- AST-VAC2 Immunotherapy Program Prepares to Enter Clinic in Second Quarter of 2018 –
- Conference Call and Webcast Today, May 9, at 5:00 p.m. ET –
“Our partner, Cancer Research UK, recently achieved additional milestones with our cancer immunotherapy product candidate AST-VAC2,” commented Michael Mulroy, President and Chief Executive Officer. “The first clinical site for the first-in-human clinical trial of AST-VAC2 in non-small cell lung cancer (NSCLC) has completed its site initiation visit and commenced the process to open enrollment following the release of the initial cGMP (current Good Manufacturing Practice) grade lot of AST-VAC2. With this progress, Asterias is poised to have two of its cell-based therapies in active clinical development programs, which will be a significant milestone for the company.”
Mulroy continued, “We are also excited about the continued progress in our spinal cord injury clinical program. The results from the SCiStar study that we reported in February 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. We will be providing additional data readouts from the SCiStar study in 2018 and into the first quarter of 2019.”
“On the corporate side, Asterias reduced its cash burn significantly in the first quarter, and we anticipate that the quarterly cash burn rate for the remainder of 2018 will be near or slightly below the first quarter burn rate,” said Ryan Chavez, Chief Financial Officer.
First Quarter 2018 and Recent Key Achievements
- Cancer Research UK released the first cGMP clinical grade lot of AST-VAC2. This lot will provide initial clinical trial material for subjects enrolling in the first-in-human Phase 1 study evaluating AST-VAC2 in NSCLC. This initial clinical trial, which is being sponsored and managed by Cancer Research UK, will examine the safety and tolerability of AST-VAC2 in NSCLC subjects as the study’s primary endpoints. Secondary and tertiary endpoints of the study include evaluations of the immunogenicity of AST-VAC2 in NSCLC subjects. The partnership between Asterias and Cancer Research UK is being conducted under Cancer Research UK’s Clinical Development Partnerships (CDP) scheme, which allows the first clinical trial of AST-VAC2 to be initiated without significant Asterias resources being allocated to the trial or the manufacturing of the product. On completion of the clinical trial, Asterias will have an exclusive first option to acquire the data from the trial.
- Initiated the process to open enrollment in the first site for the AST-VAC2 trial in NSCLC. The study will enroll up to 24 subjects into one of two cohorts, depending on the stage of each subject’s NSCLC.
The company anticipates the first subject in the NSCLC study being enrolled and dosed in the second quarter of 2018. AST-VAC2 is a platform cancer immunotherapy that could be investigated as a potential therapeutic for many cancer indications and for targeting of many antigens. The results from the Phase 1 clinical trial sponsored by Cancer Research UK could be used to support advanced clinical studies in one or more of the following areas:
- Non-small cell lung cancer
- Other indications showing high levels of telomerase activity and susceptibility to immunotherapy
- In combination with check point or immune pathway inhibitors
- In combination with additional antigens, including those arising from the exciting new field of tumor
- In February, Asterias reported additional results from the company’s ongoing Phase 1/2a SCiStar study that continued to 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.
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.
First Quarter 2018 Financial Results
Cash, cash equivalents, and available-for-sale securities totaled $18.8 million as of March 31, 2018.
Total revenues were $0.5 million for the first quarter, which were comprised of license revenues and royalty revenues on product sales by licensees. Research and development expenses were $3.6 million in the first quarter, with the primary driver being expenses associated with the company’s AST-OPC1 program. General and administrative expenses were $1.9 million in the first quarter. Total operating expenses were $5.5 million in the first quarter of 2018 compared to $11.1 million in the first quarter of 2017.
Net loss was $2.3 million, or $0.04 per share, for the first quarter of 2018, compared to a net loss of $6.3 million, or $0.13 per share, for the first quarter of 2017. For the quarter ended March 31, 2018, net cash used in operating activities was $3.9 million compared to $7.2 million for the quarter ended March 31, 2017.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today, May 9, 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 session, the call can be accessed by dialing 877-591-4959 (U.S./Canada) or 719-325-2329 (international) five minutes prior to the start of the call and providing the Conference ID 8804469. 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 8804469. 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-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy that also targets telomerase presenting tumor cells. 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. AST-VAC1 (antigen-presenting autologous dendritic cells) is an autologous cancer immunotherapy targeting telomerase presenting tumor cells, with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML) which the company believes is proof of concept data for AST-VAC2. 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.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(IN THOUSANDS, EXCEPT PER SHARE DATA)|
|Three Months Ended|
|Royalties from product sales||112||116|
|Cost of sales||(63||)||(53||)|
|Research and development||(3,626||)||(6,598||)|
|General and administrative||(1,912||)||(4,466||)|
|Total operating expenses||(5,538||)||(11,064||)|
|Loss from operations||(5,123||)||(9,107||)|
|Gain from change in fair value on warrant liability||1,519||2,954|
|Gain from change in fair value on equity securities||1,157||-|
|Interest expense, net||(106||)||(125||)|
|Other income/(expense), net||239||(9||)|
|Total other income, net||2,809||2,820|
|LOSS BEFORE INCOME TAX BENEFIT||(2,314||)||(6,287||)|
|Deferred income tax benefit||2||-|
|BASIC AND DILUTED NET LOSS PER SHARE||$||(0.04||)||$||(0.13||)|
|WEIGHTED AVERAGE SHARES OUTSTANDING: BASIC AND DILUTED||54,185||48,357|
|ASTERIAS BIOTHERAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|(IN THOUSANDS EXCEPT PAR VALUE AMOUNTS)|
|March 31, |
|Cash and cash equivalents||$||10,519||$||13,266|
|Equity securities, at fair value||8,281||8,329|
|Prepaid expenses and other current assets||1,148||1,121|
|Total current assets||19,948||22,716|
|Intangible assets, net||14,773||15,444|
|Property, plant and equipment, net||4,282||4,543|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Capital lease liability, current||7||7|
|Lease liability, current||576||556|
|Total current liabilities||1,965||3,521|
|Capital lease liability, noncurrent||12||14|
|Deferred rent liability||320||316|
|Lease liability, noncurrent||2,789||2,941|
|Preferred Stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding||-||-|
|Common Stock, $0.0001 par value, authorized 75,000 Series A Common Stock and 75,000 Series B Common Stock; 54,691 and 54,051 shares Series A Common Stock issued|
|and outstanding at March 31, 2018 and December 31, 2017, respectively; no Series B Common Stock issued and outstanding at March 31, 2018 and December 31, 2017||5||5|
|Additional paid-in capital||153,824||152,136|
|Accumulated other comprehensive loss||-||(6,498||)|
|Total stockholders’ equity||33,003||33,543|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||39,327||$||43,092|
Contacts:Investor Relations(510) 456-3892InvestorRelations@asteriasbio.comorEVC Group, Inc.Michael Polyviou/Greg Gin(732) firstname.lastname@example.org