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Aditxt, Inc.

ADTX
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Business Summary

Aditxt, Inc. (ADTX) is an innovation platform incorporated in Delaware on September 28, 2017, with headquarters in Mountain View, California, focused on redefining health innovation through a socially owned and guided ecosystem . The company's core business model revolves around discovering, developing, and deploying promising health innovations, primarily through its subsidiaries and licensed technologies. Aditxt generates revenue from services related to its AditxtScore™ platform, which provides personalized immune system profiles . However, the company has generated no significant revenue from commercial sales to date and has incurred substantial operating losses since its inception, raising substantial doubt about its ability to continue as a going concern , .

Aditxt operates through several key subsidiaries and licensed technologies. Adimune™, Inc., formed in January 2023, leads the immune modulation therapeutic programs, with its proprietary Apoptotic DNA Immunotherapy™ (ADI™) platform . The first product candidate, ADI-100, is designed to induce tolerance against glutamic acid decarboxylase (GAD), implicated in type-1 diabetes (T1D), psoriasis, and autoimmune diseases of the CNS . Preclinical studies for ADI-100 have been completed, showing potential effectiveness in restoring durable tolerance and absence of drug toxicity . Clinical-grade drug substances have been manufactured, and Adimune has engaged a Contract Research Organization (CRO) for planned clinical trials in Germany for psoriasis and T1D . A human trial for Stiff Person Syndrome (SPS) is expected to begin in 2026 with 10-20 patients, pending regulatory approvals .

Pearsanta, Inc. is focused on developing molecular tests based on mitochondrial DNA (mtDNA) for early cancer detection . Pearsanta acquired the assets of MDNA Life Sciences, Inc. on January 4, 2024, including the Mitomic® Technology platform . While Pearsanta has no commercially available FDA or foreign regulatory approved products, it has two product candidates in development: a potential product for prostate cancer diagnosis (Mitomic® Prostate Test or MPT™) and a potential product for the detection of endometriosis (Mitomic Endometriosis Test or MET™) . Pearsanta has also discovered mtDNA-based biomarkers associated with ovarian and lung cancer and intends to pursue biomarker identification for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers . Pearsanta leases a CLIA-certified, CAP-accredited, and NYS CLEP-approved laboratory facility in Richmond, VA . Additionally, on March 21, 2025, Pearsanta acquired patents related to Adductomics Technology, which aims to assess DNA adducts for early cancer risk identification, with further development anticipated over the next two to three years .

Adivir™, Inc., formed in April 2023, is a wholly owned subsidiary dedicated to advancing innovative products for infectious disease and population health, focusing on antiviral and antimicrobial solutions . Adifem, Inc., formed in April 2024, was established for a planned strategic expansion into women's health through a proposed acquisition of Evofem Biosciences . However, Aditxt is no longer pursuing the acquisition of Evofem Biosciences, though it retains its holdings of Evofem F-1 Preferred Stock, convertible notes, and Evofem Warrants .

For the fiscal year ended December 31, 2025, Aditxt reported total revenue of $3,195 , a significant decrease from $133,985 in the prior year . Cost of goods sold was $2,927 , resulting in a gross profit of $268 . The company incurred a net loss of $42,787,043 for the year, compared to a net loss of $35,020,058 in 2024 . The net loss attributable to Aditxt, Inc. & Subsidiaries was $43,101,451 . Basic and diluted net loss per common share was $(1,153.83) . Cash and equivalents stood at $3,198,599 as of December 31, 2025 , up from $833,031 in 2024 . Total current liabilities were $12,220,193 , and total liabilities were $12,563,099 . The company had an accumulated deficit of $209,808,770 as of December 31, 2025 .

The decrease in revenue and cost of goods sold in 2025 compared to 2024 was primarily due to a decrease in AditxtScore™ orders, specifically decreased COVID testing . Operating expenses decreased from $27,370,209 in 2024 to $19,570,992 in 2025, mainly driven by decreased research and development spend , . General and administrative expenses were $15,974,863 in 2025, including $4,438,898 in payroll expenses and $5,477,124 in professional fees . Research and development expenses were $3,194,133 in 2025, including $995,473 in consulting expenses . Other expenses in 2025 totaled $23,216,319, primarily due to a loss on the change in the fair value of Evofem F-1 preferred stock of $23,766,209, partially offset by a gain on the change in the fair value of Evofem warrants of $2,806,983 and a bargain purchase gain from Evofem convertible notes of $328,071 .

During the reported period, Aditxt terminated its exclusive worldwide sublicense agreement with Pearsanta for the AditxtScore™ technology on September 23, 2025, and subsequently granted Pearsanta a non-exclusive licensing agreement for evaluating SARS-CoV-2 antibodies as of December 30, 2025 . The planned acquisition of Evofem Biosciences was terminated on October 20, 2025, due to the end date having passed and failure to obtain shareholder approval . The company also acquired certain patents related to Adductomics Technology on March 21, 2025 . Aditxt effectuated a 1-for-250 reverse stock split on March 14, 2025, and a 1-for-113 reverse stock split on November 3, 2025 , .

Business Outlook

Aditxt has not provided formal revenue, margin, or EPS guidance for the upcoming period. The company explicitly states that it has generated no significant revenue from commercial sales to date and expects to continue operating at a net loss for at least the next several years as it commences research and development efforts, conducts clinical trials, and develops manufacturing, sales, marketing, and distribution capabilities . The company's ability to continue as a going concern is dependent upon its ability to complete clinical studies, implement its business plan, generate sufficient revenues, and control operating expenses .

A major growth area for Aditxt is the advancement of its immune modulation therapeutic programs through its Adimune™ subsidiary. The first product candidate, ADI-100, has completed preclinical studies and is being prepared for clinical trials in Germany for psoriasis and T1D . A human trial for Stiff Person Syndrome (SPS) is expected to get underway in 2026 with enrollment of 10-20 patients, some of whom may also have T1D . The primary readouts for these studies will be safety and tolerability, as well as clinical and immunological signals of tolerance induction . Adimune believes its ADI™ platform, which mimics the body's natural tolerance induction, can be engineered to address a wide variety of indications and offers advantages such as selective immune suppression and in-body induction of apoptosis, not requiring additional hospitalization .

Another significant growth vector is Pearsanta's development of molecular tests based on mitochondrial DNA (mtDNA) for early cancer detection. Pearsanta has two product candidates in development: the Mitomic® Prostate Test (MPT™) for prostate cancer diagnosis and the Mitomic Endometriosis Test (MET™) for endometriosis detection . The MPT™ is designed as a blood-based assay to quantify the 3.4kb mtDNA deletion, potentially aiding in biopsy decisions for men in the PSA grey zone . The MET™ is a blood-based assay for mtDNA deletions associated with endometriosis, intended for females of child-bearing age with symptoms . Pearsanta also plans to pursue biomarker identification for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers . The company intends to license distribution rights through various agreements with U.S.-based and international business partners to commercialize its Mitomic® Technology, pending successful development and regulatory approvals . The recently acquired Adductomics Technology, focused on detecting DNA adducts for early cancer risk, is anticipated to advance toward clinical and commercial applications over the next two to three years .

Regarding operational outlook, Aditxt anticipates incurring additional net expenses over the next several years as it continues to maintain and expand existing operations . The company's current cash position is not expected to be sufficient to fund operations for the next 12 months . Aditxt is consistently focused on raising capital, strategic acquisitions, and alliances, and other initiatives to strengthen the company . The company relies on third parties for the production and distribution of its future products, including its AditxtScore™ platform, and any failure by these parties to perform satisfactorily could delay sales and development efforts .

Aditxt plans to finance acquisitions primarily through additional debt and equity financings . The company has the ability to raise capital from equity or debt through private placements or public offerings pursuant to a registration statement on Form S-1, and may also secure loans from related parties . As of December 31, 2025, the maximum amount of securities that the Company could offer and sell under its shelf registration statement on Form S-3 was $54,053,691 . The company does not intend to declare dividends for the foreseeable future, as it anticipates reinvesting any future earnings in the development and growth of its business .

The company faces structural headwinds related to its financial situation, which creates doubt about its ability to continue as a going concern . Aditxt is not compliant with Nasdaq Listing Rule 5550(b)(1) requiring a minimum of $2,500,000 in stockholders' equity, and has been granted an extension until May 15, 2026, to regain compliance . Furthermore, its common stock has traded below $1.00 for 6 consecutive trading days as of the filing date, potentially leading to a minimum bid price deficiency notice . A proposed Nasdaq rule change could also lead to immediate suspension and delisting if market capitalization falls below a specified minimum threshold, such as $5.0 million, for 30 consecutive business days; Aditxt's market capitalization was approximately $713,000 as of March 30, 2026 . The regulatory approval process for its product candidates is expensive, time-consuming, and uncertain, and delays in clinical studies could lead to additional costs or failure to demonstrate adequate safety and efficacy . The company's technologies are subject to licenses from Loma Linda University (LLU) and Stanford, which are revocable if certain payment and milestone deadlines are not met . For instance, the LLU License Agreement requires regulatory approval of an IND application by March 31, 2024 (extended from March 31, 2023 with a $100,000 extension fee), completion of Phase I/II clinical trials by March 31, 2024, completion of Phase III clinical trials by March 31, 2026, and BLA approval by March 31, 2027 .

Risk Factors

Aditxt faces significant risks, including substantial doubt about its ability to continue as a going concern due to a limited operating history, no significant commercial revenue to date, and net losses of $42,787,043 in 2025 and $35,020,058 in 2024, with an accumulated deficit of $209,808,770 as of December 31, 2025 . The company's ability to remain listed on The Nasdaq Capital Market is at risk, as it is non-compliant with the minimum $2,500,000 stockholders' equity requirement and has been granted an extension until May 15, 2026, to regain compliance . Additionally, its common stock has traded below $1.00 for 6 consecutive trading days, and a proposed Nasdaq rule could lead to delisting if market capitalization falls below $5.0 million for 30 consecutive business days, while Aditxt's market capitalization was approximately $713,000 as of March 30, 2026 . The regulatory approval process for product candidates is expensive, time-consuming, and uncertain, with potential for substantial delays in clinical studies and failure to demonstrate adequate safety and efficacy . The company relies on licenses from Loma Linda University and Stanford for key technologies, which are revocable if specific payment and milestone deadlines are not met, such as IND approval by March 31, 2024, and BLA approval by March 31, 2027, for the LLU License Agreement . Operational risks include reliance on third parties for manufacturing and distribution, potential for product recalls due to adverse events, and the challenge of attracting and retaining highly skilled employees . The company is also involved in legal proceedings, including a lawsuit by Vertalo, Inc. seeking $300,000 in alleged unpaid fees, warrants for 6,250 shares of common stock, $26,000 in travel-related costs, and additional damages of at least $500,000 .

Management Priorities

Management's message to shareholders emphasizes a mission of redefining health innovation by harnessing the power of large groups of stakeholders to advance human well-being . They highlight the socialization of innovation as key to transforming more innovations more rapidly and efficiently . Despite significant net losses of $42,787,043 in 2025 and $35,020,058 in 2024, and an accumulated deficit of $209,808,770 as of December 31, 2025, management acknowledges the substantial doubt about the company's ability to continue as a going concern . Their strategic priorities include actively pursuing numerous capital raising transactions to secure sufficient bridge funding for existing capital needs and more substantial capital raises for longer-term requirements . They are also focused on completing clinical studies for product candidates like ADI-100, with a human trial for Stiff Person Syndrome expected to get underway in 2026 , and advancing the development and commercialization of diagnostic tests through Pearsanta, such as the Mitomic® Prostate Test and Mitomic Endometriosis Test . Management also stresses the importance of strategic acquisitions and alliances to strengthen the company .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview and Mission
  2. [2] Item 3, Summary of Significant Accounting Policies — Revenue Recognition
  3. [3] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need for Capital
  4. [4] Item 7, MD&A — Going Concern
  5. [5] Item 1, Business — ADIMUNE™, INC. Subsidiary
  6. [6] Item 1, Business — ADIMUNE™, INC. Subsidiary
  7. [7] Item 1, Business — ADIMUNE™, INC. Subsidiary
  8. [8] Item 1, Business — ADIMUNE™, INC. Subsidiary
  9. [9] Item 1, Business — ADIMUNE™, INC. Subsidiary
  10. [10] Item 1, Business — PEARSANTA, INC. Subsidiary
  11. [11] Item 1, Business — PEARSANTA, INC. Subsidiary
  12. [12] Item 1, Business — PEARSANTA, INC. Subsidiary
  13. [13] Item 1, Business — PEARSANTA, INC. Subsidiary
  14. [14] Item 1, Business — Technologies – Mitomic® Technology Platform
  15. [15] Item 1, Business — Technologies – Adductomics Technology
  16. [16] Item 1, Business — ADIVIR™, INC. Subsidiary
  17. [17] Item 1, Business — ADIFEM, INC. Subsidiary
  18. [18] Item 1, Business — Evofem Termination
  19. [19] Item 7, MD&A — Financial Results
  20. [20] Item 7, MD&A — Financial Results
  21. [21] Item 7, MD&A — Financial Results
  22. [22] Item 7, MD&A — Financial Results
  23. [23] Item 7, MD&A — Financial Results
  24. [24] Item 7, MD&A — Financial Results
  25. [25] Item 8, Consolidated Statements of Operations — Net Loss Attributable to Aditxt, Inc. & Subsidiaries
  26. [26] Item 8, Consolidated Statements of Operations — Net loss per share, basic and diluted
  27. [27] Item 8, Consolidated Balance Sheets — Cash
  28. [28] Item 8, Consolidated Balance Sheets — Cash
  29. [29] Item 8, Consolidated Balance Sheets — TOTAL CURRENT LIABILITIES
  30. [30] Item 8, Consolidated Balance Sheets — TOTAL LIABILITIES
  31. [31] Item 8, Consolidated Balance Sheets — Accumulated deficit
  32. [32] Item 7, MD&A — Results of Operations
  33. [33] Item 7, MD&A — Results of Operations
  34. [34] Item 7, MD&A — Results of Operations
  35. [35] Item 7, MD&A — Results of Operations
  36. [36] Item 7, MD&A — Results of Operations
  37. [37] Item 7, MD&A — Results of Operations
  38. [38] Item 1, Business — Licensed Technologies – AditxtScore™
  39. [39] Item 1, Business — Evofem Termination
  40. [40] Item 1, Business — Technologies – Adductomics Technology
  41. [41] Item 1, Note 1 — Reverse Stock Splits
  42. [42] Item 1, Note 1 — Reverse Stock Splits
  43. [43] Item 1A, Risk Factors — We have generated no significant revenue from commercial sales to date and our future profitability is uncertain.
  44. [44] Item 2, Going Concern Analysis — Management Plans
  45. [45] Item 1, Business — ADIMUNE™, INC. Subsidiary
  46. [46] Item 1, Business — ADIMUNE™, INC. Subsidiary
  47. [47] Item 1, Business — ADIMUNE™, INC. Subsidiary
  48. [48] Item 1, Business — Advantages
  49. [49] Item 1, Business — Our Mitomic® Products and Product Candidates
  50. [50] Item 1, Business — Mitomic® Prostate Test (MPT™)
  51. [51] Item 1, Business — Mitomic Endometriosis Test (MET™)
  52. [52] Item 1, Business — PEARSANTA, INC. Subsidiary
  53. [53] Item 1, Business — Technologies – Mitomic® Technology Platform
  54. [54] Item 1, Business — Technologies – Adductomics Technology
  55. [55] Item 7, MD&A — Financial Results
  56. [56] Item 1A, Risk Factors — We may need to raise additional funding, which may not be available on acceptable terms, or at all.
  57. [57] Item 2, Going Concern Analysis — Management Plans
  58. [58] Item 1A, Risk Factors — We rely on third parties for the distribution of our current and future products, including our AditxtScore™ platform.
  59. [59] Item 1A, Risk Factors — We may not be able to successfully fund acquisitions due to the unavailability of equity or debt financing on acceptable terms, which could impede the implementation of our acquisition strategy.
  60. [60] Item 2, Going Concern Analysis — Management Plans
  61. [61] Item 2, Going Concern Analysis — Management Plans
  62. [62] Item 5, Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities — Dividend Policy
  63. [63] Item 1A, Risk Factors — Our financial situation creates doubt whether we will continue as a going concern; Item 2, Going Concern Analysis — Management Plans
  64. [64] Item 1A, Risk Factors — Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
  65. [65] Item 1A, Risk Factors — Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
  66. [66] Item 1A, Risk Factors — Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
  67. [67] Item 1A, Risk Factors — The regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates, if any.
  68. [68] Item 1A, Risk Factors — Certain technologies are subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including in the event we do not achieve certain payments and milestone deadlines.
  69. [69] Item 1A, Risk Factors — Certain technologies are subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including in the event we do not achieve certain payments and milestone deadlines.
  70. [70] Item 1A, Risk Factors — Our financial situation creates doubt whether we will continue as a going concern; Item 1A, Risk Factors — We have generated no significant revenue from commercial sales to date and our future profitability is uncertain.
  71. [71] Item 1A, Risk Factors — Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
  72. [72] Item 1A, Risk Factors — Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
  73. [73] Item 1A, Risk Factors — The regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates, if any.
  74. [74] Item 1A, Risk Factors — Certain technologies are subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including in the event we do not achieve certain payments and milestone deadlines.
  75. [75] Item 1A, Risk Factors — We rely on third parties for the distribution of our current and future products, including our AditxtScore™ platform; Item 1A, Risk Factors — Adverse events involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results; Item 1A, Risk Factors — If we are not able to attract and retain highly skilled employees and contractors, we may not be able to implement our business model successfully.
  76. [76] Item 1A, Risk Factors — Claims, litigation, government investigations, product liability and recalls, and other proceedings may adversely affect our business, operating results, financial condition, and cash flows.
  77. [77] Item 1, Business — Overview and Mission
  78. [78] Item 1, Business — Overview and Mission
  79. [79] Item 7, MD&A — Going Concern
  80. [80] Item 2, Going Concern Analysis — Management Plans
  81. [81] Item 1, Business — ADIMUNE™, INC. Subsidiary
  82. [82] Item 1, Business — Our Mitomic® Products and Product Candidates
  83. [83] Item 2, Going Concern Analysis — Management Plans

Analysis on 5/22/2026