Biggest changeFor more information, see “ Risk Factors — Risks Related to Our Intellectual Property .” As of December 9, 2024, our patent portfolio included the following issued and pending patent applications applicable to each of our three primary business markets: ● Therapeutic DNA Production Services o 8 issued patents and 11 pending patent applications in the United States o 11 issued foreign patents and 9 pending foreign patent applications ● MDx Testing Services o 5 issued patents and no pending patent applications in the United States o 4 issued foreign patents and no pending foreign patent applications ● DNA Tagging and Security Products and Services o 26 issued patents and 2 pending patent applications in the United States o 47 issued foreign patents and 10 pending foreign patent applications In addition to patent protection, we also rely on trademarks, trade secrets, know how, other proprietary information and continuing technological innovation to develop and maintain our competitive position.
Biggest changeAs of December 15, 2025, our patent portfolio relating to our Therapeutic DNA Production Services business included the following: ● Therapeutic DNA Production Services o 8 issued patents and 8 pending patent applications in the United States o 12 issued foreign patents and 8 pending foreign patent applications In addition to patent protection, we also rely on trademarks, trade secrets, know how, other proprietary information and continuing technological innovation to develop and maintain our competitive position.
Raw Materials and Suppliers We utilize DNA polymerase (“DNAP”) in all of our PCR reactions to amplify DNA. DNAP is available from multiple sources. Our sources of raw materials also include synthesized sources of DNA templates which we can amplify to use in our product/services offerings and that are available from multiple sources.
(“Spindle”). Raw Materials and Suppliers We utilize DNA polymerase (“DNAP”) in all of our PCR reactions to amplify DNA. DNAP is available from multiple sources. Our sources of raw materials also include synthesized sources of DNA templates which we can amplify to use in our product/services offerings and that are available from multiple sources.
The LineaDNA platform enzymatically produces a linear form of DNA we call “LineaDNA” that is an alternative to plasmid-based DNA manufacturing technologies that have supplied the DNA used in biotherapeutics for the past 40 years.
The LineaDNA platform enzymatically produces a linear form of synthetic DNA we call “LineaDNA” that is an alternative to plasmid-based DNA manufacturing technologies that have supplied the DNA used in biotherapeutics for the past 40 years.
Our agreements with employees 13 Table of Contents also provide that all inventions conceived by the employee in the course of employment with us or from the employee’s use of our confidential information are our exclusive property. However, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach.
Our agreements with employees also provide that all inventions conceived by the employee in the course of employment with us or from the employee’s use of our confidential information are our exclusive property. However, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate 17 Table of Contents coverage against potential liabilities.
We do not plan to seek approval of a drug or licensure of a biological product based on our LineaDNA platform, but the demand for our LineaDNA is in part dependent on our customer’s ability to seek and obtain approval of a drug or biological product using our technology.
We do not plan to seek approval of a drug or licensure of a biological product based on our LineaDNA platform, but the demand for our LineaDNA is in part dependent on our customer’s ability to seek and 15 Table of Contents obtain approval of a drug or biological product using our technology.
Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our preclinical trials, future clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, prospects, financial condition, results of operations, and prospects.
Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and preclinical trials, future clinical trials or regulatory approvals related to our product or services could be suspended, which could have a material adverse effect on our business, prospects, financial condition, results of operations, and prospects.
Because we file documents electronically with the SEC, you may obtain this information by visiting the SEC’s website at: www.sec.gov . Our website is located at: www.adnas.com . The information on, or that may be accessed through, our website is not incorporated by reference into and should not be considered a part of this report. 16 Table of Contents
Because we file documents electronically with the SEC, you may obtain this information by visiting the SEC’s website at: www.sec.gov . Our website is located at: www.bnb.plus , www.adnas.com and www.linearxdna.com. The information on, or that may be accessed through, our website is not incorporated by reference into and should not be considered a part of this report.
Further, we believe that LineaDNA is also substitutable for plasmid DNA in the following nucleic acid-based therapies: ● viral vector manufacturing for in vivo and ex vivo gene editing; ● clustered regularly interspaced short palindromic repeats (“CRISPR”)-mediated gene therapy; and ● non-viral gene therapy.
Further, we believe that LineaDNA is also substitutable for plasmid DNA in the following nucleic acid-based therapies: ● viral vector manufacturing for in vivo and ex vivo gene editing; ● clustered regularly interspaced short palindromic repeats-mediated gene therapy (CRISPR); and 10 Table of Contents ● non-viral gene therapy.
Our success depends in part on our ability to protect the proprietary nature of our technologies and know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. We seek and maintain patent protection in the United States and internationally for our various technologies associated with our three primary business markets.
Our success depends in part on our ability to protect the proprietary nature of our technologies and know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. We seek and maintain patent protection in the United States and internationally for our Therapeutic DNA Production Services business.
Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as the FDA’s refusal to file a marketing application, to issue a Complete Response letter or to not approve pending New Drug Applications (“NDA”) or Biologics Licensing Applications (“BLA”), or to issue warning letters, untitled letters, Form 483s, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, litigation, government investigation and criminal prosecution. 14 Table of Contents Drug and biologic products that must undergo preclinical and clinical evaluation relating to product safety and efficacy before they are approved as commercial therapeutics products.
Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as the FDA’s refusal to file a marketing application, to issue a Complete Response letter or to not approve pending New Drug Applications (“NDA”) or Biologics Licensing Applications (“BLA”), or to issue warning letters, untitled letters, Form 483s, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, litigation, government investigation and criminal prosecution.
Preclinical studies conducted by the Company have shown that LineaDNA is substitutable for plasmid DNA in numerous nucleic acid-based therapies, including: ● DNA vaccines; ● DNA templates to produce various types of RNA, including non-replicating, and self-amplifying mRNA therapeutics; ● adoptive cell therapy (CAR-T) manufacturing, and ● homology-directed repair (HDR) mediated gene editing.
Preclinical studies conducted by the Company have shown that LineaDNA is substitutable for plasmid DNA in numerous biotherapeutic applications, including: ● DNA vaccines; ● DNA templates to produce RNA, including mRNA therapeutics; ● adoptive cell therapy (CAR-T) manufacturing; and ● homology-directed repair (HDR)-mediated gene editing.
Currently, Linea RNAP is produced for the Company under an ISO 13485 quality system by Alphazyme, LLC (“Alphazyme”) a third-party CDMO located in the United States, which the Company believes is sufficient for early-stage clinical use of the enzyme.
LineaRNAP is produced for the Company under an ISO 13485 quality system by Alphazyme, LLC (“Alphazyme”), a third-party Contract Development and Manufacturing Organization (“CDMO”) located in the United States, which the Company believes is sufficient for early-stage clinical use of the enzyme.
As of June 30, 2024, the employment contract automatically renewed for an additional year. Available Information We are subject to the informational requirements of the Exchange Act, which requires us to file our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, amendments to such reports and other information with the SEC.
Available Information We are subject to the informational requirements of the Exchange Act, which requires us to file our Annual Reports on Form 10 - K, Quarterly Reports on Form 10 - Q, Current Reports on Form 8 - K, amendments to such reports and other information with the SEC.
Industry Background and Markets Therapeutic DNA Production Services Through LineaRx, Inc. (“LRx”) our 98% owned subsidiary we are developing and commercializing our LineaDNA and Linea IVT platforms for the manufacture of synthetic DNA and associated enzymes for use in the production of nucleic acid-based therapeutics.
LineaRx Business Strategy Through LineaRx our 98% owned subsidiary, we are developing and commercializing our LineaDNA and Linea IVT platforms for the manufacture of synthetic DNA and associated enzymes for use in the production of nucleic acid-based therapeutics (the “Therapeutic DNA Production Services”).
Employees As of September 30, 2024, we had a total of 48 employees (46 fulltime and 2 part-time), consisting of 4 in executive management, 8 in research and development, 8 in quality and compliance, 3 in finance, accounting and human resources, 8 in operations/production, 5 in sales and marketing, 4 in administration and support services, 4 in information services, and 4 in clinical laboratory operations.
Employees As of September 30, 2025, we had a total of 26 employees, consisting of 3 in executive management, 5 in research and development, 6 in quality and compliance, 3 in finance, accounting and human resources, 3 in operations/production, 3 in sales and marketing, 1 in administration and support services, and 2 in information services.
Our corporate headquarters are located at the Long Island High Technology Incubator at Stony Brook University in Stony Brook, New York, where we have established laboratories for the manufacture of DNA and the detection of DNA and RNA to support our various business units.
Our corporate headquarters are located at the Long Island High Technology Incubator at Stony Brook University in Stony Brook, New York, where we have established laboratories for the manufacture and development of our nucleic acid production solutions.
LineaDNA Platform Our LineaDNA platform is our core enabling technology, and enables the rapid, efficient, and large-scale cell-free manufacture of high-fidelity DNA sequences for use in the manufacturing of a broad range of nucleic acid-based therapeutics.
LineaDNA LineaDNA is our core enabling technology for rapid, efficient, and scalable cell-free manufacture of high-fidelity synthetic DNA sequences used in the manufacturing of a broad range of biotherapeutics.
Based on data generated by the Company and its collaborators, we believe the integrated Linea IVT platform offers the following advantages over conventional mRNA production to therapy developers and manufacturers: ● The prevention or reduction of double stranded RNA (“dsRNA”) contamination resulting in higher target mRNA yields with the potential to reduce downstream processing steps. dsRNA is a problematic immunogenic byproduct produced during conventional mRNA manufacture; ● delivery of IVT templates in as little as 14 days for milligram scale and 30 days for gram scale; ● reduced mRNA manufacturing complexities; and ● potentially enabling mRNA manufactures to produce mRNA drug substance in less than 45 days.
We believe the key advantages of the LineaIVT platform include: ● The reduction of dsRNA contamination resulting in higher target mRNA yields with the potential to reduce downstream processing steps. dsRNA is a problematic immunogenic byproduct produced during conventional mRNA manufacture; ● delivery of LineaDNA IVT templates in as little as 14 days for milligram scale and 30 days for gram scale; ● reduced manufacturing complexities through single sourcing and potentially reduced mRNA purification requirement to meet target quality standards; and ● potentially enabling mRNA manufacturers to produce mRNA drug substance in less than 45 days.
In conjunction with Alphazyme, the Company recently completed manufacturing process development work on its Linea RNAP to increase the production scale of the enzyme and reduce unit costs. Manufacturing Scale-up The Company plans to offer several quality grades of Linea DNA, each of which will have different permitted uses.
In conjunction with Alphazyme, the Company completed manufacturing process development work on its LineaRNAP to increase the production scale of the enzyme and reduce unit costs.
Once amplified, the DNA must be separated from the living cells and other process contaminants via multiple rounds of purification, adding further complexity, costs and regulatory burdens. Unlike plasmid-based DNA manufacturing, the LineaDNA platform does not require living cells and instead amplifies DNA via the enzymatic process of PCR.
Plasmid-based DNA manufacturing is based on the complex, costly and time-consuming biological process of amplifying DNA in living bacterial cells. Once amplified, the DNA must be separated from the living cells and other process contaminants via multiple rounds of purification, adding further complexity and costs.
In 1998, we reincorporated in the State of Nevada, and in 2002, we changed our name to our current name, Applied DNA Sciences, Inc. On December 17, 2008, we reincorporated from the State of Nevada to the State of Delaware.
On December 17, 2008, we reincorporated from the State of Nevada to the State of Delaware. On November 13, 2025 we changed our Company name to our current name, BNB Plus Corp.
Manufacturing For our Therapeutic DNA Production Services and DNA Tagging and Security Products and Services segments, we have the capability to manufacture large quantities of DNA via our LineaDNA platform at our facility in Stony Brook.
In addition, while our Linea RNAP is manufacturable by multiple sources, it is currently manufactured by a single provider. Manufacturing For our Therapeutic DNA Production Services segment, we have the capability to manufacture large quantities of DNA via our LineaDNA platform at our facility in Stony Brook. For our Therapeutic DNA Production Services, we currently manufacture GLP grade DNA.
We expect that based on available opportunities and our beliefs regarding future opportunities, we will continue to modify and refine our business strategy. 5 Table of Contents Corporate History We are a Delaware corporation, which was initially formed in 1983 under the laws of the State of Florida as Datalink Systems, Inc.
Corporate History We are a Delaware corporation, which was initially formed in 1983 under the laws of the State of Florida as Datalink Systems, Inc. In 1998, we reincorporated in the State of Nevada, and in 2002, we changed our name to Applied DNA Sciences, Inc.
Competition Some of our competitors that operate in the nucleic-acid based therapeutic, biologics and DNA manufacturing markets include: MilliporeSigma, Precigen, Inc., Aldevron, LLC, Charles River Laboratories, Integrated DNA Technologies, Inc., 4basebio PLC, MaxCyte, Inc., Touchlight Genetics Ltd., Quantoom Bioscience, Syngoi Technologies, S.L.U., Generation Bio, Co., Novartis AG, Kite Pharma, Inc., Juno Therapeutics, Inc., Promega Corporation, OriGene Technologies, Inc., Blue Heron Biotech, LLC, Gene Art, GenScript Biotech Corporation, Elegen, Inc., ANSA Biotechnologies, Merck & Co., Inc. and others.
The loss of any of our significant customers, any substantial decline in sales to these customers, or any significant change in the timing or volume of purchases by our customers, could result in lower revenues and could harm our business, financial condition or results of operations. 14 Table of Contents Competition Some of our competitors in our Therapeutic DNA Production Services segment include: MilliporeSigma, Precigen, Inc., Aldevron, LLC, Integrated DNA Technologies, Inc., 4basebio PLC, MaxCyte, Inc., Touchlight Genetics Ltd., Quantoom Bioscience, Syngoi Technologies, S.L.U., Novartis AG, OriGene Technologies, Inc., Blue Heron Biotech, LLC, Gene Art, GenScript Biotech Corporation, Elegen, Inc., ANSA Biotechnologies, Merck & Co., Inc. and others.
For more information regarding the risks related to our COVID-19 testing services and our LDTs, see “ Risks Related to Regulatory Approval of Our Customer and Collaborator’s Pharmaceutical and Biotherapeutic Product Candidates and Other Legal Compliance Matters ” Government Regulation of Drug and Biologic Products The DNA manufactured via our LineaDNA platform may be used by a customer directly as a drug or biological product or it may be incorporated by a customer into a drug or biological product.
Government Regulation Therapeutic DNA Production Services The DNA manufactured via our LineaDNA platform may be used by a customer directly as a drug or biological product or it may be incorporated by a customer into a drug or biological product.
In addition, this location also houses our New York State Department of Health (“NYSDOH”) Clinical Laboratory Evaluation Program (“CLEP”)-permitted, Clinical Laboratory Improvement Amendments (“CLIA”)-certified clinical laboratory where we perform MDx testing services. The mailing address of our corporate headquarters is 50 Health Sciences Drive, Stony Brook, New York 11790, and our telephone number is (631) 240-8800.
The mailing 11 Table of Contents address of our corporate headquarters is 50 Health Sciences Drive, Stony Brook, New York 11790, and our telephone number is (631) 240 - 8800.
Since June 2012, we have been working with Insperity Inc. to assist in managing many of our back-end administrative human resources, benefits, and payroll responsibilities. We are an at-will employer and generally do not enter into employment agreements requiring our employees to continue in our employment for any period of time, with the exception of our Chief Executive Officer, Dr.
Since June 2012, we have been working with Insperity Inc. to assist in managing many of our back-end administrative human resources, benefits, and payroll responsibilities. Subsequent to September 30, 2025, the Company reduced its total employees to 13 in accordance with a restructuring plan authorized by its Board of Directors on October 6, 2025.
Research and Development For all of our business segments, we believe that our continued development of new and enhanced technologies is essential to our future success. 10 Table of Contents In our Therapeutic DNA Production Services segment, our research and development efforts are focused on the development and optimization of our LineaDNA and Linea IVT platforms.
Research and Development During the fiscal year ended September 30, 2025 our research and development efforts, in our Therapeutic DNA Production Services segment were focused on the further development and optimization of our LineaDNA and Linea IVT platforms. Going forward, the Company is focusing its research and development efforts only on the further optimization of its LineaDNA platform.
Linea IVT Platform The number of mRNA therapies under development is growing at a rapid rate, thanks in part to the success of the mRNA COVID-19 vaccines. mRNA therapeutics are produced via a process called in vitro transcription (“IVT”) that requires DNA as a starting material.
LineaRNAP mRNA therapeutics are produced via a process called in vitro transcription (“IVT”) that requires a DNA template and RNAP as starting materials. Typically, the RNAP is derived from the T7 bacteriophage (“WT-T7”).
The LineaDNA platform is simple and can rapidly produce very large quantities of DNA utilizing a cell-free process without the need for complex purification steps.
Unlike plasmid-based DNA manufacturing, LineaDNA does not require living cells and instead amplifies DNA via the exponential enzymatic process of PCR. The LineaDNA platform is simple, scalable and can rapidly produce large quantities of DNA with minimal purification steps.
Our revenues earned from 11 Table of Contents sale of products and services for the fiscal year ended September 30, 2023 includes 65% and 14% from two customers within our MDx Testing Services segment. 65% of the revenues earned for the fiscal year ended September 30, 2023 was derived from the COVID-19 testing contract with CUNY that terminated during June 2023.
Customers Our revenues earned from the sale of products and services for the fiscal year ended September 30, 2025, includes 29% from one customer within our Therapeutic DNA Production segment and an aggregate of 30% from two customers within our former DNA Tagging Security Products segment. As of September 30, 2025, three customers accounted for 99% of our accounts receivable.