- Achieved Meaningful Progress with Key Clinical Programs -
- Anticipate Multiple Data Readouts from SCiStar Study in 2018 into First Quarter of 2019 -
- Expect to Enroll First Subject in AST-VAC2 Randomized Clinical Trial in NSCLC in Second Quarter -
- Conference Call and Webcast Today, March 15, at 5:00 p.m. ET -
FREMONT, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, today reported financial and operational results for the quarter and full year ended December 31, 2017, as well as recent corporate progress.
“We have continued to make significant progress in our spinal cord injury clinical program,” commented Michael Mulroy, President and Chief Executive Officer. “The additional results from the SCiStar study that we recently reported further support AST-OPC1’s positive safety profile and its potential to durably engraft and help restore upper extremity motor function improvement to individuals with severe cervical spinal cord injuries. Currently, these severely injured patients have no approved treatment options. We look forward to providing additional data readouts from the SCiStar study in 2018 into the first quarter of 2019.”
Mulroy continued, “We are equally excited for the planned start of the first-in-human clinical trial of AST-VAC2, our cancer immunotherapy product candidate, in non-small cell lung cancer (NSCLC). Upon this achievement, Asterias will have two product candidates in clinical trials that are aimed at addressing substantial unmet medical needs.”
“On the corporate side, Asterias completed a capital raise in 2017 and significantly improved its cost structure heading into 2018,” said Ryan Chavez, Chief Financial Officer. “The more focused allocation of capital in 2018 allows the company to reduce its cash burn during a period of additional data readouts from the SCiStar study and the start of the AST-VAC2 clinical trial.”
Anticipated 2018 Milestones
The company intends to report the following AST-OPC1 data readouts later this year:
- Six-month update for the entire SCiStar study, including Cohort 5, late in the second quarter or early third quarter of 2018.
- 12-month update for Cohorts 3 and 4 in the third quarter of 2018.
- 24-month update for Cohort 2 in the third or fourth quarter of 2018.
- 12-month update for the entire SCiStar study, including Cohort 5, late in the fourth quarter of 2018 or early in the first quarter of 2019.
The company anticipates achieving the following AST-VAC2 milestones in 2018:
- Open two sites for the AST-VAC2 study in NSCLC and enroll the first subject in the randomized trial in second quarter of 2018. The study will enroll up to 24 subjects into one of two cohorts, depending on the stage of each subject’s NSCLC.
- Assuming the first subject is dosed in the second quarter, the company plans to provide initial safety and immunogenicity data readouts in the second half of 2018.
Asterias plans to host a conference call to discuss the AST-VAC2 program and its potential as a ready-to-administer, off-the-shelf cancer immunotherapy after the first subject is dosed in the study.
2017 and Recent Key Achievements
AST-OPC1:
- During 2017 and in February 2018, Asterias continued to provide updates with promising data from the ongoing SCiStar study on recovery of arm, hand, and finger function in subjects who have been administered AST-OPC1.
- Reported MRI data from the SCiStar study that indicates AST-OPC1 cells have durably engrafted in patients post-implantation, demonstrating the potential for AST-OPC1 to prevent lesion cavity formation and possibly reducing spinal cord tissue deterioration after spinal cord injury.
- Reported continued positive safety profile for AST-OPC1 based on trial results to date. In September 2017, an independent Data Monitoring Committee (DMC) recommended the SCiStar study continue as planned after it completed a regularly scheduled review of the accumulated safety data to date from the study.
- Completed enrollment and dosing in all five of the planned cohorts in the SCiStar study, positioning the company for additional anticipated data readouts in 2018 and into the first quarter of 2019.
- Obtained U.S. Food and Drug Administration (FDA) designation as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act, which is intended to facilitate expedited development, review, and approval for important new regenerative medicine therapies for which preliminary clinical evidence indicates the potential to address a serious or life-threatening disease or condition.
- Published new efficacy and safety data from preclinical studies of AST-OPC1 in the peer-reviewed journal “Stem Cells Translational Medicine.”
AST-VAC2:
- Received regulatory clearance in the United Kingdom to initiate a first-in-human clinical trial of Asterias’ cancer immunotherapy product AST-VAC2. This trial is being sponsored and managed by Cancer Research UK, and will examine the safety, tolerability, immunogenicity and activity of AST-VAC2 in subjects with early and late stage NSCLC.
- Cancer Research UK, supported by Asterias technical personnel, successfully completed the manufacture of the first cGMP (current Good Manufacturing Practice) clinical grade lot of AST-VAC2. This lot will provide initial clinical trial material for subjects enrolling in the upcoming Phase 1 study evaluating AST-VAC2 in NSCLC.
- Published positive AST-VAC1 Phase 2 clinical data in Acute Myeloid Leukemia in ‘Cancer,’ a leading peer-reviewed journal of the American Cancer Society.
Corporate:
- Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds.
- Asterias expanded its operating expense reduction efforts and reduced staffing allocated to non-clinical activities as part of a broader effort to more closely align operating expenses with the company’s primary goal of continuing to generate clinical data in its key clinical stage programs.
Financial Results
As of December 31, 2017, the combined total of cash, cash equivalents, and available-for-sale securities totaled $21.6 million. In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds.
Revenue was $4.0 million for the year ended December 31, 2017, comprised of grant income as well as royalty revenue on product sales by licensees. Research and development expenses were $6.4 million in the fourth quarter and $26.6 million in the year ended December 31, 2017. General and administrative expenses were $2.1 million in the fourth quarter and $10.5 million in the year ended December 31, 2017. As a result of the operating cost saving initiatives implemented in 2017, the company expects to reduce its operating costs by approximately 40% in 2018. Asterias believes that its reduced operating costs and cash and cash equivalents as of December 31, 2017 will be sufficient to fund its operations through at least the first quarter of 2019.
Net loss was $6.5 million, or $0.12 per share, for the fourth quarter and $28.4 million, or $0.56 per share, for the year ended December 31, 2017. For the year ended December 31, 2017, net cash used in operating activities was $24.4 million and net cash provided from financing activities was $17.2 million.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today, March 15, 2018, at 5:00 p.m. Eastern / 2:00 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 portion of the call, the dial-in number in the U.S./Canada is 888-503-8163. For international participants outside the U.S./Canada, the dial-in number is 719-325-4857. For all callers, refer to Conference ID 9547064. To access the live webcast, go to http://asteriasbiotherapeutics.com/inv_events_presentations.php.
A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 9547064. 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 dedicated to developing cell-based therapeutics to treat neurological conditions associated with de-myelination and cellular immunotherapies to treat cancer. 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 an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML). 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 first-in-human (FIH) clinical trial of AST-VAC2 in non-small cell lung cancer. 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 December 31, | Year ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| REVENUE | ||||||||||||||||
| Grant income | $ | - | $ | 1,707 | $ | 3,711 | $ | 6,572 | ||||||||
| License Revenue | - | - | - | 125 | ||||||||||||
| Royalties from product sales | 28 | 44 | 331 | 257 | ||||||||||||
| Total revenues | 28 | 1,751 | 4,042 | 6,954 | ||||||||||||
| Cost of sales | (14 | ) | (9 | ) | (165 | ) | (128 | ) | ||||||||
| Total gross profit | 14 | 1,742 | 3,877 | 6,826 | ||||||||||||
| EXPENSES | ||||||||||||||||
| Research and development | (6,434 | ) | (7,874 | ) | (26,640 | ) | (25,467 | ) | ||||||||
| General and administrative | (2,128 | ) | (2,400 | ) | (10,488 | ) | (15,482 | ) | ||||||||
| Total operating expenses | (8,562 | ) | (10,274 | ) | (37,128 | ) | (40,949 | ) | ||||||||
| Loss from operations | (8,548 | ) | (8,532 | ) | (33,251 | ) | (34,123 | ) | ||||||||
| OTHER INCOME/(EXPENSES): | ||||||||||||||||
| Gain/(loss) from change in fair value on warrant liability | 2,504 | (740 | ) | 5,908 | (3,108 | ) | ||||||||||
| Interest expense, net | (114 | ) | (134 | ) | (465 | ) | (546 | ) | ||||||||
| Other expense, net | (390 | ) | (9 | ) | (564 | ) | (37 | ) | ||||||||
| Total other income (expenses), net | 2,000 | (883 | ) | 4,879 | (3,691 | ) | ||||||||||
| LOSS BEFORE INCOME TAX BENEFIT | (6,548 | ) | (9,415 | ) | (28,372 | ) | (37,814 | ) | ||||||||
| Deferred income tax benefit | - | 69 | - | 2,325 | ||||||||||||
| NET LOSS | $ | (6,548 | ) | $ | (9,346 | ) | $ | (28,372 | ) | $ | (35,489 | ) | ||||
| Basic and diluted net loss per share | $ | (0.12 | ) | $ | (0.20 | ) | $ | (0.56 | ) | $ | (0.83 | ) | ||||
| Weighted average shares outstanding: basic and diluted | 53,254 | 45,957 | 50,271 | 42,934 | ||||||||||||
| ASTERIAS BIOTHERAPEUTICS, INC. | |||||||||
| BALANCE SHEETS | |||||||||
| (IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS) | |||||||||
| December 31, 2017 | December 31, 2016 | ||||||||
| ASSETS | |||||||||
| CURRENT ASSETS | |||||||||
| Cash and cash equivalents | $ | 13,266 | $ | 19,800 | |||||
| Available-for-sale securities, at fair value | 8,329 | 15,269 | |||||||
| Prepaid expenses and other current assets | 1,121 | 1,921 | |||||||
| Total current assets | 22,716 | 36,990 | |||||||
| NONCURRENT ASSETS | |||||||||
| Intangible assets, net | 15,444 | 18,130 | |||||||
| Property, plant and equipment, net | 4,543 | 5,475 | |||||||
| Other assets | 389 | 415 | |||||||
| TOTAL ASSETS | $ | 43,092 | $ | 61,010 | |||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
| CURRENT LIABILITIES | |||||||||
| Amount due to BioTime, Inc. | $ | - | $ | 288 | |||||
| Accounts payable | 401 | 1,076 | |||||||
| Accrued expenses | 2,557 | 2,495 | |||||||
| Capital lease liability, current | 7 | 7 | |||||||
| Lease liability, current | 556 | 484 | |||||||
| Deferred grant income | - | 2,185 | |||||||
| Total current liabilities | 3,521 | 6,535 | |||||||
| LONG-TERM LIABILITIES | |||||||||
| Warrant liability | 2,757 | 8,665 | |||||||
| Capital lease liability, noncurrent | 14 | 20 | |||||||
| Deferred rent liability | 316 | 266 | |||||||
| Lease liability, noncurrent | 2,941 | 3,496 | |||||||
| TOTAL LIABILITIES | 9,549 | 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; 54,051 and 47,467 shares Series A Common Stock issued and outstanding at December 31, 2017 and 2016, respectively; no Series B Common Stock issued and outstanding at December 31, 2017 and 2016 | 5 | 5 | |||||||
| Additional paid-in capital | 152,136 | 126,829 | |||||||
| Accumulated other comprehensive loss | (6,498 | ) | (1,078 | ) | |||||
| Accumulated deficit | (112,100 | ) | (83,728 | ) | |||||
| Total stockholders’ equity | 33,543 | 42,028 | |||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 43,092 | $ | 61,010 | |||||