Jim Joyce
Analyst · Zacks Investment Research. Please go ahead
Thank you, Scott, and good afternoon everyone. We've been quite busy since our last quarterly call. On August 11, we delivered an expedited access pathway submission to the FDA as the means to acceleration the potential commercialization of our Hemopurifier to treat infectious viral pathogens. On September 12, we disclosed that the FDA awarded our Hemopurifier with an Expedited Access Pathway designation, which also allows for the broad spectrum indication of use against life threatening viruses. I'm pleased to report that this past week, the FDA published guidance that our Hemopurifier and other Expedited Access Pathway devices will now be advanced under a new breakthrough device designation, which is being established as a result of the 21st Century Cures Act that was signed in the long last December. On September 14, we disclosed that we were awarded a National Cancer Institute contract and on October 2 we announced the completion of the $6 million financing. During the quarter, we also utilized our aftermarket facility to bring in an additional $1.6 million as a result of these financing activities. We eliminated the balance sheet risk optics that overhung our company and became compliant with NASDAQ shareholder equity listing requirements, which we disclosed on October 10th. And our most recent disclosure we announced the large scale manufacturing collaboration with iBio on October 16. This is related to scaling up the production of the lectin-affinity agent that resides within our Hemopurifier and capture infectious viral pathogens. During the quarter, we also disclosed that the institutional review board at the Translational Genomics Research Institute had approved the clinical study protocol to support our next CTE and Tauopathy biomarker study in former NFL players. We are now planning the formal kickoff of this study, which is being advanced by our Exosome Sciences diagnostic subsidiary. Now before I turn the call over to Jim Frakes, our CFO, I want to provide some further details regarding our breakthrough device designation. Beyond accelerating our potential pathway to market, the FDA agreed to the following indication of use for our technology. The Hemopurifier is a single-use device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment. So instead of an indication of use against a specific virus, the FDA allowed us an indication of use that is based on a surface structure, in this case by cost related and is common to a broad spectrum of infectious viruses. To support this statement that I want to share that in coordination with the centers for disease control and infection, the National Institute of Allergy and Infectious Diseases classified 42 viruses, could be life threatening category A, B or C pathogen threats in the United States. Of these 42, 40 are highly glycosylated viruses and of those 40 only two are addressed with an approved post exposure therapy. This statistics is not inclusive of newly emerging viral threats. It is not inclusive of mutant strains of treatable viruses that evolved to become life threatening nor does it include viruses that maybe genetically engineered to be agents of bioterror. As Bill Gates has been quoted this form of viral threat could kill more than ten million people in a single incident. In reality, the treatment of life threatening viruses represents one of the most significant unmet needs in global health and biodefense. At present there are life threatening outbreaks occurring around the world. There are real world concerns that circulating strains of influenza virus to trigger global pandemic. China has reported that 39% – 39% of the 1500 plus individuals that had been impacted with the H7N9 strain of influenza have died and at the same time neglect the strain of H3M2 influenza has caused the worst outbreak in 50 years in Australia, New Zealand. There is a plague outbreak in Madagascar and Marburg virus infections are being reported in Africa. Last week, the World Bank reported that it conducted a pandemic’s simulation with a dozen countries that reinforce the urgent need for therapies to combat pandemic viruses and Harvard University Belfer Center for Science and International Affairs with a recent report that claim North Korea has an advanced biological weapons program that may include thirteen different pathogen threats including smallpox and deadly hemorrhagic viruses. Again, the treatment of life threatening viruses represents one of the most significant unmet needs and global health and biodefense. Since receiving an Expedited Access Pathway designation, which will be known as the breakthrough device designation going forward, we have conducted a telephonic meeting with our FDA review team and we have agreed to schedule a follow on meeting at FDA headquarters to determine the clinical pathway to support commercialization of our life threatening virus indication of use. As soon as we have further clarity from FDA, we will provide immediate guidance. In the meantime, we are exploring other life threatening glycosylated disease targets that are not addressable to proved therapies. This includes tumor-derived exosomes, which are focus of the National Cancer Institute contract that we disclosed in September. We have already achieved our first milestone under this contract program. And finally, in parallel to our FDA endeavors, we have assembled a small capable and experienced team to navigate opportunities within the U.S. government to financially support the implementation of our technology as a broad spectrum treatment countermeasure against bioterror and pandemic threats. We believe our Hemopurifier – device or Hemopurifier aligns to full fill several of the primarily objectives of the Department of Health and Human Services, Public Health Emergency Medical Countermeasure Enterprise otherwise known as PHEMCE. PHEMCE’s objective includes the support and potential procurement of medical countermeasures into the Strategic National Stockpile. In recent years, the PHEMCE initiative has shifted from attempts to align a V specific countermeasure with each pathogen threat through a transition towards broad spectrum countermeasures with activity against high priority threats including both known and unknown threats pandemic strains of influenza, an emerging threats including Zika, Ebola and MERS-coronavirus for which we have data against all three as well as numerous other high priority threats. With that said, I will now turn the mic over to Jim Frakes, who will discuss our financial results.