ADTX 10-K & 10-Q changes, risk factors and insider trading
Aditxt, Inc. · OTC · Pharmaceutical Preparations · CIK 1726711 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “RISK FACTOR SUMMARY”
New heading “Risks Relating to the Litigation and Government Regulation”
New heading “Claims, litigation, government investigations, product liability and recalls, and other proceedings may adversely affect our business, operating results, financial condition, and cash flows.”
New heading “We must successfully manage compliance with current and expanding laws and regulations, as well as manage new and pending legal and regulatory matters in the U.S. and abroad.”
New heading “We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make it more difficult to compare our performance with other public companies and make our common stock less attractive to investors.”
Removed heading “We need to ensure strong product performance and reliability to maintain and grow our business.”
Removed heading “Technological breakthroughs in electric motors could render our Motion Products obsolete.”
Removed heading “We expect to rely on third-party manufacturers for certain of our products and will be dependent on their quality and effectiveness.”
Removed heading “Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.”
Removed heading “We may spend considerable resources developing and maintaining patents, licensing agreements and other intellectual property that may later be abandoned or may otherwise never result in products brought to market.”
Removed heading “While we have entered into a Merger Agreement with Evofem and an Arrangement Agreement with Appili, we cannot assure you that the transactions contemplated by such agreements will be consummated or, that if such transactions are consummated, they will be accretive to stockholder value.”
Removed heading “Upon dissolution of our Company, you may not recoup all or any portion of your investment.”
Removed heading “Limitation of Liability and Indemnification of Management.”
Removed heading “Our management team is required to devote substantial time to public company compliance initiatives.”
Removed heading “Failure to develop our internal controls over financial reporting as we grow could have an adverse impact on us.”
Largest changes
“If our common stock were delisted from Nasdaq, we could face significant adverse consequences, including: reduced trading liquidity; increased volatility; reduced analyst coverage and diminished investor interest; decreased ability to raise capital; and potential defaults, penalties or other adverse consequences under agreements that include listing-related covenants or that are affected by a reduced trading market. …”see in full comparison
“Claims, litigation, government investigations, product liability and recalls, and other proceedings may adversely affect our business, operating results, financial condition, and cash flows.”see in full comparison
“We are subject in the ordinary course of our business, in the U.S. and internationally, to many statutes, ordinances, rules and regulations that, if violated by us or the third parties we work with, could have a material adverse effect on our business, operating results, financial condition, and cash flows. These laws and regulations include but are not limited to accounting and financial reporting, advertising, anti-bribery and anti-corruption, consumer protection, data security and privacy, electronic commerce, employment, intellectual property, product liability, and trade. …”see in full comparison
“We are, from time to time, involved in various claims, litigation matters and regulatory proceedings that could have a material adverse effect on us. These matters may include personal injury and other tort claims, deceptive trade practice disputes, intellectual property disputes, product recalls, contract disputes, employment and tax matters and other proceedings and litigation, including class actions lawsuits. …”see in full comparison
“The Delaware General Corporation Law and the Company’s Amended and Restated Certificate of Incorporation provide for the limitation of the liability of directors for monetary damages. Such provisions may discourage shareholders from bringing a lawsuit against directors for breaches of fiduciary duty and may also have the effect of reducing the likelihood of derivative litigation against directors and officers even though such action, if successful, might otherwise be a benefit to the Company’s shareholders. …”see in full comparison
“As previously reported in a Current Report on Form 8-K filed by the Company, on December 1, 2025, the Company received written notice from the Listing Qualifications Department of The Nasdaq Capital Market LLC stating that, based upon the stockholders’ equity reported by the Company in its Form 10-Q for the period ended September 30, 2025, the Company was no longer in compliance with Nasdaq Listing Rule 5550(b)(1), which requires a company to maintain a minimum of $2,500,000 in stockholders’ equity, a market value of listed securities of at least $35 million, or net income from continuing …”see in full comparison
Full comparison: every changed paragraph (56)
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. 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. Such risks include, but are not limited to:
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, 2025, and 2024, the Company had a net loss of $42,787,043 and $35,020,058, respectively. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements, public offerings and/or bank financing necessary to support our working capital requirements. To the extent that funds generated from any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment.
As previously reported in a Current Report on Form 8-K filed by the Company, on December 1, 2025, the Company received written notice from the Listing Qualifications Department of The Nasdaq Capital Market LLC stating that, based upon the stockholders’ equity reported by the Company in its Form 10-Q for the period ended September 30, 2025, the Company was no longer in compliance with Nasdaq Listing Rule 5550(b)(1), which requires a company to maintain a minimum of $2,500,000 in stockholders’ equity, a market value of listed securities of at least $35 million, or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years. In accordance with the Nasdaq Listing Rules, the Company had 45 calendar days, or until January 15, 2026, to submit a plan to regain compliance. The Company submitted its plan of compliance on January 15, 2026, and was granted an extension by Nasdaq until May 15, 2026, to regain compliance. A delisting could materially and adversely affect our business, financial condition and results of operations and could reduce the liquidity and market price of our common stock.
Although Nasdaq granted the extension, we must satisfy the requirements for continued listing by the end of the extension period. Our ability to regain compliance may depend on factors that are outside our control, including market conditions, our operating performance, our ability to improve our stockholders’ equity, and our ability to access capital on acceptable terms, if at all. In addition, Nasdaq may require that we meet interim milestones or other conditions during the extension period, and there can be no assurance that we will satisfy any such conditions. Even if we regain compliance, Nasdaq may subsequently determine that we fail to satisfy other continued listing requirements, and we may again become subject to delisting.
As of the date of this Annual Report, our common stock has traded below $1.00 for 6 consecutive trading days. Under Nasdaq’s continued listing requirements, if our common stock trades below $1.00 for 30 consecutive trading days, we would be subject to a minimum bid price deficiency and Nasdaq would generally provide notice that we are not in compliance. As of the date of this Annual Report, we have not received a deficiency notice from Nasdaq; however, there can be no assurance that we will not receive such notice if our common stock continues to trade below the minimum bid price threshold for the required period.
In addition, on January 26, 2026, Nasdaq filed a rule proposal with the SEC that, if approved and implemented, could require the immediate suspension and delisting of companies whose market capitalization falls below a specified minimum threshold, including a proposed threshold of $5.0 million, for 30 consecutive business days. On March 11, 2026, the SEC issued a release extending the period to approve, disapprove or institute proceedings to determine whether to disapprove the proposed new continued listing standard from March 16, 2026 to April 29, 2026. Because the rule is proposed, it may be modified, delayed or not adopted, and any final rule could differ materially from the proposal, including with respect to the applicable market capitalization test, measurement period, cure period, compliance deadlines, and available remedies. However, if a minimum market capitalization requirement at or near the proposed level is adopted and becomes applicable to us, and our market capitalization falls below the applicable threshold for the relevant period, we could be deemed noncompliant and become subject to delisting from Nasdaq.
Our market capitalization has fluctuated in the past and may continue to fluctuate significantly due to factors beyond our control, including overall market conditions, volatility in the trading price or volume of our common stock, industry developments, the availability of research coverage, and investor sentiment. In addition, events such as equity issuances, reverse stock splits, or other corporate actions may not increase our market capitalization and could adversely affect it. As of March 30, 2026, our market capitalization is approximately $713,000. As a result, there can be no assurance that we would be able to satisfy any new minimum market capitalization continued listing standard, if adopted.
Unlike most Nasdaq continued listing deficiencies, the proposed rule would allow suspension and delisting to take effect without a prior hearing and without any automatic stay. Although an affected company could seek review of a delisting determination and appeal to the Nasdaq Listing and Hearing Review Council, its securities would remain suspended from Nasdaq trading during that process and would generally trade in the over-the-counter market. The scope of any hearing would be narrowly limited to whether Nasdaq staff made a factual error, with no discretion to grant additional time or consider subsequent compliance.
If our common stock were delisted from Nasdaq, we could face significant adverse consequences, including: reduced trading liquidity; increased volatility; reduced analyst coverage and diminished investor interest; decreased ability to raise capital; and potential defaults, penalties or other adverse consequences under agreements that include listing-related covenants or that are affected by a reduced trading market. Delisting could also impair our ability to use equity or equity-linked securities for strategic transactions, employee compensation and other corporate purposes, and could increase our cost of capital. If our common stock were to trade on an over-the-counter market, the market price and liquidity of our common stock could be adversely affected and investors may have difficulty selling their shares.
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. There can be no assurances that we will be able to
achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements,
public offerings and/or bank financing necessary to support our working capital requirements. To the extent that funds generated from
any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No
assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise
substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to
discontinue operations, which would cause investors to lose their entire investment.
The February 2020 License
Agreement Agreement
with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments; (ii) are not diligently developing
and 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 Termination discussed
above will take effect only upon 30 days written notice by Stanford unless we remedy the breach within a 30-day cure period. If the February
2020 License Agreement were to be terminated by Stanford, we would lose a significant asset and may no longer be able to develop our
product product
candidates, which would have a material adverse effect on our operations. The Company is current with its obligations and havehas
submitted submitted
a year end report as well as provided additional milestone plans for research and development as well as commercialization.
We need to ensure
strong product performance and reliability to maintain and grow our business.
Upon
reaching commercialization, we will need to maintain and continuously improve the performance and reliability of our diagnostic tests
to achieve our profitability objectives. Poor product performance and reliability could lead to customer dissatisfaction, adversely affect
our reputation and revenues, and increase our service and distribution costs and working capital requirements. Our diagnostic tests may
contain errors or defects, and while we have made efforts to test them extensively, we cannot assure that our current diagnostic tests,
or those developed in the future, will not have performance problems. 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.
Technological
breakthroughs in electric motors could render our Motion Products obsolete.
The
electric motor market is subject to rapid technological change and product innovation. Our electric motors are based on its proprietary
technology, but several companies are pursuing new technologies, including sensing technologies for electric engines. Any technological
breakthroughs could render our Motion Products obsolete, would have a material adverse effect on our business, financial condition and
results of operations and could result in our shareholders losing their entire investment.
We expect to rely
on third-party manufacturers for certain of our products and will be dependent on their quality and effectiveness.
Our
neurological and electric motor products will require precise, high-quality manufacturing. The failure to achieve and maintain high manufacturing
standards, including failure to detect or control anticipated or unanticipated manufacturing errors or the frequent occurrence of such
errors, could result in user injury or death, discontinuance or delay of ongoing or planned clinical studies, delays or failures in product
testing or delivery, cost overruns, product recalls or withdrawals and other problems that could seriously hurt our business. Contract
medical device manufacturers often encounter difficulties involving production yields, quality control and quality assurance and shortages
of qualified personnel. These manufacturers are subject to stringent regulatory requirements, including the FDA’s current good-manufacturing-practices
regulations. If our contract manufacturers fail to maintain ongoing compliance at any time, the production of our products could be interrupted,
resulting in delays or discontinuance of our clinical studies, additional costs and loss of potential revenues.
WeFrom 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 arebe privately held, we may experience difficulty in evaluating
potential target businesses as much of the information concerning these
businesses is not publicly available. Therefore, our estimates
and assumptions used to evaluate the operations, management and market
risks with respect to potential target businesses may be subject
to various risks and uncertainties. Further, the time and costs associated
with identifying and evaluating potential target businesses
may cause a substantial drain on our resources and may divert our management
team’s attention away from the operations of our businesses
for significant periods of time.
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 patent position
of life
science companies generally is highly uncertain, involves complex legal and factual questions and has in past years been the
subject of
much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the
United States
States, and we may fail to seek or obtain patent protection in all major markets. For example, unlike the U.S., European patent
law restricts
the patentability of methods of treatment of the human body. Our pending and future patent applications may not result
in patents being
issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing
competitive competitive
technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and
other countries
may diminish the value of our patents or narrow the scope of our patent protection, even post-grant.
Obtaining and maintaining our
patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental
patent agencies, and our own patent protection could be reduced or eliminated for noncompliance with these requirements.
Intellectual property litigation could cause
us to spend substantial resources and distract our personnel from their normal responsibilities.
Even if resolved in our favor,
litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract
our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results
of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be
negative, it could have an adverse effect on the price of our common stock. Such litigation or proceedings could increase our operating
losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may
not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be
able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to
compete in the marketplace.
We may spend considerable resources developing
and maintaining patents, licensing agreements and other intellectual property that may later be abandoned or may otherwise never result
in products brought to market.
Not all technologies and candidate
products that initially show potential as the basis for future products ultimately meet the rigors of our development process and as a
result may be abandoned and/or never otherwise result in products brought to market. In some cases, prior to abandonment we may be
required to incur significant costs developing and maintaining intellectual property and/or maintaining license agreements and our business
could be harmed by such costs.
Risks Relating to the Litigation and Government Regulation
Claims, litigation, government investigations, product liability and recalls, and other proceedings may adversely affect our business, operating results, financial condition, and cash flows.
We are, from time to time, involved in various claims, litigation matters and regulatory proceedings that could have a material adverse effect on us. These matters may include personal injury and other tort claims, deceptive trade practice disputes, intellectual property disputes, product recalls, contract disputes, employment and tax matters and other proceedings and litigation, including class actions lawsuits. It is not possible to predict the outcome of pending or future litigation and any such claims, with or without merit, could be time consuming and expensive, and may require the Company to incur substantial costs and divert the resources of management.
On February 3, 2026, Vertalo, Inc. filed an Original Petition against Aditxt, Inc. in the District Court of Travis County, Texas (98th Judicial District), Cause No. D-1-GN-26-000795. The complaint asserts claims for breach of contract and seeks, among other relief, alleged unpaid fees of $300,000, warrants to acquire 6,250 shares of Aditxt common stock, $26,000 of alleged travel-related costs, additional alleged damages of at least $500,000, attorneys’ fees, and interest. Aditxt disputes the allegations and intends to defend the matter vigorously, pursue counterclaims and pursue available claims and defenses. Based on information available to the Company at present, the Company cannot reasonably estimate a range of loss for this potential action We cannot predict the outcome of this dispute with certainty. Regardless of the outcome, these can have an adverse impact on us because of legal costs, diversion of management resources and other factors.
Determining legal reserves or possible losses from claims against us involves judgment and may not reflect the full range of uncertainties and unpredictable outcomes. Until the final resolution of such matters, we may be exposed to losses in excess of the amount recorded, and such excess amounts could have a material effect on our business, results of operations, financial condition, and cash flows. In addition, it is possible that a resolution of any claim, including as a result of a settlement, could require us to make substantial future payments, prevent us from offering certain products or services, or require us to change our business practices each of which could have a material adverse effect on our business, operating results, financial condition, and cash flows.
We must successfully manage compliance with current and expanding laws and regulations, as well as manage new and pending legal and regulatory matters in the U.S. and abroad.
We are subject in the ordinary course of our business, in the U.S. and internationally, to many statutes, ordinances, rules and regulations that, if violated by us or the third parties we work with, could have a material adverse effect on our business, operating results, financial condition, and cash flows. These laws and regulations include but are not limited to accounting and financial reporting, advertising, anti-bribery and anti-corruption, consumer protection, data security and privacy, electronic commerce, employment, intellectual property, product liability, and trade. In addition, increasing governmental and societal attention to environmental, social and governance (ESG) matters, including expanding mandatory and voluntary reporting, diligence and disclosure on topics such as climate change, waste production, water usage, human capital, labor and risk oversight, could expand the nature, scope and complexity of matters that we are required to control, assess and report, each of which can be challenging given our reliance on third party suppliers. These and other rapidly changing laws, regulations, policies and related interpretations as well as increased enforcement actions by various governmental and regulatory agencies, create challenges for us, including our compliance and ethics programs, may alter the environment in which we do business and may increase the ongoing costs of compliance, which could adversely impact our business, operating results, financial condition, and cash flows. If we are unable to continue to meet these challenges and to comply with all laws, regulations, policies and related interpretations, it could negatively impact our reputation and our business, operating results, financial condition, and cash flows. Additionally, we may in the future be subject to inquiries, investigations, claims, proceedings and requests for information from governmental agencies or private parties, the adverse outcomes of which could harm our business. Failure to successfully manage these new or pending regulatory and legal matters and to resolve such matters without significant liability or damage to our reputation may materially adversely impact our operating results, financial condition, and cash flows. Furthermore, if new legal or regulatory matters result in fines or costs in excess of the amounts accrued to date, that may also materially impact our operating results and financial position.
As previously
reported in a Current Report on Form 8-K filed by the Company, on October 3, 2024, the Company was notified (the “October Notification
Letter”) by the staff (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) that it was not in compliance
with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital
Market as the bid price of its securities had closed at less than $1.00 per share over the previous 30 consecutive business days. Therefore,
in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company was provided 180 calendar days, or util April 1, 2025, to regain compliance
with the rule.
On
March 7, 2025, the Company was notified by the Staff that it has determined that as of March 6, 2025, the Company’s securities had
a closing bid price of $0.10 or less for ten consecutive trading days. As a result, the Company is subject to the provisions contemplated
under Listing Rule 5810(c)(3)A)(iii) and the Staff has determined to delist the Company’s securities from The Nasdaq Capital Market.
On
March 14, 2025, the Company submitted an appeal to Nasdaq, which will stay the delisting and suspension of the Company’s securities
pending the decision of the Nasdaq Hearings Panel (the “Panel”). Hearings are typically scheduled to occur approximately 30-45
days after the date of the hearing request. At the hearing, the Company intends to present its views and its plans to regain compliance
with the minimum bid price rules to the Panel. There can be no assurance that the Company will be able to evidence compliance with the
minimum bid price rules or any other applicable requirements for continued listing on The Nasdaq Capital Market prior to the hearing.
It is the Company’s understanding that the Panel typically issues its decision within 30 days after the hearing.
If we are delisted from Nasdaq,
our common stock may be eligible for trading on an over-the-counter market. If we are not able to obtain a listing on another stock exchange
or quotation service for our common stock, it may be extremely difficult or impossible for stockholders to sell their shares. We intend
to monitor the closing bid price of our common stock and may be required to seek approval from our stockholders to affect a reverse stock
split of the issued and outstanding shares of our common stock. However, there can be no assurance that the reverse stock split would
be approved by our stockholders. Further, there can be no assurance that the market price per new share of our common stock after the
reverse stock split will remain unchanged or increase in proportion to the reduction in the number of old shares of our common stock outstanding
before the reverse stock split. Even if the reverse stock split is approved by our stockholders, there can be no assurance that we will
be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing rules.
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. Stockholders may not be able to sell their shares of common stock on any such substitute
market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result
of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our common stock, warrants and pre-funded warrants
would likely be significantly adversely affected. A delisting of our common stock from Nasdaq could also adversely affect our ability
to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners.
While we have entered into a Merger Agreement
with Evofem and an Arrangement Agreement with Appili, we cannot assure you that the transactions contemplated by such agreements will
be consummated or, that if such transactions are consummated, they will be accretive to stockholder value.
As described herein, we entered
into a Merger Agreement with Evofem and an Arrangement Agreement with Appili. We will be required to obtain additional financing through
the sale of additional equity and/or debt securities to fund our obligations under such agreements, including but not limited to a $20
million financing continency in the Appili transaction. We can provide no assurance that we will be successful in securing such financing.
In addition, such financing, if available, may not be on favorable terms and may result in additional dilution to our current stockholders.
The closing of such transactions
are subject to the satisfaction or waiver of a number of closing conditions. There is no guarantee that the conditions to closing will
be satisfied. Further, even if all conditions to closing are satisfied, there is no guarantee that the transaction will be completed in
the time frame or in the manner currently anticipated, or that we will recognize the anticipated benefits of the transaction.
Upon dissolution of our Company, you may
not recoup all or any portion of your investment.
In the event of a liquidation,
dissolution or winding-up of our Company, whether voluntary or involuntary, our assets would be used to pay all of our debts and liabilities,
and only thereafter would any remaining assets be distributed to our stockholders, subject to rights of the holders of the Preferred Stock,
if any, on a pro rata basis. There can be no assurance that we will have assets available from which to pay any amounts
to our stockholders upon such a liquidation, dissolution or winding-up. In such an event, you would lose all of your investment.
AsObtaining describedfinancing
for herein,future we entered
into a Merger Agreement with Evofem and an Arrangement Agreement with Appili. Weacquisitions may needonly tobe acquire additional financing to fund our
obligations under the Share Exchange Agreement, the letter of intent or to fund other potential acquisitions or strategic transactions
(particularly, if the acquired entity is not cash flow positive or does not have significant cash on hand). Obtaining financingpossible 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. Additionally, any such transactiontransactions 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. For example, an
acquisition or strategic transaction may entail numerous operational
and financial risks, including the risks outlined above and additionally:
Limitation of Liability and Indemnification
of Management.
The Delaware General Corporation
Law and the Company’s Amended and Restated Certificate of Incorporation provide for the limitation of the liability of directors
for monetary damages. Such provisions may discourage shareholders from bringing a lawsuit against directors for breaches of fiduciary
duty and may also have the effect of reducing the likelihood of derivative litigation against directors and officers even though such
action, if successful, might otherwise be a benefit to the Company’s shareholders. In addition, a shareholder’s investment
in the Company may be adversely affected to the extent that costs of settlement and damage awards against the Company’s officers
or directors are paid by the Company pursuant to such provisions. Additionally, in accordance with Delaware law and the Company’s
Amended and Restated Certificate of Incorporation, the Company shall indemnify, hold harmless and provide advancement of expenses, to
the fullest extent permitted by applicable law, directors, officers, employees, and agents that are made a party or threatened to be made
a party to legal proceedings by reason of the fact that such parties were working at the request of the Company. We direct you to
the Company’s Amended and Restated Certificate of Incorporation for more information.
Our management team is required to devote
substantial time to public company compliance initiatives.
As a publicly reporting company,
we incur significant legal, accounting and other expenses. Our management and other personnel devote a substantial amount of time to comply
with our reporting obligations. Moreover, these reporting obligations increase our legal and financial compliance costs and make some
activities more time-consuming and costly.
Failure to develop our internal controls
over financial reporting as we grow could have an adverse impact on us.
As our Company matures, we
will need to develop our current internal control systems and procedures to manage our growth. We are required to establish and maintain
appropriate internal controls over financial reporting. Failure to establish appropriate controls, or any failure of those controls once
established, could adversely impact our public disclosures regarding our business, financial condition or results of operations. In addition,
management’s assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed
in our internal controls over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses
and conditions that need to be addressed in our internal control over financial reporting, disclosure of management’s assessment
of our internal controls over financial reporting or disclosure of our public accounting firm’s attestation to or report on management’s
assessment of our internal controls over financial reporting may have an adverse impact on the price of our common stock.
We areno longer qualify
as an “emerging growth company”
and willas beof 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, which could make our common
stock less attractive to investors.companies.
As of January 1, 2026 we no longer qualify as an emerging growth company within the meaning of Section 2(a) of the Securities Act, as modified by the JOBS Act. As such, we are subject to certain disclosure and compliance requirements that apply to other public companies but did not previously apply to us due to our status as an emerging growth company.
We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make it more difficult to compare our performance with other public companies and make our common stock less attractive to investors.
We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited consolidated financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by nonaffiliates exceeds $250 million as of the prior June 30 or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common stock held by non affiliates exceeds $700 million as of the prior June 30. To the extent we take advantage of such reduced disclosure obligations, it may also make comparisons of our consolidated financial statement with other public companies difficult or impossible.
We are an “emerging growth
company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to take advantage
of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth
companies” including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley
Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from
the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments
not previously approved. In addition, pursuant to Section 107 of the JOBS Act, as an “emerging growth company” we intend
to 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. As a result, our financial statements may not be comparable
to those of companies that comply with public company effective dates for complying with new or revised accounting standards.
We cannot predict if investors
will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. We may take advantage
of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth
company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion
or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public
offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;
or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Management's Discussion & Analysis (MD&A)
New heading “ADIFEM, INC. Subsidiary”
New heading “Evofem Merger Agreement and Termination”
New heading “Amended and Restated Merger Agreement”
New heading “Effect on Capital Stock”
New heading “Representations and Warranties”
New heading “Closing Conditions”
New heading “The Company and Merger Sub”
New heading “Effect of Termination”
New heading “Amendments to Evofem Amended and Restated Merger Agreement”
New heading “Third Evofem Amendment & Parent Equity Investment”
New heading “Evofem Parent Equity Investment”
New heading “Fifth Amendment to Amended and Restated Merger Agreement”
New heading “Sixth Amendment to Amended and Restated Merger Agreement”
New heading “Evofem Termination”
New heading “Fair value of investments in Evofem warrants and convertible notes receivable”
New heading “Investments in Evofem preferred stock”
New heading “Nasdaq Equity Compliance”
Largest changes
“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. …”see in full comparison
“The Merger Agreement may be terminated at any time prior to the consummation of the Closing by mutual written consent of the Company and Evofem. Either the Company or Evofem may also terminate the Merger Agreement if (i) the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time on September 30, 2024; (ii) if any judgment, law or order prohibiting the Merger or the Transactions has become final and non-appealable; (iii) the required vote of Evofem stockholders was not obtained; or (iv) in the event of any Terminable Breach (as defined in the Merger Agreement). …”see in full comparison
“The Company accounts for its investments in Evofem preferred stock at cost, less impairment, as the securities do not have a readily determinable fair value and the Company has not elected the fair value option; accordingly, these investments are not remeasured at fair value on a recurring basis. Management evaluates the investment for impairment each reporting period by considering qualitative and quantitative factors, including Evofem’s financial condition, operating performance, and prospects, as well as general market conditions and the timing and likelihood of a liquidity event. …”see in full comparison
“On August 26, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 6 to the Amended and Restated Merger Agreement(“Amendment No. …”see in full comparison
“Fair value of investments in Evofem warrants and convertible notes receivable”see in full comparison
“On February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with regard to a patent concerning a method for detection and measurement of specific cellular responses. 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). …”see in full comparison
Full comparison: every changed paragraph (117)
ADIMUNE,ADIMUNE™,
INC. INC.- Subsidiary
Formed
in January 2023,
Adimune™, Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs. Adimune’s proprietary
proprietary immune modulation productproduct, Apoptotic DNA Immunotherapy™ (ADI™), utilizes a novel approach that mimics the way our bodies
bodies naturally induce tolerance to our own tissues. It includes two DNA molecules designed to deliver signals to induce tolerance. 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,diabetes (T1D), psoriasis, and in many autoimmune diseases of the CNS and has been
successfully successfully
tested in several preclinical models (e.g., skin grafting, psoriasis, typeand 1 diabetes, multiple sclerosisT1D).
All
preclinical studies
for ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring durable
durable tolerance overas the 10-month duration of the T1D studies bothshown in prevention and treatment studystudies designs.in T1D. 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).
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.
Good
Manufacturing Process Practices
(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. Lastly, twoone remaining
drug product release assays
assay specifically designed for ADI-100 areis in the final stages of validationqualification to be used once the final drug product
is ready.
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.T1D. In parallel, Adimune is working with the Mayo
Clinic to prepare the IND package for
FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to
review the package before full submission.
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”). According to the National Organization of Rare Diseases, the exact incidence
and prevalence of SPS is unknown;
however, one estimate places the incidence at approximately one in one million individuals in the general
population. Pending approval
by the International Review Board and U.S. Food and Drug Administration, a human trial for SPS is expected
to get underway in 20252026 with
enrollment of 10-20 patients, some of whom may also have typeT1D. 1In diabetes.these studies, the primary readouts for ADI-100 will initially
be tested for safety and efficacy.tolerability
as well as clinical and immunological signals of tolerance induction.
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. 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. While the use of these drugs has been justifiable because they prevent or delay organ rejection, their use for treatment of autoimmune diseases and allergies may not be acceptable because of the aforementioned side effects. Furthermore, often transplanted organs ultimately fail despite the use of immune suppression, and about 40% of transplanted organs survive no more than five years.
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”). While immune suppression requires continuous administration
to prevent rejection of a transplanted organ, induction
of tolerance has the potential to retrain the immune system to accept the organ
for longer periods of time. ADI may allow patients to
live with transplanted organs with significantly reduced immune suppression. ADI
is a technology platform which we believe can be engineered
to address a wide variety of indications.
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 and(in transplanted tissues and organs.organs). It does so by tapping into the body’s natural
process of cell
turnover (i.e., apoptosis) to retrain the immune system to stop unwanted attacks on self or transplanted tissues. Apoptosis
is a natural
process used by the body to clear dying cells and to allow recognition and tolerance to self-tissues. ADI triggers this
process by enabling
the cells of the immune system to recognize the targeted tissues as “self.” Conceptually, it is designed
to retrain the immune
system to accept the tissues, similar to how natural apoptosis reminds our immune system to be tolerant to our
own “self”
tissues.
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 genome DNA
to develop tests for early
detection of cancer. 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.
Pearsanta acquired the
assets assets
of MDNA Life Sciences Inc. on January 4, 2024. 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
DNAmtDNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mitochondrialmtDNA
DNA based biomarkers for a wide spectrum of human diseases.
Pearsanta
is continuing
to leverage this technology to discover mitochondrial DNA basedmtDNA-based biomarkers. Though Pearsanta has no commercially available
FDA or foreign regulator
approved products, Pearsanta has two product candidates in developdevelopment and hopes to enter the cancer screening market
with these two
product candidates, and if proven successful continue to discover mitochondrial DNA basedmtDNA-based biomarkers and develop a pipeline
of disease screening
and diagnostics tests. 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 basedmtDNA-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.
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. 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. 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. 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.
The advantages of the AditxtScore technology include the following:
On February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with regard to a patent concerning a method for detection and measurement of specific cellular responses. 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. 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”). However, Stanford agreed not to grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. 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.
AditxtScore has been
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. We believe AditxtScore can also assist the medical community and individuals
by being able
to anticipate the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as transplanted
transplanted organs. This technology may be able to serve as a warning signal, thereby allowing for more time to respond appropriately.
Its advantages
include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine the
immune status
with respect to several factors simultaneously, in approximately 3-16 hours. In addition, it can determine and differentiate between
between distinct types of cellular and humoral immune responses (e.g., T and B cells and other cell types). It also provides for simultaneous
monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).
The
sophistication of the AditxtScore technology includes the following:
On
February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with
regard to a patent concerning a method for detection and measurement of specific cellular responses. 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. 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”). However, Stanford agreed
not to grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. 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 AditxtScoreTM and securing worldwide exclusivity in all fields of use of the licensed technology.
Acquired Technologies
– Mitomic®
Technology Platform
In January 20242024, Pearsanta
acquired 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. 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.
Pearsanta plans to license
distribution rights through various agreements with U.S.-based and international business partners to commercialize our Mitomic®
Technology, Technology,
should Mitomic® tests be successfully developed and successfully approved by the FDA or a foreign regulator.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, CAP-accredited and CAP-accreditedNYS CLEP-approved accredited laboratory
equipped to accommodate rapid
development and rollout of innovative laboratory tests for the clinical market. 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.
The Mitomic®
Technology Technology
targets mutations in mitochondrial DNA (mtDNA) to detect disease. Every human cell is home to multiple copies of
mitochondrial DNA,mtDNA, 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. If the development of Mitomic®
tests is successful and if Mitomic® tests can achieve their still unproven
objective of early disease detection,
our Mitomic® Technology presents an opportunity to detect disease before it presents clinically.
To date, the Mitomic®
Technology Technology
biomarker discoveries have identified numerous biomarker targets from the in-silico database and we plan to use these biomarker
targets targets
in itsour 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
DNAmtDNA deletion. Published analytical data for the 3.4kb mitochondrial DNAmtDNA deletion associated with prostate cancer, suggests the 3.4kb mitochondrial
DNAmtDNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone
(PSA
< 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mitochondrial DNAmtDNA deletion may be able to aid in the decision to biopsy.
biopsy. Some of the significant clinical challenges that have not been met for prostate cancer are that up to 50% of men will be ‘over’
diagnosed with cancer that never harms them1 and the risks associated with treatment of low-grade cancers (≤ Gleason
6)
appear to outweigh the benefits –e.g. urinary incontinence, erectile dysfunction. 1dysfunction.1 NIH National Cancer Institute
reports reports
this number is even higher at ~ 75% based on 5-year survival rates. Seer database (https://seer.cancer.gov/statfacts/html/prost.html).
Mitomic Endometriosis
Test Test
(MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one
or more mitochondrial
DNAmtDNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately
1 1
in 10 women according to Endometriosis World and the World Health Organization. The Mitomic Endometriosis Test is intended for use
in in
females of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention is warranted.
Endometriosis occurs
when the
tissue of the uterus (endometrium) grows onin areas where it does not belong, most often on the ovaries, fallopian tubes, outer
surface surface
of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body. Endometriosis is challenging to
identify, 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 Pearsanta
acquired certain patents related to the detection and analysis of DNA adducts. 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 acquired technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity of DNA adduct
detection detection
across a full genomic landscape.
ADIVIR,ADIVIR™,
INC. INC.Subsidiary
Formed
in April of 2023, Adivir™, Inc. (“Adivir”) is a wholly owned subsidiary,subsidiary of Aditxt, Inc., dedicated to advancing
the clinical and commercial development efforts of innovative
products for population health, including antiviral and other antimicrobial products, which have the potentialintended to address asignificant wideunmet range
ofneeds in infectious diseases,disease includingand those that currently lack viable treatment options.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. 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. Through Adivir, the Company seeks to contribute to addressing the ongoing and evolving challenges posed by infectious diseases worldwide.
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. Adifem is a wholly owned subsidiary of the Company dedicated to advancing innovative solutions that address critical unmet needs in women’s health.
Although we are no longer pursuing the acquisition of Evofem Biosciences, our commitment to women’s health reflects a broader strategic objective to invest in therapeutic areas where there are significant unmet medical need and opportunity for meaningful patient impact. We believe that empowering women with innovative, science-driven solutions remains an important and timely priority in global healthcare.
Evofem Merger Agreement and Termination
On December 11, 2023 (the “Execution Date”), Aditxt, Inc., a Delaware corporation (the “Company”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Adifem, a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”), pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary of the Company.
Subject to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common Stock held by the Company or Merger Sub immediately prior to the Effective Time, will be converted into the right to receive an aggregate of 8 shares of the Company’s common stock, par value $0.001 per share; and (ii) all issued and outstanding shares of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred Stock”), other than any shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior to the Effective Time, will be converted into the right to receive an aggregate of 2,327 shares of Series A-1 Convertible Preferred Stock, par value $0.001 of the Company (the “Company Preferred Stock”), having such rights, powers, and preferences set forth in the form of Certificate of Designation of Series A-1 Convertible Preferred Stock.
On January 8, 2024, the Company, Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”), and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”) entered into the First Amendment (the “First Amendment to Merger Agreement”), to the Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which the parties agreed to extend the date by which the joint proxy statement would be filed with the SEC until February 14, 2024.
On January 30, 2024, the Company, Adicure and Evofem entered into the Second Amendment to the Merger Agreement (the “Second Amendment to Merger Agreement”) to amend (i) the date of the Parent Loan (as defined in the Merger Agreement) to Evofem to be February 29, 2024, (ii) to change the date by which Evofem may terminate the Merger Agreement for failure to receive the Parent Loan to be February 29, 2024, and (iii) to change the filing date for the Joint Proxy Statement (as defined in the Merger Agreement) to April 1, 2024.
On February 29, 2024, the Company, Adicure and Evofem entered into the Third Amendment to the Merger Agreement (the “Third Amendment to Merger Agreement”) in order to (i) make certain conforming changes to the Merger Agreement regarding the Notes, (ii) extend the date by which the Company and Evofem will file the joint proxy statement until April 30, 2024, and (iii) remove the requirement that the Company make the Parent Loan (as defined in the Merger Agreement) by February 29, 2024 and replace it with the requirement that the Company make an equity investment into Evofem consisting of (a) a purchase of 2,000 shares of Evofem Series F-1 Preferred Stock for an aggregate purchase price of $2.0 million on or prior to April 1, 2024, and (b) a purchase of 1,500 shares of Evofem Series F-1 Preferred Stock for an aggregate purchase price of $1.5 million on or prior to April 30, 2024.
On April 26, 2024, the Company received notice from Evofem (the “Termination Notice”) that Evofem was exercising its right to terminate the Merger Agreement as a result of the Company’s failure to provide the Initial Parent Equity Investment (as defined in the Merger Agreement, as amended).
On May 2, 2024, the Company, Adifem, Inc. f/k/a Adicure, Inc. and Evofem Biosciences, Inc. (“Evofem”) entered into the Reinstatement and Fourth Amendment to the Merger Agreement (the “Fourth Amendment”) in order to waive and amend, among other things, the several provisions listed below.
Amendments to Article VI: Covenants and Agreement
Article VI of the Merger Agreement is amended to:
Amendments to Article VIII: Termination
Article VIII of the Merger Agreement is amended to:
Amended and Restated Merger Agreement
On July 12, 2024 (the “A&R Execution Date”), the Company entered into an Amended and Restated Agreement and Plan of Merger (the “Merger Agreement”) with Adifem, Inc. f/k/a Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”) and Evofem, pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary of the Company. The Merger Agreement amended and restated that certain Agreement and Plan of Merger dated as of December 11, 2023, by and among the Company, Merger Sub and Evofem (as amended, the “Original Agreement”).
Effect on Capital Stock
Subject to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common Stock either held by the Company or Merger Sub immediately prior to the Effective Time or which are Dissenting Shares (as hereinafter defined), will be converted into the right to receive an aggregate of $1,800,000; and (ii) each issued and outstanding share of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred Stock”), other than any shares of Evofem Unconverted Preferred Stock either held by the Company or Merger Sub immediately prior to the Effective Time or which are Dissenting Shares, will be converted into the right to receive one (1) share of Series A-2 Preferred Stock, par value $0.001 of the Company (the “Company Preferred Stock”), having such rights, powers, and preferences set forth in the form of Certificate of Designation of Series A-2 Preferred Stock, the form of which is attached as Exhibit C to the Merger Agreement.
Any Evofem capital stock outstanding immediately prior to the Effective Time and held by an Evofem shareholder who has not voted in favor of or consented to the adoption of the Merger Agreement and who is entitled to demand and has properly demanded appraisal for such Company Capital Stock in accordance with the Delaware General Corporation Law (“DGCL”), and who, as of the Effective Time, has not effectively withdrawn or lost such appraisal rights (such Evofem capital Stock, “Dissenting Shares”) shall not be converted into or be exchangeable for the right to receive a portion of the Merger Consideration and, instead, shall be entitled to only those rights as set forth in the DGCL. If, after the Effective Time, any such holder fails to perfect or withdraws or loses his, her or its right to appraisal under the DGCL, with respect to any Dissenting Shares, upon surrender of the certificate(s) representing such Dissenting Shares, such Dissenting Shares shall thereupon be treated as if they had been converted as of the Effective Time into the right to receive the portion of the merger consideration, if any, to which such Evofem capital stock is entitled pursuant to the Merger Agreement, without interest.
As a closing condition for the Company, there shall be no more than 4,141,434 Dissenting Shares that are Evofem Common Stock or 98 Dissenting Shares that are Evofem Preferred Stock.
Treatment of Evofem Options and Employee Stock Purchase Plan At the Effective Time, each option outstanding under the Evofem 2014 Equity Incentive Plan, the Evofem 2018 Inducement Equity Incentive Plan and the Evofem 2019 Employee Stock Purchase Plan (collectively, the “Evofem Option Plans”), whether or not vested, will be canceled without the right to receive any consideration, and the board of directors of Evofem shall take such action such that the Evofem Option Plans are cancelled as of the Effective Time.
As soon as practicable following the A&R Execution Date, Evofem will take all action that may be reasonably necessary to provide that: (i) no new offering period will commence under the Evofem 2019 Employee Stock Purchase Plan (the “Evofem ESPP”); (ii) participants in the Evofem ESPP as of the A&R Execution Date shall not be permitted to increase their payroll deductions or make separate non-payroll contributions to the Evofem ESPP; and (iii) no new participants may commence participation in the Evofem ESPP following the A&R Execution Date. Prior to the Effective Time, Evofem will take all action that may be reasonably necessary to: (A) cause any offering period or purchase period that otherwise be in progress at the Effective Time to be the final offering period under the Evofem ESPP and to be terminated no later than five business days prior to the anticipated closing date (the “Final Exercise Date”); (B) make any pro-rata adjustments that may be necessary to reflect the shortened offering period or purchase period; (C) cause each participant’s then-outstanding share purchase right under the Evofem ESPP to be exercised as of the Final Exercise Date; and (D) terminate the Evofem ESPP, as of and contingent upon, the Effective Time.
Representations and Warranties
The parties to the Merger Agreement have agreed to customary representations and warranties for transactions of this type.
Covenants
What changed in the latest 10-Q
Risk Factors
New heading “We have received a Staff Determination letter from Nasdaq notifying us that our securities are subject to delisting.”
Removed heading “Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.”
Largest changes
“We have received a Staff Determination letter from Nasdaq notifying us that our securities are subject to delisting.”see in full comparison
“On May 6, 2026, we received a Staff Determination letter (the “Staff Determination”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the Nasdaq staff has determined to delist our securities from The Nasdaq Capital Market for failure to comply with Nasdaq Listing Rule 5550(a)(2), which requires that listed securities maintain a minimum bid price of at least $1.00 per share. …”see in full comparison
“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. Stockholders may not be able to sell their shares of common stock on any such substitute market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. …”see in full comparison
“Our ability to have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.”see in full comparison
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,see in full comparison20242025 and2023,2024, the Company had a net loss of$34,446,486$42,787,043 and$32,390,447,$35,020,058, respectively. Our condensed consolidated financial statements as ofSeptemberMarch30,31,2025,2026, show a net loss of$37,555,792.$16,189,200. Our cash and cash equivalents were approximately$163,041$268,852 as ofSeptemberMarch30,31,2025.2026. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements, public offerings and/or bank financing necessary to support our working capital requirements. To the extent that funds generated from any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment.
As ofsee in full comparisonSeptemberMarch30,31,2025,2026, wewehave approximately$11.6$6.6 million in accounts payable with approximately$9.1$5.8 million that is over 90 days past due. If we are unable totorepay these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates ororrefinance these obligations, we would be in default. We cannot provide any assurances that we will be able to raise the necessary amountamountof capital to repay these obligations or that we will be able to extend the maturity dates or otherwise refinance these obligations. Upon a default, our secured lenders would have the right to exercise their rights and remedies to collect, which would include foreclosing on our assets. Accordingly, a default would have a material adverse effect on our business, and we would likely be forced to seek bankruptcy protection.
Full comparison: every changed paragraph (8)
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 2025
and 2023,2024, the Company had a net loss
of $34,446,486$42,787,043 and $32,390,447,$35,020,058, respectively. Our condensed consolidated financial statements as
of SeptemberMarch 30,31, 2025,2026, show a net loss
of $37,555,792.$16,189,200. Our cash and cash equivalents were approximately $163,041$268,852 as of SeptemberMarch 30,31, 2025.2026. There
can be no assurances that we
will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or
additional financing through
private placements, public offerings and/or bank financing necessary to support our working capital requirements.
To the extent that funds
generated from any private placements, public offerings and/or bank financing are insufficient, we will have
to raise additional working
capital. No assurance can be given that additional financing will be available, or if available, will be on
acceptable terms. These conditions
raise substantial doubt about our ability to continue as a going concern. If adequate working capital
is not available, we may be forced
to discontinue operations, which would cause investors to lose their entire investment.
As of SeptemberMarch 30,31, 2025,2026, we
we have approximately $11.6$6.6 million in accounts payable with approximately $9.1$5.8 million that is over 90 days past due. If we are unable to
to repay these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates or
or refinance these obligations, we would be in default. We cannot provide any assurances that we will be able to raise the necessary amount
amount of capital to repay these obligations or that we will be able to extend the maturity dates or otherwise refinance these obligations.
Upon a default, our secured lenders would have the right to exercise their rights and remedies to collect, which would include foreclosing
on our assets. Accordingly, a default would have a material adverse effect on our business, and we would likely be forced to seek bankruptcy
protection.
As of SeptemberMarch 30,31, 2025,2026, there
there were 55 shares of common stock issuable under outstanding options, 5,379698,871 shares of common stock issuable upon exercise of outstanding
warrants at various exercise prices and approximately 3,1441,924,734 shares of common stock reserved for issuance upon the standard conversion
of outstanding convertible preferred stock. To the extent that holders of existing options, warrants or convertible preferred stock sell
the shares of common stock issued upon the exercise of options or warrants or conversion of the convertible preferred stock, the market
price of our common stock may decrease due to the additional selling pressure in the market. The risk of dilution from issuances
of shares of common stock underlying existing options, warrants and convertible preferred stock may cause shareholders to sell their common
common stock, which could further decline in the market price.
Our obligations to certain
of our creditors are secured by security interests in our assets. As of SeptemberMarch 30,31, 2025,2026, approximately $4.4$0.6 million was owed to such secured
secured creditors. Under such agreements, we are required to pay $277,800$99,000 on a weekly basis to sucha creditors.certain creditor. If we default on our obligations
under these agreements, our secured creditors could foreclose on its security interests and liquidate some or all of these assets, which
would harm our financial condition and results of operations and would require us to reduce or cease operations and possibly seek Bankruptcy
Protection.
We have received a Staff Determination letter from Nasdaq notifying us that our securities are subject to delisting.
On May 6, 2026, we received a Staff Determination letter (the “Staff Determination”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the Nasdaq staff has determined to delist our securities from The Nasdaq Capital Market for failure to comply with Nasdaq Listing Rule 5550(a)(2), which requires that listed securities maintain a minimum bid price of at least $1.00 per share. The Staff Determination further notified us that we are not eligible for an additional compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv) due to the fact we have effected a reverse stock split over the prior one-year period and have effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more. We intend to appeal the Staff Determination to the Nasdaq Hearings Panel (the “Panel”) in accordance with Nasdaq Listing Rule 5815(a), and the delisting action will be stayed pending the outcome of such appeal. However, there can be no assurance that the Panel will grant our request for continued listing or that we will be able to satisfy the conditions, if any, imposed by the Panel for continued listing. If our common stock is delisted from Nasdaq, it will likely be traded on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq. Stockholders may not be able to sell their shares of common stock on any such substitute market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. A delisting of our common stock from Nasdaq could also adversely affect our ability to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners. In addition, certain institutional investors are restricted from investing in securities not listed on a national securities exchange, which could further reduce the liquidity and market price of our common stock.
Our ability to have our securities traded
on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
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. Stockholders may not be able to sell their shares of common stock on any such substitute
market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result
of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our common stock, warrants and pre-funded warrants
would likely be significantly adversely affected. A delisting of our common stock from Nasdaq could also adversely affect our ability
to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners.
Management's Discussion & Analysis (MD&A)
New heading “ADIFEM, INC. Subsidiary”
Removed heading “Evofem Merger Agreement and Termination”
Removed heading “Amended and Restated Merger Agreement”
Removed heading “Effect on Capital Stock”
Removed heading “Representations and Warranties”
Removed heading “Closing Conditions”
Removed heading “The Company and Merger Sub”
Removed heading “Effect of Termination”
Removed heading “Amendments to Evofem Amended and Restated Merger Agreement”
Removed heading “Third Evofem Amendment & Parent Equity Investment”
Removed heading “Evofem Parent Equity Investment”
Removed heading “Fifth Amendment to Amended and Restated Merger Agreement”
Removed heading “Sixth Amendment to Amended and Restated Merger Agreement”
Removed heading “Results of operations for the nine months ended September 30, 2025 and 2024”
Largest changes
“The Merger Agreement may be terminated at any time prior to the consummation of the Closing by mutual written consent of the Company and Evofem. Either the Company or Evofem may also terminate the Merger Agreement if (i) the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time on September 30, 2024; (ii) if any judgment, law or order prohibiting the Merger or the Transactions has become final and non-appealable; (iii) the required vote of Evofem stockholders was not obtained; or (iv) in the event of any Terminable Breach (as defined in the Merger Agreement). …”see in full comparison
“On August 26, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 6 to the Amended and Restated Merger Agreement(“Amendment No. …”see in full comparison
“Results of operations for the nine months ended September 30, 2025 and 2024”see in full comparison
“Subject to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common Stock either held by the Company or Merger Sub immediately prior to the Effective Time or which are Dissenting Shares (as hereinafter defined), will be converted into the right to receive an aggregate of $1,800,000; …”see in full comparison
Full comparison: every changed paragraph (119)
We
believe the world needs—and deserves—a new approach to innovatinginnovation that harnesses the power of large groups of stakeholders
who work together to ensure that the most promising innovations make it into the hands ofreach people who need them most.
We
were incorporated in the State of Delaware on September 28, 2017, and our headquarters are in Mountain View, California. The Company
was founded with a mission of bringingredefining stakeholdershow together,health innovations are discovered, developed, and deployed—transforming a highly centralized
industry into a socially owned and guided ecosystem to transformadvance promisinghuman innovations into products and services that could
address some of the most challenging needs.well-being. The socialization of innovation through engaging stakeholders
in every aspect of it, is key
to transforming more innovations, more rapidly, and more efficiently.
At
inception, the first innovation we took on was an immune modulation technology titled ADI/Adimune with a focus on prolonging life and
enhancing life quality of patients that have undergone organ transplants. Since then, we expanded our portfolio of innovations,innovations and subsidiaries,
and we
continue to evaluate a variety of promising health innovations.
ADIMUNE,ADIMUNE™,
INC. INC.Subsidiary
Formed
in January 2023, Adimune™, Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs. Adimune’s
proprietary immune modulation productproduct, Apoptotic DNA Immunotherapy™ (ADI™), utilizes a novel approach that mimics the way
our our
bodies naturally induce tolerance to our own tissues. It includes two DNA molecules designed to deliver signals to induce tolerance.
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,diabetes (T1D), psoriasis, and in many autoimmune diseases of the CNS and has been
successfully successfully
tested in several preclinical models (e.g., skin grafting, psoriasis, typeand 1 diabetes, multiple sclerosisT1D).
All
preclinical studies for ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in
restoring restoring
durable tolerance overas theillustrated in 10-month duration of the T1D studies both in prevention and treatment studyof designs.T1D in nonclinical animal models. 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. evaluated except the skin (at the injection site). 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 ProcessPractices (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. Lastly, twoone
remaining drug product release assaysstability assay specifically designed for ADI-100 areis in the final stages of validationqualification to be used once
the final
drug product is ready.
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.T1D. In parallel, Adimune is working with the Mayo
Clinic to prepare
the IND package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to
review the package
before full submission. In May 2023, Adimune entered into a clinical trial agreement with the Mayo Clinic to advance clinical studies
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”). According to the National Organization of Rare Diseases, the exact incidence
and prevalence of SPS is unknown; however, one estimate places the incidence at approximately one in one million individuals in the general
population. Pending approval by the International Review Board and U.S. 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 typeT1D. 1In diabetes.these studies, the primary readouts for
ADI-100 will initially
be tested for safety and efficacy.tolerability as well as clinical and immunological signals of tolerance induction.
The
discovery of immunosuppressive (anti-rejection and monoclonal antibodies) drugs over the past 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. While the use of these drugs has been justifiable because they prevent or
delay organ rejection,
their use for treatment of autoimmune diseases and allergies may not be widely acceptable because of the aforementioned
side effects. Furthermore,
often transplanted organs ultimately fail despite the use of immune suppression, and about 40% of transplanted
organs survive no more
than five years.
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 useshas been designed to use a novel approach that mimics the way the body naturally
induces tolerance to our own tissues
(“therapeutically induced immune tolerance”). While immune suppression requires continuous
administration to prevent rejection
of a transplanted organ, induction of tolerance has the potential to retrain the immune system to
accept the organ for longer periods
of time. ADI may potentially allow patients to live with transplanted organs with significantly reduced need for immune suppression.
suppression. ADI is a technology platform which we believe can be engineered to address a wide variety of indications.
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 and(in transplanted tissues and organs.organs). It does so by tapping into the body’s
natural process of cell
turnover (i.e., apoptosis) to retrain the immune system to stop unwanted attacks on self or transplanted tissues.
Apoptosis is a natural
process used by the body to clear dying cells and to allow recognition and tolerance to self-tissues. ADI triggers
this process by enabling
the cells of the immune system to recognize the targeted tissues as “self.” Conceptually, it is
designed to retrain the immune
system to accept the tissues, similar to how natural apoptosis reminds our immune system to be tolerant
to our own “self”
tissues.
While
various groups have promoted tolerance through cell therapies and ex vivo manipulation of patient cells (i.e., takesconducted
place outside the body), to our knowledge, we will be unique in our approach of using in-body induction of apoptosis to promote tolerance to
to specific tissues. In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute
amounts of the therapeutic drug into the skin.
On
March 15, 2018, we entered into a License Agreement with LLU, which was subsequently amended on July 1, 2020. Pursuant to the LLU License
Agreement, we obtained the exclusive royalty-bearing worldwide license to all intellectual property, including patents, technical information,
trade secrets, proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or
any of its affiliates (the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases
(the ADI™ technology). In consideration forof the LLU License Agreement, we issued 1 share of common stock to LLU.
PEARSANTA,
INC. INC.Subsidiary
The
best approach for addressing cancer may be its early detection. Pearsanta is pioneering the development of molecular tests based on the
mitochondrial mitochondrial
genomeDNA (mtDNA) to develop tests for early detection of cancer. 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),mtDNA, and more specifically mutated mtDNA, makerender mtDNAit a biological system suitable for biomarker identification, early
disease disease
detection, monitoring, risk assessment, and therapeutic targeting.
Pearsanta
acquired the assets of MDNA Life SciencesSciences, Inc. on January 4, 2024. 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
discovery of mitochondrial DNA basedmtDNA-based biomarkers, and though untested and requiring clinical validation, the development and commercial
application of mitochondrial DNA based mtDNA-based
biomarkers for a wide spectrum of human diseases.
Pearsanta
is continuing to leverage this technology to discover mitochondrial DNA basedmtDNA-based biomarkers. Though Pearsanta has no commercially available
FDA or foreign regulator
regulatory 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 mitochondrialadditional DNA basedmtDNA-based biomarkers and develop
a pipeline
of disease screening and diagnostics tests. The current in-development products include a potential product for prostate cancer diagnosis
diagnosis and a potential product for the detection of endometriosis. Pearsanta has also discovered mitochondrial DNA basedmtDNA-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.
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.
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, 20252025, the Company and Pearsanta entered in a Mutual Termination Agreement (the “Exclusive
Worldwide Sublicense Termination Agreement”) to terminate the Exclusive Worldwide Sublicense Agreement. 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. 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.
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. We believe AditxtScore can also assist the medical community and individuals
by being able to anticipate the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as
transplanted organs. This technology may be able to serve as a warning signal, thereby allowing for more time to respond appropriately.
Its advantages include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine the
immune status with respect to several factors simultaneously, in approximately 3-16 hours. In addition, it can determine and differentiate
between distinct types of cellular and humoral immune responses (e.g., T and B cells and other cell types). It also provides for simultaneous
monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).
In
collaboration with its partners, the platforms underlying AditxtScore are being further evaluated for evaluating the immune status of
individuals including those with hypersensitivity to certain antigens (e.g., patients with autoimmunity). These tests may become tools
that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens.
The
sophisticationadvantages of the AditxtScore technology includesinclude the following:
On
February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with
regard to a patent concerning a method for detection and measurement of specific cellular responses. 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 beginning
on the effective date of the agreement, and ending when the patent expires. 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”). However, Stanford
agreed agreed
not to grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. On December 29,
2021, 2021,
we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology deployed
in AditxtScoreTM and securing worldwide exclusivity in all fields of use of the licensed technology.
AditxtScore and FlowSpot have 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. We believe these platforms can also assist the medical community and individuals in anticipating the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as transplanted organs. These technologies may be able to serve as tools allowing for more time to respond appropriately. Their advantages include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine immune status with respect to several factors simultaneously, in approximately 3-16 hours. In addition, they can determine and differentiate between distinct types of cellular and humoral immune responses (e.g., T and B cells and other cell types). The FlowSpot technology can also provide simultaneous monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).
In collaboration with its partners, the platforms underlying AditxtScore and FlowSpot are being further evaluated for evaluating the immune status of individuals including those with hypersensitivity to certain antigens (e.g., patients with autoimmunity). These tests may become tools that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens.
Acquired Technologies
– Mitomic® Technology Platform
In
January 20242024, Pearsanta acquired the assets comprising our Mitomic® Technology platform from MDNA Life Sciences Inc. This
platform platform
seeks to harness the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based
liquid biopsies. 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 and
therapeutic targeting.
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
FDA, or a foreign regulator.
regulator or other relevant regulatory agency. We believe our biomarker portfolio covers many high-clinical need cancers,
with potential applications outside oncology.
Pearsanta
leases a state-of-the-art facility located in Richmond VA, that is a high-complexity, CLIA-certified, CAP-accredited and CAP-accreditedNYS CLEP-approved
laboratory equipped
to accommodate rapid development and rollout of innovative laboratory tests for the clinical market. 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.
The
Mitomic® Technology targets mutations in mitochondrial DNAmtDNA to detect disease. Every human cell is home to multiple
copies copies
of mitochondrial DNA,mtDNA, 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,utility, Mitomic® tests are being designed to detect this
mutated DNA,
which can accumulate from the very early stages of a disease. If the development of Mitomic® tests is successful
and if Mitomic®
tests can achieve their still unproven objective of early disease detection, our Mitomic®
Technology presents an opportunity to detect
disease before it presents clinically.
To
date, the Mitomic® Technology biomarker discoveries have identified numerous biomarker targets from the in-silico database database,
and we
plan to use these biomarker targets in itsour 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 DNAmtDNA deletion. Published analytical data for the 3.4kb mitochondrial DNAmtDNA deletion associated with prostate
cancer, suggests the 3.4kb mitochondrial DNA
mtDNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific
antigen (PSA) grey zone
(PSA < 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mitochondrial DNAmtDNA deletion may be
able to aid in the decision to biopsy.
Some of the significant clinical challenges that have not been met for prostate cancer are that
up to 50% of men will be ‘over’
diagnosed with cancer that never harms them1them 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. Seer database (https://seer.cancer.gov/statfacts/html/prost.html).
Our
Mitomic®
Prostate Test (MPT™) is in development and is being designed with the following objectives:
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 DNAmtDNA 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. The Mitomic Endometriosis
TestMET is intended for use in females
of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical
intervention is warranted.
Endometriosis
occurs when the tissue of the uterus (endometrium) grows onin 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. 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 acquired technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity
specificity of DNA adduct detection across a full genomic landscape.
ADIVIR,ADIVIR™
INC. INC.Subsidiary
Formed
in April of 2023, Adivir™, Inc. (“Adivir”) is a wholly owned subsidiary,subsidiary of Aditxt, Inc., dedicated to advancing the clinical
and commercial development efforts of innovative
products for population health, including antiviral and other antimicrobial products, which have the potentialintended to address asignificant wideunmet range
ofneeds in infectious diseases,disease includingand thosepopulation that currently lack viable treatment options.health.
Adivir is focused on building a portfolio of antiviral and other antimicrobial solutions designed to target life-threatening viral infections and emerging pathogens. 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. Through Adivir, the Company seeks to contribute to addressing the ongoing and evolving challenges posed by infectious diseases worldwide.
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. Adifem is a wholly owned subsidiary of the Company dedicated to advancing innovative solutions that address critical unmet needs in women’s health.
Although we are no longer pursuing the acquisition of Evofem Biosciences, our commitment to women’s health reflects a broader strategic objective to invest in therapeutic areas where there are significant unmet medical need and opportunity for meaningful patient impact. We believe that empowering women with innovative, science-driven solutions remains an important and timely priority in global healthcare.
Our
commitment to building our antiviral portfolio is strategic and timely. We believe that there has never has there been a more important
time to address the growing global need to uncover new treatments or commercialize existing ones that treat life-threatening global viral
infections.
Evofem Merger Agreement
and Termination
On December 11, 2023 (the “Execution Date”),
Aditxt, Inc., a Delaware corporation (the “Company”) entered into an Agreement and Plan of Merger (the “Merger Agreement”)
with Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”) and Evofem Biosciences,
Inc., a Delaware corporation (“Evofem”), pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”),
with Evofem surviving the Merger as a wholly owned subsidiary of the Company.
In connection with the Merger Agreement the Company
assumed $13.0 million in notes payable held by Evofem and assumed a payable for $154,480. These items were capitalized on the Company’s
balance sheet to deposit on acquisition as of March 31, 2025. The Company recognized a debt discount of $1,924,276. As of March 31, 2025,
there was an unamortized discount of $0. During the three months ended March 31, 2025 and 2024, the Company recognized an amortization
of debt discount of $0 and $571,904.
Subject to the terms and conditions set forth
in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) all issued and outstanding shares
of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”), other than any shares of Evofem Common
Stock held by the Company or Merger Sub immediately prior to the Effective Time, will be converted into the right to receive an aggregate
of 61 shares of the Company’s common stock, par value $0.001 per share; and (ii) all issued and outstanding shares
of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred Stock”), other than any
shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior to the Effective Time, will be converted
into the right to receive an aggregate of 2,327 shares of Series A-1 Convertible Preferred Stock, par value $0.001 of the
Company (the “Company Preferred Stock”), having such rights, powers, and preferences set forth in the form of Certificate
of Designation of Series A-1 Convertible Preferred Stock.
On December 11, 2023 the Company entered into
an Agreement and Plan of Merger (the “Merger Agreement”) with Adicure, Inc., a Delaware corporation and wholly owned subsidiary
of the Company (“Merger Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”), pursuant to which,
Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary
of the Company.
On January 8, 2024, the Company, Adicure, Inc.,
a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”), and Evofem Biosciences, Inc., a Delaware
corporation (“Evofem”) entered into the First Amendment (the “First Amendment to Merger Agreement”), to the Agreement
and Plan of Merger (the “Merger Agreement”) pursuant to which the parties agreed to extend the date by which the joint proxy
statement would be filed with the SEC until February 14, 2024.
On January 30, 2024, the Company, Adicure and
Evofem entered into the Second Amendment to the Merger Agreement (the “Second Amendment to Merger Agreement”) to amend (i)
the date of the Parent Loan (as defined in the Merger Agreement) to Evofem to be February 29, 2024, (ii) to change the date by which Evofem
may terminate the Merger Agreement for failure to receive the Parent Loan to be February 29, 2024, and (iii) to change the filing date
for the Joint Proxy Statement (as defined in the Merger Agreement) to April 1, 2024.
On February 29, 2024, the Company, Adicure and
Evofem entered into the Third Amendment to the Merger Agreement (the “Third Amendment to Merger Agreement”) in order to (i)
make certain conforming changes to the Merger Agreement regarding the Notes, (ii) extend the date by which the Company and Evofem will
file the joint proxy statement until April 30, 2024, and (iii) remove the requirement that the Company make the Parent Loan (as defined
in the Merger Agreement) by February 29, 2024 and replace it with the requirement that the Company make an equity investment into Evofem
consisting of (a) a purchase of 2,000 shares of Evofem Series F-1 Preferred Stock for an aggregate purchase price of $2.0 million
on or prior to April 1, 2024, and (b) a purchase of 1,500 shares of Evofem Series F-1 Preferred Stock for an aggregate purchase
price of $1.5 million on or prior to April 30, 2024.
On April 26, 2024, the Company received notice
from Evofem (the “Termination Notice”) that Evofem was exercising its right to terminate the Merger Agreement as a result
of the Company’s failure to provide the Initial Parent Equity Investment (as defined in the Merger Agreement, as amended).
On May 2, 2024, the Company, Adifem, Inc. f/k/a
Adicure, Inc. and Evofem Biosciences, Inc. (“Evofem”) entered into the Reinstatement and Fourth Amendment to the Merger Agreement
(the “Fourth Amendment”) in order to waive and amend, among other things, the several provisions listed below.
Amendments to Article VI: Covenants and Agreement
Article VI of the Merger Agreement is amended
to:
Amendments to Article VIII: Termination
Article VIII of the Merger Agreement is amended
to:
Amended and Restated Merger Agreement
On July 12, 2024 (the “Execution Date”),
the Company entered into an Amended and Restated Agreement and Plan of Merger (the “Merger Agreement”) with Adifem, Inc. f/k/a
Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”) and Evofem, pursuant to which,
Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary
of the Company. The Merger Agreement amended and restated that certain Agreement and Plan of Merger dated as of December 11, 2023 by and
among the Company, Merger Sub and Evofem (as amended, the “Original Agreement”).
ADTX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 7 Form 4 filings (2 insiders, 8 trade dates, 16,772,653 shares, about $356.8K) and open-market sales in 11 filings (5 insiders, 10 trade dates, 16,392,967 shares, about $322.2K). Net open-market shares: 379,686 (purchases minus sales); net value about $34.7K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-23 | Takeover Time 2026 Llc |
Open-market sale | 3,420,439 | $0.02 | $68.4K |
| 2026-06-22 | Hrt Financial Lp |
Open-market sale | 5,120,480 | $0.02 | $102.4K |
| 2026-06-18 | Hrt Financial Lp |
Open-market purchase | 7,340,178 | $0.01 | $73.4K |
| 2026-06-17 | Drw Securities, Llc |
Open-market sale | 126,772 | $0.01 | $1.3K |
| 2026-06-16 | Hrt Financial Lp |
Open-market sale | 3,132,480 | $0.01 | $31.3K |
| 2026-06-15 | Hrt Financial Lp |
Open-market purchase | 2,114,344 | $0.01 | $21.1K |
| 2026-06-12 | Hrt Financial Lp |
Open-market purchase | 4,252,767 | $0.02 | $85.1K |
| 2026-06-11 | Bofa Securities, Inc. |
Open-market purchase | 1 | $0.02 | $0 |
| 2026-06-11 | Bofa Securities, Inc. |
Open-market purchase | 1 | $0.01 | $0 |
| 2026-06-11 | Bofa Securities, Inc. |
Open-market purchase | 3 | $0.01 | $0 |
| 2026-06-11 | Bofa Securities, Inc. |
Open-market sale | 15 | $0.01 | $0 |
| 2026-06-11 | Bofa Securities, Inc. |
Open-market purchase | 1 | $0.02 | $0 |
| 2026-06-11 | Bofa Securities, Inc. |
Open-market purchase | 1 | $0.01 | $0 |
| 2026-06-11 | Hrt Financial Lp |
Open-market sale | 2,833,463 | $0.01 | $28.3K |
| 2026-06-10 | Hrt Financial Lp |
Open-market purchase | 725,330 | $0.02 | $14.5K |
| 2026-06-09 | Hrt Financial Lp |
Open-market sale | 878,659 | $0.03 | $26.4K |
| 2026-06-09 | Gong Sandie |
Open-market sale | 100,000 | $0.07 | $7.0K |
| 2026-06-08 | Hrt Financial Lp |
Open-market purchase | 1,423,493 | $0.05 | $71.2K |
| 2026-06-05 | Hrt Financial Lp |
Open-market sale | 735,462 | $0.06 | $44.1K |
| 2026-06-04 | Hrt Financial Lp |
Open-market purchase | 843,622 | $0.08 | $67.5K |
| 2026-04-24 | Hrt Financial Lp |
Open-market sale | 29,404 | $0.28 | $8.2K |
| 2026-04-23 | Hrt Financial Lp |
Open-market sale | 3,811 | $0.29 | $1.1K |
| 2026-04-22 | Hrt Financial Lp |
Open-market sale | 11,982 | $0.30 | $3.6K |
| 2026-04-21 | Hrt Financial Lp |
Open-market purchase | 72,912 | $0.33 | $24.1K |
Well-known investors holding ADTX (13F)
None of the 59 investors we track reported a position in their latest 13F.