Applied DNA Sciences, Inc.

Good day and welcome to the Applied DNA Sciences First Quarter Fiscal 2025 Financial Results. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your touchtone phone. To withdraw your question, please press star and then 2. Please note this event is being recorded. I would now like to turn the conference over to Sanjay Hari, Head of Investor Relations. Please go ahead.

Thank you, David. Good afternoon and welcome to the Applied DNA's First Quarter Fiscal 2025 Financial Results Conference Call, where we will discuss our financial and operational performance, business progress, and growth opportunities. Joining me on the call today are James Ayerwood, our Chairman and CEO, Judy Murrah, our recently appointed President, Beth Jansen, our Chief Financial Officer, and Clay Shorrock, our Chief Legal Officer and the newly appointed President of our LinearX subsidiary. Following management's remarks, we will open the line to questions from our analysts and institutional investors. You may access the press release that was issued after market closed today, as well as the slide presentation accompanying this call on the Investor Relations section of our corporate website. A replay of the audio portion of this call would be archived also on the IR section of the website. Before we get started, let me take this opportunity to remind you that our remarks today may include forward-looking statements. I refer you to slide 3 of the presentation and our Form 10-Q for important risk factors that could cause the company's actual performance and results to differ materially from those expressed or implied in any forward-looking statements. We undertake no obligation to update or revise any forward-looking statements or other information provided on this call as a result of new information or future results or developments. Now, it's my pleasure to introduce our first speaker on today's call, Beth Jansen. Please go ahead, Beth.

Thank you, Sanjay, and good afternoon, everyone. First, let me set the agenda for our call today. I will provide a high-level overview of the finances of the company. Next, Jim will briefly walk you through our important milestones achieved during fiscal year 2024. Then Clay will provide an update on the LRX business and its growth strategy. And finally, Judy will provide you with an update on our operations. Prefacing my review of our financial results for the quarter and to put our performance into its necessary context, During the first quarter, we initiated a strategic restructuring intended to bolster our cash reserves and optimize our cost structure. This initiative was undertaken to reduce our cash burn rate and support the growth of our synthetic DNA manufacturing strategy via our linear RRX subsidiary. Having laid much of the necessary groundwork to support this strategy in fiscal 2024, the restructuring reflects our belief that linear RRX offers the greatest potential to create sustainable value for our shareholders. Our October 2024 financing supports linear RRX during what we expect to be a year of execution in fiscal 2025. A point reinforced last month with the certification of our GMP Site 1 facility, which Jim and Clay will elaborate on this point in their remarks. With our quarterly results press release today, we are announcing our exit from the DNA Tagging and Security Products and Services business segment. We anticipate the wind down to be completed by the end of the current quarter. As a result, we implemented a workforce reduction of approximately 20% of total headcount, related primarily to employees in this segment. We will incur a one-time charge of approximately $300,000 in the quarter ending March 31st related to this action. Turning to our financial results for the first quarter and beginning with our Statement of Operations, total revenues for the first quarter of fiscal 2025 were $1.2 million compared with $891,000 for the same period of fiscal 2024. The -over-year increase was a result of higher product revenues from our DNA Tagging business segment and from an increase in our Textiles Isotopic Testing Services revenue. Our operating loss for the first quarter was $3 million compared with $3.8 million in the prior year period. This improvement in our operating loss is primarily attributable to a lower selling, general, and administrative costs -over-year related to lower stock-based compensation expense and to a lesser extent from a decrease in consulting expenses resulting from the closure of the DNA Tagging segment's European subsidiary. Net loss for the first quarter was $2.7 million compared with $1.1 million in the prior year period. I remind shareholders that our net loss includes an unrealized gain on the change in the Fair Value of Warrants classified as a liability, which has an inverse relationship with our stock price. For this reason, we highlight operating loss as best representing the company's operations. Adjusted EBITDA for the first quarter improved to a negative $2.9 million compared with a negative $3.2 million in the prior year period. Now turning to our balance sheet, cash and cash equivalents on December 31st totaled $9.3 million, which includes net proceeds of approximately $5.7 million from our October offering and series A warrant exercises of $509,000. This compares to cash and cash equivalents balance of $6.4 million on September 30th, 2024. As of December 31st, our accounts receivable stood at approximately $912,000. Our average monthly cash burn is just over $1.2 million fiscal -to-date and essentially flat with the same period in the prior year.

Our

average monthly cash burn for the fourth quarter of fiscal 2024 was $1.3 million. Cash and cash equivalents on January 31st, 2025 was $8.2 million. This figure includes additional series A warrant exercises totaling approximately $215,000. Our just filed 10Q maintains a disclosure from our prior form 10K of a substantial doubt of a going concern. Our ability to alleviate the going concern is dependent on our ability to further implement our business plan and generate revenues or raise capital. We sought shareholder approval for the exercise ability of the warrants issued in the October 2024 financing on January 23rd in a special meeting that was adjourned due to a lack of quorum. We will reconvene the meeting tomorrow at 11 a.m. Eastern Time. And we encourage all shareholders who own shares as of the record date of November 25th, 2024 who have not yet voted their shares on the proposal to vote. As of the January 23rd meeting, 80% of all shares that were voted did so in favor of the proposal. This concludes my prepared remarks. Thank you for joining us today. I will now turn the call over to Jim for his comments. Jim.

Thank you, Beth. And good afternoon, everyone. Thank you all for joining us on today's call. I want to begin by addressing our strategic restructuring. The restructuring reflects our full commitment to rebuilding shareholder value through an optimized cost structure, prudent financial management, and a deeper focus on linear Rx. Post pandemic, emergent trends in biotherapeutics and interest among the investor community has centered chiefly on our linear Rx subsidiary and its ability to enzymatically produce DNA at scale to meet the growing demand for alternatives to plasmid DNA. In particular, in the last 18 months, we've seen an acceleration in the pace of linear Rx's operational progress. Interest and feedback on our linear DNA and linear IVT platforms have exceeded even our most optimistic expectations. The biotherapeutics market is ready for what we have to offer. And as we'll talk about on this call, we are now ready to deliver. We recognize that while each of our business segments offered their own return on investment, but cumulatively, these disparate ROIs blur our path to profitability. This drove our decision to exit our DNA tagging business segment and implement the workforce reduction. Segment customers have been informed, and certain of them will be supported for a period of time. Fiscal 2024 had significant successes. We did not have the benefit of a fourth quarter investor call. Therefore, let me summarize certain key milestones we achieved during the year. Then Clay and I will address our strategy for fiscal 2025. So in fiscal 2024, we validated our linear IVT platform. Data generated internally and with a CDMO partner were conclusive. Our platform demonstrates a reduction in problematic double-stranded RNA contamination on a commercial scale. And is cost neutral to legacy manufacturing platforms. Linear DNA also entered the clinic. We announced that the Institute of Fematology and Blood Transfusion, or IHBT, in Prague received approval for and initiated a phase one trial of a first in human CAR T clinical trial. IHBT's therapy utilizes linear DNA as a critical component of its CAR T therapy to enable a rapidly manufacturable viral vector free workflow for the treatment of relapsed and or refractory acute myeloid leukemia. This approval highlights the first instance of regulatory consent of linear DNA's use in a clinical setting, a key milestone. Linear RX's customer acquisition raise has exceeded our expectations. In fiscal 2024, we engaged over 25 customer projects and we expect multiple projects to enter the clinic in calendar 2025. Furthermore, in advance of our GMP certification, multiple customers validated us as a GMP supplier. As part of our strategic restructuring, the board promoted Judy Mara to president, where she will oversee a continued drive toward operational excellence and quality across our business segments. Congratulations, Judy. In a moment, Judy will discuss her role in greater detail. Similarly, the board has given the additional responsibility of president of Linear RX to Clay Chirac. Congratulations, Clay. In addition to his corporate officer duties, in recent years, Clay has led global sales and business strategy for Linear RX and has cultivated a marquee list of customers. Applied DNA clinical out secured New York State Department of Health LDT approval for TRAIT PGX, our pharmacogenomics assay that forms the basis for our PGX testing service. And we secured an expansion in use for our MPOX assay. And we are now licensed to accept samples from all 50 states. Finally, last month, our GMP site one was certified operational as an ISO 7 space with ISO 5 workspaces. With this site, we've demonstrated a low capex approach to enzymatic DNA production at scale, empowering our entry into long term GMP supply agreements. Now let me turn the call over to Clay to offer some specific insights into Linear RX's plans for fiscal 2025. Clay?

Well, thank you, Jim. First, I want to thank the Applied DNA Board of Directors and Management team for the opportunity to lead Linear RX as we approach what I believe is an inflection point in its trajectory. For those of you who are new to our story, I've been with Applied DNA since 2016, sitting in various legal and business roles. My background is in biology and intellectual property, and I have 15 years of legal and business experience. I have a passion for building companies, and I believe with the plan we have in place, Linear RX will be a growth engine for Applied DNA. Now, since the COVID-19 pandemic, the growth trajectory for enzymatically produced DNA has rapidly increased. As Jim mentioned, with over 25 active projects in fiscal 2024, we see a strong market demand for our Linear DNA and Linear IVT platforms. With our initial GMP site now online, we are focused on monetizing this demand. But to this end, our commercial emphasis is threefold. First, to sell our GMP capacity for IVT templates. Second, to develop additional Linear RX products and capabilities. And third, to leverage our platform scalability with minimal catbacks to de-risk growth and reach break even. So first, as a quick primer, mRNA is made from a DNA-started material called an in-vitro transcription or IVT template. It's these IVT template materials that we are ready to produce in our GMP facility. The mRNA market continues to grow with almost 500 therapies in the global pipelines. We believe each of these therapies represents a manufacturing opportunity to produce IVT templates at our new GMP facility. Based on our current customer interactions, the initial revenue opportunity for Linear RX for IVT templates used in the production of Phase I clinical trial materials varies. It ranges from about $50,000 to $1 million per opportunity for IVT templates alone. We order about $150,000 to $3 million for opportunity for IVT templates sold with corresponding Linear RNAF under the Linear IVT platform. These opportunities grow rapidly as the projects progress through the clinical phases and eventually into commercial supply. It's against this exciting backdrop that we entered 2025 with a robust sales pipeline for GMP IVT templates. We are currently in the final stages of project development with a Boston-based mRNA Therapeutics Developer for potential GMP supplies. If development is successfully completed, we anticipate GMP manufacturing for this customer in the May-June timeframe. In addition, we continue to work on closing GMP manufacturing contracts with several CDMOs and therapeutic developers that have undergone successful evaluations of our technology and are targeting the clinic in the next 12 months. To help further stand our sales funnel, during our restructuring we created a new multi-person sales team within Linear RX. This organization will be led by a vice president level employee for which we seek to hire an industry key opinion leader. We plan to have these position staff by the end of the current quarter. In addition, we have increased our attendance at trade shows and are in the process of overhauling the Linear RX website and marketing materials. Finally, we are in the late stages of development of a new and proprietary enzyme and buffer system to increase the manufacturing, yields, and sequence fidelity of our Linear DNA. In addition to being a valuable sales tool as a proprietary technology, we believe this new enzyme, once launched, will provide us with a distinct advantage over enzymatic DNA producers while at the same time potentially improve our margin profile through lower cost of goods and higher DNA yields. Now, history shows us that rarely does a single product make for a successful business and we're no different. So as such, we have developed LRX to be a multi-product business. While IVT templates have been our initial focus, LRX built a diverse revenue base in fiscal 2024. To support additional growth in non-IVT template segments, we are currently engaged in the development of several new forms of Linear DNA. To this end, we are announcing today the availability of a new type of Linear DNA we call Linear Donor DNA for use as a donor DNA in CRISPR gene editing applications. Linear Donor DNA is a high fidelity, double-stranded, blunt-ended form of DNA optimized for use in CRISPR-mediated homology direct repair or HDR applications, which are commonly used in a wide range of gene editing modalities. We believe that enzymatically produced Linear Donor DNA has numerous advantages over platelet donor DNA and like IVT templates, the market is primed for a large-scale, cell-free alternative. Linear Donor DNA is available now for research use only with targeted GMP availability later in this calendar year. In addition, we are actively upgrading our GMP capabilities to allow for the manufacture of Linear DNA drug substance and drug product. These upgrades will allow Linear DNA to be used in a wide range of high-value clinical applications in genetic medicine ranging from CAR-T manufacturing to personalized DNA vaccines. Turning finally to our first strategy. Our ability to manufacture at scale is now proven and our initial GMP facility is operational. We are now sharpening our focus on using our platform's low capex requirements to achieve growth and evented profitability. As opposed to GMP platelet-based DNA manufacturing that require large environmentally controlled spaces and expensive instrumentation, the Linear DNA platform uses benchtop instruments with minimal space requirements. Our initial GMP facility was designed to use modular cleanroom designs and have an -to-end manufacturing workflow in less than 1,000 square feet of environmentally controlled space. Our benchtop instrumentation is cost effective and since we manufacture in smaller volumes of plasma DNA, our purification instruments are smaller and less expensive. In addition, PCR has fewer raw materials and potential contaminants in plasma DNA workflows which leads to lower incoming and batch release QC costs. We believe these unique attributes of our platform enable our ability to rapidly scale our GMP manufacturing using a simple copy and paste approach for a fraction of the capex that would be required for legacy DNA manufacturing technologies. This results in two near-term benefits. First, using our simple copy and paste approach, we can scale and deal real-time with our production contracts. We don't face the build-it and hopefully, there will come a dilemma where it's necessary to build a large complex and capital-intensive facility before commercial contracts are signed. Instead, because we can rapidly build additional manufacturing capacity via the construction of small identical modular cleanrooms, we can align capex spend to closely mimic our commercial contract timing, thereby reducing our balance sheet risk. Second, we believe that our target capex investment needed to achieve DNA production capacity necessary to support our profitability is significantly less than other legacy technologies, particularly in the biologic space. Based on our current cost of modular cleanroom construction and instrumentation, each of our cleanrooms cost less than $1 million, yet each has a potential revenue opportunity of $10 million to $30 million per year, depending on the applicable mix of products. This, we believe, coupled with a strong margin profile for our products, allows the company to break even on a fraction of the capital investment that has historically been required for the biologic CDMOs. In conclusion, we believe the operational launch of our GMB facility is a pivotal juncture for this company, representing the final piece of the multiyear business strategy to commercialize our expertise in PCR-based production of DNA into new markets with higher margin profiles. We look forward to what the future holds. Now, Judy, over to you.

Thank you, Clay, and good afternoon, everyone. It's my pleasure to speak with you today. Let me use this occasion to first thank Jim, my fellow officers, and our Board of Directors for the opportunity to continue to lead applied DNA operations with now a broader charter as president of the company. From Jim's and Clay's comments, it should be clear that we are a highly innovative company, sitting at the precipice of tremendous market opportunity. I'm eager now to expand my efforts and further unlock value for all of our stakeholders. My immediate and ongoing focus will be centered on overseeing the company's operations, driving operational excellence, and enabling the company in setting and achieving its key business objectives. How well we orchestrate sales opportunity closure, product mix, quality, delivery volumes and schedules to ensure top-notch customer success. These will determine much of our future success. Also in my new role, I will work with the team in orchestrating deliberate resource allocation towards growth initiatives. While at the same time, we drive and maintain spending discipline and a quality culture. With GMP execution of the cornerstone, we delivered. And we have a deep bench in how to manage going forward. We are not starting from scratch. We've operated under ISO 9001 for 10 plus years. We've managed our clinical lab operations at scale and to the high bar of a demanding New York State Department of Health, the FDA, and in direct contact with health care providers and their patients. Leveraging this experience, GMP is also predicated on a quality culture. A quality that must permeate every individual, every function, and our pursuit in every opportunity. Our customer base resides globally. They have no missed manufacturing schedules. And these force us as a mission critical supplier to adhere to higher level FDA, European Medicine Authority, and Asian regulatory body requirements. We do have the building blocks in place today. To our knowledge, we have today the largest manufacturing capacity for GMP grade PCR produced DNA in North America, implemented under budget. This, in addition to continuing our supply of RUO and GLP grade materials for IVT templates and genetic medicine. And we also offer large scale supply for the IVD market. We have an initial projected annual IVT template capacity of over 10 grams. A quantity we actually have delivered annually across several product categories in GLP grade. For context, 10 grams is sufficient product capacity for our customers to produce up to 30 million doses of mRNA vaccines. We complement all of this manufacturing capability with a full suite of analytical instruments, stability chambers and programs to offer our customers, and an operative quality system from incoming materials to outbound product. Moving to our clinical lab. In the face of the considerable undertaking that has been GMP, our pharmacogenomics testing service, trait PGX at applied DNA clinical labs has admittedly been managed at a steady state. Looking forward, we are assessing our markets and our capabilities to evaluate elements that could potentially establish further value in our New York State certified laboratory asset, which is a very rare commodity. Under evaluation are such things as more promising target segments for PGX, the qualification for insurance reimbursement, and the validation of additional diagnostic assays. In closing, our goals are significant. Our resources are finite. To that end, we will remain prudent in managing our financial structures and allocations through this restructuring and thereafter to capture the market that we know is out there. We will stay closely tuned to our business operations and market dynamics, ready to modify and refine our business strategy as context may change. I strongly believe that we have the infrastructure, the people, and the determination to execute across all aspects of the company to unlock value for shareholders. Thank you, and I will now turn the call back over to Jim for concluding remarks.

Thank you, Judy. Before opening the call to questions, I want to reinforce some key takeaways from our collective remarks. The market is very receptive to our platforms. Our GMP one site is in place, and we can now deliver product ranging from evaluation and RUO to clinical grade. And we have a blueprint for a further expansion of Site 1 as warranted by customer demand. We have an excellent stable of DNA customers to convert into recurring orders, and those order sizes will increase as these therapies graduate through the late preclinical and clinical phases of their development. We are targeting additional new DNA markets and bolstering our product offering. And we recognize that the path to rebuilding shareholder value will come from a combination of disciplined op-ex and growth through enzymatic DNA production. Well, thank you all for your time and attention this afternoon. Operator, please open the call to questions.

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then 2. Our first question comes from Yi Chen with HC Wainwright. Please go ahead.

Good afternoon. This is Eduardo on for Yi from HC Wainwright. I was wondering if you could provide any color on the new linear product. I'm kind of interested to know how you quantify the opportunity there for these CRISPR therapies versus maybe the conventional IVT or even the existing CAR-T therapies that you guys are developing products for.

Clay, that's for you.

Sure, absolutely. Nice to meet you, Eduardo. So, yeah, we think that there's a lot of parallels between the IVT template and the donor DNA market. In part, PCR is very good at making blunt-ended DNA. And so we looked at the market and saw where there's market opportunities for large-scale blunt-ended DNA. One of them is IVT templates. The other is ACR donor DNA. So that's the logic there. We can use our existing workflow, null and modifications to our manufacturing workflow to make the donor DNA. So it's an amplification of the kind of existing manufacturing line. In terms of market opportunity, obviously CRISPR and CRISPR-based therapeutics are less mature than mRNA in some ways. In some ways, they're not. But we do believe it is a very large market, especially in kind of the cell and gene therapy as CAR-T start to move more to the gene editing space versus the viral vector like lentivirus-based manufacturing workflows. And that's something we're very excited about. We also think in vivo gene editing has a future. But I think near term, we're really focused on kind of those -T-like workflows and ex vivo gene editing.

Great. That's really helpful. Then kind of I was also hoping if I could get any color on where the revenue increases were coming from, if they were primarily new customer acquisitions or primarily from increased kind of scaling and manufacturing of existing customers.

So for Q1, the two increases came from product revenue. The primary reason for that was a shipment of DNA tagging for the marking of cotton. That's one of our customer's contracts we've had for a while. And the other bump in revenue this quarter came from increased volume within our isotopic testing services business.

Clay, is there anything you'd like to add?

You know, I would add to the shipment of DNA tagging to a cotton tagging customer is a contract we are currently retaining post restructuring. We're able to manufacture that with the same workflows that we have for the Linea RX. So it makes sense to keep that contract. But no, Jim, that's the bottom of that.

Great. Thanks so much. And then if I could just have maybe one more kind of in that line of the, you mentioned the AML therapy. And I'm curious what the timeline and kind of I know it's phase one, I think you mentioned first in human, the timeline and revenue recognition dynamics that we should expect for that.

Yeah, the timeline for that trial, so it is in the Czech Republic. I think phase one is probably about 18 months. It's an interesting therapy in that it's a non-viral CAR T. It uses a transposon system to actually make the CARs. So we are excited for that. We don't know in terms of revenue opportunity how large it's going to scale because it's a hospital based trial. It's not run by a commercial entity. But the important part there was twofold. One, we were able to get through the regulatory approval process quite easily. And two, we were chosen over a plasmid competitor because we were faster, but also it eased the regulatory process for the customer. So those are two of the main takeaways from that. Jim, I don't know if there's a large revenue opportunity in that trial necessarily, but it was critically important validation in the gear up.

Right. I think it demonstrates to a broader industry base, the entire CAR T industry, that linear DNA is an adequate material to utilize in the generation of these therapies. And we provide a faster path, which in many cases is urgently required.

Wonderful. Thanks so much for that and exciting developments. Congrats on the quarter.

Thank you.

Thanks.

Again, if you have a question, please press star and then one. This concludes our question and answer session. I would like to turn the conference back over to Dr. Hayward for any closing remarks.

Well, thank you. And thank you everyone for joining us on today's call. Operator, you can now conclude the call.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.