Aditxt Subsidiary Pearsanta Submits a Grant Application Seeking to Advance Clinical Trials for Mitomic® Prostate Test, Targeting Early Detection in High-Risk Patients

Rhea-AI Summary

Aditxt (NASDAQ: ADTX) subsidiary Pearsanta has submitted a $2 million grant application to the DoD's Prostate Cancer Research Program. The funding aims to advance clinical trials for the Mitomic® Prostate Test (MPT™), a blood test for early detection of clinically significant prostate cancer. The proposed study involves validating MPT™ and conducting a randomized clinical trial with up to 1,000 men to evaluate its effectiveness in reducing unnecessary biopsies.

The prostate cancer diagnostic market is expected to grow from $6.2 billion in 2023 to $11.5 billion by 2032. Prostate cancer affects 1 in 8 men, with an estimated 299,010 new cases and 35,250 deaths expected in the US this year. Pearsanta's Mitomic Technology Platform uses mitochondrial DNA mutations for early disease detection, focusing on various cancers and conditions like endometriosis.

Positive

• Potential $2 million non-dilutive funding for clinical trials
• MPT™ blood test shows robust diagnostic performance for clinically significant prostate cancer
• Prostate cancer diagnostic market expected to grow from $6.2 billion to $11.5 billion by 2032
• Mitomic Technology Platform has potential for early detection of various cancers and conditions

Negative

• Grant application outcome uncertain
• Clinical trial results and effectiveness of MPT™ not yet proven
• Closing of transactions with Appili and Evofem subject to various conditions and approvals

Medical Research Analyst

The submission of a grant application by Pearsanta for the Mitomic® Prostate Test (MPT™) is a potentially significant step in prostate cancer diagnostics. The $2 million funding sought could accelerate the validation and clinical trial process for this blood-based test, which detects a specific mitochondrial DNA deletion associated with clinically significant prostate cancer.

If successful, the MPT™ could address a critical need in prostate cancer screening. The test aims to better identify men with PSA levels in the 2-10 ng/mL range who have clinically significant prostate cancer, potentially reducing unnecessary biopsies. This is particularly important given the high prevalence of prostate cancer and the limitations of current screening methods.

However, it's important to note that this is still in the early stages. The grant application doesn't guarantee funding and even if funded, the clinical trial results will be critical in determining the test's actual effectiveness and potential market impact.

Market Research Analyst

The prostate cancer diagnostic market presents a significant opportunity, with projected growth from $6.2 billion in 2023 to $11.5 billion by 2032. This 85.5% increase reflects the rising demand for early detection technologies.

Pearsanta's MPT™, if successful, could capture a portion of this growing market. The test's potential to reduce unnecessary biopsies aligns with the trend towards non-invasive, cost-effective diagnostic solutions. However, market penetration will depend on:

• Clinical trial results demonstrating clear advantages over existing methods
• Regulatory approvals
• Adoption by healthcare providers and inclusion in screening guidelines

While promising, investors should be cautious. The path from grant application to market success is long and uncertain, especially in the competitive and highly regulated healthcare sector.

Prostate Cancer Diagnostic Market: Expected Growth from $6.2 Billion in 2023 to $11.5 Billion by 2032 Amid Rising Demand for Early Detection Technologies

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- 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.

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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/

Mary O’ Brien

mobrien@aditxt.com

(516) 753-9933

Source: Aditxt, Inc.

FAQ

What is the purpose of Pearsanta's grant application for ADTX?

Pearsanta, an Aditxt subsidiary, applied for a $2 million grant to advance clinical trials for the Mitomic® Prostate Test (MPT™), aiming to improve early detection of clinically significant prostate cancer and potentially reduce unnecessary biopsies.

How many men are expected to participate in the MPT™ clinical trial for ADTX?

The proposed randomized clinical trial for the MPT™ is expected to involve up to 1,000 men at risk for prostate cancer, with PSA levels between 2-10 ng/mL.

What is the projected growth of the prostate cancer diagnostic market relevant to ADTX?

The prostate cancer diagnostic market, relevant to Aditxt's (ADTX) subsidiary Pearsanta, is expected to grow from $6.2 billion in 2023 to $11.5 billion by 2032, driven by rising demand for early detection technologies.

How many new prostate cancer cases are expected in the US this year, according to ADTX's press release?

According to the American Cancer Society data cited in Aditxt's (ADTX) press release, approximately 299,010 new prostate cancer cases are expected in the United States this year.