City University of New York

- Pursuing Divestiture of CertainT® Platform, Implements Changes to Corporate Leadership -- Build-out 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, NY / ACCESSWIRE / December 17, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today reported financial results for its fourth quarter and fiscal year ended September 30, 2024. An update on the buildout of the Company's GMP manufacturing facility is available for viewing via slideshow on the Presentations page of the Investor Relations portion of the Company's website. The Company's Form 10-K can be viewed on the SEC Filings page.Concurrently, the Company announced a strategic restructuring of its business operations to focus its resources on manufacturing critical starting materials for genetic medicines enabled by its Linea™ DNA and Linea™ IVT platforms. Ongoing and future actions supporting Applied DNA's restructuring strategy include:The pursuit of a divestiture of the CertainT® platform for supply chain traceability and authentication1;The targeting of operating expense reductions of 15% compared to fiscal 2024, inclusive of costs associated with the potential divestiture of the CertainT platform. Cost reductions are expected to be completed in the second quarter of fiscal 2025 (ending March 31, 2025);The retention of Applied DNA Clinical Labs, the Company's clinical laboratory subsidiary, which will pursue profitable growth via its TR8™ pharmacogenomic (PGx) testing services; andThe immediate promotion of Chief Operating Officer Judith Murrah to President. Chief Legal Officer and Executive Director of Business Development Clay Shorrock assumes the additional role of President of LineaRx, Inc., the Company's majority-owned enzymatic DNA manufacturing subsidiary. Dr. James A. Hayward remains Chairman of the Board of Directors and Chief Executive Officer.Retention of its non-GMP DNA manufacturing business for in vitro diagnostics (IVD) and other specialty applications.Management Commentary"Following a thorough review of our businesses to enhance value for shareholders, we believe that our expertise and experience in enzymatic DNA production, the wealth of data generated over years that validate Linea DNA as a compelling alternative to plasmid DNA, and our proximity to GMP manufacturing is not fully recognized in our current structure. Our actions today will sharpen our focus on commercialization initiatives for our Linea DNA and Linea IVT platforms to return the Company to revenue growth and expand shareholder value," stated Dr. Hayward. "With several of our existing customers expected to initiate clinical trials in the next twelve months, we believe the completion of our GMP manufacturing facility will allow us to win several long-term, high-margin GMP supply agreements for IVT templates, resulting in the significant utilization of our GMP manufacturing capacity in FY2025."Recent Operational HighlightsTherapeutic DNA Production Services (LineaRx)GMP roadmap execution:The buildout of the Company's GMP manufacturing facility is expected to be completed by January 9, 2025, with an annual revenue capacity ranging between $4 million and $16 million depending on product mix (sales of Linea DNA or the paired-Linea DNA IVT template-and-Linea RNA polymerase for mRNA production)2.Linea DNA/Linea IVT template commercialization:GMP production runs are expected to begin in the first half of CY2025 to supply Linea DNA IVT templates to existing customers for the manufacture of mRNA clinical trial materials.Initiated a development program with a well-known enzyme engineering company for a next-generation high fidelity, long-range DNA polymerase (DNAP) and buffer system to amplify long and complex DNA sequences via PCR. The resultant DNAP/buffer system combination will be exclusive to LineaRx and will allow for greater efficiencies and sequence fidelity in the manufacture of Linea DNA of >6kb in length.The Linea IVT platform (paired IVT template and RNA polymerase) is being evaluated by a multinational pharmaceuticals manufacturer in Japan.Linea DNA commercialization for IVT diagnostics:Received a $500,000 follow-on order from a global manufacturer of IVDs for a cancer diagnostic application.MDx Testing Services (Applied DNA Clinical Labs)TR8 PGx testing service commercialization:Applied DNA Clinical Labs (ADCL), the Company's clinical molecular diagnostics and genetic testing services subsidiary, is presently exploring reference lab opportunities for volume-based testing. ADCL continues to refine its go-to-market strategy for its precision medicine approach to personalized prescribing.________________________________1 While the Company is currently in negotiations for the potential divestiture of the CertainT platform, no assurance can be given that a potential divestiture will be completed.2 Based on internal company assumptions and modeling using a 1/100 DNA-to-RNA amplification ratio and an mRNA vaccine dose of 30μg. Manufacture of the final mRNA drug substance will be conducted by therapy developers or their CDMO.Financial HighlightsTotal revenues for the fourth quarter of fiscal 2024 were $813 thousand compared with $780 thousand for the same period of fiscal 2023. The year-over-year increase was a result of higher Service revenues primarily related to an increase in isotopic testing services revenues that offset lower clinical laboratory services revenues due to a decrease in demand for COVID-19 testing.Operating loss for the fourth quarter of fiscal 2024 was $3.3 million compared with $4.2 million in the prior year period. The improvement is primarily attributable to lower selling, general and administrative costs year-over-year attributable to lower stock-based compensation, offset by an increase in professional fees.Net loss for the fourth quarter of fiscal 2024 was $3.3 million, or $0.32 per share, compared with $3.6 million, or $5.29 per share, in the prior year period and on a higher number of shares outstanding. Adjusted EBITDA for the fourth quarter of fiscal 2024 was a negative $3.2 million compared with a negative $3.5 million in the prior year period.Total revenues for fiscal 2024 were $3.4 million compared with $13.4 million in fiscal 2023. The decrease was driven by lower clinical laboratory services revenues due to a decrease in demand for COVID-19 testing services, as the prior fiscal year included testing revenues under our contract with CUNY, which terminated in June 2023.Operating loss for fiscal 2024 was $14.0 million compared with $11.0 million in the prior year period. The increase was driven primarily by lower clinical laboratory services revenues, offset by a decrease in total operating expenses.Net loss for fiscal 2024 was $7.1 million, or $1.82 per share, compared with $10.0 million, or $15.21 per share in the prior year period and on a higher number of shares outstanding.Cash and cash equivalents on September 30, 2024, totaled $6.4 million. On October 31, 2024, the Company completed a registered direct offering and received net proceeds of approximately $5.8 million after deducting placement agent fees and other estimated offering costs payable by the Company. As a result of this offering, cash and cash equivalents as of November 3, 2024, were approximately $10.1 million.January 9 Investor Update Conference Call InformationThe Company will hold a conference call and webcast to update investors on its restructuring and GMP roadmap on January 9, 2025, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors' questions on the Q&A portion of the call, not all questions may be answered.To participate, please ask to be joined to the ‘Applied DNA Sciences' call:Domestic callers (toll free): 844-887-9402International callers: 412-317-6798Canadian callers (toll free): 866-605-3852Live and replay of webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=3UkskFxGTelephonic replay (available 1 hour following the conclusion of the live call through January 16, 2025):Domestic callers (toll free): 1-877-344-7529Canadian callers (toll free): 1-855-669-9658Participant Passcode: 7896562An accompanying slide presentation that will be embedded in the webcast can be accessed under ‘News & Events' tab and ‘Company Events' section of the Applied DNA investor relations website at https://investors.adnas.com/Information about Non-GAAP Financial MeasuresAs used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company's historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core businesses. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our businesses by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making."EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense."Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.About Applied DNA SciencesApplied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA, 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 and the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.Visit adnas.com for more information. Follow us on X and LinkedIn. Join our mailing list.Forward-Looking StatementsThe statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. These forward-looking statements are based largely on the Company's expectations and projections about future events and future trends affecting our business and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including statements regarding its belief that restructuring will position the company for future growth potential, its goal to position the company for long term-growth and value creation and the potential to achieve that goal, the future success of its Linea DNA and Linea IVT platforms and future reductions in operating expenses. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from our Linea IVT and or Linea DNA platforms, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT platform approved for therapeutic use, the unknown amount of revenues and profits that will result from its TR8 PGx testing service, the unknown outcome of the potential divestiture of the Company's CertainT Platform, and if successfully divested, the unknown consideration that will be received by the Company, the limited market acceptance for its CertainT Platform, as well as various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 7, 2023, its Quarterly Reports on Form 10-Q filed on February 8, 2024, May 10, 2024, August 8, 2024, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.Investor Relations contact: Sanjay M. Hurry, 917-733-5573, [email protected]Web: www.adnas.comX: @APDN- Financial Tables Follow -APPLIED DNA SCIENCES, INC.CONSOLIDATED BALANCE SHEETS September 30, September 30, 2024 2023 ASSETS Current assets: Cash and cash equivalents $6,431,095 $7,151,800 Accounts receivable, net of allowance for credit losses of $75,000 at September 30, 2024 and 2023 362,013 255,502 Inventories 438,592 330,027 Prepaid expenses and other current assets 815,970 389,241 Total current assets 8,047,670 8,126,570 Property and equipment, net 553,233 838,270 Other assets: Restricted cash 750,000 750,000 Intangible assets 2,698,975 2,698,975 Operating right of use asset 739,162 1,237,762 Total assets $12,789,040 $13,651,577 LIABILITIES AND EQUITY Current liabilities: Accounts payable and accrued liabilities $1,793,427 $2,270,388 Operating lease liability, current 545,912 498,598 Deferred revenue 58,785 76,435 Total current liabilities 2,398,124 2,845,421 Long term accrued liabilities 31,467 31,467 Deferred revenue, long term 194,000 194,000 Operating lease liability, long term 193,249 739,162 Deferred tax liability, net 684,115 684,115 Warrants classified as a liability 320,000 4,285,000 Total liabilities 3,820,955 8,779,165 Commitments and contingencies Applied DNA Sciences, Inc. stockholders' equity: Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of September 30, 2024 and 2023 - - Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of September 30, 2024 and 2023 - - Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of September 30, 2024 and 2023 - - Common stock, par value $0.001 per share; 200,000,000 shares authorized as of September 30, 2024 and 2023, 10,311,885 and 682,926 shares issued and outstanding as of September 30, 2024 and 2023, respectively 10,314 683 Additional paid in capital 318,805,058 307,397,623 Accumulated deficit (309,672,755) (302,447,147)Applied DNA Sciences, Inc. stockholders' equity 9,142,617 4,951,159 Noncontrolling interest (174,532) (78,747)Total equity 8,968,085 4,872,412 Total liabilities and equity $12,789,040 $13,651,577 APPLIED DNA SCIENCES, INC.CONSOLIDATED STATEMENTS OF OPERATIONS Three Month Period Ended Twelve Month Period Ended September 30, September 30, 2024 2023 2024 2023 (unaudited) (unaudited) Revenues Product revenues $127,727 $87,385 $1,074,813 $1,218,185 Service revenues 359,899 170,053 1,038,677 996,866 Clinical laboratory service revenues 325,480 522,298 1,317,930 11,152,392 Total revenues 813,106 779,736 3,431,420 13,367,443 Cost of product revenues 285,616 204,777 1,138,650 1,308,620 Cost of clinical laboratory service revenues 282,591 495,963 1,275,891 6,525,391 Total cost of revenues 568,207 700,740 2,414,541 7,834,011 Operating expenses: Selling, general and administrative 2,684,444 3,310,910 11,447,894 12,751,644 Research and development 831,711 938,907 3,593,750 3,735,078 Total operating expenses 3,516,155 4,249,817 15,041,644 16,486,722 LOSS FROM OPERATIONS (3,271,256) (4,170,821) (14,024,765) (10,953,290) Interest income 91,329 41,224 176,301 75,332 Unrealized (loss) gain on change in fair value of warrants (134,000) 519,700 9,430,000 854,400 Unrealized (loss) on change in fair value of warrants - warrant modifications - - (394,000) - Transaction costs related to warrant liabilities - - (633,198) - Loss on issuance of warrants - (1,633,767) - Other income (expense), net 183 (5,754) (8,877) 642 NET LOSS $(3,313,744) $(3,615,651) $(7,088,306) $(10,022,916) Less: Net loss attributable to noncontrolling interest $17,000 $23,387 $95,785 $75,857 Deemed dividend warrant repricing $- $- $(233,087) $- Net loss applicable to common stockholders $(3,296,744) $(3,592,264) $(7,225,608) $(9,947,059) Net loss per share-basic and diluted $(0.32) $(5.29) $(1.82) $(15.21) Weighted average shares outstanding- basic and diluted 10,301,831 678,442 3,966,026 653,771 APPLIED DNA SCIENCES, INC.CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA(unaudited) Three Month Period Ended September 30, 2024 2023 Net loss $(3,313,744) $(3,615,651)Interest income (91,329) (41,224)Depreciation and amortization 76,985 329,681 Provision for bad debt (6,089) 16,810 Stock based compensation expense 30,248 341,495 Unrealized loss (gain) on change in fair value of warrants classified as a liability 134,000 (519,700)Share issuance Spindle earnout 17,125 - Total non-cash items 160,940 127,062 Consolidated Adjusted EBITDA (loss) $(3,152,804) $(3,488,589) SOURCE: Applied DNA SciencesRelated Documents:

TORONTO--( BUSINESS WIRE )--Breast Cancer Canada, a national charity dedicated to advancing breast cancer research and care, is excited to announce several initiatives that underscore its commitment to improving patient outcomes and driving innovation in breast cancer treatment and detection. Empowering Patients with the mBC Know More App Breast Cancer Canada is proud to be launching the mBC Know More app, an innovative tool designed to support Canadians living with metastatic breast cancer (mBC). Developed under the leadership of Dr. Nancy Nixon, Medical Oncologist at the Arthur J.E. Child Comprehensive Cancer Centre, this app provides patients with tools to better manage their care and communicate with healthcare providers. Metastatic breast cancer (mBC), or stage IV breast cancer, occurs when cancer spreads to other parts of the body and remains incurable, accounting for 14% of cancer-related deaths among Canadian women. The mBC Know More app addresses the unique challenges of living with mBC through features such as: Medication tracking Symptom tracking Health journey logging Peer support connectivity Caregiver support Patient-reported outcomes research “I lost my mom to breast cancer in 1994, and that loss has profoundly shaped my career,” says Dr. Nixon. “It drives me to create tools and resources that truly empower patients. The launch of the mBC Know More app is a meaningful step in supporting individuals living with metastatic breast cancer.” Dr. Nixon’s work focuses on understanding patient needs and improving their care experience. The app, which allows patients to track their symptoms, medications, and treatment plans, is designed to provide personalized support and help patients feel more in control of their journey. “Managing metastatic breast cancer can feel overwhelming but having a tool like the mBC Know More app helps patients take an active role in their care,” she explains. “By tracking their symptoms and medications, they can better understand their treatment, communicate more effectively with their care teams, and feel empowered to make informed decisions. It’s about giving patients the tools they need to stay on top of their health.” “In developing the mBC Know More app, we worked closely with metastatic breast cancer patients to ensure its features address their unique needs and challenges,” said Dr. Nixon. “This patient-centered approach makes the app an indispensable tool for navigating the complexities of metastatic breast cancer care.” “Metastatic breast cancer is an ongoing journey, filled with constant changes and adjustments. Having one central place to connect with others, track symptoms, and stay organized isn’t just helpful—it’s a game changer. The mBC Know More app will support patients like me. It's empowering us to take control of our care and allowing all Canadians to have information on the latest advancements," shares Connie Claeys, a mBC patient in Calgary. This patient-facing app represents a significant step forward in improving the quality of life for Canadians living with mBC. Advancing Equity in Breast Cancer Research In partnership with AstraZeneca Canada, Breast Cancer Canada is proud to announce $200,000 in new funding for the Neo-Adjuvant Equity and Outcomes Research Matching Grants. These grants aim to advance research on improving equity in uptake, experience, and outcomes from neo-adjuvant therapy (NACT) for early-stage breast cancer patients. Funding has been awarded to two nationally and internationally recognized research teams: Dr. Tulin Cil (Surgical Oncology, Women’s College Hospital, Toronto, ON): The PATHWAY Study: Piloting a Clinical Care Pathway for breast cancer Neoadjuvant Chemotherapy Referral Dr. Stephen Chia (Medical Oncology, BC Cancer, Vancouver, BC): Understanding and Overcoming Disparity in the Use of Neoadjuvant Systemic Therapy for Early-Stage breast cancer Patients Living in Non-Large Urban Regions of British Columbia These studies represent two distinct yet complementary approaches to addressing equity challenges in NACT: Perspectives from both surgical and medical oncology, providing actionable insights for health policy advocacy. Representation from Eastern and Western Canada, ensuring broad applicability. Potential for these findings to be adapted to other regions across Canada. Integration of patient-reported outcomes (PROs) to capture patient-centered perspectives. “At AstraZeneca, we’re incredibly proud of our collaboration with Breast Cancer Canada in support of this important Canadian research to improve outcomes and experience for early-stage breast cancer patients,” said Brian Seguin, AstraZeneca Canada, Head – Breast Cancer. “I would like to thank Breast Cancer Canada for their continued partnership on these awards and we look forward to seeing the results of these two exciting research projects in the near future.” Addressing Critical Gaps in Early Detection To improve early detection and screening, Breast Cancer Canada is investing in a new research initiative to study how breast cancer is detected—whether through patient-discovered symptoms or routine mammogram screenings. Led by Dr. Anna Wilkinson and Dr. Jean Seely at the Ottawa Hospital Cancer Centre, this program will provide critical evidence to guide inclusive and effective breast cancer screening policies. “Recent studies show that expanding screening to women, especially in provinces with self-referral mammograms, improves survival rates and reduces mortality,” said Dr. Wilkinson. New Funding Announced by Breast Cancer Canada Additionally, Breast Cancer Canada is announcing a new call for grants offering $250,000 to fund research in breast cancer screening, diagnostics, and targeted treatments, reinforcing the organization’s mission to drive impactful research and patient care advancements. “We are excited to build on this momentum in the year ahead as we continue to research and advocate for better outcomes for Canadian patients,” said Kimberly Carson, CEO of Breast Cancer Canada. “By investing in personalized breast cancer approaches, we’re fueling progress across the country.” To learn about ways to donate and continue to support BCC’s research opportunities, visit: breastcancerprogress.ca. About Breast Cancer Canada Breast Cancer Canada is a national charity dedicated to saving lives through breast cancer research. With a focus on precision oncology (personalized care), it is the only national breast cancer organization in Canada that has a clear mandate to raise money for research and advocate and educate on the progress of new research evidence. The organization receives no government funding, meaning all research is funded through the generosity of donors. For more information, visit breastcancerprogress.ca .

VALENCIA, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Nusano, a physics company transforming the production of radioisotopes, today announced it will host a virtual key opinion leader (KOL) panel discussion on Tuesday, December 17, 2024 at 1:00 PM ET to preview the year ahead in radiopharmaceuticals. Interested participants can register here. The moderated discussion will feature Elcin Zan, MD (Cleveland Clinic) and Brian Zeglis, PhD (Hunter College), who will discuss emerging trends shaping the radioligand therapy (RLT) landscape, including the latest advancements and exciting developments on the horizon for 2025. The educational event is designed to be of interest to investors, emerging biotech companies, and all interested in learning more about how radiopharmaceuticals are changing the way cancers are detected and treated. A live Q&A session will follow the formal discussion, offering attendees the opportunity to interact directly with the experts. About Elcin Zan, MDElcin Zan, MD is dual board-certified radiologist specializing in neuroradiology and nuclear medicine. She currently serves as Chair of the Division of Nuclear Medicine at Cleveland Clinic. Prior to her current role, Dr. Zan worked in Molecular Imaging and Therapy at Weill Cornell Medicine, and as the Director of Nuclear Theranostics at NYU Langone Health. About Brian Zeglis, PhDDr. Brian Zeglis is Associate Professor in the Department of Chemistry at Hunter College, New York. His research focus is biochemistry, organic chemistry, inorganic chemistry and radiochemistry. Dr. Zeglis received his BA from Yale University and a PhD from the California Institute of Technology. He completed a postdoc at the Memorial Sloan Kettering Cancer Center. The research in the Zeglis Laboratory at Hunter focuses on the design, synthesis, preclinical validation, and clinical translation of novel pharmaceuticals for the imaging and therapy of disease, particularly cancer. In most, if not all of its work, the members of the Zeglis Laboratory work closely with their fellow collaborators in the Department of Radiology at Memorial Sloan Kettering Cancer Center. About NusanoNusano is a privately held physics company committed to bringing stability and innovation to the rapidly emerging and critically undersupplied medical radioisotopes market. Nusano’s proprietary ion source is smaller and more efficient than existing production methods. This results in significantly greater yields and allows for the simultaneous manufacturing of multiple radioisotopes. Nusano’s technologies will supply the fight against cancer and support diagnostic and therapeutic radiopharmaceutical development. The company’s state-of-the-art production facility opens in 2025 in West Valley City, Utah. For more, please visit www.nusano.com. Contacts: Media: Scott Larrivee, Nusano, 608-345-6629, scott.larrivee@nusano.comInvestor Relations: Joyce Allaire, LifeSci Advisors, LLC, 212-915-2569, jallaire@lifesciadvisors.com