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Applied DNA Sciences, Inc. (NASDAQ: APDN) is a biotechnology company pioneering advanced DNA-based technologies to safeguard assets and enhance industrial and healthcare applications. Headquartered in Stony Brook, NY, Applied DNA leverages Polymerase Chain Reaction (PCR) to produce and detect DNA and RNA, operating in three key segments: Therapeutic DNA Production Services, MDx Testing Services, and DNA Tagging and Security Products and Services.
In the Therapeutic DNA Production Services segment, Applied DNA produces synthetic DNA for nucleic acid-based therapeutics. With the acquisition of Spindle Biotech, the company has expanded its portfolio to include a proprietary RNA polymerase (RNAP) for mRNA therapeutics manufacturing. The recent contract with HDT Bio under the 'Project NextGen: Enabler' award aims to expedite mRNA vaccine production, highlighting the company's commitment to rapid-response medical solutions.
The MDx Testing Services segment, which includes clinical molecular diagnostic and genetic testing services, significantly contributes to the company's revenue. Applied DNA's innovative Linea™ IVT platform, designed to produce high-fidelity mRNA with reduced contamination, is a game-changer in molecular diagnostics.
Through the DNA Tagging and Security Products and Services segment, the company offers solutions under the brands Applied DNA Sciences, SigNature®, SigNature® T, fiberTyping, and SigNify®, providing robust anti-counterfeiting and product authentication services. These services are essential for supply chain security across various industries, including textiles and pharmaceuticals.
Recent achievements include closing a $12 million public offering to fund the development of DNA production services and the successful reverse stock split to comply with Nasdaq's minimum bid price requirements. Additionally, Applied DNA received a Notice of Allowance from the USPTO for a patent on its Linea™ RNAP, solidifying its intellectual property portfolio and extending patent protection into 2041.
Applied DNA remains dedicated to advancing DNA technology to meet the world’s evolving needs in healthcare, supply chain security, and beyond. For more information, visit their website at www.adnas.com and follow them on social media for the latest updates.
Applied DNA Sciences (NASDAQ:APDN) reported Q1 fiscal 2025 financial results, announcing strategic restructuring initiatives. The company is exiting its DNA Tagging and Security Products business segment and implemented a 20% workforce reduction in January, expected to reduce annual payroll costs by 13% with one-time separation costs of $300,000.
Key financial highlights include revenue of $1.2 million (up 34% YoY), operating loss of $3.0 million, and net loss of $2.7 million. Cash position stands at $9.3 million as of December 31, 2024.
The company completed its GMP Site 1 facility in Stony Brook, NY, with an initial manufacturing capacity of approximately ten grams per annum, supporting potential annual revenues of $10-30 million. The facility received commercial operation certification in January 2025 and enables enzymatic manufacture of Linea DNA™ IVT templates for mRNA clinical trial materials.
Applied DNA Sciences (NASDAQ:APDN) has announced it will release its first quarter fiscal 2025 financial results after market close on Thursday, February 13, 2025. The company will host a conference call and webcast for shareholders and investors at 4:30 p.m. ET on the same day.
The conference call will be accessible via multiple channels including domestic toll-free, international, and Canadian toll-free numbers. A live webcast will be available, and an accompanying slide presentation will be embedded in both live and replay formats. A replay of the conference call will be available for 7 days following the event through various access numbers with the replay access code 7896562.
Applied DNA Sciences (NASDAQ:APDN) has issued a reminder to shareholders to cast their votes before the reconvening of a Special Meeting of Stockholders scheduled for February 14, 2025, at 11:00 a.m. The meeting, originally held on January 23, 2025, was adjourned due to lack of quorum.
The primary focus is the Warrant Exercise Proposal, which seeks approval for the exercisability of certain common stock purchase warrants and the issuance of underlying common stock. These warrants were issued during a securities offering on October 30, 2024. Shareholders of record as of November 25, 2024, who haven't yet voted can contact Kingsdale Advisors at 1-855-682-9644 or contactus@kingsdaleadvisors.com.
The proposal requires approval in accordance with Nasdaq Listing Rule 5635(d), as detailed in the Company's definitive proxy statement filed with the SEC on December 10, 2024.
Applied DNA Sciences (NASDAQ:APDN) has completed the buildout of its new Good Manufacturing Practices (GMP) facility at its Stony Brook, New York headquarters. The facility, expected to be fully operational by January's end, will manufacture LineaDNA IVT templates for mRNA clinical trial materials.
Key facility specifications include:
- Annual IVT template manufacturing capacity of ~10 grams with 100% cell-free workflow
- 10mg to gram-scale production in 6-14 weeks
- Projected revenue capacity of $10-30 million depending on product mix
- Multiple purification options and dedicated quality control areas
The company is currently negotiating a supply agreement for GMP IVT template with an mRNA therapeutic developer and reaffirmed its plan to complete strategic restructuring by quarter-end to drive sustainable growth, optimize costs, and extend cash runway.
Applied DNA Sciences (NASDAQ:APDN) has announced the rescheduling of its Investor Update call from January 9, 2025, to Thursday, February 13, 2025. The rescheduling aligns with the release of the company's first quarter fiscal 2025 financial results. The original call was intended to provide shareholders with updates on the company's strategic restructuring announced in December 2024 and GMP initiative. The schedule change is due to the observance of the National Day of Mourning in recognition of the passing of former President Jimmy Carter.
Applied DNA Sciences (NASDAQ:APDN) announced that the Czech Republic's State Institute for Drug Control approved a Phase I clinical trial for UHKT-CAR123-01, a CD123-specific autologous CAR T-cell therapy using Applied DNA's Linea DNA technology. The trial, conducted by the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, targets relapsed and/or refractory acute myeloid leukemia (AML).
The therapy aims to address high costs and long manufacturing times associated with traditional viral vector-based CAR T-cell therapies. Preclinical data demonstrated that ÚHKT's non-viral workflow using Linea DNA achieved rapid production of CAR T-cells with high potency while reducing manufacturing costs and timelines.
Applied DNA Sciences (NASDAQ:APDN) announced strategic restructuring to focus on manufacturing critical starting materials for genetic medicines. The company plans to divest its CertainT® platform and targets 15% operating expense reduction by Q2 FY2025. The company's GMP manufacturing facility is expected to be completed by January 9, 2025, with projected annual revenue capacity between $4-16 million.
Q4 FY2024 financial results showed revenues of $813,000 (up from $780,000 in Q4 FY2023), with an operating loss of $3.3 million (improved from $4.2 million). FY2024 total revenues were $3.4 million, down from $13.4 million in FY2023. Cash position was $6.4 million as of September 30, 2024, with additional $5.8 million raised through an October offering.
Applied DNA Sciences (NASDAQ:APDN) announced it will release its fourth quarter and fiscal year 2024 financial results after market close on December 17, 2024. The company will host a conference call and webcast for investors on January 9, 2025, at 4:30 p.m. ET, which will include an update on its GMP manufacturing facility build-out. The presentation will be accessible via webcast and conference call, with replay options available for 7 days following the event. An accompanying slide presentation will be available on the company's investor relations website.
Applied DNA Sciences (NASDAQ:APDN) has announced the pricing of a $6.5 million registered direct offering and concurrent private placement. The offering includes 20,312,500 shares at $0.32 per share, along with Series C and Series D Warrants. The Series C Warrants expire in 5 years and Series D Warrants in 18 months after stockholder approval, both with an exercise price of $0.32. The company plans to use proceeds for developing Therapeutic DNA Production Services and general corporate purposes. The offering is expected to close around October 31, 2024, with Craig-Hallum acting as exclusive placement agent.
Applied DNA Sciences, Inc. (NASDAQ:APDN) has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's president and CEO, Dr. James A. Hayward, will engage in a fireside chat on Wednesday, October 16, 2024, at 12:50 p.m. EDT. This virtual event, hosted by Maxim Group , runs from October 15th to 17th.
The interview will be conducted by Jason McCarthy, Ph.D., Maxim's senior managing director and head of Biotechnology Research. Registered conference attendees will have access to view Applied DNA's fireside chat. Applied DNA, known for its leadership in PCR-based DNA technologies, will use this platform to share insights with the healthcare investment community.
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