Aditxt, Inc. ("Aditxt") (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, announced that its subsidiary, Pearsanta, Inc. (“Pearsanta”), has submitted a grant application to the Prostate Cancer Research Program (PCRP) under the Department of Defense (DoD) Implementation Science Award funding mechanism seeking $2 million in funding. This non-dilutive funding initiative aims to advance the early detection and management of prostate cancer, a disease that remains one of the most prevalent and challenging cancers affecting men globally.

The MPT™, a blood test detecting a specific 3.4 kb mitochondrial DNA deletion, has shown robust diagnostic performance for clinically significant prostate cancer. The proposed study aims to first validate the MPT™ in its CLIA/CAP facility in Virginia. Once the validation is completed, the Science Award, if granted, would be expected to provide Pearsanta with sufficient funds to evaluate the test in a randomized clinical trial (RCT) to determine its effectiveness in better identifying men with PSA levels in the gray zone who would have clinically significant prostate cancer and potentially reducing unnecessary biopsies. Up to 1,000 men at risk for prostate cancer based on PSA levels 2-10 ng/mL will be randomized to “MPT-informed care” or standard of care and followed for one year to determine the number and results of any performed biopsies.

Prostate cancer is a significant health concern worldwide, according to the World Health Organization (WHO), with an estimated 1.5 million new cases diagnosed globally in 2024, making it the second most common cancer among men and the fourth most common cancer overall. In the United States alone, approximately 299,010 new cases and around 35,250 deaths are expected this year, according to the American Cancer Society. The lifetime risk for a man being diagnosed with prostate cancer is about 1 in 8, while the risk of dying from it is approximately 1 in 44.

Pearsanta’s Mitomic Technology Platform seeks to harness the unique properties of mitochondrial DNA (mtDNA) to detect disease through non-invasive, blood-based liquid biopsies. This platform is designed to identify specific mutations in mtDNA indicative of various diseases. Due to its high mutation rate and cell persistence, mtDNA has the potential to be an excellent biomarker for early disease detection. Currently, the program focuses on developing tests for early cancer detection, ovarian, prostate, and lung cancers, and addressing non-cancerous conditions like endometriosis.

“Submitting this grant application to the Prostate Cancer Research Program is a significant step in our ongoing mission to revolutionize early disease detection,” said Christopher Mitton, President of Pearsanta. “Prostate cancer remains one of the most challenging cancers for men worldwide, highlighting the urgent need for more accurate and non-invasive diagnostic tools. We believe that securing this non-dilutive funding would allow us to accelerate our efforts to demonstrate the test's clinical utility and contribution to prostate cancer diagnostics. The MPT™ has the potential to significantly improve clinical outcomes by reducing unnecessary biopsies and enabling the early detection of prostate cancers. As we advance the validation of the MPT™ for clinical use and position it as a laboratory-developed test, we are confident that this innovation, if successful, will transform prostate cancer diagnostics and improve patient outcomes globally."

The DoD’s PCRP Implementation Science Award is a highly competitive funding opportunity to accelerate the adoption of evidence-based practices in prostate cancer care. Pearsanta's application underscores its commitment to advancing healthcare through innovative diagnostic solutions and reflects its ongoing efforts to address some of the most pressing challenges in healthcare.

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented, “Through the Aditxt platform, we are seeking to accelerate Pearsanta’s path to commercialization, positioning it for long-term success as it advances innovations in precision health. This aligns with our broader strategy to accelerate each subsidiary to achieve growth and make a significant impact. By advancing these efforts, we aim to bring promising innovations to market that address critical healthcare needs and improve patient outcomes globally.”

Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For the latter two programs, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM), which focuses on women’s health. Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close.

About Aditxt, Inc.

Aditxt, Inc.^® is an innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.

For more information, www.aditxt.com.

Follow us on:

Linkedin: https://www.linkedin.com/company/aditxt
Facebook: https://www.facebook.com/aditxtplatform/

About Pearsanta, Inc.

Pearsanta is a commercial-stage company dedicated to revolutionizing precision diagnostics through advanced technologies. Leveraging its proprietary Mitomic® Technology Platform, Pearsanta focuses on early disease detection, significantly improving patient outcomes. The company’s diagnostic portfolio includes ovarian and prostate cancers and endometriosis tests. By identifying specific mitochondrial DNA (mtDNA) mutations, Pearsanta’s non-invasive, blood-based liquid biopsies provide rapid and accurate disease detection. Committed to enhancing lifelong well-being, Pearsanta addresses critical healthcare needs with innovative solutions that empower individuals to achieve optimal health.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute its strategic M&A initiatives; the Company’s ability to obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth, and strategies; the Company’s ability to raise additional capital; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in Aditxt’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240904120561/en/