Financial Data and Key Metrics Changes - Total revenues for Q1 2024 were approximately $891,000, a decline of $4.4 million compared to $5.3 million in the same period last year [5][6] - Gross profit was $231,000 or 26%, down from $2.4 million or 45% in the prior year, primarily due to a higher percentage of COVID-19 testing service revenue in the previous year [6][7] - Operating loss for the first quarter was $3.8 million compared to $1.2 million in the prior fiscal period [8] - Adjusted EBITDA deteriorated by $2.1 million to a negative $3.2 million compared to a negative $1.1 million in the prior fiscal year period [8] Business Line Data and Key Metrics Changes - Clinical laboratory service revenues decreased significantly, contributing approximately $4.2 million to the total revenue decline [5][6] - Service revenues increased by approximately $15,000 year-over-year, driven by demand for isotopic testing within the DNA Tagging and Security Products and Services segment [6] Market Data and Key Metrics Changes - The company is focusing on the biotherapeutics market, particularly in mRNA therapeutics, with approximately 425 mRNA therapies currently in development [15][17] - The establishment of a GMP capacity is crucial for supporting clinical-grade messenger RNA therapeutics, which is expected to come online in the first half of 2024 [15][16] Company Strategy and Development Direction - The primary objective is the commercialization of the Linea IVT and Linea DNA platforms, with a focus on capital allocation to support biotherapeutic goals [11] - The company aims to transition customers to scale-up agreements for Linea IVT templates and RNA polymerase manufactured under applicable GMPs [14][15] - The partnership with Kudo Bio aims to validate the commercial scale-up of the Linea IVT platform [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing demand for mRNA therapeutics and the company's ability to meet this demand through its unique business model [15][24] - The establishment of a GMP footprint is seen as a significant step towards long-term shareholder value [26] Other Important Information - The company closed a registered direct public offering for gross proceeds of approximately $3.4 million, which will support the establishment of its GMP capacity [9][10] - Cash and cash equivalents totaled $3.4 million as of December 31, 2023, down from $7.2 million on September 30, 2023 [8][9] Q&A Session Summary Question: Can you talk about the CD123 CAR work at the Prague Hematology Institute? - Management highlighted the quality of the scientists involved and the approval process for GMP-grade materials [27] Question: What amount of product is needed for the clinical Phase I trial? - It was estimated that enough material would be needed to treat about 10 patients [29] Question: Can you provide details on Kudo Bio's scale and production? - Kudo Bio is a large player with international facilities and the capability for significant scale in mRNA manufacturing [34][35] Question: What is the customer distribution between the U.S. and international markets? - The majority of customers are currently U.S.-based, with expectations for increased international customer engagement [41][42] Question: What assumptions underlie the projected $15 million annual revenue for Linea IVT? - The projection is based on slightly greater than 100% utilization of the facility, with plans for accommodating increased customer demand [43][44] Question: How does the company benchmark against competitors in production speed? - The company is exceeding turnaround times compared to other enzymatic manufacturers in the scale-up process [48][49]

Applied DNA Sciences (APDN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.14 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 70.97%. A quarter ago, it was expected that this DNA-based security technology company would post a loss of $0.27 per share when it actually produced a loss of $0.26, delivering a surprise of 3.70%.Over the last four ...

Financial Performance - Total revenues for the three months ended December 31, 2023, were $891,164, a decrease of 83.1% compared to $5,262,752 for the same period in 2022[12]. - Product revenues were $307,317, down 40.4% from $516,396 in the prior year[12]. - Clinical laboratory service revenues significantly dropped to $336,700 from $4,514,295, reflecting a decline of 92.6%[12]. - The company reported a gross profit of $231,097, a significant decline from $2,377,683 in the same quarter last year[12]. - The net loss attributable to Applied DNA Sciences, Inc. was $1,105,100, compared to a net loss of $3,843,372 for the same period in 2022[12]. - The company reported a net loss of $1,130,281 for the three months ended December 31, 2023, compared to a net loss of $3,844,246 for the same period in 2022, indicating an improvement in financial performance[20]. - Operating cash flow was negative at $3,757,679 for the three-month period ended December 31, 2023, compared to negative cash flow of $2,383,106 for the same period in 2022[20]. - The loss from operations for reportable segments in Q4 2023 was $(2,539,861), compared to $(217,084) in Q4 2022[74]. - The company reported a discretionary bonus of $500,000 for the CEO for fiscal 2023, which was declined due to the company's cash position[68]. Cash and Assets - Cash and cash equivalents decreased to $3,359,045 from $7,151,800 as of September 30, 2023[8]. - Total assets as of December 31, 2023, were $9,913,210, down from $13,651,577 at the end of the previous quarter[10]. - The company had cash and cash equivalents of $3,359,045 as of December 31, 2023, down from $15,215,285 at the beginning of the period[20]. - The company reported total current assets of $4,590,046 as of December 31, 2023, down from $8,126,570 as of September 30, 2023, indicating a decrease of approximately 43%[8]. - Cash, cash equivalents, and restricted cash at the end of the period were $4,109,045, down from $12,877,179 at the end of December 2022[20]. - As of December 31, 2023, the company had working capital of $2,002,107 and cash and cash equivalents of $3,359,045[131]. Liabilities and Equity - Total liabilities decreased to $5,784,808 from $8,779,165 as of September 30, 2023[9]. - The company recorded warrant liabilities of $1,646,000 as of December 31, 2023, down from $4,285,000, indicating a decrease of about 62%[9]. - Accounts payable and accrued liabilities totaled $2,023,876 as of December 31, 2023, down from $2,270,388 as of September 30, 2023, representing a decrease of 10.9%[56]. - The company issued 61,200 shares of common stock for net proceeds of approximately $45,480 under an Equity Distribution Agreement, with an aggregate offering price of up to $6,397,939[57][58]. - The balance of warrants outstanding as of December 31, 2023, was 5,213,213, with a weighted average exercise price of $3.32 per share[62]. Revenue Recognition and Segments - The company recognized revenue for its clinical laboratory testing services upon completion of services, with performance obligations satisfied at the point of releasing testing results[141]. - Revenue for research and development contracts is recognized over time, primarily using the cost-to-cost method, reflecting the progress towards completion[142]. - The company has three reportable segments: Therapeutic DNA Production Services, MDx Testing Services, and DNA Tagging and Security Products and Services[46][47]. - For the three-month period ended December 31, 2023, revenues included 25% from one customer in the MDx Testing Services segment and 22% from one customer in the DNA Tagging and Security Products and Services segment[45]. Operational Highlights - The company is focused on expanding its business in the biotechnology sector, particularly in therapeutic DNA production and molecular diagnostics[23]. - The company launched DNA IVT templates in August 2022 and has secured proof of concept contracts with multiple mRNA manufacturing customers, indicating strong market demand[105]. - The acquisition of Spindle in July 2023 is expected to enhance the company's mRNA-related total addressable market (TAM) by approximately 3x compared to selling Linea DNA IVT templates alone[106]. - The company plans to manufacture Linea DNA IVT templates under Good Manufacturing Practices (GMP) with availability expected in the first half of CY2024, and additional GMP materials for drug products planned for 2025[107]. Expenses - Total operating expenses increased to $4,020,163, up 11.8% from $3,596,661 in the same quarter last year[12]. - Selling, general and administrative expenses increased by $458,991 or 17% for the three-month period ended December 31, 2023, totaling $3,084,348[125]. - Research and development expenses decreased by $35,489 or 4% for the three-month period ended December 31, 2023, totaling $935,815[126]. - The total rent expense for the three-month period ended December 31, 2023, was $174,419, compared to $148,826 for the same period in 2022, reflecting an increase of 17.2%[63]. Market Conditions - The effect of inflation on revenue and operating results was not significant, indicating stable operational performance despite economic pressures[146]. - As of Q4 2023, there are 3,951 gene, cell, and RNA therapies in development, almost all utilizing DNA in their manufacturing process, representing a substantial market opportunity for the Linea DNA platform[100]. - The Linea DNA platform offers advantages over plasmid-based DNA manufacturing, including speed, scalability, purity, simplicity, and flexibility, allowing for rapid production of high-fidelity DNA sequences[101][102][103].

Financial Data and Key Metrics Changes - Total revenues for Q4 2023 were $780,000, a decrease from $3.6 million in the same period last year, primarily due to a decline in COVID-19 testing services revenue and a reduction in product revenue [5][6][10] - Gross profit was $79,000 (10% margin) compared to $417,000 (12% margin) in the prior year, with the decline attributed to a higher percentage of COVID-19 testing services and textiles revenue in the previous year [6] - Operating loss for Q4 2023 was $4.2 million, slightly improved from a loss of $4.3 million in the prior year [7] - Cash and cash equivalents totaled $7.2 million on September 30, 2023, down from $10.8 million on June 30, 2023 [8] Business Line Data and Key Metrics Changes - The decline in revenue was largely due to a $2.4 million decrease in COVID-19 testing services, following the expiry of a testing contract [6] - The textiles vertical saw a decrease in cotton tagging revenues, contributing to a reduction in product revenue of $341,000 [6] Market Data and Key Metrics Changes - The company is experiencing strong demand in the cotton industry for traceability technologies due to federal and international legislation related to forced labor [18] - Interest in the linearDNA platform is growing, with several large CDMOs as evaluation customers, indicating a positive market response [25][33] Company Strategy and Development Direction - The company is focusing on biotherapeutic manufacturing, particularly through the linearDNA platform, which aims to provide an alternative to plasmid DNA for genetic medicines [12][32] - Plans for fiscal 2024 include launching GMP manufacturing capacity for mRNA starting materials, which is expected to unlock significant revenue opportunities [30][31] - The company aims to convert existing customers into larger, long-term commercial supply agreements, leveraging the anticipated growth in mRNA manufacturing demand [33] Management's Comments on Operating Environment and Future Outlook - Management anticipates a decline in COVID-19 testing revenues, reflecting a broader trend in the industry as public interest wanes [46] - The approval of the first IND for enzymatically-produced DNA is seen as a positive sign for the industry, indicating regulatory acceptance of enzymatic manufacturing [40] - The company is optimistic about the upcoming fiscal year, expecting to secure larger contracts and capitalize on the growing demand for mRNA starting materials [31][33] Other Important Information - The company filed an 8-K disclosing non-compliance with Nasdaq listing rules regarding minimum bid price requirements, with a 180-day period to regain compliance [10] - The average monthly cash burn for Q4 2023 was $1.2 million, aligning with forecasts post-CUNY contract expiry [8] Q&A Session Summary Question: Can you discuss the Spindle RNA polymerase acquisition and its implications? - The acquisition allowed the company to optimize the polymerase for self-amplifying RNA production, which is promising for the IP portfolio and market demand [38] Question: Who received the first IND approval for enzymatically-produced DNA? - The approval was granted to Touchlight Genetics, indicating FDA's willingness to engage with enzymatically-produced materials, which is a positive sign for the company [40] Question: What is the revenue outlook for clinical laboratory services? - A decline is expected, although local increases in COVID positivity may affect this trend [46] Question: How many customers have ordered from the Linea IVT platform? - There are over 10 customers for IVT templates, with 3 evaluation customers for the Linea IVT platform, expecting to sign more substantive agreements soon [50] Question: What is the cash position after September? - The cash position as of November 30th is approximately $4.5 million [53]

Table of Contents | --- | --- | --- | |--------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------| | 50 Health Sciences Drive, Stony Brook, New York | 11790 | (631) 240-8800 | | (Address of principal executive offices) | (Zip Code) | (Registrant's telephone number, | | | Securities registered pursuant to Section 12(b) of the Act: | including area code) | | | | ...

Third Quarter Fiscal 2023 Financial Results 10 August 2023 ...

Applied DNA Sciences, Inc. (NASDAQ:APDN) Q3 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Sanjay Hurry - Head of IR Beth Jantzen - CFO James Hayward - Chairman, President and CEO Clay Shorrock - Chief Legal Officer and Head of Business Development Conference Call Participants Jason McCarthy - Maxim Group Operator Good day, and welcome to the Applied DNA Sciences Inc. Fiscal Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this event i ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value APDN The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commi ...

Second Quarter Fiscal 2023 Financial Results 11 May 2023 ...

Applied DNA Sciences, Inc. (NASDAQ:APDN) Q2 2023 Earnings Conference Call May 12, 2023 4:30 PM ET Company Participants Sanjay Hurry - Head of Investor Relations Beth Jantzen - Chief Financial Officer James Hayward - Chairman, President and Chief Executive Officer Conference Call Participants Jason McCarthy - Maxim Group Yi Chen - H.C. Wainwright & Co., LLC Operator Hello and welcome to the Applied DNA Sciences Fiscal Second Quarter 2023 Financial Results. All parties will be in listen-only mode. [Operator I ...