NASDAQ:APDN Applied DNA Sciences Q3 2024 Earnings Report $0.58 -0.02 (-2.80%) Closing price 04:00 PM EasternExtended Trading$0.59 +0.01 (+1.50%) As of 05:12 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Applied DNA Sciences EPS ResultsActual EPS$23.50Consensus EPS -$32.00Beat/MissBeat by +$55.50One Year Ago EPS-$240.00Applied DNA Sciences Revenue ResultsActual Revenue$0.80 millionExpected Revenue$0.95 millionBeat/MissMissed by -$150.00 thousandYoY Revenue GrowthN/AApplied DNA Sciences Announcement DetailsQuarterQ3 2024Date8/8/2024TimeAfter Market ClosesConference Call DateThursday, August 8, 2024Conference Call Time4:30PM ETUpcoming EarningsApplied DNA Sciences' Q2 2025 earnings is scheduled for Wednesday, August 6, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Applied DNA Sciences Q3 2024 Earnings Call TranscriptProvided by QuartrAugust 8, 2024 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good day, and welcome to the Applied DNA Fiscal Third Quarter 2024 Investor Conference Call. 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. Speaker 100:00:47Thank you, Cindy. Good afternoon, everyone, and welcome to Applied DNA's conference call to discuss our Q3 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 Doctor. James Hayward, our Chairman, President and CEO Beth Jansen, our Chief Financial Officer and Clay Surok, our Chief Legal Officer and Head of Business Development. Speaker 100:01:21Judy Murrah, our Chief Operating Officer, will also be available to answer questions on the Q and 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. Speaker 100:02:09Please go ahead, Beth. Speaker 200:02:11Thank you, Sanjay. Good afternoon, everyone, and thank you for joining us on our Q3 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 Doctor. James Hayward and Clay Sharrock, who will update you on our ongoing business initiatives. Speaker 200:02:38We will then 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 surveillance testing for CUNY. That contract concluded in June 2023. Beginning with our statement of operations, total revenues for the Q3 of fiscal 'twenty four, which ended on June 30, were approximately $798,000 or a decline of $2,100,000 compared to $2,900,000 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 1,850,000 dollars which relates to the aforementioned COVID surveillance testing contract for CUNY, which is included in our June 2023 financial results. Speaker 200:04:00Approximately $70,000 of the decrease in total revenue is attributable to lower product revenues and specifically to decreases in shipments for consumer asset marketing and from a nutraceutical customer, both within our DNA Tagging and Security Products and Services segment. Service revenues decreased by approximately $200,000 year over year. This decrease is attributable to a decrease in R and 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 percent as compared to $1,300,000 or 44% in the prior fiscal year period. The decrease in gross profit was primarily due to a decline in gross profit for our MDF Testing Services segment, specifically related to significantly decreased COVID-nineteen testing volumes year over year. Speaker 200:05:25Total operating expenses decreased by approximately $500,000 to $3,600,000 compared to $4,100,000 in the prior fiscal year period. The decrease in total operating expenses reflects lower SG and 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. Dollars The decrease in SG and A was offset by an increase in R and D of approximately 77,000 to 913,000 from 836,000 in the year ago period. This increase relates to the development of a commercial quantity of our linear RNA polymerase used by our linear IVT platform and for consultants to further optimize the RNA polymerase acquired from the Spindle acquisition. Our operating loss for the 3rd quarter was $3,300,000 compared to $2,900,000 in the prior fiscal period. Speaker 200:06:57Turning to Slide 5, excluding non cash expenses, adjusted EBITDA decreased by $1,100,000 to negative $3,200,000 compared to a negative $2,100,000 in the prior fiscal year period. Now turning to our balance sheet on Slide 6. Cash and cash equivalents totaled $10,400,000 on June 30 compared to $7,200,000 on September 30, 2023. The June 30 cash and cash equivalents figure includes the net proceeds of 10,500,000 dollars 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. Speaker 200:08:00Our average monthly cash burn is $1,200,000 fiscal year to date compared to $500,000 in the prior year. Our average monthly cash burn for the Q3 of fiscal 2024 was $1,300,000 The increase in our cash burn during the Q3 of fiscal 2024 reflects a catch up on payments made after the financing and the payment of professional fees related to our 2 finances conducted during fiscal year. I also note that our just filed Form 10 Q maintains a disclosure from our prior Form 10Q 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 8,900,000 dollars Turning to the offering, we issued 9,230,000 common shares and pre funded warrants to purchase common shares, Series A warrants to purchase 9,230,000 common shares at an exercise price of $1.99 with a 5 year term from the shareholder approval date. Speaker 200:09:38We also issued Series B warrants to purchase 9,230,000 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 exercise ability 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 $18,400,000 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 point $4,000,000 Where under the alternative 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. Speaker 200:10:59If 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 47,200,000 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 1s 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 exercise ability of the series warrant. 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. Speaker 200:12:06A 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. Speaker 200:13:13In 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 secured 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 twenty twenty five. 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. Speaker 200:14:39This concludes my prepared remarks. Thank you for joining us today. I will now turn the call over to Jim for his comments. Jim? Speaker 300:14:49Thank you, Beth. Good afternoon, everyone. Thank you for joining us on our 3rd quarterly investor call of fiscal 2024. We have a great deal to update you on today across each of our 3 business segments. I encourage you to follow along with our slide deck that supports my remarks this afternoon. Speaker 300:15:14Our efforts during the Q3 and fiscal 20 24 have continued a value creation strategy that we put in place after the pandemic to leverage our expertise in the scaled manufacturer 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 Q3, executing against our commercial roadmap momentum. During the quarter, we accomplished the following significant developments. We continue 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 30, our fiscal year end. Speaker 300:16:40We have received full New York State Department of Health approval for a laboratory developed test. We commercially launched TraitPGX, our pharmacogenomic testing service. And after the close of the quarter, we entered into a multi year 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 twenty twenty five. We believe that our return to growth will be primarily catalyzed by anticipated near term developments at LineaRx, our BioTherapeutics segment and from our DNA Tagging segment with initial contributions from ADCL and its pharmacogenomic testing service. Speaker 300:17:57Clay 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 Q3, we negotiated and then entered into a 5 year CertainT commercialization agreement with Indus Group, a key global cotton apparel manufacturer. The agreement calls for us to supply spray systems, DNA tag int, testing services for DNA tag int and genotyping, devices and materials for on-site testing and isotope testing services. Speaker 300:19:08When 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 1 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' footprint will be based on their demand for tagged cotton. And 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. Speaker 300:20:16The 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 £450,000,000 of cotton annually. In an environment so influenced by the UFLPA or the Uighur Forced Labor Prevention Act, The ability to sell UFLPA compliant apparel to customers becomes a key selling point for new customer acquisition and retention. Speaker 300:21:31The 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 supply in our sales pipeline. Speaker 300:22:23In short, we believe Indus solves the issue of tag count and supply that has always gated the growth of this segment. Our CertainT platform enables customers to provide forensic evidence supporting UF PLA compliance. It is still an issue as supported by evidence in a report we published earlier this year by us and our isotope testing partner. The report indicated traces of banned Chinese cotton were found in 19% of a sample of merchandise sold at U. S. Speaker 300:23:09And 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 in this for a ready supply of Speaker 400:23:57cotton. Speaker 300:24:02Now 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 $25,000,000 in annual revenue today. Our goal with PGx testing is to avoid pricing pressures common to commoditize diagnostics. To this end, our initial sales effort is to build a demand for concierge testing before turning to the higher volume enterprise testing. Speaker 300:25:07In 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 twenty twenty five. Now before I turn the call over to Clay, who will take you through some very exciting developments in the commercialization of Linea IVT Templates and our Linea IVT platform, I want to provide some context that demonstrates the speed with which the field of genetics medicines is progressing. In fiscal 2022, with the biotherapeutics industries coalescing around messenger RNA technology that was driven by the success of the COVID vaccines, we initiated sales of Linea DNA as an IVT template for mRNA production. Speaker 300:26:52We positioned Linea IVT templates as a differentiated approach plasmid templated IVT mRNA. Relative to plasmid templates, lineal IVD 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 gated commercial adoption beyond technology evaluation projects. Speaker 300:27:48It 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 20 23, 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. And as we approach the end of fiscal 2024, I'm 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 linear RNA polymerase enzyme, a critical component of our lineal IVT platform. I'm also happy to report that we have recently completed long term validation studies with 2 Linea DNA template customers and we are now being onboarded as a validated GMP vendor into their workflows. Speaker 300:29:17We 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 3rd Linea DNA template customer and hope to be on boarded 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. Speaker 300:30:21Clay? Speaker 400:30:25Thank you, Jim, and good afternoon, everyone. In recent years, we've established a market footprint, demonstrated credibility and as Jim noted, have generated an endurable roster of valuation customers. Last week, I attended the 4th Annual mRNA Therapeutic Summit in Boston. This is our 3rd 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. Speaker 400:30:57And 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 saw 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. Speaker 400:31:51Now as Jim noted, we are being onboarded as a validated GMPU vendor IVT template into the manufacturing workflow to 2 customers. 1, 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 2020 5 for our fiscal Q2. Speaker 400:32:22We are also involved in an additional customer evaluation where we were recently told that our IBC 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 run-in first half of calendar year twenty twenty five. In addition to these early success stories, we are currently engaged with numerous biotech, pharma and large CDMOs going to process evaluating our Linea IVT database. 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 have multiple assets in their pipelines and initial GMP success of any of these customers hold the potential for long term manufacturing contracts. Speaker 400:33:20It's also significant that we are gaining traction with evaluation customers for our Linea IVC platform. The combination of our proprietary Linea RNA and our IVC templates allows us to increase our relevance to the mRNA value chain for approximately 5% to approximately 30% of mRNA manufacturing costs, providing us with a much larger total addressable market than IVT templates alone. Launched just 1 year ago, our Linea IVC 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 TechPlates and also Endosc in the coming fiscal quarters. Thanks to our recently completed manufacturing process development project on our Linea RNA, 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. Speaker 400:34:26The value of LineaRnap further bolstered this quarter with our receipt of the first U. S. Patent with claims covering the enzyme 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 2 years, but also in the promising state of mRNA based therapeutics. Speaker 400:34:59MRNA empowers much more than just vaccines against infectious disease, such as those against COVID-nineteen. MRNA is a flexible technology that we believe will empower a diverse range of therapies 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 platforms' main selling point, we believe we are very well positioned to capture new customers in this growing area. Speaker 400:35:43Likewise, 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. So in sum, we believe we are in the last stage of what has been 2 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 fortunately favors the bold and we are excited for what the future holds. Now, I'll give the call back to Jim. Speaker 300:36:24Thank 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 empowered by pharmaco genomics, we really find ourselves at the center of the new revolution in biotechnology. Operator, you can now open the session to Q and A. Operator00:37:42Our question comes from Yi Chen from Applied DNA. Go ahead please. Speaker 500:37:49Good afternoon. This is Dan on for Yi. Thanks for taking our questions. Also H. C. Speaker 500:37:56Wainwright. 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 2 approved and 3rd pending 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. Speaker 300:38:20Clay, would you like to take the first half? And I'll take pharmacogenomics. Speaker 400:38:26Absolutely. 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 we don't expect to have signed contracts today that it launches. Speaker 400:38:46But that being said, and as we talked about in the prepared remarks, we have been through this evaluation process with 2 large customers and based on their manufacturing timelines which is really outside of our control, the indications are that those first GMP with manufacturing runs will be early calendar year 2025. That being said, the GMV process is that it's a process, right? It's not given us materials and we will 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 late fiscal 2024, Q1 Q1 fiscal, late 2025. Speaker 400:39:36That makes sense? Speaker 500:39:39Yes, that's perfect. Thank you. Speaker 400:39:41And then in terms I think you asked that in terms number of customers after fiscal 2024 or does that answer your question? Speaker 500:39:51Whatever beyond 2024 would be just to get like an overall picture of how quickly you think this uptick is expected? Speaker 400:40:02Yes. So right now, I mean we have the verbal commitments that we have discussed on this call for about half of our G and T capacity in early calendar year 2025. As we showed in that slide, we think we have a robust sales funnel for the RevVNet capacity and we're going to work to close that. So it's not really a number of customers game. It's the size and the therapeutic modality of their mRNA order that really matters. Speaker 500:40:35Thank you. That's perfect. Speaker 300:40:39And Dan, to answer your pharmacogenomics question. We believe that we are the 1st 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 will have a turnaround time advantage in providing service. Speaker 300:41:26Now 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, a typical concierge physician has somewhere between 2 15500 patients is it allows us to provide the white glove service consistent with the 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 Q1 of 'twenty five. Those customers, which include things like large hospital networks and here on Long Island, we're surrounded by them. Speaker 300:43:07We 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 $25,000,000 of revenue per year, but it's imminently scalable. Of course, we can add more shifts. We can add more testing lines as well. Speaker 300:43:55So we're excited about the opportunity and we're anxious to get started. Speaker 500:44:04That sounds great. If I could ask a follow-up, are there any other states that you're targeting and do they require similar approval process in those states? Speaker 300:44:15It'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 LVT and it was deemed during the validation process as they always are high risk. And so it 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 500:45:11That's awesome. Congratulations on the approval and we're looking forward to the ramp. Thank you. Speaker 300:45:16Thank you. Operator00:46:01This concludes our question and answer session. I would like to turn the conference back over to Doctor. James Hayward for any closing remarks. Speaker 300:46:10Thank 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.Read morePowered by Key Takeaways In Q3 fiscal 2024, Applied DNA reported total revenues of approximately $798k, down from $2.9m a year ago as its CUNY COVID surveillance contract ended, resulting in a gross profit of $245k and an operating loss of $3.3m. The company ended the quarter with $10.4m in cash (including $10.5m from a May public offering), an average monthly cash burn of $1.3m, and disclosed substantial doubt about its ability to continue as a going concern. Applied DNA issued Series A and B warrants to purchase common shares that could raise up to ~$36.8m upon exercise, but lacked a quorum at its special meeting and is seeking shareholder approval (and potentially a reverse stock split) at its annual meeting. In its DNA tagging segment, the company signed a five-year CertainT commercialization agreement with Indus Group to supply DNA tags and testing services for UFLPA-compliant cotton, which could drive steady volume growth in FY25. The LineaRx biotherapeutics division is on track to complete its GMP facility by September 30, has two customers onboarded for mRNA clinical trial materials in early 2025, and is scaling up its Linea IVT platform with a newly patented RNA polymerase. A.I. generated. May contain errors.Conference Call Audio Live Call not available Earnings Conference CallApplied DNA Sciences Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Applied DNA Sciences Earnings HeadlinesApplied DNA’s LineaRx ‘ready to support’ reshoring of drug developmentApril 22, 2025 | markets.businessinsider.comApplied DNA regains compliance with Nasdaq minimum bid price ruleApril 9, 2025 | markets.businessinsider.comTrump’s treachery Trump’s Final Reset Inside the shocking plot to re-engineer America’s financial system…and why you need to move your money now.May 21, 2025 | Porter & Company (Ad)Applied DNA positions TR8 PGx testing as pre-emptive for therapeutic safetyApril 2, 2025 | markets.businessinsider.comWhy Applied DNA Sciences (APDN) Stock Is RisingApril 2, 2025 | benzinga.comApplied DNA Sciences submits validation package to NYSDOH for bird flu testMarch 27, 2025 | markets.businessinsider.comSee More Applied DNA Sciences Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Applied DNA Sciences? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Applied DNA Sciences and other key companies, straight to your email. Email Address About Applied DNA SciencesApplied DNA Sciences (NASDAQ:APDN), a biotechnology company, develops and commercializes technologies to produce and detect deoxyribonucleic acid (DNA) in the Americas, Europe, Asia, and internationally. It operates through three segments: Therapeutic DNA Production Services; MDx Testing Services; and DNA Tagging and Security Products and Services. The Therapeutic DNA Production Services segment develops and commercializes the LinearDNA platform, which enables a cell-free manufacture of high-fidelity synthetic DNA sequences for use in nucleic acid-based therapeutics. The MDx Testing Services segment provides clinical molecular diagnostics (MDx) testing and clinical laboratory testing services; COVID-19 testing services, including test scheduling, sample collection, and automated results reporting for higher education institutions, private clients, and businesses under the safeCircle trademark; polymerase chain reaction (PCR) for production and detection of DNA and RNA; and MDx test kits and related supplies, as well as Isotopic analysis testing services. The DNA Tagging and Security Products and Services segment offers SigNature Molecular Tags, which provides a methodology to authenticate goods within large and complex supply chains for materials, such as cotton, nutraceuticals, and other products; SigNify portable DNA readers and SigNify consumable reagent test kits; and fiberTyping, which uses PCR-based DNA detection to detect a product's naturally occurring DNA sequences for the purposes of product provenance authentication and supply chain security. The company was formerly known as Datalink Systems, Inc. and changed its name to Applied DNA Sciences, Inc. in 2002. Applied DNA Sciences, Inc. was founded in 1983 and is headquartered in Stony Brook, New York.View Applied DNA Sciences ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Alibaba's Earnings Just Changed Everything for the StockCisco Stock Eyes New Highs in 2025 on AI, Earnings, UpgradesSymbotic Gets Big Earnings Lift: Is the Stock Investable Again?D-Wave Pushes Back on Short Seller Case With Strong EarningsAppLovin Surges on Earnings: What's Next for This Tech Standout?Can Shopify Stock Make a Comeback After an Earnings Sell-Off?Rocket Lab: Earnings Miss But Neutron Momentum Holds Upcoming Earnings Autodesk (5/22/2025)Analog Devices (5/22/2025)Copart (5/22/2025)Intuit (5/22/2025)Ross Stores (5/22/2025)Workday (5/22/2025)Toronto-Dominion Bank (5/22/2025)AutoZone (5/27/2025)Bank of Nova Scotia (5/27/2025)NVIDIA (5/28/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 6 speakers on the call. Operator00:00:00Good day, and welcome to the Applied DNA Fiscal Third Quarter 2024 Investor Conference Call. 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. Speaker 100:00:47Thank you, Cindy. Good afternoon, everyone, and welcome to Applied DNA's conference call to discuss our Q3 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 Doctor. James Hayward, our Chairman, President and CEO Beth Jansen, our Chief Financial Officer and Clay Surok, our Chief Legal Officer and Head of Business Development. Speaker 100:01:21Judy Murrah, our Chief Operating Officer, will also be available to answer questions on the Q and 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. Speaker 100:02:09Please go ahead, Beth. Speaker 200:02:11Thank you, Sanjay. Good afternoon, everyone, and thank you for joining us on our Q3 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 Doctor. James Hayward and Clay Sharrock, who will update you on our ongoing business initiatives. Speaker 200:02:38We will then 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 surveillance testing for CUNY. That contract concluded in June 2023. Beginning with our statement of operations, total revenues for the Q3 of fiscal 'twenty four, which ended on June 30, were approximately $798,000 or a decline of $2,100,000 compared to $2,900,000 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 1,850,000 dollars which relates to the aforementioned COVID surveillance testing contract for CUNY, which is included in our June 2023 financial results. Speaker 200:04:00Approximately $70,000 of the decrease in total revenue is attributable to lower product revenues and specifically to decreases in shipments for consumer asset marketing and from a nutraceutical customer, both within our DNA Tagging and Security Products and Services segment. Service revenues decreased by approximately $200,000 year over year. This decrease is attributable to a decrease in R and 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 percent as compared to $1,300,000 or 44% in the prior fiscal year period. The decrease in gross profit was primarily due to a decline in gross profit for our MDF Testing Services segment, specifically related to significantly decreased COVID-nineteen testing volumes year over year. Speaker 200:05:25Total operating expenses decreased by approximately $500,000 to $3,600,000 compared to $4,100,000 in the prior fiscal year period. The decrease in total operating expenses reflects lower SG and 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. Dollars The decrease in SG and A was offset by an increase in R and D of approximately 77,000 to 913,000 from 836,000 in the year ago period. This increase relates to the development of a commercial quantity of our linear RNA polymerase used by our linear IVT platform and for consultants to further optimize the RNA polymerase acquired from the Spindle acquisition. Our operating loss for the 3rd quarter was $3,300,000 compared to $2,900,000 in the prior fiscal period. Speaker 200:06:57Turning to Slide 5, excluding non cash expenses, adjusted EBITDA decreased by $1,100,000 to negative $3,200,000 compared to a negative $2,100,000 in the prior fiscal year period. Now turning to our balance sheet on Slide 6. Cash and cash equivalents totaled $10,400,000 on June 30 compared to $7,200,000 on September 30, 2023. The June 30 cash and cash equivalents figure includes the net proceeds of 10,500,000 dollars 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. Speaker 200:08:00Our average monthly cash burn is $1,200,000 fiscal year to date compared to $500,000 in the prior year. Our average monthly cash burn for the Q3 of fiscal 2024 was $1,300,000 The increase in our cash burn during the Q3 of fiscal 2024 reflects a catch up on payments made after the financing and the payment of professional fees related to our 2 finances conducted during fiscal year. I also note that our just filed Form 10 Q maintains a disclosure from our prior Form 10Q 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 8,900,000 dollars Turning to the offering, we issued 9,230,000 common shares and pre funded warrants to purchase common shares, Series A warrants to purchase 9,230,000 common shares at an exercise price of $1.99 with a 5 year term from the shareholder approval date. Speaker 200:09:38We also issued Series B warrants to purchase 9,230,000 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 exercise ability 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 $18,400,000 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 point $4,000,000 Where under the alternative 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. Speaker 200:10:59If 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 47,200,000 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 1s 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 exercise ability of the series warrant. 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. Speaker 200:12:06A 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. Speaker 200:13:13In 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 secured 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 twenty twenty five. 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. Speaker 200:14:39This concludes my prepared remarks. Thank you for joining us today. I will now turn the call over to Jim for his comments. Jim? Speaker 300:14:49Thank you, Beth. Good afternoon, everyone. Thank you for joining us on our 3rd quarterly investor call of fiscal 2024. We have a great deal to update you on today across each of our 3 business segments. I encourage you to follow along with our slide deck that supports my remarks this afternoon. Speaker 300:15:14Our efforts during the Q3 and fiscal 20 24 have continued a value creation strategy that we put in place after the pandemic to leverage our expertise in the scaled manufacturer 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 Q3, executing against our commercial roadmap momentum. During the quarter, we accomplished the following significant developments. We continue 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 30, our fiscal year end. Speaker 300:16:40We have received full New York State Department of Health approval for a laboratory developed test. We commercially launched TraitPGX, our pharmacogenomic testing service. And after the close of the quarter, we entered into a multi year 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 twenty twenty five. We believe that our return to growth will be primarily catalyzed by anticipated near term developments at LineaRx, our BioTherapeutics segment and from our DNA Tagging segment with initial contributions from ADCL and its pharmacogenomic testing service. Speaker 300:17:57Clay 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 Q3, we negotiated and then entered into a 5 year CertainT commercialization agreement with Indus Group, a key global cotton apparel manufacturer. The agreement calls for us to supply spray systems, DNA tag int, testing services for DNA tag int and genotyping, devices and materials for on-site testing and isotope testing services. Speaker 300:19:08When 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 1 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' footprint will be based on their demand for tagged cotton. And 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. Speaker 300:20:16The 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 £450,000,000 of cotton annually. In an environment so influenced by the UFLPA or the Uighur Forced Labor Prevention Act, The ability to sell UFLPA compliant apparel to customers becomes a key selling point for new customer acquisition and retention. Speaker 300:21:31The 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 supply in our sales pipeline. Speaker 300:22:23In short, we believe Indus solves the issue of tag count and supply that has always gated the growth of this segment. Our CertainT platform enables customers to provide forensic evidence supporting UF PLA compliance. It is still an issue as supported by evidence in a report we published earlier this year by us and our isotope testing partner. The report indicated traces of banned Chinese cotton were found in 19% of a sample of merchandise sold at U. S. Speaker 300:23:09And 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 in this for a ready supply of Speaker 400:23:57cotton. Speaker 300:24:02Now 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 $25,000,000 in annual revenue today. Our goal with PGx testing is to avoid pricing pressures common to commoditize diagnostics. To this end, our initial sales effort is to build a demand for concierge testing before turning to the higher volume enterprise testing. Speaker 300:25:07In 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 twenty twenty five. Now before I turn the call over to Clay, who will take you through some very exciting developments in the commercialization of Linea IVT Templates and our Linea IVT platform, I want to provide some context that demonstrates the speed with which the field of genetics medicines is progressing. In fiscal 2022, with the biotherapeutics industries coalescing around messenger RNA technology that was driven by the success of the COVID vaccines, we initiated sales of Linea DNA as an IVT template for mRNA production. Speaker 300:26:52We positioned Linea IVT templates as a differentiated approach plasmid templated IVT mRNA. Relative to plasmid templates, lineal IVD 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 gated commercial adoption beyond technology evaluation projects. Speaker 300:27:48It 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 20 23, 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. And as we approach the end of fiscal 2024, I'm 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 linear RNA polymerase enzyme, a critical component of our lineal IVT platform. I'm also happy to report that we have recently completed long term validation studies with 2 Linea DNA template customers and we are now being onboarded as a validated GMP vendor into their workflows. Speaker 300:29:17We 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 3rd Linea DNA template customer and hope to be on boarded 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. Speaker 300:30:21Clay? Speaker 400:30:25Thank you, Jim, and good afternoon, everyone. In recent years, we've established a market footprint, demonstrated credibility and as Jim noted, have generated an endurable roster of valuation customers. Last week, I attended the 4th Annual mRNA Therapeutic Summit in Boston. This is our 3rd 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. Speaker 400:30:57And 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 saw 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. Speaker 400:31:51Now as Jim noted, we are being onboarded as a validated GMPU vendor IVT template into the manufacturing workflow to 2 customers. 1, 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 2020 5 for our fiscal Q2. Speaker 400:32:22We are also involved in an additional customer evaluation where we were recently told that our IBC 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 run-in first half of calendar year twenty twenty five. In addition to these early success stories, we are currently engaged with numerous biotech, pharma and large CDMOs going to process evaluating our Linea IVT database. 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 have multiple assets in their pipelines and initial GMP success of any of these customers hold the potential for long term manufacturing contracts. Speaker 400:33:20It's also significant that we are gaining traction with evaluation customers for our Linea IVC platform. The combination of our proprietary Linea RNA and our IVC templates allows us to increase our relevance to the mRNA value chain for approximately 5% to approximately 30% of mRNA manufacturing costs, providing us with a much larger total addressable market than IVT templates alone. Launched just 1 year ago, our Linea IVC 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 TechPlates and also Endosc in the coming fiscal quarters. Thanks to our recently completed manufacturing process development project on our Linea RNA, 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. Speaker 400:34:26The value of LineaRnap further bolstered this quarter with our receipt of the first U. S. Patent with claims covering the enzyme 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 2 years, but also in the promising state of mRNA based therapeutics. Speaker 400:34:59MRNA empowers much more than just vaccines against infectious disease, such as those against COVID-nineteen. MRNA is a flexible technology that we believe will empower a diverse range of therapies 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 platforms' main selling point, we believe we are very well positioned to capture new customers in this growing area. Speaker 400:35:43Likewise, 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. So in sum, we believe we are in the last stage of what has been 2 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 fortunately favors the bold and we are excited for what the future holds. Now, I'll give the call back to Jim. Speaker 300:36:24Thank 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 empowered by pharmaco genomics, we really find ourselves at the center of the new revolution in biotechnology. Operator, you can now open the session to Q and A. Operator00:37:42Our question comes from Yi Chen from Applied DNA. Go ahead please. Speaker 500:37:49Good afternoon. This is Dan on for Yi. Thanks for taking our questions. Also H. C. Speaker 500:37:56Wainwright. 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 2 approved and 3rd pending 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. Speaker 300:38:20Clay, would you like to take the first half? And I'll take pharmacogenomics. Speaker 400:38:26Absolutely. 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 we don't expect to have signed contracts today that it launches. Speaker 400:38:46But that being said, and as we talked about in the prepared remarks, we have been through this evaluation process with 2 large customers and based on their manufacturing timelines which is really outside of our control, the indications are that those first GMP with manufacturing runs will be early calendar year 2025. That being said, the GMV process is that it's a process, right? It's not given us materials and we will 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 late fiscal 2024, Q1 Q1 fiscal, late 2025. Speaker 400:39:36That makes sense? Speaker 500:39:39Yes, that's perfect. Thank you. Speaker 400:39:41And then in terms I think you asked that in terms number of customers after fiscal 2024 or does that answer your question? Speaker 500:39:51Whatever beyond 2024 would be just to get like an overall picture of how quickly you think this uptick is expected? Speaker 400:40:02Yes. So right now, I mean we have the verbal commitments that we have discussed on this call for about half of our G and T capacity in early calendar year 2025. As we showed in that slide, we think we have a robust sales funnel for the RevVNet capacity and we're going to work to close that. So it's not really a number of customers game. It's the size and the therapeutic modality of their mRNA order that really matters. Speaker 500:40:35Thank you. That's perfect. Speaker 300:40:39And Dan, to answer your pharmacogenomics question. We believe that we are the 1st 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 will have a turnaround time advantage in providing service. Speaker 300:41:26Now 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, a typical concierge physician has somewhere between 2 15500 patients is it allows us to provide the white glove service consistent with the 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 Q1 of 'twenty five. Those customers, which include things like large hospital networks and here on Long Island, we're surrounded by them. Speaker 300:43:07We 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 $25,000,000 of revenue per year, but it's imminently scalable. Of course, we can add more shifts. We can add more testing lines as well. Speaker 300:43:55So we're excited about the opportunity and we're anxious to get started. Speaker 500:44:04That sounds great. If I could ask a follow-up, are there any other states that you're targeting and do they require similar approval process in those states? Speaker 300:44:15It'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 LVT and it was deemed during the validation process as they always are high risk. And so it 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 500:45:11That's awesome. Congratulations on the approval and we're looking forward to the ramp. Thank you. Speaker 300:45:16Thank you. Operator00:46:01This concludes our question and answer session. I would like to turn the conference back over to Doctor. James Hayward for any closing remarks. Speaker 300:46:10Thank 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.Read morePowered by