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Asterias Biotherapeutics Reports Second Quarter Financial Results and Recent Development Progress
Company Progressing Neurology and Immunotherapy Clinical Programs
Anticipates Achievement of Significant Execution Milestones in the Second Half of 2018 and Full Year 2019 to Advance the Development of its Platform Technologies
Conference Call and Webcast Today, August 9, at 5:00 p.m. ET
FREMONT, Calif., Aug. 09, 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 second quarter ended June 30, 2018, as well as recent corporate progress.
“During the second quarter, we executed on our primary operational objectives for OPC1 and VAC2, and for the first time in Asterias’ history we now have two programs in the clinic, simultaneously,” commented Michael Mulroy, President and Chief Executive Officer. “Our Phase 1/2a SCiStar study, which is nearing its conclusion in the next few months, again reaffirmed OPC1’s positive safety profile, which was demonstrated in the additional data we reported for Cohorts 3, 4, and 5. We remain encouraged by the very high rate of cell engraftment we have seen in the data so far, as well as by the improvement in motor function for many of the patients. We are now preparing for discussions with the FDA later this year regarding the design of the next spinal cord injury trial.
“VAC2 achieved a major milestone in the second quarter as the first subject in its Phase 1 clinical trial for non-small cell lung cancer was dosed. Following the positive outcome from the Safety Review Committee’s review, two additional patients have been dosed. We continue to work closely with Cancer Research UK, the trial’s sponsor, and are encouraged by its commitment to the trial. Cancer Research UK has initiated the cGMP manufacturing run to manufacture the next lot of VAC2 to be used in the study. Cancer Research UK has just opened a second site to support open enrollment following the safety review meeting that is expected to take place later this quarter.”
“Recently, we have taken some important steps to further demonstrate the depth of these technology platforms,” added Mr. Mulroy. “We have initiated pre-clinical collaborations to evaluate the efficacy of OPC1 to treat stroke and multiple sclerosis, both demyelinating conditions where there are large, unmet medical needs. With regard to stroke, we also entered into an exclusive license agreement with the Regents of the University of California. Pertaining to our allogeneic therapeutic vaccine product candidate VAC2, we have held several KOL meetings focused on additional indications to potentially pursue. Acute myeloid leukemia (AML) meets much of our internal criteria and we are considering a study that would seek to confirm the signal we saw in our previous autologous VAC1 trial as well as examine the safety and efficacy of VAC2 in combination with an immune checkpoint inhibitor. We plan to move forward with a pre-IND meeting with the Food and Drug Administration (FDA) later this year with the goal of filing an Investigational New Drug (IND) application in the U.S. for VAC2 in 2019,” he concluded.
Second Quarter 2018 and Recent Key Achievements
OPC1, an oligodendrocyte progenitor cell population derived from pluripotent stem cells, has been shown in preclinical testing in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed in demyelination disorders, such as spinal cord injuries, and multiple neurodegenerative diseases, including multiple sclerosis and white matter stroke. These potential reparative functions of OPC1 include the production of neurotrophic factors, the stimulation of vascularization, and the induction of remyelination of denuded axons, all of which are critical for survival and regrowth of—and conduction of nerve impulses through—axons at the injury site. The following operational achievements have recently occurred for OPC1:
- Asterias reported results from the Company’s ongoing Phase 1/2a SCiStar study showing six-month (Cohort 5) and 12-month (Cohorts 3 and 4) follow-up data. The data continued to demonstrate that OPC1 has a positive safety profile and that OPC1 cells are successfully engrafting in patients, which may have the potential to improve motor function.
- The Independent Data Monitoring Committee (DMC) for the Company’s SCiStar Phase 1/2a study of OPC1 in acute spinal cord injury has completed a regularly scheduled review of the safety data from all subjects in the five study cohorts and recommended that the SCiStar study continue according to protocol to its final data readout.
- Asterias announced exclusive license agreement with The Regents of the University of California under which Asterias has exclusive rights in all fields of use for a patent family that claims a method of improving recovery in a patient that has suffered an ischemic stroke. This exclusive license agreement is a part of the Company’s strategy to explore the efficacy of its OPC1 product candidate in other neurological conditions. The Company has initiated testing of OPC1 in a second pre-clinical model of subcortical and white matter ischemia in collaboration with a leading expert in pre-clinical models of cerebral ischemia and cell transplantation. The Company has also initiated pre-clinical testing of OPC1 in multiple sclerosis.
- Asterias expects to request a formal meeting with FDA under the Regenerative Medicine Advanced Therapy (RMAT) designation later this month to discuss the continued development of OPC1.
VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase invokes enhanced stimulation of immune responses to the protein. Similar to an earlier, Asterias-sponsored, hematological cancer program using an autologous approach, the VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. VAC2’s mode of action is complementary to and potentially synergistic with other immune therapies such as checkpoint inhibitors or other immune pathway inhibitors. The following operational achievements have recently occurred for VAC2:
- Asterias announced enrollment and dosing of the first subject in the first-in-human Phase 1 clinical trial of VAC2 in the United Kingdom. This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK, will examine the safety and tolerability of VAC2 in non-small cell lung cancer as the study’s primary endpoints.
- Asterias announced positive outcome from a Safety Review Committee review of the safety and tolerability data generated in the first clinical trial of VAC2, with recommendation for continuation of the clinical trial in non-small cell lung cancer.
- Patients two and three have each been given three of the scheduled six doses of 10 million VAC2 cells. In August, Cancer Research UK opened a second site to support enrollment of the trial.
Second Quarter 2018 Financial Results
Research and development expenses were $3.6 million in the second quarter. General and administrative expenses were $2.0 million in the second quarter. Total operating expenses were $5.6 million in the second quarter of 2018, compared to $8.8 million in the second quarter of 2017.
Net loss was $7.0 million, or $0.13 per share, for the second quarter of 2018 compared to a net loss of $8.7 million, or $0.18 per share, for the second quarter of 2017. For the quarter ended June 30, 2018, net cash used in operating activities was $3.2 million compared to $7.0 million for the quarter ended June 30, 2017.
Cash, cash equivalents, and available-for-sale securities totaled $14.8 million as of June 30, 2018. The Company has successfully lowered its quarterly cash burn during the first half of 2018 and anticipates similar low quarterly cash utilization for the remainder of 2018.
Conference Call and Webcast Details
The Company will provide an overview of the second quarter results as well as the recently released SCiStar data. The conference call is scheduled for 5:00pm ET/2:00pm PT on Thursday, August 9, 2018. 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 888-599-8686. For international participants outside the U.S./Canada, the dial-in number is 323-994-2093. For all callers, refer to Conference ID 7991938. 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 7991938. 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 demyelination and cellular immunotherapies to treat cancer. Asterias is presently focused on advancing two clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. VAC2 (antigen-presenting allogeneic dendritic cells) is an allogeneic cancer immunotherapy. The Company's research partner, Cancer Research UK, has commenced a first-in-human clinical trial of VAC2 in non-small cell lung cancer. Asterias is also sponsoring pre-clinical work in two conditions with a demyelinating component: Multiple Sclerosis and White Matter Stroke, and is evaluating other cancer indications where its immunotherapy platform could provide therapeutic benefit. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
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 June 30,|
|Six months ended June 30,|
|Royalties from product sales||109||25||221||141|
|Cost of sales||(57||)||(18||)||(120||)||(70||)|
|Research and development||3,617||6,984||7,243||13,582|
|General and administrative||1,987||1,847||3,899||6,314|
|Total operating expenses||5,604||8,831||11,142||19,896|
|Loss from operations||(5,552||)||(8,533||)||(10,675||)||(17,640||)|
|Gain/(loss) from change in fair value on warrant liability||366||(56||)||1,885||2,898|
|Loss from change in fair value of marketable equity securities||(1,695||)||-||(260||)||-|
|Interest expense, net||(95||)||(114||)||(201||)||(239||)|
|Other expense, net||(6||)||(25||)||(43||)||(34||)|
|Total other income (expense), net||(1,430||)||(195||)||1,381||2,625|
|BASIC AND DILUTED NET LOSS PER SHARE||$||(0.13||)||$||(0.18||)||$||(0.17||)||$||(0.31||)|
|WEIGHTED AVERAGE SHARES OUTSTANDING: BASIC AND DILUTED||55,138||48,511||54,664||48,129|
|ASTERIAS BIOTHERAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)|
| June 30, 2018 (Unaudited)|| December 31, 2017|
|Cash and cash equivalents||$||9,217||$||13,166|
|Marketable equity securities||5,588||8,329|
|Prepaid expenses and other current assets||1,083||1,221|
|Total current assets||15,888||22,716|
|Intangible assets, net||14,101||15,444|
|Property, plant and equipment, net||4,030||4,543|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$||1,827||$||2,958|
|Capital lease liability, current||7||7|
|Lease liability, current||597||556|
|Total current liabilities||2,431||3,521|
|Capital lease liability, noncurrent||11||14|
|Lease liability, noncurrent||2,632||2,941|
|Preferred Stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding||-||-|
|Common Stock, $0.0001 par value, authorized 75,000 Series A Common Stock and 75,000 Series B Common Stock; 55,509 and 54,051 shares Series A Common Stock issued and outstanding at June 30, 2018 and December 31, 2017, respectively; no Series B Common Stock issued and outstanding at June 30, 2018 and December 31, 2017||6||5|
|Additional paid-in capital||155,873||152,136|
|Accumulated other comprehensive loss||-||(6,498||)|
|Total stockholders’ equity||28,072||33,543|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||34,343||$||43,092|