Aditxt’s Target Acquisition Appili Therapeutics Announces Alignment with FDA on Development Requirements for ATI-1801 Topical Antiparasitic Product NDA Submission

Rhea-AI Summary

Aditxt (NASDAQ: ADTX) has announced a significant development regarding its target acquisition, Appili Therapeutics (TSX: APLI; OTCPink: APLIF). The U.S. Food and Drug Administration (FDA) has provided positive feedback on the development strategy for ATI-1801, Appili's topical antiparasitic product. This feedback aligns with the requirements for the New Drug Application (NDA) submission.

Positive

• FDA's positive feedback on ATI-1801 development strategy indicates progress toward NDA submission
• Advancement in acquisition process of Appili Therapeutics shows strategic expansion

Negative

• None.

Insights

Medical Research Analyst

The FDA alignment for ATI-1801's development pathway represents a significant milestone, but lacks important details about the specific requirements or timeline for the NDA submission. While positive FDA feedback typically reduces regulatory uncertainty, this announcement provides insufficient information about the actual development requirements, potential market size, or financial implications. The news is particularly relevant given ADTX's planned acquisition of Appili, but without specifics on the acquisition terms or ATI-1801's commercial potential, the immediate impact remains Key missing elements include: clinical trial requirements, development costs, market opportunity size and acquisition completion timeline.

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a social innovation platform dedicated to accelerating promising health innovations, today shared an important milestone for its target acquisition, Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (“Appili”), announcing that the U.S. Food and Drug Administration (“FDA”) has provided positive feedback regarding the development strategy for ATI-1801. For additional information, please visit https://finance.yahoo.com/quote/APLIF/news/.

About Appili Therapeutics, Inc.

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfil its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

About Aditxt, Inc.

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. 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.

Follow us on:

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

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/20241031421903/en/

Aditxt, Inc.

Investors:

Jeff Ramson, PCG Advisory, Inc.

T: 646-863-6893 M: 917-912-9130

Jramson@pcgadvisory.com

Media:

Mary O’Brien

Mobrien@aditxt.com

Source: Aditxt, Inc.

FAQ

What feedback did FDA provide for Aditxt's (ADTX) target acquisition Appili regarding ATI-1801?

The FDA provided positive feedback regarding the development strategy for ATI-1801, Appili's topical antiparasitic product, aligning with NDA submission requirements.

What is the significance of FDA's feedback for Aditxt (ADTX) and Appili's ATI-1801?

The FDA's positive feedback represents an important milestone in the development pathway for ATI-1801, supporting progress toward NDA submission and potentially advancing the acquisition process.

What type of product is Appili's ATI-1801 that Aditxt (ADTX) is targeting to acquire?

ATI-1801 is a topical antiparasitic product being developed by Appili Therapeutics, which is currently a target acquisition for Aditxt.