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Aditxt Inc. (NASDAQ: ADTX)

 

Aditxt Inc. (NASDAQ: ADTX) is a innovation company developing technologies focused on mapping and reprogramming the immune system. Aditxt's immune mapping technologies are designed to provide a personalized immune profile. Aditxt's immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.

As further discussed below, the company's first commercial product is an immune mapping technology, AditxtScore™, which is designed to provide a personalized profile of the immune system.

The company's preclinical immune reprogramming technology, Apoptotic DNA Immunotherapy™ ("ADi™"), aims to retrain the immune system to induce tolerance, with the goal of addressing vast unmet needs in transplanted organ rejection, autoimmune diseases, and allergies. The company is developing specific ADi™ products for psoriasis, type 1 diabetes, and skin grafting.

Headquartered in Richmond, Virginia, Aditxt also operates locations in Silicon Valley and New York.

AditxtScore™

AditxtScore™ is a proprietary platform designed to provide a personalized, comprehensive profile of an individual's immune system. The underlying technology, licensed from Stanford University through an exclusive worldwide agreement, offers a highly sensitive and accurate method of detecting and quantifying cellular responses, allowing greater specificity, quantification, and amplification of both clinical and commercial opportunities.

The company's first commercial application of the platform, AditxtScore™ for COVID-19, delivers timely reports on vulnerability and immune status relating to SARS-CoV-2 and its known variants, giving consumers and physicians the data needed to make informed health decisions. Potential future applications will offer early detection of an array of conditions, including diabetes, cardio-metabolic maladies and hormonal imbalances.

Aditxt's AditxtScore™ immune monitoring center in Richmond, Virginia, is operational and designed to support the anticipated increased demand for AditxtScore™ as well as related products and services. The company is currently scaling its capabilities at this location, with a goal of processing up to 10 million immune system tests/reports annually.

ADi™

ADi™ is Aditxt's immune reprogramming platform addressing disease-causing immune responses while maintaining the immune system's ability to combat pathogenic infection. The company is commercializing a nucleic acid-based technology called Apoptotic DNA Immunotherapy™ (ADi™) which utilizes a novel approach that mimics the way our bodies naturally induce tolerance to our own tissues (therapeutically induced immune tolerance). Aditxt believes its ADi™ technology platform can be engineered to address a wide variety of indications.

Aditxt is currently developing ADi™ products for psoriasis, type 1 diabetes and skin grafting.

Currently, immuno-tolerance is achievable through chimerism and cell-based therapy, but there is a clinical need for a more practical and cost-effective approach which:

  • Can be made into a product
  • Does not require additional hospitalization
  • Is simple to produce and ship

Preclinical studies have demonstrated that ADi™ treatment significantly and substantially prolongs graft survival, in addition to successfully "reversing" other established immune-mediated inflammatory processes. ADi™ treatment is not expected to require hospitalization, instead being delivered as an injection in minute amounts into the skin.

IP Portfolio

Both AditxtScore™ and ADi™ are supported by a strong IP portfolio.

AditxtScore™, built upon initial technology invented, licensed from and used at Stanford University, is protected by U.S. patents encompassing methods, systems, and kits for detection and measurement of specific immune responses.

ADi™ technology is protected by seven patent families, including:

  • 8 U.S. patents
  • 4 pending U.S. patent applications
  • 86 foreign patents and 14 pending foreign patent applications spanning the EU, Australia, Canada, Japan, China, India and Hong Kong

These patents are broadly categorized into three groups:

  • Autoimmune diseases and Type 1 Diabetes
  • Organ transplantation and a method of producing plasmid DNA to prevent immune activation
  • Composition of matter for a tolerance delivery system for antigens of interest

Aditxt also possesses and/or in-licenses substantial know-how and trade secrets relating to the development and commercialization of its product candidates, including related manufacturing processes and technologies.

Market Overview

The potential market opportunities presented by immune monitoring and reprogramming are extensive, particularly as Aditxt continues to evaluate additional applications for the platforms.

The company's initial focus on organ transplantation and related autoimmune response provides some insight into the potential of its approach. According to BCC Research, the global organ and tissue transplantation and alternatives market is on course to reach $120.3 billion by 2024, recording a CAGR of 7.4% from 2019. Industry data suggest that approximately 50% of all transplanted organs are rejected within 10-12 years, further highlighting the critical need for a practical, cost-effective solution to harmful autoimmune responses.

Through its focus on the COVID-19 testing market with AditxtScore™, Aditxt demonstrated the wide-ranging potential of its portfolio. Fortune Business Insights estimated the global COVID-19 diagnostics market at $48.64 billion for 2022. While demand for COVID-19 diagnostics is expected to lessen in the coming years, Aditxt will be uniquely positioned to leverage its existing infrastructure stemming from these operations as the company works to advance broader applications for the AditxtScore™ platform.

Leadership Team

Amro Albanna is the Co-Founder, Chairman, and CEO of Aditxt. He has founded multiple startups to commercialize innovations in various industries, including healthcare, enterprise software, telecommunications, nano technology, consumer health, and biotech. Mr. Albanna has led numerous M&A and going-public transactions as a founder, co-founder, and senior executive.

Shahrokh Shabahang, D.D.S., MS, Ph.D., is the company's Co-Founder, Chief Innovation Officer, and a member of its board. He brings to the team more than 20 years of experience in developing and commercializing life science technologies focused on product and clinical development in the fields of microbiology and immunology.

Corinne Pankovcin, CPA, MBA, is the President of Aditxt. Prior to joining Aditxt, Ms. Pankovcin served as CFO for several world class organizations, including Business Development Corporation of America, Blackrock Kelso Capital and AIG Capital Partners. In these roles, Ms. Pankovcin was responsible for executing portfolio investments and managing significant M&A transactions.

Thomas Farley is the Chief Financial Officer of Aditxt. From December 2015 to June 2020, Mr. Farley was the Controller and Treasurer of Business Development Corporation of America ("BDCA"), a publicly listed business development company. Prior thereto, from January 2011 to August 2015, Mr. Farley was the Senior Controller of Blackrock Capital Investment Corporation (NASDAQ: BKCC). Prior to joining BlackRock Capital Investment Corporation, Mr. Farley was a Senior Controller for PineBridge Investments Emerging Markets practice. Mr. Farley was also an Accounting Manager for Bessemer Venture Partners prior to his tenue at PineBridge. Mr. Farley began his career with PricewaterhouseCoopers LLP, from 1996 to 2001. Mr. Farley earned his B.S. in Accounting from Long Island University and is a Certified Public Accountant.

Rowena Albanna is the company's Chief Operating Officer. Ms. Albanna has over two decades of experience in senior leadership roles for both technology startups and public companies. Ms. Albanna's experience spans a wide variety of industries, including biotechnology, insect control, nanotechnology, consumer electronics, financials, telecommunications, e-commerce, online marketing, medical, and defense.

Matthew Shatzkes is the Chief Legal Officer and General Counsel of Aditxt. As a former partner at an AM Law 50 law firm, Mr. Shatzkes advised a wide variety of healthcare related entities, including biotech companies, on corporate, regulatory, and strategic business matters. Mr. Shatzkes will oversee all aspects of the legal functions at Aditxt, including, providing advice and counsel on governance, regulatory matters, strategic alliances, mergers and acquisitions, and commercial transactions.

 

Investment Considerations

  • Aditxt is commercializing new innovations with focus on mapping and reprogramming the immune system.
  • Aditxt is actively adding distribution channel partners for AditxtScore™ throughout the U.S. and globally.
  • The company aims to expand reimbursement coverage for AditxtScore™ for COVID-19 from private insurance and public payers while developing and commercializing tests for other indications.
  • Aditxt intends to advance its ADi™ therapeutics pipeline into clinical trials in the coming months, with initial studies targeting psoriasis, type 1 diabetes, and skin allograft transplantation.
  • The company is led by a team of experts coming from a variety of different scientific fields and business backgrounds.

 

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