James Hayward
Analyst · the Maxim Group
Thank you, Beth and thank you Clay, and good afternoon everyone. Thank you for joining us today. As you've just heard Beth state, new revenue rules put in place at the start of the fiscal year don’t give you a complete picture of the progress we are making to monetize our DNA Taggants platform technology. We continue to cede the market with customers that can scale their orders as their confidence in our taggant technology builds. Over the past several quarters, we've shared with you details of our robust pipeline of pre-commercial studies, each reflective of new interest in our platform and each representative of an opportunity to generate incremental revenues if adopted at a commercial scale. Today, I will focus my prepared remarks on our opportunities in the near-term that offer us the potential for additional growth and diversification. Now, we have restructured and improved our global sales organization but was a special focus on textiles with two stellar additions to our team, Wayne Buchen as its Vice President of Strategic Sales and Steve Birkhold as the Member of the Strategic Advisory Board and a special consultant to our sales team, but especially with regard to brands. Now many manufacturers and brands are increasing the transparency of their supply chains to better control their quality and compliance to the criteria for sustainability, the circular economy and ethical sourcing, and to keep their consumers and efficacy communities better informed. In fact, Wayne Buchen just returned from the outdoor retailer show in Denver last week where we had a great reception. We are already in discussions with leading sportswear and lifestyle brands on evaluations of the initial scope of strategic projects. Now cotton would remain integral to our business. And it is being rapidly complemented by other natural fibers in a number of synthetic fibers. Despite the change in revenue recognized from the adoption of the new guidance, the demand for taggant has remained consistent as compared to the prior year's ginning season. We continue to move aggressively to open new cotton opportunities, including in the apparel market and in offshore markets. Steve Birkhold offers a stellar pedigree to help hone our strategy and network in the apparel market. He is a 30 year veteran of the fashion industry and formally Chief Executive Officer of Bebe Stores, Co-Chief Executive Officer of Diesel U.S.A and Lacoste, President of Earl Jeans brand at VF jeanswear. He is ideally qualified to lead the development of the new go to market strategy for us in the fashion and luxury apparel and accessory markets, utilizing his industry contacts to facilitate the introduction to and adoption of our technology with key decision-makers across all of these markets. Our newly organized sales team has already built increased demand for our CertainT platform. And we have been very actively fielding inquiries and preparing for much larger tagging volumes, and executing pre-commercial runs at some of the largest sites in the world. Now, turning to synthetic fibers. This market represents an addressable market that is a large multiple of the annual cotton market and its growing aggressively. Moreover, in the sustainability and circular economy, synthetic fibers are more readily recycled than natural fibers, whereas our authentication platform protects cotton brands against counterfeiting and insurers' problems. In synthetic fibers, our platform protects claims of participation in the secular economy, seeking to replace today's disposable textiles culture with one that emphasizes, supports and promotes, a more sustainable fashion apparel and home textile industry. We continue to execute on our strategy to engage key ecosystem participants, along multiple points in the global synthetic textile value chain to more broadly drive adoption of our authentication technology platform. Now, I just returned from several key meetings with large synthetic fiber manufacturers and recyclers in India, and I'm very encouraged by our commercial progress. Beginning about two years ago, we first contacted synthetic fiber manufacturers. The length of the sales cycle is such that only recently have we seen a maturation of pre-commercial pilot in our progress toward a next level of revenue generation. We are today on the cusp of generating our initial CertainT licensing revenues, as retailers begin to start GHCL and Loftex products made of recycled PET tags with signature DNA. GHCL will soon be initiating first shipments to Amazon where recycled PET made into bedding products and sold under its Rekoop brand. Loftex, which manufactures towels made of recycled PET, will soon have product on shelves at several major U.S. retailers. We expect our first royalty income for the use of our CertainT brand this year. From our recent announcements, you've seen that our business development efforts have focused on partnerships with supply chain companies that are working with textile brands and manufacturers that are based in Taiwan. It's China, Asia and supply chains across three continents. Taiwan is known as the hub of textiles innovation in Asia, producing 50% of the world's synthetic fabrics. The MOUs we have signed with Sun Chemical and Tex-Ray give us an instant presence and access to this important market to break impediments in the distance, language, culture and logistics, without incurring the costs associated with slowly-building a physical presence there. Sun Chemical with over 20 sales people located throughout Asia will be trained in our platform, and as the reseller of textile chemicals and related services, and will serve as the reseller of our CertainT platform. Tex-Ray, which has a global footprint, is the textile innovator both the products and processes that gives us entrée into established supply chains in service of large global brands utilizing synthetic fibers. Turning now to pharmaceuticals the nutraceuticals, let me update you on progress being made in penetrating the excipients market with our taggant technology. Since the completion of product development, followed by the filing of our Drug Master File with the FDA, we've worked closely with Colorcon to the operational infrastructure in place to ultimately be ready to deliver our mutual first-order. We're now readying for our first large-scale manufacturing run with Colorcon Opadry to take place in the coming weeks for process validation. Concurrently, we're working with Colorcon on an early stage study for a multinational biotech company. The timeline to our first order is yet to be determined and will be contingent on customer interest and that preparation for regulatory review, including stability and other testing regimes and the approval of the customers' drug candidate. We believe that pharmaceutical and nutraceutical excipients are a natural home for our taggant technology. And to that end, we are moving to request participation in the emerging technology program at the FDA to seek guidance on the FDA's regulatory requirements and roadmap for our technology platform with the goal of ensuring readiness for the regulatory approval process when it occurs. The emerging technology program seeks to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. Through the program, industry representatives like us can meet with the emerging technology program members to discuss, identify and to resolve potential technical and regulatory issues regarding the development and implementation of a novel technology, such as ours prior to filing a regulatory submission. Now, I will have more to say about this as this initiative progresses. We have been working very closely with our valuable go to market partner, TheraCann International, to develop a robust pipeline of tagging opportunities with growers and processors. As a reminder, our DNA technology platform is the basis of ETCH biotrace, one of four key services offered by TheraCann. ETCH biotrace is a verification technology that employs molecular tagging methods to ensure the integrity and provenance of ingredients and components in the cannabis supply chain from seed to point-of-sale and is supported by Cloud and Blockchain technology. We launched our demand generation campaign this past June with an industry webinar that was well attended, followed by print, online and social media programs with industry leading media properties. Then we launched our first cannabis tagging system this past July at the national cannabis industry Association in San Jose, California. Our patent pending concept of using a cold micron sized fog to tag the cannabis plant and then track it through the supply chain to retail shelves was very well received by the large industry players. We then launched a second version of the tagging system at the November MJBiz Tradeshow in Las Vegas that also received a great deal of interest, over 29,000 people attended the event. We also attended the CannaTech event in Sydney, Australia in October that is hosted by iCAN and I will attend the CannaTech event next week in Panama. TheraCann is the sponsor of the CannaTech shows, and will also be launching its cannabis center of excellence that same week in Panama that will feature the ETCH Biotrace solution, powered by our CertainT platform. Now the 2018 United States Farm Bill signed in December makes ETCH Biotrace more of an urgent need for the industry. The Farm Bill legalizes the regulated production of hemp, which until now has not been differentiated from other cannabis plants. The industry needs to be able to attract legal cannabis and THC based products. And now legal hemp CBD based products back to their source to prevent the encouraging into those supply chains by black market sources of the same materials that are often contaminated with toxins or to mitigate tax avoidance. As an example of the latter, in 2017, growers in California grew 13 million pounds of cannabis and used 2 million pounds in the state, illegally exporting 11 million pounds. We believe our platform would curb or eliminate intrastate transport that allows states to track and verify their cannabis tax revenues. Now, our near-term opportunities include 12 accounts across the globe. I hope to share news of our progress in cannabis very soon that will likely have a direct impact on our top line. Yesterday, we shared two announcements from iCAN, or Israel Cannabis, that concerns; firstly, the approval by the Israeli parliament or Knesset of the exportation of medical cannabis; and secondly, also concerned an agreement between our partner TheraCann International and iCAN. This bilateral agreement enables iCAN to offer our DNA tagging to control grey market diversion and to secure Israeli intellectual property that protects their cannabis business. And as you know, Israel leads the globe in security and in agricultural technology. So we regard this as a very positive pair of related developments. Finally, let me briefly update you on our LineaRx subsidiary. Following the introduction of LineaRx to the world via our webinar in early December, we attended the J.P. Morgan Healthcare Conference in January, which is the seminal conference for biotech and healthcare companies that seek to draw the attention of Wallstreet, potential industry partners and strategic investors. I believe it's actually attended by over 100,000 people. The LineaRx platform was very well received. And it is clear from our presentations there that there was an urgent need to replace plasmids as a means of manufacturing DNA at volume. Our research activities for LineaRx adopted for nucleic acid-based therapies are steadily progressing. Early results are promising. Our ongoing development of anticancer Linear DNA-based vaccines continues to show strong immunogenicity in mice, and at tumor challenge in mice is on the near horizon. We are very excited about that. Our CRO funded work projects are performing well and attracting new companies, especially in the field of RNA template design and bulk manufacture. We are beginning to see larger than typical dollar value for new opportunities that are entering our pipeline, particularly as our CRO customers face maturation into longer contract manufacturing relationship. The company recently received a purchase order in excess of $500,000 for Linear DNA and diagnostics to be delivered over the next 12 to 18 months. Now in the field of adoptive cell therapy, or CART, our early results are very encouraging and show that transfection of human T-cells with linear DNA at high-efficiency is possible and can produce strong and persistent expression in vitro. Now, this microscope image is of human T-cells grown in primary culture. The image was derived only 24 hours after the modification by electroporation with a Linear DNA amplicon produced, design and manufactured by us via LineaRx PCR technology. And this amplicon contains the complete gene, which encodes the production of green fluorescent protein or GFP. The microscope image you saw is of that green fluorescence generated from the synthesis of GFP protein in the cell. Each cell that has taken up the linear amplicon in a functional form is converted to a 10 micron diameter green cell. And as is striking from this microscopic image, hundreds of such T-cells have taken up the linear GFP amplicon, thus generating a constellation of green fluorescent cells in the micrograph. Now to our knowledge, these are the first data to demonstrate the uptake in subsequent gene expression of the PCR generated gene fragment in human T-cells, facilitated by commercially scalable, high throughput electroporation. The GFP system is well known in cell biology to be an excellent target for optimizing human gene expression in cells. Along these same lines, LineaRX has begun taken the lessons learned from the present GFP studies with human T-cells and will now begin corresponding studies with the linear amplicon that LineaRX has designed an already manufactured for the anti-CD19 CAR T-cell therapeutic candidates we recently licensed from iCell. We anticipate these studies will begin in mid-February. We will soon be transfecting in human T-cells with our anti-CD19 LineaRX CAR T construct, which if successful, will be proof of our concept of our viral and plasmid-free CAR T manufacturing platform. Now, during the fourth quarter of fiscal 2018, we had closed on a $1.65 million round of secured convertible notes with certain members of the management team, the Board of Directors including me. During the first quarter of 2019, we closed on an additional $550,000 of the secured convertible notes with anticipation by me and another member of management. The participation by management and the Board of Directors serves to further align our interests with those of our shareholders. As Beth noted, we also closed on the public offering during December 2018 for total gross proceeds of $2.75 million. During January Maxim Group exercise most of their overallotment for an additional $250,000 in gross proceeds, and we've also seen a small degree of warrant conversion. We remain committed to maximizing the value of our platform to the benefit of you, our shareholders. The management team and employees of Applied DNA are singularly focused on bringing the opportunities I have discussed to revenue. Adoption of our platform has taken a long time. But we are starting to see the initial through of our many years of labor. Along the way, we have honed our platform's value proposition around responsible sourcing, sustainability, compliance to supply chain management, quality assurance and verification of marketing plans to manufacturers and brands across our select target verticals. Now, this concludes my prepared remarks. Operator, can you please open the call to questions.