Aditxt’s Subsidiary Pearsanta to Collaborate with Evofem Biosciences for Targeted U.S. Launch of Endometriosis Diagnostic in Mid-2025

Rhea-AI Summary

Aditxt, Inc. (NASDAQ: ADTX) announced that its subsidiary, Pearsanta, has entered into a collaboration agreement with Evofem Biosciences for the U.S. launch of a blood-based diagnostic test for endometriosis in mid-2025. The Mitomic® Endometriosis Test (MET™) detects a specific deletion in mitochondrial DNA, a novel biomarker for endometriosis.

Endometriosis affects approximately 190 million women worldwide, with no current validated blood-based tests available. The collaboration aims to develop a go-to-market strategy and commercial plan for MET. Over 300 endometriosis cases have been evaluated using MET, with 600 planned for clinical validation.

This partnership aligns with Evofem's strategy to expand its women's health product offerings and Aditxt's goal of accelerating healthcare innovations. The collaboration may also lead to future tests, such as early detection of ovarian cancer.

Positive

• Collaboration with Evofem Biosciences for targeted U.S. launch of endometriosis diagnostic in mid-2025
• MET aims to be the first validated blood-based biomarker test for endometriosis
• Over 300 endometriosis cases evaluated using MET, with 600 planned for clinical validation
• Potential for expansion into other diagnostic tests, such as early detection of ovarian cancer

Negative

• Launch of the diagnostic test is not expected until mid-2025, indicating a long wait for potential revenue generation
• Clinical validation of the test is still ongoing, with results not yet finalized

Insights

Medical Research Analyst

Pearsanta's Mitomic® Endometriosis Test (MET™) represents a significant breakthrough in endometriosis diagnostics. The test's focus on a specific deletion in mitochondrial DNA as a biomarker is innovative and could potentially revolutionize early detection. With 70% of endometriosis patients experiencing chronic pelvic pain and 50% facing infertility challenges, a non-invasive blood test could dramatically improve diagnosis rates and patient outcomes. The planned clinical validation involving 600 cases strengthens the test's credibility. However, it's important to note that while promising, the test is still in development and its mid-2025 launch target means it's not an immediate solution. The collaboration with Evofem Biosciences could accelerate market penetration, but success will ultimately depend on the test's accuracy and adoption by healthcare providers.

Women's Health Specialist

This collaboration between Pearsanta and Evofem Biosciences is a significant step forward in addressing the critical need for non-invasive endometriosis diagnostics. With approximately 190 million women worldwide affected by endometriosis, the potential impact of an accurate blood-based test is enormous. Early diagnosis is important for managing symptoms and potentially slowing disease progression. The MET™ could significantly reduce the current delay in diagnosis, which often takes years. However, it's important to temper expectations; while promising, the test still needs to complete clinical validation. The partnership with Evofem, given their established presence in women's health, could provide valuable market insights and distribution channels. This collaboration also aligns with the broader trend of comprehensive women's health solutions, potentially leading to improved care across various reproductive health issues.

Market Research Analyst

The collaboration between Pearsanta and Evofem Biosciences presents a compelling market opportunity. The global endometriosis market is projected to reach $2.3 billion by 2026, with diagnostics playing a important role. As the first potential blood-based biomarker test for endometriosis, MET™ could capture a significant market share if successful. Evofem's established relationships with OB/GYNs and healthcare providers offer a strong foundation for market penetration. However, the mid-2025 launch timeline means a considerable wait before potential revenue realization. Investors should also consider the competitive landscape; while currently unique, other companies may develop similar tests in the interim. The collaboration's success hinges on clinical validation results, regulatory approvals and effective commercialization strategies. The potential expansion into ovarian cancer detection further enhances the long-term market prospects but also increases execution complexity.

Endometriosis Affects Approximately 190 Million Women Worldwide

Non-invasive MET™ Diagnostic Test for Endometriosis Leverages Novel Biomarker: A Specific Deletion in Mitochondrial DNA

Pearsanta’s MET is Seeking to Become the First and Only Validated and Commercialized Blood-based Biomarker Test for Endometriosis

MOUNTAIN VIEW, Calif. & SAN DIEGO--(BUSINESS WIRE)-- Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), an innovation platform dedicated to accelerating promising health innovations, today announced that its majority-owned subsidiary, Pearsanta, Inc. (“Pearsanta”), has entered into a Market Development Collaboration Agreement (the “Agreement”) with women’s health pioneer Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM) focused on Pearsanta’s blood-based diagnostic test for endometriosis.

Endometriosis is a chronic disease associated with severe, life-impacting pain. It affects approximately one in ten women of reproductive age around the world – approximately 190 million women and girls - according to the World Health Organization.¹

Pearsanta’s Mitomic^® Endometriosis Test (“MET™”) looks for a specific deletion in mitochondrial DNA (“mtDNA”), which is a novel, proprietary biomarker for endometriosis. There are currently no validated blood-based tests for endometriosis available in the United States or anywhere around the world.

Under the Agreement, Evofem and Pearsanta will collaboratively develop a comprehensive go-to-market strategy and MET commercial plan ahead of the planned U.S. launch in mid-2025. To date, over 300 endometriosis cases have been evaluated using the MET; 600 are planned to support its clinical validation.

This collaboration supports Evofem’s strategy to expand its commercial offering of innovative products that address key challenges in women’s health. The company currently commercializes a single-dose oral treatment for bacterial vaginosis and trichomoniasis and a hormone-free contraceptive vaginal gel. Its long-term goal is to deliver comprehensive healthcare solutions spanning prevention, diagnosis and treatment of sexual and reproductive health concerns facing women at every stage of life.

“We believe that Evofem's proven expertise and strategic focus on women’s health make them the ideal partner for the U.S. launch of our Mitomic Endometriosis Test. Their deep industry knowledge and established relationships will be invaluable as we introduce this innovative diagnostic to the market and pave the way for future applications of our mitochondrial DNA platform,” said Christopher Mitton, President of Pearsanta.

Endometriosis has a profound impact on women's health, with significant implications beyond painful symptoms. Studies indicate that approximately 70% of women with endometriosis experience chronic pelvic pain, which can be debilitating and affect daily functioning. Moreover, nearly 50% of women with endometriosis also face challenges with infertility, as the condition is a leading cause of female infertility. Additionally, endometriosis is associated with a higher risk of comorbid conditions such as irritable bowel syndrome (IBS) and interstitial cystitis, complicating overall health management. The condition can lead to substantial psychological stress, with many women reporting anxiety, depression, and a reduced quality of life due to persistent pain and infertility issues.

Early diagnosis of endometriosis is important to allow medical or surgical intervention to alleviate its symptoms and potentially slow or halt the natural progression of the disease. At present, there are no validated blood-based diagnostic tests for endometriosis¹. Pearsanta aims to address this unmet need with its MET.

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, said, “This partnership showcases the Aditxt platform in action, accelerating growth and transforming high-impact innovations into reality. By seeking to advance Pearsanta toward the commercialization of its Mitomic Endometriosis Test in 2025, while simultaneously supporting Evofem’s goals to expand its portfolio and diversify revenue streams through its existing infrastructure, we demonstrate how our platform seeks to drive progress for both current and incoming subsidiaries. We at Aditxt are proud to empower innovation and strive to help companies deliver transformative healthcare solutions to the market.”

“Knowledge is power and using Pearsanta’s Mitomic Endometriosis Test physicians will be able to diagnose and improve the lives of women who suffer from this debilitating chronic disease,” said Saundra Pelletier, CEO of Evofem Biosciences. “We look forward to leveraging our strong relationships with OB/GYNs and allied healthcare providers to plan and execute the successful U.S. launch of this first-in-class non-invasive diagnostic.”

Beyond the MET, this collaboration has the potential to further expand Evofem’s women’s health business with future tests developed by Pearsanta, such as the Mitomic Ovarian Test for early detection of ovarian cancer.

About the Mitomic Technology Platform

Pearsanta’s proprietary Mitomic® Technology Platform harnesses 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 continued persistence in cells, mtDNA has the potential to be an excellent biomarker for early disease detection. The program currently focuses on developing tests for early cancer detection (ovarian, prostate, and lung cancers), as well as non-cancerous conditions like endometriosis.

About Pearsanta, Inc.

Pearsanta is at the forefront of precision health, focusing on early cancer detection through advanced diagnostic technologies. Its proprietary Mitomic Technology Platform leverages the unique properties of mitochondrial DNA to detect cancer and other diseases with high accuracy via non-invasive, blood-based liquid biopsy tests. Pearsanta's asset portfolio also includes a range of other innovative diagnostic technologies, all aimed at transforming early disease detection and monitoring, enabling more informed treatment decisions, and ultimately improving patient outcomes.

Mitomic® is a registered trademark and MET™ is a trademark of Pearsanta, Inc.

About Evofem Biosciences, Inc.

Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi^® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.

In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC^® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose.

Follow us on:

LinkedIn: https://www.linkedin.com/company/evofem
Facebook: http://www.facebook.com/Evofem
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Phexxi^® and SOLOSEC^® are registered trademarks of Evofem Biosciences, Inc.

About Aditxt, Inc.

Aditxt, Inc.® is an innovation platform dedicated to accelerating promising health 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.

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 these, 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. 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.

For more information, www.aditxt.com.

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

Sources

¹World Health Organization fact sheet: Endometriosis. 24 March 2023. https://www.who.int/news-room/fact-sheets/detail/endometriosis.

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/20240920482981/en/

Aditxt, Inc.

Mary O’Brien

Mobrien@aditxt.com

516-753-9933

Source: Aditxt, Inc.

FAQ

What is the Mitomic Endometriosis Test (MET) developed by Aditxt's subsidiary Pearsanta?

The Mitomic Endometriosis Test (MET) is a blood-based diagnostic test that detects a specific deletion in mitochondrial DNA, serving as a novel biomarker for endometriosis. It aims to be the first validated blood-based test for endometriosis in the U.S.

When is Aditxt (ADTX) planning to launch the endometriosis diagnostic test in the U.S.?

Aditxt (ADTX) is planning to launch the Mitomic Endometriosis Test (MET) in the United States in mid-2025, as announced in their collaboration agreement with Evofem Biosciences.

How many endometriosis cases have been evaluated using Aditxt's MET diagnostic?

To date, over 300 endometriosis cases have been evaluated using the Mitomic Endometriosis Test (MET). The company plans to evaluate a total of 600 cases to support its clinical validation.

What is the potential market size for Aditxt's (ADTX) endometriosis diagnostic test?

According to the World Health Organization, endometriosis affects approximately 190 million women and girls worldwide, or about one in ten women of reproductive age, representing a significant potential market for Aditxt's (ADTX) diagnostic test.