What changed in Aditxt, Inc.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of Aditxt, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+527 added−770 removedSource: 10-K (2026-03-31) vs 10-K (2025-03-31)
Top changes in Aditxt, Inc.'s 2025 10-K
527 paragraphs added · 770 removed · 297 edited across 7 sections
- Item 1. Business+261 / −526 · 154 edited
- Item 1A. Risk Factors+128 / −135 · 70 edited
- Item 7. Management's Discussion & Analysis+116 / −86 · 60 edited
- Item 1C. Cybersecurity+14 / −15 · 7 edited
- Item 5. Market for Registrant's Common Equity+4 / −6 · 4 edited
Item 1. Business
Business — how the company describes what it does
154 edited+107 added−372 removed84 unchanged
Item 1. Business
Business — how the company describes what it does
154 edited+107 added−372 removed84 unchanged
2024 filing
2025 filing
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Amendment to Amended and Restated Merger Agreement On March 23, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 5 to the Amended and Restated Merger Agreement (“Amendment No. 5”), pursuant to which, the parties agreed that (i) Evofem shall use commercially reasonable efforts to hold the Company Shareholders Meeting (as defined under the A&R Merger Agreement) no later than September 26, 2025, (ii) the Company shall invest an additional $1,500,000 in Evofem no later than April 7, 2025 in exchange for additional shares of F-1 Preferred Stock and/or, at the Company’s option, senior subordinated notes of Evofem, and (iii) the End Date shall be extended to September 30, 2025.
Fifth Amendment to Amended and Restated Merger Agreement On March 23, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 5 to the Amended and Restated Merger Agreement (“Amendment No. 5”), pursuant to which, the parties agreed that (i) Evofem shall use commercially reasonable efforts to hold the Company Shareholders Meeting (as defined under the A&R Merger Agreement) no later than September 26, 2025, (ii) the Company shall invest an additional $1,500,000 in Evofem no later than April 7, 2025 in exchange for additional shares of F-1 Preferred Stock and/or, at the Company’s option, senior subordinated notes of Evofem, and (iii) the End Date shall be extended to September 30, 2025.
Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Pearsanta Preferred Stock, the Pearsanta Preferred Stock will be mandatorily and automatically converted, with no further action on the part of the holders thereof, into 1,000 fully paid and nonassessable shares of common stock (1:1,000) (the “Series B Conversion Ratio ”) of Pearsanta upon the consummation of a firm underwritten initial public offering of the common stock for cash effected pursuant to a registration statement or similar document filed by or on behalf of Pearsanta under the Securities Act of 1933, as amended (a “Pearsanta Qualifying IPO” ), provided, however, that if the value of such Pearsanta Series B Preferred Stock, on an as-converted basis, at the time of the pricing of the Pearsanta common stock in connection with the Pearsanta Qualifying IPO does not equal $1,000,000, then the conversion ratio of the Pearsanta Series B Preferred Stock will be adjusted such that the value of the securities received in the Pearsanta Qualifying IPO by the Asset Holders shall equal $1,000,000 in the aggregate.
Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Pearsanta Series B Preferred Stock, the Pearsanta Series B Preferred Stock will be mandatorily and automatically converted, with no further action on the part of the holders thereof, into 1,000 fully paid and nonassessable shares of common stock (1:1,000) (the “Series B Conversion Ratio”) of Pearsanta upon the consummation of a firm underwritten initial public offering of the common stock for cash effected pursuant to a registration statement or similar document filed by or on behalf of Pearsanta under the Securities Act of 1933, as amended (a “Pearsanta Qualifying IPO”), provided, however, that if the value of such Pearsanta Series B Preferred Stock, on an as-converted basis, at the time of the pricing of the Pearsanta common stock in connection with the Pearsanta Qualifying IPO does not equal $1,000,000, then the conversion ratio of the Pearsanta Series B Preferred Stock will be adjusted such that the value of the securities received in the Pearsanta Qualifying IPO by the Asset Holders shall equal $1,000,000 in the aggregate.
Any fraction of a share of common stock created as a result of the March Reverse Stock Split was rounded up to the next whole share. Holders of the Company’s common stock held in book-entry form or through a bank, broker or other nominee did not need to take any action in connection with the March Reverse Stock Split.
Any fraction of a share of common stock created as a result of the March 2026 Reverse Split was rounded up to the next whole share. Holders of the Company’s common stock held in book-entry form or through a bank, broker or other nominee did not need to take any action in connection with the March 2026 Reverse Split.
Diluted loss per share is computed by dividing the net loss attributable of common stockholders by the weighted average number of shares of common stock outstanding plus the dilutive effect of shares issuable through the common stock equivalents. The weighted-average number of common shares outstanding excludes common stock equivalents because their inclusion would be anti-dilutive.
Diluted loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding plus the dilutive effect of shares issuable through the common stock equivalents. The weighted-average number of common shares outstanding excludes common stock equivalents because their inclusion would be anti-dilutive.
Appili Mutual Waiver On January 30, 2025, the Company, Adivir, and Appili (the “Parties”) entered into a mutual waiver, pursuant to which, among other things, the Parties waived certain provisions of the Arrangement Agreement relating to the Outside Date not occurring on or before January 31, 2025, such waiver effective until 5:00pm (ET) on February 28, 2025, in consideration of (i) a payment by Adivir to Appili in the amount of $125,000 on or before January 31, 2025, and (ii) a payment by Adivir to Appili in the amount of $125,000 not later than February 14, 2025, to the extent the Arrangement Agreement has not been completed prior to that time.
Appili Mutual Waiver On January 30, 2025, the Company, Adivir, and Appili (the “Parties”) entered into a mutual waiver, pursuant to which, among other things, the Parties waived certain provisions of the Arrangement Agreement relating to the Outside Date not occurring on or before January 31, 2025, such waiver effective until 5:00pm (ET) on February 28, 2025, in consideration of (i) a payment by Adivir to Appili in the amount of $125,000 on or before January 31, 2025, which was paid, and (ii) a payment by Adivir to Appili in the amount of $125,000 not later than February 14, 2025, which was paid, to the extent the Arrangement Agreement has not been completed prior to that time.
Under the exclusivity agreement, we acknowledged that Stanford had already granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory (as those terms are defined in the February 2020 License Agreement”).
Under the exclusivity agreement, we acknowledged that Stanford had already granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory (as those terms are defined in the February 2020 License Agreement).
January Loan Agreement On January 24, 2024, the Company entered into a Business Loan and Security Agreement (the “January Loan Agreement”) with a commercial funding source (the “Lender”), pursuant to which the Company obtained a loan from the Lender in the principal amount of $3,600,000 and an interest rate of 49%, which includes origination fees of $252,000 (the “January Loan”).
January Loan Agreement On January 24, 2024, the Company entered into a Business Loan and Security Agreement (the “January Loan Agreement”) with a commercial funding source (the “January Lender”), pursuant to which the Company obtained a loan from the Lender in the principal amount of $3,600,000 and an interest rate of 49%, which includes origination fees of $252,000 (the “January Loan”).
In addition to the annual license maintenance fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined in the February 2020 License Agreement) during the of the term of the agreement as follows: 4% when Net Sales are below or equal to $5 million annually or 6% when Net Sales are above $5 million annually.
F-24 In addition to the annual license maintenance fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined in the February 2020 License Agreement) during the term of the agreement as follows: 4% when Net Sales are below or equal to $5 million annually or 6% when Net Sales are above $5 million annually.
Stockholders of record received information from the Company’s transfer agent regarding their common stock ownership post- the March Reverse Stock Split. The Company’s common stock continues to trade on the Nasdaq Stock Market LLC under the existing symbol “ADTX”, but the security has been assigned a new CUSIP number (007025802).
Stockholders of record received information from the Company’s transfer agent regarding their common stock ownership post- the March Reverse Stock Split. The Company’s common stock continues to trade on the Nasdaq Stock Market LLC under the existing symbol “ADTX”, but the security has been assigned a new CUSIP number (007025877).
All share amounts referenced in this report are adjusted to reflect the 2025 Reverse Split. F-8 On March 14, 2025, Pearsanta effectuated a 1 for 60 reverse stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of Pearsanta’s common stock.
On March 14, 2025, Pearsanta effectuated a 1-for-60 reverse stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of Pearsanta’s common stock. All share amounts referenced in this report are adjusted to reflect the 2025 Pearsanta Reverse Split.
Useful lives assigned to fixed assets are as follows: Computers Three years to five years Lab Equipment Seven to ten years Office Furniture Five to ten years Other fixed assets Five to ten years Leasehold Improvements Shorter of estimated useful life or remaining lease term Intangible Assets Intangible assets are stated at cost less accumulated amortization.
Useful lives assigned to fixed assets are as follows: Computers Three years to five years Lab Equipment Seven to ten years Office Furniture Five to ten years Other Fixed Assets Five to ten years Leasehold Improvements Shorter of estimated useful life or remaining lease term F-11 Intangible Assets Intangible assets are stated at cost less accumulated amortization.
Stock-based compensation is recognized as expense over the employee’s requisite vesting period and over the nonemployee’s period of providing goods or services. F-16 Patents The Company incurs fees from patent licenses, which are reflected in research and development expenses, and are expensed as incurred.
Stock-based compensation is recognized as expense over the employee’s requisite vesting period and over the nonemployee’s period of providing goods or services. Patents The Company incurs fees from patent licenses, which are reflected in research and development expenses, and are expensed as incurred.
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”).
F-9 NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”).
F-52 On February 24, 2021, our Board of Directors adopted the Aditx Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). The 2021 Plan provides for grants of nonqualified stock options, incentive stock options, stock appreciation rights, restricted stock and restricted stock units, and other stock-based awards (collectively, the “Awards”).
On February 24, 2021, our Board of Directors adopted the Aditx Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). The 2021 Plan provides for grants of nonqualified stock options, incentive stock options, stock appreciation rights, restricted stock and restricted stock units, and other stock-based awards (collectively, the “Awards”).
As of December 31, 2024 and 2023, the Company has recorded no liability for unrecognized tax benefits, interest, or penalties related to federal and state income tax matters and there currently no pending tax examinations. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense.
As of December 31, 2025 and 2024, the Company has recorded no liability for unrecognized tax benefits, interest, or penalties related to federal and state income tax matters and there currently no pending tax examinations. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense.
F-11 The financial statements included in this report do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the matters discussed herein.
The financial statements included in this report do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the matters discussed herein.
Carrying Fair Value Measurement Using Value Level 1 Level 2 Level 3 Total Derivative liability $ 14,517 — $ 14,517 — $ 14,517 Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable.
Carrying Fair Value Measurement Using Value Level 1 Level 2 Level 3 Total Derivative liability $ 14,517 — $ 14,517 — $ 14,517 F-10 Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable.
F-28 The LLU License Agreement shall terminate on the last day that a patent granted to us by LLU is valid and enforceable or the day that the last patent application licensed to us is abandoned. The LLU License Agreement may be terminated by mutual agreement or by us upon 90 days written notice to LLU.
The LLU License Agreement shall terminate on the last day that a patent granted to us by LLU is valid and enforceable or the day that the last patent application licensed to us is abandoned. The LLU License Agreement may be terminated by mutual agreement or by us upon 90 days written notice to LLU.
Equity Line of Credit On May 2, 2024, the Company entered into a Common Stock Purchase Agreement (the “ELOC Purchase Agreement”) with an equity line investor (the “ELOC Investor”), pursuant to which the ELOC Investor has agreed to purchase from the Company, at the Company’s direction from time to time, in its sole discretion, from and after the date effective date of the Registration Statement (as defined below) and until the termination of the ELOC Purchase Agreement in accordance with the terms thereof, shares of the Company’s common stock having a total maximum aggregate purchase price of $150,000,000 (the “ELOC Purchase Shares”), upon the terms and subject to the conditions and limitations set forth in the ELOC Purchase Agreement.
(Note 14) ELOC Activity On May 2, 2024, the Company entered into a Common Stock Purchase Agreement (the “ELOC Purchase Agreement”) with an equity line investor (the “ELOC Investor”), pursuant to which the ELOC Investor has agreed to purchase from the Company, at the Company’s direction from time to time, in its sole discretion, from and after the date effective date of the Registration Statement (as defined below) and until the termination of the ELOC Purchase Agreement in accordance with the terms thereof, shares of the Company’s common stock having a total maximum aggregate purchase price of $150,000,000 (the “ELOC Purchase Shares”), upon the terms and subject to the conditions and limitations set forth in the ELOC Purchase Agreement.
At December 31, 2024 and December 31, 2023, the Company had a full valuation allowance against its deferred tax assets. Offering Costs Offering costs incurred in connection with equity are recorded as a reduction of equity and offering costs incurred in connection with debt are recorded as a reduction of debt as a debt discount.
At December 31, 2025 and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets. Offering Costs Offering costs incurred in connection with equity are recorded as a reduction of equity and offering costs incurred in connection with debt are recorded as a reduction of debt as a debt discount.
Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2024 and 2023, respectively. The Company reevaluates the positive and negative evidence at each reporting period.
Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2025 and 2024, respectively. The Company reevaluates the positive and negative evidence at each reporting period.
Stock-Based Compensation The Company accounts for stock-based compensation costs under the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation expense related to the fair value of stock-based compensation awards that are ultimately expected to vest.
F-15 Stock-Based Compensation The Company accounts for stock-based compensation costs under the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation expense related to the fair value of stock-based compensation awards that are ultimately expected to vest.
The Pearsanta 2023 Plan consists of a total of 15,000,000 shares of Pearsanta common stock, par value $0.001 per share, which may be issued pursuant to Pearsanta Awards granted under the Pearsanta 2023 Plan.
The Pearsanta 2023 Plan consists of a total of 250,000 shares of Pearsanta common stock, par value $0.001 per share, which may be issued pursuant to Pearsanta Awards granted under the Pearsanta 2023 Plan.
As of December 31, 2024, the Company had $ 0.1 million federal tax credit carryforwards available to reduce future tax liabilities which expire at various dates through 2042. As of December 31, 2023, the Company had $ 0.1 federal tax credit carryforwards.
As of December 31, 2025, the Company had $0.0 million federal tax credit carryforwards available to reduce future tax liabilities which expire at various dates through 2042. As of December 31, 2024, the Company had $0.1 million federal tax credit carryforwards.
We were obligated to pay and paid a fee of $25,000 to Stanford within 60 days of February 3, 2020. We also issued 1 shares of the Company’s common stock to Stanford.
We were obligated to pay and paid a fee of $25,000 to Stanford within 60 days of February 3, 2020. We also issued 1 share of the Company’s common stock to Stanford.
F-25 September Note On September 17, 2024, the Company issued and sold a senior note (the “2024 September Note”) to an accredited investor (the “2024 September Note Holder”) in the original principal amount of $923,077 for a purchase price of $600,000, reflecting an original issue discount of $323,077.
(Note 14) F-20 September Note On September 17, 2024, the Company issued and sold a senior note (the “2024 September Note”) to an accredited investor (the “2024 September Note Holder”) in the original principal amount of $923,077 for a purchase price of $600,000, reflecting an original issue discount of $323,077.
On December 18, 2023, our Board of Directors adopted the Pearsanta, Inc. 2023 Omnibus Equity Incentive Plan (the “Pearsanta 2023 Plan”) and the 2023 Parent Service Provider Equity Incentive Plan (the “Pearsanta Parent 2023 Plan”), collectively (the “Pearsanta Plans”).
F-29 On December 18, 2023, our Board of Directors adopted the Pearsanta, Inc. 2023 Omnibus Equity Incentive Plan (the “Pearsanta 2023 Plan”) and the 2023 Parent Service Provider Equity Incentive Plan (the “Pearsanta Parent 2023 Plan”), collectively (the “Pearsanta Plans”).
November Loan Agreement On November 7, 2023, the Company entered into a Business Loan and Security Agreement (the “November Loan Agreement”) with the lender (the “Lender”), pursuant to which the Company obtained a loan from the Lender in the principal amount of $2,100,000 with an interest rate of 49%, which satisfied the outstanding balance on the August Loan of $1,089,000 and includes origination fees of $140,000 (the “November Loan”).
NOTE 8 – NOTES PAYABLE November Loan Agreement On November 7, 2023, the Company entered into a Business Loan and Security Agreement (the “November Loan Agreement”) with the lender (the “Lender”), pursuant to which the Company obtained a loan from the Lender in the principal amount of $2,100,000 with an interest rate of 49%, which satisfied the outstanding balance on the August Loan of $1,089,000 and includes origination fees of $140,000 (the “November Loan”).
When the March Reverse Stock Split became effective, every 250 shares of the Company’s issued and outstanding common stock were automatically combined, converted and changed into 1 share of the Company’s common stock, without any change in the number of authorized shares or the par value per share.
When the March 2026 Reverse Split became effective, every 8 shares of the Company’s issued and outstanding common stock were automatically combined, converted and changed into 1 share of the Company’s common stock, without any change in the number of authorized shares or the par value per share.
(Note 12) NOTE 8 – LEASES Our lease agreements generally do not provide an implicit borrowing rate; therefore, an internal incremental borrowing rate is determined based on information available at lease commencement date for purposes of determining the present value of lease payments.
NOTE 9 – LEASES Our lease agreements generally do not provide an implicit borrowing rate; therefore, an internal incremental borrowing rate is determined based on information available at lease commencement date for purposes of determining the present value of lease payments.
In addition to the shelf registration, 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. We may also secure loans from related parties.
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. We may also secure loans from related parties.
We used the incremental borrowing rate on December 31, 2024 and December 31, 2023 for all leases that commenced prior to that date.
We used the incremental borrowing rate on December 31, 2025 and December 31, 2024 for all leases that commenced prior to that date.
The Company’s valuation allowance increased during 2024 by approximately $ 8.1 million primarily due to the generation of net operating loss and tax credit carryforwards and the capitalization of research and experimental expenditures.
The Company’s valuation allowance increased during 2024 by approximately $9.9 million primarily due to the generation of net operating loss and tax credit carryforwards and the capitalization of research and experimental expenditures.
In consideration for the LLU License Agreement, we issued 1 shares of common stock to LLU. Pursuant to the LLU License Agreement, we are required to pay an annual license fee to LLU. Also, we paid LLU $455,000 in July 2020 for outstanding milestone payments and license fees.
In consideration for the LLU License Agreement, we issued 1 share of common stock to LLU. F-23 Pursuant to the LLU License Agreement, we are required to pay an annual license fee to LLU. Also, we paid LLU $455,000 in July 2020 for outstanding milestone payments and license fees.
F-56 NOTE 11 – INCOME TAXES For the years ended December 31, 2024 and 2023, the Company did not record a current or deferred income tax expense or benefit due to current and historical losses incurred by the Company. The Company’s losses before income taxes consist solely of losses from domestic operations.
F-31 NOTE 12 – INCOME TAXES For the years ended December 31, 2025 and 2024, the Company did not record a current or deferred income tax expense or benefit due to current and historical losses incurred by the Company. The Company’s losses before income taxes consist solely of losses from domestic operations.
Pursuant to the Notice, the Landlord has demanded that a payment of $590,557 plus administrative charges and interest, which shall accrue at the Default Rate (as defined in the Lease) be made no later than May 17, 2024. As of December 31, 2024, the Company has made the payment of $431,182.
Pursuant to the Notice, the Landlord has demanded that a payment of $590,557 plus administrative charges and interest, which shall accrue at the Default Rate (as defined in the Lease) be made no later than May 17, 2024.
On February 28, 2025, the Parties entered into a waiver to waive any termination rights that they may have as a result of the effective time not occurring by February 28, 2025,which waiver shall expire on March 31, 2025 in consideration of (i) a payment by Adivir to Appili in the amount of $125,000 on or before February 28, 2025, and (ii) a payment by Adivir to Appili in the amount of $125,000 not later than March 14, 2025, to the extent the Arrangement Agreement has not been completed prior to that time.
On February 28, 2025, the Parties entered into a waiver to waive any termination rights that they may have as a result of the effective time not occurring by February 28, 2025, which waiver shall expire on September 30, 2025 in consideration of (i) a payment by Adivir to Appili in the amount of $125,000 on or before February 28, 2025, which was paid, and (ii) a payment by Adivir to Appili in the amount of $125,000 not later than March 14, 2025 (collectively the “February Appili Waiver Payments”), which was paid, to the extent the Arrangement Agreement has not been completed prior to that time.
This derivative arose from a conversion feature of these classes of preferred stock that allows for 50% additional shares to be issued under certain circumstances, in this case a default on one of the Company’s leases. (See Note 10) The Company value the derivative based on the conversion formula outline in the certificate of designation for the preferred stock.
This derivative arose from a conversion feature of these classes of preferred stock that allows for 50% additional shares to be issued under certain circumstances, in this case a default on one of the Company’s leases. (See Note 11) The Company valued the derivative based on the conversion formula outlined in the certificate of designation for the preferred stock.
As of December 31, 2024 and 2023, the Company had state research and development tax credit carryforwards of approximately $ 0.4 million and $0.4 million, respectively, which may be available to reduce future tax liabilities and can be carried over indefinitely.
As of December 31, 2025 and 2024, the Company had state research and development tax credit carryforwards of approximately $0.6 million and $0.8 million, respectively, which may be available to reduce future tax liabilities and can be carried over indefinitely.
The Company has determined that a derivative feature exists on its shares of 22,071 shares of Series A-1 Convertible Preferred Stock, 2,689 shares of Series B-1 Convertible Preferred Stock, and 2,625 shares of Series B-2 Convertible Preferred Stock.
The Company has determined that a derivative feature exists on its shares of 20,864 shares of Series A-1 Convertible Preferred Stock, 2,689 shares of Series B-1 Convertible Preferred Stock, and 2,625 shares of Series B-2 Convertible Preferred Stock.
Basic and Diluted Net Loss per Common Share Basic loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for each period.
Basic and Diluted Net Loss per Common Share Basic loss per common share is computed by dividing the net loss, less any deemed dividends, by the weighted average number of shares of common stock outstanding for each period.
Eastern Time on March 14, 2025, and the Company’s common stock began trading on a split-adjusted basis when the Nasdaq Stock Market opened on March 17, 2025. The March Reverse Stock Split is primarily intended to bring the Company into compliance with Nasdaq’s minimum bid price requirement.
Eastern Time on March 6, 2026, and the Company’s common stock began trading on a split-adjusted basis when the Nasdaq Stock Market opened on March 9, 2026. The March 2026 Reverse Stock Split is primarily intended to bring the Company into compliance with Nasdaq’s minimum bid price requirement.
On March 12, 2025, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment to its certificate of incorporation (the “Certificate of Amendment”) to effect the March Reverse Stock Split. The March Reverse Stock Split became effective as of 4:01 p.m.
On March 9, 2026, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment to its certificate of incorporation (the “Certificate of Amendment”) to effect the March 2026 Reverse Split. The March 2026 Reverse Split became effective as of 4:01 p.m.
The Company’s stock began trading on a split-adjusted basis effective on the Nasdaq Stock Market on October 3, 2024. There was no change to the number of authorized shares of the Company’s common stock. All share amounts referenced in this report are adjusted to reflect the 2024 Reverse Split.
The Company’s stock began trading on a split-adjusted basis effective on the Nasdaq Stock Market on March 9, 2026. There was no change to the number of authorized shares of the Company’s common stock. All share amounts referenced in this report are adjusted to reflect the March 2026 Reverse Split.
The Company recognized stock-based compensation expense related to all options granted and vesting expense of $32,918 during the year ended December 31, 2024, of which $32,918 is included in general and administrative expenses in the accompanying statements of operations. The remaining value to be expensed is $0 as of December 31, 2024.
The Company recognized stock-based compensation expense related to all options granted and vesting expense of $32,918 during the year ended December 31, 2024, of which $32,918 is included in general and administrative expenses in the accompanying statements of operations.
As of December 31, 2024 and 2023, the Company also had U.S. state net operating loss carryforwards (post-apportioned) of $ 31.0 million and $28.2 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2042.
F-33 As of December 31, 2025 and 2024, the Company also had U.S. state net operating loss carryforwards (post-apportioned) of $2.8 million and $2.8 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2042.
The Pearsanta Parent 2023 Plan consists of a total of 9,320,000 shares of Pearsanta common stock, par value $0.001 per share, which may be issued pursuant to Pearsanta Awards granted under the Pearsanta Parent 2023 Plan.
The Pearsanta Parent 2023 Plan consists of a total of 155,334 shares of Pearsanta common stock, par value $0.001 per share, which may be issued pursuant to Pearsanta Awards granted under the Pearsanta Parent 2023 Plan.
The Company’s valuation allowance increased during 2023 by approximately $6.2 million primarily due to the generation of net operating loss and tax credit carryforwards and the capitalization of research and experimental expenditures.
The Company’s valuation allowance increased during 2025 by approximately $9.9 million primarily due to the generation of net operating loss and tax credit carryforwards and the capitalization of research and experimental expenditures.
During the years ended December 31, 2024 and 2023, the Company incurred patent licensing fees of $61,913 and $123,541, respectively. Research and Development We incur research and development costs during the process of researching and developing our technologies and future offerings. We expense these costs as incurred unless such costs qualify for capitalization under applicable guidance.
During the year ended December 31, 2025 and 2024, the Company incurred patent licensing fees of $119,808 and $61,913, respectively. Research and Development We incur research and development costs during the process of researching and developing our technologies and future offerings. We expense these costs as incurred unless such costs qualify for capitalization under applicable guidance.
Stock-Based Compensation In October 2017, our Board of Directors adopted the Aditx Therapeutics, Inc. 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provides for the grant of equity awards to directors, employees, and consultants. The Company is authorized to issue up to 2,500,000 shares of our common stock pursuant to awards granted under the 2017 Plan.
F-28 Stock-Based Compensation In October 2017, our Board of Directors adopted the Aditx Therapeutics, Inc. 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provides for the grant of equity awards to directors, employees, and consultants. The Company is authorized to issue up to 1 share of our common stock pursuant to awards granted under the 2017 Plan.
Accounts receivable is made up of billed and unbilled of $120,296 and $1,286 as of December 31, 2024 and $236,605 and $171,721 as of December 31, 2023, respectively. Inventory Inventory consists of laboratory materials and supplies used in laboratory analysis. We capitalize inventory when purchased.
Accounts receivable is made up of billed and unbilled of $0 and $0 as of December 31, 2025, respectively, and $120,296 and $1,286 as of December 31, 2024, respectively. Inventory Inventory consists of laboratory materials and supplies used in laboratory analysis. We capitalize inventory when purchased.
As of December 31, 2024, the Company has four payments in arrears. In January of 2021, the Company purchased one piece of lab equipment and financed it for a period of twenty-four months with a monthly payment of $9,733, with an interest rate of 8%. As of December 31, 2024, the Company has four payments in arrears.
In January of 2021, the Company purchased one piece of lab equipment and financed it for a period of twenty-four months with a monthly payment of $9,733, with an interest rate of 8%.
During the years ended December 31, 2024 and 2023, the Company incurred sales and marketing costs of $197,863 and $269,284, respectively. Non-controlling Interest in Subsidiary Non-controlling interests represent the Company’s subsidiary’s cumulative results of operations and changes in deficit attributable to non-controlling shareholders.
During the year ended December 31, 2025 and 2024, the Company incurred sales and marketing costs of $401,996 and $197,863, respectively. Non-controlling Interest in Subsidiary Non-controlling interests represent the Company’s subsidiary’s cumulative results of operations and changes in deficit attributable to non-controlling shareholders.
On March 14, 2025, Pearsanta effectuated a 1 for 60 reverse stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of Pearsanta’s common stock. All share amounts referenced in this report are adjusted to reflect the 2025 Pearsanta Reverse Split. Formed in January 2023, our majority owned subsidiary Pearsanta™, Inc.
There was no change to the number of authorized shares of the Company’s common stock. All share amounts referenced in this report are adjusted to reflect the 2025 Reverse Split. On March 14, 2025, Pearsanta effectuated a 1-for-60 reverse stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of Pearsanta’s common stock.
Principles of Consolidation The consolidated financial statements include the accounts of Aditxt, Inc., its wholly owned subsidiaries and, one majority owned subsidiary. All significant intercompany balances and transactions have been eliminated in the consolidated financial statements.
Principles of Consolidation The consolidated financial statements include the accounts of Aditxt, Inc., its wholly owned subsidiaries and one majority owned subsidiary. All significant intercompany balances and transactions have been eliminated in the consolidated financial statements. Use of Estimates The preparation of financial statements in conformity with U.S.
Intangible asset activity for the year ended December 31, 2024 consisted of the following: For the year ended December 31, 2024 As of December 31, 2023 331,000 Additions - As of December 31, 2024 $ 331,000 NOTE 6 – RELATED PARTY TRANSACTIONS On November 30, 2023, Amro Albanna, the Chief Executive Officer of the Company, loaned $10,000 to the Company.
Intangible asset activity for the year ended December 31, 2025 consisted of the following: For the year ended December 31, 2025 As of December 31, 2024 331,000 Additions - As of December 31, 2025 $ 331,000 NOTE 6 – RELATED PARTY TRANSACTIONS On May 22, 2025, Amro Albanna, the Chief Executive Officer of the Company loaned $233,000 to the Company.
Warrants For the year ended December 31, 2024, the fair value of each warrant granted was estimated using the assumption and/or factors in the Black-Scholes Model as follows: Exercise price $ 52,300 Expected dividend yield 0 % Risk free interest rate 3.97 % Expected life in years 5.0 Expected volatility 219 % F-54 The risk-free interest rate assumption for warrants granted is based upon observed interest rates on the United States Government Bond Equivalent Yield appropriate for the expected term of warrants.
F-30 Warrants For the year ended December 31, 2025, the fair value of each warrant granted was estimated using the assumption and/or factors in the Black-Scholes Model as follows: Exercise price $ 1,808.00 Expected dividend yield 0 % Risk free interest rate 3.75 % Expected life in years 1.0 Expected volatility 190 % The risk-free interest rate assumption for warrants granted is based upon observed interest rates on the United States Government Bond Equivalent Yield appropriate for the expected term of warrants.
See Risk Factors and Note 12 for additional details regarding Nasdaq compliance. If we are delisted from Nasdaq, but obtain a substitute listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq.
If we are delisted from Nasdaq, but obtain a substitute listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq.
The Company’s stock began trading at the 2023 Reverse Split price effective on the Nasdaq Stock Market on August 17, 2023. There was no change to the number of authorized shares of the Company’s common stock. On October 2, 2024, the Company effectuated a 1 for 40 reverse stock split (the “2024 Reverse Split”).
Reverse Stock Splits On October 2, 2024, the Company effectuated a 1-for-40 reverse stock split (the “2024 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective on the Nasdaq Stock Market on October 3, 2024. There was no change to the number of authorized shares of the Company’s common stock.
NOTE 5 – INTANGIBLE ASSETS The Company’s intangible assets include the following on December 31, 2024: Cost Basis Accumulated Amortization Net Proprietary Technology $ 321,000 $ (321,000 ) $ - Intellectual property 10,000 (3,889 ) 6,111 Total Intangible Assets $ 331,000 $ (324,889 ) $ 6,111 The Company’s intangible assets include the following on December 31, 2023: Cost Basis Accumulated Amortization Net Proprietary Technology $ 321,000 $ (321,000 ) $ - Intellectual property 10,000 (556 ) 9,444 Total Intangible Assets $ 331,000 $ (321,556 ) $ 9,444 Amortization expense was $3,333 and $107,556 for the years ended December 31, 2024 and 2023, respectively.
NOTE 5 – INTANGIBLE ASSETS The Company’s intangible assets include the following on December 31, 2025: Cost Basis Accumulated Amortization Net Proprietary Technology $ 321,000 $ (321,000 ) $ - Intellectual property 10,000 (7,222 ) 2,778 Total Intangible Assets $ 331,000 $ (328,222 ) $ 2,778 The Company’s intangible assets include the following on December 31, 2024: Cost Basis Accumulated Amortization Net Proprietary Technology $ 321,000 $ (321,000 ) $ - Intellectual property 10,000 (3,889 ) 6,111 Total Intangible Assets $ 331,000 $ (324,889 ) $ 6,111 Amortization expense was $3,333 and $3,333 for the years ended December 31, 2025 and 2024, respectively.
During the years ended December 31, 2024 and 2023, the Company incurred research and development costs of $10,886,130 and $7,074,339, respectively. Sales and Marketing We incur sales and marketing costs marketing our technologies. We expense these costs as incurred unless such costs qualify for capitalization under applicable guidance.
During the year ended December 31, 2025 and 2024, the Company incurred research and development costs of $3,194,133 and $10,886,130, respectively. Sales and Marketing We incur sales and marketing costs marketing our technologies. We expense these costs as incurred unless such costs qualify for capitalization under applicable guidance.
On March 14, 2025, the Company effectuated a 1 for 250 reverse stock split (the “2025 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective on the Nasdaq Stock Market on March 17, 2025. There was no change to the number of authorized shares of the Company’s common stock.
On November 3, 2025, the Company effectuated a 1-for-113 reverse stock split (the “November 2025 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective on the Nasdaq Stock Market on November 3, 2025. There was no change to the number of authorized shares of the Company’s common stock.
For the Year ended December 31, 2024 As of December 31, 2023 $ - Fair value of derivative liability of Series A-1 Convertible Preferred Stock 49 Fair value of derivative liability of Series B-1 Convertible Preferred Stock 7,857 Fair value of derivative liability of Series B-2 Convertible Preferred Stock 6,611 As of December 31, 2024 $ 14,517 Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards.
December 31, 2025 Fair value of derivative liability of Series A-1 Convertible Preferred Stock - Fair value of derivative liability of Series B-1 Convertible Preferred Stock 1 Fair value of derivative liability of Series B-2 Convertible Preferred Stock 1 Total derivative liability $ 2 Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards.
The Company’s convertible preferred stock also contains floor pricing provisions; the Company has the discretion to issue shares below the floor price.
All series of the Company’s convertible preferred stock include alternate conversion provisions. The Company’s convertible preferred stock also contains floor pricing provisions; the Company has the discretion to issue shares below the floor price.
F-53 During the years ended December 31, 2024 and 2023, Pearsanta granted no new options under the Pearsanta 2023 Plan.
During the year ended December 31, 2025 and 2024, Pearsanta granted no new options under the Pearsanta 2023 Plan.
Adverse conditions may include: changes in the biotechnology regulatory environment, technological advances that render our technologies obsolete, availability of resources for clinical trials, acceptance of technologies into the medical community, and competition from larger, more well-funded companies. These adverse conditions could affect the Company’s financial condition and the results of its operations.
A host of factors beyond the Company’s control could cause fluctuations in these conditions. Adverse conditions may include: changes in the biotechnology regulatory environment, technological advances that render our technologies obsolete, availability of resources for clinical trials, acceptance of technologies into the medical community, and competition from larger, more well-funded companies.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT) YEARS ENDED DECEMBER 31, 2024 AND 2023 Preferred A-1 Shares Preferred A-1 Shares Par Preferred B-1 Shares Preferred B-1 Shares Par Preferred B-2 Shares Preferred B-2 Shares Par Preferred D-1 Shares Preferred D-1 Shares Par Common Shares Outstanding Common Shares Par Treasury Stock Additional Paid-in Capital Accumulated Deficit Non- Controlling Interest Total Stockholders’ Equity Preferred C-1 Shares Redeemable Preferred C-1 Total Mezzanine Equity Balance December 31, 2023 22,280 $ 22 - $ - 2,625 $ 3 - $ - 165 $ 11 $ (201,605 ) $ 143,999,018 $ (127,741,072 ) $ (9,608 ) $ 16,046,769 - - - Stock option compensation - - - - - - - - - - - 32,918 - - 32,918 - - - MDNA asset purchase - - - - - - - - 5 1 - 1,008,668 - - 1,008,669 - - - Brain asset purchase - - 6,000 6 - - - - - - - 5,970,437 - - 5,970,443 - - - Issuance of shares for settlement - - - - - - - - 30 1 - 1,599,999 - - 1,600,000 - - - Restricted stock unit compensation - - - - - - - - 1 - - 153 - - 153 - - - Issuance of shares for offering, net of issuance costs - - - - - - 4,186 4 - - - (532,164 ) - - (532,160 ) 4,186 4,186,000 4,186,000 Issuance of shares for debt issuance costs - - - - - - - - 33 1 - 662,717 - - 662,718 - - - Modification of warrants - - - - - - - - - - - 4,137 (4,137 ) - - - - - Issuance of shares for registered direct offering, net of issuance costs - - - - - - - - 31,547 33 - 3,022,908 - - 3,022,941 - - - Issuance of shares under ELOC, net of issuance costs - - - - - - - - 93,595 94 - 12,739,464 - - 12,739,558 - - - Exchange of warrants for Series C-1 Convertible Preferred Stock - - - - - - - - - - - (6,000,006 ) - - (6,000,006 ) 6,000 6,000,000 6,000,000 Liquidation damages - - - - - - - - - - - (1 ) - - (1 ) 667 667,000 667,000 Conversion of Series A-1 Convertible Preferred stock (209 ) - - - - - - - 26 1 - (1 ) - - - - - - Conversion of Series B-1 Convertible Preferred stock - - (3,311 ) (3 ) - - - - 3,175 4 - (1 ) - - - - - - Exercise of warrants - - - - - - - - 178 1 - 1,246,489 - - 1,246,490 - - - Issuance of warrants as debt issuance costs - - - - - - - - - - - 913,713 - - 913,713 - - - Modifications of warrants as debt issuance costs - - - - - - - - - - - 376,901 - - 376,901 - - - Modifications of warrants - - - - - - - - - - - 5,902,874 (5,902,874 ) - - - - - Derivative liability from conversion feature on preferred stock - - - - - - - - - - - (429,018 ) - - (429,018 ) - - - Rounding from reverse stock split - - - - - - - - 924 (17 ) - 17 - - - - - - Redemption of C-1 preferred stock - - - - - - - - - - - (1,726,602 ) - - (1,726,602 ) (2,480 ) (2,480,000 ) (2,480,000 ) Redemption of D-1 preferred stock - - - - - - (4,186 ) (4 ) - - - (28 ) - - (32 ) - - - Net loss - - - - - - - - - - - - (34,446,486 ) (573,572 ) (35,020,058 ) - - - Balance December 31, 2024 22,071 $ 22 2,689 $ 3 2,625 $ 3 - $ - 129,679 $ 130 $ (201,605 ) $ 168,972,592 $ (168,094,569 ) $ (583,180 ) $ (86,604 ) 8,373 8,373,000 8,373,000 See accompanying notes to the consolidated financial statements.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY YEAR ENDED DECEMBER 31, 2025 AND 2024 Preferred A-1 Shares Preferred A-1 Shares Par Preferred B-1 Shares Preferred B-1 Shares Par Preferred B-2 Shares Preferred B-2 Shares Par Preferred D-1 Shares Preferred D-1 Shares Par Common Shares Outstanding Common Shares Par Treasury Stock Additional Paid-in Capital Accumulated Deficit Non- Controlling Interest Total Stockholders’ Equity Preferred C-1 Shares Redeemable Preferred C-1 Total Mezzanine Equity Balance December 31, 2023 22,280 $ 22 - $ - 2,625 $ 3 - $ - 41 $ - $ (201,605 ) $ 143,999,018 $ (127,741,072 ) $ (9,608 ) $ 16,046,758 - $ - $ - Stock option compensation - - - - - - - - - - - 32,918 - - 32,918 - - - MDNA asset purchase - - - - - - - - 1 - - 1,008,668 - - 1,008,668 - - - Brain asset purchase - - 6,000 6 - - - - - - - 5,970,437 - - 5,970,443 - - - Issuance of shares for settlement - - - - - - - - 1 - - 1,599,999 - - 1,599,999 - - - Restricted stock unit compensation - - - - - - - - 1 - - 153 - - 153 - - - Issuance of shares for offering, net of issuance costs - - - - - - 4,186 4 - - - (532,164 ) - - (532,160 ) 4,186 4,186,000 4,186,000 Issuance of shares for debt issuance costs - - - - - - - - 1 - - 662,717 - - 662,717 - - - Modification of warrants - - - - - - - - - - - 4,137 (4,137 ) - - - - - Issuance of shares for registered direct offering, net of issuance costs - - - - - - - - 36 - - 3,022,939 - - 3,022,939 - - - Issuance of shares under ELOC, net of issuance costs - - - - - - - - 105 1 - 12,739,556 - - 12,739,557 - - - Exchange of warrants for Series C-1 Convertible Preferred Stock - - - - - - - - - - - (6,000,006 ) - - (6,000,006 ) 6,000 6,000,000 6,000,000 Liquidation damages - - - - - - - - - - - (1 ) - - (1 ) 667 667,000 667,000 Conversion of Series A-1 Convertible Preferred stock (209 ) - - - - - - - 1 - - (1 ) - - (1 ) - - - Conversion of Series B-1 Convertible Preferred stock - - (3,311 ) (3 ) - - - - 4 - - 1 - - (2 ) - - - Exercise of warrants - - - - - - - - 1 - - 1,246,489 - - 1,246,489 - - - Issuance of warrants as debt issuance costs - - - - - - - - - - - 913,713 - - 913,713 - - - Modifications of warrants as debt issuance costs - - - - - - - - - - - 376,901 - - 376,901 - - - Modifications of warrants - - - - - - - - - - - 5,902,874 (5,902,874 ) - - - - - Derivative liability from conversion feature on preferred stock - - - - - - - - - - - (429,018 ) - - (429,018 ) - - - Rounding from reverse stock split - - - - - - - - 1 - - 21 - - 21 - - - Redemption of C-1 preferred stock - - - - - - - - - - - (548,602 ) - - (548,602 ) (3,658 ) (3,658,000 ) (3,658,000 ) Redemption of D-1 preferred stock - - - - - - (4,186 ) (4 ) - - - (28 ) - - (32 ) - - - Net loss - - - - - - - - - - - - (34,446,486 ) (573,572 ) (35,020,058 ) - - - Balance December 31, 2024 22,071 $ 22 2,689 $ 3 2,625 $ 3 - $ - 193 $ 1 $ (201,605 ) $ 169,970,721 $ (168,094,569 ) $ (583,180 ) $ 1,091,396 7,195 $ 7,195,000 $ 7,195,000 See accompanying notes to the consolidated financial statements.
Pearsanta Acquisition of Assets On March 24, 2025, Pearsanta, a majority-owned subsidiary of the Company entered into an Agreement for the Acquisition of Patents (the “Pearsanta Acquisition Agreement ”) with the holders (the “Asset Holders ”) of certain patents and intellectual property assets (the “Pearsanta Acquired Assets ”), pursuant to which Pearsanta acquired the Pearsanta Acquired Assets in consideration of the issuance by Pearsanta to the Asset Holders of an aggregate of 200 shares of Series B Convertible Preferred Stock, par value $0.001 per share (the “ Pearsanta Series B Preferred Stock ”).
Pearsanta Acquisition of Assets On March 24, 2025, Pearsanta, a majority-owned subsidiary of the Company entered into an Agreement for the Acquisition of Patents (the “Pearsanta Acquisition Agreement”) with the holders (the “Asset Holders”) of certain patents and intellectual property assets (the “Pearsanta Acquired Assets”), which are related to the detection of DNA adducts for detection of changes to the DNA that may lead to potentially disease-causing mutations, pursuant to which Pearsanta acquired the Pearsanta Acquired Assets in consideration of the issuance by Pearsanta to the Asset Holders of an aggregate of 200 shares of Series B Convertible Preferred Stock, par value $0.001 per share (the “Pearsanta Series B Preferred Stock”).
Thus, the maximum amount of securities that the Company could offer and sell under its shelf registration statement on Form S-3 as of December 31, 2024 was approximately $1.8 million.
Thus, the maximum amount of securities that the Company could offer and sell under its shelf registration statement on Form S-3 as of December 31, 2025 was $54,053,691.
Accounts Payable and Accrued Expenses As of December 31, 2024 and 2023, accounts payable and accrued expenses was comprised of: For the Year ended December 31, 2024 For the Year ended December 31, 2023 Accounts payable $ 10,192,373 $ 7,523,658 Accrued wages 1,130,181 590,734 Accrued interest 1,889,527 387,692 Other 158 52,875 Total accounts payable and accrued expenses $ 13,212,239 $ 8,554,959 F-14 Derivative Liability The Company evaluates its options, warrants, other equity instruments, and other contracts, if any, to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for in accordance with ASC 815-10-05-4 and 815-40-25.
(See Note 4) Accounts Payable and Accrued Expenses As of December 31, 2025 and 2024, accounts payable and accrued expenses was comprised of: December 31, 2025 December 31, 2024 Accounts payable $ 7,340,490 $ 10,192,373 Accrued wages 52,689 1,130,181 Accrued interest 300,041 1,889,527 Other 190 158 Total accounts payable and accrued expenses $ 7,693,410 $ 13,212,239 F-13 Derivative Liability The Company evaluates its options, warrants, other equity instruments, and other contracts, if any, to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for in accordance with ASC 815-10-05-4 and 815-40-25.
F-18 In March of 2021, the Company purchased five pieces of lab equipment and financed them for a period of twenty-four months with a monthly payment of $37,171, with an interest rate of 8%. As of December 31, 2024, the Company has seven payments in arrears.
In March of 2021, the Company purchased five pieces of lab equipment and financed them for a period of twenty-four months with a monthly payment of $37,171, with an interest rate of 8%. As of December 31, 2025, the Company has settled all obligations relating to the financed assets.
The Company’s stock began trading at the 2024 Reverse Split price effective on the Nasdaq Stock Market on October 3, 2024. On March 14, 2025, the Company effectuated a 1 for 250 reverse stock split (the “2025 Reverse Split”). The Company’s stock began trading at the 2024 Reverse Split price effective on the Nasdaq Stock Market on March 17, 2025.
F-26 NOTE 11 – STOCKHOLDERS’ EQUITY Common Stock On March 14, 2025, the Company effectuated a 1-for-250 reverse stock split (the “2025 Reverse Split”). The Company’s stock began trading at the 2025 Reverse Split price effective on the Nasdaq Stock Market on March 17, 2025.
An aggregate of 27,279,927 shares of the Company’s Common Stock or 34.57% of the voting authority, constituting a quorum, were represented virtually, in person, or by valid proxies at the Special Meeting.
An aggregate of 64,571 shares of the Company’s common stock or 33.39% of the voting authority, constituting a quorum, were represented virtually, in person, or by valid proxies at the Reconvened Special Meeting.
There was no change to the number of authorized shares of the Company’s common stock. All share amounts referenced in this report are adjusted to reflect the 2023 Reverse Split. On October 2, 2024, the Company effectuated a 1 for 40 reverse stock split (the “2024 Reverse Split”).
There was no change to the number of authorized shares of the Company’s common stock. All share amounts referenced in this report are adjusted to reflect the November 2025 Reverse Split. On March 9, 2026, the Company effectuated a 1-for-8 reverse stock split (the “March 2026 Reverse Split”).
License Agreement with Leland Stanford Junior University On February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford regarding a patent concerning a method for detection and measurement of specific cellular responses.
The Company has not initiated clinical trials to date and the Company intends to obtain an extension to commence human trials. License Agreement with Leland Stanford Junior University On February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford regarding a patent concerning a method for detection and measurement of specific cellular responses.
Pursuant to the terms of the note, it will accrue interest at a rate of eight and a half percent (8.50%) per annum, and is due on the earlier of December 26, 2024 or an event of default, as defined therein. As of December 31, 2024 the note was fully paid off.
Pursuant to the terms of the June 5th Note, it will accrue interest at the Prime rate of seven and one-half percent (7.5%) per annum and is due on the earlier of December 5, 2025 or an event of default, as defined therein. As of December 31, 2025, the June 5th Note was fully paid off.
F-57 As of December 31, 2024 and 2023, the Company had U.S. federal net operating loss carryforwards of $ 99.9 million and $75.2 million, respectively, which may be available to offset future income tax liabilities.
As of December 31, 2025 and 2024, the Company had U.S. federal net operating loss carryforwards of $34.1 million and $24.7 million, respectively, which may be available to offset future income tax liabilities.
Per the formula, a stated value was $1,000, with an additional premium of 50%, and alternative conversion amount per share of $500, and a floor price of $8,880 for the Series A-1 Convertible Preferred Stock, $8,120 for the Series B-1 Convertible Preferred Stock, and $9,420 for the Series B-2 Convertible Preferred Stock.
Per the formula, the stated value was $1,000, with an additional premium of 50%, and alternative conversion amount per share of $4,000, and a floor price of $8,027,520 for the Series A-1 Convertible Preferred Stock, $7,340,480 for the Series B-1 Convertible Preferred Stock, and $8,515,680 for the Series B-2 Convertible Preferred Stock.
The following is an analysis of the stock option grant activity under the Pearsanta Plans: Vested and Nonvested Stock Options Number Weighted Average Exercise Price Weighted Average Remaining Life Outstanding December 31, 2023 222,000 $ 1.20 9.97 Granted 3,651 0.60 2.33 Exercised - - - Expired or forfeited (44,434 ) 1.20 - Rounding in connection with Reverse Split 10 - - Outstanding December 31, 2024 181,227 $ 1.19 8.84 Nonvested Stock Options Number Weighted- Average Exercise Price Nonvested on December 31, 2023 66,667 $ 1.20 Granted 3,651 0.60 Vested (25,884 ) 1.12 Forfeited (44,434 ) 1.20 Nonvested on December 31, 2024 - $ - As of December 31, 2024, there were 181,226 exercisable options; these options had a weighted average exercise price $1.19.
The following is an analysis of the stock option grant activity under the Pearsanta Plans: Vested and Nonvested Stock Options Number Weighted Average Exercise Price Weighted Average Remaining Life Outstanding December 31, 2024 181,227 $ 1.19 8.84 Granted - - - Exercised - - - Expired or forfeited - - - Rounding in connection with Reverse Split - - - Outstanding December 31, 2025 181,227 $ 1.19 7.84 Nonvested Stock Options Number Weighted- Average Exercise Price Nonvested on December 31, 2024 - $ - Granted - - Vested - - Forfeited - - Nonvested on December 31, 2025 - $ - As of December 31, 2025, there were 181,227 exercisable options; these options had a weighted average exercise price $1.19.
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Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
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Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
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2024 filing
2025 filing
Biggest changeA control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.
Biggest changeFurther, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
The risks and uncertainties that we face with respect to our rights principally include the following: ● pending patent applications we have filed or will file may not result in issued patents or may take longer than we expect to result in issued patents; ● we may be subject to interference proceedings; ● we may be subject to reexamination proceedings; ● we may be subject to post grant review proceedings; ● we may be subject to inter partes review proceedings; ● we may be subject to derivation proceedings; ● we may be subject to opposition proceedings in the U.S. or in foreign countries; ● any patents that are issued to us may not provide meaningful protection; ● we may not be able to develop additional proprietary technologies that are patentable; ● other companies may challenge patents licensed or issued to us; ● other companies may have independently developed and patented (or may in the future independently develop and patent) similar or alternative technologies, or duplicate our technologies; ● other companies may design around technologies we have licensed or developed; ● enforcement of patents is complex, uncertain and very expensive and we may not be able to secure, enforce and defend our patents; and ● in the event that we were to ever seek to enforce our patents in ligation, there is some risk that they could be deemed invalid, not infringed, or unenforceable.
The risks and uncertainties that we face with respect to our rights principally include the following: ● pending patent applications we have filed or will file may not result in issued patents or may take longer than we expect to result in issued patents; ● we may be subject to interference proceedings; ● we may be subject to reexamination proceedings; ● we may be subject to post grant review proceedings; ● we may be subject to inter partes review proceedings; ● we may be subject to derivation proceedings; ● we may be subject to opposition proceedings in the U.S. or in foreign countries; ● any patents that are issued to us may not provide meaningful protection; ● we may not be able to develop additional proprietary technologies that are patentable; ● other companies may challenge patents licensed or issued to us; ● other companies may have independently developed and patented (or may in the future independently develop and patent) similar or alternative technologies, or duplicate our technologies; 31 ● other companies may design around technologies we have licensed or developed; ● enforcement of patents is complex, uncertain and very expensive and we may not be able to secure, enforce and defend our patents; and ● in the event that we were to ever seek to enforce our patents in ligation, there is some risk that they could be deemed invalid, not infringed, or unenforceable.
Our reliance on third parties to manufacture our future products may present significant risks to us, including the following: ● reduced control over delivery schedules, yields and product reliability; ● price increases; ● manufacturing deviations from internal and regulatory specifications; ● the failure of a key manufacturer to perform as we require for technical, market or other reasons; ● difficulties in establishing additional manufacturer relationships if we are presented with the need to transfer our manufacturing process technologies to them; ● misappropriation of our intellectual property; and ● other risks in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct customers and end users.
Our reliance on third parties to manufacture our future products may present significant risks to us, including the following: ● reduced control over delivery schedules, yields and product reliability; ● price increases; ● manufacturing deviations from internal and regulatory specifications; ● the failure of a key manufacturer to perform as we require for technical, market or other reasons; 24 ● difficulties in establishing additional manufacturer relationships if we are presented with the need to transfer our manufacturing process technologies to them; ● misappropriation of our intellectual property; and ● other risks in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct customers and end users.
These risks include the possibility that any of our technologies or future products may: ● be found unsafe; ● be ineffective or less effective than anticipated; ● fail to receive necessary regulatory approvals; ● be difficult to competitively price relative to alternative solutions; ● be harmful to consumers or the environment; ● be difficult to manufacture on an economically viable scale; ● be subject to supply chain constraints for raw materials; ● fail to be developed and accepted by the market prior to the successful marketing of alternative products by competitors; ● be difficult to market because of infringement on the proprietary rights of third parties; or ● be too expensive for commercial use.
These risks include the possibility that any of our technologies or future products may: ● be found unsafe; ● be ineffective or less effective than anticipated; ● fail to receive necessary regulatory approvals; ● be difficult to competitively price relative to alternative solutions; ● be harmful to consumers or the environment; ● be difficult to manufacture on an economically viable scale; ● be subject to supply chain constraints for raw materials; 23 ● fail to be developed and accepted by the market prior to the successful marketing of alternative products by competitors; ● be difficult to market because of infringement on the proprietary rights of third parties; or ● be too expensive for commercial use.
The loss of any one of these individuals or any other future key personnel could have a material adverse effect on the Company and our ability to further execute our intended business. The commercial success of our in-development and future diagnostic tests and services depends upon attaining significant market acceptance among payers, providers, clinics, patients, and biopharmaceutical companies.
The loss of any one of these individuals or any other future key personnel could have a material adverse effect on the Company and our ability to further execute our intended business. 25 The commercial success of our in-development and future diagnostic tests and services depends upon attaining significant market acceptance among payers, providers, clinics, patients, and biopharmaceutical companies.
Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transactions that we do complete could have a material adverse effect on our business, results of operations, financial condition and prospects. 33 Upon dissolution of our Company, you may not recoup all or any portion of your investment.
Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transactions that we do complete could have a material adverse effect on our business, results of operations, financial condition and prospects. Upon dissolution of our Company, you may not recoup all or any portion of your investment.
Our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful. In addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully.
Our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful. 20 In addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully.
As a result, the consummation of acquisitions may have a material adverse effect on our business, financial condition, results of operations and cash flows. 23 We may experience difficulty as we evaluate, acquire and integrate businesses that we may acquire, which could result in drains on our resources, including the attention of our management, and disruptions of our on-going business.
As a result, the consummation of acquisitions may have a material adverse effect on our business, financial condition, results of operations and cash flows. We may experience difficulty as we evaluate, acquire and integrate businesses that we may acquire, which could result in drains on our resources, including the attention of our management, and disruptions of our on-going business.
We cannot assure you of a positive return on your investment or that you will not lose the entire amount of your investment. Future sales or issuances of substantial amounts of our common stock, including, potentially, as a result of the future acquisitions or strategic transactions could result in significant dilution.
We cannot assure you of a positive return on your investment or that you will not lose the entire amount of your investment. 35 Future sales or issuances of substantial amounts of our common stock, including, potentially, as a result of the future acquisitions or strategic transactions could result in significant dilution.
We may not be able to raise sufficient funds to commercialize the product candidates we intend to develop. If we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical studies or future operations.
We may not be able to raise sufficient funds to commercialize the product candidates we intend to develop. 15 If we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical studies or future operations.
Additionally, if we need to enter into agreements for the distribution of our future products with other third parties, there can be no assurance we will be able to do so on favorable terms, if at all. 19 We may rely on third parties for the production of our future products.
Additionally, if we need to enter into agreements for the distribution of our future products with other third parties, there can be no assurance we will be able to do so on favorable terms, if at all. We may rely on third parties for the production of our future products.
Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively. 20 The loss of our management team or other key personnel would have an adverse impact on our future development and impair our ability to succeed.
Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively. The loss of our management team or other key personnel would have an adverse impact on our future development and impair our ability to succeed.
If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued viability will be materially adversely affected. 11 Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization 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.
If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued viability will be materially adversely affected. 16 Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization 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.
This can be a costly and resource draining activity. What appear to be promising technologies when we license them may not lead to viable technologies or products, or to commercial success. 16 Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
This can be a costly and resource draining activity. What appear to be promising technologies when we license them may not lead to viable technologies or products, or to commercial success. 21 Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
In such an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business. 29 We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.
In such an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business. 33 We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.
Additionally, any such transaction may require us to incur non-recurring or other charges, may increase our near and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results.
Additionally, any such transactions may require us to incur non-recurring or other charges, may increase our near and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results.
Successfully completing our clinical program and obtaining approval of a Biologics License Application (“BLA”) is a complex, lengthy, expensive and uncertain process, and the FDA or other applicable foreign regulator may delay, limit or deny approval of our product candidates for many reasons, including, among others, because: ● we may not be able to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA or foreign regulator; ● the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or foreign regulator for marketing approval; ● the FDA or foreign regulator may disagree with the number, design, size, conduct or implementation of our clinical trials; ● the FDA or foreign regulator may require that we conduct additional clinical trials; ● the FDA or foreign regulator may not approve the formulation, labeling or specifications of our product candidates; ● the contract research organizations (CROs) and other contractors that we may retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; ● the FDA or foreign regulator may find the data from preclinical studies and clinical trials insufficient to demonstrate that our product candidate(s) are safe and effective for their proposed indications; ● the FDA or foreign regulator may disagree with our interpretation of data from our preclinical studies and clinical trials; ● the FDA or foreign regulator may not accept data generated at our clinical trial sites or may disagree with us over whether to accept efficacy results from clinical trial sites outside the United States or outside the EU, as applicable, where the standard of care is potentially different from that in the United States or in the EU, as applicable; 12 ● if and when our BLAs or foreign equivalents are submitted to the applicable regulatory authorities, such agencies may have difficulties scheduling the necessary review meetings in a timely manner, may recommend against approval of our application or may recommend or require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; ● the FDA or foreign regulator may require development of a Risk Evaluation and Mitigation Strategy (REMS), which would use risk minimization strategies to ensure that the benefits of certain prescription drugs outweigh their risks, as a condition of approval or post-approval; ● the FDA or other applicable foreign regulatory agencies may not approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or ● the FDA or the other applicable foreign regulatory agencies may change their approval policies or adopt new regulations.
Successfully completing our clinical program and obtaining approval of a Biologics License Application (“BLA”) is a complex, lengthy, expensive and uncertain process, and the FDA or other applicable foreign regulator may delay, limit or deny approval of our product candidates for many reasons, including, among others, because: ● we may not be able to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA or foreign regulator; ● the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or foreign regulator for marketing approval; ● the FDA or foreign regulator may disagree with the number, design, size, conduct or implementation of our clinical trials; ● the FDA or foreign regulator may require that we conduct additional clinical trials; ● the FDA or foreign regulator may not approve the formulation, labeling or specifications of our product candidates; ● the contract research organizations (CROs) and other contractors that we may retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; ● the FDA or foreign regulator may find the data from preclinical studies and clinical trials insufficient to demonstrate that our product candidate(s) are safe and effective for their proposed indications; ● the FDA or foreign regulator may disagree with our interpretation of data from our preclinical studies and clinical trials; ● the FDA or foreign regulator may not accept data generated at our clinical trial sites or may disagree with us over whether to accept efficacy results from clinical trial sites outside the United States or outside the EU, as applicable, where the standard of care is potentially different from that in the United States or in the EU, as applicable; ● if and when our BLAs or foreign equivalents are submitted to the applicable regulatory authorities, such agencies may have difficulties scheduling the necessary review meetings in a timely manner, may recommend against approval of our application or may recommend or require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; ● the FDA or foreign regulator may require development of a Risk Evaluation and Mitigation Strategy (REMS), which would use risk minimization strategies to ensure that the benefits of certain prescription drugs outweigh their risks, as a condition of approval or post-approval; ● the FDA or other applicable foreign regulatory agencies may not approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or ● the FDA or the other applicable foreign regulatory agencies may change their approval policies or adopt new regulations. 17 We may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities.
The Company is current with its obligations and have submitted a year end report as well as provided additional milestone plans for research and development as well as commercialization. Our results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties.
The Company is current with its obligations and has submitted a year end report as well as provided additional milestone plans for research and development as well as commercialization. 22 Our results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties.
If we make significant investments in businesses that we do not operate or control, or that we cease to operate or control, or if we commence certain investment-related activities, we may be deemed to be an investment company under the Investment Company Act.
We have the ability to make investments in businesses that we will not operate or control. If we make significant investments in businesses that we do not operate or control, or that we cease to operate or control, or if we commence certain investment-related activities, we may be deemed to be an investment company under the Investment Company Act.
Obtaining financing through the issuance or sale of additional equity and/or debt securities, if possible, may not be at favorable terms and may result in additional dilution to our current stockholders.
Obtaining financing for future acquisitions may only be possible through the issuance or sale of additional equity and/or debt securities, if possible, may not be at favorable terms and may result in additional dilution to our current stockholders.
The degree of market acceptance for any of our product candidates will depend on a number of factors, including: ● demonstration of clinical safety and efficacy; ● relative convenience, dosing burden and ease of administration; ● the prevalence and severity of any adverse effects; ● the willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies; ● efficacy of our product candidates compared to competing products; ● the introduction of any new products that may in the future become available targeting indications for which our product candidates may be approved; ● new procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility; ● pricing and cost-effectiveness; ● the inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines; ● the effectiveness of our own or any future collaborators’ sales and marketing strategies; ● limitations or warnings contained in approved labeling from regulatory authorities; ● our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics; and ● the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals. 15 If any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate sufficient revenues and we may not be able to achieve or sustain profitability.
The degree of market acceptance for any of our product candidates will depend on a number of factors, including: ● demonstration of clinical safety and efficacy; ● relative convenience, dosing burden and ease of administration; ● the prevalence and severity of any adverse effects; ● the willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies; ● efficacy of our product candidates compared to competing products; ● the introduction of any new products that may in the future become available targeting indications for which our product candidates may be approved; ● new procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility; ● pricing and cost-effectiveness; ● the inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines; ● the effectiveness of our own or any future collaborators’ sales and marketing strategies; ● limitations or warnings contained in approved labeling from regulatory authorities; ● our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics; and ● the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.
Events that may prevent successful or timely completion of clinical development include: ● delays in reaching, or failing to reach, a consensus with regulatory agencies on study design; ● delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● delays in obtaining required Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approval at each clinical study site; ● delays in recruiting a sufficient number of suitable patients to participate in our clinical studies; ● imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites; ● failure by our CROs, other third parties or us to adhere to the clinical study, regulatory or legal requirements; ● failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in other countries; ● delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites; ● delays in having patients’ complete participation in a study or return for post-treatment follow-up; ● clinical study sites or patients dropping out of a study; ● delay or failure to address any patient safety concerns that arise during the course of a trial; ● unanticipated costs or increases in costs of clinical trials of our product candidates; ● occurrence of serious adverse events associated with the product candidates that are viewed to outweigh their potential benefits; or ● changes in regulatory requirements and guidance that require amending or submitting new clinical protocols. 13 We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such trials are being conducted, by an independent Safety Review Board (“SRB”) for such trial or by the FDA, European Medicines Agency (“EMA”), or other regulatory authorities.
Events that may prevent successful or timely completion of clinical development include: ● delays in reaching, or failing to reach, a consensus with regulatory agencies on study design; ● delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● delays in obtaining required Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approval at each clinical study site; ● delays in recruiting a sufficient number of suitable patients to participate in our clinical studies; ● imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites; ● failure by our CROs, other third parties or us to adhere to the clinical study, regulatory or legal requirements; ● failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in other countries; ● delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites; ● delays in having patients’ complete participation in a study or return for post-treatment follow-up; ● clinical study sites or patients dropping out of a study; ● delay or failure to address any patient safety concerns that arise during the course of a trial; ● unanticipated costs or increases in costs of clinical trials of our product candidates; ● occurrence of serious adverse events associated with the product candidates that are viewed to outweigh their potential benefits; or ● changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
Such acquisitions are subject to various risks and uncertainties, including: ● the inability to integrate effectively the operations, products, technologies and personnel of the acquired companies (some of which are in diverse geographic regions) and achieve expected synergies; ● the potential disruption of existing business and diversion of management’s attention from day-to-day operations; ● the inability to maintain uniform standards, controls, procedures and policies; ● the need or obligation to divest portions of the acquired companies; ● the potential failure to identify material problems and liabilities during due diligence review of acquisition targets; ● the potential failure to obtain sufficient indemnification rights to fully offset possible liabilities associated with acquired businesses; and ● the challenges associated with operating in new geographic regions. 24 The integration of our acquisitions may result in significant accounting charges that adversely affect the announced results of our Company.
Such acquisitions are subject to various risks and uncertainties, including: ● the inability to integrate effectively the operations, products, technologies and personnel of the acquired companies (some of which are in diverse geographic regions) and achieve expected synergies; ● the potential disruption of existing business and diversion of management’s attention from day-to-day operations; ● the inability to maintain uniform standards, controls, procedures and policies; ● the need or obligation to divest portions of the acquired companies; ● the potential failure to identify material problems and liabilities during due diligence review of acquisition targets; ● the potential failure to obtain sufficient indemnification rights to fully offset possible liabilities associated with acquired businesses; and ● the challenges associated with operating in new geographic regions.
If we are unable to achieve profitability, we may be unable to continue our operations. 9 If we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.
If we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.
Undiscovered risks may result in us incurring financial liabilities, which could be material and have a negative impact on our business operations. Failure to manage our growing and changing business could have a material adverse effect on our business, prospects, financial condition, and results of operations.
Some of these risks could produce unexpected and unwanted consequences for us. Undiscovered risks may result in us incurring financial liabilities, which could be material and have a negative impact on our business operations. Failure to manage our growing and changing business could have a material adverse effect on our business, prospects, financial condition, and results of operations.
If we cannot successfully integrate and manage the businesses within a reasonable time, we may not be able to realize the potential and anticipated benefits of such acquisitions, which could have a material adverse effect on our stock price, business, cash flows, results of operations and financial position.
If we cannot successfully integrate and manage the businesses within a reasonable time, we may not be able to realize the potential and anticipated benefits of such acquisitions, which could have a material adverse effect on our stock price, business, cash flows, results of operations and financial position. 28 We will consider acquisitions that we believe will complement, strengthen and enhance our growth.
We acquire small to mid-sized businesses in various industry segments. Generally, because such businesses are privately held, we may experience difficulty in evaluating potential target businesses as much of the information concerning these businesses is not publicly available.
From time to time we have acquired and may continue to acquire small to mid-sized businesses in various industry segments. Generally, because such businesses may be privately held, we may experience difficulty in evaluating potential target businesses as much of the information concerning these businesses is not publicly available.
Although we believe that our planned acquisitions will generally be subject to risks similar to those to which we are subject to in our existing operations, we may not have discovered all risks applicable to these businesses during the due diligence process. Some of these risks could produce unexpected and unwanted consequences for us.
Our planned acquisitions may result in unexpected consequences to our business and results of operations. Although we believe that our planned acquisitions will generally be subject to risks similar to those to which we are subject to in our existing operations, we may not have discovered all risks applicable to these businesses during the due diligence process.
The incurrence of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants that would restrict our operations. Financing may not be available in amounts or on terms acceptable to us, if at all.
The incurrence of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants that would restrict our operations. Financing may not be available in amounts or on terms acceptable to us, if at all. These risks may materially adversely affect our ability to pursue our acquisition strategy.
Furthermore, there can be no assurance that if such products are approved, they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain.
Furthermore, there can be no assurance that if such products are approved, they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability, we may be unable to continue our operations.
We may be held liable for, or incur costs to settle, liability and remediation claims if any products we develop, or any products that use or incorporate any of our technologies, cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or use.
The costs of remediation or products liability could materially adversely affect our results, financial condition and operations. 26 We may be held liable for, or incur costs to settle, liability and remediation claims if any products we develop, or any products that use or incorporate any of our technologies, cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or use.
We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical studies can occur at any stage of testing.
Clinical testing is expensive, time-consuming and uncertain as to outcome. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical studies can occur at any stage of testing.
These risks may materially adversely affect our ability to pursue our acquisition strategy. 25 We may change our management and acquisition strategies without the consent of our stockholders, which may result in a determination by us to pursue riskier business activities.
We may change our management and acquisition strategies without the consent of our stockholders, which may result in a determination by us to pursue riskier business activities.
We will bear the risk that the rates that we are charged by our lenders will increase faster than we can grow the cash flow from our businesses or businesses that we may acquire in the future, which could reduce profitability, materially adversely affect our ability to service our debt, cause us to breach covenants contained in our third-party credit facilities and reduce cash flow available for distribution.
We will bear the risk that the rates that we are charged by our lenders will increase faster than we can grow the cash flow from our businesses or businesses that we may acquire in the future, which could reduce profitability, materially adversely affect our ability to service our debt, cause us to breach covenants contained in our third-party credit facilities and reduce cash flow available for distribution. 30 If, in the future, if we cease to control and operate our businesses or other businesses that we acquire in the future or engage in certain other activities, we may be deemed to be an investment company under the Investment Company Act.
The use of our planned products may be regulated by various local, state, federal and foreign regulators. Even if we are able to comply with all such regulations and obtain all necessary registrations, we cannot provide assurance that our future products will not cause injury to the environment, people, or animals and/or otherwise have unintended adverse consequences, under all circumstances.
Even if we are able to comply with all such regulations and obtain all necessary registrations, we cannot provide assurance that our future products will not cause injury to the environment, people, or animals and/or otherwise have unintended adverse consequences, under all circumstances.
In addition, advanced notice is required prior to stockholder proposals, which might further delay a change of control. 34 Our Amended and Restated Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with the Company or its directors, officers or employees.
Our Amended and Restated Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with the Company or its directors, officers or employees.
Our net loss for the years ended December 31, 2024 and 2023 was $35,020,058 and $32,390,447, respectively, and our accumulated deficit as of December 31, 2024 was $168,094,569. There can be no assurance that the products under development by us will be approved for sale in the U.S. or elsewhere.
Our net loss for the years ended December 31, 2025 and 2024 was $42,787,043 and $35,020,058, respectively, and our accumulated deficit as of December 31, 2025 was $209,808,770. There can be no assurance that the products under development by us will be approved for sale in the U.S. or elsewhere.
Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner. 28 The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or owned patents may be challenged in the courts or patent offices in the United States and abroad.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or owned patents may be challenged in the courts or patent offices in the United States and abroad.
If the LLU License Agreement were to be terminated by LLU, we would lose our most significant asset and may no longer be able to develop our product candidates, which would have a material adverse effect on our operations. 17 The February 2020 License Agreement with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments; (ii) are not diligently developing and commercializing Licensed Product (as defined in the February 2020 License Agreement); (iii) miss a milestone described in the agreement; (iv) are in breach of any other provision of the agreement; or (v) if we provide a false report to Stanford.
The February 2020 License Agreement with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments; (ii) are not diligently developing and commercializing Licensed Product (as defined in the February 2020 License Agreement); (iii) miss a milestone described in the agreement; (iv) are in breach of any other provision of the agreement; or (v) if we provide a false report to Stanford.
We were incorporated in September 2017 and have a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise.
We have generated no significant revenue from commercial sales to date and our future profitability is uncertain. We were incorporated in September 2017 and have a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise.
Clinical study delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates.
In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions. 18 Clinical study delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates.
We will consider acquisitions that we believe will complement, strengthen and enhance our growth. We evaluate opportunities on a preliminary basis from time to time, but these transactions may not advance beyond the preliminary stages or be completed.
We evaluate opportunities on a preliminary basis from time to time, but these transactions may not advance beyond the preliminary stages or be completed.
If we are unable to manage our growth effectively, we may not be able to take advantage of market opportunities, execute our business strategies successfully or respond to competitive pressures. As a result, our business, prospects, financial condition, and results of operations could be materially and adversely affected.
If we are unable to manage our growth effectively, we may not be able to take advantage of market opportunities, execute our business strategies successfully or respond to competitive pressures.
We may engage in future acquisitions or strategic transactions, which may require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management. As described herein, we entered into a Merger Agreement with Evofem and an Arrangement Agreement with Appili.
We may engage in future acquisitions or strategic transactions, which may require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management.
We direct you to the Company’s Amended and Restated Certificate of Incorporation for more information. Anti-takeover provisions under Delaware law could discourage, delay or prevent a change in control of our Company and could affect the trading price of our securities.
Anti-takeover provisions under Delaware law could discourage, delay or prevent a change in control of our Company and could affect the trading price of our securities.
We are a Delaware corporation and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders.
We are a Delaware corporation and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders. 36 We could issue “blank check” preferred stock without stockholder approval with the effect of diluting interests of then-current stockholders and impairing their voting rights, and provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.
Generally, we expect to engage third parties such as consultants, universities or other collaboration partners to conduct clinical trials on our behalf. Incompatible practices or misapplication of our products by these third parties could impair the success of our clinical trials.
Generally, we expect to engage third parties such as consultants, universities or other collaboration partners to conduct clinical trials on our behalf.
In addition, if the breadth or strength of protection provided by our patents and patent applications (whether licensed or otherwise held) is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
In addition, if the breadth or strength of protection provided by our patents and patent applications (whether licensed or otherwise held) is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates. 32 Even if our patent applications (whether licensed or otherwise held) result in the issuance of patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.
Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their sales, if any, may be limited.
Incompatible practices or misapplication of our products by these third parties could impair the success of our clinical trials. 19 Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their sales, if any, may be limited.
Any reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods. 26 Risks Relating to Our Intellectual Property Rights The failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively.
Any reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods.
As to those patents that we have licensed, our rights depend on maintaining our obligations to the licensor under the applicable license agreement, and we may be unable to do so. 27 If we are unable to obtain and maintain patent protection for our products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products could be impaired.
If we are unable to obtain and maintain patent protection for our products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products could be impaired.
Our financial situation creates doubt whether we will continue as a going concern. The Company was incorporated on September 28, 2017 and through the date of this report has generated no significant revenues. For the years ended December 31, 2024 and 2023, the Company had a net loss of $35,020,058 and $32,390,447, respectively.
Risks Related to Our Financial Position and Need for Capital Our financial situation creates doubt whether we will continue as a going concern. The Company was incorporated on September 28, 2017, and through the date of this report has generated no significant revenues.
Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming and uncertain as to outcome.
It is difficult to predict if or when any of our product candidates, will prove safe or effective in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans.
The financial results of our Company may be adversely affected by cash expenses and non-cash accounting charges incurred in connection with our recent acquisitions. In addition to the anticipated cash charges, costs associated with the amortization of intangible assets are expected.
The integration of our acquisitions may result in significant accounting charges that adversely affect the announced results of our Company. The financial results of our Company may be adversely affected by cash expenses and non-cash accounting charges incurred in connection with our recent acquisitions.
For example, our products may be improperly combined with other chemicals or, even when properly combined, our products may be blamed for damage caused by those other chemicals. The costs of remediation or products liability could materially adversely affect our results, financial condition and operations.
For example, our products may be improperly combined with other chemicals or, even when properly combined, our products may be blamed for damage caused by those other chemicals.
Periodic maintenance fees and annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
Although the pool of potential purchasers for such businesses is typically smaller than for larger businesses, those potential purchasers can be aggressive in their approach to acquiring such businesses. Furthermore, we expect that we will need to use third-party financing in order to fund some or all of these potential acquisitions, thereby increasing our acquisition costs.
Furthermore, we expect that we will need to use third-party financing in order to fund some or all of these potential acquisitions, thereby increasing our acquisition costs.
We face competition for businesses that fit our acquisition strategy and, therefore, we may have to acquire targets at sub-optimal prices or, alternatively, forego certain acquisition opportunities. Our acquisition strategy is focused on the acquisition of small to mid-sized businesses. In pursuing such acquisitions, we expect to face strong competition from a wide range of other potential purchasers.
As a result, our business, prospects, financial condition, and results of operations could be materially and adversely affected. 29 We face competition for businesses that fit our acquisition strategy and, therefore, we may have to acquire targets at sub-optimal prices or, alternatively, forego certain acquisition opportunities. Our acquisition strategy is focused on the acquisition of small to mid-sized businesses.
The price of our common stock could decline to the extent our financial results are materially affected by the foregoing charges or if the foregoing charges are larger than anticipated. Our planned acquisitions may result in unexpected consequences to our business and results of operations.
In addition to the anticipated cash charges, costs associated with the amortization of intangible assets are expected. The price of our common stock could decline to the extent our financial results are materially affected by the foregoing charges or if the foregoing charges are larger than anticipated.
As described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability to commercialize our products. 14 If our future pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product candidates on a timely basis or at all.
If our future pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product candidates on a timely basis or at all. The successful completion of pre-clinical development and multiple clinical trials is critical to the success of our future products.
This preference for United States manufacturers may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property.
This preference for United States manufacturers may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. Any exercise by the government of any of the foregoing rights could harm our competitive position, business, financial condition, results of operations and prospects.
Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations. We do not expect that our current cash position will be sufficient to fund our current operations for the next 12 months.
We do not expect that our current cash position will be sufficient to fund our current operations for the next 12 months.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Periodic maintenance fees and annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent.
These companies compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. 18 Our technologies and products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result.
Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Failure of our control systems to prevent error or fraud could materially adversely affect our business. Risks Related to Our Acquisition Strategy Our acquisition strategy exposes us to substantial risk.
Failure of our control systems to prevent error or fraud could materially adversely affect our business. 27 Risks Related to Our Acquisition Strategy Our acquisition strategy exposes us to substantial risk.
If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment. 10 We may need to raise additional funding, which may not be available on acceptable terms, or at all.
If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment. Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
We are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock less attractive to investors.
We no longer qualify as an “emerging growth company” as of January 1, 2026 and, as a result, we are no longer able to avail ourselves of certain reduced disclosure requirements applicable to emerging growth companies.
There may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm our Company. We do not expect that internal control over financial accounting and disclosure, even if timely and well established, will prevent all error and all fraud.
We do not expect that internal control over financial accounting and disclosure, even if timely and well established, will prevent all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met.
These companies, professionals, and institutions compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring necessary product technologies. 22 Technological breakthroughs in electric motors could render our Motion Products obsolete. The electric motor market is subject to rapid technological change and product innovation.
These companies, professionals, and institutions compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring necessary product technologies. There may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm our Company.
Any performance issues with our diagnostic tests now or in the future will increase our costs and accordingly adversely affect our business, financial condition and results of operations. 21 The use of our products may be limited by regulations, and we may be exposed to product liability and remediation claims.
The use of our products may be limited by regulations, and we may be exposed to product liability and remediation claims. The use of our planned products may be regulated by various local, state, federal and foreign regulators.
Removed
Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our business. Risks Related to Our Financial Position and Need for Capital We have generated no significant revenue from commercial sales to date and our future profitability is uncertain.
Added
Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our business. RISK FACTOR SUMMARY Our business is subject to numerous risks and uncertainties, including those highlighted in Section 1A titled “Risk Factors,” that represent challenges that we face in connection with the successful implementation of our strategy.
Removed
We may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities. It is difficult to predict if or when any of our product candidates, will prove safe or effective in humans or will receive regulatory approval.
Added
The occurrence of one or more of the events or circumstances described in the section titled “Risk Factors,” alone or in combination with other events or circumstances, may have an adverse effect on our business, cash flows, financial condition and results of operations.
Removed
In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions.
Added
Such risks include, but are not limited to: ● our financial situation creates doubt whether we will continue as a going concern; ● our ability to remain compliant with the requirements for continued listing on The Nasdaq Capital Market ● we have generated no significant revenue from commercial sales to date, and our future profitability is uncertain; ● if we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development, and you will likely lose your entire investment; ● we may need to raise additional funding, which may not be available on acceptable terms, or at all; ● even if we can raise additional funding, we may be required to do so on terms that are dilutive to you; ● 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; ● we may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities; ● if our future pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product candidates on a timely basis or at all; ● even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their sales, if any, may be limited; ● 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; ● 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.
Removed
The successful completion of pre-clinical development and multiple clinical trials is critical to the success of our future products.
Added
Without these licenses, we may not be able to continue to develop our product candidates; ● if we were to lose our CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business.
Removed
Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
Added
If we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens from those states; ● our results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties; ● we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do; ● our technologies and products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result; ● customers may not adopt our products quickly, or at all; 13 ● the failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively; ● some of our intellectual property may be subject to “march-in” rights by the U.S. federal government; ● we do not expect to pay dividends in the foreseeable future; ● we have issued a significant number of shares of convertible preferred stock and warrants and may continue to do so in the future.
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Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
7 edited+7 added−8 removed2 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
7 edited+7 added−8 removed2 unchanged
2024 filing
2025 filing
Biggest changeWe must comply with extensive regulations, including requirements imposed by the Federal Drug Administration related to adequately safeguarding patient information and reporting cybersecurity incidents to the SEC. We believe we are positioned to meet the requirements of the SEC. Assessing, identifying, and managing cybersecurity related risks are factored into our overall business approach.
Biggest changeWe have implemented a governance structure and processes to assess, identify, manage, and report cybersecurity risks. We must comply with extensive regulations, including requirements imposed by the U.S. Food and Drug Administration, laws governing the protection of patient information, and SEC requirements related to cybersecurity incident disclosure. Assessing, identifying, and managing cybersecurity-related risks are factored into our overall business approach.
We rely heavily on our supply chain to deliver our products and services, and a cybersecurity incident at a clinical site, subcontractor, or business partner could materially adversely impact us. We require that our subcontractors report cybersecurity incidents to us so that we can assess the direct impact of the incident.
We rely heavily on our supply chain to deliver our products and services, and a cybersecurity incident at a clinical site, subcontractor, or business partner could materially adversely impact us. We expect our subcontractors to report cybersecurity incidents to us so that we can assess the potential impact.
Notwithstanding the extensive approach we take to cybersecurity, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us. While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. See “Risk Factors” for a discussion of cybersecurity risks.
Despite the measures we take to manage cybersecurity risk, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us. While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. See “Risk Factors” for a discussion of cybersecurity risks.
Item 1C. Cybersecurity. We believe cybersecurity is critical to advancing our technological developments. We face a multitude of cybersecurity threats that range from attacks common to most industries, such as ransomware and denial-of service.
Item 1C. Cybersecurity. Cybersecurity is important to our operations and technological development efforts. We face a multitude of cybersecurity threats that range from attacks common to most industries, such as ransomware and denial-of-service.
Senior management regularly discusses cyber risks and trends and, should they arise, any material incidents with the Audit Committee. While we have not experienced any material cybersecurity threats or incidents in recent years, there can be no guarantee that we will not be the subject of future threats or incidents.
Management provides periodic reports to the Audit Committee regarding cybersecurity risks and trends and any material cybersecurity incidents. While we have not experienced any material cybersecurity threats or incidents in recent years, there can be no guarantee that we will not be the subject of future threats or incidents.
Risk Management We engage third-party services to conduct evaluations of our security controls, whether through penetration testing, independent audits, or consulting on best practices to address new challenges. We have established cybersecurity security awareness training and ongoing monitoring.
Management reports to the Audit Committee regarding cybersecurity risks and significant cybersecurity incidents. 38 Risk Management We evaluate our security controls through internal assessments and may engage third-party services to support penetration testing, independent reviews, or consulting on best practices. We have established cybersecurity awareness training and ongoing monitoring.
Notwithstanding the extensive approach we take to cybersecurity, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us. While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. See “Risk Factors” for a discussion of cybersecurity risks.
Despite the measures we take to manage cybersecurity risk, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on the Company or its stakeholders. The Audit Committee oversees the Company’s cybersecurity risk management, including oversight of the Company’s Information Security & Risk Management Strategy (“ISRM”).
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In the event of an incident, we intend to follow our cybersecurity incident response plan, which outlines the steps to be followed from incident detection to mitigation, and notification. We contract with external firms that have extensive information technology and program management experience. We have implemented a governance structure and processes to assess, identify, manage, and report cybersecurity risks.
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We have processes in place for assessing, identifying, and managing material risks from potential unauthorized occurrences on or through our information systems that could adversely affect the confidentiality, integrity, or availability of our information systems or the information residing on those systems.
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Responsible personnel regularly discusses cyber risks and trends and, should they arise, any material incidents with the Audit Committee. 36 While we have not experienced any material cybersecurity threats or incidents in recent years, there can be no guarantee that we will not be the subject of future threats or incidents.
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These include mechanisms, controls, and processes that are designed to prevent, detect, or mitigate data loss, theft, misuse, unauthorized access, or other security incidents or vulnerabilities affecting the data. The data includes confidential, proprietary, and business and personal information that we collect, process, store, and transmit as part of our business, including on behalf of third parties.
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Risk Management We engage third-party services to conduct evaluations of our security controls, whether through penetration testing, independent audits, or consulting on best practices to address new challenges. We have established cybersecurity security awareness training and ongoing monitoring.
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We consider cybersecurity risks associated with third-party vendors and service providers as part of our overall risk management processes and may assess such vendors’ security practices where appropriate. We maintain a cybersecurity risk management program operating under our Information Security & Risk Management Strategy (“ISRM”).
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In the event of an incident, we intend to follow our cybersecurity incident response plan, which outlines the steps to be followed from incident detection to mitigation, and notification. We contract with external firms that have extensive information technology and program management experience. We have implemented a governance structure and processes to assess, identify, manage, and report cybersecurity risks.
Added
This program is responsible for implementing and maintaining cybersecurity and data protection practices at Aditxt in close coordination with management and other teams across Aditxt. In addition to our in-house cybersecurity capabilities, we may engage assessors, consultants, auditors, or other third parties to assist with assessing, identifying, and managing cybersecurity risks. Management evaluates cybersecurity risks and associated mitigation efforts.
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We must comply with extensive regulations, including requirements imposed by the Federal Drug Administration related to adequately safeguarding patient information and reporting cybersecurity incidents to the SEC. We believe we are positioned to meet the requirements of the SEC.
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As of the date of this report, the Company is not aware of any material risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company, including its business strategy, results of operations, or financial condition.
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In addition to following SEC guidance and implementing pre-existing third party frameworks, we have developed our own practices and frameworks, which we believe enhance our ability to identify and manage cybersecurity risks. Assessing, identifying, and managing cybersecurity related risks are factored into our overall business approach.
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The ISRM establishes a governance framework for cybersecurity oversight and designates an ISRM Leadership Group responsible for implementing and maintaining the Company’s cybersecurity and data protection practices.
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We rely heavily on our supply chain to deliver our products and services, and a cybersecurity incident at a clinical site, subcontractor, or business partner could materially adversely impact us. We require that our subcontractors report cybersecurity incidents to us so that we can assess the direct impact of the incident.
Added
In the event of a cybersecurity incident, we follow established procedures to respond to and mitigate its impact, including coordination among internal personnel, use of external service providers where appropriate, and implementation of disaster recovery procedures. We may engage external firms with information technology and program management experience to assist in evaluating or managing cybersecurity risks.
Removed
Governance The Audit Committee has oversight responsibility for risks and incidents relating to cybersecurity threats, including compliance with disclosure requirements, cooperation with law enforcement, and related effects on financial and other risks, and it reports any findings and recommendations, as appropriate, to the full board of directors for consideration.
Item 2. Properties
Properties — owned and leased real estate
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Item 2. Properties
Properties — owned and leased real estate
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2024 filing
2025 filing
Biggest changeItem 2. Properties. We lease property consisting of office and laboratory space located at 2569 Wyandotte, St., Suite 101 Mountain View, CA 94043. The lease expires on August 31, 2024, subject to extension. As of December 31, 2024 the Company is 7.3 months in arrears on our Mountain View lease.
Biggest changeItem 2. Properties. We lease property consisting of office and laboratory space located at 2569 Wyandotte, St., Suite 101 Mountain View, CA 94043. On March 20, 2025, the Company entered an amendment to the Mountain View lease, extending the term through March 31, 2028. As of December 31, 2025 the Company is current on our Mountain View lease.
We lease property consisting of office and laboratory space located at 737 N. 5 th Street Richmond, Virginia 23219. The lease expires on August 31, 2026, subject to extension. As of December 31, 2024 the Company is 6.0 months in arrears on our Richmond lease.
We lease property consisting of office and laboratory space located at 737 N. 5 th Street Richmond, Virginia 23219. The lease expires on August 31, 2026, subject to extension. As of December 31, 2025 the Company is in default on the lease in the amount of $159,375 due to an outstanding security deposit.
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
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Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
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2024 filing
2025 filing
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The Company does not believe that the final outcome of any current legal proceedings will have a material adverse effect on the Company’s financial position or results of operations. In addition, the Company maintains what it believes is adequate insurance coverage to further mitigate risk.
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However, no assurance can be given that the final outcome of any such proceedings will not materially impact the Company’s financial condition or results of operations. Further, no assurance can be given that the amount or scope of existing insurance coverage will be sufficient to cover losses arising from any such matters.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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2024 filing
2025 filing
Biggest changeRecent Sales of Unregistered Securities On January 31, 2022 the Company issued a consultant 1 shares of common stock for services rendered. On February 28, 2022 the Company issued a consultant 1 shares of common stock for services rendered. On March 31, 2022 the Company issued a consultant 1 shares of common stock for services rendered.
Biggest changeRecent Sales of Unregistered Securities On June 24, 2025, the Company issued a consultant 664 common stock warrants to purchase 664 shares of common stock for services rendered.
Equity Compensation Plans The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report on Form 10-K. 38 Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report.
Equity Compensation Plans The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report on Form 10-K. Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report.
The actual number of holders of our common stock is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers or held by other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
The actual number of holders of our common stock is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers or held by other nominees.
Holders As of March 31, 2025, there were approximately 168 record holders of our common stock. As of April 12, 2024, there were 5, 13, and 1 holder(s) of Series A-1 Convertible Preferred Stock, Series B-1 Convertible Preferred Stock, and Series B-2 Convertible Preferred Stock, respectively.
Holders As of March 31, 2026, there were approximately 174 record holders of our common stock. As of March 31, 2026, there were 6, 2, 5, 1, and 2 holder(s) of Series A-1 Convertible Preferred Stock, Series A-2 Convertible Preferred Stock, Series B-1 Convertible Preferred Stock, Series B-2 Convertible Preferred Stock, and Series C-1 Convertible Preferred Stock respectively.
Removed
On December 12, 2022 the Company issued a consultant 1 shares of common stock for services rendered. On December 27, 2023, the Company issued a consultant 1 shares of common stock for services rendered. On March 17, 2023, the Company issued a consultant 1 shares of common stock for services rendered.
Removed
On December 20, 2023, the Company issued a consultant 7 shares of common stock for services rendered. The issuances above were made pursuant to Section 4(a)(2) of the Securities Act.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
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Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
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2024 filing
2025 filing
Biggest changeOn May 2, 2024, the Company entered into a Securities Purchase Agreement (the “May PIPE Purchase Agreement”) with certain accredited investors, pursuant to which the Company agreed to issue and sell to such investors in a private placement (the “Private Placement”) (i) an aggregate of 17 shares of the Company’s Series C-1 Convertible Preferred Stock (the “Series C-1 Convertible Preferred Stock”), (ii) an aggregate of 17 shares of the Company’s Series D-1 Preferred Stock (the “Series D-1 Preferred Stock”), and (iii) warrants (the “May PIPE Warrants”) to purchase up to an aggregate of 162 shares of the Company’s common stock.
Biggest changeOn October 2, 2024, the Company completed the purchase of 460 shares of Evofem F-1 Preferred Stock for an aggregate purchase price of $460,000. 51 Evofem Parent Equity Investment On October 28, 2024, the Company entered into a Securities Purchase Agreement (the “Series F-1 Securities Purchase Agreement”) with Evofem, pursuant to which the Company purchased the Fourth Parent Equity Investment of 2,280 shares of Evofem Series F-1 Convertible Preferred Stock for an aggregate purchase price of $2,280,000.
In May 2023, Adimune entered into a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome (“SPS”).
In May 2023, Adimune entered into a clinical trial agreement with the Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome (“SPS”).
Endometriosis occurs when the tissue of the uterus (endometrium) grows on areas where it does not belong, most often on the ovaries, fallopian tubes, outer surface of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body.
Endometriosis occurs when the tissue of the uterus (endometrium) grows in areas where it does not belong, most often on the ovaries, fallopian tubes, outer surface of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body.
Endometriosis is challenging to identify, and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe symptoms. Acquired Technologies – Adductomics Technology On March 21 , 2025, Pearsanta acquired certain patents related to the detection and analysis of DNA adducts.
Endometriosis is challenging to identify, and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe symptoms. Technologies – Adductomics Technology On March 21, 2025, Pearsanta acquired certain patents related to the detection and analysis of DNA adducts.
Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of mtDNA, and more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.
Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of mtDNA, and more specifically mutated mtDNA, make mtDNA a biological system suitable for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.
Pursuant to the February 2020 License Agreement, we received an exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed Products (as defined in the agreement). The license to the patented technology is exclusive, including the right to sublicense, beginning on the effective date of the agreement, and ending when the patent expires.
Pursuant to the February 2020 License Agreement, we received an exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed Products (as defined in the agreement). The license to the patented FlowSpot technology is exclusive, including the right to sublicense, beginning on the effective date of the agreement, and ending when the patent expires.
Since then, we expanded our portfolio of innovations, and we continue to evaluate a variety of promising health innovations. ADIMUNE, INC. Formed in January 2023, Adimune™, Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs.
Since then, we expanded our portfolio of innovations, and we continue to evaluate a variety of promising health innovations. ADIMUNE ™ , INC. - Subsidiary Formed in January 2023, Adimune™, Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs.
Published analytical data for the 3.4kb mitochondrial DNA deletion associated with prostate cancer, suggests the 3.4kb mitochondrial DNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone (PSA 1 and the risks associated with treatment of low-grade cancers (≤ Gleason 6) appear to outweigh the benefits –e.g. urinary incontinence, erectile dysfunction. 1 NIH National Cancer Institute reports this number is even higher at ~ 75% based on 5-year survival rates.
Published analytical data for the 3.4kb mtDNA deletion associated with prostate cancer, suggests the 3.4kb mtDNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone (PSA 1 and the risks associated with treatment of low-grade cancers (≤ Gleason 6) appear to outweigh the benefits –e.g. urinary incontinence, erectile dysfunction. 1 NIH National Cancer Institute reports this number is even higher at ~ 75% based on 5-year survival rates.
ADI is a technology platform which we believe can be engineered to address a wide variety of indications. Advantages ADI™ is a nucleic acid-based technology ( e.g. , DNA-based), which we believe selectively suppresses only those immune cells involved in attacking or rejecting self and transplanted tissues and organs.
ADI is a technology platform which we believe can be engineered to address a wide variety of indications. Advantages ADI™ is a nucleic acid-based technology ( e.g. , DNA-based), which we believe selectively suppresses only those immune cells involved in attacking (in autoimmune diseases) or rejecting self (in transplanted tissues and organs).
Our Mitomic® Prostate Test is in development and is being designed with the following objectives: ● Simple – The test is expected to be completed using a patient’s blood sample and is not expected to require an algorithm. ● Provide New Information – If ongoing clinical studies support the published analytical data for the 3.4kb mitochondrial DNA deletion, healthcare providers will be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and family history.
Our Mitomic ® Prostate Test is in development and is being designed with the following objectives: ● Simple – The test is expected to be completed using a patient’s blood sample and is not expected to require an algorithm. ● Provide New Information – If ongoing clinical studies support the published analytical data for the 3.4kb mtDNA deletion, healthcare providers will be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and family history.
ADI-100, the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which is implicated in type-1 diabetes, psoriasis, and in many autoimmune diseases of the CNS and has been successfully tested in several preclinical models (e.g., skin grafting, psoriasis, type 1 diabetes, multiple sclerosis).
ADI-100, the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which is implicated in type-1 diabetes (T1D), psoriasis, and in many autoimmune diseases of the CNS and has been successfully tested in several preclinical models (e.g., skin grafting, psoriasis, and T1D).
The current in-development products include a potential product for prostate cancer diagnosis and a potential product for the detection of endometriosis. Pearsanta has also discovered mitochondrial DNA based biomarkers, which it believes are associated with ovarian cancer and lung cancer; and Pearsanta intends to pursue the biomarker identification phase of development for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers.
The current in-development products include a potential product for prostate cancer diagnosis and a potential product for the detection of endometriosis. Pearsanta has also discovered mtDNA-based biomarkers, which it believes are associated with ovarian cancer and lung cancer; and Pearsanta intends to pursue the biomarker identification phase of development for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers.
Mitomic Endometriosis Test (MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one or more mitochondrial DNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately 1 in 10 women according to Endometriosis World and the World Health Organization.
Mitomic Endometriosis Test (MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one or more mtDNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately 1 in 10 women according to Endometriosis World and the World Health Organization.
Licensed Technologies – AditxtScore TM We issued Pearsanta an exclusive worldwide sub-license for commercializing the AditxtScore™ technology which provides a personalized comprehensive profile of the immune system. AditxtScore is intended to detect individual immune responses to viruses, bacteria, peptides, drugs, supplements, bone marrow and solid organ transplants, and cancer.
Licensed Technologies – AditxtScore TM We issued Pearsanta an exclusive worldwide sub-license (the “Exclusive Worldwide Sublicense Agreement”) for commercializing the AditxtScore™ technology which provides a personalized comprehensive profile of the immune system. AditxtScore is intended to detect individual immune responses to viruses, bacteria, peptides, drugs, supplements, bone marrow and solid organ transplants, and cancer.
Through the acquisition of these assets, and in particular the Mitomic Technology platform, patents, and intellectual property, our management believes that the Pearsanta is well positioned for research and discovery of mitochondrial DNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mitochondrial DNA based biomarkers for a wide spectrum of human diseases.
Through the acquisition of these assets, and in particular the Mitomic ® Technology platform, patents, and intellectual property, our management believes that Pearsanta is well positioned for research and discovery of mtDNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mtDNA based biomarkers for a wide spectrum of human diseases.
Pearsanta plans to license distribution rights through various agreements with U.S.-based and international business partners to commercialize our Mitomic® Technology, should Mitomic® tests be successfully developed and successfully approved by the FDA or a foreign regulator. We believe our biomarker portfolio covers many high-clinical need cancers, with potential applications outside oncology.
Pearsanta plans to license distribution rights through various agreements with U.S.-based and international business partners to commercialize our Mitomic ® Technology, should Mitomic ® tests be successfully developed and successfully approved by the FDA or a foreign regulator or other relevant regulatory body. We believe our biomarker portfolio covers many high-clinical need cancers, with potential applications outside oncology.
Pearsanta a state-of-the-art facility located in Richmond VA, that is a high-complexity, CLIA-certified, and CAP-accredited laboratory equipped to accommodate rapid development and rollout of innovative laboratory tests for the clinical market.
Pearsanta a state-of-the-art facility located in Richmond VA, that is a high-complexity, CLIA-certified, CAP-accredited and NYS CLEP-approved accredited laboratory equipped to accommodate rapid development and rollout of innovative laboratory tests for the clinical market.
Though Pearsanta has no commercially available FDA or foreign regulator approved products, Pearsanta has two product candidates in develop and hopes to enter the cancer screening market with these two product candidates, and if proven successful continue to discover mitochondrial DNA based biomarkers and develop a pipeline of disease screening and diagnostics tests.
Though Pearsanta has no commercially available FDA or foreign regulator approved products, Pearsanta has two product candidates in development and hopes to enter the cancer screening market with these two product candidates, and if proven successful continue to discover mtDNA-based biomarkers and develop a pipeline of disease screening and diagnostics tests.
Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested. For the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process, including site selection for clinical studies planned in psoriasis and type 1 diabetes.
Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested. For the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process, including site selection for clinical studies planned in psoriasis and T1D.
In consideration for the LLU License Agreement, we issued 1 shares of common stock to LLU. PEARSANTA, INC. The best approach may be its early detection. Pearsanta is pioneering the development of molecular tests based on the mitochondrial genome to develop tests for early detection of cancer.
In consideration for the LLU License Agreement, we issued 1 shares of common stock to LLU. PEARSANTA, INC. Subsidiary The best approach to addressing cancer may be its early detection. Pearsanta is pioneering the development of molecular tests based on the mitochondrial DNA to develop tests for early detection of cancer.
Recently Issued and Adopted Accounting Pronouncements See Note 3 - Summary of Significant Accounting Policies to the accompanying consolidated financial statements for a description of other accounting policies and recently issued accounting pronouncements. Recent Developments See Note 12 – Subsequent Event to the accompanying consolidated financial statements for a description of material recent developments. 48
Recently Issued and Adopted Accounting Pronouncements See Note 3 - Summary of Significant Accounting Policies to the accompanying condensed consolidated financial statements for a description of other accounting policies and recently issued accounting pronouncements. Recent Developments See Note 14 – Subsequent Event to the accompanying condensed consolidated financial statements for a description of material recent developments.
Through Aditxt, Adimune has the right of use to the exclusive worldwide license for commercializing ADI nucleic acid-based technology (which is currently at the pre-clinical stage) from Loma Linda University. ADI uses a novel approach that mimics the way the body naturally induces tolerance to our own tissues (“therapeutically induced immune tolerance”).
Through Aditxt, Adimune has the right to the exclusive worldwide license for commercializing ADI nucleic acid-based technology from Loma Linda University. ADI uses a novel approach that mimics the way the body naturally induces tolerance to our own tissues (“therapeutically induced immune tolerance”).
Our financial statements as of December 31, 2024, show a net loss of $35,020,058. We expect to incur additional net expenses over the next several years as we continue to maintain and expand our existing operations. The amount of future losses and when, if ever, we will achieve profitability are uncertain.
Our condensed consolidated financial statements as of December 31, 2025, show a net loss of $42,787,043. We expect to incur additional net expenses over the next several years as we continue to maintain and expand our existing operations. The amount of future losses and when, if ever, we will achieve profitability are uncertain.
Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of mitochondrial DNA (mtDNA), and more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.
Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of mitochondrial DNA (mtDNA), and more specifically mutated mtDNA, make mtDNA a biological system suitable for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting. 42 Pearsanta acquired the assets of MDNA Life Sciences Inc. on January 4, 2024.
Pearsanta is continuing to leverage this technology to discover mitochondrial DNA based biomarkers.
Pearsanta is continuing to leverage this technology to discover mtDNA-based biomarkers.
Our laboratory facility is optimized for contamination prevention including dedicated workspaces for key functions; advanced molecular biology capabilities including digital PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy; and automated and semi-automated (robotic) processes for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows. 42 Our Mitomic® Products and Product Candidates The Mitomic® Technology targets mutations in mitochondrial DNA to detect disease.
Our laboratory facility is optimized for contamination prevention including dedicated workspaces for key functions; advanced molecular biology capabilities including digital PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy; and automated and semi-automated (robotic) processes for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows.
Going Concern We were incorporated on September 28, 2017 and have not generated significant revenues to date. During the year ended and as of December 31, 2024, we had a net loss of $35,020,058 and cash of $833,031. We are currently over 90 days past due on a significant number of vendor obligations.
Going Concern We were incorporated on September 28, 2017 and have not generated significant revenues to date. During the year ended December 31, 2025 we had a net loss of $42,787,043 and cash of $3,198,599 as of December 31, 2025. We are currently over 90 days past due on a significant number of vendor obligations.
Good Manufacturing Process (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer. The clinical grade drug substances are now being prepared for shipment to another contract manufacturer to be formulated into the final drug product in preparation for stability testing and use in the clinical trials pending required regulatory submissions.
The clinical grade drug substances are now being prepared for shipment to another contract manufacturer to be formulated into the final drug product in preparation for stability testing and use in the clinical trials pending required regulatory submissions.
All preclinical studies ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring durable tolerance over the 10-month duration of the T1D studies both in prevention and treatment study designs.
All preclinical studies for ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring durable tolerance as shown in prevention and treatment studies in T1D.
These tests may become tools that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens. 41 Advantages The sophistication of the AditxtScore technology includes the following: ● greater sensitivity/specificity. ● 20-fold higher dynamic range, greatly reducing signal to noise compared to conventional assays. ● ability to customize assays and multiplex a large number of analytes with speed and efficiency. ● ability to test for cellular immune responses (i.e., T and B cells and cytokines). ● proprietary reporting algorithm.
Advantages The advantages of the AditxtScore technology include the following: ● greater sensitivity/specificity. ● 20-fold higher dynamic range, greatly reducing signal to noise compared to conventional assays. ● ability to customize assays and multiplex a large number of analytes with speed and efficiency. ● ability to test for cellular immune responses (i.e., T and B cells and cytokines). ● proprietary reporting algorithm.
Our Team We have assembled a team of experts from a variety of scientific fields and commercial backgrounds, with many years of collective experience that ranges from founding startup biotech companies, to developing and marketing biopharmaceutical products, to designing clinical trials, and to management of private and public companies.
The Company retains its holdings of Evofem F-1 Preferred Stock, convertible notes, and Evofem Warrants. 52 Our Team We have assembled a team of experts from a variety of scientific fields and commercial backgrounds, with many years of collective experience that ranges from founding startup biotech companies, to developing and marketing biopharmaceutical products, to designing clinical trials, and to managing private and public companies.
Lastly, two remaining drug product release assays specifically designed for ADI-100 are in the final stages of validation to be used once the final drug product is ready. 39 Preclinical and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical trials.
Preclinical and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical trials.
While still in the early stages, Pearsanta anticipates that additional development over the next two to three years will advance this platform toward clinical and commercial applications. ADIVIR, INC.
The development roadmap includes further validation of the technology and the creation of commercially available diagnostic kits. While still in the early stages, Pearsanta anticipates that additional development over the next two to three years will advance this platform toward clinical and commercial applications. ADIVIR ™ , INC. Subsidiary Formed in April 2023, Adivir™, Inc .
The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares.
In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our common shares.
Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
JOBS Act On April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.
Every human cell is home to multiple copies of mitochondrial DNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer. Though further technical development and clinical validation is required to determine efficacy, Mitomic® tests are being designed to detect this mutated DNA, which can accumulate from the very early stages of a disease.
Though further technical development and clinical validation is required to determine efficacy, Mitomic ® tests are being designed to detect this mutated DNA, which can accumulate from the very early stages of a disease.
Food and Drug Administration, a human trial for SPS is expected get underway in 2025 with enrollment of 10-20 patients, some of whom may also have type 1 diabetes. ADI-100 will initially be tested for safety and efficacy.
Food and Drug Administration, a human trial for SPS is expected to get underway in 2026 with enrollment of 10-20 patients, some of whom may also have T1D.
The decrease in expenses during the year ended December 31, 2024 compared to the year ended December 31, 2023 was due to decreased research and development spend and the termination of a sales and marketing vendor.
The decrease in expenses during the year ended December 31, 2025 compared to the year ended December 31, 2024 was due to decreased research and development spend. During the year ended December 31, 2025, the Company had other expenses of $23,216,319.
DNA adducts are chemically modified nucleotides that result from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability and increased cancer risk.
DNA adducts are chemically modified nucleotides that result from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability and increased cancer risk. The technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity of DNA adduct detection across a full genomic landscape.
If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected.
If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected. 54 Off-Balance Sheet Arrangements We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
During the year ended December 31, 2024, we purchased $0 in fixed assets. Our consolidated financial statements have been prepared assuming that we will continue as a going concern.
As of December 31, 2025, we had an accumulated deficit of $209,808,770. We had working capital of $(8,398,458) as of December 31, 2025. During the year ended December 31, 2025, we purchased $13,743 in fixed assets. Our consolidated financial statements have been prepared assuming that we will continue as a going concern.
On December 29, 2021, we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology deployed in AditxtScore TM and securing worldwide exclusivity in all fields of use of the licensed technology.
On December 29, 2021, we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology and securing worldwide exclusivity in all fields of use of the licensed technology. 43 AditxtScore has been designed to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles and to stay informed about attacks on or by their immune system.
Results of Operations Results of operations for the years ended December 31, 2024 and 2023 We generated revenue of $133,985 and $645,176 for the years ended December 31, 2024 and 2023, respectively. Cost of sales for the years ended December 31, 2024 and 2023 was $627,474 and $756,836, respectively.
Results of Operations Results of operations for the year ended December 31, 2025 and 2024 We generated revenue of $3,195 and $133,985 for the year ended December 31, 2025 and 2024, respectively. Cost of goods sold for the year ended December 31, 2025 and 2024 was $2,927 and $627,474, respectively.
Acquired Technologies – Mitomic® Technology Platform In January 2024 Pearsanta acquired the assets comprising our Mitomic® Technology platform from MDNA Life Sciences Inc. This platform seeks to harness the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based liquid biopsies.
This platform seeks to harness the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based liquid biopsies.
The biomarker identification program is based on the identification of a new class of molecules generated through a process associated with mitochondria. The Mitomic® Technology platform has already discovered biomarkers which are believed to be associated with cancer and has generated an “in-silico” database, which is an experiment that generates thousands of potential biomarkers, developed through computer software and simulation.
The Mitomic ® Technology platform has already discovered biomarkers which are believed to be associated with cancer and has generated an “in-silico” database, which is an experiment that generates thousands of potential biomarkers, developed through computer software and simulation. 44 To date, the Mitomic ® Technology biomarker discoveries have identified numerous biomarker targets from the in-silico database and we plan to use these biomarker targets in our various assay development programs.
Preclinical safety and toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs evaluated. Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness of the immune system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors.
Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness of the immune system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors. Good Manufacturing Practices (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer.
To date, the Mitomic® Technology biomarker discoveries have identified numerous biomarker targets from the in-silico database and we plan to use these biomarker targets in its various assay development programs. Mitomic® Prostate Test (MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level of the 3.4kb mitochondrial DNA deletion.
Mitomic ® Prostate Test (MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level of the 3.4kb mtDNA deletion.
Background The discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible life-saving organ transplantation procedures and blocking of unwanted immune responses in autoimmune diseases. However, immune suppression leads to significant undesirable side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses immune function throughout the body.
However, immune suppression leads to significant undesirable side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses immune function throughout the body.
In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute amounts of the therapeutic drug into the skin.
In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute amounts of the therapeutic drug into the skin. Moreover, preclinical studies have demonstrated that ADI treatment significantly and substantially prolongs graft survival, in addition to successfully “reversing” other established immune-mediated inflammatory processes.
Research and development expenses were $10,886,130 which includes $1,772,108 in consulting expenses and $6,712,663 in stock-based compensation. Sales and marketing expenses were $197,863, which includes $0 in stock-based compensation. 45 During the year ended December 31, 2023, we incurred a loss from operations of $26,062,425. This is due primarily to general and administrative expenses of $18,607,142.
This is due primarily to general and administrative expenses of $16,286,216. This includes approximately $4,903,086 in payroll expenses, $4,998,772 in professional fees, and $33,071 in stock-based compensation. Research and development expenses were $10,886,130 which includes $1,772,108 in consulting expenses and $6,712,663 in stock-based compensation. Sales and marketing expenses were $197,863, which includes $0 in stock-based compensation.
We may seek to sell common stock, preferred stock or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants.
We will need significant additional capital to continue to fund our operations and the clinical trials for our product candidates. We may seek to sell common stock, preferred stock or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing.
Contractual Obligations The following table shows our contractual obligations as of December 31, 2024: Payment Due by Year Total 2025 2026 Lease $ 1,134,476 $ 710,546 $ 423,930 Critical Accounting Polices and Estimates The preparation of financial statements in conformity with U.S.
Contractual Obligations The following table shows our contractual obligations as of December 31, 2025: Payment Due by Year Total 2026 2027 2028 Lease $ 1,288,930 $ 801,760 $ 389,165 $ 98,005 Critical Accounting Policies and Estimates Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States.
This approach aims to provide actionable insights into DNA damage before mutations occur, offering the potential to identify environmental or biological factors that contribute to cancer risk. The development roadmap includes further validation of the technology and the creation of commercially available diagnostic kits.
Pearsanta intends to develop this platform to enable a comprehensive, panoramic assessment of DNA adducts using urine, blood, or solid tissue samples. This approach aims to provide actionable insights into DNA damage before mutations occur, offering the potential to identify environmental or biological factors that contribute to cancer risk.
Liquidity and Capital Resources We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2024, we had an accumulated deficit of $168,094,569. We had working capital of $(21,407,282) as of December 31, 2024.
This was primarily comprised of an interest expense of $4,188,725 and an amortization of debt discount of $3,174,920. 53 Liquidity and Capital Resources We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable.
Moreover, preclinical studies have demonstrated that ADI treatment significantly and substantially prolongs graft survival, in addition to successfully “reversing” other established immune-mediated inflammatory processes. 40 License Agreement with Loma Linda University (“LLU”) On March 15, 2018, we entered into a License Agreement with LLU, which was subsequently amended on July 1, 2020.
License Agreement with Loma Linda University (“LLU”) On March 15, 2018, we entered into a License Agreement with LLU, which was subsequently amended on July 1, 2020.
Significant estimates underlying the financial statements include the value of preferred shares issued and related derivative liability, our investment in Evofem preferred stock and the fair value of stock options and warrants. 47 ● Fair value of options and warrants ● Preferred Stock and Derivative Liabilities ● Investments Accordingly, we believe the policies set forth above are critical to fully understanding and evaluating our financial condition and results of operations.
Because this assessment requires significant judgment, actual results could differ materially from these estimates. Accordingly, we believe the policies set forth above are critical to fully understanding and evaluating our financial condition and results of operations.
It has broad applicability to many other agents of clinical interest impacting the immune system, including those not yet identified such as emerging infectious agents. AditxtScore is being designed to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles and to stay informed about attacks on or by their immune system.
It has broad applicability to many other agents of clinical interest impacting the immune system, including those not yet identified such as emerging infectious agents. On September 23, 2025, the Company and Pearsanta entered in a Mutual Termination Agreement (the “Exclusive Worldwide Sublicense Termination Agreement”) to terminate the Exclusive Worldwide Sublicense Agreement.
The decrease in sales and cost of sales is due to the Company selling less AditxtScores. During the year ended December 31, 2024, we incurred a loss from operations of $27,006,739. This is due primarily to general and administrative expenses of $16,286,216. This includes approximately $4,903,086 in payroll expenses, $4,998,772 in professional fees, and $33,071 in stock-based compensation.
This is due to general and administrative expenses of $15,974,863, which includes approximately $4,438,898 in payroll expenses and $5,477,124 in professional fees. Research and development expenses were $3,194,133 which includes $995,473 in consulting expenses. Sales and marketing expenses were $401,996. During the year ended December 31, 2024, we incurred a loss from operations of $27,863,698.
Formed in April of 2023, Adivir™, Inc. is a wholly owned subsidiary, dedicated to the clinical and commercial development efforts of innovative products for population health, including antiviral and other antimicrobial products, which have the potential to address a wide range of infectious diseases, including those that currently lack viable treatment options.
(“Adivir”) is a wholly owned subsidiary of Aditxt, Inc., dedicated to advancing the clinical and commercial development of innovative products intended to address significant unmet needs in infectious disease and population health. Adivir is focused on building a portfolio of antiviral and other antimicrobial solutions designed to target life-threatening viral infections and emerging pathogens.
GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could differ from those estimates.
The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures.
Removed
Pearsanta acquired the assets of MDNA Life Sciences Inc. on January 4, 2024.
Added
Preclinical safety and toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs evaluated except the skin (at the injection site).
Removed
The acquired technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity of DNA adduct detection across a full genomic landscape. 43 Pearsanta intends to develop this platform to enable a comprehensive, panoramic assessment of DNA adducts using urine, blood, or solid tissue samples.
Added
Lastly, one remaining drug product release assay specifically designed for ADI-100 is in the final stages of qualification to be used once the final drug product is ready.
Removed
Background On April 18, 2023, we entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Cellvera Global Holdings LLC (“Cellvera Global”), Cellvera Holdings Ltd. (“BVI Holdco”), Cellvera, Ltd. (“Cellvera Ltd.”), Cellvera Development LLC (“Cellvera Development” and together with Cellvera Global, BVI Holdco, Cellvera Ltd. and Cellvera Development (the “Sellers”), AiPharma Group Ltd.
Added
In these studies, the primary readouts for ADI-100 will be safety and tolerability as well as clinical and immunological signals of tolerance induction. 41 Background The discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible treatment of autoimmune diseases and life-saving organ transplantation procedures and blocking of unwanted immune responses in autoimmune diseases.
Removed
(“Seller Owner” and collectively with the Sellers, “Cellvera”), and the legal representative of Cellvera, pursuant to which, the Company will purchase Cellvera’s 50% ownership interest in G Response Aid FZE (“GRA”), certain other intellectual property and all goodwill related thereto (the “Acquired Assets”).
Added
As provided in the Exclusive Worldwide Sublicense Termination Agreement, the Exclusive Worldwide Sublicense Agreement has been terminated in its entirety and all rights and obligations of the parties under the Exclusive Worldwide Sublicense Agreement have ceased.
Removed
Unless expressly stated otherwise herein, capitalized terms used but not defined herein have the meanings ascribed to them in the Asset Purchase Agreement.
Added
A non-exclusive licensing agreement has been granted by Aditxt to Pearsanta as of December 30, 2025 for the use of the technology for evaluating levels of antibodies and neutralizing antibodies to SARS-CoV-2, which are currently available in use by the CLIA/CAP facility in Richmond, VA.
Removed
Pursuant to the Asset Purchase Agreement, the consideration for the Acquired Assets consists of (A) $24.5 million, comprised of: (i) the forgiveness of the Company’s $14.5 million loan to Cellvera Global, and (ii) approximately $10 million in cash, and (B) future revenue sharing payments for a term of seven years.
Added
These tests may become tools that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens. Technologies – Mitomic ® Technology Platform In January 2024, Pearsanta acquired the assets comprising our Mitomic ® Technology platform from MDNA Life Sciences Inc.
Removed
GRA holds an exclusive, worldwide license for the antiviral medication, Avigan® 200mg, excluding Japan, China and Russia. The other 50% interest in GRA is held by Agility, Inc. (“Agility”).
Added
Our Mitomic ® Products and Product Candidates The Mitomic ® Technology targets mutations in mitochondrial DNA (mtDNA) to detect disease. Every human cell is home to multiple copies of mitochondrial mtDNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer.
Removed
Additionally, upon the closing, the Share Exchange Agreement previously entered into as of December 28, 2021, between Cellvera Global Holdings, LLC f/k/a AiPharma Global Holdings, LLC (together with other affiliates and subsidiaries) and the Company, and all other related agreements will be terminated.
Added
The biomarker identification program is based on the identification of a new class of molecules generated through a process associated with mitochondria.
Removed
The obligations of the Company to consummate the Closing under the Asset Purchase Agreement are subject to the satisfaction or waiver, at or prior to the Closing of certain conditions, including but not limited to, the following: (i) Satisfactory completion of due diligence; (ii) Completion by the Company of financing sufficient to consummate the transactions contemplated by the Asset Purchase Agreement; (iii) Receipt by the Company of all required Consents from Governmental Bodies for the Acquisition, including but not limited to, any consents required to complete the transfer and assignment of Cellvera’s membership interests in GRA; (iv) Receipt of executed payoff letters reflecting the amount required to be fully pay all of each of Seller’s and Seller Owner’s Debt to be paid at Closing; (v) Receipt by the Company of a release from Agility; (vi) Execution of an agreement acceptable to the Company with respect to the acquisition by the Company of certain intellectual property presently held by a third party; 44 (vii) Execution of an amendment to an asset purchase agreement previously entered into by Cellvera with a third party that effectively grants the Company the rights to acquire the intellectual property from the third party under such agreement; (viii) Receipt of a fairness opinion by the Company with respect to the transactions contemplated by the Asset Purchase Agreement; and (ix) Receipt by the Company from the Seller Owner of written consent, whether through its official liquidator or the Board of Directors of Seller Owner, to the sale and purchase of the Acquired Assets and Assumed Liabilities pursuant to the Assert Purchase Agreement.
Added
Its strategic objective is to identify, develop, and commercialize therapeutic candidates that have the potential to improve treatment access and outcomes in areas where existing options are limited or inadequate. We believe the global healthcare landscape underscores the critical importance of strengthening antiviral preparedness and accelerating development of both novel and repurposed therapeutic solutions.
Removed
In October 2024, the Company received notice that Cellvera was the subject of a liquidation proceeding and that a liquidator had been appointed by the order of the Eastern Caribbean Supreme Court. As a result, the Company does not presently believe that the proposed acquisition of Cellvera will be completed as proposed or at all.
Added
Through Adivir, the Company seeks to contribute to addressing the ongoing and evolving challenges posed by infectious diseases worldwide. 45 ADIFEM, INC. Subsidiary Adifem, Inc. (“Adifem”), f/k/a Adicure, Inc., was formed in April of 2024 connection with Aditxt’s planned strategic expansion into women’s health through its proposed acquisition of Evofem Biosciences.
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