS, INC.

(a company in the development stage)


CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)




Nine Months Ended

September 30,



Period from
inception

(September 24,
2012) to




2014



2013



September 30, 2014


CASH FLOWS FROM OPERATING ACTIVITIES:










Net loss


$

(6,770,790)



$

(4,814,722)



$

(29,909,427)


Adjustments to reconcile net loss to net cash provided by/(used in) operating activities:













Acquired in-process research and development



-




-




17,458,766


Depreciation expense



408,613




95,244




629,208


Stock-based compensation



1,400,193




441,434




2,103,927


Amortization of intangible assets



2,176,276




-




2,901,701


Gain on sale of equipment and furniture



-




(2,430)




(2,430)


Deferred income tax benefit



(5,174,977)




-




(8,455,672)


Changes in operating assets and liabilities:













Prepaid expenses and other current assets



(12,410)




(220,160)




(352,502)


Accounts payable



(181,076)




353,744




386,064


Accrued liabilities



44,515




234,907




140,400


Amount due to BioTime



(1,658,053)




5,630,991




4,005,125


Net cash (used in)/provided by operating activities



(9,767,709)




1,719,008




(11,094,840)















CASH FLOWS FROM INVESTING ACTIVITIES:













Purchase of equipment and furniture



(200,253)




(1,600,506)




(1,446,982)


Proceeds from sale of equipment and furniture



-




27,500




27,500


Proceeds from sale of available-for-sale securities



12,660,908




-




12,660,908


Payment of security deposits



(306,560)




(54,423)




(360,983)


Net cash provided by/(used in) investing activities



12,154,095




(1,627,429)




10,880,443















CASH FLOWS FROM FINANCING ACTIVITIES:













Proceeds from issuance of common stock



468,000




-




5,468,000


Payment to Geron in connection with acquisition of assets on October 1, 2013



-




-




(228,104)


Net cash provided by financing activities



468,000




-




5,239,896















Net increase in cash and cash equivalents



2,854,386




91,579




5,025,499


Cash and cash equivalents at beginning of period



2,171,113




-




-


Cash and cash equivalents at end of period


$

5,025,499



$

91,579



$

5,025,499















SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:













Purchase of equipment and furniture, contributed by BioTime


$

-



$

-



$

(459,454)


Available-for-sale BioTime securities contributed by BioTime


$

-



$

-



$

34,985,163


Cancellation of indebtedness to BioTime


$

-



$

-



$

5,000,000


Transaction costs paid by BioTime, on behalf of the Company


$

-



$

-



$

300,000


Intangible assets acquired from Geron


$

-



$

-



$

29,017,009


Deferred tax liability arising from difference in book versus tax basis on Geron intangible assets acquired


$

-



$

-



$

11,558,243


Investment in affiliates, contributed by BioTime


$

-



$

-



$

415,543


Common stock and common stock warrants issued to BioTime and Geron in connection with acquisition and transfer of assets


$

-



$

-



$

74,098,333


Common stock issued upon investment by BioTime


$

-



$

-



$

50,000


Reduction of subscription receivable


$

-



$

-



$

(50,000)


Common stock issued in exchange for non-cash consideration in connection with investment by officer


$

-



$

-



$

1,740


 

 

SOURCE Asterias Biotherapeutics, Inc.



Asterias Biotherapeutics Tel: (510) 456-3800