Inmune Bio, Inc.
For the period ended Dec 31, 2025. Filed Mar 30, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 30, 2026
INMB$1.13-3.8%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-27.
0001013762-25-003354
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-30.
0001213900-26-036370
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 157 previous paragraphs and 187 current paragraphs.
14 unchanged; 36 reworded; 132 added; 106 removed; 1 previous and 5 current paragraphs rearranged.
Tables are not compared: 37 previous and 26 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (132)
Current report
As of December 31, 2025, the Company had an accumulated deficit of $209,037,000. These losses primarily reflect the substantial resources devoted to research and development of our product candidates, along with general and administrative expenses, and the absence of revenues until commercialization of our products.
Current report
We Have a History of Losses and May Never Achieve or Sustain Profitability
Current report
We expect to continue incurring significant losses for the foreseeable future as we advance the research, development, and regulatory approval of our product candidates. The costs of clinical development increase substantially at each phase, and the total expenses to achieve marketing approval for any product candidate, even in a single jurisdiction, will be substantial. Due to the inherent risks and uncertainties of pharmaceutical product development, we cannot predict when, or if, we will generate revenue or achieve profitability.
Current report
Our ability to achieve and sustain profitability depends on, among other factors, our success in developing, obtaining regulatory approval for, and commercializing our product candidates, alone or through collaborations, as well as our ability to control costs. If we are unable to achieve or sustain profitability, or if revenues from approved products are insufficient, our business, financial condition, and the value of our common stock will be materially and adversely affected.
Current report
Limitations on Capital Raising Due to Low Public Float
Current report
Our ability to raise additional capital, including through sales of common stock under our ATM Program, may be limited if the public float of our common stock remains below $75.0 million.
Current report
Under SEC rules, if the aggregate market value of our common stock held by non-affiliates (public float) is less than $75.0 million at the time we file an Annual Report—or in some cases, earlier—the amount we can raise through primary public offerings using shelf registration statements is limited to one-third of our public float in any 12-month period. However, the SEC has recently published a Corporate Finance Interpretation stating that the Staff will not object if a company continue offering and selling the full amount of securities covered by any prospectus supplement filed prior to its Section 10(a)(3) update (such as filing of an annual report on Form 10-K) , without being limited to one-third of its public float in any 12-month period, even when such company will not meet the public float requirement of Instruction I.B.1 of Form S-3 at the time it files its annual report. As of December 31, 2025, our public float was approximately $36.8 million and the amount of securities we would be able to sell under our Form S-3 would be reduced; however, as we have an effective Form S-3 registration statement, we were eligible to offer and sell securities in reliance on General Instruction I.B.1, and we filed a prospectus supplement for the offering of the common stock under our ATM program prior to the date of this Annual Report, we believe, based on the SEC’s Corporate Finance Interpretation, that we will be able to continue using our existing ATM without the aforementioned limitation.
Current report
If approved, our product candidates may compete with drugs marketed by large pharmaceutical and biotechnology companies. Competitors could market products more effectively, identify drug candidates or develop products faster, or produce therapies that are more effective, safer, or lower cost than ours.
Current report
If a competitor obtains FDA approval before us for a similar drug, approval of our product candidate may be delayed or precluded due to periods of non-patent exclusivity or patent listings by the competitor.
Current report
Competition and Technological Change Could Reduce the Attractiveness of Our Product Candidates
Current report
We face intense competition from established pharmaceutical and biotechnology companies pursuing treatments for the same indications as our product candidates. Many competitors have substantially greater financial, research, and regulatory resources, and may succeed in developing products more quickly, obtaining FDA approvals sooner, or creating therapies that are more effective than ours.
Current report
Research and development by others could render our technologies or product candidates obsolete or noncompetitive. Competitors may also acquire or internally develop technologies that limit or prevent our commercialization efforts, reducing potential revenues.
Current report
Even if we successfully develop and obtain regulatory approval for our product candidates, there can be no assurance that physicians, patients, or payors will adopt our products as a preferred treatment. Approval of competing products before ours could further complicate our regulatory path or market acceptance.
Current report
The pharmaceutical and biotechnology industry is complex, diverse, and rapidly changing. Factors such as competition, intellectual property disputes, market acceptance, and evolving regulations make it difficult to predict revenues or profitability with certainty.
Current report
We are substantially dependent on the success of CORDStrom, and we may never obtain regulatory approval.
Current report
Our future success is highly dependent on our ability to obtain regulatory approval for CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa (“RDEB”). Although we believe the clinical data generated to date support the potential therapeutic benefit of CORDStrom, regulatory authorities may interpret the data differently or determine that the evidence is insufficient to support approval. Regulatory agencies may require additional preclinical studies or clinical trials, impose limitations on the indicated patient population, or determine that the benefit-risk profile does not support approval. As a result, we may experience significant delays in the development and review process, incur substantial additional costs, or ultimately be unable to obtain regulatory approval for CORDStrom. Failure to obtain approval would materially and adversely affect our business, financial condition and results of operations.
Current report
Global economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts, such as the conflict between Russia and Ukraine and the recent military conflict in the Middle East involving Iran, could make it more difficult for us to access financing and could adversely affect our business and operations.
Current report
Our ability to access capital markets and raise additional funds depends in large part on investor confidence and market valuations of our securities. The market value and liquidity of our common stock are subject to significant fluctuations based on factors beyond our control, including changes in general economic conditions, interest rate environments, inflationary pressures, investor sentiment toward biotechnology and early-stage issuers, and overall equity market volatility. Periods of macroeconomic weakness or recession, rising interest rates, tightening credit markets, or risk-off investor behavior may limit the availability of equity or debt financing on acceptable terms, or at all. A decline in the market price of our securities could also impair our ability to raise capital without substantial dilution to existing shareholders.
Current report
In addition, geopolitical developments and international conflicts, such as instability or war in the Middle East, the ongoing conflict between Russia and Ukraine, or a deterioration in relations between the United States and China, may contribute to global uncertainty, disrupt financial and commodity markets, and adversely affect investor risk appetite. Resulting government actions, including the imposition of sanctions, export controls, tariffs, or other trade restrictions, could disrupt global supply chains and trade flows, further exacerbating inflationary or recessionary pressures. Such events may impair our ability to source key raw materials, reagents, or specialized components required for our research and development programs and clinical manufacturing activities, potentially leading to increased costs, delays in development timelines, or operational interruptions.
Current report
Continued market instability or geopolitical tension could also constrain venture capital and institutional investment into the life sciences sector more broadly, reduce valuations for comparable companies, and limit opportunities for strategic partnerships or follow-on financings. If we are unable to obtain additional capital when needed, or only on unfavorable terms, we may be forced to delay, scale back, or discontinue one or more of our product development programs, which could materially and adversely affect our business, financial condition, and prospects.
Current report
Even if we commercialize our product candidates, pricing, reimbursement, and healthcare regulations could limit their market success.
Current report
The commercial success of our products will depend largely on coverage and reimbursement by government programs (such as Medicare and Medicaid), private insurers, and other third-party payors, both in the U.S. and abroad. If reimbursement is unavailable, limited, or insufficient, we may be unable to successfully commercialize our products or achieve a meaningful return on investment.
Current report
Third-party coverage and reimbursement policies for newly approved drugs are uncertain and vary significantly across countries. Some jurisdictions require pricing approval before marketing, and ongoing governmental price controls may apply even after initial approval. Consequently, we could face delays in product launches or limitations on revenues, which may hinder our ability to recoup development and commercialization costs.
Current report
We are subject to extensive government regulations.
Current report
The products we are developing require substantial investment, development, and testing before commercialization. Obtaining regulatory approvals is costly and time-consuming, and there is no assurance that any product will prove safe and effective or receive the necessary approvals. Investors should be aware that our business is subject to significant regulatory risks, delays, and expenses inherent in the development and commercialization of therapeutic products.
Current report
We operate in a rapidly evolving field with intense competition from established pharmaceutical and biotechnology companies, smaller companies, and academic or governmental institutions. Many competitors have greater financial resources, expertise in research, development, manufacturing, regulatory approvals, and marketing, as well as ongoing product pipelines. They also compete for qualified scientific and management personnel.
Current report
Competition will be based on product efficacy and safety, regulatory approvals, supply, marketing and sales capabilities, pricing, reimbursement, and patent protection. There is no assurance that our competitors will not develop more effective or affordable products, secure earlier approvals, or achieve earlier commercialization. Even as we seek to expand our technological capabilities, research by others may render our products less competitive, obsolete, or inferior to alternative therapies.
Current report
We may request priority review, but the FDA may not grant it, and even if granted, it may not accelerate approval.
Current report
We may seek priority review for our product candidate if the FDA determines it offers a major advance in treatment or addresses a condition with no adequate therapy. Priority review sets a goal of six months for FDA action rather than the standard ten-month review. However, the FDA has broad discretion in granting this designation, and our product candidate may not receive it. Even if granted, priority review does not guarantee faster approval or confer any advantage in the ultimate regulatory decision.
Current report
If we are unable to obtain accelerated approval or other expedited regulatory designations, development and commercialization of our product candidates may be delayed or more costly.
Current report
We may seek accelerated approval for our product candidates under FDA or comparable non-U.S. regulatory pathways intended for therapies addressing serious or life-threatening conditions. Such pathways often rely on surrogate or intermediate clinical endpoints reasonably likely to predict clinical benefit, and approval may be contingent on conducting confirmatory post-approval studies. If these studies fail to confirm clinical benefit, regulatory authorities may withdraw approval.
Current report
There can be no assurance that we will pursue, be granted, or successfully achieve accelerated or expedited approval. Regulatory authorities could require additional preclinical studies or clinical trials, delay acceptance of our submissions, or impose other conditions that could increase development costs, extend timelines, and harm our competitive position.
Current report
Clinical drug development is lengthy, expensive, and inherently uncertain, and our product candidates may never receive regulatory approval.
Current report
Our product candidates are in early stages of development, and the risk of failure is high. Before obtaining marketing approval, we must complete preclinical studies and extensive clinical trials to demonstrate safety and efficacy. Clinical development is time-consuming, costly, and uncertain, and a failure can occur at any stage. Product candidates may fail to demonstrate efficacy, may cause unacceptable adverse events, may not perform consistently across patient populations, or may fail to meet regulatory requirements. Even if a product candidate shows promising results in early studies, those results may not be replicated in later-stage trials.
Current report
Clinical trial outcomes can be affected by numerous factors, including trial design, patient selection, protocol adherence, statistical analysis, and variability across trial sites. Preclinical and clinical data are subject to differing interpretations, and regulatory authorities may disagree with our conclusions regarding safety or efficacy. As a result, we may incur substantial additional costs, experience significant delays, or be unable to obtain marketing approval for our product candidates, which would materially harm our business and prospects.
Current report
Preclinical and early-stage clinical trial results may not predict later results, and interim or preliminary data may change materially.
Current report
Results from preclinical studies or early-stage clinical trials may not be predictive of outcomes in later-stage trials or final results. Initial success in a clinical trial, particularly in small early trials, may not indicate success in larger or later-stage studies. Preclinical and clinical data are subject to varying interpretations, and many drug candidates that initially appeared promising have failed to achieve marketing approval. Any setbacks in our clinical development could materially harm our business, financial condition, results of operations, and prospects.
Current report
Interim or top-line data from ongoing trials may differ materially from final results. Such preliminary data are subject to audit, verification, and changes as additional patient data become available. Adverse differences between early data and final results could negatively affect our reputation, investor perception, and business prospects.
Current report
We cannot market or sell any product candidate in the United States without FDA approval, nor in other jurisdictions without comparable regulatory authorizations. Clinical testing is expensive, time-consuming, complex, and inherently uncertain. We have not previously submitted an NDA or equivalent application to any regulatory authority, and there is no guarantee that we will obtain marketing approval for any product candidate.
Current report
Failure to successfully complete preclinical or clinical development, or unfavorable trial outcomes, could delay or prevent approval, result in narrower indications or restrictive labeling, require additional post-marketing studies, or lead to withdrawal from the market. Any of these outcomes could materially increase costs, delay revenue generation, and harm our business, financial condition, and results of operations.
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Removed paragraphs (106)
Previous report
There is no assurance that we will be successful in raising the additional funds needed to fund our business plan. If we are not able to raise sufficient capital in the near future, our continued operations will be in jeopardy and we may be forced to cease operations and sell or otherwise transfer all or substantially all of our remaining assets.
Previous report
We expect that our product candidates under development, if approved, will face intense competition from existing and future drugs marketed by large companies. These competitors may successfully market products that compete with our products, successfully identify drug candidates or develop products earlier than we do, or develop products that are more effective, have fewer side effects or cost less than our products, if any.
Previous report
Additionally, if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering its newly-approved drug product. Periods of non-patent exclusivity for new versions of existing drugs such as our current product candidates can extend up to three and one-half years. See the section entitled “Government Regulation.”
Previous report
Competition and technological change may make our product candidates and technologies less attractive or obsolete.
Previous report
We compete with established pharmaceutical and biotechnology companies that are pursuing other forms of treatment for the same indications we are pursuing and that have greater financial and other resources. Other companies may succeed in developing products earlier than us, obtaining FDA approval for products more rapidly, or developing products that are more effective than our product candidates. Research and development by others may render our technology or product candidates obsolete or noncompetitive or result in treatments or cures superior to any therapy we develop. We face competition from companies that internally develop competing technology or acquire competing technology from universities and other research institutions. As these companies develop their technologies, they may develop competitive positions that may prevent, make futile, or limit our product commercialization efforts, which would result in a decrease in the revenue we would be able to derive from the sale of any products.
Previous report
There can be no assurance that any of our product candidates will be accepted by the marketplace as readily as these or other competing treatments. Furthermore, if our competitors’ products are approved before ours, it could be more difficult for us to obtain approval from the FDA. Even if our products are successfully developed and approved for use by all governing regulatory bodies, there can be no assurance that physicians and patients will accept our product(s) as a treatment of choice.
Previous report
Furthermore, the pharmaceutical research industry is diverse, complex, and rapidly changing. By its nature, the business risks associated therewith are numerous and significant. The effects of competition, intellectual property disputes, market acceptance, and FDA regulations preclude us from forecasting revenues or income with certainty or even confidence.
Previous report
We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability.
Previous report
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates and now that we are no longer an emerging growth company, as defined in Section 2(a) of the Securities Act of 1933, as amended. As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the Dodd-Frank Act, as well as rules adopted, and to be adopted, by the SEC and The Nasdaq Stock Market LLC. We also expect that compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and increased disclosure requirements will increase our legal and financial compliance costs. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any. The costs of advancing product candidates into each clinical phase tend to increase substantially over the duration of the clinical development process. Therefore, the total costs to advance any of our product candidates to marketing approval in even a single jurisdiction will be substantial. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of any products or achieve or maintain profitability.
Previous report
The costs of advancing product candidates into each clinical phase tend to increase substantially over the duration of the clinical development process. Therefore, the total costs to advance any of our product candidates to marketing approval in even a single jurisdiction will be substantial. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of any products or achieve or maintain profitability.
Previous report
Furthermore, our ability to successfully develop, commercialize and license any product candidates and generate product revenue is subject to substantial additional risks and uncertainties. As a result, we expect to continue to incur net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. The amount of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If we are unable to develop and commercialize one or more product candidates, either alone or through collaborations, or if revenues from any product that receives marketing approval are insufficient, we will not achieve profitability. Even if we do achieve profitability, we may not be able to sustain profitability or meet outside expectations for our profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially and adversely affected.
Previous report
Even if we are able to commercialize any product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives that could harm our business.
Previous report
The commercial success of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities (such as Medicare and Medicaid), private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish and maintain pricing sufficient to realize a meaningful return on our investment.
Previous report
There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved drugs. Marketing approvals, pricing and reimbursement for new drug products vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some non-U.S. markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval.
Previous report
We are subject to various government regulations.
Previous report
The products we are currently developing will require significant development, preclinical and clinical testing and investment of substantial funds prior to its commercialization. The process of obtaining required approvals can be costly and time-consuming, and there can be no assurance that we develop successfully this product or any future products, or that this product or any future products we develop will prove to be safe and effective in clinical trials or receive applicable regulatory approvals. Potential investors and shareholders should be aware of the risks, problems, delays, expenses and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.
Previous report
We are engaged in a rapidly changing field. Other products and therapies that will compete directly with the products that we are seeking to develop and market currently exist or are being developed. Competition from fully integrated pharmaceutical companies and more established biotechnology companies is intense and is expected to increase. Most of these companies have significantly greater financial resources and expertise in discovery and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing than us. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established biopharmaceutical or biotechnology companies. Many of these competitors have significant products that have been approved or are in development and operate large, well-funded discovery and development programs. Academic institutions, governmental agencies and other public and private research organizations also conduct research, seek patent protection and establish collaborative arrangements for therapeutic products and clinical development and marketing. These companies and institutions compete with us in recruiting and retaining highly qualified scientific and management personnel. In addition to the above factors, we will face competition based on product efficacy and safety, the timing and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage, price and patent position. There is no assurance that our competitors will not develop more effective or more affordable products, or achieve earlier patent protection or product commercialization, than our own.
Previous report
Other companies may succeed in developing products earlier than ourselves, obtaining FDA and European Medicines Agency (“EMA”) approvals for such products more rapidly than we will, or in developing products that are more effective than products we propose to develop. While we will seek to expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop, or that any therapy we develop will be preferred to any existing or newly developed technologies.
Previous report
We may request priority review for our product candidate in the future. The FDA may not grant priority review for our product candidate. Moreover, even if the FDA designates such product for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, would not assure FDA approval.
Previous report
We may be eligible for priority review designation for our product candidate if the FDA determines such product candidate offers major advances in treatment or provides a treatment where no adequate therapy exists. A priority review designation means that the goal for the FDA is to take action on an application in six months, rather than the standard review period of ten months. The FDA has broad discretion with respect to whether or not to grant priority review status to a product candidate, so even if we believe a particular product candidate is eligible for such designation or status, the FDA may decide not to grant it. Thus, while the FDA has granted priority review to other oncology disease products, our product candidate, should we determine to seek priority review, may not receive similar designation. Moreover, even if our product candidate is designated for priority review, such a designation does not necessarily mean a faster regulatory review process or necessarily confer any advantage with respect to approval compared to conventional FDA procedures. Receiving priority review from the FDA does not guarantee approval within an accelerated timeline or thereafter.
Previous report
We believe we may in some instances be able to secure approval from the FDA or comparable non-U.S. regulatory authorities to use accelerated development pathways. If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.
Previous report
We anticipate that we may seek an accelerated approval pathway for our product candidates. Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, or FDCA, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug.
Previous report
Prior to seeking such accelerated approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval. There can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a New Drug Application, or NDA, for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that after subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDA or other non-U.S. authorities could also require us to conduct further studies prior to considering our application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.
Previous report
Our product candidates are in early clinical development. Therefore, the risk of failure of our product candidates is high. It is impossible to predict when or if our product candidates will prove effective or safe in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The clinical development of our product candidates is susceptible to the risk of failure inherent at any stage of drug development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of severe or medically or commercially unacceptable adverse events, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any comparable non-U.S. regulatory authority that a drug product is not safe or effective for its intended uses. It is possible that even if our product candidate has a beneficial effect, that effect will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials. Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any. Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability caused by our product candidates, or mistakenly believe that our product candidates are toxic or not well tolerated when that is not in fact the case.
Previous report
Success in early development does not mean that later development will be successful because, for example, drug candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials.
Previous report
The design of a clinical trial can determine whether its results will support approval of a product; however, flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced or completed. In addition, preclinical and clinical data are often susceptible to varying interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for the product candidates. Even if we believe that the results of clinical trials for our product candidate warrant marketing approval, the FDA or comparable non-U.S. regulatory authorities may disagree and may not grant marketing approval of our product candidate.
Previous report
In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. Any clinical trials that we may conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market our product candidate.
Previous report
The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials.
Previous report
The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed. In particular, the small number of patients in our planned early clinical trials may make the results of these trials less predictive of the outcome of later clinical trials. For example, even if successful, the results of our initial clinical trials for XPro may not be predictive of the results of further clinical trials of this drug candidate or any of our other drug candidates. Moreover, preclinical and clinical data often are susceptible to varying interpretations and analyses, and many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical trials nonetheless have failed to obtain marketing approval of their products. Our future clinical trials may not ultimately be successful or support further clinical development of any of our drug candidates. There is a high failure rate for drug candidates proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving encouraging results in earlier studies. Any such setbacks in our clinical development could materially harm our business, results of operations, financial condition and prospects.
Previous report
Interim top-line and preliminary data from our planned clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Previous report
From time to time, we may publish interim top-line or preliminary data from our planned clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data becomes available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data is available. Adverse differences between preliminary or interim data and final data could significantly harm our reputation and business prospects.
Previous report
We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Comparable non-U.S. regulatory authorities, such as the EMA, impose similar restrictions. We may never receive such approvals. We must complete extensive preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidate in humans before we will be able to obtain these approvals.
Previous report
Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We have not previously submitted an NDA to the FDA or similar drug approval filings to comparable non-U.S. regulatory authorities for any product candidate.
Previous report
Any inability to successfully complete preclinical and clinical development could result in additional costs to us and impair our ability to generate revenues from product sales, regulatory and commercialization milestones and royalties. In addition, if (1) we are required to conduct additional clinical trials or other testing of our product candidate beyond the trials and testing than we contemplate, (2) we are unable to successfully complete clinical trials of our product candidate or other testing, (3) the results of these trials or tests are unfavorable, uncertain or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition to incurring additional costs, may:
Previous report
If we experience any of a number of possible unforeseen events in connection with clinical trials of any of our product candidates, potential marketing approval or commercialization of that product candidate could be delayed or prevented.
Previous report
Product development costs for us will increase if we experience delays in testing or pursuing marketing approvals and we may be required to obtain additional funds to complete clinical trials and prepare for possible commercialization of our product candidates. We do not know whether any preclinical tests or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and may harm our business and results of operations. In addition, many of the factors that cause, or lead to, clinical trial delays may ultimately lead to the denial of marketing approval of our product candidates.
Previous report
If we experience delays or difficulties in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all, and our receipt of necessary regulatory approvals could be delayed or prevented.
Previous report
We may not be able to initiate or continue clinical trials for CORDStrom, INKmune our DN-TNF product platform or any other product candidate if we are unable to locate and enroll a sufficient number of eligible patients to participate in clinical trials. Patient enrollment is a significant factor in the timing of clinical trials, and is affected by many factors, including:
Previous report
Our inability to enroll a sufficient number of patients for our clinical trials could result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, delay or halt the development of and approval processes for our product candidates and jeopardize our ability to achieve our clinical development timeline and goals, including the dates by which we will commence, complete and receive results from clinical trials. Enrollment delays may also delay or jeopardize our ability to commence sales and generate revenues from our product candidates. Any of the foregoing could cause the value of the Company to decline and limit our ability to obtain additional financing, if needed.
Previous report
We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.
Showing the first 40 of 106 passages. Open the source sections for the rest.
Reworded paragraphs (36)
Previous wording
There is doubt about our ability to continue as a going concern.
Current wording
There is a Substantial Doubt About Our Ability to Continue as a Going Concern
Previous wording
As of December 31, 2024, the Company had an accumulated deficit of $163,104,000. Losses have principally occurred as a result of the substantial resources required for research and development of the Company’s product candidates which included the general and administrative expenses associated with its organization and product development as well as the lack of sources of revenues until such time as the Company’s products are commercialized. These factors raise substantial doubt about the Company’s ability to continue as a going concern for the 12 months from the issuance date of these financial statements. These financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of these uncertainties. Management intends to pursue additional funding and implement its strategic plan to allow the opportunity for the Company to continue as a going concern, however, there cannot be any assurance that we will be successful in doing so. The opinion of our independent registered public accounts on our audited financial statements for the year ended December 31, 2024, contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
Current wording
These factors raise substantial doubt about our ability to continue as a going concern for the 12 months following the issuance of these financial statements. The financial statements do not include adjustments that might result if we are unable to continue as a going concern, including the possible impact on the recoverability and classification of assets or the amounts and classifications of liabilities.
Previous wording
We were formed in September 2015 and have only a limited operating history and have incurred losses since our formation. We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $42.1 million and $30.0 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and 2023, we had cash and cash equivalents of $20.9 million and $35.8 million, respectively.
Current wording
We have incurred losses since our inception in September 2015 and are not currently profitable. We reported net losses of $45.9 million and $42.1 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had cash and cash equivalents of $24.8 million.
Previous wording
We face intense competition in the markets targeted by our lead product candidates. Many of our competitors have substantially greater resources than we do, and we expect that all of our product candidates under development will face intense competition from existing or future drugs.
Current wording
We face intense competition in the markets targeted by our product candidates. Many competitors have substantially greater resources, and all of our product candidates are expected to face strong competition from existing and future drugs.
Previous wording
These competitive factors could require us to conduct substantial new research and development activities to establish new product targets, which would be costly and time-consuming. These activities would adversely affect our ability to commercialize products and achieve revenue and profits.
Current wording
These competitive pressures may require substantial additional research and development to establish new product targets, increasing costs and timelines, and could adversely affect our ability to commercialize products and achieve revenue and profits.
Previous wording
The manufacture and sale of human therapeutic products in the U.S. and foreign jurisdictions are governed by a variety of statutes and regulations. These laws require approval of manufacturing facilities, controlled research and testing of products and government review and approval of a submission containing manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the safety and efficacy of the product for each use sought, including adherence to current cGMP during production and storage, and control of marketing activities, including advertising and labeling.
Current wording
The manufacture and sale of human therapeutic products in the U.S. and abroad are governed by numerous laws and regulations. These requirements include approval of manufacturing facilities, controlled preclinical and clinical testing, submission of extensive data on safety and efficacy, compliance with current Good Manufacturing Practices (cGMP) during production and storage, and oversight of marketing activities, including advertising and labeling.
Previous wording
If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.
Current wording
If we cannot keep pace with rapid technological changes or compete effectively, we may not operate profitably.
Previous wording
If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
Current wording
If clinical trials fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs, experience delays, or be unable to commercialize our product candidates.
Previous wording
We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent marketing approval of any of our product candidates, including:
Current wording
Unforeseen events in clinical trials could delay or prevent marketing approval of our product candidates.
Previous wording
A pharmaceutical product cannot be marketed in the U.S. or other countries until we have completed rigorous and extensive regulatory review processes, including approval of a brand name. Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured a formal trademark registration from the U.S. Patent and Trademark Office, or the USPTO. The FDA typically conducts a review of proposed product brand names, including an evaluation of potential for confusion with other product names. The FDA may also object to a product brand name if it believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed product brand names, we may be required to adopt an alternative brand name for our product candidates. If we adopt an alternative brand name, we will 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. 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.
Current wording
Any pharmaceutical product we develop cannot be marketed in the U.S. or other countries until it completes rigorous regulatory review processes, including approval of a brand name. All proposed brand names for our product candidates require FDA approval, regardless of whether we have obtained a trademark registration from the U.S. Patent and Trademark Office (USPTO).
Previous wording
We believe that our potential patient population is active on social media. Social media practices in the pharmaceutical and biotechnology industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, a product candidate, which could result in reporting obligations. In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us or our product candidates on any social networking website. In addition, our employees or third parties with whom we contract, such as our CROs or CMOs, may knowingly or inadvertently make use of social media in a manner that may give rise to liability, lead to the loss of trade secrets or other intellectual property or result in public exposure of personal information of our employees, clinical trial patients, customers and others or information regarding our product candidates or clinical trials. Any of these events could have a material adverse effect on our business, prospects, operating results and financial condition and could adversely affect the price of our common shares.
Current wording
Risk of Noncompliance with Regulatory Requirements
Previous wording
The development and commercialization of new drug products is highly competitive. We expect that we will face significant competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to our DN-TNF product platform, INKmune and any other of our product candidates that we may seek to develop or commercialize in the future. Specifically, due to the large unmet medical need, global demographics and relatively attractive reimbursement dynamics, the oncology market is fiercely competitive and there are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates for the treatment of cancer. Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective, have fewer or more tolerable side effects or are less costly than any product candidates that we are currently developing or that we may develop, which could render our product candidates obsolete and noncompetitive.
Current wording
The development and commercialization of new drug products is highly competitive. We expect to face significant competition from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide with respect to any product candidates we may develop or commercialize.
Previous wording
Although we plan to maintain general liability insurance, this insurance may not fully cover potential liabilities that we may incur. The cost of any product liability litigation or other proceeding, even if resolved in our favor, could be substantial. In addition, insurance coverage is becoming increasingly expensive. If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate, which could adversely affect our business, financial condition, results of operations and prospects.
Current wording
Although we plan to maintain general liability insurance, it may not fully cover potential claims, and insurance coverage is increasingly costly. If we are unable to obtain or maintain adequate insurance at reasonable cost, we could face significant financial exposure, which could materially and adversely affect our business, financial condition, results of operations, and prospects.
Previous wording
We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing this growth.
Current wording
We will need to expand our organization and may encounter challenges in managing this growth.
Previous wording
Current and future legislation may increase the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved for commercialization.
Current wording
Current and future healthcare reform measures and pricing regulations may increase the difficulty and cost of commercializing our product candidates and may materially reduce the prices we may obtain and the revenues we may generate if any of our product candidates are approved.
Previous wording
Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation.
Current wording
Our employees, principal investigators, consultants, and collaborators may engage in misconduct or fail to comply with regulatory requirements, which could result in liability and harm our reputation.
Previous wording
A cybersecurity incident and other technological disruptions could negatively affect our business and our relationships with customers.
Current wording
Cybersecurity Incidents and Other Technological Disruptions Could Negatively Affect Our Business and Customer Relationships
Previous wording
We use technology in substantially all aspects of our business operations. The widespread use of technology, including mobile devices, cloud computing, and the internet, gives rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information. Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectual property, including information relating to suppliers, private information about employees, and financial and strategic information about us and our business partners. If we fail to effectively assess and identify cybersecurity risks associated with the use of technology in our business operations, we may become increasingly vulnerable to such risks. Additionally, while we have implemented measures to prevent security breaches and cyber incidents, our preventative measures and incident response efforts may not be entirely effective. The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property, or interference with our information technology systems or the technology systems of third parties on which we rely, could result in business disruption, negative publicity, brand damage, violation of privacy laws, loss of customers, potential liability and competitive disadvantage.
Current wording
We rely on technology in substantially all aspects of our business operations. The widespread use of technology, including mobile devices, cloud computing, and the internet, exposes us to cybersecurity risks, such as security breaches, espionage, system disruptions, theft, and inadvertent disclosure of information.
Previous wording
Our success will depend, in part, on our ability to obtain patents, maintain trade secret protection and operate without infringing on the proprietary rights of third parties or having third parties circumvent our rights. We have filed and are actively pursuing a patent application for our product candidates. The patent positions of biotechnology, biopharmaceutical and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. Thus, there can be no assurance that our patent application will result in the issuance of a patent, that we will develop additional proprietary products that are patentable, that any patents issued to us will provide us with any competitive advantages or will not be challenged by any third parties, that the patents of others will not impede our ability to do business or that third parties will not be able to circumvent our patents. Furthermore, there can be no assurance that others will not independently develop similar products, duplicate any of our products not under patent protection, or, if patents are issued to us, design around the patented products we developed or will develop.
Current wording
Our success depends in part on our ability to obtain and maintain patents, protect trade secrets, and operate without infringing the proprietary rights of others. We have filed and are actively pursuing patent applications for our product candidates, but the patent positions of biotechnology, biopharmaceutical, and pharmaceutical companies are inherently uncertain and involve complex legal and factual questions. There can be no assurance that any patent application will result in the issuance of a patent, that patents issued to us will provide a competitive advantage, that patents issued to others will not impede our business, or that third parties will not circumvent any patents we obtain. Others may independently develop similar products or duplicate products not under patent protection, or design around our patents.
Previous wording
We may be required to obtain licenses from third parties to avoid infringing patents or other proprietary rights. No assurance can be given that any licenses required under any such patents or proprietary rights would be made available, if at all, on terms we find acceptable. If we do not obtain such licenses, we could encounter delays in the introduction of products or could find that the development, manufacture or sale of products requiring such licenses could be prohibited.
Current wording
We may need to obtain licenses from third parties to avoid infringing their patents or proprietary rights. There can be no assurance that such licenses would be available on acceptable terms, or at all. Failure to obtain necessary licenses could delay or prevent the development, manufacture, or commercialization of our product candidates.
Previous wording
Much of our know-how and technology may not be patentable. To protect our rights, we plan to require employees, consultants, advisors and collaborators to enter into confidentiality agreements. There can be no assurance, however, that these agreements will provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure. Further, our business may be adversely affected by competitors who independently develop competing technologies, especially if we obtain no, or only narrow, patent protection.
Current wording
Much of our proprietary know-how and technology may not be patentable. To protect our rights, we require employees, consultants, advisors, and collaborators to enter into confidentiality and nondisclosure agreements. However, these agreements may not provide meaningful protection in the event of unauthorized use or disclosure. Competitors may independently develop competing technologies, particularly if patent protection is narrow or unavailable, which could erode our competitive advantage and harm our business prospects.
Previous wording
Our success will depend, in part, on our ability to obtain patents and maintain adequate protection of our technologies and products. If we do not adequately protect our intellectual property, competitors may be able to use our technologies to produce and market drugs in direct competition with us and erode our competitive advantage. Some foreign countries lack rules and methods for defending intellectual property rights and do not protect proprietary rights to the same extent as the United States. Many companies have had difficulty protecting their proprietary rights in these foreign countries. We may not be able to prevent misappropriation of our proprietary rights.
Current wording
Our success depends in part on our ability to obtain and maintain adequate protection of our technologies and products. If we fail to adequately protect our intellectual property, competitors may be able to use our technologies to develop and market products that compete directly with us, eroding our competitive advantage. Some foreign countries lack robust rules or enforcement mechanisms for intellectual property, which may make it difficult to protect our proprietary rights internationally.
Previous wording
Further, our rights to current or future in-licensed patents and patent applications may be dependent, in part, on inter-institutional or other operating agreements between the joint owners of such in-licensed patents and patent applications. If one or more of such joint owners breaches such inter-institutional or operating agreements, our rights to such in-licensed patents and patent applications may be adversely affected. Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
Current wording
Our rights to current and future in-licensed patents may also depend on inter-institutional or operating agreements among joint owners. If any joint owner breaches such agreements, our rights to these patents and patent applications could be adversely affected. Any of these events could materially harm our competitive position, business, financial condition, results of operations, and prospects.
Previous wording
We are a party to a number of licenses that give us rights to third-party intellectual property that is necessary or useful to our business. To this end, we are dependent on our licenses with Xencor, Inc., Immune Ventures, LLC, the University of Pittsburgh and GOSH. Our success will depend in part on the ability of our licensors to obtain, maintain and enforce our licensed intellectual property. Our licensors may not successfully prosecute any applications for or maintain intellectual property to which we have licenses, may determine not to pursue litigation against other companies that are infringing such intellectual property, or may pursue such litigation less aggressively than we would. Without protection for the intellectual property we license, other companies might be able to offer similar products for sale, which could adversely affect our competitive business position and harm our business prospects. If we lose any of our right to use third-party intellectual property, it could adversely affect our ability to commercialize our technologies, products or services, as well as harm our competitive business position and our business prospects.
Current wording
We rely on licenses from third parties for certain intellectual property that is necessary or useful to our business. Our licensors include Xencor, Inc., Immune Ventures, LLC, the University of Pittsburgh, and GOSH.
Previous wording
On October 29, 2015, we entered into an exclusive license agreement with Immune Ventures, LLC (Immune Ventures). The license agreement relates to our natural killer program, INKmune. Immune Ventures is owned by our RJ Tesi, our CEO and Chairman of the Board of Directors, David Moss, our Chief Financial Officer and Treasurer and Mark Lowdell, our Chief Scientific Officer. Because our officers and directors also own Immune Ventures there may be an inherent conflict of interest which could result in unanticipated actions that adversely affect us.
Current wording
On October 29, 2015, we entered into an exclusive license agreement with Immune Ventures, LLC (“Immune Ventures”) for our natural killer cell program, INKmune. Immune Ventures is owned by our Chief Executive Officer and Treasurer, David Moss, our Chief Scientific Officer, Mark Lowdell, and our former CEO and former Chairman of the Board, RJ Tesi.
Previous wording
As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity and is costly, time-consuming and inherently uncertain. For example, on September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act included a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted and that may also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled to the patent. Third parties are allowed to submit prior art before the issuance of a patent by the USPTO, and may become involved in post-grant proceedings, including opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position.
Current wording
Our success depends heavily on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry is costly, complex, time-consuming, and uncertain.
Previous wording
We are a public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other federal securities laws, including compliance with the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”). The costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing audited reports to stockholders would cause our expenses to be higher than they would be if we remained privately held.
Current wording
As a public company, we are subject to the reporting and disclosure obligations of the Securities Exchange Act of 1934 (the “Exchange Act”) and other federal securities laws, including the Sarbanes-Oxley Act of 2002. Preparing and filing annual and quarterly reports, proxy statements, and other required disclosures with the SEC, as well as providing audited financial statements to stockholders, increases our operating expenses compared to private companies.
Previous wording
It may be time consuming, difficult and costly for us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act. We may need to hire additional financial reporting, internal controls and other finance personnel in order to develop and implement appropriate internal controls and reporting procedures.
Current wording
Developing, implementing, and maintaining the internal controls and reporting procedures required under the Sarbanes-Oxley Act may be time-consuming, complex, and costly. We may also need to hire additional personnel with expertise in financial reporting and internal controls to ensure compliance, which could further divert resources from other growth initiatives.
Previous wording
Our securities are not actively traded, and the bid and asked prices for our common stock may fluctuate widely. As a result, investors may find it difficult to dispose of, or to obtain accurate quotations of the price of, our securities. This severely limits the liquidity of the common stock and would likely reduce the market price of our common stock and hamper our ability to raise additional capital. There is a limited market for our securities. Accordingly, investors may therefore bear the economic risk of an investment in our securities for an indefinite period of time.
Current wording
Our securities are not actively traded, and the bid and asked prices for our common stock may fluctuate significantly. As a result, investors may experience difficulty selling their shares or obtaining accurate quotations for the price of our securities. This limited trading activity reduces liquidity, may adversely affect the market price of our common stock, and could hamper our ability to raise additional capital. Given the limited market for our securities, investors may bear the economic risk of an investment in our shares for an indefinite period of time.
Previous wording
Additional stock offerings in the future may dilute your percentage ownership of our company.
Current wording
Additional stock offerings in the future may dilute your ownership interest in our company.
Previous wording
Given our plans and expectations that we may need additional capital and personnel, we may need to issue additional shares of common stock or securities convertible or exercisable for shares of common stock, including convertible preferred stock, convertible notes, stock options or warrants. The issuance of additional securities in the future will dilute the percentage ownership of then current stockholders.
Current wording
To support our growth plans and capital requirements, we may need to issue additional shares of common stock or securities convertible or exercisable for common stock, including convertible preferred stock, convertible notes, stock options, or warrants. Any future issuance of such securities would dilute the ownership percentage of current stockholders.
Previous wording
Our management is currently required to report on the effectiveness of our internal control over financial reporting. However, as a smaller reporting company and a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 for as long as we are not deemed an “accelerated filer” or “large accelerated filer.” The rules governing the standards that must be met for our management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.
Current wording
Management is required to assess and report on the effectiveness of our internal control over financial reporting. As a smaller reporting company and a non-accelerated filer, our independent registered public accounting firm is not required to attest to the effectiveness of our internal controls under Section 404 for as long as we do not qualify as an “accelerated filer” or “large accelerated filer.” The standards for assessing internal controls are complex and require substantial documentation, testing, and, if necessary, remediation.
Previous wording
In connection with the implementation of the necessary procedures and practices related to internal control over financial reporting, we may identify deficiencies or material weaknesses that we may not be able to remediate in time to meet the deadline imposed by the Sarbanes-Oxley Act for compliance with the requirements of Section 404. In addition, we may encounter problems or delays in completing the implementation of any requested improvements and receiving a favorable attestation in connection with the attestation provided by our independent registered public accounting firm. Failure to achieve and maintain an effective internal control environment could have a material adverse effect on our business, financial condition and results of operations and could limit our ability to report our financial results accurately and in a timely manner.
Current wording
In implementing the necessary procedures, we may identify deficiencies or material weaknesses that we cannot remediate in time to meet Section 404 deadlines. We may also face delays in completing improvements or obtaining a favorable attestation from our independent registered public accounting firm. Failure to establish and maintain effective internal controls could materially harm our business, financial condition, and results of operations, and could impair our ability to report financial results accurately and on a timely basis.
Previous wording
Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition of us difficult.
Current wording
Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition more difficult.
Previous wording
We have a stockholder rights plan that may have the effect of discouraging unsolicited takeover proposals. Specifically, the rights issued under the stockholder rights plan could cause significant dilution to a person or group that attempts to acquire us on terms not approved in advance by our board of directors. The rights plan is not intended to prevent a takeover, and we believe it will enable all our stockholders to realize the full potential value of their investment in the Company and protect the Company and its stockholders from efforts to obtain control of the Company that are inconsistent with the best interests of the Company and its stockholders. The rights under the plan will expire on December 30, 2025, subject to a possible earlier expiration to the extent provided in the stockholder rights plan, unless extended.
Current wording
The plan is not intended to prevent a takeover outright. We believe it helps stockholders realize the full potential value of their investment and protects the Company and its stockholders from attempts to gain control in ways inconsistent with their best interests.
Previous wording
Sales of our common shares by our employees, including our executive officers, could cause the trading price of our common shares to fall or prevent it from increasing for numerous reasons, and sales by such persons could be viewed negatively by other investors.
Current wording
Sales of our common stock by employees, including executive officers, could cause the trading price of our common stock to decline and may be viewed negatively by investors.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Management intends to pursue additional funding and implement its strategic plan to support continuation of the Company, but there can be no assurance that these efforts will be successful. The opinion of our independent registered public accounting firm on our audited financial statements for the year ended December 31, 2025, includes an explanatory paragraph regarding this substantial doubt.
Current report — wording carried from elsewhere
Our business involves the storage and transmission of sensitive and/or confidential information and intellectual property, including data relating to suppliers, private employee information, and financial and strategic information about us and our business partners. If we fail to adequately assess and manage cybersecurity risks, we may become increasingly vulnerable to such threats.
Current report — wording carried from elsewhere
Although we have implemented measures to prevent security breaches and cyber incidents, these measures and our incident response efforts may not be entirely effective. Theft, destruction, loss, misappropriation, or unauthorized disclosure of sensitive or confidential information, or interference with our information technology systems—or the systems of third parties on which we rely—could result in business disruption, negative publicity, reputational harm, violations of privacy laws, loss of customers, potential liability, and competitive disadvantage.
Current report — wording carried from elsewhere
We believe that our potential patient population is active on social media. Social media practices in the pharmaceutical and biotechnology industries are evolving, creating uncertainty and risks of noncompliance with applicable regulations. For example, patients may post comments regarding the effectiveness of, or adverse experiences with, a product candidate, which could trigger reporting obligations.
Current report — wording carried from elsewhere
Any of these events could materially harm our business, prospects, operating results, and financial condition, and could adversely affect the price of our common shares.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We may fail to comply with regulatory requirements*.*