DWTX

Certain of the risk factors described below include references to past events as examples.
These examples, or the absence of other examples, should not be viewed as a representation as to whether or not the events, factors or contingencies described in our risk factors have or have not occurred.
Instead, the disclosures in this section reflect our beliefs and opinions as to the factors, events or contingencies that could materially and adversely affect us in the future.
Our financial statements as of December 31, 2025 were prepared under the assumption that we will continue as a going concern for the next twelve months.
We incurred consolidated net losses of $34,257,370 and $12,349,724 for each of the years ended December 31, 2025 and 2024.
As of December 31, 2025, we had an accumulated deficit of $108,076,316.
We expect to incur significant additional operating losses for the next several years, at least, as we advance our product candidates through clinical development, complete clinical trials, seek regulatory approval and commercialize the drug or any other product candidates we develop in the future, if approved.
Our expenses will also increase substantially if and as we: ● conduct our Phase 3 studies or conduct clinical trials for any other indications or other product candidates; ● establish sales, marketing, distribution, and compliance infrastructures to commercialize products for which we obtain marketing approval; ● maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, scientific and commercial personnel; ● add operational, financial and management information systems and personnel, including personnel to support our development and planned future commercialization efforts, as well as to support our transition to a public reporting company; and ● acquire or in-license or invent other product candidates or assets.
These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity (deficit) and working capital.
We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
We expect to continue to spend substantial amounts to advance the clinical development, launch and commercialization (if we receive regulatory approval) of our development product candidates.
We will require additional capital for the further development and potential commercialization of our product candidates.
Our cash and cash equivalents on hand as of December 31, 2025 is not sufficient to fund our operations and capital requirements for at least the next 12 months subsequent to the filing date of the Company’s Annual Report on Form 10-K.
Currently, the planned research and development activities for the next year include advancing the Halneuron® Phase 2b clinical trial for the treatment of CINP with top-line data readout in the third quarter of 2026.
The capital raised in January of 2026 funds the ongoing Halneuron® Phase 2b CINP study through completion; the commencement of a Phase 2b extension study; further development of the synthetic production and scale-up process of Halneuron®; continued salaries and benefits; and continued operations in the U.S. and Canada.
Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to the: ● initiation, progress, timing, costs and results of preclinical studies and clinical trials, including patient enrollment in such trials; ● clinical development plans we establish for product candidates we develop in the future ; ● obligation to make royalty and non-royalty sublicense receipt payments to third-party licensors, if any, under our licensing agreements; ● number and characteristics of product candidates that we discover or in-license and develop; ● outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect; ● costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights; ● effects of competing technological and market developments; ● costs and timing of the implementation of commercial-scale manufacturing activities; and ● costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval.
For example, the Russia-Ukraine conflict and the conflict between U.S., Israel and Iran have created extreme volatility in the global capital markets and may continue to have further global economic consequences, including disruptions of the global supply chain and energy markets.
If the equity and credit markets deteriorate, including as a result of geopolitical unrest or war, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.
SP16 is the focus of a planned Phase 1b study that is fully funded through a research grant supplied by the National Cancer Institute, with patient enrollment projected to start in mid-2026.
Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval We are heavily dependent on the success of our product candidates which are still under clinical development, and if these candidates do not receive regulatory approval or, if approved, our commercialization efforts are unsuccessful, our business may be harmed.
Currently, our product candidates under active development include Halneuron® for the treatment of CINP and SP16 for the treatment of neuropathy and nerve damage.
As a result, our business is dependent on our ability to successfully complete clinical development of, obtain regulatory approval for, and, if approved, successfully commercialize these candidates in a timely manner.
We cannot commercialize these candidates in the United States without first obtaining regulatory approval from the FDA; similarly, we cannot commercialize these candidates outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the commercial sale of these candidates for a target indication, we must demonstrate with substantial evidence gathered in preclinical studies and clinical trials and, with respect to approval in the United States, to the satisfaction of the FDA, that our product candidates are safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate.
If we are unable to obtain regulatory approval for our product candidates in one or more jurisdictions, or any approval we receive contains significant limitations or requirements, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of any other product candidate that we may in-license, develop or acquire in the future.
Furthermore, even if we obtain regulatory approval, we will still need to develop a commercial organization, establish commercially viable pricing and obtain approval for adequate reimbursement from third-party and government payors.
If we are unable to successfully commercialize approved products, we may not be able to earn sufficient revenue to continue our business.
Approved products are subject to continuing obligations regarding manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, post-marketing studies, and submission of safety and efficacy data under U.S. federal and state laws and comparable foreign regulations.
Holders of Biologics License Applications (BLAs) or New Drug Applications (NDAs), as well as manufacturing facilities, must comply with current Good Manufacturing Practice (cGMP) requirements and are subject to ongoing inspections by the FDA and foreign authorities.
Compliance requires significant time, resources, and investment in manufacturing, quality control, and regulatory oversight.
Promotional activities are strictly regulated and must align with approved labeling; “off-label” promotion is prohibited.
Changes to an approved product, its labeling, or manufacturing process generally require prior regulatory approval.
Regulatory authorities may also mandate post-marketing studies to confirm safety and efficacy.
Failure to complete such studies or negative outcomes could result in withdrawal of marketing approval.
If regulators identify previously unknown safety issues, manufacturing deficiencies, or improper marketing practices, they may impose restrictions or require product withdrawal.
Noncompliance with regulatory requirements could result in: • Warning letters; • Civil or criminal penalties; • Suspension or withdrawal of approvals; • Clinical trial holds; • Refusal to approve pending applications; • Operational restrictions, including closure of manufacturing facilities; or • Product seizures or recalls.
Government investigations of alleged violations could require significant resources and generate negative publicity.
Any sanctions or loss of approval would adversely affect commercialization and revenue generation, and materially harm our business.
Regulatory policies may change, and new requirements may be introduced that delay or prevent approval of products derived from our candidates.
We cannot predict future legislative or administrative actions in the United States, Europe, or other jurisdictions.

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Gone since FY2024

Our financial statements as of December 31, 2024 were prepared under the assumption that we will continue as a going concern for the next twelve months.
We incurred consolidated net losses of $12,349,724 and $5,296,015 for each of the years ended December 31, 2024 and 2023.
As of December 31, 2024, we had an accumulated deficit of $73,818,946.
We expect to incur significant additional operating losses for the next several years, at least, as we advance Halneuron ® , IMC-1, IMC-2 and any other product candidates through clinical development, complete clinical trials, seek regulatory approval and commercialize the drug or any other product candidates, if approved.
Our expenses will also increase substantially if and as we: ● conduct our Phase 3 studies or conduct clinical trials for any other indications or other product candidates; ● establish sales, marketing, distribution, and compliance infrastructures to commercialize Halneuron ® , IMC-1 or IMC-2, if approved, and for any other product candidates for which we may obtain marketing approval; ● maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, scientific and commercial personnel; ● add operational, financial and management information systems and personnel, including personnel to support our development and planned future commercialization efforts, as well as to support our transition to a public reporting company; and ● acquire or in-license or invent other product candidates or assets.
These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ (deficit) equity and working capital.
We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of Halneuron ® , IMC-1 or IMC-2.
We expect to continue to spend substantial amounts to advance the clinical development, launch and commercialization (if we receive regulatory approval) of Halneuron ® , IMC-1 and/or IMC-2.
We will require additional capital for the further development and potential commercialization of Halneuron ® , IMC-1 or IMC-2.
Our cash on hand as of December 31, 2024 is not sufficient to fund our operations and capital requirements for at least the next 12 months subsequent to the filing date of the Company’s Annual Report on Form 10-K.
Currently, the planned research and development activities for the next year include advancing the Halneuron ® Phase 2b clinical trial for the treatment of CINP with an interim data readout in the fourth quarter of 2025; further developing the synthetic production and scale-up process of TTX; continued salaries and benefits; and maintaining operations in the U.S. and Canada.
Additional capital will need to be raised to fund the second half of the Halneuron ® Phase 2b for the treatment of CINP and before initiating additional research and development activities.
Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to the: ● initiation, progress, timing, costs and results of preclinical studies and clinical trials, including patient enrollment in such trials, for Halneuron ® , IMC-1 or IMC-2 or any other product candidates we develop in the future; ● clinical development plans we establish for Halneuron ® , IMC-1 and/or IMC-2 or any other product candidates we develop in the future ; ● obligation to make royalty and non-royalty sublicense receipt payments to third-party licensors, if any, under our licensing agreements; ● number and characteristics of product candidates that we discover or in-license and develop; ● outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect; ● costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights; ● effects of competing technological and market developments; ● costs and timing of the implementation of commercial-scale manufacturing activities; and ● costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval.
For example, the ongoing conflict between Ukraine and Russia has created extreme volatility in the global capital markets and is expected to have further global economic consequences, including disruptions of the global supply chain and energy markets.
If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.
Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval We are heavily dependent on the success of our product candidates, Halneuron ® , IMC-1 and IMC-2, which are still under clinical development, and if these candidates do not receive regulatory approval or, if approved, our commercialization efforts are unsuccessful, our business may be harmed.
Currently, our product candidates include Halneuron ® for the treatment of CINP, IMC-1 for the treatment of FM and IMC-2 for the treatment of LC.
As a result, our business is dependent on our ability to successfully complete clinical development of, obtain regulatory approval for, and, if approved, successfully commercialize Halneuron ® , IMC-1 and/or IMC-2 in a timely manner.
We cannot commercialize Halneuron ® , IMC-1 or IMC-2 in the United States without first obtaining regulatory approval from the FDA; similarly, we cannot commercialize Halneuron ® , IMC-1 or IMC-2 outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the commercial sale of Halneuron ® , IMC-1 or IMC-2 for a target indication, we must demonstrate with substantial evidence gathered in preclinical studies and clinical trials and, with respect to approval in the United States, to the satisfaction of the FDA, that Halneuron ® , IMC-1 or IMC-2 is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate.
In our most recent clinical trial involving IMC-1, the Phase 2b FORTRESS study, IMC-1 did not achieve statistically significant efficacy outcomes.
Even if IMC-1 were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements.
If we are unable to obtain regulatory approval for Halneuron ® IMC-1 or IMC-2 in one or more jurisdictions, or any approval we receive contains significant limitations or requirements, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of any other product candidate that we may in-license, develop or acquire in the future.
Furthermore, even if we obtain regulatory approval for Halneuron ® , IMC-1 or IMC-2, we will still need to develop a commercial organization, establish commercially viable pricing and obtain approval for adequate reimbursement from third-party and government payors.
If we are unable to successfully commercialize Halneuron ® , IMC-1 or IMC-2, we may not be able to earn sufficient revenue to continue our business.
Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, Halneuron ® , IMC-1, IMC-2 and our other compounds may not have favorable results in later preclinical and clinical studies or receive regulatory approval.
Clinical trials can be delayed for a variety of reasons, including delays related to: ● the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies; ● obtaining regulatory approval to commence a trial; ● reaching an agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● obtaining Institutional Review Board, or IRB, approval at each site, or Independent Ethics Committee, or IEC, approval at sites outside the United States; ● recruiting suitable patients to participate in a trial in a timely manner and in sufficient numbers; ● having patients complete a trial or return for post-treatment follow-up; ● imposition of a clinical hold by regulatory authorities or IRBs, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere to regulatory requirements or follow trial protocols; ● clinical sites deviating from trial protocol, committing fraud or other violations of regulatory requirements, or dropping out of a trial, which can render data from that site unusable in support of regulatory approval; ● addressing patient safety concerns that arise during the course of a trial; ● adding a sufficient number of clinical trial sites; or ● manufacturing sufficient quantities of Halneuron ® , IMC-1 or IMC-2 for use in clinical trials.
Furthermore, we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we have agreements governing their committed activities, we have limited influence over their actual performance, as described in “Risks Related to Our Dependence on Third Parties.” The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for Halneuron ® , IMC-1, IMC-2 or any other product candidates, our business will be substantially harmed.
We have not obtained regulatory approval for any product candidate and it is possible that we will never obtain regulatory approval for Halneuron ® , IMC-1, IMC-2 or any other product candidates.
The FDA or comparable foreign regulatory bodies can delay, limit or deny approval of our product candidates or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including: ● the FDA or comparable foreign regulatory authorities may disagree with the adequacy of the design or implementation of our clinical trials; ● the FDA or comparable foreign regulatory authorities may disagree with our safety interpretation of our drug; ● the FDA or comparable foreign regulatory authorities may disagree with our efficacy interpretation of our drug; or ● the FDA or comparable foreign regulatory authorities may regard our CMC package as inadequate, and more particularly: ● if our NDA does not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; ● if the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; ● if the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; ● if FDA determines that it has insufficient information to determine whether such drug is safe for use under such conditions; ● if based on information we submit and any other information before the FDA, the FDA determines there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or ● if FDA determines that our labeling is false or misleading in any particular way.
This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market Halneuron ® , IMC-1, IMC-2 or another product candidate, which would significantly harm our business, results of operations and prospects.
Even if our clinical trials for Halneuron ® , IMC-1 and IMC-2 are completed as planned, we cannot be certain that their results will support the safety and efficacy sufficient to obtain regulatory approval.
Serious adverse events or undesirable side effects caused by Halneuron ® , IMC-1, IMC-2 or any other product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities.
Patients treated with IMC-1 in our Phase 2a and Phase 2b studies discontinued their participation due to adverse events at a rate lower than patients treated with placebo.
The most common adverse events IMC-1 patients experienced (other than COVID-19 infection) were gastrointestinal events and headache at rates less than 5%.
There were three serious adverse events observed in the Phase 2a study, two on patients treated with IMC-1, and one for a placebo treated patient.
In the larger Phase 2b study, there were three serious adverse events that occurred in two patients, both of whom were treated with placebo.
Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw approvals of such product; ● regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication; ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; ● we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a medication guide outlining the risks of such side effects for distribution to patients; ● we could be sued and held liable for harm caused to patients; ● the product may become less competitive; and ● our reputation may suffer.
The market opportunities for Halneuron ® , IMC-1 or IMC-2, if approved, may be smaller than we anticipate.
We are developing Halneuron ® for the treatment of CINP, IMC-1 for the treatment of FM and IMC-2 for the treatment of LC.

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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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