Title

Presentation

Applied DNA Sciences, Inc. misses on earnings expectations. Reported EPS is $-0.56 EPS, expectations were $-0.32.

Operator: Good day, and welcome to the Applied DNA Sciences First Quarter Fiscal 2025 Financial Results. All participants will be in listen-only mode. Please note this event is being recorded. I would now like to turn the conference over to Sanjay Hurry, Head of Investor Relations. Please go ahead.

Sanjay Hurry: Thank you, David. Good afternoon, and welcome to Applied DNA’s first quarter fiscal 2025 financial results conference call. We will discuss our financial and operational performance, business progress, and growth opportunities. Joining me on the call today are James Hayward, our Chairman and CEO, Judy Murrah, our recently appointed President, Beth Jantzen, 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 will 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 three 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, future results, or developments. Now it’s my pleasure to introduce our first speaker on today’s call, Beth Jantzen. Please go ahead, Beth.

Beth Jantzen: 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. Next, Jim will briefly walk you through our important milestones achieved during fiscal year 2024. Then Clay will provide an update on the LineaRx business and its growth strategy. And finally, Judy will provide you with an update on our operations. Prepping 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 LineaRx subsidiary.

Having laid much of the necessary groundwork to support this strategy in fiscal 2024, the restructuring reflects our belief that LineaRx offers the greatest potential to create sustainable value for our shareholders. Our October 2024 financing supports LineaRx 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 One facility, which Jim and Clay will elaborate on 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, I’m 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 year-over-year increase was a result of higher product revenue 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 lower selling, general, and administrative costs year-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 a 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 year 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 10-Q maintains a disclosure from our prior Form 10-Ks 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, raise capital.

We sought shareholder approval for the exercisability of the warrants issued in the October 2024 offering. On January 23rd, in a special meeting that was adjourned due to a lack of quorum, we will reconvene the meeting tomorrow at 11 AM 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?

Dr. James Hayward: 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 LineaRx. Post-pandemic, emergent trends in biotherapeutics and interest among the investor community have centered chiefly on our LineaRx 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 eighteen months, we’ve seen an acceleration in the pace of LineaRx’s operational progress. Interest and feedback on our Linea DNA and Linea 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, 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 Linea 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 Hematology 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 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 regulatory consent of Linear DNA’s use in a clinical setting, a key milestone.

LineaRx’s customer acquisition rates have exceeded our expectations. In fiscal 2024, we engaged over twenty-five 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 Murrah 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 LineaRx to Clay Shorrock. Congratulations, Clay. In addition to his corporate officer duties in recent years, Clay has led global sales and business strategy for LineaRx and has cultivated a marquee list of customers.

Applied DNA Clinical Labs secured New York State Department of Health LDT approval for TREAT PGx, our pharmacogenomics assay that forms the basis for our PGx testing service. And we secured an expansion in use for our mBox assay, and we are now licensed to accept samples from all fifty states. Finally, last month, our GMP Site One was certified operational as an ISO seven space with ISO five workspaces. With this site, we’ve demonstrated a low CapEx approach to enzymatic DNA production at scale, empowering our entry into long-term GMP supplier agreements. Now let me turn the call over to Clay to offer some specific insights into LineaRx plans for fiscal 2025. Clay?

Clay Shorrock: Well, thank you, Jim. First, I want to thank the Applied DNA Board of Directors and management team for the opportunity to lead LineaRx as we approach what I believe is an inflection point in our story. For those of you who are new to our story, I’ve been with Applied DNA since 2016, serving in various legal and business roles. My background is in biology and intellectual property, and I have fifteen years of legal and business experience. I have a passion for building companies, and I believe with the plan we have in place, LineaRx 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 twenty-five active projects in fiscal 2024, we see a strong market demand for our linear DNA and Linea IVT platforms.

With our initial GMP site now online, we are focused on monetizing this demand. To this end, our commercial emphasis is threefold. First, sell our GMP capacity for IVT templates. Second, to develop additional LineaRx products and capabilities, and third, to leverage our platform’s scalability with minimal CapEx to de-risk growth and reach breakeven. So first, as a quick primer, mRNA is made from a DNA starting material called an in vitro transcription or IVT template. It is these IVT template materials that we are ready to produce in our GMP facility. The mRNA market continues to grow with almost five hundred therapies in the global pipeline. 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 LineaRx for IVT templates used in the production of phase one clinical trial materials varies. It ranges from about $50,000 to $1 million per opportunity for IVT templates alone, or about $150,000 to $3 million per opportunity for IVT templates sold with corresponding Linea mRNA under the Linea IVT platform. These opportunities grow rapidly as the projects progress through the clinical phases and eventually into commercial supply. It is against this exciting backdrop that we enter 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 supply.

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 twelve months. To help further expand our sales funnel, during our restructuring, we created a new multi-person sales team within LineaRx. 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 positions staffed 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 LineaRx 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 other enzymatic DNA producers. While at the same time potentially improving 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. As such, we have developed LineaRx to be a multiproduct business. While IVT templates have been our initial focus, LineaRx 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. Today, we are announcing the availability of a new type of linear DNA, we call Linea Donor DNA, for use as a donor DNA in CRISPR gene editing applications. Linea Donor DNA is a high-fidelity, double-stranded blunt-ended form of DNA optimized for use in CRISPR-mediated homology-directed 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 plasmid donor DNA, and like IVT templates, the market is primed for a large-scale cell-free alternative. Linea 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 growth strategy, our ability to manufacture at scale is now proven. Our initial GMP facility is operational. We are now sharpening our focus on using our platform’s low CapEx requirements to achieve growth and eventually profitability. As opposed to GMP plasmid-based DNA manufacturing that requires 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 end-to-end manufacturing workflow in less than a thousand square feet of environmentally controlled space. Our benchtop instrumentation is cost-effective, and since we manufacture in smaller volumes than plasmid DNA, our purification instruments are smaller and less expensive. In addition, PCR has fewer raw materials and potential contaminants than plasmid DNA workflows, which leads to lower incoming and batch release QC costs. We believe these unique attributes of our platform allow 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 in real-time with our production contracts. Unlike other CDMOs, we don’t face the build-it-and-hopefully-they-will-come dilemma, where it is 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 profitability is significantly less than other legacy technologies, particularly in the biologic space.

Based on our current cost and modular cleanroom construction and instrumentation, each of our cleanrooms costs less than $1 million, and each has a potential revenue opportunity of $10 million to $30 million per year, depending on the applicable mix of product. This, we believe, coupled with a strong margin profile for our products, allows the company to breakeven on a fraction of the capital investment that has historically been required for biologics CDMOs. In conclusion, we believe the operational launch of our GMP facility is a pivotal juncture for this company, representing the final piece of the multiyear business strategy to commercialize our expertise in PCR production of DNA into new markets with higher margin programs. We look forward to what the future holds.

Now, Judy, over to you.

Judy Murrah: 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 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 driving and maintaining spending discipline and a quality culture. With GMP execution as 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 ten 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, FDA, and in direct contact with healthcare 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-miss 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 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 quantity we actually have delivered annually across several product categories in GLP grades.

For context, ten grams is sufficient product capacity for our customers to produce up to thirty 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, TREAT 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.

Under evaluation are such things as more processing target segments for PGx, 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 structure 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.

Dr. James Hayward: 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 products ranging from evaluation and RUO to clinical grade. And we have a blueprint for further expansion of Site One 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 OpEx and growth through enzymatic DNA production. Well, thank you all for your time and attention this afternoon. Operator, please open the call to questions.

Operator: We will now begin the question and answer session. If at any time, your question has been addressed and you would like to withdraw your question, our first question comes from Yi Chen with H. C. Wainwright. Please go ahead.

Yi Chen: Good afternoon. This is Eduardo on for Yi from H. C. Wainwright. I was wondering if you could provide any color on the new Linear product. Kind of interested to know how you quantify the opportunity there for these CRISPR therapies versus maybe the kind of conventional IVT or even the existing CAR T therapies that you guys are developing products for.

Clay Shorrock: 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. You know, 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 PCR donor DNA. So that’s the logic there. We can use our existing workflow, no major 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, they’re not. But we do believe it is a very large market, especially kind of the cell and gene therapy as CAR Ts 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 CAR T-like workflows and ex vivo gene editing.

Yi Chen: 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?

Beth Jantzen: 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 with one of our customers’ 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 Shorrock: 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 LineaRx. So it makes sense to keep that contract.

Yi Chen: Great. Thanks so much. And then if I could just have maybe one more kind of in that line of the 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.

Clay Shorrock: Yeah. The timeline for that trial, so it is in the Czech Republic. I think phase one is probably about eighteen months. An interesting therapy in that it’s a non-viral CAR T. It uses a transposon system to actually make the CAR T. 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 you feel differently. I don’t know if it’s this large revenue opportunity in that trial necessarily, but it was critically important validation in Europe.

Dr. James Hayward: Right. I think it demonstrates to a broader industry space, 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.

Operator: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Dr. Hayward for any closing remarks.

Dr. James Hayward: Well, thank you and thank you everyone for joining us on today’s call. Operator, you can now conclude the call.

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