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

Business risks include risks associated with our products (including as a result of pausingterminating the development of our prior drug candidates and refocusing on new drug candidates) and regulatory approval, licensing licensing agreements, historical losses, managing growth, acquisitions, and acquisitions.economic uncertainty or downturns. In general, the risks related to our business can cause variability in the future profits of the Company.

Clinical and regulatory matters include risks associated with clinical trials and the future ability to commercially market the product. In order for any of our products to be commercialized and produce future profits, successful trials need to be completed with supporting data to receive regulatory approval. Failing to complete the trial will significantly increase our cost of doing business. In addition, the active ingredient in some of our products is a controlled substance which can affect the supply available for clinical trials, as well as commercial sales. A limited supply could increase the time needed to complete clinical trials and overall costs including product liability claims. We could also face potential fines or reputational risk if we do not comply. Developments from competitors and the ability to obtain market exclusivity could also negatively impact future profits.

WeRegulatory matters present ongoing risks due to the evolving, complex, and often uncertain nature of the healthcare regulatory and political landscape in which we operate. In this environment, we are required to comply with various federal and state pharmaceutical and healthcare laws and regulations, and to maintain secure systems to protect sensitive confidential information. Complying with the various regulations can increase our cost of doing business. We could also face potential fines or reputational risk if we do not comply. Litigation or investigations can increase costs, negatively affect our operating results and create adverse publicity for us.

The Company relies on third parties to conduct nonclinical non-clinical and clinical studies, as well as to manufacture our product candidates. Third parties’ failure to perform the trials as contractually required could impact our ability to obtain regulatory approval. If our third-party manufacturers fail to meet our requirements and strict regulatory requirements, our product development and commercialization efforts may be materially harmed.

PausingEnding Development of Our Former Primary Drug Candidate Candidates May Adversely Affect Our Business and Financial Condition

We recently pausedterminated the development of our former primary drug candidate, esmethadone (d-methadone, dextromethadone, or REL-1017) as a potential treatment for major depressive disorder (MDD), which had been the cornerstone of our research and development efforts. This decision was made due to an interim analysis indicating that our Phase 3 study of esmethadone, Reliance II, was futile and unlikely to meet the primary efficacy endpoint with statistical significance. We also recently paused terminated development of REL-P11, a modified-release formulation of psilocybin, as an investigational agent for the treatment of metabolic disease. These determinations have resulted in the loss of significant time, resources and capital invested in the development of esmethadone and REL-P11. There can be no assurance that our refocusing on our new drug candidates will successfully offset these setbacks.

There is a high failure rate for drugs and biological products proceeding through clinical trials. Failure can occur at any time during the clinical trial process. The results of nonclinical non-clinical studies and early clinical trials of our drug candidates or any future product candidate may not be predictive of the results of later-stage clinical studies or trials and the results of studies or trials in one set of patients or line of treatment may not be predictive of those obtained in another. In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late stage clinical trials even after achieving promising results in nonclinicalnon-clinical studies and earlier stage clinical trials. In addition, data obtained from nonclinical non-clinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. Owing in part to the complexity of biological pathways, our drug candidates or any future product candidate may not demonstrate in patients the biochemical and pharmacological properties we anticipate based on laboratory studies or earlier stage clinical trials, and they may interact with human biological systems or other drugs in unforeseen, ineffective or harmful ways. The number of patients exposed to product candidates and the average exposure time in the clinical development programs may be inadequate to detect rare adverse events or findings that may only be detected once a product candidate is administered to more patients and for greater periods of time. If we are unable to successfully demonstrate the safety and efficacy of our drug candidates or other future product candidates and receive the necessary regulatory approvals, our business will be materially harmed.

The pausetermination of development of our former drug candidates and the pivot to new candidates may increase our need for additional capital to fund ongoing research, clinical trials and operational expenses. There is no guarantee that we will be able to secure additional funding on acceptable terms, or at all, particularly given the perceived risk associated with our recent strategic shift. Failure to obtain sufficient capital could force us to curtail operations, delay development or seek alternative strategies, such as liquidation or bankruptcy.

Our operations have been limited to organizing and staffing, on a limited basis, our company, acquiring, developing and securing our proprietary technology and undertaking nonclinical non-clinical studies and clinical trials of our principal product candidates. These operations provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing in our common stock.

As of December 31, 2024,2025, we had Federal, New York StateFederal and New York City State net operating loss (NOL) carryforwards of approximately $127,041,000, $1,068,000$246,410,000, and $1,068,000,$2,719,000, respectively, which begin expiring in 2027, 2032 and 2032, respectively. Under U.S. federal tax legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act, or Tax Act, federal NOLs incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of taxable income in the year. It is uncertain if and to what extent various states will conform to the Tax Act. Under Sections 382 and 383 of the U.S. Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage-point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-change taxable income or taxes may be limited. We may also experience ownership changes as a result of stock offerings or as a result of subsequent shifts in our stock ownership, some of which are outside our control. The We have notCompany completed an analysis to determineand whetherdetermined anythat such limitationsthere have been triggered.multiple Ifchanges anyof wereownership determinedas to bedefined triggered,by ourSection ability382 of the IRC. As a result the utilization of the NOLs are limited annually. Due to usethe ourannual currentlimitation some of the NOLs andwill otherexpire pre-changeunused taxregardless of attributes to offset post-changefuture taxable income or taxes would be subject to limitation. We will be unable to use our NOLs if we do not attain profitability sufficient to offset our available NOLs prior to their expiration.income.

Our future success also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical, clinical and regulatory personnel. Our success depends heavily on the expertise of our management team and scientific personnel. The pivot to new drug candidates may require specialized knowledge or skills that our current team lacks. If we lose key personnel or fail to attract and retain qualified replacements, our ability to execute our revised strategy could be compromised, leading to delays or failure in our development program. We currently only have 17 full time employees and are likely to hire additional qualified personnel with expertise in nonclinicalnon-clinical pharmacology and toxicology, pharmaceutical development, clinical research, regulatory affairs, manufacturing, sales and marketing. We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions. Competition for such individuals, particularly in the United States, is intense, and we may not be able to hire sufficient personnel to support our efforts. There can be no assurance that these professionals will be available in the market, or that we will be able to retain existing professionals or to meet or to continue to meet their compensation requirements. Furthermore, the cost base in relation to such compensation, which may include equity compensation, may increase significantly, which could have a material adverse effect on us. Failure to establish and maintain an effective management team and work force could adversely affect our ability to operate, grow and manage our business.

Even if we or our collaborators comply with all FDA regulatory requirements, our drug candidates may never obtain regulatory approval. If we or our collaborators fail to obtain regulatory approval for any of our drug candidates we will have fewer commercial products, if any, and corresponding lower product revenues, if any. any. Even if our drug candidates receive regulatory approval, such approval may involve limitations on the indications and conditions of use or marketing claims for our products. Further, later discovery of previously unknown problems or adverse events could result in additional additional regulatory restrictions, including withdrawal of products. The FDA may also require us or our collaborators to commit to perform lengthy lengthy Phase 4IV post-approval clinical efficacy or safety studies. Our expending additional resources on such trials would have an adverse effect effect on our operating results and financial condition.

Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinicalnon-clinical testing and clinical trials that the product is both safe and effective for use in each target indication.

Results from early clinical trials may not support moving a drug candidate to later-stage clinical trials. Phase 3 clinical trials may not demonstrate the safety or efficacy of our drug candidates. Success in nonclinical non-clinical studies and early clinical trials does not ensure that later clinical trials will be successful. Results of later clinical trials may not replicate the results of prior clinical trials and nonclinicalnon-clinical studies.

We or our collaborators may have to commit substantial time and additional resources to conducting further nonclinicalnon-clinical studies and clinical trials before obtaining FDA approval for any of our drug candidates.

The FDA’s and other regulatory agencies’ decisions to approve our product candidates will depend on our ability to demonstrate, through adequate well-controlled clinical trials, that the product candidate is effective. However, there is a possibility that our data may fail to show a clinically meaningful response rate or a statistically significant difference frombetween the placeboproduct control orcandidate and the active control. Alternatively, there is a possibility that our data may be statistically significant, but that the actual clinical benefit of the product candidates may not be considered to be clinically significant, clinically relevant or clinically meaningful. Even if we believe that the data from our trials will support marketing approval in the United States or in Europe, we cannot predict whether the agencies will agree with our analysis and approve our applications.

We havemay obtainedseek Fast Track Designation for esmethadoneour forproduct the adjunctive treatment of MDD.candidates. Fast Track Designation is granted if a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition. Fast Track Designation does not guarantee a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development program. Our esmethadone development program is currently paused and under evaluation.

Even thoughif we have obtainedobtain orphan drug designation in the United States for esmethadone for the treatment any of postherpeticour neuralgia,drug product candidates, we may not obtain or maintain orphan drug exclusivity for that productdrug candidate, and we may not obtain orphan drug designation or exclusivity for any of our otherproduct product candidates or indications.

We have obtained orphan drug designation for esmethadone for the treatment of postherpetic neuralgia. If the product candidate were to obtain orphan drug exclusivity upon approval, such exclusivity would prevent the FDA from approving another application to market a drug containing the same active moiety for the same orphan indication, except in very limited circumstances, including when the FDA concludes that the later drug is safer, more effective or makes a major contribution to patient care. In addition, a designated orphan drug may not receive orphan drug exclusivity if it is approved for a use, such as MDD,use that is broader than the indication for which it received orphan designation.

Even thoughif we have receivedreceive orphan drug designation for esmethadone for a theproduct treatment of postherpetic neuralgia,candidate, we may not be the first to obtain marketing approval for this active moiety for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical product candidates. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition or a drug with the same active moiety can be approved for a different indication. Orphan drug designation by the FDA neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. In addition, even if we intend to seek orphan drug designation for other product candidates or indications, we may never receive such designations or obtain orphan drug exclusivity.

We intend to rely, in part, on Hatch-Waxman exclusivity for the commercialization of our products in the United States, if approved. The Hatch-Waxman Amendments provide marketing exclusivity to the first applicant to gain approval of an NDA under specific provisions of the FDCA. For esmethadone, which we intend to elect to have not be considered the same active ingredient as methadone and therefore an NCE, we anticipate obtaining 5-year exclusivity. If FDA were to determine that we do not meet the requirements toof makean the election, NCE, we may not be able to obtain 5-year exclusivity for the product. In addition, under the statute, this election currently may only be made in an NDA submitted before October 1, 2027.

There can be no assurance that European authorities will grant data exclusivity for esmethadone,any becauseof itour doesproduct not contain a new active molecule.candidates. Even if European data exclusivity is granted for esmethadone,granted, this may not protect us from direct competition. A competitor(s) with a generic version of our product may be able to obtain approval of its product during our product’s period of data exclusivity, by submitting a marketing authorization application (MAA) with a less than full package of nonclinical and clinical data.

If our drug development efforts fail, or if the competitive landscape or investment climate for antidepressanta drugtherapeutic developmentarea is less attractive, we may need to change the company’s strategic focus to include development of our product candidates, or of newly acquired product candidates. We have very limited drug development experience in therapeutic areas other than depression and we may be unsuccessful in making this change from a depression focused company to a company with a focus in areas other areas, or a company with a focus in multiple therapeutic areas.

We do not know whether our pharmaceutical development, manufacturing manufacturing or clinical testing will be on time or be completed on schedule, if at all. For example, we may encounter delays during the manufacture of pilot scale batches including delays with our contract development or manufacturing organization, sourcing satisfactory quantities quantities of APIs, narcotic import and export permits, sourcing of excipients, contract disputes with our third party vendors and manufacturers, or failure of the product to meet specification. Similar delays may occur a during our cGMP manufacture of the product.

Our products candidates face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology companies as well as academic and research institutions. We compete in an industry that is characterized by: (i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product introductions. Our competitors have existing products and technologies that will compete with our products and technologies and may develop and commercialize additional products and technologies that will compete with our products and technologies. Because several competing companies and institutions have greater financial resources than us, they may be able to: (i) provide broader services and product lines, (ii) make greater investments in research and development, (R&D), and (iii) carry on larger R&D initiatives. Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking nonclinicalnon-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products. They also have greater name recognition and better access to customers than us. Our chief competitors include companies such as Johnson and Johnson, CG Oncology, UroGen, Soleno Therapeutics, Aardvark Therapeutics, and Protara Therapeutics, among others.

In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. information. Our internal technology systems and infrastructure, and those of our current or future third-party collaborators, service providers, contractors and consultants are vulnerable to damage from computer viruses, unauthorized access or use resulting from malware, natural disasters, terrorism, war and telecommunication and electrical failures, denial-of-service attacks, cyber-attacks or cyber-intrusions over the internet, hacking, phishing and other social engineering attacks, persons inside our organizations (including employees or contractors), loss or theft, or persons with access to systems inside our organization. Attacks on information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and they are being conducted by increasingly sophisticated and organized foreign governments, groups and individuals with a wide range of motives and expertise. Threat actors are increasingly leveraging artificial intelligence and automation to enhance the scale, speed, and effectiveness of these attacks, making them more difficult to detect and prevent. In addition to extracting or accessing sensitive information, such attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the security, confidentiality, integrity and availability of information. The prevalent use of mobile devices that access sensitive information also increases the risk of data security incidents which could lead to the loss of confidential information or other intellectual property. Cybersecurity incidents affecting these third parties, or failures in their security controls, could result in unauthorized access to or disclosure of our data, service interruptions, or loss of system functionality, even if our own systems are not directly compromised. Our ability to monitor and mitigate risks associated with third-party providers may be limited. While to our knowledge we have not experienced any material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations or the operations of third-party collaborators, service providers, contractors and consultants, it could result in the loss, theft, or unauthorized disclosure of sensitive or personal information, disruption of our operations, degradation of system performance, and a material disruption of our development programs and significant reputational, financial, legal, regulatory, litigation, business or operational harm.harm, and significant remediation costs. The costs to us to mitigate, investigate and respond to potential security incidents, breaches, disruptions, network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position.

Enacted and future legislation may affect the prices we may set.set and third-party payment for our product candidates. The full effect of recent United States healthcare reform and other changes in the healthcare industry, laws, and regulations and in healthcare spending is currently unknown, and the reform and other changes may adversely affect our business model.

The commercial potential for our products, if any, could also be affected by changes in healthcare spending and policy in the United States and abroad. New laws, regulations, or judicial decisions or new interpretations of existing laws, regulations, or decisions, related to healthcare availability, the method of delivery, or payment for healthcare products and services could adversely affect our business, operations, and financial condition, if and when we are able to obtain marketing approval and commercialize our products. For example, the ACA was enacted in 2010 with a goal, among others, of reducing the cost of healthcare and substantially changing the way healthcare is financed by both government and private insurers. The ACA, among other things, expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program, imposed a significant annual, nondeductible fee on companies that manufacture or import certain branded prescription drug products, and enacted substantial provisions affecting compliance, which may affect our business practices with healthcare practitioners.

ThereFor example, there have been and continue to be a number of initiatives initiatives at the U.S. federal and state levels that seek to reduce healthcare costs in general and the cost of pharmaceuticals in particular. Several Theseof these initiatives recently culminated in the enactment of the IRA in August 2022, which, among other things, allowsrequires HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D. The negotiated price may not exceed a statutory ceiling price. Only high-expenditure single-source drug that have been approved for at least 7 years (11 years for single-source biologics) canare eligible be selected by CMS for negotiation, with the negotiated price taking effect effect two years after the selection year. For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced. In addition, CMS has selected and announced the negotiates maximum fair pricing for 15 additional Medicare Part D drugsdrugs, forwhich negotiatedwill maximum fair pricingbecome effective in 2027. For 2028, CMS selected an additional 15 drugs, whichcomprised may beof drugs covered under eitherMedicare Part D and , for the first time, drugs payable under Medicare Part BB. or Part D, will be selected, and forFor 2029 and subsequent years, 20 Part B or Part D drugs will be selected. ACurrently, a drug or biological product that has an orphan drug designation for only one rare disease or condition will be excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it has designations for more than one rare disease or condition, or if is approved for an indication that is not within that single designated rare disease or condition, unless such additional designation designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation. However, as a result of a statutory amendment enacted in July 2025, beginning with the 2028 negotiated price applicability year, a drug may be designated for more than one rare disease or condition and still be excluded from price negotiation, as long as the only approved indications are for such rare diseases or conditions. The IRA also imposes rebates on Medicare Part D and Part B drugs whose prices have increased at a rate greater than the rate of inflation and in November 2024, CMS finalized regulations for these inflation rebates. In addition, the law eliminates, beginning in 2025, the coverage gap under Medicare Part D by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescriptions costs for brand drugs below the out-of-pocket limit, and 20% once the out-of-pocket limit has been reached. The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. These provisions will take effect progressively starting in 2023, although they may be subject to legal challenges. For example, the provisions related to the negotiation of selling prices of high-expenditure single-source drugs and biologics have been challenged in multiple lawsuits brought by pharmaceutical manufacturers. Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the pharmaceutical industry.

Realized gainloss on short-term investments was approximately approximately $374,900$79,200 for the year ended December 31, 2025 compared to a realized lossgain of approximately $4,064,400$374,900 for the sameyear periodended December 31, 2024, a decrease of 2023, an increase of $4,439,300.$454,100. The increase decrease was related to the timing of the sales of short-term investments along with market conditions.

Unrealized gain on short-term investments was was approximately $6,700$398,300 for the year ended December 31, 2025 compared to approximately $3,823,200$6,700 for the sameyear periodended December 31, 2024, an increase of 2023, a decrease of $3,816,500.$391,600. The decreaseincrease was related to the market conditions.

As shown in the accompanying audited consolidated financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. During the twelve months ended December 31, 2024,2025, the Company incurred a net loss of $79,979,354$57,385,163 and had negative operating cash flows of $51,755,798. Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.$45,786,988.

For the year ended December 31, 2024,2025, net cash providedused byin investing activities was $51,561,597,$48,138,306, due to $12,079,628$83,828,576 of purchases of short term investments offset by $63,641,225$35,690,270 of sales sales of short term investments.

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. On a continual basis, management reviews its estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such reviews, and if deemed appropriate, managementsmanagement’s estimates are adjusted accordingly. Actual results results could differ from those estimates and assumptions under different and/or future circumstances. Management considers an accounting estimate estimate to be critical if:

This Quarterly Report on Form 10-Q (this Report) contains forward-lookingforward looking statements that involve risks and uncertainties, principally in the sections entitled “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements other than statements of historical fact contained in this Quarterly Report, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Risk Factors” or elsewhere in this Quarterly Report, which may cause our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements.

Relmada Therapeutics, Inc. (Relmada, the Company, we or us) (a Nevada corporation), is a publicly traded, clinical-stage biotechnology company. We substantially redesigned our development programs following a comprehensive strategic review in late 2024 and early 2025. We concluded in our review that the most promising path to create shareholder value was to lever our extensive drug development expertise and clinical operations capabilities by acquiring new development candidates, while terminating further work on esmethadone (d-methadone, dextromethadone or REL-1017). Hence we accelerated ongoing efforts to augment our development pipeline while diversifying its risk, which culminated in the licensing of NDV-01, a novel novel, sustained-release, delivery formulation of a chemotherapy regimen widely used to treat non muscle-invasive bladder cancer (NMIBC) that is currently in Phase 2, and the acquisition of sepranolone, a Phase 2b-ready neurosteroid with potential applications in Prader-Willi syndrome (PWS), Tourette Syndrome (TS), essential tremor and other diseases related to excessive GABAergic activity.

Currently, our lead product,product NDV-01candidate, NDV-01, is a novel, controlled-release intravesicalsustained-release formulation of gemcitabine and docetaxel.docetaxel, with the potential to be a best-in-class intravesical treatment across the NMIBC disease spectrum. NDV-01 is currently in a Phase 2 clinical trial in Israel to assess its safety and efficacy in patients with aggressive forms of NMIBC. We intend to develop NDV-01 for two separate indications: (1) the treatment of high-risk, 2nd line Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC and (2) the treatment of intermediate risk NMIBC patients in the adjuvant setting. We expect to initiatefile an United States Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) by year-end 2026. Subsequently, upon IND clearance, we anticipate initiation of Phase 3 programs for each indication mid-2026.indication.

Our second product, sepranolone is a novel neurosteroid epimer of allopregnanolone. Sepranolone is being developed for the potential treatment of PWS, with additional potential indications in TS, essential tremor and other diseases related to excessive GABAergic activity. We expect to initiatefile an IND application with the FDA by year-end 2026. Upon IND clearance, we anticipate initiation of a Phase 2b study in PWS mid-2026.PWS..

On March 25, 2025, Relmada announced the in-license agreement from Trigone Pharma Ltd. (Trigone) of NDV-01, a novelnovel, sustained-release, delivery formulation of a widely used chemotherapeutic regimen used to treat NMIBC.

We expect multipleseveral key milestones over the next 12 upcoming months. These include:

NDV-01, our lead program, was in-licensed on March 24, 2025, NDV-01, is a novelnovel, intravascularintravesical delivery technology designed for the long-acting, controlled releasesustained-release of gemcitabine and docetaxel. This combination therapy has gained significant interest as an alternative to BCG for treating NMIBC, especially given the global BCG shortage since 2019 and for patients that do not respond adequately to BCG. Clinical studies have shown that gemcitabine and docetaxel achieve response rates and Recurrence-Free Survival comparable to or better than BCG. However, conventional administration is cumbersome, requiring sequential drug delivery over three to four hours, with limited tumor exposure time.

NDV-01 is formulated as a controlled-releasesustained-release intravesical therapy containing gemcitabine and docetaxel. By maintaining continuous drug exposure within the bladder, NDV-01 may optimize local efficacy while minimizing systemic absorption and associated side effects. Unlike conventional intravesical instillations, which result in fluctuating drug levels, NDV-01 provides a continuous release of both agents over 10 days. This sustained delivery may improve cancer cell eradication and reduce recurrence risk while lowering the frequency of administration.

NDV-01 is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with aggressive NMIBC. The Phase 2 study is a single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with High Grade-NMIBC.Risk-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (Complete Response Rate at 12 months), and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

The Company also previously announced the successful completion and receipt of written feedback from a Type B pre-IND submissions with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in NMIBC patients. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin inby mid-2026,year-end 2026, and incorporating two studies for two separate indications:

About the Planned High-GradeHigh-Risk Registrational Study

The planned pivotal Phase 3 study in 2nd-line, refractory,high high-graderisk, BCG-unresponsive NMIBC with CIS will be an open-label, single-arm trial evaluating:

Relmada expects to initiatefile a PhaseUnited 2States pilotIND study ofapplication for sepranolone inwith PWSthe inFDA mid-2026.by year-end 2026.

We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of approximately $19,052,000$31,966,100 for the threesix months ended MarchJune 31,30, 2026. At MarchJune 31,30, 2026, we had an accumulated deficit of approximately $717,319,200.$730,233,300.

We have more than 10 issued patents and pending patent applications related to NDV-01 for multiple uses, including formulations and methods for controlled releasesustained-release of therapeutics for treatment of diseases such as bladder cancer, potentially providing coverage beyond 2038.

For the Three Months Ended MarchJune 31,30, 2026 versus MarchJune 31,30, 2025

Research and development expense for the three months ended MarchJune 31, 30, 2026 was approximately $8,087,8008,393,800 compared to $11,951,000$2,819,400 for the three months ended MarchJune 31,30, 2025, aan decreaseincrease of approximately $3,863,200. $5,574,400. The change was primarily driven by:

General and administrative expense for the three months ended MarchJune 31,30, 2026 was approximately $11,373,900$6,617,200 compared to $6,267,400$7,401,900 for the three months ended MarchJune 31,30, 2025, ana increase decrease of approximately $5,106,500.$784,700. The change was primarily due to:

Interest/investment income was approximately $959,800 $2,301,400 and $440,300$321,500 for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase was due to higher average investment balance. Realized loss on short-term investments was approximately $9,900$37,300 andfor the three months ended June 30, 2026 compared to a realized gain of $47,200 for the three months ended June 30, 2025. Unrealized loss on short-term investments was approximately $63,000 for the three months ended March 31, 2026$167,300 and 2025, respectively. Unrealized loss on short-term investments and unrealized gain on short-term investments$13,800 for the three months ended MarchJune 31,30, 2026 and 2025 was approximately $540,100 and $155,700, respectively.2025.

The Company did not provide for income taxes for the three months ended MarchJune 31,30, 2026 and 2025, since there was a loss and a full valuation allowance against all deferred tax assets.

The net loss for the Company for the threesix months ended MarchJune 31,30, 2026 and 2025 was approximately $19,052,000$31,966,100 and $17,559,500$27,425,900 respectively. The Company had loss per share, basic and diluted of $0.22$0.32 and $0.58 $0.86 for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.

As shown in the accompanying audited consolidated financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. During the three six months ended MarchJune 31,30, 2026, the Company incurred a net loss of $19,051,956$31,966,141 and had negative operating cash flows of $15,067,488.$24,673,921.

For the threesix months ended MarchJune 31,30, 2026, cash used in operating activities was $15,067,488$24,673,921 primarily due to the net loss of $19,051,956$31,966,141 offset by non-cash stock-based compensation charges of $956,186$1,859,089 and stock appreciation rights compensation of $2,677,652.$4,019,150. There were realized and unrealized losses on short-term investments of $9,867$47,162 and $540,097,$707,354, respectively. In addition, there was an increase in operating assets and liabilities of $199,334.$659,465.

For the threesix months ended MarchJune 31,30, 2025, cash used in operating activities was $18,067,033$24,468,909 primarily due to the net loss of $17,559,465$27,425,907 offset by non-cash stock-based compensation charges of $3,572,769$7,,021,222 and stock appreciation rights compensation of $3,038.$27,649 and proceeds from the issuance of restricted common stock of $905,226. There were realized gains and unrealized gains on short-term investments of $62,952$110,156 and $155,731,$141,934, respectively. In addition, there was an increase in operating assets and liabilities of $4,769,918.$4,745,009.

For the threesix months ended MarchJune 31,30, 2026, cash used in investing activities was $135,226,997$117,641,611, due to $149,517,480$174,270,466 of purchases of short-term investments offset by $14,290,483$56,628,855 of sales of short-term investments.

For the threesix months ended MarchJune 31,30, 2025, cash provided by investing activities was $15,359,713$22,038,255, due to $487,916$809,375 of purchases of short-term investments offset by $15,847,629$22,847,630 of sales of short-term investments.

ForNet cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026,2026 net cashwas from financing activities totaled $156,574,345$150,153,362 due to proceeds from the issuance of common stock for $159,999,996$159,999,996, proceeds from options exercised for common stock of $101,497, and proceeds from warrants exercised for common stock of $1,683 offset by fees for issuance of common stock of $3,360,000$9,817,890 and ATM fees of $65,651.$131,924.

Net cash providedused byin financing activities for the threesix months ended MarchJune 31,30, 2025 was $0.$73,021 related to ATM fees.

Our unaudited condensed consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of MarchJune 31,30, 2026 have been taken into consideration in preparing the unaudited consolidated financial statements. The preparation of unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. On a continual basis, management reviews its estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such reviews, and if deemed appropriate, management’s estimates are adjusted accordingly. Actual results could differ from those estimates and assumptions under different and/or future circumstances. Management considers an accounting estimate to be critical if: