DWTX 10-K & 10-Q changes, risk factors and insider trading

An investment in our securities involves a high degree of risk. You should carefully consider the risks and uncertainties described below and the other information contained in the Annual Report on Form 10-K. Our business, financial condition, results of operations or prospects could be materially and adversely affected if any of these risks occurs, and as a result, the market price of our common stock could decline. 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.

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 otherour product candidates through clinical development, complete clinical trials, seek regulatory approval and commercialize the drug or any other product candidates,candidates we develop in the future, if approved. 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. Our expenses will also increase substantially if and as we:

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 described below under “— Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval” and “— Risks Related to Commercialization.” 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 (deficit) 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.

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®,our IMC-1product or IMC-2.candidates.

Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts to advance the clinical development, launch and commercialization (if we receive regulatory approval) of Halneuron®,our IMC-1development and/orproduct IMC-2.candidates. We will require additional capital for the further development and potential commercialization of Halneuron®,our IMC-1product or IMC-2.candidates. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.

Our cash and cash equivalents on hand as of December 31, 20242025 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 interimtop-line data readout in the fourththird quarter of 20252026. 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 developingdevelopment of the synthetic production and scale-up process of TTXHalneuron®; continued salaries and benefits; and maintainingcontinued 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. We have based this estimate on assumptions that may prove to be wrong, and we could deploy our available capital resources sooner or for other purposes than we currently expect. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to the:

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, increases in inflation rates and uncertainty about economic stability. For example, the ongoingRussia-Ukraine conflict and the conflict between UkraineU.S., Israel and RussiaIran hashave created extreme volatility in the global capital markets and ismay expectedcontinue to have further global economic consequences, including disruptions of the global supply chain and energy markets. Any such volatility and disruptions may have adverse consequences on us or the third parties on whom we rely. If the equity and credit markets deteriorate, including as a result of politicalgeopolitical 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.

We were established and began operations in 2012. Our operations to date have been limited to financing and staffing our company, conducting proof-of-concept studies for IMC-1 and IMC-2, and conducting preclinical and clinical studies of IMC-1. In October 2024, we acquired Halneuron® through the formation of Dogwood Therapeutics, Inc. and are currently conducting a Phase 2b clinical trial in CINP. 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. Our experience includes testing IMC-1 and IMC-2 in clinical trials for safety and proof-of-concept. We have not yet demonstrated the ability to successfully obtain marketing approval, manufacture a commercial scale product, arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.

We are heavily dependent on the success of our product candidates, Halneuron®, IMC-1 and IMC-2,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.

We do not have any products that have been granted regulatory approval. Currently, our product candidates under active development include Halneuron® for the treatment of CINP,CINP IMC-1and SP16 for the treatment of FMneuropathy and IMC-2nerve for the treatment of LC.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 Halneuron®,these IMC-1 and/or IMC-2candidates in a timely manner. We cannot commercialize Halneuron®,these IMC-1 or IMC-2candidates in the United States without first obtaining regulatory approval from the FDA; similarly, we cannot commercialize Halneuron®,these IMC-1 or IMC-2candidates outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of Halneuron®,these IMC-1 or IMC-2candidates 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®,our IMC-1product orcandidates IMC-2 isare 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®our IMC-1product or IMC-2candidates 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,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 Halneuron®,approved IMC-1 or IMC-2,products, we may not be able to earn sufficient revenue to continue our business.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, Halneuron®, IMC-1, IMC-2 and our otherproduct compoundscandidates may not have favorable results in later preclinical and clinical studies or receive regulatory approval. We may experience delays in initiating and completing any clinical trials that we intend to conduct, and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

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-2SP16 or any other product candidates,candidates we develop in the future, our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. 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. We are not permitted to market any of our product candidates in the United States until we receive regulatory approval from the FDA. Our ability to successfully obtain regulatory approval from the FDA or comparable foreign regulatory authorities is subject to many risks and uncertainties, including the occurrence of one or more of the following:

Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval processes and are commercialized. 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®,any IMC-1,of IMC-2 or anotherour product candidate,candidates, which would significantly harm our business, results of operations and prospects.

The results of preclinical studies, early clinical trials or analyses of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. In addition, conclusions based on promising data from analyses of clinical results may be shown to be incorrect when implemented in prospective clinical trials. Even if our clinical trials for Halneuron®,any IMC-1of andour IMC-2product candidates 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 otherof our 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. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. 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.

The market opportunities for Halneuron®, IMC-1 and/or IMC-2,SP16, if approved, may be smaller than we anticipate.

We are developing Halneuron® for the treatment of CINP,CINP IMC-1and neuropathic pain and SP16 for the treatment of FM and IMC-2 for the treatment of LC.neuropathy. Our estimates of market potential have been derived from a variety of sources, including scientific literature, patient foundations and primary and secondary market research, and may prove to be incorrect. Even if we obtain significant market share for any product candidate, if approved, if the potential target populations are small, we may never achieve profitability without obtaining marketing approval for additional indications.

Even if we obtain FDA approval for Halneuron®, IMC-1, IMC-2SP16 or any other product candidatescandidate we develop in the future in the United States, we may never obtain approval for or commercialize Halneuron®, IMC-1, IMC-2 or any otherthose product candidatecandidates in any other jurisdiction, which would limit our ability to realize their full global market potential.

Even if we obtain regulatory approval for Halneuron®, IMC-1, IMC-2SP16 or any other product candidate,candidate we develop in the future, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties.

We may seek a Breakthrough Therapy designation for Halneuron®, IMC-1 or IMC-2 from the FDA. However, we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.

We may seek a Breakthrough Therapy designation for Halneuron®, IMC-1, IMC-2SP16 or one or more of our other product candidates. A Breakthrough Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA may also be eligible for priority review if supported by clinical data at the time the NDA is submitted to the FDA.

The use of Halneuron®, IMC-1, IMC-2SP16 or any other product candidates we may develop in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by patients, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects.effects or unanticipated manufacturing defects. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

The biopharmaceutical and pharmaceutical industries are highly competitive and subject to significant and rapid technological change. Our success is highly dependent on our ability to acquire, develop, and obtain marketing approval for new products on a cost-effective basis and to market them successfully. If either Halneuron®, IMC-1SP16 and/or IMC-2other isdevelopment products are approved, we will face intense competition from a variety of businesses, including large, fully integrated pharmaceutical companies, specialty pharmaceutical companies and biopharmaceutical companies in the United States and other jurisdictions. These organizations may have significantly greater resources than we do and may conduct similar research; seek patent protection; and establish collaborative arrangements for research, development, manufacturing and marketing of products that may compete with us.

We may face early generic competition for Halneuron®, IMC-1, IMC-2SP16 or any other products we successfully develop and market.

Pharmaceutical companies developing novel products face intense competition from generic drug manufacturers who aggressively seek to challenge patents and non-patent exclusivities for branded products, and who are able to use much less-onerous product development and FDA approval pathways for their generic products. The active ingredient of Halneuron®, tetrodotoxin, is available for purchase in the open market today. Both of the active ingredients of IMC-1, famciclovir and celecoxib, and IMC-2, valacyclovir and celecoxib, are marketed in numerous FDA-approved single-ingredient generic products that copy the original brand name products containing those active ingredients, indicating that numerous potential generic competitors have successfully developed formulation and manufacturing processes to make finished drug products of the individual components of IMC-1 and IMC-2 using these ingredients. Such generic competitors could apply those processes to develop equivalent generic versions of Halneuron®, IMC-1 or IMC-2. Under FDA’s generic drug approval processes, described in more detail in the section titled “Hatch-Waxman and Generic Competition,” we do not believe that either Halneuron®, IMC-1 or IMC-2 would still be eligible for the 5-year5 year NCE Exclusivity period, because bothHalneuron activehas ingredients havenot previously been approved for any indication by FDA in other branded drug products, although Halneuron®, IMC-1 or IMC-2 may qualify for a 3-year exclusivity period during which no generic version could be approved.FDA.

The successful commercialization of Halneuron®, IMC-1, IMC-2 andor any other product candidate we develop in the future will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford prescription medications such as Halneuron®, IMC-1 or IMC-2, if approved.medications. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize our drug and any other product candidates we develop. Assuming we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Even if Halneuron®, IMC-1, IMC-2 or any otherof our product candidatecandidates we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

If Halneuron®, IMC-1, IMC-2 or any other product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If it does not achieve an adequate level of acceptance, we may not generate significant product revenues or become profitable. The degree of market acceptance of our product candidates, if approved, will depend on a number of factors, including but not limited to:

If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing Halneuron®,any IMC-1product orcandidate IMC-2,that ifreceives approved.regulatory approval.

We do not have any infrastructure for the sales, marketing or distribution of Halneuron®,any IMC-1 or IMC-2,products, or compliance functions related to such activities, and the cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to market and successfully commercialize any of our product candidates that receive regulatory approval, we must build our sales, distribution, marketing, managerial, compliance, and other non-technical capabilities or make arrangements with third parties to perform these services. We expectmay choose to build a focused sales, distribution and marketing infrastructure to market Halneuron®,an IMC-1approved and/or IMC-2, if approved,product in the United States and potential other major markets. There are significant expenses and risks involved with establishing our own sales, marketing and distribution capabilities, including our ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, oversee the compliance of sales and marketing functions, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing, distribution and compliance capabilities could delay any product launch, which would adversely impact the commercialization of that product. For example, if the commercial launch of Halneuron®, IMC-1 and/or IMC-2 for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

If we are unable to build our own sales force or negotiate a collaborative relationship for the commercialization of Halneuron®our approved product(s), IMC-1 and/or IMC-2, we may be forced to delay the potential commercialization of the drug or reduce the scope of our sales or marketing activities. If we need to increase our expenditures to fund commercialization activities for Halneuron®, IMC-1 and/or IMC-2activities, we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all. We may also have to enter into collaborative arrangements for Halneuron®,product IMC-1 or IMC-2candidates at an earlier stage than otherwise would be ideal and we may be required to relinquish rights to it or otherwise agree to terms unfavorable to us. Any of these occurrences may have an adverse effect on our business, operating results and prospects.

We currently rely on third-party contract manufacturing organizations, or CMOs, for the production of clinical supply of Halneuron®, IMC-1 and IMC-2SP16 and intend to rely on CMOs for the production of commercial supply of Halneuron®, IMC-1 and IMC-2, if approved.supplies. Our dependence on CMOs may impair the development and commercialization of the drug, which would adversely impact our business and financial position.

We have limited personnel with experience in manufacturing, and we do not own facilities for manufacturing. Instead, we rely on and expect to continue to rely on CMOs for the supply of cGMP grade clinical trial materials and commercial quantities of Halneuron®, IMC-1, IMC-2 and any product candidates we develop, if approved.quantities. Reliance on CMOs may expose us to more risk than if we were to manufacture our product candidates ourselves. We intend to manufacture a sufficient clinical supply of Halneuron®, IMC-1 and IMC-2SP16 to enable us to complete future clinical trials, and we have also engaged a CMO to provide clinical and commercial supply of the drug product.

Our CROs are not our employees, and we do not control whether or not they devote sufficient time and resources to our clinical trials. Our CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities, which could harm our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that we develop. As a result, our financial results and the commercial prospects for any product candidate that we develop would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

As of December 31, 2024,2025, we had U.S. federal net operating loss carryforwards, or NOLs, of approximately $36,669,000 million$45,410,000 and Georgia and Florida state NOLs of approximately $44,443,000 million$58,689,000 and $1,372,000 million,$1,750,000, respectively. As of December 31, 2024,2025, we also had Canadian non-capital loss carryforwards of approximately $25,277,000,$22,024,000, which have a twenty yeartwenty-year carryforward and begin expiring in 20252026 and Hong Kong tax losses carryforwards orof approximately $58,126,000$58,026,000, which have no expiry. These net operating losses can be carried forward and applied against future taxable income, if any. A full allowance for the value of the NOLs is provided for in our audited consolidated financial statements for the year of December 31, 20242025 included in this Annual Report on Form 10-K. We cannot guarantee what the ultimate outcome or amount of the benefit we may receive from the NOLs, if any, will be. If we become profitable in the future, our ability to use net operating loss carryforwards and other tax attributes to offset future taxable income or reduce taxes may be subject to limitations.

There is no assurance that all the potentially relevant prior art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue and even if such patents further cover Halneuron®, IMC-1, IMC-2SP16 or any other product candidates we develop in the future, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated, or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any product candidates that we may develop. Further, if we encounter delays in regulatory approvals, the period during which we could market a product candidate under patent protection could be reduced.

We consider proprietary trade secrets or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. Because we expect to rely on third parties to manufacture Halneuron®, IMC-1, IMC-2 and any otherof our product candidates we develop in the future,candidates, and we expect to collaborate with third parties on the development of Halneuron®, IMC-1, IMC-2 and any otherof our product candidates we develop in the future, we must, at times, share trade secrets with them. We also conduct joint research and development programs that may require us to share trade secrets under the terms of our research and development partnerships or similar agreements. However, trade secrets or confidential know-how can be difficult to maintain as confidential.

A third party may hold intellectual property, including patent rights that are important or necessary to the development or commercialization of Halneuron®, IMC-1, IMC-2 or any otherof our product candidates we develop in the future.candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize Halneuron®, IMC-1, IMC-2 or any otherour product candidates we develop in the future, in which case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or at all, which could materially harm our business. At this time, we are unaware of any intellectual property that interferes with ours or is complementary and needed to commercialize Halneuron®, IMC-1 or IMC-2.SP16.

In the first quarter of 2025, we commenced a HALT-CINP-203HAL-CINP-203 clinical trial in the United States. HALT-CINP-203HAL-CINP-203 is a double-blind, placebo controlled clinical trial to access the efficacy and safety of Halneuron® in 200approximately 240 patients with moderate to severe neuropathic pain caused by previous platinum and/or taxane chemotherapy. The primary efficacy endpoint is the change from baseline at week 4 in the weekly average of daily 24-hour recall pain intensity scores, comparing Halneuron® to the placebo. The secondary endpoints are patient global impression of change, PROMIS regarding fatigue, PROMIS related to sleep, PROMIS-29, pain interference, hospital anxiety and depression scale and neuropathic pain symptom inventory. We expect to releasereleased interim data from HALF-CINP-203HAL-CINP-203 in December 2025 and expect to have top-line results available during the secondthird halfquarter of 2025.2026.

AntiviralSP16 Program

OnSubsequent Marchto 12,year 2025,end, weon January 11, 2026, the Company entered into an agreement with Maxim Group LLC as placement agent in connection with the issuance and sale by the Company in a registered direct offering of 578,9502,338,948 shares of ourits Common Stock at a price of $8.26 per share in (the March“Registered 2025 Offering,Offering”), pursuant to an effective shelf registration statement on Form S-3 (File No. 333-263700333-287575). In a concurrent private placement (together with the Registered Offering, the “January 2026 Offering”), the Company agreed to sell (i) unregistered pre-funded warrants to purchase up to 2,047,089 shares of Common Stock (the “Pre-funded Warrants”) and (ii) unregistered common stock warrants to purchase up to 4,386,037 shares of Common Stock (the “Common Stock Warrants”) at a combined offering price of $2.85 per share of Common Stock and accompanying Common Stock Warrant and $2.8499 per Pre-funded Warrant and accompanying Common Stock Warrant. The MarchJanuary 20252026 Offering closed on MarchJanuary 14,13, 2025,2026, and the gross proceeds fromto the March 2025 OfferingCompany were approximately $4.78$12.5 million. The net proceeds of the MarchJanuary 20252026 Offering were approximately $4.25$11.4 million after deducting placement agent fees and offering expenses payable by the Company.

As we advance the HALT-CINP-203HAL-CINP-203 clinical trial, we expect our research and development expenses related to the development of Halneuron® to increase. These expenditures are subject to numerous uncertainties regarding timing and cost to completion. Completion of our clinical development and clinical trials may take several years or more. Because of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion costs of the current or future studies and clinical trials or if, when, or to what extent we will generate revenues from the commercialization and sale of our product candidates. We may never succeed in achieving regulatory approval for our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:

The Company uses Gendreau Consulting, LLCLLC, a consulting firm (“Gendreau”), a consulting firm, for drug development, clinical trial design,design and the planning, implementation and execution of contracted activities with CROs.the clinical research organization. Gendreau’s managing member becameis the Company’s Chief Medical Officer (“CMO”). effectiveFrom Januarytime 1,to 2021.time, Thethe Company has and may continue to contractcontracts the services of immediate family members of the CMO’sCompany’s spouseCMO through Gendreau to perform certain activities in connection with the Company’s ongoing clinical programs.development of its product candidates. Such services have included service as the Company’s Medical Monitor and currently include service by immediate family members of the CMO as the Company’s Chief Safety Officer for the HAL-CINP-203 clinical trial and as an assistant in connection with various clinical site related activities.

On October 7, 2024, in connection with the Exchange Agreement, the Company entered into the Loan Agreement with LenderLender, who is an affiliate of CKLS. Pursuant to the Loan Agreement, the Lender agreed to make a loan to the Company in the aggregate principal amount of $19,500,000, of which (i) $16,500,000 was disbursed on October 7, 2024 and (ii) $3,000,000 was disbursed on February 18, 2025. The Loan Agreement bore interest at SOFR plus 2.00%. On March 12, 2025, the principal amount of all loans made to the Company under the Loan Agreement, along with accrued interest through such date was deemed repaid and all of the Company’s obligations with respect to the principal amount and accrued interest was satisfied in full and cancelled in connection with the Debt Exchange and Cancellation Transaction.

As of December 31, 2024,2025, the Company has U.S. federal net operating loss carryforwards of approximately $36,669,000,$45,410,000, which have an indefinite carryforward and Georgia and Florida state net operating loss carryforwards of approximately $44,443,000$58,689,000 and $1,372,000,$1,750,000, respectively, which have a twenty-year carryforward and begin expiring in 2037. As of December 31, 2024,2025, the Company also had Canadian non-capital loss carryforwards of approximately $25,277,000,$22,024,000, which have a twenty yeartwenty-year carryforward and begin expiring in 20252026 and Hong Kong tax losses carryforwards orof approximately $58,126,000$58,026,000, which have no expiry. These net operating losses can be carried forward and applied against future taxable income, if any. As the Company was incorporated in December 2020, all tax years of the Company remain open to examination by tax authorities.

The Company has provided a full valuation allowance for its deferred tax assets as of December 31, 2023 due to the uncertainty surrounding the ability to realize these assets. At December 31, 2024, the Company evaluated the realizability of its deferred tax assets and determined that the valuation allowance should be adjusted for the consideration of the acquired in-process research and development intangible assets. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which these temporary differences become deductible.

Indefinite-lived intangible assets consist of In-Process Research and Development (“IPR&D”).D. The fair values of IPR&D project assets acquired in business combinations are capitalized. The Company generally utilizes the Multi-Period Excess Earning Method to determine the estimated fair value of the IPR&D assets acquired in a business combination.combination and for subsequent annual impairment testing. The projections used in this valuation approach are based on many factors, such as relevant market size, the estimated probability of regulatory success rates, anticipated patent protection, expected pricing, expected treated population, and estimated payments (e.g., royalty).payments. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate.

Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of our intangible assets with indefinite lives may not be recoverable, including, but not limited to, recent clinical data, expected growth rates, the cost of equity and debt capital, general economic conditions, outlook and market performance of the Company’s industry and recent and forecasted financial performance.

The Company applies ASC 480480, Distinguishing Liabilities from Equity, when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity (deficit) equity..

Operating expenses and other (expense) income were comprised of the following:

Research and development expenses increased by $1.8$18.3 million to $21.8 million for the year ended December 31, 2025 from $3.5 million for the year ended December 31, 2024 from $1.7 million for the year ended December 31, 2023.2024. The increase was primarily due to $12.0 million of acquired In-Process Research and Development (“IPR&D”) related to the Licensing Agreement with Serpin and the impact of the Combination, including increases in expenses for clinical trials of $1.0$6.1 million,million researchrelated andto preclinicalthe activitiesHAL-CINP-203 of $0.3 million,study, drug development and manufacturing costs of $0.4$0.3 million and salaries and related personnel costs of $0.3 million partially offset by a decrease in regulatoryresearch consultingand preclinical costs of $0.2$0.4 million.

General and administrative expenses increaseddecreased by $5.0$2.6 million to $6.1 million for the year ended December 31, 2025 from $8.7 million for the year ended December 31, 2024 from $3.7 million for the year ended December 31, 2023.2024. This increasedecrease was primarily due to a decrease in nonrecurring transaction costs of $4.9$3.9 million related to the Combination,Combination anwith increasePharmagesic in October 2024 and a decrease in expenses associated with being a pubic company of $0.2 million offset by increases in salaries and related personnel costs of $0.4$0.5 million, legal and professional fees of $0.6 million, franchise tax fees of $0.2 million offsetand byother ageneral decreaseand administrative costs of $0.3$0.2 million related to costs associated with being a public company primarily due to lower insurance expenses.million.

Other (Expense) Income

Other (expense) income increased by $0.3$6.0 million to $6.1 million in expense for the year ended December 31, 2025 from $0.1 million in expense for the year ended December 31, 2024 from $0.2 million in income for the year ended December 31, 2023.2024. The increase in other expense was primarily due theto interesta and$6.1 loanmillion discount amortizationloss on thedebt conversion with a related party loanrelated ofto $0.3the millionExchange and Cancellation Agreement with the Lender offset by interest income of $0.2$0.1 million versus $0.2 million in interest income for the year ended December 31, 2023.million.

Since our inception, we have financed our operations through public offerings of common stock and proceeds from private placements of membership interests and convertible promissory notes. To date, we have not generated any revenue from the sale of productsproducts, and we do not anticipate generating any revenue from the sales of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of December 31, 2024,2025, our principal source of liquidity was our cash, which totaled $14.8$6.5 million.

OnSubsequent Mayto 19,year 2024,end, on January 11, 2026, the Company entered into an agreement with Maxim Group LLC as placement agent in connection with the issuance and sale by the Company in a publicregistered direct offering of 340,0002,338,948 shares of its Common Stock at a public offering price of $5.00 per share (the “May 2024Registered Offering”), pursuant to an effective shelf registration statement on Form S-3 (File No. 333-263700333-287575). In a concurrent private placement (together with the Registered Offering, the “January 2026 Offering”), the Company agreed to sell (i) unregistered pre-funded warrants to purchase up to 2,047,089 shares of Common Stock (the “Pre-funded Warrants”) and (ii) unregistered common stock warrants to purchase up to 4,386,037 shares of Common Stock (the “Common Stock Warrants”) at a combined offering price of $2.85 per share of Common Stock and accompanying Common Stock Warrant and $2.8499 per Pre-funded Warrant and accompanying Common Stock Warrant. The MayJanuary 20242026 Offering closed on MayJanuary 22,13, 2024,2026, and the gross proceeds fromto the May 2024 OfferingCompany were $1,700,000.approximately $12.5 million. The net proceeds of the MayJanuary 20242026 Offering were $1,382,170approximately $11.4 million after deducting placement agent fees and offering expenses payable by the Company.

There were no debt financings during the year ended December 31, 2023. There was no debt outstanding at December 31, 2023.2025.

We anticipate our cash and cash equivalents on hand at December 31, 20242025 of approximately $14.8$6.5 millionmillion, plus the additional loannet proceeds of $3approximately $11.4 million received onfrom Februarythe 18,January 20252026 and net offering proceeds of $4.25 million received on March 14, 2025,Offering, will fund operations through the firstthird quarter of 2026. The Company will need to secure additional financing to fund its ongoing clinical trials and operations beyond the firstthird quarter of 2026 to continue to execute its strategy. We will need to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. To the extent that we raise additional funds by issuing equity or equity-linked securities, our shareholders will experience dilution. We can give no assurances that we will be able to secure such additional sources of funds to support our operations, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs. As a result, substantial doubt exists regarding our ability to continue as a going concern 12 months from the issuance of the Annual Report on Form 10-K. Failure to secure the necessary financing in a timely manner and on favorable terms could have a material adverse effect on the Company’s strategy and value and could require the delay of product development and clinical trial plans.

There were no investing activities for the year ended December 31, 2025. Net cash provided by investing activities for the year ended December 31, 2024 consisted of $3.8 million in cash acquired in connection with the Combination. There were no investing activities for the year ended December 31, 2023.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on March 18, 2026 (the “2025 Annual Report on Form 10-K”), under “SectionItem 1A. Risk Factors”, available on the SEC EDGAR website at www.sec.gov, Part II, and Item 1A of the report, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those risks noted above.

DuringOn theApril first quarter of21, 2026, ourDogwood pipelineentered includedinto IMC-1,an agreement with PRIDCor Therapeutics, LLC (“PRIDCor”) pursuant to which PRIDCor will be fully responsible for financing and executing future development, commercialization and intellectual property maintenance for both IMC-1 and IMC-2. IMC-1 is a novel, proprietary, fixed dose combination of a nucleoside analog and the anti-inflammatory agent celecoxib for the treatment of fibromyalgia and IMC-2, a combination of valacyclovir and celecoxib that is intended to synergistically suppress herpesvirus activation for the treatment of Long-COVID. On April 21, 2026, Dogwood entered into an agreement with PRIDCor Therapeutics, LLC (“PRIDCor”) pursuant to which PRIDCor will be fully responsible for financing and executing future development, commercialization and intellectual property maintenance for both IMC-1 and IMC-2. In exchange, Dogwood is entitled to a tiered royalty on net sales of up to 15% upon commercialization of IMC-1 or IMC-2. Further, Dogwood is entitled to receive 10% of PRIDCor’s initial Series A financing and 9% of all future capital raised by PRIDCor to advance IMC-1 or IMC-2, as well as future PRIDCor partnership-related development and regulatory payments associated with IMC-1 or IMC-2. Potential payments to Dogwood under the development partnership are capped at $100 million. In July 2026, PRIDCor broke escrow subject to the Series A Payment and Escrow Break Minimum of $1,000,000. As a result, the Company received its first payment under the PRIDCor License Agreement in the amount of $100,000 and submitted $87,750 related to the payment made to the Rights Agent to be distributed to the CVR holders under the CVR Agreement.

In the first quarter of 2025, we commenced dosing of patients in the HAL-CINP-203 clinical trial in the United States. HAL-CINP-203 is a Phase 2b, double-blind, placebo controlled clinical trial intended to assess the efficacy and safety of Halneuron® in approximately 240230 patients with moderate to severe neuropathic pain caused by previous platinum and/or taxane based cancer chemotherapy. The primary efficacy endpoint is the changereduction in pain from baseline to week 4 in the weekly average of daily 24-hour recall pain intensity scores captured on an electronic diary,diary comparingand analyzed as a responder analysis. The responder analysis will compare Halneuron® to placebo.placebo in terms of the proportion of patients who achieve 50% or more reduction in their pain from baseline to the primary endpoint. The secondary endpoints include patient global impression of change, PROMIS fatigue, PROMIS sleep, PROMIS-29, pain interference, hospital anxiety and depression scale and the neuropathic pain symptom inventory. In December 2025, we announced interim results from a planned interim assessment of the ongoing Halneuron® Phase 2b trial, the goal of which was to finalize the statistical methodology and the endpoint analysis to be used to determine Halneuron® safety and effectiveness as a treatment for CINP. Key highlights from the first 97 patients completing the trial included Halneuron demonstrating treatment effect versus placebo, with responders exhibiting durable treatment effects over the course of the four-week trial. Halneuron®’s treatment effect was observed when used alone or in combination with other pain medications as compared with placebo. Notably, the overall drop out rate ofwas 4.5% for this cohort and is far below the drop out rate observed with other FDA approved chronic pain medications, including duloxetine (20+%) and pregabalin (30-40%). Based on the recommendation of the independent statisticians conducting the assessment, we plan to enroll between 210-240 patients by the end of summer to ensure a sample size that provides 80+% power to achieve a statistically significant outcome via responder analysis. Currently, we have enrolled 164217 patients and expect top-line data from the trial in the fall of 2026.

We licensed the rights to the IV formulation of SP16 for the treatment of CIPN in September 2025. SP16 is a 17 amino acid peptide drug that has been designed to mimic the anti-inflammatory and immunomodulatory properties of Alpha-1 Antitrypsin, without the limitations seen with the much larger Alpha-1 Antitrypsin protein. The initial Phase 1 evaluation of SP16’s safety when used to treat CIPN will be conducted by the University of Virginia Cancer Center under a National Cancer Institute (“NCI”) grant. Patient recruitment for this initial evaluation is expected to start in the firstsecond half of 2026. We will be providing our clinical development expertise, but with the NCI funding the trial, we will incur no further expenses in connection with this initial evaluation of the safety of SP16 in cancer patients. Dogwood announced FDA acceptance of the Investigational New Drug (“IND”) application for SP16, administered intravenously (“IV”), for the treatment of CINP. Patient dosing in the planned Phase 1b trial should commence in the middlesecond half of this year.

On January 11, 2026, we entered entered into a securities purchase agreement (the “Purchase Agreement”) with a single healthcare-focused institutional investor (the “Purchaser”) pursuant to which we agreed to issue and sell, in a registered direct offering (the “Registered Offering”), 2,338,948 shares of our Common Stock. In a concurrent private placement (the “Private Offering” and, together with the Registered Offering, the “January 2026 Offerings”), and pursuant to the Purchase Agreement, the Company agreed to sell to the Purchaser (i) unregistered pre-funded warrants to purchase 2,047,089 shares of Common Stock (the “Pre-funded Warrants”) and (ii) unregistered common warrants to purchase up purchase up to an aggregate of 4,386,037 shares of Common Stock (the “Common Stock Warrants”, together with the Pre-funded Warrants, the “Warrants”). The Common Stock Warrants and Pre-funded Warrants are classified as equity on the Company’s condensed consolidated balance sheet. The Common Stock Warrants include certain rights upon "fundamental transactions," as described in the warrant agreement, including the right of the holder thereof to receive from the Company or a successor entity the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such fundamental transaction if it had been the holder of the number of warrant shares immediately prior to such fundamental transaction. At the holder's option, exercisable within thirty (30) days after the consummation of a fundamental transaction (if within the Company's control), the Company or any successor entity shall purchase the Common Stock Warrant from the holder by paying to the holder an amount of cash equal to the Black Scholes Value of the remaining unexercised portion of the Warrants on the date of the consummation of such fundamental transaction. Each share of Common Stock (or Pre-funded Warrant in lieu thereof) was sold together with one Common Stock Warrant at a combined purchase price of $2.85 per share and accompanying warrant (or $2.8499 per Pre-funded Warrant and accompanying warrant), priced at-the-market under Nasdaq rules. The aggregate gross proceeds to the Company from the January 2026 Offerings were approximately $12.5 million, before deducting placement agent fees and offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Stock Warrants. Net proceeds were approximately $11.4 million.

On January 15, 2026, we filed a Form S-3 Registration Statement for the resale of up to 6,433,126 shares of the outour Common Stock consisting of (i) 2,047,089 shares of Common Stock underlying the Pre-funded Warrants at an exercise price of $0.0001 per share; and (ii) 4,386,037 shares of Common Stock underlying the Common Stock Warrants to purchase shares of Common Stock at an exercise price of $3.28 per share. The Form S-3 Registration Statement was declared effective by the SEC on January 29, 2026.

Three and six months ended MarchJune 31,30, 2026 and 2025

General and administrative expenses increased by $0.4$0.3 million and $0.7 million for the three and six months ended June 30, 2026, respectively, compared to $2.4prior periods. The increase of $0.3 million for the three months ended MarchJune 31,30, 2026,2026 fromwas $2.0primarily related to an increase in salaries and related personnel costs of $0.3 million and an increase in franchise fees of $0.1 million offset by a decrease in public company costs of $0.1 million. The increase of $0.7 million for the threesix months ended MarchJune 31, 2025. The increase of $0.4 million for the three months ended March 31,30, 2026 was primarily due to an increase in salaries and related personnel costs of $0.5$0.8 million offset by a decrease in franchise fees of $0.1 million.

Since our inception, we have financed our operations through public offerings of common stock and proceeds from private placements of membership interests and convertible promissory notes. To date, we have not generated any revenue from the sale of products and we do not anticipate generating any revenue from the sales of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of MarchJune 31,30, 2026, our principal source of liquidity was our cash, which totaled $13.2$9.6 million.

OnIn January 13, 2026, we closed the January 2026 Offerings, consisting of the Registered Offering of 2,338,948 shares of our Common Stock and a Private Offering of Pre-funded Warrants to purchase up to 2,047,089 shares of Common Stock and Common Stock Warrants to purchase up to 4,386,037 shares of Common Stock, at a combined offering price of $2.85 per share and accompanying Common Stock Warrant (and $2.8499 per Pre-funded Warrant and accompanying Common Stock Warrant). Gross proceeds were approximately $12.5 million and net proceeds were approximately $11.4 million, after deducting placement agent fees and offering expenses. The Common Stock Warrants have an exercise price of $3.28 per share, and, if exercised in full for cash, would generate up to approximately $14.4 million of additional gross proceeds.

OnIn March 14, 2025, we closed the March 2025 Offering, which was a registered direct offering of 578,950 shares of our Common Stock, raising gross proceeds of approximately $4.78 million and net proceeds of approximately $4.25 million, after deducting placement agent fees and offering expenses.

We anticipate our cash on hand at MarchJune 31,30, 2026 of approximately $13.2$9.6 million will fund operations into the fourth quarter of 2026. The Company will need to secure additional financing to fund its ongoing clinical trials and operations beyond the fourth quarter of 2026 to continue to execute its strategy. We will need to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. To the extent that we raise additional funds by issuing equity or equity-linked securities, our shareholders will experience dilution. We can give no assurances that we will be able to secure such additional sources of funds to support our operations, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs. As a result, substantial doubt exists regarding our ability to continue as a going concern 12 months from the issuance of this Quarterly Report on Form 10-Q. Failure to secure the necessary financing in a timely manner and on favorable terms could have a material adverse effect on the Company’s strategy and value and could require the delay of product development and clinical trial plans.

The following table summarizes our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively:

Cash Flows for the threesix months ended MarchJune 31,30, 2026 and 2025

For the threesix months ended MarchJune 31,30, 2026, net cash used in operations was $4.6$8.2 million and consisted of a net loss of $5.0$16.5 million andoffset by a net change in operating assets and liabilities of $0.1$0.5 million attributable to a decrease in accounts payable of $0.6 million offset by a decrease in prepaid expenses and other current assets of $0.3$0.6 million and an increase in accrued liabilities of $0.2 million offset by a decrease in accounts payable of $0.3 million further offset by non-cash items of $0.5$7.8 million attributable mainlyto tothe IPR&D impairment of $9.2 million, share-based compensation of $0.4$1.0 million and deferred sublease income and reduction in the carrying amount of right-of-use asset and loss on foreign exchange of $0.1 million offset by a deferred tax benefit related to the IPR&D impairment of $2.5 million.

For the threesix months ended MarchJune 31,30, 2025, net cash used in operations was $4.7$8.7 million and consisted of a net loss of $10.9$14.7 million and a net change in operating assets and liabilities of $0.2$0.5 million attributable to a decrease in accounts payable and accrued liabilities of $0.3$0.9 million offset by a decrease in prepaid expenses and other current assets of $0.1$0.4 million further offset by non-cash items of $6.4$6.5 million attributable to loss on conversion of debt with related party of $6.1 million, deferred tax expense of $0.2 million and share-based compensation, depreciation and amortization of $0.1$0.2 million.

Net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 was $11.3 million and was attributable to gross proceeds from our concurrent registered direct and private placement offering in January 2026 of $12.5 million, net of placement fees and offering costs paid by us during the three months ended MarchJune 31,30, 2026 of $1.1 million and the payment of issuance costs associated with the equity distribution agreement that was terminated in January 2026 of $0.1 million.

Net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2025 was $7.4$7.3 million and was attributable to cash proceeds from the Loan Agreement of $3.0 million and gross proceeds from our registered direct offering in March 2025 of $4.8 million, net of placement agent fees and offering costs paid by us during the three months ended March 2025 of $0.4$0.5 million.

As of MarchJune 31,30, 2026, we did not have any off-balance sheet arrangements or relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities.

The preparation of financial statements in conformity with U.S. GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by management in order to make estimates about the effect of matters that are inherently uncertain. During the threesix months ended MarchJune 31,30, 2026, there were no significant changes to our critical accounting policies from those described in our annual financial statements for the year ended December 31, 2025, which we included in our 2025 Annual Report on Form 10-K.

BecauseThe the excess of fair value over carrying value is narrower than at the date of theCompany’s most recent annualimpairment assessment, performed as of June 30, 2026, concluded that the Companycertain considersIPR&D assets were impaired but that goodwill was not impaired. If the Company’s market capitalization continues to decline, the Company’s remaining IPR&D asset and goodwill tomay be at risk of future impairment. Events that could cause management to conclude that fair value has declined below carrying value, and that could result in a material impairment charge in a future period, include but are not limited to, (i) a sustained further decline in the Company’s stock price or market capitalization; (ii) adverse changes in macroeconomic or capital-market conditions; (iii) unfavorable results; (iv) delays in, or failure to obtain, regulatory approval from the U.S. Food and Drug Administration; and (v) the emergence of competitive therapies or changes in the standard of care for chemotherapy-induced neuropathic pain. Should the market value of the Company’s common stock decline further, impairment charges may be recorded in future periods.