Applied DNA Completes Buildout of GMP Facility for LineaDNA IVT Templates
Applied DNA Sciences (NASDAQ:APDN) has completed the buildout of its new Good Manufacturing Practices (GMP) facility at its Stony Brook, New York headquarters. The facility, expected to be fully operational by January's end, will manufacture LineaDNA IVT templates for mRNA clinical trial materials.
Key facility specifications include:
- Annual IVT template manufacturing capacity of ~10 grams with 100% cell-free workflow
- 10mg to gram-scale production in 6-14 weeks
- Projected revenue capacity of $10-30 million depending on product mix
- Multiple purification options and dedicated quality control areas
The company is currently negotiating a supply agreement for GMP IVT template with an mRNA therapeutic developer and reaffirmed its plan to complete strategic restructuring by quarter-end to drive sustainable growth, optimize costs, and extend cash runway.
Applied DNA Sciences (NASDAQ:APDN) ha completato la costruzione della sua nuova struttura per le Buone Pratiche di Fabbricazione (GMP) nella sua sede di Stony Brook, New York. La struttura, che si prevede sarà pienamente operativa entro la fine di gennaio, produrrà template IVT LineaDNA per materiali di trial clinici mRNA.
Le principali specifiche della struttura includono:
- Capacità annuale di produzione di template IVT di ~10 grammi con flusso di lavoro 100% privo di cellule
- Produzione da 10 mg a scala di grammi in 6-14 settimane
- Capacità di fatturato prevista di $10-30 milioni a seconda del mix di prodotti
- Multiple opzioni di purificazione e aree dedicate al controllo qualità
L'azienda sta attualmente negoziando un accordo di fornitura per il template IVT GMP con un sviluppatore terapeutico mRNA e ha ribadito il suo piano di completare la ristrutturazione strategica entro la fine del trimestre per incentivare una crescita sostenibile, ottimizzare i costi e prolungare il margine di liquidità.
Applied DNA Sciences (NASDAQ:APDN) ha completado la construcción de su nueva instalación de Buenas Prácticas de Fabricación (GMP) en su sede en Stony Brook, Nueva York. Se espera que la instalación, que estará totalmente operativa a finales de enero, fabrique plantillas IVT LineaDNA para materiales de ensayos clínicos de mRNA.
Las principales especificaciones de la instalación incluyen:
- Capacidad de fabricación anual de plantillas IVT de aproximadamente 10 gramos con un flujo de trabajo 100% libre de células
- Producción de 10 mg a escala de gramos en 6-14 semanas
- Capacidad de ingresos proyectada de $10-30 millones dependiendo de la mezcla de productos
- Múltiples opciones de purificación y áreas dedicadas al control de calidad
La compañía está negociando actualmente un acuerdo de suministro para plantillas IVT GMP con un desarrollador terapéutico de mRNA y reafirmó su plan de completar una reestructuración estratégica para el final del trimestre con el fin de impulsar un crecimiento sostenible, optimizar costos y extender el margen de liquidez.
Applied DNA Sciences (NASDAQ:APDN)는 뉴욕 스토니브룩 본사의 새로운 우수 제조 관행(GMP) 시설을 완공했습니다. 이 시설은 1월 말까지 완전 가동될 예정이며, mRNA 임상 시험 자료를 위한 LineaDNA IVT 템플릿을 제조할 것입니다.
주요 시설 사양은 다음과 같습니다:
- 연간 IVT 템플릿 제조 용량 약 10그램, 100% 세포 없는 워크플로우
- 10mg에서 1그램 규모로 생산에 6-14주 소요
- 제품 혼합에 따라 예측되는 수익 능력은 $10-30 백만
- 다양한 정제 옵션과 전용 품질 관리 구역
회사는 현재 mRNA 치료제 개발자와 GMP IVT 템플릿 공급 계약을 협상 중이며, 지속 가능한 성장을 주도하고 비용을 최적화하며 현금 여유를 확장하기 위해 분기 말까지 전략적 구조조정을 완료할 계획을 재확인했습니다.
Applied DNA Sciences (NASDAQ:APDN) a terminé la construction de sa nouvelle installation de Bonnes Pratiques de Fabrication (GMP) dans son siège de Stony Brook, New York. L'installation devrait être pleinement opérationnelle d'ici la fin janvier et produira des modèles IVT LineaDNA pour des matériaux d'essai clinique en mRNA.
Les principales spécifications de l'installation incluent :
- Capacité de fabrication annuelle de modèles IVT d'environ 10 grammes avec un flux de travail 100% sans cellules
- Production de 10 mg à l'échelle du gramme en 6-14 semaines
- Capacité de revenus projetée de 10 à 30 millions de dollars selon le mélange de produits
- Multiples options de purification et zones de contrôle de qualité dédiées
L'entreprise négocie actuellement un contrat d'approvisionnement pour les modèles IVT GMP avec un développeur thérapeutique en mRNA et a réaffirmé son intention de finaliser une restructuration stratégique d'ici la fin du trimestre afin de favoriser une croissance durable, d'optimiser les coûts et d'étendre sa marge de liquidité.
Applied DNA Sciences (NASDAQ:APDN) hat den Aufbau seiner neuen Anlage für Gute Herstellungspraxis (GMP) in der Zentrale in Stony Brook, New York, abgeschlossen. Die Anlage, die bis Ende Januar voll operational sein soll, wird LineaDNA IVT-Vorlagen für mRNA-Klinikmaterialien herstellen.
Wichtige Anlagenspezifikationen umfassen:
- Jährliche Produktionskapazität von ca. 10 Gramm mit 100% zellfreier Arbeitsweise
- Produktion im Maßstab von 10 mg bis 1 Gramm in 6-14 Wochen
- Prognostizierte Einnahmenkapazität von 10-30 Millionen USD, abhängig von der Produktmischung
- Verschiedene Reinigungsoptionen und spezielle Qualitätskontrollbereiche
Das Unternehmen führt derzeit Verhandlungen über einen Liefervertrag für GMP IVT-Vorlagen mit einem mRNA-Therapeutik-Entwickler und hat seinen Plan bestätigt, bis zum Ende des Quartals eine strategische Umstrukturierung abzuschließen, um nachhaltiges Wachstum zu fördern, Kosten zu optimieren und die Liquiditätsreserve zu verlängern.
- New GMP facility completion enables commercial-scale production
- Projected annual revenue capacity of $10-30 million from facility operations
- Active negotiations for first supply agreement underway
- Implementation of cost optimization and restructuring plan
- Facility not yet fully operational
- Revenue projections based on internal modeling without market validation
Insights
The completion of Applied DNA's GMP facility marks a strategic pivot towards commercial-scale manufacturing of LineaDNA IVT templates for mRNA therapeutics. The projected annual capacity of 10 grams and potential revenue range of
The facility's 100% cell-free workflow and ability to produce chemically modified templates with proprietary RNA polymerase addresses a critical industry need for higher purity starting materials in mRNA production. The ongoing negotiation of a GMP supply agreement suggests market validation of their technology platform. The facility's modular design with dedicated areas for warehousing, process development and quality control aligns with current GMP best practices while maintaining operational efficiency.
This development represents a important inflection point for APDN's revenue potential. The projected annual revenue capacity of
The business model flexibility, offering both standalone IVT templates and paired solutions with proprietary RNA polymerase, creates multiple revenue streams and potential pricing power. The active negotiation of a supply agreement could provide stable recurring revenue, essential for a company of APDN's size. The completion of this facility on schedule, combined with the restructuring initiatives, positions APDN to potentially achieve operational profitability with minimal additional capital requirements.
- Signals Start of New Commercialization Phase for LineaRx Subsidiary -
- Company Negotiating GMP Supply Agreement -
- Company Reaffirms Strategic Restructuring Timeline -
STONY BROOK, NY / ACCESSWIRE / January 10, 2025 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the completion of the buildout of its new Good Manufacturing Practices (GMP) manufacturing facility (the "facility") within its Stony Brook, New York, headquarters and readiness to accept orders for the manufacture of LineaDNA™ IVT templates that clients can utilize for the production of mRNA clinical trial materials. The facility is undergoing final testing and is expected to be fully operational by the end of the current month. The Company also announced that it is actively negotiating a supply agreement for GMP IVT template with a mRNA therapeutic developer.
Separately, the Company reaffirmed its intention to complete the implementation of its previously announced strategic restructuring plan by the end of the current quarter. The restructuring is intended to drive sustainable growth from LineaRx, Inc., its biotherapeutic subsidiary, optimize Applied DNA's cost structure, and extend the parent company's cash runway.
GMP Facility Overview:
Based on updated modeling, an initial projected annual IVT template manufacturing capacity of approximately ten (10) grams with
100% cell-free workflow;10mg to gram-scale production in 6-14 weeks with multiple purification options;
Dedicated warehouse, process development, analytical testing, and quality control areas;
The capacity to deliver chemically modified LineaDNA IVT templates paired with the Company's proprietary RNA polymerase to mitigate double-stranded DNA (dsRNA) contaminants in commercial-scale mRNA production; and,
A projected revenue capacity ranging from
$10 million to$30 million , depending on product mix (sales of IVT template or the paired-IVT template and Linea™ RNA polymerase for mRNA production[1].)
"Once operational, our GMP facility stands ready to support the development of next-generation genetic medicines with a cell-free, enzymatic approach to IVT template production that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid-DNA (fermentation)-based IVT template manufacturing processes. We believe we are in an unmatched position to help bring the advantages of synthetic DNA to our clients to develop innovative therapies," stated Dr. James A. Hayward, chairman and CEO of Applied DNA.
Added Clay Shorrock, president of LineaRx, Inc., "We believe the upcoming operational launch of our GMP facility is a pivotal junction for the Company, representing the final piece of a multi-year business strategy to commercialize our LineaDNA and Linea IVT platforms and return us to a growth trajectory. With a strong GMP sales funnel for IVT templates and in active negotiations on our first supply agreement, we look forward to engaging with our therapeutic developer and CDMO customers to support their cell-free DNA needs."
[1] Based on internal Company data and modeling.
About the LineaDNA™ and Linea™ IVT Platforms
The LineaDNA platform is an entirely cell-free DNA production platform founded on Applied DNA's long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the LineaDNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the LineaDNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs. The Linea IVT platform combines DNA IVT templates manufacturing via the LineaDNA platform with a proprietary Linea™ RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA, we currently operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
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Forward-Looking Statements
The statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, the unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from its Linea IVT and or Linea DNA platforms, the fact that there has never been clinical trial material and/or commercial drug product produced utilizing the LineaDNA and/or Linea IVT platforms, and various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K on December 17, 2024, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Contacts:
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Program contact: Clay Shorrock, 631-912-6454, clay.shorrock@adnas.com
Web: www.adnas.com
X: @APDN
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SOURCE: Applied DNA Sciences, Inc.
View the original press release on accesswire.com
FAQ
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