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Aditxt Subsidiary Pearsanta Engages Dominari Securities for its Initial Public Offering, to Drive U.S. and Global Commercial Launch of Early Cancer Detection and Diagnosis Targeted for H2 2025

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Aditxt (NASDAQ: ADTX) announced that its subsidiary, Pearsanta, has engaged Dominari Securities as lead underwriter for its planned IPO, targeted for H2 2025. The IPO aims to support Pearsanta's commercial launch of early cancer detection technology in the U.S. and internationally.

Pearsanta is developing a non-invasive blood-based test using proprietary Mitomic® Technology, which utilizes mitochondrial DNA deletions as biomarkers for disease detection. The company is currently advancing clinical validation, including a randomized controlled study of the Mitomic Prostate Test (MPT).

The company has submitted two research proposals: a $2.3M proposal to evaluate MPT's role in reducing unnecessary biopsies, with a decision expected in H1 2025, and a $1.1M proposal for validating the Mitomic Ovarian Test (MOT), which was not funded. IPO proceeds will fund the U.S. launch of Laboratory Developed Tests and drive global commercialization through partnerships and regulatory approvals.

Aditxt (NASDAQ: ADTX) ha annunciato che la sua controllata, Pearsanta, ha incaricato Dominari Securities come principale sottoscrittore per la sua IPO pianificata, prevista per il secondo semestre del 2025. L'IPO mira a supportare il lancio commerciale della tecnologia di rilevamento precoce del cancro di Pearsanta negli Stati Uniti e a livello internazionale.

Pearsanta sta sviluppando un test non invasivo basato su un campione di sangue utilizzando la Mitomic® Technology, che sfrutta le delezioni del DNA mitocondriale come biomarcatori per la rilevazione delle malattie. L'azienda sta attualmente portando avanti la validazione clinica, inclusa uno studio controllato randomizzato del Mitomic Prostate Test (MPT).

L'azienda ha presentato due proposte di ricerca: una proposta da 2,3 milioni di dollari per valutare il ruolo dell'MPT nella riduzione delle biopsie non necessarie, con una decisione attesa nel primo semestre del 2025, e una proposta da 1,1 milioni di dollari per la validazione del Mitomic Ovarian Test (MOT), che non è stata finanziata. I proventi dell'IPO finanzieranno il lancio negli Stati Uniti dei Test Sviluppati in Laboratorio e guideranno la commercializzazione globale attraverso partnership e approvazioni normative.

Aditxt (NASDAQ: ADTX) anunció que su subsidiaria, Pearsanta, ha contratado a Dominari Securities como el suscriptor principal para su próxima OPI, prevista para el segundo semestre de 2025. La OPI tiene como objetivo apoyar el lanzamiento comercial de la tecnología de detección temprana de cáncer de Pearsanta en EE. UU. y a nivel internacional.

Pearsanta está desarrollando una prueba no invasiva basada en sangre utilizando la Mitomic® Technology, que utiliza deleciones de ADN mitocondrial como biomarcadores para la detección de enfermedades. La compañía está avanzando en la validación clínica, incluyendo un estudio controlado aleatorio del Mitomic Prostate Test (MPT).

La empresa ha presentado dos propuestas de investigación: una propuesta de 2,3 millones de dólares para evaluar el papel del MPT en la reducción de biopsias innecesarias, con una decisión esperada para el primer semestre de 2025, y una propuesta de 1,1 millones de dólares para validar el Mitomic Ovarian Test (MOT), que no fue financiada. Los ingresos de la OPI financiarán el lanzamiento de Tests Desarrollados en Laboratorio en EE. UU. y impulsarán la comercialización global a través de asociaciones y aprobaciones regulatorias.

Aditxt (NASDAQ: ADTX)는 자회사인 Pearsanta가 2025년 하반기로 예정된 IPO를 위해 Dominari Securities를 주관 주식 인수인으로 선정했다고 발표했습니다. 이 IPO는 Pearsanta의 미국 및 국제 시장에서 조기 암 탐지 기술의 상업적 출시를 지원하는 것을 목표로 합니다.

Pearsanta는 질병 탐지를 위한 바이오마커로 미토콘드리아 DNA 결실을 활용하는 독자적인 Mitomic® Technology를 사용하여 비침습적인 혈액 기반 검사를 개발하고 있습니다. 현재 회사는 Mitomic Prostate Test (MPT)에 대한 무작위 대조 연구를 포함한 임상 검증을 진행하고 있습니다.

회사는 두 가지 연구 제안을 제출했습니다: 불필요한 생검을 줄이는 데 있어 MPT의 역할을 평가하기 위한 230만 달러 제안이 있으며, 2025년 상반기 내에 결정이 예상됩니다. 또 다른 제안은 Mitomic Ovarian Test (MOT)의 검증을 위한 110만 달러 제안이지만, 이는 자금 지원을 받지 못했습니다. IPO 수익은 미국에서의 실험실 개발 검사 출시를 지원하고, 파트너십 및 규제 승인을 통해 글로벌 상업화를 추진할 것입니다.

Aditxt (NASDAQ: ADTX) a annoncé que sa filiale, Pearsanta, a engagé Dominari Securities en tant que principal souscripteur pour son introduction en bourse (IPO) prévue pour le second semestre 2025. L'IPO vise à soutenir le lancement commercial de la technologie de détection précoce du cancer de Pearsanta aux États-Unis et à l'international.

Pearsanta développe un test non invasif basé sur le sang utilisant la Mitomic® Technology, qui exploite les délétions d'ADN mitochondrial comme biomarqueurs pour la détection des maladies. L'entreprise avance actuellement dans la validation clinique, y compris une étude contrôlée randomisée du Mitomic Prostate Test (MPT).

L'entreprise a soumis deux propositions de recherche : une proposition de 2,3 millions de dollars pour évaluer le rôle du MPT dans la réduction des biopsies inutiles, avec une décision attendue au premier semestre 2025, et une proposition de 1,1 million de dollars pour valider le Mitomic Ovarian Test (MOT), qui n'a pas été financée. Les produits de l'IPO financeront le lancement des Tests Développés en Laboratoire aux États-Unis et favoriseront la commercialisation mondiale par le biais de partenariats et d'approbations réglementaires.

Aditxt (NASDAQ: ADTX) gab bekannt, dass ihre Tochtergesellschaft Pearsanta Dominari Securities als Hauptunterzeichner für den geplanten Börsengang (IPO) beauftragt hat, der für das zweite Halbjahr 2025 angestrebt wird. Der IPO zielt darauf ab, den kommerziellen Start der frühen Krebsdiagnosetechnologie von Pearsanta in den USA und international zu unterstützen.

Pearsanta entwickelt einen nicht-invasiven blutbasierten Test unter Verwendung der proprietären Mitomic® Technology, die mitochondriale DNA-Deletionen als Biomarker zur Krankheitsdetektion nutzt. Das Unternehmen arbeitet derzeit an der klinischen Validierung, einschließlich einer randomisierten kontrollierten Studie des Mitomic Prostate Test (MPT).

Das Unternehmen hat zwei Forschungsanträge eingereicht: einen Antrag über 2,3 Millionen Dollar zur Bewertung der Rolle des MPT bei der Reduzierung unnötiger Biopsien, mit einer Entscheidung, die im ersten Halbjahr 2025 erwartet wird, und einen Antrag über 1,1 Millionen Dollar zur Validierung des Mitomic Ovarian Test (MOT), der nicht finanziert wurde. Die Erlöse aus dem IPO werden den Start von im Labor entwickelten Tests in den USA finanzieren und die globale Vermarktung durch Partnerschaften und regulatorische Genehmigungen vorantreiben.

Positive
  • Strategic engagement with Dominari Securities for IPO underwriting
  • Development of innovative non-invasive blood-based cancer detection technology
  • $2.3M research proposal under review for prostate cancer detection technology
Negative
  • $1.1M proposal for ovarian cancer test validation was rejected
  • Commercial launch not expected until H2 2025
  • Early stage of development with no current revenue generation

Insights

The engagement of Dominari Securities for Pearsanta's IPO represents a strategic move in the highly competitive cancer diagnostics market, though several critical factors warrant careful consideration. The Mitomic Technology platform's focus on mitochondrial DNA deletions as cancer biomarkers presents an innovative approach, potentially differentiating it from conventional liquid biopsy tests that typically target circulating tumor DNA or protein markers.

The choice of the Laboratory Developed Test (LDT) pathway is particularly noteworthy. LDTs typically face lower regulatory hurdles compared to FDA-approved diagnostic tests, potentially enabling faster market entry. However, this approach also comes with limitations - LDTs must be performed in a single laboratory rather than distributed as test kits, which could constrain scalability and market penetration.

The company's funding strategy reveals both opportunities and challenges. The pending $2.3M Department of Defense proposal for prostate cancer testing could provide important validation, but the rejection of the $1.1M ovarian cancer proposal highlights the early stage of certain programs. This mixed funding success suggests varying levels of technical readiness across their pipeline.

The timing of the IPO announcement, targeting H2 2025, appears ambitious given the current development stage. Several critical milestones need to be achieved before then:

  • Clinical validation of their lead programs
  • Establishment of a CLIA-certified laboratory for LDT deployment
  • Development of clear reimbursement strategies
  • Building commercial infrastructure for test marketing and distribution

For Aditxt shareholders, this development presents a complex scenario. While a successful Pearsanta IPO could unlock value, the parent company's $10.1M market capitalization suggests significant execution risks. The structure of the planned IPO and Aditxt's retained ownership stake will be important factors in determining the potential upside for current shareholders.

The broader cancer diagnostics market context is essential - while early detection represents a substantial opportunity, the field is increasingly crowded with both established players and well-funded startups. Pearsanta's success will depend not only on technical validation but also on demonstrating clear clinical utility and cost-effectiveness to drive adoption among healthcare providers and secure favorable reimbursement coverage.

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a social innovation platform dedicated to accelerating promising health innovations, today announced that its subsidiary, Pearsanta, Inc. (“Pearsanta”), has engaged Dominari Securities LLC as lead underwriter for Pearsanta’s planned initial public offering (IPO). The proposed IPO, advised by Dominari Securities, is intended to support Pearsanta’s U.S. and international commercial launch efforts and further advance its Mitomic® Technology platform for early cancer detection and diagnosis.

Pearsanta is developing a non-invasive blood-based test designed to detect cancer at earlier stages when treatment outcomes are more favorable. The Company’s proprietary Mitomic® Technology leverages mitochondrial DNA deletions as biomarkers for disease detection, providing a unique approach to identifying malignancies. We believe that Pearsanta’s biomarker portfolio covers many high-clinical need cancers, with potential applications outside oncology.

As Pearsanta prepares for its planned IPO targeted for the second half of 2025, the Company is focused on advancing its commercialization strategy. IPO proceeds are intended to be used to fund the U.S. launch of its Laboratory Developed Tests (LDTs) for early cancer detection and drive global commercialization through distribution partnerships and key international regulatory approvals.

"This marks a transformative milestone for Pearsanta as we seek to revolutionize early cancer detection," said Chris Mitton, President of Pearsanta. "With more than 50% of cancers still diagnosed at late stages—drastically reducing survival rates—we believe that there is a critical need for earlier and more accurate diagnostics. By securing a strong banking team and working alongside experienced advisors, we are seeking to position Pearsanta to accelerate the commercialization of its technologies. Our mission is to expand access to innovative, non-invasive diagnostics that have the potential to improve outcomes for millions of patients worldwide."

“Cancer is one of the most pressing health challenges, and early detection is key to the fight against cancer,” said Amro Albanna, Co-Founder, Chairman and CEO of Aditxt. “Pearsanta’s planned IPO reflects Aditxt’s business model of identifying, developing and launching promising innovative solutions that drive medical advancements, improve healthcare accessibility and address critical unmet needs. We believe that this milestone is a critical step in Pearsanta’s path to commercialization, expanding its potential beyond oncology to a broader range of diseases where early intervention can have a meaningful impact.”

Clinical Validation and Funding Initiatives

Pearsanta continues to advance clinical validation and funding opportunities to expand its diagnostic pipeline. The Company is progressing key research programs, including a randomized controlled study evaluating the Mitomic Prostate Test (MPT). In August 2024, Pearsanta submitted a $2.3M proposal (PC240675) to the Department of Defense’s Congressionally Directed Medical Research Program (CDMRP) to assess MPT’s role in reducing unnecessary biopsies and improving the detection of clinically significant prostate cancer. The proposal is currently under review, with a decision anticipated in the first half of 2025.

Additionally, Pearsanta submitted a $1.1M proposal (OC240463) to the CDMRP for a clinical study validating the Mitomic Ovarian Test (MOT). This study aimed to demonstrate MOT’s potential as a novel blood test for ovarian cancer based on mitochondrial DNA deletions. While the proposal was not funded due to the early stage of the program, Pearsanta remains committed to securing additional funding and advancing clinical validation efforts to bring innovative diagnostic solutions to market.

About Pearsanta

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.

About Dominari Securities LLC

Dominari Securities LLC, a principal subsidiary of Dominari Holdings Inc., is a dynamic, forward-thinking financial services company that seeks to create wealth for all stakeholders by capitalizing on emerging trends in the financial services sector and identifying early-stage future opportunities that are expected to generate a high rate of return for investors.

About Aditxt

Aditxt, Inc.® is a social 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 Biosciences, Inc. ("Evofem") (OTCQB: EVFM). 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. These obligations include cash payments of approximately $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 million required to satisfy Evofem's senior secured noteholder; should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. On December 23, 2024, Evofem announced the cancellation of its special stockholders meeting and the withdrawal of the merger proposal with Aditxt from consideration by the stockholders. 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.

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; expected usage of the Company’s ELOC and ATM facilities; 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.

Aditxt, Inc.

Corporate Communications

Jeff Ramson, PCG Advisory, Inc.

T: 646-863-6893

Source: Aditxt, Inc.

FAQ

When is Pearsanta, Aditxt's subsidiary, planning to launch its IPO?

Pearsanta is targeting its IPO launch for the second half of 2025.

What is the status of ADTX's $2.3M Department of Defense proposal for the Mitomic Prostate Test?

The proposal (PC240675) is currently under review, with a decision expected in the first half of 2025.

What technology is Pearsanta using for cancer detection?

Pearsanta uses Mitomic® Technology, which leverages mitochondrial DNA deletions as biomarkers for disease detection through non-invasive blood-based tests.

What happened to Pearsanta's $1.1M CDMRP proposal for the Mitomic Ovarian Test?

The proposal (OC240463) was not funded due to the early stage of the program.

How will Pearsanta use the IPO proceeds?

The proceeds will fund the U.S. launch of Laboratory Developed Tests for early cancer detection and drive global commercialization through distribution partnerships and regulatory approvals.

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