James Hayward
Analyst · H.C. Wainwright
Okay. Well, thank you, Beth, and good afternoon, everyone. Thank you for joining our call this afternoon. COVID-19 has been Applied DNA's primary focus since the start of this pandemic that has challenged the spirit, science and creativity of the global society and economy. The first phase in our company's response was focused on the health and safety of our employees. And in this regard, I'm pleased to report that we have and continue to execute well. I also want to use the opportunity to praise the performance of our team throughout the lockdown and in their continued isolation and social distancing. Those of us working from home have actually shown an increase in productivity, while many in the labs and in production worked throughout the lockdown and took on extraordinary goals that required working around the clock. This is how our linear COVID-19 diagnostic came to be. We all, shareholders and management alike, have many reasons to be proud of our team. Today, fully 60% of our technical headcount is dedicated to our COVID-19 diagnostics business and vaccine development programs. Applied DNA has developed a highly sensitive and specific diagnostic assay for COVID-19. And since March, our focus has been to develop a leading diagnostic kit and obtain the appropriate regulatory approvals to ramp up our production capabilities, now measured in tens of thousands of patient reactions per day, and to engage leading institutions, hospital networks, companies and schools as customers for our diagnostic kits and testing services. My remarks this afternoon will focus on that portion of our response, in which we moved to perform against our COVID-19 commercialization strategy. Having secured the FDA Emergency Use Authorization for our linear COVID-19 diagnostic assay kit and then several subsequent amendments, I will offer insight into our go-to-market strategy as we anticipate receipt of our first commercial diagnostic kit orders. I will also shed light on the establishment of our clinical lab subsidiary that I believe has the potential to be a significant revenue and profit center for the company. In our vaccine development program, we are very encouraged by our recent results in animal models that echo the effectiveness announced by some of the COVID-19 vaccines that are already in human trials. We will look to build on this momentum in the near term with toxicology screens in large animal trials and with the support of industry and big pharma partners, with whom we are already in negotiations. Beginning first with the science behind our COVID-19 programs, our science is grounded in the central feature of the virus that is the Spike protein, or the S gene encoded protein, to both detect and protect against the virus. For our diagnostic kit, this means that we can detect all currently sequenced stable variance of the virus and, we believe, any new stable and infective variants that may develop in the future. Should, as some have suggested, the virus eventually become seasonal, our assay would be able to detect those new genetic variants. Our focus on Spike in the diagnostic ensures that we can detect all variants still capable of binding to the host cell ACE2 receptor. Without this event, the virus would lose its mechanism to bind to and enter host cells. Other diagnostics that are not focused on Spike, and there are many, lack this advantage. Given this ability to detect current and future genetic variants, should there be a sudden mutation in the sequence of the virus that impacted the effectiveness of current and planned vaccines, we believe that in conjunction with our partner, Takis, we can more quickly develop a corresponding linear DNA vaccine that we believe could be manufactured at scale for global consumption faster than anyone in the industry. And this is the power of our linear DNA platform. Having received the EUA for our diagnostic kit in mid-May, we began to put into place the foundation necessary to commercialize it. In the ensuing months, our activities have yielded an expandable, addressable market, further improvements to our kit and the installation of an expanded sales and marketing infrastructure with which to drive demand. Now our kit comes in three capacities: 100, 500 and 1,000 reactions or tests per kit. Our current manufacturing infrastructure can support the filling of tens of thousands of tests per day with inventory managed to enable quick response to orders. We are pricing within industry norms of $25 to $40 per test. Our cost per reaction to manufacture a kit is profitable across all these kit sizes and, of course, our cost diminishes with scale. Our commercial strategy is twofold: one, gross sales of our diagnostic kit to authorized clinical laboratories and the large-scale screening of asymptomatic individuals necessitated by reopening businesses and schools; and two, to grow testing volumes of our own kits at our own clinical laboratory. And I'll address each of these in turn. Our kit is designed for high sensitivity with a low likelihood of false negatives, and is designed for high throughput and same-day results. It can be applied in 96-well high-throughput systems; EUA approved for use with our kit, and is suitable for laboratories screening large amounts of patient samples. And to that end, through a steady campaign of EUA amendments, we have grown the footprint of systems on which our diagnostic kit can run. With the recent second amendment to our EUA, we have added Applied Biosystems' QuantStudio 5 Real-Time PCR System to our fold that represents a tenfold expansion in the addressable market for our kit. We are working on a new amendment targeting the use of our diagnostic kit on what we believe is the most prolific real-time PCR system installed in clinical labs, which we believe will further increase our addressable market. We anticipate this next amendment to our EUA in the coming weeks. Increasing the relevant installed base of instruments that can use our linear COVID diagnostics will help us to gain market share against instruments that are not as widely approved. Now on July 24, FDA issued new guidance that prevents the use of any EUA kit for the screening of asymptomatic individuals without the specific approval of FDA. Now we applaud this step and that was not broadly anticipated by the COVID diagnostics industry as necessary to ensure the safe screening of presymptomatic or asymptomatic individuals. Now high analytical sensitivity increases the likelihood that a test will be positive for any samples that contain the virus, even if the patient has no apparent symptoms. High specificity increases the probability that the test will remain negative for individuals with respiratory illnesses that are other than COVID-19. But given the speed of the U.S. response to COVID-19, there were no indexed methods to evaluate the sensitivity and specificity across the spectrum of approved EUAs, that is until recently. Roughly coincident with the guidance for asymptomatic screening, FDA developed a reference panel for the blinded assessment of both sensitivity and specificity. And I'm pleased to say we've just completed our analysis of that reference panel and submitted the results back to FDA. In addition, we are now preparing another amendment to enable large-scale pooling and testing of asymptomatic individuals as additional claims to our EUA, whether utilized by our customers or in our own clinical lab. We expect to submit our amendment to FDA shortly. It should be noted that FDA recently granted a similar amendment to a large testing laboratory whose sensitivity of their assay is 10x less than ours. In other words, our lower limit of detection is to 10x less viral RNA, is to 10x less viral RNA than the competitor's assay. I'll say that again. In other words, our lower limit of detection is to 10x less viral RNA than our competitor's assay. I think you might agree that we're in a competitive position in this regard. As parts of the country undergo their first wave of the virus and other parts that have endured the first wave are today seeing infection rates spike yet again, we believe that pooled asymptomatic screening could help the nation alleviate the difficulties in keeping up with the testing demand, and we intend to be ready to meet that demand. Now patient accessibility is also a crucial aspect of a diagnostic kit's commercial success. In addition to offering nasopharyngeal swab sample collection, our EUA provides us the ability to collect patient samples through the use of an anterior nasal swab collection system, known as ANS, that's less invasive and far more comfortable method, should prove very beneficial in terms of accelerating screening for COVID-19, especially in student populations that are unlikely to comply with repetitive nasopharyngeal swabs. By contrast, our anterior nasal swabs are painless and easy to administer to testing subjects of all ages, including children. To facilitate the use of an anterior nasal swab collection with our diagnostic kit, we plan on launching our own proprietary nasal sampling kit in the coming weeks. As our diagnostic kit becomes relevant to more laboratories, we have expanded our sales infrastructure through internal hires and external recruitment that is designed to get our kit in front of laboratories nationally. We have invested aggressively in our supply chains and have established sufficient inventory to support our expectations for kit demand. We are closing in on our first commercial diagnostic kit contract that we hope to announce very soon. We expect the customer, a major regional medical center and teaching hospital, will serve as validation of our kit in the marketplace and could ultimately encompass testing across patients, students and staff populations. This will be an important customer site, and it will serve a second benefit. We've also been working concurrently to implement a high-throughput COVID testing workflow for our kit at their laboratory, consisting of robotic RNA extraction, robotic sample preparation and software interfacing with the customer's laboratory information system. We believe this smooth workflow serves as a model for other diagnostic kit customers to adopt to their laboratories. It also serves as the basis for the end-to-end high throughput workflow solutions currently being deployed at Applied DNA Clinical Labs, our new testing subsidiary, to offer testing as a service. Now with regard to our clinical lab subsidiary, we established it to enable clinical testing of patient samples using our own diagnostic test to help satisfy the growing testing demand in the U.S. The economics of testing, however, make our intention to offer testing as a service, or TaaS, a hidden gem within Applied DNA given its potential for revenue contribution at a level per test of possibly up to 4x that of stand-alone kit cells. Now to illustrate the current CMS reimbursement for COVID-19 testing is $100 per test. In a hypothetical scenario, a standing - a stand-alone kit cell would yield $25 to us per test at the lower end of the pricing range I provided a moment ago. This then leaves $75 on the table that is captured by a laboratory conducting the testing. By running our own kits through our own clinical lab, we can capture much of the increment up to the approved reimbursable $100 per test. We can also serve as an overflow service laboratory for our own customers who purchase our linear COVID-19 diagnostic kits, thereby providing additional value to our customers in times of stress caused by increased demand. With cases seemingly on the rise that suggests greater and long-term demand for testing, we expect fully to be an overflow facility. In order to launch testing as a service, our clinical lab must be certified by the state of New York. This certification process has been significantly delayed by COVID-19 and the shutdown of government systems as a consequence of stay-at-home orders. Certification requires an inspection of our clinical lab and the submission of validation data, both of which we hope to complete in the coming weeks. Now as we await certification, Applied DNA Clinical Labs is already generating a revenue stream in the form of sponsored research contracts under which we are performing anterior nasal swab sampling research in pooling models that will help the U.S. increase testing throughput. The advantage of recruiting for research use-only sponsored studies at this time is the incremental revenue they generate as well as being able to leverage their data for use in our certification process with the state of New York. Furthermore, the data also serves as the basis for application for new approvals from FDA for asymptomatic screening testing and sample pooling. Now the nucleic acid-based responses to the pandemic are being validated by other companies who are in pursuit of a COVID-19 vaccine. And nowhere is that more evident than at the unprecedented pace of development that has a DNA- or RNA-based vaccine candidate, comprising about 40% of all the current clinical trials, a record breaker for the first time. In our recent tests conducted on mouse models, all 5 of our linear DNA COVID-19 vaccine candidates, designed in concert with Takis Biotech, provoked 0 conversion in all mice to produce IgG against Spike protein by day 14 and significantly enhanced those responses by day 38. Our results suggest that a low-dose vaccine could be potentially effective in providing protection with neutralizing antibodies, while the T cell responses in both CD4 and CD8 lineages suggest potential long-term immunopersistence. And as I noted earlier, these results in animal models echo the effectiveness announced by some of the COVID-19 vaccines already in trial. We believe this bodes well for the human responses to our vaccines. Together, both Takis and Applied DNA have entered into dialogue with biotech partners and potential big pharma partners for the evaluation of efficacy in more complex animal models and to fund the completion of toxicology studies. Our potential big pharma partner is already a customer of our CRO/CMO division, LineaRx, and has engaged in the valuation of many constructs of linear DNA for their planned therapeutics. A second benefit of this potential collaboration on the linear DNA COVID vaccines may include enhancements to our DNA delivery systems. Very exciting. We believe that our linear DNA vaccines, however, have inherent advantages over even the speed of development that conventional DNA and RNA vaccines offer. We can revise our vaccines rapidly in days to weeks without the need for cloning techniques. Our linear DNA vaccines have the inherent advantages of vaccine expression without integration into the human genome and the avoidance of antibiotics and the transference of antibiotic-resistance genes, the avoidance of bacterial vectors and the high purity in a very, very simple means of production. Linear DNA vaccines are much more stable during storage and shipment than RNA-based vaccines, which is a practical advantage during worldwide deployment. Now we believe that we are the world's largest manufacturer of linear DNA. Should the virus mutate, we can improve our linear DNA vaccine within weeks of obtaining the sequence of a genetic variant of that virus. And with our manufacturing capacity, we could produce quantities for mass consumption globally. Or should another company develop an efficacious vaccine, we would be in a position to develop a linear DNA form of their vaccine and supply it at quantities relevant to worldwide inoculation. Now our CRO/CMO service business has, since its beginning, developed a strong client base, many of those clients with state-of-the-art challenges in the manufacture of contemporary gene therapies. And recently, we have succeeded in the production of single stranded DNA by PCR, a real feat, and in the production of the linear genes necessary for the manufacture of some viruses that play central roles in gene therapy and in redirected cell therapy. These are not inconsequential developments. We've received requests to scale these processes under cGMP in quantities adequate to serve initial clinical trials. Now though our business focus year-to-date has been on our COVID-19 programs, we have not lost sight of our supply chain security business. And as Beth noted, the impact of COVID-19 on business activity has had a negative and pronounced impact on the supply chains we service that generate the bulk of this segment's revenues. Segment revenues principally generated from the textile industry that uses our molecular tags for the marking of cotton and certain manmade fibers that are sold at Bed Bath & Beyond and other retail channels. As we await the return of increased demand patterns, we're focused on business building across key industrial and regulated markets, including textiles, as well as cannabis, personal care, nutraceuticals and pharmaceuticals. By setting the stage today, we are positioning the company for further adoption of our supply chain security and authenticity solutions tomorrow. Now even though we've been working at break-net speed to address the COVID-19 pandemic, we've not forgotten about the importance of our intellectual property which has always been one of the central underpinnings of the company. Over the last few months, we've received 4 notices of allowances for important patent applications related to cotton tagging; Beacon, which is our locked optical marker system; and a system to DNA tag and inventory through the use of a fogging system that has broad applicability to several markets, including cannabis. In addition, we continue to bolster our IP estate in the domestic and biotherapeutic markets with the recent filings of several patent applications for our COVID-19 diagnostic and novel biotherapeutic applications of linear DNA. We also continue to prosecute previously filed patent applications related to the use of linear DNA in CAR T therapies and vaccines. And so now to conclude my remarks, we really have accomplished much over the quarter to position Applied DNA to serve unmet and evolving needs for both COVID-19 testing and vaccines. We are today primed for increased market penetration and commercial sales. With our strategy set and supported by solid cash reserves and with a continued laser focus on execution, we believe we are very well positioned to succeed. And this concludes my prepared remarks. Operator, please open the call up to questions.