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We have a limited operating history.
−Removed: We have focused primarily on organizing, acquiring, developing and securing our proprietary technology and identifying and obtaining preclinical data or clinical data for various product candidates, with the goal of supporting regulatory approval for these product candidates.
+Added: We have focused primarily on organizing, acquiring, developing and securing our proprietary technology and identifying and obtaining preclinical data for various product candidates, with the goal of supporting regulatory approval for these product candidates.
We have incurred losses since our inception in March 2015.
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A decline in the value of our Company could also cause you to lose all or part of your investment in our Securities.
−Removed: There is substantial doubt regarding our ability to continue as a going concern.
−Removed: We will need to raise additional funding (which may not be available on acceptable terms to us, or at all) and/or delay, limit or terminate our product development efforts or other operations.
−Removed: If we are unable to raise capital, we could be required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us.
+Added: We may in the future need to raise substantial additional funding, which may not be available on acceptable terms to us, or at all.
+Added: If we are unable to raise capital, we could be required to delay, limit or terminate our product development efforts or other operations, or seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us.
We are currently advancing our programs in hematologic cancers, autoimmune diseases and solid tumors through clinical development.
Developing and commercializing CAR T products is expensive, and we do not expect to generate meaningful product revenues in the foreseeable future until we obtain marketing approval for products in the United States and following any potential commercial launch.
−Removed: As of December 31, 2024, our cash and cash equivalents were $6.8 million.
−Removed: Based on our current business plan, there is substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that our financial statements for the year ended December 31, 2024, are issued.
−Removed: Our fundraising efforts to raise additional funding may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our potential products following marketing approval if and when obtained.
−Removed: In addition, we cannot guarantee that financing will be available in sufficient amounts or on terms acceptable to us, if at all.
−Removed: Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.
−Removed: The sale of additional equity or convertible securities would dilute all of our stockholders.
−Removed: Potential indebtedness, if incurred, would result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could
−Removed: adversely impact our ability to conduct our business.
−Removed: We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
−Removed: In addition, in order to address our current funding constraints, we may be required to further revise our business plan and strategy, which may result in us (i) further curtailing, delaying or discontinuing one or more of our research or development programs or the commercialization of any product candidates, (ii) selling certain of our assets and/or (iii) may result in our being unable to expand our operations or otherwise capitalize on our business opportunities.
−Removed: Such actions may become necessary whether or not we are able to raise additional capital.
−Removed: As a result, our business, financial condition, and results of operations could be materially affected.
−Removed: Furthermore, if we are unable to raise capital, we could be required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us.
−Removed: Our short operating history makes it difficult to evaluate our business and prospects.
−Removed: We have been conducting operations only since our incorporation in March 2015.
−Removed: Our operations to date have been limited.
−Removed: We have not yet demonstrated an ability to successfully complete clinical trials, obtain regulatory approvals, manufacture a clinical scale or commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
−Removed: Consequently, any predictions about our future performance may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.
−Removed: In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors.
−Removed: We will need to expand our capabilities to support commercial activities.
−Removed: We may not be successful in adding such capabilities.
−Removed: We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.
−Removed: Accordingly, you should not rely upon the results of any past quarterly period as an indication of future operating performance.
−Removed: We will require substantial additional funding which may not be available to us on acceptable terms, or at all.
−Removed: If we fail to raise the necessary additional capital, we may be unable to complete the development and commercialization of our product candidates or continue our development programs.
−Removed: Our operations have consumed substantial amounts of cash since inception.
We will need to significantly increase our spending to advance the preclinical and clinical development of our product candidates and launch and commercialize any product candidates for which we may receive regulatory approval, including building our own commercial organizations to address certain markets.
We will require substantial additional capital for the further development and, if approved, commercialization of our product candidates, as well as to fund our other operating expenses and capital expenditures.
−Removed: As of December 31, 2024, we had $6.8 million in cash and restricted cash and have not generated positive cash flows from operations.
−Removed: We cannot provide any assurance that we will be able to raise funds to complete the development of our product candidates.
−Removed: Additionally, if we are unable to secure additional funding, it is likely that we will need to delay or terminate the development of certain product candidates;
−Removed: any such delay or termination, or the announcement of any such delay or termination, may impact our potential growth and have a material adverse effect on the value of our Securities.
−Removed: In order to carry out our business plan and implement our strategy, we will need to obtain substantial additional financing and may choose to raise additional funds through strategic collaborations, licensing arrangements, public or private equity or debt financing, bank lines of credit, asset sales, government grants, or other arrangements.
−Removed: We cannot be certain that additional funding will be available on acceptable terms, or at all.
+Added: Since our inception, we have incurred substantial operating losses and expect to continue to incur significant operating losses for the foreseeable future, and we may never become profitable.
+Added: To date, we have not generated positive cash flows from operations and have funded our operations primarily with the proceeds from sales of equity securities.
+Added: As of December 31, 2025, we had an accumulated deficit of $398.6 million, and cash and cash equivalents of $17.3 million.
+Added: We previously disclosed in our financial statements for the year ended December 31, 2024 and in our most recent quarterly report on Form 10-Q for the period ended September 30, 2025 that substantial doubt existed regarding our ability to continue as a going concern.
+Added: Although we have a history of negative cash flows from operations and operating losses, during the year ended December 31, 2025 we raised approximately $14.5 million in net proceeds from the February 2025 Equity Offering, the ATM Agreement and the July 2025 warrant exercises.
+Added: In addition to these net proceeds, we have been actively negotiating settlements of aged payables and have recognized approximately $2.1 million in savings during the year ended December 31, 2025, and we have significantly reduced our operating costs.
+Added: Based on the resulting improvement in our cash position for the year ended December 31, 2025, we believe we have sufficient cash and cash equivalents to fund our operations for at least twelve months from the date of this Annual Report on Form 10-K, and therefore have concluded that substantial doubt about our ability to continue as a going concern no longer exists.
+Added: Notwithstanding this improvement, we expect to continue generating operating losses and negative operating cash flows as we develop our product candidates, and we may need to raise substantial additional financing in the future to fund our operations and to support the continued development and potential commercialization of our product candidates.
+Added: We may choose to raise additional funds through strategic collaborations, licensing arrangements, public or private equity or debt financing, bank lines of credit, asset sales, government grants, or other arrangements.
+Added: Our future fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our potential products following marketing approval, if and when obtained.
+Added: In addition, we cannot guarantee that financing will be available in sufficient amounts or on terms acceptable to us, if at all.
Additional funding may be more difficult to obtain, or may be more expensive, as a result of recent increases in inflation and interest rates in the U.S.
economy generally.
−Removed: If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or, if approved, commercialization of one or more of our product candidates.
−Removed: We may also seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available.
−Removed: Any of these events could significantly harm our business, financial condition and prospects.
+Added: Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.
+Added: The sale of additional equity or convertible securities would dilute all of our stockholders.
+Added: Potential indebtedness, if incurred, would result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
+Added: We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable, and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
Our future funding requirements will depend on many factors, including, but not limited to:
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● the costs of establishing a commercial organization to sell, market and distribute our product candidates;
−Removed: ● the rate of progress and costs of our efforts to prepare for the submission of a New Drug Application (“NDA”) or Biologics License Application (“BLA”) for any product candidates that we may in-license or acquire in the future, and the potential that we may need to conduct additional clinical trials to support applications for regulatory approval;
+Added: ● the rate of progress and costs of our efforts to prepare for the submission of an NDA or BLA for any product candidates that we may in-license or acquire in the future, and the potential that we may need to conduct additional clinical trials to support applications for regulatory approval;
● the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our product candidates, including any such costs we may be required to expend if our licensors are unwilling or unable to do so;
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and international financial banking systems, supply disruptions due to political unrest, conflict and war or other factors, and pandemics.
−Removed: Our inability to raise capital when needed would harm our business, financial condition and results of operations, and could cause our stock value to decline or require that we wind down our operations altogether.
+Added: In addition, in order to address our current or future funding constraints, we may be required to further revise our business plan and strategy, which may result in us (i) curtailing, delaying or discontinuing one or more of our research or development programs or the commercialization of any product candidates, (ii) selling certain of our assets and/or (iii) being unable to expand our operations or otherwise capitalize on our business opportunities.
+Added: Such actions may become necessary whether or not we are able to raise additional capital.
+Added: As a result, our business, financial condition, and results of operations could be materially affected.
+Added: Furthermore, if we are unable to raise capital, the value of our stock could decline, or we could be required to wind down our operations or seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us.
+Added: Our limited operating history makes it difficult to evaluate our business and prospects.
+Added: We have been conducting operations since our incorporation in March 2015.
+Added: Our operations to date have been limited.
+Added: We have not yet demonstrated an ability to successfully complete clinical trials, obtain regulatory approvals, manufacture a clinical scale or commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
+Added: Consequently, any predictions about our future performance may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.
+Added: In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors.
+Added: We will need to expand our capabilities to support commercial activities.
+Added: We may not be successful in adding such capabilities.
+Added: We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.
+Added: Accordingly, you should not rely upon the results of any past quarterly period as an indication of future operating performance.
SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3.
−Removed: Under current SEC regulations, if at the time we file our Annual Report on Form 10-K our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is referred to as the baby shelf rules.
+Added: Under current SEC regulations, if at the time we file our Annual Report on Form 10-K our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is commonly referred to as the baby shelf rules.
SEC regulations permit us to use the highest closing sales price of our common stock (or the average of the last bid and last ask prices of our common stock) on any day within 60 days of sales under the registration statement to calculate our public float.
As of the date of this Form 10-K, our public float was less than $75 million.
−Removed: As a result, for sales following the date of this Form 10-K, and until we again have a public float with a value in exceeds of $75 million, if ever, we only have the capacity to sell shares up to one-third of our public float under shelf registration statements in any twelve-month period.
+Added: As a result, for sales following the date of this Form 10-K, and until we again have a public float with a value in excess of $75 million, if ever, we only have the capacity to sell an amount of securities up to one-third of our public float under shelf registration statements in any twelve-month period.
If our public float decreases, the number of securities we may sell under our Form S-3 shelf registration statements will also decrease.
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Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, grants and license and development agreements in connection with any collaborations.
−Removed: To the extent that we raise
−Removed: additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.
+Added: To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.
Debt financing, including through lending arrangements, and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
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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 reduced or more volatile.
−Removed: Our ability to use our pre-change NOLs and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation.
+Added: Our ability to use our pre-change net operating loss carryforwards and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation.
We may, from time to time, carry net operating loss carryforwards (“NOLs”) as deferred tax assets on our balance sheet.
−Removed: Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50-percentage- point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year
−Removed: period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-change taxable income or taxes may be limited.
+Added: Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50-percentage- point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-change taxable income or taxes may be limited.
We may experience ownership changes in the future as a result of shifts in our stock ownership, some of which changes are outside our control.
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Our future success is substantially dependent on our ability to successfully develop, obtain regulatory approval for, and then commercialize such product candidates.
−Removed: Most of our product candidates are currently in early stage clinical trials.
+Added: Our product candidates are currently in early-stage clinical trials.
Our business depends entirely on the successful development and commercialization of our product candidates, which may never occur.
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Our operations have historically been limited to organizing the Company, acquiring, developing and securing our proprietary technology and identifying and obtaining preclinical data or clinical data for various product candidates.
−Removed: These operations provide a limited basis for you to assess our ability to continue to develop our technology, identify product candidates, develop and commercialize any product candidates we are able to identify and enter into successful collaborative arrangements with other companies, as well as for you to assess the advisability of investing in our securities.
+Added: These operations provide a limited basis for you to assess our ability to continue to develop our technology, identify product candidates, develop and commercialize any product candidates and enter into successful collaborative arrangements with other companies, as well as for you to assess the advisability of investing in our securities.
Each of these requirements will require substantial time, effort and financial resources.
Each of our product candidates will require additional clinical development, management of clinical and manufacturing activities, regulatory approval in the jurisdictions in which we plan to market the product, obtaining manufacturing supply, building a commercial organization, and significant marketing efforts before we generate any revenues from product sales, which may not occur.
−Removed: We are not permitted to market
−Removed: or promote any of our product candidates in the U.S.
+Added: We are not permitted to market or promote any of our product candidates in the U.S.
or any other jurisdiction before we receive regulatory approval from the FDA or comparable foreign regulatory authority, respectively, and we may never receive such regulatory approval for any of our product candidates.
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CAR T is a relatively new approach to cancer treatment that presents significant challenges .
−Removed: We have concentrated much of our research and development efforts on CAR T technology, and our future success is highly dependent on the successful development of T cell immunotherapies in general and our CAR T technology and product candidates in particular.
−Removed: Because CAR T is a relatively new approach to cancer immunotherapy and cancer treatment generally, developing and commercializing our product candidates subjects us to a number of challenges, including, but not necessarily limited to:
+Added: We have concentrated much of our research and development efforts on CAR T technology, and our future success is highly dependent on the successful development of T cell immunotherapies in general and our CAR T technology and product candidate in particular.
+Added: Because CAR T is a relatively new approach to cancer immunotherapy and cancer treatment generally, developing and commercializing our CAR T product candidate, if approved, subjects us to a number of challenges, including, but not necessarily limited to:
● obtaining regulatory approval from the FDA and other regulatory authorities that may have very limited experience with the commercial development of genetically modified T cell therapies for cancer;
+Added: ● complying with evolving regulatory requirements specifically applicable to gene and cell therapies, including potential class-wide safety concerns and long-term patient follow-up obligations, any of which could delay, limit or prevent the development and approval of our CAR T product candidates;
● developing and deploying consistent and reliable processes for engineering a patient’s T cells ex vivo and infusing the engineered T cells back into the patient;
−Removed: ● conditioning patients with chemotherapy in conjunction with delivering each of our products, which may increase the risk of adverse side effects of our product candidates;
−Removed: ● educating medical personnel regarding the potential side effect profile of each of our product candidates;
−Removed: ● developing processes for the safe administration of these product candidates, including long-term follow-up for all patients who receive our product candidates;
−Removed: ● sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;
+Added: ● conditioning patients with chemotherapy in conjunction with delivering our CAR T product candidate, which may increase the risk of adverse events associated with our CAR T product candidate;
+Added: ● educating medical personnel regarding the potential side effect profile of each of our CAR T product candidate;
+Added: ● developing processes for the safe administration of this product candidate, including long-term follow-up for all patients who receive our product candidate;
+Added: ● sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our CAR T product candidate;
● developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment;
● establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance, and obtaining adequate coverage, reimbursement and pricing by third-party payors and government authorities;
−Removed: ● developing therapies for indications beyond those addressed by our current product candidates.
+Added: ● developing therapies for indications beyond those addressed by our current product candidate.
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
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In addition to significant and expensive clinical testing requirements, our ability to obtain marketing approval for product candidates depends on obtaining the final results of required non-clinical testing, including characterization of the manufactured components of our product candidates and validation of our manufacturing processes.
−Removed: The FDA may determine that our product manufacturing processes, testing procedures or equipment and facilities are inadequate to support approval.
+Added: The FDA may determine that our product manufacturing processes, testing procedures or
+Added: equipment and facilities are inadequate to support approval.
Approval policies or regulations may change, and the FDA has substantial discretion in the pharmaceutical approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons.
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Any delay in obtaining, or inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates.
−Removed: It is also unclear what actions will be taken by the current presidential administration or through legislative action that could impact the FDA and our ability to obtain regulatory approvals.
+Added: It is also unclear what actions will be taken by the U.S.
+Added: government that could impact the FDA and our ability to obtain regulatory approvals.
+Added: Additionally, over the last several years, the U.S.
+Added: government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.
+Added: If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to review and process our regulatory submissions in a timely manner, which could have a material adverse effect on our business.
+Added: Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Regulatory approval for our product candidates by the FDA, or any similar regulatory authorities outside the United States, is limited to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
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Regulatory authorities do, however, restrict communications by pharmaceutical companies on the promotion of off-label use.
−Removed: If our promotional activities fail to comply with these regulations or guidelines, we may be subject to compliance or enforcement actions, including Warning Letters, by these authorities.
+Added: If our promotional activities fail to comply with these regulations or guidelines, we may be subject to compliance or enforcement actions, including Warning
+Added: Letters, by these authorities.
In addition, our failure to follow FDA laws, regulations and guidelines relating to promotion and advertising may cause the FDA to suspend or withdraw an approved product from the market, request a recall or institute fines or penalties, or could result in disgorgement of money, operating restrictions, corrective advertising, injunctions or criminal prosecution, any of which could harm our business.
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We may enter into development and supply agreements with contract manufacturers for the completion of pre-commercialization manufacturing development activities and, if approved, the manufacture of commercial supplies for one or more of our product candidates.
−Removed: Any termination or disruption of our relationships with our contract manufacturers may materially harm our business and financial condition and frustrate any commercialization efforts for each respective product candidate.
+Added: Any termination or disruption of our relationships with our contract manufacturers may materially harm our business and financial condition and frustrate any commercialization efforts for each respective product candidate, if approved.
All of our contract manufacturers must comply with strictly enforced federal, state and foreign regulations, including cGMP requirements enforced by the FDA through its establishment inspection program.
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Any failure to comply with applicable regulations may result in fines and civil penalties, suspension of production, restrictions on imports and exports, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval, and would limit the availability of our product and customer confidence in our product.
−Removed: Any manufacturing
−Removed: defect or error discovered after products have been produced and distributed could result in even more significant consequences, including costly recalls, re-stocking costs, damage to our reputation and potential for product liability claims.
−Removed: If the contract manufacturers upon whom we may rely to manufacture one or more of our product candidates, and any future product candidate we may in-license, fails to deliver the required commercial quantities on a timely basis at commercially reasonable prices, we would likely be unable to meet demand for our approved product and we would lose potential revenues.
−Removed: If serious adverse or unacceptable side effects are identified during the development of one or more of our product candidates or any future product candidate, we may need to abandon or limit the development of some of our product candidates.
−Removed: If one or more of our product candidates or any future product candidate are associated with undesirable side effects or adverse events in clinical trials or have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses or subpopulations in which the adverse events, undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.
−Removed: In our industry, many compounds that initially showed promise in early stage testing have later been found to cause serious adverse events that prevented further development of the compound.
+Added: Any manufacturing defect or error discovered after products have been produced and distributed could result in even more significant consequences, including costly recalls, re-stocking costs, damage to our reputation and potential for product liability claims.
+Added: If the contract manufacturers upon whom we may rely to manufacture one or more of our product candidates, and any future product candidate we may in-license, fail to deliver the required commercial quantities on a timely basis at commercially reasonable prices, we would likely be unable to meet demand for our approved product and we would lose potential revenues.
+Added: If serious adverse events are identified during the development of one or more of our product candidates or any future product candidate, we may need to abandon or limit the development of some of our product candidates.
+Added: If one or more of our product candidates or any future product candidate are associated with undesirable adverse events in clinical trials or have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses or subpopulations in which the adverse events or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.
+Added: In our industry, many compounds that initially showed promise in early-stage testing have later been found to be associated with adverse events that prevented further development of the compound.
In the event that our clinical trials reveal a high or unacceptable severity and prevalence of adverse events, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of one or more of our product candidates or any future product candidate for any or all targeted indications.
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The number of requests for additional data or information issued by the FDA in recent years has increased and has resulted in substantial delays in the approval of several new drugs.
−Removed: Adverse events or undesirable side effects caused by one or more of our product candidates or any future product candidate could also result in the inclusion of unfavorable information in our product labeling or in denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications, which would, in turn, prevent us from commercializing and generating market acceptance and revenues from the sale of that product candidate.
−Removed: Adverse events or side effects could affect patient recruitment or the ability of enrolled patients to complete the trial and could result in potential product liability claims.
−Removed: Additionally, if one or more of our product candidates or any future product candidate receives marketing approval and we or others later identify undesirable side effects caused by this product, a number of potentially significant negative consequences could result, including:
+Added: Adverse events associated with one or more of our product candidates or any future product candidate could also result in the inclusion of unfavorable information in our product labeling or in denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications, which would, in turn, prevent us from commercializing and generating market acceptance and revenues from the sale of that product candidate, if approved.
+Added: Adverse events could affect patient recruitment or the ability of enrolled patients to complete the trial and could result in potential product liability claims.
+Added: Additionally, if one or more of our product candidates or any future product candidate receives marketing approval and we or others later identify adverse events associated with this product, a number of potentially significant negative consequences could result, including:
● regulatory authorities may require the addition of unfavorable labeling statements, including specific warnings , black box warnings, adverse reactions, precautions, and/or contraindications;
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● our reputation may suffer.
−Removed: Any of these events could prevent us from achieving or maintaining market acceptance of any of our product candidates or any future product candidate or could substantially increase our commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues, or any revenues, from their sale.
+Added: Any of these events could prevent us from achieving or maintaining market acceptance of either of our product candidates or any future product candidate, if approved, or could substantially increase our commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues, or any revenues, from their sale.
Even if one or more of our product candidates receives regulatory approval, it and any other products we may market will remain subject to substantial regulatory scrutiny.
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The FDA, or other regulatory authorities, may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product.
−Removed: The FDA and other applicable regulatory authorities closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of
−Removed: the approved labeling.
+Added: The FDA and other applicable regulatory authorities closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling.
The FDA and other applicable regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we market any approved product in a way which is not consistent with the approved labeling, we may be subject to enforcement action for off-label marketing.
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The FDA’s policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates, or negatively affect those products for which we may have already received regulatory approval, if any.
−Removed: There is added uncertainty in light of actions that may be taken by the current presidential administration or Congress with respect to the FDA.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to the various actions listed above, including losing any marketing approval that we may have obtained.
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If we adopt an alternative brand name, we would lose the benefit of our existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product brand name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.
−Removed: We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our product candidates.
+Added: We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our product candidates, if approved.
Public concern regarding the safety of drug products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs.
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If the FDA requires us to conduct additional preclinical studies or clinical trials prior to approving any of our product candidates, our ability to obtain approval of this product candidate will be delayed.
−Removed: If the FDA requires us to provide additional clinical or preclinical data following the approval of any of our product candidates, the indications for which this product candidate is approved may be limited or there may be specific warnings or limitations on dosing, and our efforts to commercialize our product candidates may be otherwise adversely impacted.
+Added: If the FDA requires us to provide additional clinical or preclinical data following the approval of any of our product candidates, the indications for which this product candidate is approved may be limited or there may be specific warnings or limitations on dosing, and our efforts to commercialize our product candidates, if approved, may be otherwise adversely impacted.
If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
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● the approval, availability, market acceptance and reimbursement for a companion diagnostic, if any;
−Removed: ● the prevalence and severity of adverse side effects;
+Added: ● the prevalence and severity of adverse events;
● the effectiveness of our sales and marketing efforts.
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We intend to seek approval to market our product candidates in the U.S., the European Union (“EU”) and other selected foreign jurisdictions.
−Removed: Market acceptance and sales of our product candidates in both domestic and international markets will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for any of our product candidates and may be affected by existing and future health care reform measures.
−Removed: Government and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new drugs and, as a result, they may not cover or provide adequate payment for our product candidates, if approved.
+Added: Market acceptance and sales of our product candidates, if approved, in both domestic and international markets will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for any of our product candidates and may be affected by existing and future health care reform measures.
+Added: Government and other third-party payors are increasingly attempting to contain healthcare
+Added: costs by limiting both coverage and the level of reimbursement for new drugs and, as a result, they may not cover or provide adequate payment for our product candidates, if approved.
These payors may conclude that our product candidates are less safe, less effective or less cost-effective than existing or future introduced products, and third-party payors may not approve our product candidates, if approved, for coverage and reimbursement or may cease providing coverage and reimbursement for these product candidates.
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For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch.
−Removed: If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses.
+Added: If the commercial launch of a product candidate, if approved, for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses.
This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
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Product liability claims might be brought against us by consumers, health care providers or others using, administering or selling our products.
−Removed: If we cannot successfully defend ourselves against these claims, we will incur substantial liabilities.
+Added: successfully defend ourselves against these claims, we will incur substantial liabilities.
Regardless of merit or eventual outcome, liability claims may result in:
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Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity, could lead to increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that do obtain approval and/or a decrease in demand for any such product candidates.
−Removed: Concern about environmental spread of our products, whether real or anticipated, may also hinder the commercialization of our products.
+Added: Changes in U.S.
+Added: government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.
+Added: There may be significant shifts in policies that directly impact the life sciences industry, including policies relating to FDA regulation and enforcement, drug approval and review processes, reimbursement and pricing (including Medicare, Medicaid and other government programs), healthcare reform, intellectual property protection, trade and tariffs, and federal research and public health funding.
+Added: The administration’s approach, together with actions by Congress and federal agencies such as the FDA, USPTO, Centers for Medicare & Medicaid Services, HHS, NIH and the Centers for Disease Control and Prevention, is inherently uncertain and may materially differ from historical norms or from our current expectations.
+Added: Potential changes may include, among others:
+Added: (i) modifications to standards, procedures or timelines for the review, clearance, approval or post-market oversight of drugs;
+Added: (ii) changes to policies on real-world evidence, accelerated approval, emergency use authorizations, and clinical trial requirements;
+Added: (iii) reforms or restrictions affecting drug pricing, reimbursement levels, coverage decisions and formulary placement for products paid for by federal healthcare programs;
+Added: (iv) increased or decreased enforcement of laws and regulations relating to manufacturing, promotion, fraud abuse, data integrity, privacy and cybersecurity;
+Added: (v) changes in federal funding priorities for biomedical research and public health programs that may impact key customers, collaborators and research partners;
+Added: and (vi) trade, tariff and supply-chain measures that could affect our access to critical materials, components, contract manufacturers, or international markets.
+Added: Any such actions, or uncertainty regarding potential actions, could increase development, regulatory, compliance, and commercialization costs;
+Added: delay, limit or prevent the development, approval, launch or commercial success of future product candidates or marketed products;
+Added: affect pricing, reimbursement and market access;
+Added: disrupt our supply chain;
+Added: alter the behavior and financial condition of our customers, clinical sites, collaborators and payors;
+Added: and contribute to volatility in capital markets that could affect our ability to raise additional financing on acceptable terms or at all.
+Added: Because we cannot predict the timing, scope, direction, or ultimate impact of policy or regulatory changes, we may not be able to anticipate or fully mitigate their effects.
+Added: Any of the foregoing could materially and adversely affect our business, financial condition, and results of operations.
Risks Related to Reliance on Third Parties
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We rely on our licensors to conduct some of our preclinical studies and some of our clinical trials for our product candidates and for future product candidates, and we rely on third-party CROs and site management organizations to conduct most of the remainder of our preclinical studies and all the rest of our clinical trials.
−Removed: We expect to continue to rely on third parties, such as our licensors, CROs, site management organizations, clinical data management organizations, medical institutions and clinical investigators, to conduct some of our preclinical studies and all of our clinical trials.
+Added: We expect to rely on third parties, such as our licensors, CROs, site management organizations, clinical data management organizations, medical institutions and clinical investigators, to conduct some of our preclinical studies and all of our clinical trials.
The agreements with these third parties might terminate for a variety of reasons, including a failure to perform by the third parties.
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Our reliance on these third parties for research and development activities reduces our control over these activities but does not relieve us of our responsibilities.
−Removed: For example, we remain responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and for ensuring that our preclinical studies are conducted in accordance with good laboratory practices (“GLPs”) as appropriate.
+Added: For example, we remain responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and for ensuring that our preclinical studies are conducted in accordance with good laboratory practices as appropriate.
Moreover, the FDA requires us to comply with standards, commonly referred to as good clinical practices (“GCPs”) for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, clinical investigators and trial sites.
−Removed: If we or any of our CROs fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
−Removed: We cannot assure you that upon inspection by a regulatory authority, such regulatory authority will determine that any of our clinical trials
−Removed: complies with GCP regulations.
+Added: If we or any third parties on which we rely fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
+Added: We cannot assure you that upon inspection by a regulatory authority, such regulatory authority will determine that any of our clinical trials complies with GCP regulations.
In addition, our clinical trials must be conducted with product produced under cGMP regulations.
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The third parties with whom we have contracted to help perform our preclinical studies and/or clinical trials may also have relationships with other entities, some of which may be our competitors.
−Removed: If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates, if approved.
+Added: If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our stated protocols, we
+Added: will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates, if approved.
If any of our relationships with these third-party CROs or site management organizations terminates, we may not be able to enter into arrangements with alternative CROs or site management organizations or to do so on commercially reasonable terms.
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As a result, delays could occur, which could compromise our ability to meet our desired development timelines.
−Removed: We are currently reliant on COH, Fred Hutch, Nationwide and UAB for all of our research and development efforts and the early clinical testing of our product candidates.
−Removed: A substantial portion of our research and development has been and will continue to be conducted by COH, Fred Hutch, Nationwide, and UAB pursuant to a sponsored research agreement and/or clinical trial agreements between Mustang Bio and each of COH and Fred Hutch, as well as a Memorandum of Understanding between Nationwide and UAB under which UAB is conducting its MB-108 Phase 1 clinical trials.
+Added: We are currently reliant on COH, Nationwide and UAB for all of our research and development efforts and the early clinical testing of our product candidates.
+Added: A substantial portion of our research and development has been and will continue to be conducted by COH, Nationwide, and UAB pursuant to a sponsored research agreement and/or clinical trial agreements between us and COH, as well as a Memorandum of Understanding between Nationwide and UAB under which UAB is conducting its MB-108 Phase 1 clinical trials.
As a result, our future success is heavily dependent on the results of research and development efforts of these institutions and their personnel.
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Forces beyond our control could disrupt the global supply chain, including imposition of tariffs, and impact our or our third-party manufacturers’ ability to obtain raw materials or other products necessary to manufacture our product candidates.
−Removed: There are a limited number of suppliers for raw materials and equipment that we use (or that are used on our behalf) to manufacture our product candidates, and there may be a need to assess alternate suppliers to prevent a possible disruption
−Removed: of the manufacture of the materials and equipment necessary to produce our product candidates for our preclinical and clinical trials, and if approved, ultimately for commercial sale.
+Added: There are a limited number of suppliers for raw materials and equipment that we use (or that are used on our behalf) to manufacture our product candidates, and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of the materials and equipment necessary to produce our product candidates for our preclinical and clinical trials, and if approved, ultimately for commercial sale.
We do not have any control over the process or timing of the acquisition of these raw materials or equipment by our third-party manufacturers.
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We rely on third parties to conduct all aspects of our LV vector production and these third parties may not perform satisfactorily.
−Removed: We do not independently conduct our LV vector production and we currently rely, and expect to continue to rely, on third parties with respect to the manufacture of these items.
+Added: We do not independently conduct our LV vector production and we currently rely, and expect to continue to rely, on third parties with respect to the manufacture of this item.
Our reliance on these third parties for manufacturing LV vector reduces our control over these activities but will not relieve us of our responsibility to ensure compliance with all required regulations and study protocols.
−Removed: For products that we develop and, if approved, commercialize, we will remain responsible for ensuring that each of our IND-enabling studies and clinical studies is conducted in accordance with the study plan and protocols, and that our LV vectors are manufactured in accordance with GMP as applied in the relevant jurisdictions.
−Removed: If these third parties do not successfully carry out their contractual duties, meet expected deadlines, conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, or manufacture our LV vectors in accordance with GMP, we will not be able to complete, or may be delayed in completing, the preclinical and clinical studies and manufacturing process validation activities required to support future IND, market authorization application and BLA submissions and approval of our product candidates, or to support commercialization of our products, if approved.
+Added: For products that we develop and, if approved, commercialize, we will remain responsible for ensuring that each of our IND-enabling studies and clinical studies is conducted in accordance with the study plan and protocols, and that our LV vector is manufactured in accordance with GMP as applied in the relevant jurisdictions.
+Added: If these third parties do not successfully carry out their contractual duties, meet expected deadlines, conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, or manufacture our LV vectors in accordance with GMP, we will not be able to complete, or may be delayed in completing, the preclinical and clinical studies and manufacturing process validation activities required to support future IND, market authorization application and BLA submissions and approval of our CAR T product candidate, or to support commercialization of our CAR T product, if approved.
Many of our agreements with these third parties contain termination provisions that allow these third parties to terminate their relationships with us at any time.
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We may be forced to enter into an agreement with a different manufacturer, which we may not be able to do on reasonable terms, if at all.
−Removed: In some cases, the technical skills required to manufacture LV vector for our drug product candidates may be unique or proprietary to the original manufacturer, and we may have difficulty or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.
−Removed: Any of these events could lead to clinical study delays or
−Removed: failure to obtain marketing approval or impact our ability to successfully commercialize our product candidates or any future product candidates, if approved.
+Added: In some cases, the technical skills required to manufacture LV vector for our CAR T drug product candidate may be unique or proprietary to the original manufacturer, and we may have difficulty or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.
+Added: Any of these events could lead to clinical study delays or failure to obtain marketing approval or impact our ability to successfully commercialize our CAR T product candidate or any future CAR T product candidates, if approved.
Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of production.
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This strategy necessarily relies upon clinical data and other results obtained by third parties that may ultimately prove to be inaccurate or unreliable.
−Removed: Further, such clinical data and results may be based on products or product candidates that are significantly different from our product candidates or any future product candidate.
+Added: Further, such clinical data and results
+Added: may be based on products or product candidates that are significantly different from our product candidates or any future product candidate.
If the third-party data and results we rely upon prove to be inaccurate, unreliable or not applicable to our product candidates or future product candidate, we could make inaccurate assumptions and conclusions about our product candidates and our research and development efforts could be compromised.
We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms .
−Removed: A third party may hold intellectual property, including patent rights that are important or necessary to the development and commercialization of our products.
+Added: A third party may hold intellectual property, including patent rights that are important or necessary to the development of our product candidates and commercialization, if approved.
It may be necessary for us to use the patented or proprietary technology of third parties, who may or may not be interested in granting such a license, to commercialize our products, in which case we would be required to obtain a license from these third parties on commercially reasonable terms, or our business could be harmed, possibly materially.
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Such collaborators may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for any future product candidate.
+Added: The contractual provisions we may be forced to agree upon in services, manufacturing, supply and other agreements may be inordinately one-sided, vis-à-vis current or historical standard market terms (especially as it pertains to contractual liability and indemnification paradigms), and as a result we may be subject to liabilities that are not attributable to our own actions or the actions of our personnel.
+Added: There is a finite number of service providers who can perform the services or produce the materials or product candidates that we need, and we therefore often have a limited number of options in choosing such service providers.
+Added: The standard market terms in many of the agreements into which we customarily enter with such service providers are subject to evolution over time, often-times in favor of our counterparties.
+Added: Also, some such agreements are “adhesion contracts” under which our contractual counterparties refuse to entertain any modifications to their template documentation.
+Added: One area where service providers often have and exert leverage over us is the negotiation of liability language – specifically in broadly-scoped indemnification by us of service providers and/or the application of liability damages “caps” to certain of such service providers’ indemnification obligations.
+Added: In any circumstance where we’ve been compelled to agree to such language, it is conceivable that we will be liable to third parties for liabilities in excess of such caps that are attributable to the actions, forbearances and/or culpability of such service providers and their indemnitees (and not to those of us and our personnel).
Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries
We are subject to new legislation, regulatory proposals and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
−Removed: In the United States and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that could prevent or delay marketing approval of our product candidate, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
+Added: In the United States and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “PPACA” or collectively, the “ACA”), substantially regulates the way healthcare is financed by both governmental and private insurers in the United States.
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expanded the eligibility criteria for Medicaid programs;
−Removed: created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
+Added: created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research,
+Added: along with funding for such research;
and established a Center for Medicare and Medicaid Innovation (“CMMI”) at the CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
Since its enactment, there have been executive, judicial, and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future.
−Removed: Drug pricing continues to be a subject of debate at the executive
−Removed: and legislative levels of U.S.
−Removed: The American Rescue Plan Act of 2021 signed into law by President Biden on March 14, 2021 includes a provision that eliminated the statutory cap on rebates drug manufacturers pay to Medicaid beginning in January 2024.
+Added: Drug pricing continues to be a subject of debate at the executive and legislative levels of U.S.
+Added: The American Rescue Plan Act of 2021 signed into law by President Biden in March 2021, includes a provision that eliminated the statutory cap on rebates drug manufacturers pay to Medicaid beginning in January 2024.
With the elimination of the rebate cap, manufacturers may be required to compensate states in an amount greater than what the state Medicaid programs pay for the drug.
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The effect of the IRA on our business and the pharmaceutical industry in general is not yet known.
+Added: In May 2025, President Trump issued an executive order implementing the concept of most-favored nation pricing.
+Added: Under this order, the HHS, in coordination with other federal agencies, is directed to take actions to ensure that the price of prescription drugs paid by federal health insurers, including Medicare and Medicaid, is in line with the prices paid in comparably developed nations.
+Added: As an alternative to the ACA, President Trump recently announced the Great Healthcare Plan.
+Added: As presented, the Great Healthcare Plan is intended to lower drug prices by increasing competition and benchmarking U.S.
+Added: drug prices to other countries, reduce insurance premiums by redirecting subsidies from insurers to individuals, increase accountability and transparency from insurers, and promote consumer choice by giving individuals more direct control over how healthcare dollars are spent.
+Added: Legislative and regulatory action will be required to fully implement the Great Healthcare Plan.
+Added: It is unclear how these proposed changes will impact our business and the pharmaceutical industry in general.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
−Removed: We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.
+Added: We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, if approved, or additional pricing pressures.
These and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any current or future product candidates.
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We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance, or interpretations will be changed, or what the impact of such changes on the marketing approvals of any current or future product candidates, if any, may be.
−Removed: In addition, increased Congressional scrutiny and scrutiny by the current presidential administration of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
+Added: In addition, increased Congressional scrutiny of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business or the business of our partners.
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In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
−Removed: There is added uncertainty in light of actions that may be taken by the current presidential administration or Congress with respect to the FDA.
−Removed: Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business or the business of our partners.
+Added: Disruptions at the FDA, including reductions in force, and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business or the business of our partners.
government has shut down several times in the past, and certain regulatory agencies, such as the FDA, have had to furlough nonessential FDA employees and stop routine activities.
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government official in order to influence official action, or otherwise obtain or retain business.
−Removed: The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls.
+Added: The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the
+Added: transactions of the corporation and to devise and maintain an adequate system of internal accounting controls.
Additionally, in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities;
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Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs.
−Removed: It is possible that governmental authorities will conclude that our business practices may not comply with current or future
−Removed: statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
+Added: It is possible that government authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could have a material adverse effect on our business.
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The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation.
−Removed: In addition, no consistent policy regarding the breadth of claims allowed in pharmaceutical or biotechnology patents has emerged to date in the U.S.
+Added: In addition, no consistent policy regarding the breadth of claims allowed
+Added: in pharmaceutical or biotechnology patents has emerged to date in the U.S.
The patent situation outside the U.S.
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We might also become involved in derivation proceedings in an event that a third party misappropriates one or more of our inventions and files their own patent application directed to such one or more inventions.
−Removed: The costs of these proceedings could be substantial, and it is possible that our efforts to establish priority of invention (or that a third party derived an invention from us) would be
−Removed: unsuccessful, resulting in a material adverse effect on our U.S.
+Added: The costs of these proceedings could be substantial, and it is possible that our efforts to establish priority of invention (or that a third party derived an invention from us) would be unsuccessful, resulting in a material adverse effect on our U.S.
patent position.
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Our licensors may also be notified of alleged infringement and be sued for infringement of third-party patents or other proprietary rights.
−Removed: We may have limited, if any, control or involvement over the defense of these claims, and our licensors could be subject to injunctions and temporary or permanent exclusionary orders in the U.S.
+Added: We may have limited, if any, control or involvement over the defense of these claims, and our licensors could be subject to injunctions and
+Added: temporary or permanent exclusionary orders in the U.S.
or other countries.
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Similarly, there may be issued patents relevant to our product candidates of which we or our licensors are not aware.
−Removed: Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S.
+Added: Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent
+Added: applications in the U.S.
and other jurisdictions are typically not published until 18 months after a first filing, or in some cases not at all.
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If we fail to comply with our obligations under our intellectual property licenses and third-party funding arrangements, we could lose rights that are important to our business.
−Removed: We are currently a party to license agreements with COH, Fred Hutch, Nationwide and other institutions.
+Added: We are currently a party to license agreements with COH and Nationwide.
In the future, we may become party to licenses that are important for product development and commercialization.
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Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.
+Added: As discussed elsewhere herein, in September 2025, we received a notice from Fred Hutch of its intent to terminate the CD20 License for cause in connection with unpaid patent expenses and maintenance fees.
+Added: A 90-day cure period was applicable under the CD20 License.
+Added: In December 2025, we agreed to terminate the CD20 License with Fred Hutch in exchange for a mutual release of liability and forgiveness of approximately fifty percent of amounts previously owed to them.
+Added: Additionally, we are eligible to receive royalties on any subsequent licensing consideration Fred Hutch may enter into during the three-year period following the termination.
+Added: If Fred Hutch or a third party successor to the program experiences future success in the development and/or commercialization of the CD20 program, it is possible that
+Added: we will have forfeited the opportunity to realize the relatively greater value from such program that would have resulted if we had continued to develop this technology ourselves.
We may be subject to claims that our employees and/or consultants have wrongfully used or disclosed to us alleged trade secrets of their former employers or other clients.
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If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
−Removed: In addition to seeking patent protection for our product candidates or any future product candidate, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position, particularly where we do not
−Removed: believe patent protection is appropriate or obtainable.
+Added: In addition to seeking patent protection for our product candidates or any future product candidate, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position, particularly where we do not believe patent protection is appropriate or obtainable.
However, trade secrets are difficult to protect.
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General Risks and Risks Associated with Ownership of our Common Stock
−Removed: Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.
+Added: We rely on information technology, and our business, reputation and operations would suffer in the event of any internet or internal computer system failures, inadequacies, interruptions, compromises, deficiencies, cyber-attacks, or other cybersecurity incidents affecting our systems or those of our third-party providers, or by any compromise of confidential information.
We are increasingly dependent upon information technology systems, infrastructure, and data to operate our business.
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Sophisticated cyber attackers (including foreign adversaries engaged in industrial espionage) are skilled at adapting to existing security technology and developing new methods of gaining access to organizations’ sensitive business data, which could result in the loss of proprietary information, including trade secrets.
−Removed: We may not be able to anticipate all types of security threats, and we may not be able to implement preventive measures effective against all such security threats.
−Removed: The techniques used by cyber criminals change frequently, may not be recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations, or hostile foreign governments or agencies.
+Added: We may not be able to anticipate all types of security threats, and we may not be able to implement effective preventive measures against all such security threats.
+Added: The techniques used by cyber criminals change frequently, may
+Added: not be recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations, or hostile foreign governments or agencies.
Any security breach or other event leading to the loss or damage to, or unauthorized access, use, alteration, disclosure, or dissemination of, personal information, including personal information regarding clinical trial subjects, contractors, directors, or employees, our intellectual property, proprietary business information, or other confidential or proprietary information, could directly harm our reputation, enable competitors to compete with us more effectively, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, or otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information.
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In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all.
−Removed: Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management
+Added: Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.
Furthermore, if the information technology systems of our third-party vendors and other contractors and consultants become subject to disruptions or security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event, and to develop and implement protections to prevent future events of this nature from occurring.
−Removed: Our business could be adversely affected by the effects of health pandemics or epidemics, which could cause significant disruptions in our operations.
−Removed: Health pandemics or epidemics, such as the COVID-19 pandemic, have in the past and could again in the future result in quarantines, stay-at-home orders, remote work policies or other similar events that may disrupt businesses, delay our research and development programs and timelines, negatively impact productivity and increase risks associated with cybersecurity, the future magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations.
−Removed: More specifically, these types of events may negatively impact personnel at third-party manufacturing facilities or the availability or cost of materials, which could disrupt our supply chain.
−Removed: In addition, impact on the operations of the FDA or other regulatory authorities could negatively affect our planned approval processes.
−Removed: Finally, economic conditions and business activity may be negatively impacted and may not recover as quickly as anticipated.
−Removed: The effects of epidemics and pandemic are highly uncertain and subject to change.
−Removed: If we are not able to respond to and manage the impact of such events effectively, our business, operating results, financial condition and cash flows could be adversely affected.
Our growth is subject to economic and geopolitical conditions.
Our business is affected by global and local economic and geopolitical conditions as well as the state of the financial markets, inflation, recession, financial liquidity, currency volatility, growth, and policy initiatives.
−Removed: There can be no assurance that global economic conditions and financial markets will not worsen and that we will not experience any adverse effects that may be material to our consolidated cash flows, results of operations, financial position or our ability to access capital, such as the adverse effects resulting from a prolonged shutdown in government operations both in the United States and internationally.
−Removed: Geopolitical changes, including war or other conflicts (including the conflicts between Russia and Ukraine and Israel and Hamas), some of which may be disruptive, could interfere with our supply chain, our customers and all of our activities in a particular location.
+Added: There can be no assurance that global economic conditions and financial markets will not worsen and that we will not experience any adverse effects that may be material to our cash flows, results of operations, financial position or our ability to access capital, such as the adverse effects resulting from a prolonged shutdown in government operations both in the United States and internationally.
+Added: Geopolitical changes, including wars, armed conflicts, acts of terrorism, civil or political unrest, trade disputes, the imposition of sanctions or other economic measures or other regional or global conflicts, some of which may be disruptive, could interfere with our supply chain, our customers and all of our activities in a particular location.
Additionally, trade policies and geopolitical disputes and other international conflicts can result in tariffs, sanctions and other measures that restrict international trade, and can materially adversely affect our business, particularly if these measures occur in regions where drug products are manufactured or raw materials are sourced.
−Removed: Tensions between the United States and China have led to a series of tariffs being imposed by the United States on imports from China mainland, as well as other business restrictions.
+Added: For example, tensions between the United States and China have led to a series of tariffs being imposed by the United States on imports from China mainland, as well as other business restrictions.
Countries may also adopt other measures, such as controls on imports or exports of goods, technology or data, that could adversely impact our operations and supply chain.
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or Chinese governments on certain products, industries or companies could significantly impact our development and commercialization efforts.
−Removed: The Trump administration may impose additional and higher tariffs and sanctions on goods imported from China and other countries which could increase the cost of goods needed to commercialize our products and continue development of our product candidates.
+Added: government may impose additional or higher tariffs, sanctions or other trade restrictions on goods imported from China and other countries which could increase the cost of goods needed to commercialize any products for which we obtain marketing authorization and continue development of our product candidates.
Further, such actions by the U.S.
−Removed: could result in retaliatory action by those countries which could impact our ability to profitably commercialize our products in those jurisdictions.
+Added: could result in retaliatory action by those countries which could impact our ability to profitably commercialize any products for which we obtain marketing authorization in those jurisdictions.
As a result, our business, operations, and financial condition could be materially harmed.
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Misconduct by employees, consultants, or third-party partners could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with cGMPs, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately, comply with internal procedures, policies or agreements to which such employees, consultants or partners are subject, or disclose unauthorized activities to us.
−Removed: In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to
−Removed: prevent fraud, kickbacks, self-dealing and other abusive practices.
+Added: In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
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The notes, analyses and memoranda that we have generated based on such information are also valuable to our businesses, and the unauthorized disclosure or misappropriation of such materials by our employees and consultants could significantly harm our strategic initiatives – especially if such disclosures are made to our competitors.
−Removed: We rely on information technology, and any internet or internal computer system failures, inadequacies, interruptions or compromises of our systems or the security of confidential information could damage our reputation and harm our business.
−Removed: Although a significant portion of our business is conducted using traditional methods of contact and communications such as face-to-face meetings, our business is increasingly dependent on critical, complex and interdependent information technology systems, including internet-based systems, to support business processes as well as internal and external communications.
−Removed: We could experience system failures and degradations in the future.
−Removed: We cannot assure you that we will be able to prevent an extended and/or material system failure if any of the following or similar events occurs:
−Removed: ● human error;
−Removed: ● subsystem, component, or software failure;
−Removed: ● a power or telecommunications failure;
−Removed: ● hacker attacks, cyber-attacks, software viruses, security breaches, unauthorized access or intentional acts of vandalism;
−Removed: ● terrorist acts or war.
−Removed: If any of the foregoing events were to occur, our business operations could be disrupted in ways that would require the incurrence of substantial expenditures to remedy.
−Removed: Any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our drug development programs.
−Removed: For example, the loss of clinical trial data from completed clinical trials for one or more of our product conducts could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
−Removed: To the extent that any disruption or security breach were to result in a loss of, or damage to, our data and applications, or inappropriate/unauthorized disclosure of confidential or proprietary information (including trade secrets), we could incur liability and our business and financial condition could be harmed.
The occurrence of a catastrophic disaster could damage our facilities beyond insurance limits, or we could lose key data which could cause us to curtail or cease operations.
−Removed: We are vulnerable to damage and/or loss of vital data from natural disasters, such as earthquakes, tornadoes, power loss, fire, health epidemics and pandemics, floods and similar events, as well as from accidental loss or destruction.
+Added: We are vulnerable to damage and/or loss of vital data from the physical impacts of climate change and other natural or man-made disasters, such as earthquakes, tornadoes, power loss, fire, health epidemics and pandemics, floods and similar events, as well as from accidental loss or destruction.
If any disaster were to occur, our ability to operate our businesses could be seriously impaired.
+Added: Our operations, and those of our third-party manufacturers, suppliers, clinical sites and other partners, depend on infrastructure and facilities that may be located in areas increasingly subject to extreme weather events and other physical risks and natural or man-made disasters.
+Added: These events could cause damage to or disrupt the operations of our contract manufacturers, suppliers, clinical trial sites, laboratories, data centers and other critical infrastructure, which could in turn:
+Added: ● delay, interrupt or prevent the manufacture, release, storage and shipment of our product candidates and the materials used to produce them, including LV vector and other critical components;
+Added: ● disrupt the conduct of our preclinical studies and clinical trials, including by impairing the ability of clinical trial sites to enroll or treat patients, collect or ship clinical specimens or perform required assessments;
+Added: ● impede the ability of our employees, contractors and collaborators to work at our or their respective facilities or to otherwise carry out our business activities;
+Added: ● damage or destroy data, biological samples, equipment or facilities, or result in prolonged outages of critical information technology systems or other infrastructure.
+Added: Any of the foregoing events or developments could result in increased costs, delays in our research and development activities, disruptions to our supply chain and clinical development programs, reduced revenue opportunities, or otherwise have a material adverse effect on our business, financial condition and results of operations.
We have property, liability and business interruption insurance that may not be adequate to cover losses resulting from disasters or other similar significant business interruptions, and we do not plan to purchase additional insurance to cover such losses due to the cost of obtaining such coverage.
−Removed: Any significant losses that are not recoverable under our insurance policies could seriously impair our business, financial condition and prospects.
−Removed: Any of the aforementioned circumstances, including without limitation the resurgence of COVID-19 virus, may also impede our employees’ and consultants’ abilities to provide services in-person and/or in a timely manner;
+Added: Any significant losses that are not recoverable under our insurance policies could seriously impair our business, financial
+Added: condition and prospects.
+Added: Any of the aforementioned circumstances may also impede our employees’ and consultants’ abilities to provide services in-person and/or in a timely manner;
hinder our ability to raise funds to finance our operations on favorable terms or at all;
and trigger effectiveness of “force majeure” clauses under agreements with respect to which we receive goods and services, or under which we are obligated to achieve developmental milestones on certain timeframes.
−Removed: Disputes with third parties over the applicability of such “force majeure” clauses, or the
−Removed: enforceability of developmental milestones and related extension mechanisms in light of such business interruptions, may arise and may become expensive and time-consuming.
+Added: Disputes with third parties over the applicability of such “force majeure” clauses, or the enforceability of developmental milestones and related extension mechanisms in light of such business interruptions, may arise and may become expensive and time-consuming.
The market price for our common stock has been volatile and may continue to fluctuate or may decline significantly in the future.
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In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities.
−Removed: This risk is especially relevant for us because biotechnology and biopharmaceutical companies have experienced significant
−Removed: stock price volatility in recent years.
+Added: This risk is especially relevant for us because biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years.
We may become involved in this type of litigation in the future.
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Our common stock is listed on the Nasdaq Capital Market under the symbol “MBIO.” The Nasdaq Capital Market requires that listed companies satisfy continued listing standards to maintain their listing.
−Removed: On March 13, 2024, we received a deficiency letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying us that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”).
−Removed: The Equity Rule requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2.5 million (or, in the alternative, a market value of listed securities of $35 million or net income from continued operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years).
−Removed: Our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, reported a stockholders’ deficit of $3.7 million.
−Removed: The Letter had no immediate effect on our continued listing Nasdaq, subject to our compliance with the other continued listing requirements.
−Removed: In accordance with the Nasdaq Listing Rules, we were provided 45 calendar days, or until April 29, 2024, to submit a plan to regain compliance with the Equity Rule (the “Compliance Plan”).
−Removed: We submitted our Compliance Plan on April 29, 2024, and the Staff granted our request for an extension of 180 calendar days, through September 9, 2024, to regain compliance with the Equity Rule.
−Removed: We were unable to demonstrate compliance with the Equity Rule by September 9, 2024.
−Removed: On September 10, 2024, the Staff formally notified us that it had determined to delist our securities from Nasdaq based upon our continued non-compliance with Equity Rule unless we timely request a hearing before the Nasdaq Hearings Panel (the “Panel”).
−Removed: On September 17, 2024, we requested a hearing before the Panel, which stayed any further action by Nasdaq at least pending completion of the hearing and the expiration of any extension that may be granted by the Panel to us following the hearing.
−Removed: The hearing took place on October 29, 2024, and we are currently awaiting the decision of the Panel.
−Removed: On May 16, 2024, we received a notice (the “Second Letter”) from the Staff indicating that the bid price of our common stock had closed below $1.00 per share for 30 consecutive business days and, as a result, we were not in compliance with Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on the Nasdaq Capital Market (the “Bid Price Rule”).
−Removed: Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we were afforded a 180-calendar day grace period, or until November 12, 2024, to regain compliance with the Bid Price Rule, which necessitates a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days by November 12, 2024.
−Removed: The hearing before the Panel occurred on October 29, 2024.
−Removed: By decision dated November 8, 2024, the Panel granted our request for an extension to evidence compliance with all applicable criteria for continued listing on the Nasdaq Capital Market, including the Bid Price Rule, through January 31, 2025, and the Equity Rule through February 18, 2025.
−Removed: On February 10, 2025, the Company completed a best-efforts public offering for net proceeds of approximately $6.9 million.
−Removed: Following the closing, the Company provided an updated forecast to the Panel evidencing compliance with the Equity Rule.
−Removed: On February 26, 2025, the Company was notified by the Staff that it had regained compliance with the Equity Rule and is subject to mandatory monitoring by the Panel for one year.
+Added: In 2024 and early 2025, we were not in compliance with certain standards for continued listing on the Nasdaq Capital Market, namely, the minimum stockholders’ equity requirement (the “Equity Rule”) and the minimum bid price requirement (the “Bid Price Rule”).
+Added: On January 15, 2025, we effected a 1-for-50 reverse stock split.
+Added: Thereafter, we were subsequently notified by the Staff of Nasdaq’s Listing Qualifications department (the “Staff”) that we had regained compliance with the Bid Price Rule.
+Added: On February 10, 2025, we completed a best-efforts public offering for net proceeds of approximately $6.8 million, and we were subsequently notified by the Staff that we had regained compliance with the Equity Rule and are subject to mandatory monitoring by a Nasdaq Hearings Panel for one year.
There can be no assurance that we will be able to maintain compliance with Nasdaq’s continued listing rules in the future.
−Removed: If we are not able to maintain compliance, we may be delisted from Nasdaq.
+Added: If we are unable to maintain compliance, we may be delisted from Nasdaq.
In the event we are delisted from Nasdaq, there can be no assurance that our common stock will be eligible for trading on another stock exchange or quotation on an over-the-counter market.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.