Financial Data and Key Metrics Changes - Total revenues for Q1 fiscal 2025 were $1.2 million, an increase from $891,000 in the same period of fiscal 2024, driven by higher product revenue from the DNA tagging business and isotopic testing services [10][11] - Operating loss for Q1 was $3 million, improved from $3.8 million in the prior year, primarily due to lower selling, general, and administrative costs [11] - Net loss for Q1 was $2.7 million compared to $1.1 million in the prior year, with adjusted EBITDA improving to a negative $2.9 million from negative $3.2 million [12][13] - Cash and cash equivalents as of December 31, 2024, totaled $9.3 million, up from $6.4 million on September 30, 2024 [13] Business Line Data and Key Metrics Changes - The company announced its exit from the DNA tagging and security products segment, with a workforce reduction of approximately 20% related to this segment [9][10] - The restructuring aims to optimize the cost structure and support the growth of the LineaRx subsidiary, which is expected to create sustainable value for shareholders [8][9] Market Data and Key Metrics Changes - The biotherapeutics market is showing increased interest in the LineaRx subsidiary, which focuses on enzymatically produced DNA to meet growing demand [19][20] - LineaRx engaged over twenty-five customer projects in fiscal 2024, with expectations for multiple projects to enter clinical trials in calendar 2025 [24] Company Strategy and Development Direction - The strategic restructuring reflects a commitment to rebuilding shareholder value through optimized cost structures and a focus on LineaRx [19][21] - The company aims to leverage its GMP-certified facility to expand its product offerings and enter new markets, particularly in enzymatic DNA production [41][60] Management's Comments on Operating Environment and Future Outlook - Management highlighted the operational launch of the GMP facility as a pivotal moment for the company, enabling entry into higher-margin markets [47] - The company is focused on maintaining disciplined operational expenditures while pursuing growth through enzymatic DNA production [60] Other Important Information - The company has received regulatory approval for its pharmacogenomics assay, TREAT PGx, and expanded its mBox assay to accept samples from all fifty states [27] - The company is actively developing new forms of linear DNA, including Linea Donor DNA for CRISPR applications, which is expected to be available for research use [39][40] Q&A Session Summary Question: Can you provide insights on the new Linear product and its market opportunity? - The company sees parallels between the IVT template and donor DNA markets, with significant opportunities in CRISPR and gene therapy applications [66] Question: Where did the revenue increases come from in Q1? - Revenue increases were primarily from a shipment of DNA tagging for cotton marking and increased volume in isotopic testing services [69][70] Question: What is the timeline for the AML therapy trial and revenue recognition? - The phase one trial in the Czech Republic is expected to last about eighteen months, with the therapy chosen for its faster regulatory approval process [72][74]

Financial Performance - Total revenues for the three months ended December 31, 2024, increased to $1,196,617, representing a 34.3% growth compared to $891,164 in the same period of 2023[12] - Product revenues rose to $495,847, up 61.2% from $307,317 year-over-year, while service revenues increased to $374,444, a 51.5% increase from $247,147[12] - Gross profit for the quarter was $684,107, significantly higher than $231,097 in the prior year, indicating improved operational efficiency[12] - The net loss attributable to common stockholders for the quarter was $(17,546,635), compared to $(1,182,857) in the same quarter of 2023, reflecting increased expenses and warrant modifications[12] - The Company 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[21] - The company reported a consolidated loss before provision for income taxes of $2,668,713 for the three-month period ended December 31, 2024, compared to a loss of $1,130,281 in 2023, indicating a significant increase in losses[87] Cash and Liquidity - Cash and cash equivalents at the end of the period were $10,044,365, up from $4,109,045 at the end of December 2023, showing improved liquidity[14] - Cash and cash equivalents increased to $9,294,365 as of December 31, 2024, up from $6,431,095 as of September 30, 2024[36] - Cash and cash equivalents as of December 31, 2024, were $9,294,365, with working capital of $8,889,342[146] Assets and Liabilities - Total assets increased to $15,970,701 as of December 31, 2024, compared to $12,789,040 at September 30, 2024, indicating growth in the company's asset base[11] - Total liabilities decreased to $3,421,056 from $3,820,955, reflecting a reduction in financial obligations[11] - Accounts payable and accrued liabilities totaled $1,610,972 as of December 31, 2024, down from $1,793,427 on September 30, 2024, indicating a decrease of about 10.1%[59] Capital and Financing - The company reported a significant increase in additional paid-in capital, rising to $339,918,754 from $318,805,058, indicating successful capital raising efforts[13] - The Company closed a registered direct offering on October 31, 2024, raising approximately $5.7 million in net proceeds after deducting fees and expenses[61] - The Company entered into a purchase agreement on October 30, 2024, to issue and sell 19,247,498 shares of Common Stock, along with various warrants, raising approximately $6.5 million in gross proceeds before expenses[170][171] Operational Changes - The Company completed a workforce reduction of approximately 20% of its total headcount and approximately 13% in annual payroll costs due to the strategic review of its DNA Tagging and Security Products and Services segment[15] - The Company plans to exit its DNA Tagging and Security Products and Services business segment, which will incur one-time personnel-related charges of approximately $300,000[15] - The company is restructuring its business model with an emphasis on Therapeutic DNA Production Services, aiming to enhance operational efficiency and market positioning[95] Segment Performance - The Company has three reportable segments: Therapeutic DNA Production Services, MDx Testing Services, and DNA Tagging and Security Products and Services[44] - Revenues from one customer within the MDx Testing Services segment accounted for 19% of total revenues for the three-month period ended December 31, 2024[42] - Two customers accounted for 61% of the Company's accounts receivable as of December 31, 2024[43] Future Outlook - The company anticipates future growth in demand for Therapeutic DNA Production Services, which is a key focus of its business strategy[95] - The company expects future demand for COVID-19 testing to continue to decline, potentially leading to the termination of COVID-19 testing services[129] Compliance and Regulatory - The Company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, with a deadline of May 12, 2025, to regain compliance[74] - The Company intends to implement a reverse stock split to regain compliance with Nasdaq's Bid Price Rule if necessary[76] - The company is currently evaluating the impact of adopting new accounting standards related to income tax disclosures and segment reporting, effective for fiscal years beginning after December 15, 2024[55][56] Research and Development - Research and development expenses increased by $79,195 or 8% to $1,015,010 for the three-month period ended December 31, 2024, compared to $935,815 in the same period of 2023[141] - As of Q4 2024, there are 4,238 gene, cell, and RNA therapies in development, almost all utilizing DNA in their manufacturing process, representing a substantial market opportunity for the LineaDNA platform[111] Miscellaneous - The total rent expense for the three-month periods ended December 31, 2024, and 2023 was $188,558 and $180,916, respectively[79] - There were no changes in internal control over financial reporting that materially affected the company's financial reporting during the fiscal quarter ended December 31, 2024[166] - The company has no ongoing legal proceedings that could materially impact its financial condition[168]

Financial Performance - Total revenues for Q1 fiscal 2025 were $1.2 million, a 34% increase from $891 thousand in Q1 fiscal 2024[10] - Net loss for the quarter was $2.7 million, compared to a net loss of $1.1 million in Q1 fiscal 2024[10] - Total revenues for the three months ended December 31, 2024, were $1,196,617, an increase of 34.3% compared to $891,164 in 2023[22] - Product revenues rose to $495,847, up 61.2% from $307,317 in the previous year[22] - Service revenues increased to $374,444, a growth of 51.5% compared to $247,147 in 2023[22] - Gross profit for the quarter was $684,107, significantly higher than $231,097 in the same period last year[22] - The net loss attributable to common stockholders was $17,456,635, compared to a loss of $1,182,857 in the prior year[22] - Net loss per share attributable to common stockholders improved to $(0.56) from $(1.73) year-over-year[22] - Consolidated Adjusted EBITDA loss for the quarter was $(2,888,877), an improvement from $(3,162,948) in the same period last year[24] - Adjusted EBITDA improved to negative $2.9 million, up from negative $3.2 million year-over-year[10] - Interest income increased to $71,440, up from $33,323 in the previous year[24] Operating Expenses and Workforce - Operating loss decreased to $3.0 million from $3.8 million in the same quarter last year[10] - Total operating expenses decreased to $3,648,108 from $4,020,163, a reduction of 9.2% year-over-year[22] - The company completed a workforce reduction of approximately 20%, leading to a 13% reduction in annual payroll costs, with one-time separation costs of about $300,000[3] Manufacturing and Product Development - The initial projected manufacturing capacity of the GMP Site 1 facility is approximately ten grams per annum, supporting potential annual revenues of $10 million to $30 million[6] - The company plans to prepare for initial orders of clinical grade materials from its GMP Site 1 facility in fiscal 2025[5] - The Linea DNA platform achieved its first-in-human clinical validation in a Phase I clinical trial for CAR-T therapy[6] - The TR8™ PGx testing service has been expanded to all 50 U.S. states following necessary certifications[4] Cash and Financial Position - Cash and cash equivalents as of December 31, 2024, were $9.3 million, including $5.7 million from a direct offering on October 31, 2024[10] - The weighted average shares outstanding increased significantly to 31,518,861 from 683,672 year-over-year[22]

Applied DNA Sciences (APDN) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $5.20 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 3.03%. A quarter ago, it was expected that this DNA-based security technology company would post a loss of $0.64 per share when it actually produced earnings of $0.47, delivering a surprise of 173.44%.Over the last fo ...

Business Development and Strategy - The company is focusing on the development and commercialization of its Therapeutic DNA Production Services, particularly expanding its contract development and manufacturing operation (CDMO) for synthetic DNA[24]. - The company is exploring the potential divestiture of its DNA Tagging and Security Products and Services business segment to reduce expenses and achieve cost savings[25]. - The company is engaged in a strategic review of its business segments, which may lead to workforce reductions and management changes[25]. - The company announced a multi-year commercialization agreement for its CertainT platform with Indus Group in July 2024, focusing on product traceability in the cotton supply chain[63]. - The company is exploring the potential divestiture of its DNA Tagging and Security Products and Services segment[125]. Market Opportunities and Product Development - As of Q3 2024, there are 4,099 gene, cell, and RNA therapies in development, almost all utilizing DNA in their manufacturing process, representing a substantial market opportunity for the company's LineaDNA platform[32]. - The LineaDNA platform offers significant advantages over traditional plasmid-based DNA manufacturing, including speed, scalability, purity, simplicity, and flexibility[34][35][38]. - The company launched its Linea IVT platform in July 2023, combining its LineaDNA IVT templates with proprietary RNAP, potentially increasing its mRNA-related total addressable market (TAM) by approximately 3-5 times[44][45]. - The company plans to manufacture GMP non-drug substance grade DNA in January 2025 and GMP drug substance grade DNA in the first half of calendar year 2026[72]. - The company has filed or intends to file patent applications for its technologies, with a patent portfolio that includes 8 issued patents and 11 pending applications in the Therapeutic DNA Production Services segment[86]. Financial Performance and Challenges - Revenue decreased from $18.2 million in fiscal 2022 to $13.4 million in fiscal 2023, and further declined to $3.4 million in fiscal 2024[121]. - The company reported a net loss of $7,088,306 for the fiscal year ended September 30, 2024, with an accumulated deficit of $309,672,755[122]. - Cash and cash equivalents as of September 30, 2024, were $6,431,095, which raised substantial doubt about the company's ability to continue as a going concern[122]. - The company closed a registered direct offering on October 31, 2024, receiving net proceeds of approximately $5.8 million, increasing the consolidated cash balance to approximately $10.1 million as of November 30, 2024[122]. - The company may require additional financing, which could lead to the issuance of additional shares, resulting in dilution for existing stockholders[126]. Regulatory and Compliance Issues - The company is subject to extensive regulations by the FDA and other authorities, which may delay product approvals and require substantial financial resources[93]. - The FDA's final rule on Laboratory Developed Tests (LDTs) will require compliance with various phases starting from May 6, 2025, impacting clinical laboratories significantly[98]. - The company is monitoring legislative developments, including the VALID Act, which could clarify the FDA's authority over LDTs and impact its business[101]. - The FDA's new regulations on Laboratory Developed Tests (LDTs) could lead to substantial costs and delays for the company in obtaining pre-market clearance or approval[167]. - Regulatory compliance is critical, and failure to comply could result in the inability to manufacture synthetic DNA products, adversely affecting revenue generation[216]. Operational Risks and Market Competition - The company faces substantial competition in the markets for drug and biologic candidates and synthetic DNA, which may hinder its ability to compete effectively[119]. - The competitive landscape for synthetic DNA and MDx Testing Services is intensifying, with many competitors having greater capital resources and market experience[179][183]. - The company must secure stable supplies of components and raw materials to avoid production delays and increased operating costs[174]. - The market for biologics and drug components is rapidly evolving, with significant competition from well-capitalized companies that may develop superior products[187]. - The company faces risks of obsolescence as competitors may develop more effective or less costly products[188]. Research and Development - The company incurred approximately $3.6 million and $3.7 million on research and development activities for the fiscal years ended September 30, 2024, and 2023, respectively[70]. - The company incurs research and development expenses to develop new products and technologies, which may face unanticipated delays and expenses, potentially leading to a total loss of investment in these new products[190]. - The success of the company's Therapeutic DNA Production Services is highly dependent on collaborators and customers obtaining regulatory approval for their pharmaceutical and biotherapeutic product candidates[204]. Customer and Market Dynamics - The company’s MDx Testing Services, which include COVID-19 testing, have seen a significant decline in revenue following the termination of a major contract with CUNY[184]. - Customer spending on pharmaceutical and biologic development will significantly impact the company's sales and profitability, influenced by factors such as available resources and access to capital[166]. - The company is dependent on consumer demand for products utilizing its technology, which could be adversely affected by various market factors[206]. Human Resources and Organizational Structure - As of September 30, 2024, the company had a total of 48 employees, including 46 full-time and 2 part-time[107]. - The company has been working with Insperity Inc. since June 2012 to manage back-end administrative human resources responsibilities[107]. - The company is engaged in a strategic review that may result in divestitures or workforce reductions, impacting its operational capabilities[141]. Risk Management and Compliance - The company is exposed to risks of fraud and misconduct by employees and third parties, which could lead to significant penalties and impact business operations[220]. - Compliance costs may increase significantly if customers obtain FDA approval and begin commercializing their products in the U.S.[221]. - The company has adopted a code of business conduct and ethics, but it may not effectively prevent misconduct or manage risks[221]. - Failure to comply with healthcare laws could result in substantial penalties, adversely affecting the company's financial conditions[222].

Exhibit 99.1 Applied DNA Announces Fourth Quarter and Fiscal Year 2024 Financial Results, Announces Strategic Restructuring to Prioritize the Manufacture of Critical Starting Materials for Genetic Medicines - Pursuing Divestiture of CertainT® Platform, Implements Changes to Corporate Leadership - - Buildout of GMP Manufacturing Facility to be Completed by January 9, 2025 - - Webcast and Conference Call Scheduled for Thursday, January 9, 2025, at 4:30 PM ET - STONY BROOK, N.Y. – December 17, 2024 - Applied D ...

The World Health Organization (WHO) is a branch of the United Nations dedicated to health. Founded in 1948, the WHO’s primary roles include supervising and coordinating health programs. The WHO also monitors health trends, establishes guidelines and suggestions, and supports countries that need it. Moreover, the WHO leads efforts to control diseases, improve healthcare systems, and tackle health emergencies and pandemics. WHO Declares Monkeypox State of EmergencyHealth officials at the world’s most-followed ...

Applied DNA Sciences, Inc. (NASDAQ:APDN) Q3 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Corporate Participants Sanjay Hurry - Head of IR Beth Jantzen - Chief Financial Officer Jim Hayward - Chairman, President and Chief Executive Officer Clay Shorrock - Chief Legal Officer and Head of Business Development Conference Call Participants Operator Good day, and welcome to the Applied DNA Fiscal Third Quarter 2024 Investor Conference Call. All participants will be listen-only mode. [Operator Instructi ...

Applied DNA Sciences (APDN) came out with quarterly earnings of $0.47 per share, beating the Zacks Consensus Estimate of a loss of $0.64 per share. This compares to loss of $4.80 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 173.44%. A quarter ago, it was expected that this DNA-based security technology company would post a loss of $4.60 per share when it actually produced a loss of $5.31, delivering a surprise of -15.43%.Ov ...

Exhibit 99.1 Applied DNA Announces Third Quarter Fiscal Year 2024 Financial Results - Conference Call/Webcast Scheduled for Today at 4:30 PM ET - STONY BROOK, N.Y. – August 8, 2024 - Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced consolidated financial results for its third fiscal quarter ended June 30, 2024. The Company's Form 10-Q can be viewed at https://investors.adnas.com/sec-filings/. Third Quarter Operational Highlig ...