Applied DNA Sciences Inc. (APDN:NASDAQ) announced the general availability of its Linea IVT platform evaluation kits and the first kit shipment to an existing Linea IVT Template customer.
Messenger RNA, or mRNA, is a genetic material that tells your body how to make proteins, according to the U.S. Centers for Disease Control and Prevention. mRNA vaccines teach your cells how to fight the virus.
Applied DNA's recently launched Linea IVT platform results in a simpler mRNA production workflow with reduced contamination from double-stranded RNA (dsRNA), the company said.
"Our recent receipt of commercial scale amounts of Linea RNAP and the availability of the kit less than seven weeks after the acquisition of Spindle highlights our ability to execute and our commitment to the Linea IVT platform," said Applied DNA President and Chief Executive Officer James A. Hayward.
"With large quantities of the RNAP in hand, we can now offer enough Kits to enable the manufacture of mRNA equivalent to approximately 233,000 COVID-19 30 μg vaccine doses, which we believe is sufficient to service our current pipeline of evaluation customers."
The newly launched kit comprises the Linea IVT template, a buffer system, and LineaTM RNA Polymerase (RNAP) and supports the conversion of current template evaluation customers to Linea IVT.
The company has also filed two provisional patent applications for the technologies, which target impurities that can reduce yields and increase the manufacturing costs of mRNA therapies like COVID-19 vaccines.
H.C. Wainwright & Co. analyst Yi Chen wrote in an August 24 research note that if the patents are approved, they should help secure the financial prospects of the Linea IVT platform as more mRNA therapeutics enter the market.
"We note that mRNA therapeutics are being developed for an expanding range of diseases, and the conventional plasmid DNA-based mRNA production presents a bottleneck in drug development," wrote Chen, who rated the stock a Buy with a price target of US$4 per share. "Linea IVT has the ability to reduce or eliminate dsRNA contamination without sacrificing production yields, which could help pharma customers lower development costs and speed up development timelines. "
Industry Interest Accelerating
Last month, Applied DNA acquired Spindle Biotech Inc., an early-stage, private biotech company. Linea IVT combines Applied DNA's linearDNA IVT templates with Spindle's RNA polymerase into an integrated offering, expanding Applied DNA's access to the mRNA value chain severalfold.
The company said Linea IVT offers several advantages over conventional mRNA production, including the elimination of plasmid DNA as a starting material, the prevention or reduction of dsRNA contamination for higher target mRNA yields, and the delivery of IVT templates in as little as 14 days.
H.C. Wainwright & Co. analyst Yi Chen wrote in an August 24 research note that if the patents are approved, they should help secure the financial prospects of the Linea IVT platform as more mRNA therapeutics enter the market.
"The Linea IVT platform's unique ability to mitigate problematic dsRNA while also providing for a simplified mRNA production workflow with potentially greater target mRNA yields is a compelling advantage over conventional mRNA production methods at a time when industry interest in mRNA therapeutics is accelerating," Applied DNA President and Chief Executive Officer James A. Hayward said.
Chen noted that the patents applied for form the backbone of the Linea IVT platform.
"In our view, the provisional patent applications, if allowed, should help secure the financial prospects of the Linea IVT platform in the industry as more mRNA therapeutics enter development," the analyst wrote.
Applied DNA first partnered with Spindle last year, the company said.
"We deeply appreciate the complementary nature of its RNAP to our linearDNA IVT templates and the combined technologies’ ability to substantially reduce or eliminate dsRNA contamination without sacrificing production yields,” Hayward said.
The Catalyst: First the Pandemic, Now Cancer Treatments
The mRNA-based therapeutics and vaccines are made in the laboratory using mammalian cells and injected into patients to activate virus-detecting sensors and make viral antigen proteins, Straits Research reported.
The global market for mRNA vaccines and therapeutics was US$36.54 billion in 2022 and is estimated to reach US$58.98 billion by 2031, a compound annual growth rate (CAGR) of 13.3%, Straits Research said.
"In our view, the provisional patent applications, if allowed, should help secure the financial prospects of the Linea IVT platform in the industry as more mRNA therapeutics enter development," the analyst wrote.
COVID-19 and the financing available for manufacturing vaccines have favorably impacted the growth of the mRNA market globally, according to a report by Grand View Research.
"In addition, the number of mRNA-based vaccine therapeutics in oncology clinical trials has dramatically expanded as a result of the success of Moderna's and Pfizer-BioNTech's vaccines against COVID-19," analysts reported.
"The infectious disease segment led the market and held 100% revenue share in 2021," according to the report. "The increasing adoption of mRNA-based vaccines, a high number of candidates entering clinical trials for various infectious diseases, and the COVID-19 outbreak in late 2019 are anticipated to drive the market over the forecast period."
The cancer segment is expected to expand "at a lucrative rate" and drive the industry over the forecast period, analysts said.
"As per . . . World Health Organization (WHO) estimates, cancer accounted for approximately 10 million deaths in 2020, making it the leading cause of death globally," the report said.
Q3 Results
Applied DNA also has a subsidiary, Applied DNA Clinical Labs, that develops and provides enterprise-scale genetic testing services. Its CertainT platform molecularly tags raw materials and products in the textile, dietary supplement, and pharmaceutical industries.
The company earlier this month also announced its financial results for the third quarter of fiscal 2023, which ended June 30.
Total revenues were about US$2.9 million, compared to US$4.3 million for the same period in 2022. The company said the decrease was due to a COVID testing services revenue decline.
While gross profit increased to US$1.3 million from US$1 million YoY, operating loss remained flat at US$2.9 million, and net loss was US$3.1 million for Q3 2023 compared to US$1.1 million in Q3 2022.
Streetwise Ownership Overview*
Applied DNA Sciences Inc. (APDN:NASDAQ)
"Looking ahead to the fourth quarter, we are focused on driving adoption of the Linea IVT platform and closing CertainT opportunities aligned with the upcoming cotton ginning season," Hayward said. "We are encouraged by initial industry feedback to our Linea IVT platform, and we are already in early discussions with prospective evaluation customers at volumes that can be met from our current production footprint."
Ownership and Share Structure
About 17% of Applied DNA is owned by institutions, according to Reuters, including AWM Investment Co. Inc. with 5.93%, The Vanguard Group Inc. with 3.71%, AMH Equity Ltd. with 2.44%, and Geode Capital Management LLC with 0.95%.
Reuters said nearly 2% of the company is with insiders and management, including the CEO Hayward with 0.98%, and Chief Legal Officer Clay Shorrock with 0.67%.
The company has a market cap of US$18.78 million, with 13.66 million shares outstanding, 13.42 million of them floating. It trades in a 52-week range of US$3.68 and US$0.97.
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