CNSP

Risks Related to the Company’s Business and Industry Our future success depends on our ability to identify, acquire or license new drug candidates, and we may not be successful in doing so.
A key element of our business strategy is to expand our pipeline by acquiring or licensing rights to additional drug candidates from third parties.
The success of this strategy depends on our ability to identify, evaluate and acquire or license suitable drug candidates on commercially reasonable terms.
Competition for attractive drug candidates is intense, and many of our competitors have substantially greater financial, technical and human resources than we do, which may limit our ability to identify and acquire promising therapeutic assets.
We may not be able to identify drug candidates that meet our strategic criteria or that we believe have sufficient probability of clinical and commercial success.
Even if we identify promising candidates, we may not be able to negotiate acquisition or licensing terms that are acceptable to us, or we may be outbid by competitors with greater resources.
Additionally, due diligence evaluations of potential acquisition or licensing targets may not reveal all relevant risks, liabilities or issues, and we may acquire or license drug candidates that ultimately prove to be less valuable or more problematic than anticipated.
If we are unable to successfully identify and acquire or license new drug candidates, our pipeline may remain limited, which could materially and adversely affect our business, financial condition, results of operations and prospects.
Any drug candidates we acquire or license may require significant additional development, and there can be no assurance that such candidates will prove to be safe, effective or commercially viable.
Even if we are successful in acquiring or licensing new drug candidates, such candidates will likely require substantial additional investment and development before they could potentially receive regulatory approval and be commercialized.
Drug development is inherently risky and uncertain.
Many drug candidates fail to demonstrate adequate safety or efficacy in clinical trials, and there can be no assurance that any drug candidate we acquire or license will be successfully developed, receive regulatory approval or achieve commercial success.
In addition, drug candidates we acquire or license may have unknown liabilities, intellectual property defects or other issues that were not identified during our due diligence evaluation.
We may also face challenges integrating newly acquired or licensed assets into our organization and development programs.
Any of these factors could result in significant delays, increased costs or failure of our development programs, which could materially and adversely affect our business, financial condition and results of operations.
We may not have access to sufficient capital to pursue acquisition or licensing opportunities, which could limit our ability to expand our pipeline.
Acquiring or licensing drug candidates often requires significant upfront payments, milestone payments, royalty obligations and ongoing development costs.
As a clinical-stage company with limited financial resources, we may not have access to sufficient capital to pursue attractive acquisition or licensing opportunities when they arise.
Our ability to raise additional capital may be limited by market conditions, investor sentiment, our financial performance and other factors beyond our control.
If we are unable to raise sufficient capital on acceptable terms, we may be forced to forgo attractive acquisition or licensing opportunities, reduce the scope of our business development activities or delay or discontinue development of drug candidates we have already acquired.
Any of these outcomes could limit our ability to expand our pipeline and materially harm our business and prospects.
We will require substantial funding to execute our new corporate strategy, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
We have primarily used the proceeds from our previous financings to, among other uses, advance Berubicin through clinical development.
In addition, we used proceeds from our previous financings to obtain the rights to TPI 287.
Under our new corporate strategy, we will seek to obtain rights to new investigational product candidates, which could include upfront cash payments, milestone payments, royalties, issuing shares of our stock, assuming liabilities or a combination of any of these considerations.
It is possible that any of these considerations may be greater than our currently available resources and require that we undertake additional financings or issue additional equity or debt securities.
We are also evaluating TPI 287 and Berubicin as we explore the potential out-licensing of these programs but there can be no assurances that we will be able to successfully complete an out-licensing transaction.
Potential licensors may require additional preclinical or clinical data, CMC data, intellectual property or other considerations before undertaking a transaction.
We may determine that the generation of additional preclinical or clinical data, CMC data or new intellectual property is not feasible or cost prohibitive relative to potential financial considerations we could potentially receive and we may instead elect to sunset TPI 287, Berubicin or both programs.
We will continue to require substantial additional capital to execute in-licensing to expand our pipeline, clinical development and commercialization activities.
We estimate that we have sufficient capital to fund operations into the third quarter of 2026.
The amount and timing of our future funding requirements will depend on many factors, including but not limited to: · the cost to obtain the rights to new assets; · whether any clinical trials will be completed on a timely basis; · the progress, costs, results of and timing of preclinical studies or clinical trials for new assets; · the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; · the costs associated with securing and establishing commercialization and manufacturing capabilities; · market acceptance of our product candidates; · our ability to out-license TPI 287 or Berubicin; · the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; · our ability to maintain, expand and enforce the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; · our need and ability to hire additional management and scientific and medical personnel; · the effect of competing drug candidates and new product approvals; · our need to implement additional internal systems and infrastructure, including quality, financial and reporting systems; and · the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
If we are unable to obtain funding on a timely basis, we may not be able to execute on our in-licensing focused strategy.
Our auditors have indicated in their report on our financial statements for the fiscal year ended December 31, 2025 that conditions exist that raise substantial doubt about our ability to continue as a going concern due to our recurring losses from operations.
To date, we have had no revenues and have relied on equity-based financing from the sale of securities in public and private placements.
As of December 31, 2025 the Company has incurred an accumulated deficit of $100,275,268 since inception and had not yet generated any revenue from operations.
Additionally, management anticipates that its cash on hand as of December 31, 2025, combined with capital raised subsequent to December 31, 2025, is sufficient to fund its planned operations within one year after the date that the financial statements are issued.
We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we in-license and initiate development of and seek regulatory approvals for new assets or programs, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our continuing product development efforts.
If any of our future drug candidates fail in clinical trials or do not gain regulatory approval, or if our drug candidates do not achieve market acceptance, we may never become profitable.
Our operations to date have been limited to acquiring our technology portfolio, preparing for and conducting our clinical trials.

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Gone since FY2024

Risks Related to the Company’s Business and Industry We will require substantial funding to complete our clinical trials, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
We have used the proceeds from our previous financings to, among other uses, advance Berubicin through clinical development.
We will require substantial additional future capital in the near term in order to complete clinical development and commercialize TPI 287 and Berubicin.
If the FDA requires that we perform additional nonclinical studies or clinical trials, our expenses would further increase beyond what we currently expect and the anticipated timing of any potential approval of TPI 287 and Berubicin would likely be delayed.
Further, there can be no assurance that the costs we will need to incur to obtain regulatory approval of TPI 287 and Berubicin will not increase.
We will continue to require substantial additional capital to continue our clinical development and commercialization activities.
We estimate that we have sufficient capital to take us into the first quarter of 2026, a period during which we would likely expect to initiate a trial of TPI 287, as well as complete the Phase 2 Berubicin trial including its further analysis.
In addition, we have working capital to fund our operations during this period (with such operations estimated at $4.5 to $5.0 million per annum).
We do not currently have a firm trial design for TPI 287 so estimates of development cost are not available, however, regardless of trial design, the cost of bringing TPI 287 to regulatory approval for marketing will require significant additional financing.
The timing and costs of clinical trials are difficult to predict and as such the foregoing estimates may prove to be inaccurate.
The amount and timing of our future funding requirements will depend on many factors, including but not limited to: · whether our plan for clinical trials will be completed on a timely basis; · whether we are successful in obtaining an accelerated approval pathway with the FDA related to Berubicin; · the progress, costs, results of and timing of our clinical trials for TPI 287 and Berubicin; · the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; · the costs associated with securing and establishing commercialization and manufacturing capabilities; · market acceptance of our product candidates; · the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies; · our ability to maintain, expand and enforce the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; · our need and ability to hire additional management and scientific and medical personnel; · the effect of competing drug candidates and new product approvals; · our need to implement additional internal systems and infrastructure, including financial and reporting systems; and · the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or development programs.
Our auditors have indicated in their report on our financial statements for the fiscal year ended December 31, 2024 that conditions exist that raise substantial doubt about our ability to continue as a going concern due to our recurring losses from operations.
Our success depends greatly on the success of TPI 287 and Berubicin’s development for the treatment of glioblastoma, and our pipeline of product candidates beyond this lead indication is extremely early stage and limited.
Other than TPI 287 and Berubicin, we do not have any other clinical-stage drug candidates in our portfolio.
As such, we are dependent on the success of TPI 287 and Berubicin in the near term.
We cannot provide you any assurance that we will be able to successfully advance TPI 287 and Berubicin through the development process or that we will be able to secure other additional assets for development.
To date, we have had no revenues and have relied on equity-based financing from the sale of securities in public and private placements and the issuance of convertible notes.
As of December 31, 2024 the Company has incurred an accumulated deficit of $84,424,704 since inception and had not yet generated any revenue from operations.
Additionally, management anticipates that its cash on hand as of December 31, 2024, combined with capital raised subsequent to December 31, 2024, is sufficient to fund its planned operations within one year after the date that the financial statements are issued.
We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we continue our development of and seek regulatory approvals for Berubicin and TPI 287, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our continuing product development efforts.
If Berubicin or any of our other drug candidates fail in clinical trials or do not gain regulatory approval, or if our drug candidates do not achieve market acceptance, we may never become profitable.
Our operations to date have been limited to acquiring our technology portfolio, preparing for and conducting our Berubicin clinical trial, and preparing for and conducting our TPI 287 clinical trial.
Factors relating to our business that may contribute to these fluctuations include: · any delays in regulatory review and approval of our product candidates in clinical development, including our ability to receive approval from the FDA for TPI 287 and Berubicin; · delays in the commencement, enrollment and timing of clinical trials; · difficulties in identifying patients suffering from our target indications; · the success of our clinical trials through all phases of clinical development; · potential side effects of our product candidate that could delay or prevent approval or cause an approved drug to be taken off the market; · our ability to obtain additional funding to develop drug candidates; · our ability to identify and develop additional drug candidates beyond Berubicin; · competition from existing products or new products that continue to emerge; · our ability to adhere to clinical trial requirements directly or with third parties such as contract research organizations (CROs); · our ability to establish or maintain collaborations, licensing, or other arrangements; · our ability to defend against any challenges to our intellectual property including, claims of patent infringement; · our ability to enforce our intellectual property rights against potential competitors; · our ability to secure additional intellectual property protection for our developing drug candidates and associated technologies; · our ability to attract and retain key personnel to manage our business effectively; and · potential product liability claims.
We cannot be certain that TPI 287 and Berubicin will receive regulatory approval, and without regulatory approval we will not be able to market TPI 287 and Berubicin.
Our business currently depends largely on the successful development and commercialization of TPI 287 and Berubicin.
Our ability to generate revenue related to product sales, if ever, will depend on the successful development and regulatory approval of TPI 287 and Berubicin for the treatment of glioblastoma.
If we are unable to obtain approval from the FDA, or other regulatory agencies, for Berubicin and our other product candidates, or if, subsequent to approval, we are unable to successfully commercialize Berubicin or our other product candidates, we will not be able to generate sufficient revenue to become profitable or to continue our operations, likely resulting in the total loss of principal for our investors.
Any statements in this filing indicating that TPI 287 and Berubicin has demonstrated preliminary evidence of efficacy are our own and are not based on the FDA’s or any other comparable governmental agency’s assessment of TPI 287 and Berubicin and do not indicate that TPI 287 and Berubicin will achieve favorable efficacy results in any later stage trials or that the FDA or any comparable agency will ultimately determine that TPI 287 and Berubicin is effective for purposes of granting marketing approval.
Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for TPI 287 and Berubicin and our other product candidates.
If TPI 287 and Berubicin is found to be unsafe or lack efficacy, we will not be able to obtain regulatory approval for it and our business would be materially and possibly irreparably harmed.
If we are unable to bring Berubicin to market, or to acquire other products that are on the market or can be developed, our ability to create long-term stockholder value will be limited.
Unforeseen side effects from any of our product candidates could arise either during clinical development or, if TPI 287 and Berubicin (or our other product candidates) are approved, after the approved product has been marketed.
The range and potential severity of possible side effects from therapies such as TPI 287 and Berubicin (or our other product candidates) are significant.
If TPI 287 and Berubicin (or our other product candidates) causes undesirable or unacceptable side effects in the future, this could interrupt, delay or halt clinical trials and result in the failure to obtain or suspension or termination of marketing approval from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities only with restrictive label warnings.
We utilize contract manufacturers for the production of the active pharmaceutical ingredients and the formulation of drug product for our pre-clinical development and clinical trials of TPI 287 and Berubicin that we will need to conduct prior to seeking regulatory approval.
However, we do not have agreements for supplies of TPI 287 and Berubicin or any of our other product candidates and we may not be able to reach agreements with these or other contract manufacturers for sufficient supplies to commercialize TPI 287 or Berubicin if they are approved.
Additionally, the facilities used by any contract manufacturer to manufacture Berubicin or any of our other product candidates must be the subject of a satisfactory inspection before the FDA approves the product candidate manufactured at that facility.
To develop sales, distribution, and marketing capabilities, we will have to invest significant amounts of financial and management resources, some of which will need to be committed prior to any confirmation that Berubicin or any of our other product candidates will be approved by the FDA.
Our licensed U.S. patents for Berubicn expired in March 2020 and the patents for TPI 287 will expire before commercialization is reasonably possible, and the expiration of our patents may subject us to increased competition, and the Orphan Drug Designations for TPI 287 and Berubicin will not bar approval of other similar products under certain circumstances.

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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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