BBLGW

Risk Factor Summary The following is a summary of the principal risks that could materially adversely affect our business operations, industry and financial results. ● Risks Related to Our Financial Position and Capital Needs ○ We have a limited operating history. ○ Our long-term capital requirements are subject to numerous risks. ○ Our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern. ○ We have incurred losses since inception and we expect our operating expenses to increase in the foreseeable future. ○ We face a number of risks associated with the incurrence of substantial debt which could adversely affect our financial condition. ● Risks Related to the Development and Regulatory Approval of our Product Candidates ○ Our product candidates are at an early stage of development and may not be successfully developed or commercialized. ○ FDA regulation is costly and time consuming, which may delay or prevent us from commercializing our product candidates. ○ Any product candidate we advance into clinical trials may cause unacceptable adverse events. ○ Suspensions or delays in the commencement and completion of clinical testing could result in increased costs to us and delay or prevent our ability to complete development of that product or generate product revenues. ○ We have limited resources to pursue product candidates and indications. ○ We may find it difficult to enroll subjects in our clinical trials. ○ Any success in preclinical studies and early clinical trials does not predict the success of later trials; our product candidates may not have favorable results or receive regulatory approval. ○ Risks associated with operating in foreign countries could negatively affect our product development. ○ We may be unable to obtain regulatory approval in non-U.S. jurisdictions. ○ Even if our lead product candidate received regulatory approval, it may still face future development and regulatory difficulties. ○ The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results. ● Risks Related to Our Dependence on Third Parties ○ We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants. ○ We rely on third parties to supply raw materials for our product candidates and to conduct our preclinical and clinical trials. ○ We depend on third parties, including researchers, who are not under our control. ○ Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses. ○ Our employees may engage in misconduct or other improper activities, which could cause significant liability for us and harm our reputation. ● Risks Related to our Intellectual Property ○ Our ability to compete may be limited or eliminated if we are not able to protect our products. ○ The terms of our patents may not be sufficient to effectively protect our product candidates and business. ○ We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits. ○ We may not be able to obtain patent protection to protect our product candidates and technology. ○ We must comply with our obligations under license agreements or risk losing rights that are important to our business. ○ We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates, and force us to pay damages. ○ We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets. ○ Our intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal. ○ If we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation, we may suffer competitive harm. ○ We may incur substantial costs in legal proceedings or other actions relating to intellectual property rights. ○ If we are unable to protect our intellectual property rights, our competitors may develop and market products with similar features that may reduce demand for our potential products. ● Risks Relating to Commercializing of our Lead Product Candidate and Future Product Candidates ○ Our commercial success and ability to generate revenue depends upon attaining significant market acceptance of our lead product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and treatment centers. ○ Our product candidates, if approved, may not be covered or adequately reimbursed by third-party payors. ○ Healthcare legislative measures aimed at reducing healthcare costs may negatively impact our business. ● Risks Related to Our Business Operations ○ We operate in a highly competitive environment. ○ Our future success depends on the performance and continued service of our officers and directors. ○ Competitors could develop and/or gain FDA approval of our products for a different indication. ○ We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. ○ The impact of public health crises is difficult to predict and could materially and adversely affect our business and results of operations. ○ Significant disruptions of information technology systems, computer system failures or breaches of information security could adversely affect our business. ○ We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth. ○ Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. ○ Our ability to use net operating losses to offset future taxable income may be subject to limitations. ● Risks Related to Healthcare Compliance Regulations ○ If we or they are unable to comply with healthcare laws and regulations, we may become subject to civil and criminal investigations and proceedings that could have a material adverse effect on our business, financial condition and prospects. ○ The application of privacy provisions of HIPAA is uncertain. ● Risks Related to Owning our Common Stock ○ The price of our common stock may fluctuate substantially. ○ Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall. ○ We may be unable to comply with the continued listing standards of the Nasdaq Stock Market LLC (“Nasdaq”). ○ We do not intend to pay cash dividends on our shares of common stock. ○ Our President and Chief Executive Officer and Chief Financial Officer have contractual rights to participate in future financings. ○ If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares. ● General Risk Factors ○ If we are unable to establish appropriate internal financial reporting controls and procedures, it could cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our common stock. ○ We may be at risk of securities class action litigation. ○ Market and economic conditions may negatively impact our business, financial condition and share price. ○ If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline. ○ Our governing documents and Delaware law have anti-takeover effects that could discourage, delay or prevent a change in control. ○ Provisions of our warrants could discourage an acquisition of us by a third party. ○ Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.
During the year ended December 31, 2025, we incurred a net loss of $3.1 million and used net cash in operating activities of $2.7 million.
Our available cash is expected to fund our operations into the fourth quarter of 2026.
In addition, our independent registered public accounting firm, in its audit report to the financial statements as of and for the year ended December 31, 2025, expressed substantial doubt about our ability to continue as a going concern.
We have no significant operating history and since inception to December 31, 2025 have incurred accumulated losses of approximately $88.1 million.
The commencement of clinical trials can be delayed for a variety of reasons, including delays in: ● obtaining regulatory clearance to commence a clinical trial; ● identifying, recruiting and training suitable clinical investigators; ● reaching agreement on acceptable terms with prospective clinical research organizations, and trial sites, the terms of which can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different clinical research organizations and trial sites; ● obtaining sufficient quantities of a product candidate for use in clinical trials; ● obtaining an IRB or ethics committee approval to conduct a clinical trial at a prospective site; ● identifying, recruiting and enrolling subjects to participate in a clinical trial; ● retaining subjects who have initiated a clinical trial but may withdraw due to adverse events from the therapy, insufficient efficacy, fatigue with the clinical trial process or personal issues: and ● issues of relationship between clinical trials in non-U.S. countries, such as our first-in-man pilot clinical trial being conducted in Australia, and FDA approval.
We may find it difficult to enroll subjects in our clinical trials which could delay or prevent the start of clinical trials for our product candidate.
Identifying and qualifying subjects to participate in clinical trials of our product candidate is essential to our success.
The timing of our clinical trials depends in part on the rate at which we can recruit subjects to participate in clinical trials of our product candidate, and we may experience delays in our clinical trials if we encounter difficulties in enrollment.
Many factors may affect our ability to identify, enroll and maintain qualified subjects, including the following: ● eligibility criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials; ● design of the clinical trial; ● size and nature of the patient population; ● subjects’ perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to other available therapies; ● the availability and effectiveness of competing therapies and clinical trials; ● pendency of other trials underway in the same patient population; ● willingness of physicians to participate in our planned clinical trials; ● severity of the disease under investigation; ● proximity of subjects to clinical sites; ● subjects who do not complete the trials for personal reasons; and ● issues with Contract Research Organizations (“CROs”) and/or with other vendors that handle our clinical trials.
Even if we are able to enroll a sufficient number of subjects in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidate may increase and the completion of our trials may be delayed or our trials could become too expensive to complete.
Success in preclinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate the effectiveness and safety of a device.
Despite the results reported in earlier preclinical studies for our lead product candidate, we do not know whether the clinical trials we may conduct will demonstrate adequate effectiveness and safety to result in regulatory approval to market our product candidate for a particular indication, in any particular jurisdiction.
Effectiveness data from prospectively designed trials may differ significantly from those obtained from retrospective subgroup analyses.
To date, long-term safety and effectiveness have not yet been demonstrated in clinical trials for any of our diagnostic product candidates.
We have filed a patent application with the USPTO regarding proprietary compositions of rhNELL-1 polypeptide for treating bone conditions.
There can be no assurance that the USPTO will approve our patent application.
If our patent application is not approved by the USPTO, we may not be able to protect our product candidates.
If a third party has also filed a patent application relating to an invention claimed by us or one or more of our licensors, we may be required to participate in an interference or derivation proceeding declared or instituted by the USPTO, which could result in substantial uncertainties and cost for us, even if the eventual outcome is favorable to us.
Market acceptance of any product candidates for which we receive approval depends on a number of factors, including: ● receipt of regulatory approval of marketing claims for the uses that we are developing; ● the effectiveness and safety of such product candidates as demonstrated in clinical trials; ● the clinical indications and patient populations for which the product candidate is approved; ● acceptance by physicians, major treatment centers and patients of the product candidates as a safe and effective treatment; ● the potential and perceived advantages of product candidates over alternative treatments; ● relative convenience and ease of administration; ● the safety of product candidates seen in a broader patient group, including our use outside the approved indications; ● any restrictions on use together with other medications; ● the prevalence and severity of any side effects; ● product labeling or product insert requirements of the FDA or other regulatory authorities; ● the timing of market introduction of our product as well as competitive products; ● the development of manufacturing and distribution processes for commercial scale manufacturing for our current product candidate and any future product candidates; ● the cost of treatment in relation to alternative treatments; ● the availability of coverage and adequate reimbursement from government and third-party payors, such as insurance companies, health maintenance organizations and other health plan administrators; ● our ability to attract corporate partners, including medical device, biotechnology and pharmaceutical companies, to assist in commercializing our proposed products; and ● the effectiveness of our sales and marketing efforts and those of our collaborators.
We may face competition with respect to product effectiveness and safety, ease of use and adaptability to various modes of administration, acceptance by physicians, the timing and scope of regulatory approvals, availability of resources, reimbursement coverage, price and patent position, including the potentially dominant patent positions of others.
The ultimate impact of a public health crisis on our business operations will depend on, among other things, the severity and length of the health crisis, the duration, effectiveness and extent of the mitigation measures and actions designed to contain the outbreak, the emergence, contagiousness and threat of new and different strains of the disease, the availability and effectiveness of vaccines and effective treatments, public acceptance of vaccines and treatments for the disease, if any, as well as the resulting economic conditions and how quickly and to what extent normal economic and operating conditions resume, all of which are highly uncertain.
As of December 31, 2025, we had federal net operating loss, or NOLs, carryforwards of approximately $46,140,000.
Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section are: ● our ability to meet the Nasdaq listing requirements; ● volatility and limitations in trading volumes of our shares of common stock; ● our ability to obtain financing to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business activities; ● the timing and success of our clinical trials and introduction of products to the market; ● changes in the development status of our product candidate; ● any delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical and clinical trials; ● safety concerns related to the use of our product candidate; ● changes in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders; ● our cash position; ● announcements and events surrounding financing efforts, including debt and equity securities; ● changes in general economic, political and market conditions in or any of the regions in which we conduct our business; ● analyst research reports, recommendations and changes in recommendations, price targets, and withdrawals of coverage; ● departures and additions of key personnel; ● disputes and litigation; ● changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and ● other events or factors, many of which may be out of our control.
Future sales and issuances of our common stock or equity-linked securities could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
Nasdaq also recently proposed a rule that, if approved, would require companies to maintain a minimum market value of listed securities (“MVLS”) of at least $5 million.
If we are unable to satisfy these standards, or if Nasdaq’s proposed rule is approved and we fail to maintain a MVLS of at least $5 million for 30 consecutive trading days, we could be subject to delisting, which would have a negative effect on the price of our common stock, impair your ability to sell or purchase our common stock or warrants when you wish to do so, and potentially cause you to lose the value of your investment in us.
If we are delisted from Nasdaq, our common stock may be eligible for trading on an over-the-counter market.
If we are not able to obtain a listing on another stock exchange or quotation service for our common stock, it may be extremely difficult or impossible for stockholders to sell their shares of common stock.
Moreover, if we are delisted from Nasdaq, but obtain a substitute listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq.
As a result of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our common stock would likely be significantly adversely affected.
A delisting of our common stock from Nasdaq could also adversely affect our ability to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners.
As of December 31, 2025, management assessed the effectiveness of our internal controls over financial reporting, and based on that evaluation, they concluded that our internal controls and procedures were effective.
Our Amended and Restated Certificate of Incorporation (“Certificate of Incorporation”) and our Amended and Restated Bylaws (“Bylaws”), and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Gone since FY2024

Risk Factor Summary The following is a summary of the principal risks that could materially adversely affect our business operations, industry and financial results. ● Risks Related to Our Financial Position and Capital Needs ○ We have a limited operating history. ○ Our long-term capital requirements are subject to numerous risks. ○ Our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern. ○ We have incurred losses since inception and we expect our operating expenses to increase in the foreseeable future. ○ We face a number of risks associated with the incurrence of substantial debt which could adversely affect our financial condition. ● Risks Related to the Development and Regulatory Approval of our Product Candidates ○ Our product candidates are at an early stage of development and may not be successfully developed or commercialized. ○ FDA regulation is costly and time consuming, which may delay or prevent us from commercializing our product candidates. ○ Any product candidate we advance into clinical trials may cause unacceptable adverse events. ○ Suspensions or delays in the commencement and completion of clinical testing could result in increased costs to us and delay or prevent our ability to complete development of that product or generate product revenues. ○ We have limited resources to pursue product candidates and indications. ○ We may find it difficult to enroll patients in our clinical trials. ○ Any success in preclinical studies and early clinical trials does not predict the success of later trials; our product candidates may not have favorable results or receive regulatory approval. ○ Risks associated with operating in foreign countries could negatively affect our product development. ○ We may be unable to obtain regulatory approval in non-U.S. jurisdictions. ○ Even if our lead product candidate received regulatory approval, it may still face future development and regulatory difficulties. ○ The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results. ● Risks Related to Our Dependence on Third Parties ○ We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants. ○ We rely on third parties to supply raw materials for our product candidates and to conduct our preclinical and clinical trials. ○ We depend on third parties, including researchers, who are not under our control. ○ Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses. ○ Our employees may engage in misconduct or other improper activities, which could cause significant liability for us and harm our reputation. ● Risks Related to our Intellectual Property ○ Our ability to compete may be limited or eliminated if we are not able to protect our products. ○ We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits. ○ We may not be able to obtain patent protection to protect our product candidates and technology. ○ We must comply with our obligations under license agreements or risk losing rights that are important to our business. ○ We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates, and force us to pay damages. ○ We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets. ○ The terms of our patents may not be sufficient to effectively protect our product candidates and business. ○ Our intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal. ○ If we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation, we may suffer competitive harm. ○ We may incur substantial costs in legal proceedings or other actions relating to intellectual property rights. ○ If we are unable to protect our intellectual property rights, our competitors may develop and market products with similar features that may reduce demand for our potential products. ● Risks Relating to Commercializing of our Lead Product Candidate and Future Product Candidates ○ Our commercial success and ability to generate revenue depends upon attaining significant market acceptance of our lead product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and treatment centers. ○ Our product candidates, if approved, may not be covered or adequately reimbursed by third-party payors. ○ Healthcare legislative measures aimed at reducing healthcare costs may negatively impact our business. ● Risks Related to Our Business Operations ○ We operate in a highly competitive environment. ○ Our future success depends on the performance and continued service of our officers and directors. ○ Competitors could develop and/or gain FDA approval of our products for a different indication. ○ We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. ○ The impact of public health crises is difficult to predict and could materially and adversely affect our business and results of operations. ○ Significant disruptions of information technology systems, computer system failures or breaches of information security could adversely affect our business. ○ We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth. ○ Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. ○ Our ability to use net operating losses to offset future taxable income may be subject to limitations. ● Risks Related to Healthcare Compliance Regulations ○ If we or they are unable to comply with healthcare laws and regulations, we may become subject to civil and criminal investigations and proceedings that could have a material adverse effect on our business, financial condition and prospects. ○ The application of privacy provisions of HIPAA is uncertain. ● Risks Related to Owning our Common Stock ○ The price of our common stock may fluctuate substantially. ○ Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall. ○ We may be unable to comply with the continued listing standards of the Nasdaq Stock Market LLC (“Nasdaq”). ○ We do not intend to pay cash dividends on our shares of common stock. ○ Our President and Chief Executive Officer and Chief Financial Officer have contractual rights to participate in future financings. ○ If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares. ● General Risk Factors ○ If we are unable to establish appropriate internal financial reporting controls and procedures, it could cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our common stock. ○ We may be at risk of securities class action litigation. ○ Market and economic conditions may negatively impact our business, financial condition and share price. ○ If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline. ○ Our governing documents and Delaware law have anti-takeover effects that could discourage, delay or prevent a change in control. ○ Provisions of our warrants could discourage an acquisition of us by a third party. ○ Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.
During the year ended December 31, 2024, we incurred a net loss of $4.1 million and used net cash in operating activities of $4.1 million.
Our available cash is expected to fund our operations up to the fourth quarter of 2025.
In addition, our independent registered public accounting firm, in its audit report to the financial statements as of and for the year ended December 31, 2024, expressed substantial doubt about our ability to continue as a going concern.
We have no significant operating history and since inception to December 31, 2024 have incurred accumulated losses of approximately $85.0 million.
The commencement of clinical trials can be delayed for a variety of reasons, including delays in: ● obtaining regulatory clearance to commence a clinical trial; ● identifying, recruiting and training suitable clinical investigators; ● reaching agreement on acceptable terms with prospective clinical research organizations, and trial sites, the terms of which can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different clinical research organizations and trial sites; ● obtaining sufficient quantities of a product candidate for use in clinical trials; ● obtaining an IRB or ethics committee approval to conduct a clinical trial at a prospective site; ● identifying, recruiting and enrolling patients to participate in a clinical trial; ● retaining patients who have initiated a clinical trial but may withdraw due to adverse events from the therapy, insufficient efficacy, fatigue with the clinical trial process or personal issues: and ● issues of relationship between clinical trials in non-U.S. countries, such as our first-in-man pilot clinical trial being conducted in Australia, and FDA approval.
We may find it difficult to enroll patients in our clinical trials which could delay or prevent the start of clinical trials for our product candidate.
Identifying and qualifying patients to participate in clinical trials of our product candidate is essential to our success.
The timing of our clinical trials depends in part on the rate at which we can recruit patients to participate in clinical trials of our product candidate, and we may experience delays in our clinical trials if we encounter difficulties in enrollment.
Many factors may affect our ability to identify, enroll and maintain qualified patients, including the following: ● eligibility criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials; ● design of the clinical trial; ● size and nature of the patient population; ● patients’ perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to other available therapies; ● the availability and efficacy of competing therapies and clinical trials; ● pendency of other trials underway in the same patient population; ● willingness of physicians to participate in our planned clinical trials; ● severity of the disease under investigation; ● proximity of patients to clinical sites; ● patients who do not complete the trials for personal reasons; and ● issues with Contract Research Organizations (“CROs”) and/or with other vendors that handle our clinical trials.
Even if we are able to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidate may increase and the completion of our trials may be delayed or our trials could become too expensive to complete.
Success in preclinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of a device.
Despite the results reported in earlier preclinical studies for our lead product candidate, we do not know whether the clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our product candidate for a particular indication, in any particular jurisdiction.
Efficacy data from prospectively designed trials may differ significantly from those obtained from retrospective subgroup analyses.
To date, long-term safety and efficacy have not yet been demonstrated in clinical trials for any of our diagnostic product candidates.
If a third party has also filed a patent application relating to an invention claimed by us or one or more of our licensors, we may be required to participate in an interference or derivation proceeding declared or instituted by the United States Patent and Trademark Office (the “USPTO”), which could result in substantial uncertainties and cost for us, even if the eventual outcome is favorable to us.
Market acceptance of any product candidates for which we receive approval depends on a number of factors, including: ● receipt of regulatory approval of marketing claims for the uses that we are developing; ● the efficacy and safety of such product candidates as demonstrated in clinical trials; ● the clinical indications and patient populations for which the product candidate is approved; ● acceptance by physicians, major treatment centers and patients of the product candidates as a safe and effective treatment; ● the potential and perceived advantages of product candidates over alternative treatments; ● relative convenience and ease of administration; ● the safety of product candidates seen in a broader patient group, including our use outside the approved indications; ● any restrictions on use together with other medications; ● the prevalence and severity of any side effects; ● product labeling or product insert requirements of the FDA or other regulatory authorities; ● the timing of market introduction of our product as well as competitive products; ● the development of manufacturing and distribution processes for commercial scale manufacturing for our current product candidate and any future product candidates; ● the cost of treatment in relation to alternative treatments; ● the availability of coverage and adequate reimbursement from government and third-party payors, such as insurance companies, health maintenance organizations and other health plan administrators; ● our ability to attract corporate partners, including medical device, biotechnology and pharmaceutical companies, to assist in commercializing our proposed products; and ● the effectiveness of our sales and marketing efforts and those of our collaborators.
We may face competition with respect to product efficacy and safety, ease of use and adaptability to various modes of administration, acceptance by physicians, the timing and scope of regulatory approvals, availability of resources, reimbursement coverage, price and patent position, including the potentially dominant patent positions of others.
The ultimate impact of a public health crisis on our business operations will depend on, among other things, the severity and length of the health crisis, the duration, effectiveness and extent of the mitigation measures and actions designed to contain the outbreak, the emergence, contagiousness and threat of new and different strains of the disease, the availability and efficacy of vaccines and effective treatments, public acceptance of vaccines and treatments for the disease, if any, as well as the resulting economic conditions and how quickly and to what extent normal economic and operating conditions resume, all of which are highly uncertain.
As of December 31, 2024, we had federal net operating loss, or NOLs, carryforwards of approximately $ 34,585,000 .
Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section are: ● our ability to meet the Nasdaq listing requirements; ● volatility and limitations in trading volumes of our shares of common stock; ● our ability to obtain financing to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business activities; ● the timing and success of our clinical trials and introduction of products to the market; ● changes in the development status of our product candidate; ● any delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical and clinical trials; ● safety concerns related to the use of our product candidate; ● changes in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders; ● our cash position; ● announcements and events surrounding financing efforts, including debt and equity securities; ● changes in general economic, political and market conditions in or any of the regions in which we conduct our business; ● analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage; ● departures and additions of key personnel; ● disputes and litigation; ● changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and ● other events or factors, many of which may be out of our control.
Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
If we are unable to satisfy these standards, we could be subject to delisting, which would have a negative effect on the price of our common stock, impair your ability to sell or purchase our common stock or warrants when you wish to do so, and potentially cause you to lose the value of your investment in us.
If the Company is delisted from Nasdaq, its common stock may be eligible for trading on an over-the-counter market.
If the Company is not able to obtain a listing on another stock exchange or quotation service for its common stock, it may be extremely difficult or impossible for stockholders to sell their shares of common stock.
Moreover, if the Company is delisted from Nasdaq, but obtains a substitute listing for its common stock, it will likely be on a market with less liquidity, and therefore experience potentially more price volatility than experienced on Nasdaq.
As a result of these factors, if the Company’s common stock is delisted from Nasdaq, the value and liquidity of the Company’s common stock would likely be significantly adversely affected.
A delisting of the Company’s common stock from Nasdaq could also adversely affect the Company’s ability to obtain financing for its operations and/or result in a loss of confidence by investors, employees and/or business partners.
As of December 31, 2024, management assessed the effectiveness of our internal controls over financial reporting, and based on that evaluation, they concluded that our internal controls and procedures were effective.
Our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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