BNB Plus - Q3 2024

Transcript

Operator (participant)

Good day, and welcome to the Applied DNA Fiscal Third Quarter 2024 Investor Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on a touch-tone phone. To withdraw your question, please press star, then 2. 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 (Executive Director, Investor Relations, and Corporate Communications)

Thank you, Cindy. Good afternoon, everyone, and welcome to Applied DNA's Conference Call to discuss our third quarter fiscal 2024 financial results. You can access the press release that was issued after market close today, as well as the slide presentation accompanying this call on the investor relations section of our corporate website or via the webcast today. Speaking on the call are Dr. James Hayward, our Chairman, President, and CEO, Beth Jantzen, our Chief Financial Officer, and Clay Shorrock, our Chief Legal Officer and Head of Business Development. Judy Murrah, our Chief Operating Officer, will also be available to answer questions on the Q&A portion of this call. Before we get started, I would like to take this opportunity to remind you that our remarks today may include forward-looking statements.

I refer you to slide 2 of the presentation and our Form 10-Q, filed a short while ago, 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 Jantzen. Please go ahead, Beth.

Beth Jantzen (CFO)

Thank you, Sanjay. Good afternoon, everyone, and thank you for joining us on our third quarter fiscal 2024 investor call. I will start this afternoon with an overview of our results for the quarter ended June 30, 2024. I will then turn the call over to Dr. James Hayward and Clay Shorrock, who will update you on our ongoing business initiatives. We will then open the line for questions from our analysts and institutional investors. Prefacing my review of our financial results for the quarter, our year-over-year comparisons reflect the June 2023 quarter, which included revenues and costs associated with our COVID-19 surveillance testing for CUNY. That contract concluded in June 2023.

Beginning with our statement of operations, total revenues for the third quarter of fiscal 2024, which ended on June 30, were approximately $798 thousand, or a decline of $2.1 million, compared to $2.9 million for the same period in the prior fiscal year. The majority of the year-over-year decline in total revenues was from a decrease in our clinical laboratory service revenues of $1.85 million, which relates to the aforementioned COVID surveillance testing contract for CUNY, which is included in our June 2023 financial results. Approximately $70 thousand of the decrease in total revenue is attributable to lower product revenues and specifically to decreases in shipments for consumer asset marking and from a nutraceutical customer, both within our DNA tagging and security products and services segment. Service revenues decreased by approximately $200 thousand year-over-year.

This decrease is attributable to a decrease in R&D projects in our therapeutic DNA production services segment, as well as to isotopic testing within our DNA tagging and security products and services segment. Gross profit was $245,000, or 31%, as compared to $1.3 million, or 44% in the prior fiscal year period. The decrease in gross profit was primarily due to a decline in gross profit for our MDx testing services segment, specifically related to significantly decreased COVID-19 testing volumes year-over-year. Total operating expenses decreased by approximately $500,000-$3.6 million, compared to $4.1 million in the prior fiscal year period.

The decrease in total operating expenses reflects lower SG&A, which is attributable to a reduction in stock-based compensation expense related to the annual option grant to non-employee members of our board and RSUs to officers, as well as the elimination of certain consultants, which together totaled approximately $500,000. The decrease in SG&A was offset by an increase in R&D of approximately $77,000-$913,000, from $836,000 in the year ago period. This increase relates to the development of a commercial quantity of our Linea RNA polymerase used by our Linea IVT platform, and for consultants to further optimize the RNA polymerase acquired from the Spindle acquisition. Our operating loss for the third quarter was $3.3 million, compared to $2.9 million in the prior fiscal period.

Turning to Slide 5, excluding non-cash expenses, adjusted EBITDA decreased by $1.1 million to negative $3.2 million, compared to a negative $2.1 million in the prior fiscal year period. Now, turning to our balance sheet on Slide 6, cash and cash equivalents totaled $10.4 million on June 30, compared to $7.2 million on September 30, 2023. The June 30 cash and cash equivalents figure includes the net proceeds of $10.5 million from a public offering that closed on May 28. As of June 30, accounts receivable stood at $531,000, the majority of which was collected after the quarter ended. Our average monthly cash burn is $1.2 million fiscal year to date, compared to $500,000 in the prior year.

Our average monthly cash burn for the third quarter of fiscal 2024 was $1.3 million. The increase in our cash burn during the third quarter of fiscal 2024 reflects a catch-up on payments made after the financing and the payment of professional fees related to our two financings conducted during the fiscal year. I also note that our just filed Form 10-Q maintains a disclosure from our prior Form 10-Q 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. On July 31, 2024, our cash and cash equivalents were approximately $8.9 million. Turning to the offering, we issued 9.23 million common shares and pre-funded warrants to purchase common shares.

Series A warrants to purchase 9.23 million common shares at an exercise price of $1.99, with a 5-year term from the shareholder approval date. We also issued Series B warrants to purchase 9.23 million common shares at an exercise price of $1.99, with a 1-year term from the shareholder approval date. The Series B warrants also allow for an alternative cashless exercise option, in which the warrant owner receives 3 shares of common stock at a $0 exercise price. The exercisability of both the Series A and B warrants are subject to shareholder approval. Subject to shareholder approval, the exercise of the Series A warrants could result in additional gross proceeds of approximately $18.4 million to the company.

Subject to the same approval by stockholders, the exercise of the Series B warrants could result in additional gross proceeds of approximately $18.4 million. Where under the alternative cashless, cashless exercise provision, holders of the Series B warrants would receive 3 shares of common stock for every Series B warrant exercised, with no gross proceeds to the company. If all of the Series A warrants are exercised, and if the Series B warrants are exercised pursuant to the cashless exercise option described above, we would have 47.2 million shares of common stock outstanding. On August 2, in accordance with the terms of the public offering, we conducted a special meeting of shareholders to seek to obtain stockholder approval for the Series warrants just discussed. The special meeting was adjourned due to a lack of quorum.

In accordance with the terms of the public offering, we are obligated to call a subsequent stockholder meeting within 90 days from August 2, to seek to obtain approval of the exercisability of the series warrants. As such, the warrant stockholder approval proposal is now included in the proxy for our annual meeting of stockholders, which is scheduled for September 30. A preliminary copy of our proxy was filed with the SEC on Monday and is viewable on the EDGAR website and our IR website. The annual meeting proxy also includes a proposal to grant the board the authority to implement a reverse stock split to meet the minimum bid price requirement under the Nasdaq Capital Market Listing Rules.

On July 12, we received notice from the Listing Qualification Department of Nasdaq, notifying us that we are not in compliance with the minimum bid price requirements set forth by Nasdaq for continued listing on the Nasdaq Capital Market. The notification letter does not impact our listing on the Nasdaq Capital Market at this time. We have 180 calendar days, or until January 8, 2025, to regain compliance with the minimum bid price requirement. In order to regain compliance, our bid price must close at or above $1 per share for a minimum of 10 consecutive business days. If we do not regain compliance with this Nasdaq listing rule by January 8, we may be eligible for an additional 180 calendar day compliance period, assuming that we are in compliance with all of the other Nasdaq listing requirements.

We believe that the 180-day period in which we have to cure the deficiency overlaps multiple biotherapeutic commercialization points that, in our view, are value creating. In a moment, you will hear Jim and Clay deliver commentary on anticipated commercial progress that we believe will drive total revenues to an inflection point, starting in the first half of fiscal 2025. We consider it prudent to seek the discretion to implement a reverse stock split to maintain Applied DNA's Nasdaq listing, should the stock market not recognize the execution of our biotherapeutic-driven value creation story by the conclusion of the 180-day cure period. This concludes my prepared remarks. Thank you for joining us today. I will now turn the call over to Jim for his comments. Jim?

James Hayward (Chairman and CEO)

Thank you, Beth, and good afternoon, everyone. Thank you for joining us on our third quarterly investor call of fiscal 2024. We have a great deal to update you on today across each of our three business segments. I encourage you to follow along with our slide deck that supports my remarks this afternoon. Our efforts during the third quarter and fiscal 2024 have continued a value creation strategy that we put in place after the pandemic to leverage our expertise in the scaled manufacture and detection of DNA via PCR, and to increase the role of linear DNA in the contemporary platforms that are driving the commercialization of new nucleic acid therapeutics and the related initiatives. All these efforts focused on the return of the company to a growth trajectory.

We accomplished much during the third quarter, executing against our commercial roadmap in all business segments and supported by a strengthened balance sheet for continued operational momentum. During the quarter, we accomplished the following significant developments. We continued to build our capacity for the enzymatic GMP production of DNA IVT templates, and are on track for completion of our GMP facility by September 30th, our fiscal year-end. We have received full New York State Department of Health approval for a laboratory-developed test. We commercially launched TR8 PGx, our pharmacogenomic testing service, and after the close of the quarter, we entered into a multiyear agreement with Indus Group that potentially represents a substantial expansion of our cotton tagging addressable market. These developments, we believe, signal Applied DNA's post-COVID return to growth strategy as we approach commercial milestones to deliver year-over-year revenue growth starting in the first half of fiscal 2025.

We believe that our return to growth will be primarily catalyzed by anticipated near-term developments at LineaRx, our biotherapeutic segment, and from our DNA tagging segment, with initial contributions from ADCL and its pharmacogenomic testing service. Clay and I will discuss these developments in greater detail in a moment. But before that, I want to be clear, our expectation of an imminent revenue inflection should not be construed as financial guidance. We have every confidence in achieving them, but they are wholly reliant on future commercial activities that have not yet formally begun. During the third quarter, we negotiated and then entered into a five-year CertainT commercialization agreement with Indus Group, a key global cotton apparel manufacturer. The agreement calls for us to supply spray systems, DNA taggant, testing services for DNA taggant and genotyping, devices and materials for on-site testing, and isotope testing services.

When they are ready, Indus plans to take testing in-house, accelerating their service velocity. We are awaiting receipt of an initial purchase order from Indus to support our deployment activities. In year one of the agreement, we and Indus intend to implement CertainT at multiple cotton spinning mills. Indus will provide regular forecasts for tagged cotton demand, and a planned subsequent broader deployment across Indus's footprint will be based on their demand for tagged cotton. As you can see on this slide, Indus serves major apparel markets, each with regulations to ensure that our customers are not complicit in using forced or slave labor in the supply chains that end in those respective markets. The historical commitment to innovation and sustainability by Indus and its strong foothold across the apparel value chain makes it an ideal CertainT partner.

And while the agreement has no minimum Indus purchase commitments, we believe our new partnership with Indus will provide for sustainable growth in this business segment for the following reasons: Indus is a leading supplier to some of the world's most renowned brands. Ours is a volume-driven business, and Indus uses approximately 450 million pounds of cotton annually. In an environment so influenced by the UFLPA, or the Uyghur Forced Labor Prevention Act, the ability to sell UFLPA-compliant apparel to customers becomes a key selling point for new customer acquisition and retention. The deployment of our CertainT platform in all aspects will enable Indus to ensure that the products they manufacture for their customers are end-market compliant.

Indus maintains year-round ginning and spinning operations, allowing for a decoupling from the revenue seasonality that's been inherent to our historical focus on U.S. Pima cotton, and which drove lumpy revenues in our business segment. And finally, Indus can supply tagged cotton at volumes required by the large users of cotton in our sales pipeline. In short, we believe Indus solves the issue of tagged cotton supply that has always gated the growth of this segment. Our CertainT platform enables customers to provide forensic evidence supporting UFLPA compliance. It is still an issue, as supported by evidence in a report we published earlier this year by us and our isotopic testing partner. The report indicated traces of banned Chinese cotton were found in 19% of a sample of merchandise sold at U.S. and global retailers in the past year.

Of the items that tested positive for Xinjiang cotton, 57% featured labels that claim the merchandise origin was solely in the U.S. With this as context, we continue to serve repeat customers for isotopic testing as entree to direct contact with very large cotton users, manufacturers, brands, and retailers, some of whom can now be introduced to Indus for a ready supply of cotton. Now, turning to our pharmacogenomics testing service, which is branded TR8 or Trait PGX. While awaiting the resolution of the New York State Department of Health's lengthy LDT review and approval process, we built this business for large-scale testing, reflecting our commercial aspirations for enterprise or other large population contracts, ADCL's PGX testing capacity can support up to $25 million in annual revenue today. Our goal with PGX testing is to avoid pricing pressures common to commoditized diagnostics.

To this end, our initial sales effort is to build a demand for concierge testing before turning to the higher volume enterprise testing. In our concierge sales model, the clinician plays a crucial role in patient uptake, and will enable us to begin generating revenue while further optimizing the testing service necessary to manage the larger enterprise testing volumes. Given PGX's favorable margin profile, we expect this segment to approach profitability over the next two quarters, even at low testing volumes. From there, our testing can be scaled quickly, and we expect our first enterprise testing customer to come sometime in the first half of calendar year 2025.

Now, before I turn the call over to Clay, who will take you through some very exciting developments in the commercialization of linear IVT templates and our Linear IVT platform, I want to provide some context that demonstrates the speed with which the field of genetic medicines is progressing. In fiscal 2022, with the biotherapeutics industry's coalescing around messenger RNA technology that was driven by the success of the COVID vaccines, we initiated sales of linear DNA as an IVT template for mRNA production. We positioned linear IVT templates as a differentiated approach to plasmid templated IVT mRNA. Relative to plasmid templates, linear IVT templates have many advantages to facilitate the broader commercialization of messenger RNA-based therapies. By fiscal 2023, we had accumulated an impressive roster of biopharma and CDMO template evaluation customers.

The industry's strong interest was very clear, but our lack of GMP production capacity gated commercial adoption beyond technology evaluation projects. It also became quickly evident that while our templates have an outsized impact on messenger RNA workflows, we were leaving considerable economics on the table. In fiscal 2023, we began to solve for both those issues with the implementation of a GMP roadmap and with the acquisition of Spindle Biotech. Our Linea IVT platform was launched, enabling us to capture more of the messenger RNA value chain and associated greater economics. As we approach the end of fiscal 2024, I am pleased to report that we are on schedule for a GMP startup by September 30, our fiscal year-end, and have successfully completed scale-up of our Linea RNA polymerase enzyme, a critical component of our Linea IVT platform.

I'm also happy to report that we have recently completed long-term validation studies with two Linea DNA template customers, and we are now being onboarded as a validated GMP vendor into their workflows. We are targeting early calendar 2025 to support them with IVT templates to produce messenger RNA clinical trial materials. We are also in the late stages of evaluation with a third Linea DNA template customer and hope to be onboarded as a validated GMP vendor shortly. So this is an exciting place to be as we approach our GMP startup. And on behalf of our board of directors, myself, the entire management team, I'd like to personally thank the LineaRx sales and business development team for the tremendous progress to ensure the success of our biotherapeutics business. Let me now turn the call to Clay for a deeper dive into our biotherapeutics opportunity. Clay?

Clay Shorrock (Chief Legal Officer and Executive Director of Business Development)

Thank you, Jim, and good afternoon, everyone. In recent years, we've established a market footprint, demonstrated credibility, and as Jim noted, have generated an annual roster of evaluation customers. Last week, I attended the fourth annual mRNA Therapeutic Summit in Boston. This is our third consecutive year in attendance. I've been privileged to have a front-row seat to our maturation from an upstart new player to an established fixture in the mRNA manufacturing industry, and I echo Jim's thanks to the entire team. The marketplace's receptivity to our Linea IVT template and Linea IVT platform continues to be strong. Relative to conventional plasmid DNA-based templates, we utilize an enzymatic manufacturing process to rapidly produce large quantities of high-purity DNA sequences, solving a major pain point for the mRNA industry.

With our Linea IVT platform, which combines Linea IVT templates with our proprietary Linea RNA, we solve yet another significant industry pain point via the reduction of double-stranded RNA contamination. Our combined technologies enable our customers to produce better mRNA faster, and we're pleased to be involved with numerous customers pursuing cutting-edge therapies. Now, as Jim noted, we are being onboarded as a validated GMP vendor of IVT templates into the manufacturing workflow of two customers, one, a U.S.-based biopharma company, and the other, a CDMO based in APAC. We expect to begin supplying Linea IVT templates for use by these customers in their manufacture of mRNA clinical trial materials in early calendar year 2025 or our fiscal second quarter. We are also involved in an additional customer evaluation, where we were recently told that our IVT templates meet or exceed all of their GMP specs.

We hope to be added as a qualified vendor with this customer in the near future, with potential GMP runs in first half of calendar year 2025. In addition to these early success stories, we are currently engaged with numerous biotech, pharma, and large CDMOs who are in the process of evaluating our Linea IVT templates. Slide 9 provides a sampling of evaluation customers who, if converted, have the potential to fill our GMP capacity in fiscal 2025. It's also notable that each of these customers has multiple assets in their pipelines, and initial GMP success with any of these customers holds the potential for long-term manufacturing contracts. It's also significant that we are gaining traction with evaluation customers for our Linea IVT platform.

The combination of our proprietary Linea RNAP and our IVT templates allows us to increase our relevance to the mRNA value chain from approximately 5% to approximately 30% of mRNA manufacturing costs, providing us with a much larger total addressable market than IVT templates alone. Launched just one year ago, our Linea IVT platform is now being evaluated by several customers, including a multinational biopharma company and a large APAC-based CDMO. Early customer data has been positive, and our goal is to convert these evaluation customers into GMP supply contracts for both IVT templates and also enzymes in the coming fiscal quarters. Thanks to our recently completed manufacturing process development project on our Linea RNAP, we now have the ability to manufacture this enzyme at reduced unit costs and in quantities necessary to meet customer demand in virtually any phase of the clinical trial process.

The value of Linea RNAP was further bolstered this quarter with our receipt of a first U.S. patent, with claims covering the enzyme's composition of matter. Now, looking ahead, we believe our goal to sell 100% of our current GMP capacity in fiscal 2025 is very feasible. Our optimism is not only based on the groundwork and customer relationships we have laid over the past two years, but also in the promising state of mRNA, mRNA-based therapeutics. mRNA empowers much more than just vaccines against infectious diseases, such as those against COVID-19. mRNA is a flexible technology that we believe will empower a diverse range of therapeutic modalities, from personalized cancer vaccines to CAR-T and gene therapy. Increasingly, we are seeing interest from customers that are using mRNA for the personalized cancer vaccines, a modality that has seen recent success in the clinic.

Here, the speed of manufacture is critical, and given that speed is one of our platform's main selling points, we believe we are very well positioned to capture new customers in this growing area. Likewise, mRNA-based CAR-T therapies have recently been shown to be safe and effective against autoimmune and also potentially cancer. This leads to yet another new market opportunity for our platform. In sum, we believe we are in the last stage of what has been two years of extraordinary effort to create a new growth opportunity for Applied DNA. The development and launching of a new technology is never easy, but fortune favors the bold, and we are excited for what the future holds. Now, I'll give the call back to Jim.

James Hayward (Chairman and CEO)

Thank you much, Clay. Our LineaRx platform is the opportunity for our team and our investors to participate in the compelling future of biotherapeutics, which is evolving at lightning speed. Combined with the benefits of precision prescribing and powered by pharmacogenomics, we really find ourselves at the center of the new revolution in biotechnology. Operator, you can now open the session to Q&A.

Operator (participant)

We will now begin the question and answer session. To ask a question, you may press Star then one 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 then two. At this time, we will pause momentarily to assemble our roster. Our question comes from Yi Chen, from Applied DNA. Go ahead, please.

Speaker 5

Good afternoon. This is Dan on for Yi. Thanks for taking our questions. Also, H.C. Wainwright. We were wondering, how many customers for GMP manufacturing products do you expect to have by the end of 2024? And are there any customers beyond the two approved and third pending in conversations? As well as, what is the level of test volume for TRA pharmacogenomic testing services you expect to have in the coming quarters? Thank you.

James Hayward (Chairman and CEO)

Clay, would you like to take the first half? I'll take pharmacogenomics.

Clay Shorrock (Chief Legal Officer and Executive Director of Business Development)

Absolutely. Sure. Hey, Dan. So to answer your first question about the number of GMP customers, in fiscal 2024, I mean, we are launching our GMP facility at the end of fiscal 2024. So, you know, we don't expect to have signed contracts the day that it launches. But that being said, and as we talked about in the prepared remarks, we have been through this evaluation process with two large customers, and based on their manufacturing timelines, which is really outside of our control, you know, the indications are that those first GMP manufacturing runs will be early calendar year 2025. That being said, you know, the GMP process is that, it's a process, right? It's not give us materials and we will instantly manufacture. There is a process development and scale-up aspect to it.

So some of those activities that predate the GMP runs could happen in, you know, late fiscal 2024, Q1 fiscal 2025. That make sense?

Speaker 5

Yeah, that's perfect. Thank you.

Clay Shorrock (Chief Legal Officer and Executive Director of Business Development)

In terms of, I think you also asked the terms number of customers after fiscal 2024, or did that answer your the question?

Speaker 5

You know, whatever beyond 2024 would be cool. Just to get, like, an overall picture of how quickly you think this uptake is expected.

Clay Shorrock (Chief Legal Officer and Executive Director of Business Development)

Yeah. Yeah. So, right now, I mean, we have the verbal commitments that we have discussed on this call for about half of our GMP capacity in early calendar year 2025. As we showed in that slide, we think we have a robust sales funnel for the rest of that capacity, and we're going to work to, like, close that. So, you know, it's not really a number of customers game, it's the size and the therapeutic modality of their mRNA order that, that it really matters.

Speaker 5

Thank you. That's perfect.

James Hayward (Chairman and CEO)

And Dan, to answer your pharmacogenomics question, you know, we believe that we are the first commercial entity in New York State to be offering a broad-based panel. We explore as many as 130 alleles in pharmacogenomics and to be targeting initially New York State. So other testers come from without the state, outside of the state, and as a consequence, we believe we'll have a turnaround time advantage in providing service. Now, speaking of service, we're starting with a service-oriented market, and that is the concierge physician practices that we have been talking to really for the last year. And this is a means for these physicians to implement precision prescribing and to compete effectively in the concierge marketplace.

So we've been very excited by the initial response, and we hope to build an adequate volume of that form of testing in due course, actually in smaller quanta. And the idea behind the smaller quanta, you know, a typical concierge physician has somewhere between 250 and 500 patients, is it allows us to provide the white glove service consistent with a concierge physician... and to habituate the workflow that we will need in order to service the much larger enterprise customer that we want to begin tackling, say, by the end of the first quarter of 2025. Those customers, which include things like large hospital networks, and here on Long Island, we're surrounded by them.

We believe there is a large opportunity to provide services of pharmacogenomics to, companies that are self-insured, to counties and governments that are self-insured, and, we believe that we can create large demand that way. The capacity we've built for is adequate to service in a single shift, more than $25 million of revenue per year, but it's imminently scalable. Of course, we can add more shifts, we can add more testing lines as well. So we're excited about the opportunity and, we're anxious to get started.

Speaker 5

That sounds great. If I could ask a follow-up, are there any other states that you're targeting, and do they require a similar approval process in those states?

James Hayward (Chairman and CEO)

It's funny you should ask, because we're just completing our registration that would enable us to sell in, I believe, 47 additional states. There is no validation required, thanks to the fact that the New York State validation is itself so difficult, and it took us over a year to obtain approval, in part because this was our first genomics LDT, and it was deemed during the validation process, as they always are, high risk, and so was given very careful consideration before it was approved. But now to march onward to other states, all we have to do is fill out an application.

Speaker 5

That's awesome. Congratulations on the approval, and we're looking forward to the ramp. Thank you.

James Hayward (Chairman and CEO)

Thank you.

Operator (participant)

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

James Hayward (Chairman and CEO)

Thank you, Cindy, and thank you all for attending our call. We look forward to keeping you updated on our progress as we move through this very exciting period. Thank you.

Operator (participant)

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