APPLIED DNA SCIENCES INC
For the period ended Dec 31, 2024. Filed Feb 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Dec 31, 2024 · Filed Feb 13, 2025
BNBX$0.16-56.8%Stored close · as of Jul 13, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0001410578-24-001226
Item 2. - Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-12-31; filed 2025-02-13.
0001410578-25-000126
Item 2. - Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 137 previous paragraphs and 100 current paragraphs.
53 unchanged; 35 reworded; 10 added; 46 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 53 previous and 55 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
We will continue to update our business strategy and monitor the use of our resources regarding our various business segments. The Company’s management engaged in a strategic review of its DNA tagging and Security Products and Services business segment. As a result of this strategic review, on February 13, 2025, we announced we are exiting our DNA Tagging and Security Products and Services business segment. As a result of exiting this segment, during January 2025, we completed a workforce reduction of approximately 20% of our total headcount and approximately 13% in annual payroll costs. As a result of these actions, during the three-month period ended March 31, 2025, we will incur one-time personnel-related charges of approximately $300,000. We will continue to service certain of our existing DNA Tagging and Security Products and Services customer contracts. The Company’s management has also been and currently remains engaged in a strategic review of its MDX Testing Services business segment.
Current report
LineaDNA Platform
Current report
On September 11, 2024, we announced that ADCL launched an expansion of its clinical testing services for the detection of Mpox (formerly monkeypox) to include testing for both Mpox Clade I and Clade II. The launch of the expanded Mpox testing service comes after ADCL’s interaction with relevant regulatory bodies, including the NYSDOH and the FDA. The Company believes that ADCL will be able to support New York and other states’ response to the threat of Mpox. ADCL’s Linea Mpox Virus 1.0 Assay was previously approved as a laboratory-developed test for the detection of Mpox Clade II by NYSDOH in September 2022. In August 2024, ADCL conducted additional validation testing showing the Assay can also detect the genetic sequence of Mpox Clade I, which is the subject of the World Health Organization’s (WHO) August 14, 2024 declaration of a public health emergency of international concern. ADCL will provide the testing service from its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y. Currently, Mpox instances in the United States are very low and the future path of Mpox is currently unknown. Accordingly, there can be no assurance that we will be able to generate revenue and profits from our approved Mpox testing.
Current report
As detailed above, on February 13, 2025 the Company announced that it is exiting its DNA Tagging and Security Products and Services business segment. As a result of exiting this business segment, the Company completed a workforce reduction of approximately 20%
Current report
of its total headcount. The Company will continue to service certain of its existing DNA Tagging and Security Products and Services customer contracts.
Current report
For the three-month periods ended December 31, 2024 and 2023, we generated $495,847 and $307,317 in revenues from product sales, respectively. Product revenue increased by $188,530 or 61% for the three-month period ended December 31, 2024 as compared to the three-month period ended December 31, 2023. The increase in product revenues was due to a net increase in our DNA Tagging and Security Products and Services segment relating to an increase of approximately $174,000 year over year in cotton DNA tagging revenue, offset by a decrease of approximately $44,000 in sales to a nutraceutical customer. We also experienced an increase of approximately $88,000 relating to our large-scale DNA manufacturing business and the timing of related orders within our Therapeutic DNA Production Services segment.
Current report
For the three-month periods ended December 31, 2024 and 2023, we generated $374,444 and $247,147 in revenues from sales of services, respectively. The increase in service revenues of $127,297 or 52% for the three-month period ended December 31, 2024, as compared to the same period in the prior fiscal year is attributable to an increase of $156,000 within our DNA Tagging and Security Products and Services segment due to an increase in our textile isotopic testing services. This increase was offset by a decrease of approximately $18,000 within our Therapeutic DNA Production Services segment due to decreased research and development projects.
Current report
Gross profit for the three-month period ended December 31, 2024, increased by $453,010 or 196% from $231,097 for the three-month period ended December 31, 2023 to $684,107. The gross profit percentage was 57% and 26% for the three-month periods ended December 31, 2024 and 2023, respectively. The increase in gross profit percentage was primarily the result of product mix, as during the three-months ended December 31, 2024, the majority of our product revenue was for the shipment of DNA for cotton tagging, which is at a higher gross margin compared to the product sales during the same period in the prior fiscal year. To a lesser extent, the improvement in gross profit percentage was due to higher product revenues during the three-month period ended December 31, 2024 as compared to the same period in the prior fiscal year. The higher volume of product revenues in the current period was able to absorb the fixed costs that are included in cost of product revenues.
Current report
Other expense, net
Current report
Other expense, net for the three-month periods ended December 31, 2024 and 2023, was $20,152 and $13,538, respectively.
Removed paragraphs (46)
Previous report
Linea DNA Platform
Previous report
In addition, we plan to leverage our Therapeutic DNA Production Services and deep knowledge of PCR to develop and monetize, ourselves or with strategic partners, one or more Linea DNA-based therapeutic or prophylactic vaccines for high-value veterinary health indications (collectively “Linea DNA Vaccines”). We currently seek to commercialize our Linea DNA Vaccines in conjunction with lipid nanoparticle (“LNP”) encapsulation to facilitate intramuscular (“IM”) administration. We have recently demonstratedin vitro andin vivo (mice studies) expression of generic reporter proteins via Linea DNA encapsulated by LNPs. For thein vivo study, successful expression of the LNP-encapsulated Linea DNA was administered and achieved via IM injection. We believe that our Linea DNA Vaccines under development provide a substantial advantage over plasmid DNA-based vaccines for the veterinary health market.
Previous report
Our business plan is to leverage consumer and governmental awareness for product traceability to expand our existing partnerships and seek new partnerships for our DNA Tagging and Security Products and Services with a focus on cotton.
Previous report
FDA Publishes Final Rule on Laboratory Developed Tests
Previous report
As an LDT, our MDx Testing Services are currently subject to enforcement discretion by the FDA. On April 29, 2024, however, the FDA published a final rule on LDTs, in which FDA outlines its plans to end enforcement discretion for many LDTs in five stages over a four-year period. In Phase 1 (effective May 6, 2025), clinical laboratories running LDTs will be required to comply with medical device (adverse event) reporting and correction/removal reporting requirements, as well as requirements for maintenance of complaint files under the FDA’s quality systems regulation (QSR). In Phase 2 (effective May 6, 2026), clinical laboratories will be required to comply with all other device requirements (e.g., registration/listing, labeling, investigational use), except for the remaining QSR requirements and premarket review. In Phase 3 (effective May 6, 2027), clinical laboratories will be required to comply with all remaining QSR requirements. In Phase 4 (effective ~November 6, 2027), clinical laboratories will be required to comply with premarket review requirements for high-risk tests (i.e., tests subject to the premarket approval (PMA) requirement). Finally, in Phase 5 (effective May 6, 2028), clinical laboratories will be required to comply with premarket review requirements for moderate- and low-risk tests (i.e., tests subject to thede novo or 510(k) requirement).
Previous report
Under the final rule, several types of tests will be eligible for some degree of continued enforcement discretion, including LDTs approved by NYSDOH. FDA notes, however, that it retains discretion to pursue enforcement action for violations of the Federal Drug and Cosmetics Act at any time and intends to do so when appropriate. FDA further explains that it may update any of the enforcement discretion policies set forth in the final rule as circumstances warrant or if the circumstances that inform those policies change, consistent with FDA’s good guidance practices. Based on our current analysis of the FDA final rule, and assuming the final rule goes into effect without modification, we believe that ADCL’s current and future NYSDOH approved LDTs, which includes our under development
Previous report
PGx Testing Services, will be exempt from FDA premarket review requirements but will remain subject to the requirements of Phases 1 through 3.
Previous report
Plan of Operations
Previous report
General
Previous report
Historically, a substantial portion of our revenues has been generated from our safeCircle COVID-19 testing solutions, for which testing demand has significantly dropped. While we continue to support several safeCircle customers, we are currently observing a marked decrease in market demand for COVID-19 testing, resulting in significantly reduced revenues. We expect future demand for COVID-19 testing to continue to be reduced. We expect future growth in revenues to be derived from our Therapeutic DNA Production Services and our MDx Testing Services, as the latter transitions to a focus on genetic testing. To a lesser extent, we expect to grow revenues from our DNA Tagging and Security Products and Services offerings as we work with companies and governments to secure supply chains for various types of products and product labeling throughout the world with a focus on cotton provenance. We have continued to incur expenses in expanding our business to meet current and anticipated future demand. We have limited sources of liquidity. We will continue to update our business strategy and monitor the use of our resources regarding our various business markets. In addition, we expect that based on available opportunities and our beliefs regarding future opportunities, we will continue to modify and refine our business strategy.
Previous report
For the three-month periods ended June 30, 2024 and 2023, we generated $246,644 and $316,950 in revenues from product sales, respectively. Product revenue decreased by $70,306 or 22% for the three-month period ended June 30, 2024 as compared to the three-month period ended June 30, 2023. The decrease in product revenues was primarily related to a decrease of approximately $60,000 within our DNA Tagging and Security Products and Services segment including a decrease in shipments for consumer asset marking of approximately $43,000 as well as decreased revenues from a nutraceutical customer totaling approximately $12,000. The decrease also related to a decrease within our Therapeutic DNA Production Services segment due to a slight decrease of approximately $12,000 in revenues for our large-scale DNA production.
Previous report
For the three month periods ended June 30, 2024 and 2023 we generated $226,145 and $425,694 in revenues from sales of services, respectively. The decrease in service revenues of $199,549 or 47% for the three-month period ended June 30, 2024, as compared to the same period in the prior fiscal year is attributable to decreases of $117,000 for research and development projects in our Therapeutic DNA Production Services segment and $73,000 for isotopic testing for textiles within our DNA Tagging and Security Products and Services segment, respectively.
Previous report
Gross profit for the three-month period ended June 30, 2024, decreased by $1,024,086 or 81% from $1,269,318 for the three-month period ended June 30, 2023 to $245,232. The gross profit percentage was 31% and 44% for the three-month periods ended June 30,
Previous report
2024 and 2023, respectively. The decrease in gross profit percentage was primarily the result of a decline in gross profit percentage for our MDx Testing Services segment specifically related to significantly decreased testing volumes year over year, as well as MDx Testing Services comprising a smaller percentage of our total revenue for the three-month period ended June 30, 2024 compared to the same period in the prior fiscal year.
Previous report
Unrealized gain (loss) on change in fair value of warrants classified as a liability
Previous report
Unrealized gain (loss) on change in fair value of warrants classified as a liability was a gain of $5,160,000 and loss of $278,400 for the three-month periods ended June 30, 2024 and 2023, respectively. The primary driver of the change is the decrease in our stock price.
Previous report
Other (expense) income, net
Previous report
Other (expense) income, net for the three-month periods ended June 30, 2024 and 2023, was expense of $101 and $3,469, respectively.
Previous report
Revenues
Previous report
For the nine-month periods ended June 30, 2024 and 2023, we generated $947,086 and $1,130,800 in revenues from product sales, respectively. Product revenue decreased by $183,714 or 16% for the nine-month period ended June 30, 2024 as compared to the nine-month period ended June 30, 2023. The decrease in product revenues was primarily due to a decrease of approximately $119,000 within our DNA Tagging and Security Products and Services segment due to decreased revenue from our consumer asset marking and textile customers of approximately $103,000 and $65,000, respectively. These decreases were offset by an increase in shipments to a
Previous report
nutraceutical customer of approximately $49,000. The remainder of the decrease in product revenue was within our Therapeutic DNA Production Services segment related to a decrease in shipments for our large scale DNA production of approximately $83,000.
Previous report
Service revenues
Previous report
For the nine-month periods ended June 30, 2024 and 2023 we generated $678,777 and $826,813 in revenues from sales of services, respectively. The decrease in service revenues of $148,036 or 18% for the nine-month period ended June 30, 2024, as compared to the same period in the prior fiscal year is attributable to a decrease of approximately $231,000 related to research and development projects within our Therapeutic DNA Production Services segment, offset by an increase of approximately $132,000 for isotopic testing for textiles within our DNA Tagging and Security Products and Services segment.
Previous report
Clinical laboratory service revenues
Previous report
For the nine month periods ended June 30, 2024 and 2023, we generated $992,450 and $10,630,094 in revenues from our clinical laboratory testing services, respectively. The decrease in service revenues of $9,637,644 or 91% for the nine-month period ended June 30, 2024 as compared to the same period in the prior fiscal year is attributable to a decrease from COVID-19 testing services. The nine-months ended June 30, 2023 included testing revenues under our contract with CUNY, which terminated during June 2023.
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Cost and Expenses
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Gross Profit
Previous report
Gross profit for the nine-month period ended June 30, 2024, decreased by $4,682,456 or 86% from $5,454,436 for the nine-month period ended June 30, 2023 to $771,980. The gross profit percentage was 29% and 43% for the nine-month periods ended June 30, 2024 and 2023, respectively. The decrease in gross profit percentage was primarily the result of a decline in gross profit percentage for our MDx Testing Services segment specifically related to significantly decreased testing volumes year over year.
Previous report
Selling, General and Administrative
Previous report
Selling, general and administrative expenses for the nine-month period ended June 30, 2024 decreased by $677,284 or 7% to $8,763,450 as compared to $9,440,734 for the nine-month period ended June 30, 2023. The decrease is primarily attributable to a decrease in payroll for bonuses paid to officers of approximately $746,000 during fiscal 2023,as well as a decrease in stock based compensation of approximately $151,000 primarily relating to the timing of the annual grants of options to non-employee members of the board of directors and restricted stock units issued to officers. These decreases were offset by increases relating to the prior nine-month period having a credit balance in bad debt expense of approximately $256,000, from a customer balance that was fully reserved during a prior period and was subsequently collected during the nine-month period ended June 30, 2023,
Previous report
Research and Development
Previous report
Research and development expenses decreased to $2,762,040 for the nine-month period ended June 30, 2024 from $2,796,171 for the nine-month period ended June 30, 2023, a decrease of $34,131 or 1%. This decrease is primarily due to decreased depreciation expense with laboratory equipment becoming fully depreciated year over year of approximately $369,000, offset by an increase in consulting
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expense of approximately $204,000 for consultants being utilized to further develop the technology acquired from the Spindle acquisition.
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Interest income
Previous report
Interest income for the nine -month period ended June 30, 2024 was $84,972 as compared to $34,108 in the nine -month period ended June 30, 2023.
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Transaction costs allocated to warrant liabilities
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Transaction cost allocated to warrant liabilities for the nine-month period ended June 30, 2024 was $633,198. These transaction costs represent the closing costs from the February 2024 financing transaction. These costs were expensed as it would have resulted in negative additional paid in capital.
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Unrealized loss on change in fair value of warrants classified as a liability-warrant modifications
Previous report
Unrealized loss on change in fair value of warrants classified as a liability-warrant modifications of $394,000 for the nine-month period ended June 30, 2024 represents the change in fair value for the modifications made to certain warrants as a result of the February 2024 financing.
Previous report
Loss on issuance of warrants
Showing the first 40 of 46 passages. Open the source sections for the rest.
Reworded paragraphs (35)
Previous wording
We believe it is important to communicate our expectations. However, forward-looking statements are based on our current expectations, assumptions, estimates and projections about our business and our industry and are subject to known and unknown risks, uncertainties and other factors. Accordingly, our actual results and the timing of certain events may differ materially from those expressed or implied in such forward-looking statements due to a variety of factors and risks, including, but not limited to, those set forth in this Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in our unaudited condensed consolidated financial statements and notes thereto included in this Quarterly Report, those set forth from time to time in our other filings with the SEC, including our Annual Report on Form 10-K, for the fiscal year ended September 30, 2023, as amended, and the following factors and risks:
Current wording
We believe it is important to communicate our expectations. However, forward-looking statements are based on our current expectations, assumptions, estimates and projections about our business and our industry and are subject to known and unknown risks, uncertainties and other factors. Accordingly, our actual results and the timing of certain events may differ materially from those expressed or implied in such forward-looking statements due to a variety of factors and risks, including, but not limited to, those set forth in this Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in our unaudited condensed consolidated financial statements and notes thereto included in this Quarterly Report, those set forth from time to time in our other filings with the SEC, including our Annual Report on Form 10-K, for the fiscal year ended September 30, 2024, and the following factors and risks:
Previous wording
Forward-looking statements may include our plans and objectives for future operations, including plans and objectives relating to our products and our future economic performance, projections, business strategy and timing and likelihood of success. Assumptions relating to the forward-looking statements included in this Quarterly Report involve judgments with respect to, among other things, future economic, competitive and market conditions, future business decisions, demand for our products and services, and the time and money required to successfully complete development and commercialization of our technologies, all of which are difficult or impossible to predict accurately and many of which are beyond our control.
Current wording
Forward-looking statements may include our plans and objectives for future operations, including plans and objectives relating to our products and our future economic performance, projections, business strategy and timing and likelihood of success. Assumptions relating to the forward-looking statements included in this Quarterly Report involve judgments with respect to, among other things, future economic, competitive and market conditions, future business decisions, regulatory outcomes, safety and efficacy, demand for our products and services, and the time and money required to successfully complete development and commercialization of our technologies, all of which are difficult or impossible to predict accurately and many of which are beyond our control.
Previous wording
Our trademarks currently used in the United States include Applied DNA Sciences®, SigNature® molecular tags, SigNature® T molecular tags, fiberTyping®, SigNify®, Beacon®, CertainT®, Linea™ DNA, Linea™ RNAP, Linea™ and TR8 TM pharmacogenetic testing. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. All trademarks, service marks and trade names included in this Quarterly Report on Form 10-Q are the property of the respective owners.
Current wording
Our trademarks currently used in the United States include Applied DNA Sciences®, SigNature® T molecular tags, fiberTyping®, SigNify®, Beacon®, CertainT®, LineaDNA®, Linea™ COVID-19 Diagnostic Assay Kit, safeCircle TM COVID-19 testing and TR8® pharmacogenetic testing. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. All trademarks, service marks and trade names included in this Quarterly Report on Form 10-Q are the property of the respective owners.
Previous wording
We are a biotechnology company developing and commercializing technologies to produce and detect DNA and RNA. Using PCR to enable the production and detection of DNA and RNA, 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 (including biologics and drugs) and, through our recent acquisition of Spindle, the development and sale of a proprietary RNAP for use in the production of mRNA therapeutics (“Therapeutic DNA Production Services”); (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services (“MDx Testing Services”); and (iii) the manufacture and detection of DNA for industrial supply chains and security services (“DNA Tagging and Security Products and Services”).
Current wording
We are a biotechnology company developing and commercializing technologies to produce and detect DNA and RNA. Using PCR to enable the production and detection of DNA and RNA, we currently operate in two primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics (including biologics and drugs), as well as the development and sale of a proprietary RNAP for use in the production of mRNA therapeutics (“Therapeutic DNA Production Services”); and (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services (“MDx Testing Services”). Previously, we operated in a third business market: the manufacture and detection of DNA for industrial supply chains and security services (“DNA Tagging and Security Products and Services”), which, as detailed above, on February 13, 2025, we announced we were exiting. However, we will continue to service certain of our existing DNA Tagging and Security Products and Services customer contracts.
Previous wording
Our current growth strategy is to primarily focus our resources on the further development, commercialization, and customer adoption of our Therapeutic DNA Production Services, including the expansion of our contract development and manufacturing operation (“CDMO”) for the manufacture of synthetic DNA for use in the production of nucleic acid-based therapies, and to further expand and commercialize our MDx Testing Services through genetic testing.
Current wording
Our current growth strategy is to primarily focus our resources on the further development, commercialization, and customer adoption of our Therapeutic DNA Production Services, including the expansion of our contract development and manufacturing operation (“CDMO”) for the sale of synthetic DNA and associated enzymes for use in the production of nucleic acid-based therapies.
Previous wording
We will continue to update our business strategy and monitor the use of our resources regarding our various business markets. In addition, we expect that based on available opportunities and our beliefs regarding future opportunities, we will continue to modify and refine our business strategy.
Current wording
We expect that based on available opportunities and our beliefs regarding future opportunities, we will continue to modify and refine our business strategy.
Previous wording
We are developing and commercializing our Linea DNA and Linea IVT platforms for the manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics.
Current wording
Through LRx we are developing and commercializing our LineaDNA and Linea IVT platforms for the sale of synthetic DNA and associated enzymes for use in the production of nucleic acid-based therapeutics.
Previous wording
Our Linea DNA 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. The Linea DNA 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.
Current wording
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. 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.
Previous wording
As of the first quarter of calendar year 2024, there were 4,047 gene, cell and RNA therapies in development from preclinical through pre-registration stages, almost all of which use DNA in their manufacturing process. (Source: ASGCT Gene, Cell & RNA Therapy Landscape: Q2 2024 Quarterly Report). Due to what we believe are the Linea DNA platform’s numerous advantages over legacy nucleic acid-based therapeutic manufacturing platforms, we believe this large number of therapies under development represents a substantial market opportunity for the Linea DNA platform to supplant legacy manufacturing methods in the manufacture of nucleic acid-based therapies.
Current wording
As of the fourth quarter of calendar year 2024, there were 4,238 gene, cell and RNA therapies in development from preclinical through pre-registration stages, almost all of which use DNA in their manufacturing process. (Source: ASGCT Gene, Cell & RNA Therapy Landscape: Q4 2024 Quarterly Report). Due to what we believe are the LineaDNA platform’s numerous advantages over legacy nucleic acid-based therapeutic manufacturing platforms, we believe this large number of therapies under development represents a substantial market opportunity for the LineaDNA platform to supplant legacy manufacturing methods in the manufacture of nucleic acid-based therapies although no assurance can be given that we will be successful in exploiting this market opportunity.
Previous wording
We believe our Linea DNA platform holds several important advantages over existing cell-based plasmid DNA manufacturing platforms. 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. Unlike plasmid-based DNA manufacturing, the Linea DNA platform does not require living cells and instead amplifies DNA via the enzymatic process of PCR. The Linea DNA platform is simple and can rapidly produce very large quantities of DNA without the need for complex purification steps.
Current wording
We believe our LineaDNA platform holds several important advantages over existing cell-based plasmid DNA manufacturing platforms. 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. Unlike plasmid-based DNA manufacturing, the LineaDNA platform does not require living cells and instead amplifies DNA via the enzymatic process of PCR. The LineaDNA platform is simple and can rapidly produce very large quantities of DNA without the need for complex purification steps.
Previous wording
We believe the key advantages of the Linea DNA platform include:
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We believe the key advantages of the LineaDNA platform include:
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Preclinical studies conducted by us have shown that Linea DNA is substitutable for plasmid DNA in numerous nucleic acid-based therapies, including:
Current wording
Preclinical studies conducted by the Company have shown that LineaDNA is substitutable for plasmid DNA in numerous nucleic acid-based therapies, including:
Previous wording
Further, we believe that Linea DNA is also substitutable for plasmid DNA in the following nucleic acid-based therapies:
Current wording
Further, we believe that LineaDNA is also substitutable for plasmid DNA in the following nucleic acid-based therapies:
Previous wording
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 calledin vitro transcription (“IVT”) that requires DNA as a starting material. As of the 1st quarter of calendar 2024, there were over 450 mRNA therapies under development, with the majority of these therapies (66%) in the preclinical stage (Source: ASGCT Gene, Cell & RNA Therapy Landscape: Q1 2024 Quarterly Report). The Company believes that the mRNA market is in a nascent stage that represents a large growth opportunity for the Company via the production and supply of DNA critical starting materials and RNAP to produce mRNA therapies.
Current wording
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. As of the fourth quarter of calendar 2024, there were over 450 mRNA therapies under development, with the majority of these therapies (65%) in the preclinical stage (Source: ASGCT Gene, Cell & RNA Therapy Landscape: Q4 2024 Quarterly Report). The Company believes that the mRNA market is in a nascent stage that represents a large growth opportunity for the Company via the production and supply of DNA critical starting materials and RNAP to produce mRNA therapies.
Previous wording
In August 2022, we launched DNA IVT templates manufactured via its Linea DNA platform and have since secured proof of concept contracts with numerous mRNA manufacturing customers. In response to this demand, the continued growth of the mRNA therapeutic market, and the unique abilities of the Linea DNA platform, the Company acquired Spindle in July 2023 to potentially increase its mRNA-related total addressable market (“TAM”).
Current wording
In August 2022, the Company launched DNA IVT templates manufactured via its LineaDNA platform that have resulted in evaluations of the Company’s IVT templates by numerous therapeutic developers and CDMOs in the United States and the Asia-Pacific. In addition, the Company’s IVT templates are currently under late-stage evaluations by two therapeutic developers and one CDMO for use as DNA templates for the production of mRNA intended for clinical use in calendar year 2025. However, there can be no assurance that related contracts will be entered into. In response to this demand, the continued growth of the mRNA therapeutic market, and the unique abilities of the LineaDNA platform, the Company acquired Spindle Biotech, Inc. (“Spindle”) in July 2023 to potentially increase its mRNA-related total addressable market (“TAM”) to include the manufacture and sale of RNAP for use in conjunction with our LineaDNA IVT templates.
Previous wording
Through our acquisition of Spindle, we launched our Linea IVT platform in July 2023, which combines Spindle’s proprietary high-performance RNAP, now marketed by the Company as Linea RNAP, with our enzymatically produced Linea DNA IVT templates. We believe the Linea IVT platform enables our customers to make better mRNA, faster. Based on data generated by the Company, we believe the integrated Linea IVT platform offers the following advantages over conventional mRNA production to therapy developers and manufacturers:
Current wording
Through our acquisition of Spindle, we launched our Linea IVT platform in July 2023, which combines Spindle’s proprietary high-performance RNAP, now marketed by the Company as Linea RNAP, with our enzymatically produced LineaDNA IVT templates. We believe the Linea IVT platform enables our customers to make better mRNA, faster. Based on data generated by the Company, we believe the integrated Linea IVT platform offers the following advantages over conventional mRNA production to therapy developers and manufacturers:
Previous wording
According to the Company’s internal modeling, the ability to sell both Linea DNA IVT templates and Linea RNAP under the Linea IVT platform potentially increases the Company’s mRNA-related TAM by approximately 3-5x as compared to selling Linea DNA IVT templates alone, while also providing a more competitive offering to the mRNA manufacturing market. Currently, Linea RNAP is produced for the Company under an ISO 13485 quality system by Alphazyme, LLC a third-party CDMO located in the United States. The Company recently completed manufacturing process development work on its Linea RNAP to increase production scale of the enzyme and reduce unit costs.
Current wording
According to the Company’s internal modeling, the ability to sell both LineaDNA IVT templates and Linea RNAP under the Linea IVT platform potentially increases the Company’s mRNA-related TAM by approximately 3x as compared to selling LineaDNA IVT templates alone, while also providing a more competitive offering to the mRNA manufacturing market. 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. 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.
Previous wording
We plan to offer several quality grades of Linea DNA, each of which will have different permitted uses.
Current wording
The Company plans to offer several quality grades of Linea DNA, each of which will have different permitted uses.
Previous wording
We are currently manufacturing Linea DNA pursuant to Good Laboratory Practices (“GLP”) and, are creating a fit for purpose manufacturing facility within our current Stony Brook, NY laboratory space capable of producing Linea DNA IVT templates under Good Manufacturing Practices (“GMP”) suitable for use as a critical starting material for clinical and commercial mRNA therapeutics, with a planned completion date in the third quarter of calendar year 2024 (“GMP Site 1”). We also plan to offer additional capacity for Linea DNA IVT templates as well as capacity for Linea DNA materials manufactured under GMP suitable for use as, or incorporation into, a biologic, drug substance and/or drug product, with availability expected during the second half of calendar year 2025, dependent upon the availability of future funding (“GMP Site 2”). GMP is a quality standard used globally and by the U.S. Food and Drug Administration (“FDA”) to ensure pharmaceutical quality. Drug substances are the pharmaceutically active components of drug products.
Current wording
We are currently manufacturing LineaDNA pursuant to Good Laboratory Practices (“GLP”) and have recently completed the buildout of a fit for purpose manufacturing facility within our current Stony Brook, NY laboratory space capable of producing LineaDNA IVT templates under Good Manufacturing Practices (“GMP”) suitable for use as a critical starting material for clinical and commercial mRNA therapeutics (“GMP Site 1”). GMP site 1 achieved operation status as of January 31, 2025. We also plan to offer additional capacity for LineaDNA IVT templates as well as capacity for LineaDNA materials manufactured under GMP suitable for use as, or incorporation into, a biologic, drug substance and/or drug product, with availability expected during the first half of calendar year 2026, dependent upon the availability of future funding and customer demand (“GMP Site 2”). GMP is a quality standard used globally and by the FDA to ensure pharmaceutical quality. Drug substances are the pharmaceutically active components of drug products.
Previous wording
Our business strategy for our Therapeutic DNA Production Services is to capitalize upon the rapid growth of mRNA therapies in the near term via our planned near term future availability of Linea DNA IVT templates manufactured under GMP at our GMP Site 1, while at the same time laying the basis for additional clinical and commercial applications of Linea DNA with our future planned availability of Linea DNA manufactured under GMP suitable for use as, or incorporation into, a biologic, drug substance and/or drug product at planned GMP Site 2. Planned GMP Site 2 may also be used for additional Linea DNA IVT template manufacturing if customer demand exceeds capacity of GMP Site 1. Our current plan is: (i) through our Linea IVT platform and planned near term future GMP manufacturing capabilities for IVT templates at GMP Site 1 to secure commercial-scale supply contracts with clinical and commercial mRNA and/or self-amplifying mRNA (“sa-RNA”) manufacturers for Linea DNA IVT templates and/or Linea RNAP as critical starting materials; (ii) to utilize our current GLP production capacity for non-IVT template applications to secure supply and/or development contracts with pre-clinical therapy developers that use DNA in their therapy manufacturing, and (iii) upon our development of our planned future Linea DNA production under GMP suitable for use as, or incorporation into, a biologic, drug substance and/or drug product at planned GMP Site 2, to convert existing and new Linea DNA customers into large-scale supply contracts to supply Linea DNA for clinical and commercial use as, or incorporation into, a biologic, drug substance and/or drug product in a wide range of nucleic acid therapies. Until we complete our GMP Site 1 to produce DNA critical starting materials (DNA IVT templates) for mRNA manufacturing, we will not be able to realize significant revenues from this business. We estimate the cost of creating GMP Site 1 will be approximately $1.5 million. If we were to expand our facilities to enable GMP production of Linea DNA for use as, or incorporation, into a biologic, drug substance and/or drug product as planned for GMP Site 2, the cost may be up to approximately $10 million which would require additional funding. We are currently building GMP Site 1 within our existing laboratory space. We anticipate that a GMP Site 2 would require us to acquire additional space.
Current wording
Our current plan is: (i) through our Linea IVT platform and GMP manufacturing capabilities for IVT templates at GMP Site 1 to secure commercial-scale supply contracts with clinical and commercial mRNA and/or self-amplifying mRNA (“sa-RNA”) manufacturers for LineaDNA IVT templates and/or Linea RNAP as critical starting materials; (ii) to utilize our current GLP production capacity for non-IVT template applications to secure supply and/or development contracts with pre-clinical therapy developers that use DNA in their therapy manufacturing, and (iii) upon our development of our planned future LineaDNA production under GMP suitable for use as, or incorporation into, a biologic, drug substance and/or drug product at planned GMP Site 2 and/or our upgrade to GMP Site 1, to convert existing and new LineaDNA customers into large-scale supply contracts to supply LineaDNA for clinical and commercial use as, or incorporation into, a biologic, drug substance and/or drug product in a wide range of nucleic acid therapies. In addition, the Company plans to utilize its current and planned DNA manufacturing capabilities in GMP Site 1 and/or GMP Site 2 to convert new and existing LineaDNA IVT template customers to LineaDNA IVT platform customers to increase the Company’s mRNA-related TAM.
Previous wording
Through Applied DNA Clinical Labs, LLC (“ADCL”), we leverage our expertise in DNA and RNA detection via PCR to provide and develop clinical molecular diagnostics and genetic (collectively “MDx”) Testing Services. ADCL is a New York State Department of Health (“NYSDOH”) clinical laboratory improvement amendments (CLIA)-certified laboratory which is currently permitted for virology and genetics (molecular). In providing MDx Testing Services, ADCL employs its own or third-party molecular diagnostic tests.
Current wording
Through ADCL, we leverage our expertise in DNA and RNA detection via PCR to provide and develop clinical molecular diagnostics and genetic (collectively “MDx”) Testing Services. ADCL is a NYSDOH clinical laboratory improvement amendments (“CLIA”)-certified laboratory which is currently permitted for virology and genetics (molecular). In providing MDx Testing Services, ADCL employs its own or third-party molecular diagnostic tests.
Previous wording
We have successfully validated internally our pharmacogenomics testing services (the “PGx Testing Services”). Our PGx Testing Services utilizes a 120-target PGx panel test to evaluate the unique genotype of a specific patient to help guide the patient’s healthcare provider in making individual drug therapy decisions. Our PGx Testing Services are designed to interrogate DNA targets on over 33 genes and provide genotyping information relevant to certain cardiac, mental health, oncology, and pain management drug therapies.
Current wording
We have successfully internally validated our pharmacogenomics testing services (the “PGx Testing Services”). Our PGx Testing Services utilizes a 120-target PGx panel test to evaluate the unique genotype of a specific patient to help guide the patient’s healthcare provider in making individual drug therapy decisions. Our PGx Testing Services are designed to interrogate DNA targets on over 33 genes and provide genotyping information relevant to certain cardiac, mental health, oncology, and pain management drug therapies.
Previous wording
On June 12, 2024 we received full approval from NYSDOH for our PGx Testing Services. Recently published studies show that population-scale PGx enabled medication management can significantly reduce overall population healthcare costs, reduce adverse drug events, and increase overall population wellbeing. These benefits can result in significant cost savings to large entities and self-insured
Current wording
On June 12, 2024 we received full approval from NYSDOH for our PGx Testing Services. Recently published studies showed that population-scale PGx enabled medication management can significantly reduce overall population healthcare costs, reduce adverse drug events, and increase overall population wellbeing. These benefits can result in significant cost savings to large entities and self-insured employers, the latter accounting for approximately 65% of all U.S. employers in 2022.We plan to leverage our PGx Testing Services to provide PGx testing services to large entities, self-insured employers and healthcare providers, as well as concierge healthcare providers.
Previous wording
By leveraging our expertise in both the manufacture and detection of DNA via PCR, our DNA Tagging and Security Products and Services allow our customers to use non-biologic DNA tags manufactured on our Linea DNA platform to mark objects in a unique manner and then identify these objects by detecting the absence or presence of the DNA tag. The Company’s core DNA Tagging and Security Products and Services, which are marketed collectively as a platform under the trademark CertainT®, include:
Current wording
By leveraging our expertise in both the manufacture and detection of DNA via PCR, our DNA Tagging and Security Products and Services allow our customers to use non-biologic DNA tags manufactured on our LineaDNA platform to mark objects in a unique manner and then identify these objects by detecting the absence or presence of the DNA tag. The Company’s core DNA Tagging and Security Products and Services, which are currently marketed collectively as a platform under the trademark CertainT®, include:
Previous wording
For the three-month periods ended June 30, 2024 and 2023, we generated $324,730 and $2,174,697 in revenues from our clinical laboratory testing services, respectively. The decrease in service revenues of $1,849,967 or 85% for the three month period ended June 30, 2024 as compared to the same period in the prior fiscal year is attributable to a decrease from COVID surveillance testing. The three-month period ended June 30, 2023 included testing revenues under our contract with the City University of New York (“CUNY”), which terminated during June 2023.
Current wording
For the three-month periods ended December 31, 2024 and 2023, we generated $326,326 and $336,700 in revenues from our clinical laboratory testing services, respectively. The decrease in service revenues of $10,374 or 3% for the three-month period ended December 31, 2024 as compared to the same period in the prior fiscal year is attributable to a decrease in COVID surveillance testing.
Previous wording
Selling, general and administrative expenses for the three-month period ended June 30, 2024 decreased by $613,410 or 19% to $2,678,894 as compared to $3,292,304 for the three-month period ended June 30, 2023. The decrease is primarily attributable to a decrease in stock based compensation expense of approximately $310,000 for the annual option grant to the non-employee members of our board of directors and officer restricted stock unit grants becoming fully vested in January and March 2024, respectively. Additional decreases related to a decrease in consulting expense of $191,000. The decrease in consulting expense was from the closure of our APDN Europe subsidiary, as well as a decrease in consulting expense from our MDX Testing services segment. There was also a decrease in insurance expense of approximately $52,000 due to a decrease in our director and officer insurance premiums, as well as approximately a $34,000 decrease in provision for bad debts.
Current wording
Selling, general and administrative expenses for the three-month period ended December 31, 2024 decreased by $451,250 or 15% to $2,633,098 as compared to $3,084,348 for the three-month period ended December 31, 2023. The decrease is attributable to a decrease in stock-based compensation expense of approximately $312,000, which primarily relates to the timing of the annual non-employee board of director grant that vests one-year from the date of grant, which was granted during the second quarter of fiscal 2023. Additional decreases related to a decrease in consulting expense of approximately $115,000. The decrease in consulting expense was from the closure of our APDN Europe subsidiary within our DNA Tagging and Security Products and Services segment, as well as a decrease in consulting expense from our MDX Testing Services segment.
Previous wording
Research and development expenses increased to $913,031 for the three-month period ended June 30, 2024 from $836,123 for the three-month period ended June 30, 2023, an increase of $76,908 or 9%. This increase is primarily due to an increase of approximately $135,000 for the development of an enzyme for use in our Therapeutic DNA Production Services segment, as well as approximately $70,000 for consultants being utilized to further develop the technology acquired from the Spindle acquisition. These increases were offset by a decrease in depreciation expense costs associated with laboratory equipment becoming fully depreciated period over period of approximately $163,000.
Current wording
Research and development expenses increased to $1,015,010 for the three-month period ended December 31, 2024 from $935,815 for the three-month period ended December 31, 2023, an increase of $79,195 or 8%. This increase is primarily due to an increase of approximately $375,000 for the development of an enzyme for use in our Therapeutic DNA Production Services segment, offset by a decrease of approximately $77,000 for consultants being utilized for cGMP readiness during the prior year period. Additional offsets included a decrease in depreciation expense associated with laboratory equipment becoming fully depreciated period over period of approximately $94,000, service contract decreases of $68,000 as well as a payroll expense decrease of approximately $50,000.
Previous wording
Interest income for the three-month period ended June 30, 2024 was $36,295 as compared to $26,783 in the three-month period ended June 30, 2023.
Current wording
Interest income for the three-month period ended December 31, 2024 increased $38,117 or 114% to $71,440 as compared to $33,323 in the three-month period ended December 31, 2023 due to interest earned on our money market accounts.
Previous wording
Unrealized gain on change in fair value of warrants classified as a liability for the nine -month period ended June 30, 2024 and 2023 was $9,564,000 and $334,700, respectively, and relates to the change in fair value of the warrants that are classified as a liability. The primary driver of the change is the decrease in our stock price, as well as the issuance of new warrants as part of the February 2024 registered direct offering.
Current wording
Unrealized gain on change in fair value of warrants classified as a liability for the three-month periods ended December 31, 2024 and 2023 was $244,000 and $2,639,000, respectively, which relates to the change in fair value of the warrants that are classified as a liability. The primary driver of the change is the decrease in our stock price.
Previous wording
Loss from operations increased $487,584, or 17% to $3,346,693 for the three-month period ended June 30, 2024 compared to $2,859,109 for the three-month period ended June 30, 2023 due to the factors noted above.
Current wording
Loss from operations decreased $825,065, or 22% to $2,964,001 for the three-month period ended December 31, 2024 compared to $3,789,066 for the three-month period ended December 31, 2023 due to the factors noted above.
Previous wording
Our liquidity needs consist of our working capital requirements and research and development expenditure funding. As of June 30, 2024, we had working capital of $8,816,648. For the nine-month period ended June 30, 2024, we used cash in operating activities of $10,462,332 consisting primarily of our loss of $3,774,563 net with non-cash adjustments of $619,440 in depreciation and amortization charges, $9,564,000 in unrealized gain on change in fair value of warrants classified as a liability, $394,000 in unrealized loss on change in fair value of warrants classified as liability-warrant modification, $633,198 in registered direct offering costs, $1,633,767 on loss on issuance of warrants, and $542,045 in stock-based compensation expense. Additionally, we had a net increase in operating assets of $425,398 and a net decrease in operating liabilities of $520,821. At June 30, 2024, we had cash and cash equivalents of $10,442,131.
Current wording
Our liquidity needs consist of our working capital requirements and research and development expenditure funding. As of December 31, 2024, we had working capital of $8,889,342. For the three-month period ended December 31, 2024, we used cash in operating activities of $3,326,074 consisting primarily of our loss of $2,668,713 net with non-cash adjustments of $58,580 in depreciation and amortization charges, $244,000 in unrealized gain on change in fair value of warrants classified as a liability, $28,973 in stock-based compensation expense, and $7,723 in provision for bad debts. Additionally, we had a net increase in operating assets of 372,738 and a net decrease in operating liabilities of $141,188. At December 31, 2024, we had cash and cash equivalents of $9,294,365.
Previous wording
We have recurring net losses. We incurred a net loss of $3,774,563 and generated negative operating cash flow of $10,462,332 for the nine-month period ended June 30, 2024. These factors raise substantial doubt about our ability to continue as a going concern for one year from the issuance of these financial statements. The ability of the Company to continue as a going concern is dependent on our
Current wording
We have recurring net losses. We incurred a net loss of $2,668,713 and generated negative operating cash flow of $3,326,074 for the three-month period ended December 31, 2024. These factors raise substantial doubt about our ability to continue as a going concern for one year from the issuance of these financial statements. The ability of the Company to continue as a going concern is dependent on our ability to further implement our business plan, raise capital, and generate revenues. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Previous wording
As discussed in Note E, on May 29, 2024, we closed on a public offering and received net proceeds, after deducting placement agent fees and other estimated offering expenses payable by us, of approximately $10.5 million.
Current wording
As discussed in Note E, to our condensed consolidated financial statements, on October 31, 2024, we closed on a registered direct offering and received net proceeds, after deducting placement agent fees and other offering expenses payable by us, of approximately $5.7 million.
Previous wording
The Company records revenue for its clinical laboratory testing service contracts, which includes its COVID-19 testing services, upon satisfying its promise to provide services to customers under the terms of its contracts. These performance obligations are satisfied at the point in time that Company services are complete, which in nearly all cases is when the testing results are released to the customer. For those customers with a fixed monthly fee, the revenue is recognized over-time as the services are provided.
Current wording
The Company records revenue for its clinical laboratory testing service contracts, which includes its COVID-19 testing services, upon satisfying its promise to provide services to customers under the terms of its contracts. These performance obligations are satisfied at the point in time that Company services are complete, which is when the testing results are released to the customer. For those customers with a fixed monthly fee, the revenue is recognized over-time as the services are provided.
Previous wording
The Company evaluates its warrants issued the “Warrants) in accordance with ASC 480 “Distinguishing Liabilities from Equity” and ASC 815-40, “Derivatives and Hedging — Contracts in Entity’s Own Equity” and concluded that due to the terms of certain of its warrant agreements, the instruments do not qualify for equity treatment. As such, the Common Warrants, Series A Warrants and Private Common Warrants were recorded as a liability on the condensed consolidated balance sheet and measured at fair value at inception and at each reporting date in accordance with ASC 820, “Fair Value Measurement”, with changes in fair value recognized in the condensed consolidated statement of operations in the period of change.
Current wording
The Company evaluates its issued warrants in accordance with ASC 480 “Distinguishing Liabilities from Equity” and ASC 815-40, “Derivatives and Hedging — Contracts in Entity’s Own Equity” and concluded that due to the terms of certain of its warrant agreements, the instruments do not qualify for equity treatment. As such, the Common Warrants, Series A Warrants and Private Common Warrants were recorded as a liability on the consolidated balance sheet and measured at fair value at inception and at each reporting date in accordance with ASC 820, “Fair Value Measurement”, with changes in fair value recognized in the condensed consolidated statement of operations in the period of change.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Our business strategy for our Therapeutic DNA Production Services is to capitalize upon the rapid growth of mRNA therapies in the near term via our ability to manufacture LineaDNA IVT templates under GMP at our GMP Site 1, while at the same time laying the basis for additional clinical and commercial applications of LineaDNA with our future planned availability of LineaDNA manufactured under GMP suitable for use as, or incorporation into, a biologic, drug substance and/or drug product at planned GMP Site 2. Planned GMP Site 2 may also be used for additional LineaDNA IVT template manufacturing if customer demand exceeds capacity of GMP Site 1. In addition, we believe GMP Site 1 is capable of manufacturing LineaDNA for use as, or incorporation into, a biologic, drug substance, and/or drug product manufacturing via facility upgrades to its existing footprint.
Current report — wording carried from elsewhere
If we were to expand our facilities to enable GMP production of LineaDNA for use as, or incorporation, into a biologic, drug substance and/or drug product as planned for GMP Site 2, the additional CAPEX may be up to approximately $10 million which would require additional funding. We anticipate upgrades to GMP Site 1 to enable the manufacture of LineaDNA for use as, or incorporation into, a biologic, drug substance and/or drug product manufacture to cost less than $1 million. Potential upgrades to GMP Site 1 would not alter its current footprint within our existing laboratory space. We anticipate that a GMP Site 2 would require us to acquire additional space.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
employers, the latter accounting for approximately 65% of all U.S. employers in 2022.We plan to leverage our PGx Testing Services to provide PGx testing services to large entities, self-insured employers and healthcare providers, as well as concierge healthcare providers.
Previous report — wording carried elsewhere
Comparison of Results of Operations for the Nine-month Periods Ended June 30, 2024 and 2023
Previous report — wording carried elsewhere
ability to further implement our business plan, raise capital, and generate revenues. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.