Asterias (AST): Blazing the Stem Cell Trail for Spinal Cord Injury

Edward Kim  |

Yesterday we highlighted the GTCbio Stem Cell Summit in Boston. Another company we've been closely following is also represented at the conference, Asterias Biotherapeutics (NYSE: AST). Asterias is developing therapies based on pluripotent stem cells to address significant unmet medical needs in neurology and oncology. According to Boston Children's Hospital, pluripotent stem cells are the body's master cells, potentially able to produce any cell or tissue the body needs to repair itself. Like all stem cells, pluripotent stem cells are also able to self-renew, meaning they can perpetually create more copies of themselves.

The company draws its name from the common starfish, Asterias rubens, which has the ability to regenerate lost limbs even in adulthood. The company's lead product candidate, AST-OPC1, is currently in a Phase 1/2a dose ranging trial for spinal cord injury. As Patrick Cox discussed two months ago, Asterias' clinical trial has been generating significant interest.

In the company's earnings call last week, CEO Steve Cartt highlighted the ongoing clinical and corporate progress:

  • Patients from a cohort with neurologically complete cervical injuries showed improvement in upper extremity motor function at 3-months following administration of AST-OPC1.
  • Asterias subsequently reported efficacy results for five patients from this cohort that showed additional motor function improvement at 6-months and 9-months following administration of AST-OPC1.
  • In March 2017, the company reported that the sixth, and final, patient in this cohort showed additional motor function improvement at 6-months following administration of AST-OPC1.
  • Received FDA clearance to expand the study to include two additional cohorts of subjects with less severe injuries.
  • Successfully completed the validation and start-up of its internal current Good Manufacturing Practices manufacturing facility at its Fremont, CA, headquarters in preparation for late-stage clinical trials of AST-OPC1.
  • Reported positive long-term follow-up results from the Phase 1 clinical trial of AST-OPC1.
  • Received Orphan Drug Designation from FDA for AST-OPC1 for the treatment of acute spinal cord injury.
  • Successfully completed an End-of-Phase 2 meeting with the FDA for its second product candidate, AST-VAC1 in Acute Myeloid Leukemia.
  • Completed clinical protocol development and the transfer of the manufacturing processes to produce AST-VAC2 to Cancer Research UK (CRUK) as part of the ongoing partnership with CRUK to conduct a Phase 1/2a study for AST-VAC2 in non-small cell lung cancer.

Source: Asterias Biotherapeutics Corporate Presentation, Jan. 24, 2017

We note that the company's cash position is much better than it was a year ago. As shown in the chart above, Asterias' spinal cord trial is funded by a grant from the California Institute of Regenerative Medicine (CIRM), which has certainly eased the burden. As of the end of February 2017, the company's cash and cash equivalents totaled $19.9 million and combined with its available-for-sale securities (mostly BioTime stock - see below*) totaled $33.5 million. Ryan Chavez, CFO, said, "We believe we currently have sufficient capital to fund operations through at least the first quarter of 2018."

* Readers may recall that Asterias was spun out of BioTime (NYSE: BTX) in 2014. BioTime remains the dominant shareholder, controlling 47% of the outstanding common and three out of the nine board seats (with a fourth board seat occupied by Broadwood Capital, BioTime's largest shareholder). Also, as mentioned above, Asterias holds about $13 million worth of BioTime stock. While the kids all seem to be playing well in the sandbox, this close relationship merits watching.

Jane Lebkowski, Asterias' President of Research and Development, was part of an immunotherapy roundtable at the Stem Cell Summit yesterday, discussing the company's research in therapeutics for lung cancer. Today, April 6th, at 10:40am ET, Dr. Michael West, CEO of BioTime, will deliver the conference keynote address entitled "The Promise of Pluripotency in the Manufacture of Advanced Cell-Based Therapeutics" - which sounds like a direct advertorial for a key BioTime asset - Asterias Biotherapeutics.

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