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

We may need to raise additional capital for operations and in order for stockholders to realize increased value on our securities. In the event the merger is consummated with Cyclo (the “Merger”) and ifIf the current Phase III3 trial for Trappsol® Cyclo™ is successful, we maywill likely need to raise capital for the manufacturing, distribution and potential commercialization of Trappsol® Cyclo™ . Given the current global economy and other factors, if we need to raise additional capital, there can be no assurance that we will be able to obtain the necessary funding on commercially reasonable terms in a timely fashion or at all. Failure to receive the funding could have a material adverse effect on our business, prospects, and financial condition.

We have not yet demonstrated our ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale medicine, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization.commercialization of any product that might receive regulatory approval. Typically, it takes about ten to fifteen years to develop one new medicine from the time it is discovered to when it is available for treating patients. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by clinical stage biopharmaceutical companies in rapidly evolving fields. We will also need to transition from a company with a research focus to a company capable of supporting commercial activities.activities should any regulatory approval be secured, if any. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer, our future revenue potential may be impacted, and our ability to pursue our growth strategy and attain profitability could be compromised.

As of July 31, 2024,2025, we held approximately $2.7$52.8 million in cash and cash equivalents, approximately $63.3$1.2 million in short-termother available-for-salereceivables, securities,and $0.4$0.6 million in third-party and related party receivables, approximately $0.5 million in interests receivable, and $2.5 million in investment in hedge funds. Investmentsreceivables. in hedge funds carry a degree of risk, as there can be no assurance that we will be able to redeem any hedge fund investments at any time or that our investment managers will be able to accurately predict the course of price movements of securities and other instruments and, in general, the securities markets have in recent years been characterized by great volatility and unpredictability. Our passive interests in other entities are not currently liquid, and we cannot assure that we will be able to liquidate them when we desire, or ever. As a result of these different market risks, our holdings of cash, cash equivalents, and investments could be materially and adversely affected.

While we are actively seekingseek corporate development opportunities, opportunities, we may not be able to find any suitable target businesses and consummate an investment, business combination or other transaction. Our Our ability to complete any such transactions may be negatively impacted by general market conditions, volatility in the debt and equity markets, decreased market liquidity, and third-party financing being unavailable on terms acceptable to us or at all.

Our future success may depend significantly on the results of Cyclothe Therapeutics’ongoing Phase III3 trial for Trappsol® Cyclo™. If Cyclowe isare unable to successfully develop, gainobtain regulatory approval foror successfully commercialize Trappsol® Cyclo™ or commercialize its product candidates or experiencesexperience significant delays in doing so, our business will be materially harmed.

We have invested a significant amount of capital in Cyclo.Cyclo and the development and clinical activity for Trappsol® Cyclo™. Our dependence on the success of Trappsol® Cyclo™ and the need for additional capital will increase if the mergerPhase is consummated and the Phase III3 trial for Trappsol® Cyclo™ is successful. Based on the independent DMC review of safety and efficacy data at the prespecified 48-week interim analysis, in June 2025, the DMC recommended to continue the trial to 96 weeks.

The success of Trappsol® Cyclo™ is beyond beyond our and Cyclo’s control, and the drug development and regulatory approval processes could cause significant delay or prevent Cyclo us from obtaining regulatory approval or commercializing Trappsol® Cyclo™ or any other product candidates. If Cyclowe are is unable to develop, obtain regulatory approval for, or, if approved, successfully commercialize its product candidates, we may not be able to generate sufficient sufficient revenue to continue our business.

The Pharmaceutical CompaniesWe may not be successful in theirour efforts to identify or discover potential product candidates.

Our business strategy includes elements for ourus subsidiaries and entities in which we invest to identify, create and test compounds, and where regulatory requirements are met, to advance clinical testing of those and other compounds. A significant portion of the research that the Pharmaceutical Companies are conducting involves new compounds and drug discovery methods and suitable drug delivery systems, including the Pharmaceutical Companies’ proprietary technology. The drug discovery that the Pharmaceutical Companies are conducting using the Pharmaceutical Companies’ proprietary technology technologies may not be successful in identifying compounds that are useful in treating cancer or other ailments. The Pharmaceutical Companies’ research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates that, subject to meeting regulatory requirements, have the potential for initiating clinical development for a number of reasons, including:

If the Pharmaceutical Companies are unable to identify suitable compounds for preclinical and clinical development, and/or are unable to successfully meet regulatory requirements or initiating clinical trials and secure regulatory approval for any such compounds, the Pharmaceutical Companies will not be able to obtain product revenue in future periods, which likely would result in significant harm to the Pharmaceutical Companies’ financial position and adversely impact the Pharmaceutical Companies’ valuation and our business.

We and the companiesPortfolio inCompanies which we hold interests may expend our and their limited resources to pursue a particular product candidate or an indication and fail to capitalize on product candidates candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because the Pharmaceutical Companies have limited financial and managerial resources, their focus on research programs and product candidates that they may or will identify for specific indications may not be exhaustive. As a result, the Pharmaceutical Companies may forego or delay pursuit of opportunities with other product product candidates or for other indications that later prove to have greater commercial potential. The Pharmaceutical Companies’ resource resource allocation decisions may cause them to fail to capitalize on viable commercial medicines or profitable market opportunities. The Pharmaceutical Companies’ spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable medicines. If the Pharmaceutical Companies do not accurately evaluate the commercial potential or target market for a particular product candidate, they may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangementsarrangements, or outright product relinquishment in cases in which it would have been more advantageous for them to retain sole development and commercialization rights to such product candidate.

Preclinical and clinical drug development is a lengthy and expensive process, with an uncertain outcome. Our and the Pharmaceutical Companies’ preclinical and clinical programs may experience delays or may never advance, which would adversely affect the ability to obtain regulatory approvals for product candidates, or commercialize any product candidates for which regulatory approval is obtained, on a timely basis or at all, which could have an adverse effect on our business.

Enrollment may be particularly challenging for some of the orphan diseases the Pharmaceutical Companies target in the Pharmaceutical Companies’ programs. In addition, there may be limited patient pools from which to draw for clinical studies. In addition to the rarity of some diseases, the eligibility (inclusion and exclusion) criteria of the Pharmaceutical Companies’ clinical studies will further limit the pool of available study participants as they may require that patients have specific characteristics that they can measure or to assure their disease is either severe enough or not too advanced to include them in a study. In addition, some of the Pharmaceutical Companies’ competitors may have approved competing products or ongoing clinical trials for product candidates that are in development to treat the same indications as the Pharmaceutical Companies’ product candidates, and patients who would otherwise be eligible for the Pharmaceutical Companies’ clinical trials may instead be prescribed a competitor's approved product or advised to enroll in clinical trials of the Pharmaceutical Companies’ competitors’ product candidates and therefore be ineligible or otherwise unwilling to enroll in the Pharmaceutical Companies’ clinical trials.

TheOur or the Pharmaceutical Companies’ product product candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could preclude further development, prevent regulatory approval, prevent market acceptance,acceptance or limit their commercial potential if regulatory approval were to be received or result in significant negative consequences.

If our or the Pharmaceutical Companies’ product product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs, we or the Pharmaceutical Companies may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability liability claims. Any of these occurrences may prevent us or the Pharmaceutical Companies from securing regulatory approval or achieving or maintaining market acceptance of the affected product candidate if it were to received regulatory approval, and may adversely affect our business, financial condition, and prospects significantly.

In addition, many compounds that initially showed promise in early-stage testing for treating cancer or other indications have later been found to cause side effects that prevented further development of the compound. Further, we expect that certain product candidates will be used in patients that have weakened immune systems, which may exacerbate any potential side effects associated with their use. Patients treated with oncology product candidates may also be undergoing surgical, radiation and/or chemotherapy treatments, which can cause side effects or adverse events that are unrelated to the product candidate but may still impact the risk-benefit profile of the product candidate and the success of clinical trials. The inclusion of critically ill patients in clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’ illnesses. It may be very challenging, or even impossible, for us or the Pharmaceutical Companies to demonstrate that any such deaths or other adverse events are traceable to other therapies or medications that such patients may be using or to the gravity of such patients’ illnesses, in which case the FDA or analogous regulatory authorities may attribute any such deaths or other adverse events to our or the Pharmaceutical Companies’ product candidate being studied in the clinical trial.

If significant adverse events or other side effects are observed in any of our or the Pharmaceutical Companies’ current or future clinical trials, we or the Pharmaceutical Companies may have difficulty recruiting patients to the clinical trials, patients may drop out of such trials, or they may be required to abandon the trials or their development efforts of a product candidate altogether. TheWe, the Pharmaceutical Companies, the FDA, other comparable regulatory authorities or an IRB may suspend or halt clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to inadequate clinical benefit and/or unacceptable health risks or adverse side effects.

Further, if any of our or the Pharmaceutical Companies’ Companies’ product candidates obtains regulatory approval, toxicities associated with such product candidates previously not seen during clinical testing may also develop after any such approval and lead to a number of potentially significant negative consequences, including, but not limited to:

Any of these events could prevent us or the Pharmaceutical Companies from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm the standing and reputation of the Pharmaceutical Companies among health-care providers and patients, and could seriously harm our business.

From time to time, we and/or the Pharmaceutical Companies may also disclose interim data from preclinical studies and clinical trials. Interim data from preclinical and clinical trials are subject to the risk that one or more of the preclinical or clinical outcomes may not be clinically relevant and may materially change as patient enrollment continues and more patient data become available or as patients from such clinical trials continue other treatments for their disease. Adverse differences between preliminary or interim data and final data could materially adversely affect our business prospects.

The outcome of preclinical studies and early clinical clinical trials may not be predictive of the success or failure of later preclinical studies or clinical trials, and interim results of preclinical studies or clinical trials do not necessarily predict success in future clinical trials. Many companies in the biopharmaceutical industry, industry, including Cornerstone, have suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier development, and the Pharmaceutical Companies could face similar setbacks. The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced or even completed. We and the Pharmaceutical Companies have limited experience in designing clinical trials and may be unable to design and execute a clinical trialtrials to support regulatory approval. In addition, preclinical and clinical data are often susceptible to varying interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval for the product candidates. Even if we or the Pharmaceutical Companies, or future collaborators, believe that the results of clinical trials for the Pharmaceutical Companies’ product candidates warrant regulatory approval, the FDA or comparable foreign regulatory authorities may disagree and may not grant regulatory approval of the Pharmaceutical Companies’ product candidates.

In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, proper implementation of inclusion and exclusion criteria, differences in standards of care in different geographical locations, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other elements of the clinical trial protocols, and the rate of dropout among clinical trial participants. If the Pharmaceutical Companies fail to receive positive results in clinical trials of the Pharmaceutical Companies’ product candidates, the development timeline and regulatory approval and commercialization prospects for the Pharmaceutical Companies’ most advanced product candidates, and, correspondingly, our or the Pharmaceutical Companies’ business and financial prospects would be negatively impacted.

The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable, and if the Pharmaceutical Companies are ultimately unable to obtain regulatory approval for their product candidates, our orand their business will be substantially harmed.

Of the large number of drugs in development, only only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in the Pharmaceutical Companies failing to obtain regulatory approval to market their product candidates, which would significantly harm our business, results of operations and prospects. In addition, even if the Pharmaceutical Companies were to obtain approval, regulatory authorities may approve any of their product candidates for fewer or more limited indications or less advantageous labeling than requested, may grant approval contingent on the performance of of costly post-marketing clinical trials, including Phase 4 clinical trials, and/or the implementation of a REMS, which may be required to to assure safe use of the drug after approval. The FDA or the applicable foreign regulatory authority also may approve a product candidate for a more limited indication or patient population than originally requested, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Even if regulatory approval were to be secured, payors in the US responsible for coverage and reimbursement determinations and foreign authorities responsible for drug pricing determinations may not provide adequate coverage or reimbursement or approve the prices the Pharmaceutical Companies intend to charge for any approved products.products or those prices could be reduced based upon most-favored-nation pricing policies. Any of the foregoing scenarios could materially harm the commercial prospects for the Pharmaceutical Companies Companies' product candidates.

If the FDA does not conclude that certain of the Pharmaceutical Companies’ product candidatescandidates, if any, satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, pathway, or if the requirements for such product candidates under Section 505(b)(2) are not as they expect, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.

In addition, notwithstanding the approval of a a number of products by the FDA under Section 505(b)(2), certain pharmaceutical companies and others have objected to the FDA’s interpretation interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, either generally or in connection with a Section 505(b)(2) submission by the Pharmaceutical Companies, the FDA may change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that the Pharmaceutical Companies submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to certain requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of the Pharmaceutical Companies NDAs for up to 30 months or longer depending on the outcome of any litigation. It also is not uncommon for a manufacturer of a previously approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such such petitions can significantly delay, or even prevent, the approval of a new product. Even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition. In addition, even if the Pharmaceutical Companies are able to utilize the Section 505(b)(2) regulatory pathway, there is no guarantee this would ultimately lead to streamlined product development or earlier approval.

TheWe and the Pharmaceutical Companies may not be able to obtain orphan drug designation or obtain or maintain the benefits associated with orphan drug designation, such as orphan drug drug exclusivity and, even if they do, that exclusivity may not prevent the FDA or other comparable foreign regulatory authorities from approving approving competing products.

As part of theirour business strategy, we and the Pharmaceutical Pharmaceutical Companies may seek orphan drug designation, or ODD, for any eligible product candidates they develop,candidates, but theywe may be unsuccessful in obtaining or maintaining the benefits of such designations.

Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing and making available the drug will be recovered from sales in the United States. Cornerstone has received ODD for CPI-613 (devimistat) for the treatment of pancreatic cancer, acute myeloid myeloid leukemia, myelodysplastic syndrome, Burkitt’s lymphoma, peripheral T-cell lymphomas,lymphoma, soft tissue sarcoma, and biliary cancer. Cyclo Cyclo received orphan drugODD for the treatment of NPC1 by the FDA for its Trappsol® product.Cyclo™.

Even if we or the Pharmaceutical Companies obtain ODD ODD for a product candidate, theywe may not be able to obtain or maintain orphan drug exclusivity for that product candidate. TheWe or the Pharmaceutical Companies may not be the first to obtain regulatory approval of any product candidate for which theywe have obtained ODD for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. If one or more third-party sponsor is the first to receive approval for an alternative product(s) for the same orphan-designated indication as our or the Pharmaceutical Companies’ product product candidate, even if FDA were to conclude that the Pharmaceutical Companies’ product candidate is not the “same drug” as the alternative product(s), the prior approval(s) of such alternative product(s) could result in a delay in the regulatory review of of our or the Pharmaceutical Companies’ product candidate and/or requests for the conduct of additional clinical trials that may further delay the prospects for any approval of our or the Pharmaceutical Companies’ product candidate. In addition, exclusive marketing rights in the United States may be limited if our or the Pharmaceutical Companies seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if they are unable to ensure that they we will be able to manufacture sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Further, even if we or the Pharmaceutical Companies obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active ingredients may be approved for the same condition, and competitors also potentially could secure approval of the same drug for different non-orphan conditions. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the product candidate any advantage in the regulatory review or approval process.

Disruptions at the FDA and other government agencies caused by funding shortagesshortages, government shutdowns or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect affect the FDA’s ability to perform routine functions, including a shutdown of the federal government. Average review times at the FDA have fluctuated in recent years. In addition, government funding of other government agencies that fund research and development activities activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the United States federal government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If the occasional U.S. government shutdowns are prolonged or other events or conditions occur that prevent the FDA or other regulatory agencies from hiring and retaining personnel and conducting their regular activities, it could significantly impact the ability of these agencies to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Even if we or the Pharmaceutical Companies receive receive regulatory approval for any product candidate, they will be subject to ongoing regulatory obligations and continued regulatory review, review, which may result in significant additional expense.

Any regulatory approvals that we or the Pharmaceutical Companies may receive for their product candidates will require the regular submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of the product, may contain significant limitations related to use restrictions for specified age groups groups or patient populations, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a REMS as a condition of approval of a product candidate, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves a a product candidate, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export, and recordkeeping for us or the Pharmaceutical Companies’ products will be subject to extensive and ongoing regulatory requirements and associated personnel and financial commitments. These requirements include submissions of safety and other post-marketing information and reports, maintenance of cGMP compliance at and registrations for all manufacturing facilities, as well as continued compliance with GCPcGCP requirements for any clinical trials that are ongoing or conducted post-approval. Manufacturers of approved products and their facilities facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with with cGMP regulations and standards. Later discovery of previously unknown problems with marketed products, including adverse events of unanticipated severity or frequency, or with third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, requirements, may result in, among other things:

The occurrence of any event or penalty described above may inhibit our or the Pharmaceutical Companies’ ability to commercialize their product candidates and generate revenue and could require us or the Pharmaceutical Companies to expend significant time and resources in response and could generate negative publicity.

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our or the Pharmaceutical Companies’ product candidates. We also cannot predict the likelihood, nature or extent of government regulation that that may arise from future legislation or administrative action, either in the United States or abroad. For example, the results of the 2024 2020 United States Presidential Election impacted our business and industry. Namely, the Trump Administration took several Executive Actions, Actions, including the issuance of a number of Executive Orders, that imposed significant burdens on, or otherwise materially delayed, the FDA’s ability to engage in routine oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. It is difficult to predict whether or how these orders will be rescinded and replaced under the current or future Administrations. The policies and priorities of any Administration and the U.S. Congress are unknown and could materially impact the regulations governing our or the Pharmaceutical Companies’ product candidates. If we or the Pharmaceutical Companies are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or they are not able to maintain regulatory compliance, we or they may be subject to enforcement action and we or they may not achieve or sustain profitability.

Even if any of our or the Pharmaceutical Companies’ Companies’ product candidates receive regulatory approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

If any of our or the Pharmaceutical Companies’ product candidates receive regulatory approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors, and others in the medical community. ForIf example,any currentof cancerour treatments like chemotherapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments. Ifor the Pharmaceutical Companies’ product candidates were to receive regulatory approval but do not achieve an adequate level of acceptance, we or the Pharmaceutical Companies may not generate significant product revenue and may not become profitable. The degree of market acceptance of our or the Pharmaceutical Companies’ product candidates, if approved for commercial sale, will depend on a number of factors, including:

This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements that contain the words “believes,believes”, “anticipates,anticipates”, “expects,expects”, “plans,plans”, “intends” and similar words and phrases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the results projected in any forward-looking statement. In addition to the factors specifically noted in the forward-looking statements, other important factors, risks and uncertainties that could result in those differences include, but are not limited to, those discussed under Item 1A to Part I “Risk Factors” in this Annual Report. The forward-looking statements are made as of the date of this Annual Report, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth in this report and the other information set forth from time to time in our reports filed with the Securities and Exchange Commission pursuant to the Securities Act of 1933 and the Securities Exchange Act of 1934, including our reports on Forms 10-Q and 8-K.

Rafael Holdings, Inc. (“Rafael Holdings”, “Rafael”, “we” or the “Company”) is a holdingbiotechnology company withthat develops pharmaceuticals and holds interests in clinical and early-stage pharmaceutical companies (thethat “Pharmaceuticaldevelop Companies”),pharmaceuticals including an investment in (and plannedmedical mergerdevices. with)Our Cyclolead Therapeuticscandidate Inc. (Nasdaq: CYTH), (“Cyclo Therapeutics” or “Cyclo”), a clinical stage biotechnology company dedicated to developingis Trappsol® Cyclo™, which is being evaluated in clinical trials for the potential treatment of Niemann-Pick Disease Type C1 (“NPC1”), a rare, fatal and progressive genetic disorder,disorder. We also hold: (i) a majority equity interest in LipoMedix Pharmaceuticals Ltd. (“LipoMedix”), a clinical stage pharmaceutical company,company; (ii) Barer Institute Inc. (“Barer”), a wholly-owned preclinical cancer metabolismresearch researchfocused entity operation,whose andoperations have been substantially curtailed; (iii) a majority interest in Cornerstone Pharmaceuticals, Inc. (“Cornerstone”), formerly known as Rafael Pharmaceuticals Inc., a cancer metabolism-based therapeutics company.company; We also hold(iv) a majority interest in Rafael Medical Devices, LLC.LLC (“Rafael Medical Devices”), an orthopedic-focused medical device company developing instruments to advance minimally invasive surgeries, surgeries; and (v) a majority interest in Day Three Labs, Inc. (“Day Three”), a company which empowers third-party manufacturers to reimagine their existing cannabisproduct offerings enabling them to bring to market better, cleaner, more precise and predictable versions by utilizing Day Three’s pharmaceutical-grade technology and innovation like Unlokt™. Our Dayprimary Threefocus andhas Rafael Medical Devices, together with the Pharmaceutical Companies, represent our “Portfolio Companies”). In November 2022,been the Company resolved to curtail its early-stagecontinued development efforts,of includingTrappsol® pre-clinicalCyclo™ research at Barer. The decision was taken to reduce spending asthrough the Company focuses on exploring strategic opportunities. Since then, the Company has sought partners for programs at Farber and has entered into a license agreement for onecompletion of its technologies.ongoing Thepivotal Phase Company’s3 primaryclinical focustrial, isthe potential filing for regulatory approval and ultimately, if approved, commercialization of the product. We also look to expand our investment portfolio through opportunistic and strategic investments including therapeutics, whichthat address high unmet medical needs. UponWe closingcontinuously evaluate our other holdings to ensure the focus of theour plannedresources merger with Cyclo, the Company intends to focus its effortsare on makingcore assets and specifically the continued development of Trappsol® Cyclo™ its lead clinical program..

In May 2023, the Companywe first invested in Cyclo Therapeutics. Cyclo isCyclo, a clinical-stage biotechnology company that develops cyclodextrin-based products for the potential treatment of neurodegenerative diseases. Cyclo’s lead drug candidate is Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin), a treatment for Niemann-Pick Disease, type C1 (“NPC1”).NPC1. NPC1 is a rare and fatal autosomal recessive genetic disease resulting in disrupted cholesterol metabolism that impacts the brain, lungs, liver, spleen, and other organs. In January 20172017, the FDA granted Fast Track designation to Trappsol® Cyclo™ for the treatment of NPC1. Initial patient enrollment in the U.S. Phase I study commenced in September 2017, 2017 and in May 20202020, Cyclo announced Top Line data demonstrating indicating Trappsol® Cyclo™ was well tolerated in this study. Cyclo is currently conducting a Phase III3 Clinical Trial Evaluating evaluating Trappsol® Cyclo™ in Pediatric and Adult Patients with Niemann-Pick Disease, Type C1. On March 25, 2025, we consummated the Merger with Cyclo whereby Cyclo became a wholly-owned subsidiary of the Company. See NotesNote 11 and 123 to theour Consolidated Financial Statements for more information on the Company’s investmentsMerger inwith Cyclo.

LipoMedix is a clinical stage Israelicompany companybased in Israel that is focused focused on the development of a product candidate that holds the potential to be an innovative, safe, and effective cancer therapy based on liposome delivery. As of July 31, 2024,2025, the Company’sour ownership interest in LipoMedix was approximately 95%. LipoMedixAs hasneeded, completedwe provide debt or equity funding variousto Lipomedix to support its development and clinical stagesefforts. ofLipoMedix Promitil®is currently exploring strategic options for its lead candidate, including Phasepotential 1Alicensing (solidopportunities, tumors)collaborations with industry partners, and 1Binvestigator-initiated (as single agent and in combination with capecitabine and/or bevacizumab in colorectal cancer). Another phase 1B testing Promitil® as radiosensitizer is ongoing and near completion. A total of 149 patients have been treated with Promitil® as a single agent, or in combination with other anticancer drugs or radiotherapy, under the framework of a phase 1A and two 1B clinical studies and under named patient approval for compassionate use.studies.

In 2019, the Companywe established Barer, originally as a preclinical cancer metabolism research operation, to focus on developing a pipeline of novel therapeutic compounds, including compounds designed to regulate cancer metabolism with potentially broader application in other indications beyond cancer. Barer has beenwas comprised of scientists and academic advisors that are experts in cancer metabolism, chemistry, and drug development. In addition to its own internal discovery efforts, Barer pursued collaborative research agreements and in-licensing opportunities with leading scientists from top academic institutions. Barer’s Barer’s majority owned subsidiary, Farber Partners, LLC (“Farber”), was formed around one such agreement with Princeton University’s University’s Office of Technology Licensing (“Princeton”) for technology from the laboratory of ProfessorDr. Joshua Rabinowitz, in the Department of Chemistry, Princeton University, for an exclusive worldwide license to its SHMT (serine hydroxymethyltransferase) inhibitor program. In November 2022, the Companywe resolved to curtail itsour early-stage development efforts, including pre-clinical research at Barer Institute.Barer. Since then, the Company haswe have sought partners for Farber programs and has entered into a license agreement for one of its technologies.technologies that is in the pre-clinical research stage with the Ludwig Institute of Cancer Research and has transferred majority ownership of another one of its technologies, SHMT, to a new company, Forme Therapeutics, that is being managed by Dr. Joshua Rabinowitz with the goal of developing SHMT. Going forward, we expect that Barer will primarily operate as an entity holding interest in these two cancer-focused opportunities.

TheWe Company ownsown a 37.5% equity interest in RP Finance Finance LLC (“RP Finance”), which was, until March 13, 2024 (the date of the RP Finance Consolidation,Consolidation (as described in Note 3 6 to the Consolidated Financial Statements)), accounted for under the equity method. RP Finance is an entity in which vehicles associated with members of the family of Howard S. Jonas (Executive Chairman, Chief Executive Officer, President, Chairman of the Board, and controlling stockholder of the Company), whichhold holdsan aggregate 37.5% equity interest of RP Finance.interest. RP Finance holds debt and equity investments in Cornerstone. In October 2021, Cornerstone received negative results of its Avenger 500 Phase 3 study for Devimistat in pancreatic cancer as well as a recommendation to stop its ARMADA 2000 Phase 3 study due to a determination that the trial would be unlikely to achieve its primary endpoint (the “Data Events”). Due to the Data Events, RP Finance fully impaired its then debt and equity investments in Cornerstone.

In April 2023, the Companywe first invested in Day Three, a company which empowers third-party manufacturers to reimagine their existing cannabisproduct offerings enabling themthose third-party manufacturers to bring to market better, cleaner, more precise and predictable versions of their products by utilizing Day Three’s pharmaceutical-grade technology and innovation like Unlokt™. In January 2024, the Companywe entered into a series of transactions with Day Three and certain of its shareholders, acquiring a controlling interest of in Day Three and subsequently consolidating Day Three’sThree's results (the “Day Three Acquisition”). On March 14, 2025, Day Three Labs Manufacturing, a majority owned subsidiary of Day Three, entered into an Asset Purchase Agreement and Licensing Agreement (the “DTLM Sale Agreement”), pursuant to which they sold assets and licensed certain applications of their Unlokt™ technology used in their cannabinoid ingredient manufacturing business. See Note 13 in the Notes to our Consolidated Financial Statements for additional information.

Our business consists of three reportable segments - Healthcare, Infusion Technology, and Real Estate. We evaluate the performance of our Healthcare segment based primarily on researchresults and development efforts and results of clinical trials,trials and ourloss from operations, and the Infusion Technology and Real Estate segments based primarily on resultsrevenues and income of(loss) from operations. Accordingly, the income and expense line items below loss from operations are only included in the discussion of consolidated results of operations.

OurResults consolidatedof expensesoperations for our Healthcare segment segment were as follows:

To date, theThe Healthcare segment hasis not generated any revenues. The entiretycomprised of the expenses in the Healthcare segment relate to the activities of Barer, LipoMedix, Farber, Cornerstone, Cyclo, and Rafael Medical Devices. As of July 31, 2024,2025, we held a 100% interest in Barer,Barer and Cyclo, a 95% interest in LipoMedix, a 93% interest in Farber, a 67% interest in Cornerstone, and a 68%73% interest in Rafael Medical Devices.

Infusion TechnologyProduct revenue. Infusion TechnologyTotal revenue increasedfor bythe Healthcare $355segment thousand duringfor the year ended July 31, 20242025, increased to approximately $515 thousand compared to $0 for the year ended July 30, 31,2024. 2023This increase is primarily due to the acquisition inclusion of Dayproduct Threerevenue generated by Cyclo following the Cyclo Merger in JanuaryMarch 2024.2025.

General and administrative expenses. General and administrative expenses consist mainly of payroll, insurance,stock-based software,compensation expense, benefits, facilities, consulting and licenses.professional fees. GeneralThe increase in general and administrative expenses increased by $374 thousand during the year ended July 31, 20242025 compared to the year ended July 31, 20232024 is primarily due to the acquisition of controlling interest in Day Three, and subsequent consolidation of itsCyclo's results,general and administrative expenses, amounting to $3.6 million, following the Cyclo Merger in JanuaryMarch 2024.2025. In addition, legal and other professional fees increased by $0.6 million compared to the year ended July 31, 2024, primarily due to services related to the Cyclo Merger.

Research and development expenses. Research and development expenses increased by $502 thousand duringfor the year ended July 31, 20242025 compared to the year ended July 31, 20232024. Research and development expenses are derived from activity at Cyclo, Barer, LipoMedix, Farber, Cornerstone, and Rafael Medical Devices. The increase is primarily due to the acquisitionconsolidation of DayCyclo's Threeresearch and development expenses, amounting to $8.4 million, following the Cyclo Merger in January 2024.March 2025.

The revenue and expenses of the 520 Property have been excluded from the real estate segment in the figures below due to its classification of held-for-sale and discontinued operations, and the sale of the 520 Property on August 22, 2022. The Real Estate segment consists of a portion of a commercial building in Israel. Consolidated incomerevenue, (loss)expenses and expensesloss for our Real Estate segment were as follows:

EquityLoss inon lossinitial of Day Three. We recognized a loss of approximately $422 and $203 thousand from our ownership interestinvestment in Day Three dueupon acquisition. toWe operatingrecognized resultsa loss of $0 and $1.6 million on initial investment in Day Three upon acquisition for the years ended July July 31, 20242025 and 2023,2024. respectively. As ofIn January 2,2024, 2024,we acquired Day Three is a majority-owned subsidiary which is consolidated.Three. See Note 1013 to our accompanying consolidated financial statements for more further information regarding the acquisition.information.

Net loss attributable to noncontrolling interests. The change in the net loss attributable to noncontrolling interests is primarily attributed to the net lossacquisition of Cornerstone whichand includesDay $89.9Three millionand inthe IPR&Dconsolidation expenses.of their activity.

Rafael Holdings, Inc. (“Rafael Holdings”, “Rafael”, “we” or the “Company”) is a biotechnology company that develops pharmaceuticals and holds interests in clinical and early-stage companies that develop pharmaceuticals and medical devices. The Company’s lead candidate is Trappsol® Cyclo™, which is being evaluated in clinical trials for the potential treatment of Niemann-Pick Disease Type C1 (“NPC1”), a rare, fatal and progressive genetic disorder. The CompanyWe also holdshold: (i) a majority equity interest in LipoMedix Pharmaceuticals Ltd. (“LipoMedix”), a clinical-stageclinical stage pharmaceutical company:; (ii) Barer Institute Inc. (“Barer”), a wholly-owned cancer research focused operation whose operations have been substantially streamlined; (iii) a majority equity, and debt, interest in Cornerstone Pharmaceuticals, Inc. Inc. (“Cornerstone”), formerly known as Rafael Pharmaceuticals Inc., a cancer metabolism-based therapeutics company; (iv) a majority equity interest in Rafael Medical Devices, LLC (“Rafael Medical Devices”), an orthopedic-focused medical device company developing developing instruments to advance minimally invasive surgeries; and (v) a majority equity interest in Day Three Labs, Inc. (“Day Three”), a company which empowers third-party manufacturers to reimagine their existing product offerings enabling those third-party manufacturers to bring to market better, cleaner, more precise and predictable versions of their product by utilizing Day Three’s technology. The Company’s Our primary focus and goals areis to finish development of Trappsol® Cyclo™ through the completion of its ongoing pivotal Phase 3 clinical trial and bring that product to regulatory approval and market, and to expand its investment portfolio through opportunistic and strategic investments, including in therapeutics, that address high unmet medical needs. We are currently evaluating our other holdings to ensure the future focus of our resources are on core assets and specifically the Trappsol® Cyclo’sCyclo™ clinical and development efforts.

Historically, we owned real estate assets. As of JanuaryApril 31,30, 2026, we hold a portion of a commercial building in Jerusalem, Israel as our sole remaining real estate asset.

In May 2023, we first invested in Cyclo, a clinical-stage biotechnology company that develops cyclodextrin-based products for the potential treatment of neurodegenerative diseases. Cyclo’s lead drug candidate is Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin), a treatment for NPC1. NPC1 is a rare and fatal autosomal recessive genetic disease resulting in disrupted cholesterol metabolism that impacts the brain, lungs, liver, spleen,spleen and other organs. In January 2017, the FDA granted Fast Track designation to Trappsol® Cyclo™ for the treatment of NPC1. Initial patient enrollment in the U.S. Phase I study commenced in September 2017 and in May 2020, Cyclo announced Top Line data indicating Trappsol® Cyclo™ was well tolerated in this study. Cyclo is currently conducting a Phase 3 Clinical Trial evaluating Trappsol® Cyclo™ in Pediatric and Adult Patients with Niemann-Pick Disease, Type C1.  On March 25, 2025, we consummated the Merger with Cyclo whereby Cyclo became a wholly-owned subsidiary of the Company. SeeIn Noteaddition, 3Cyclo entered into an exclusive, worldwide, royalty-bearing Patent License Agreement with the Massachusetts Institute of Technology (“MIT”) for morecertain informationpatent onrights therelating Mergerto withsmall Cyclo.molecules to improve myelination in Alzheimer’s disease and APOE4 carriers.

LipoMedix is a clinical-stageclinical stage Israeli company focused on the development of a product candidate that holds the potential to be an innovative, safe,safe and effective cancer therapy based on liposome delivery. As of October 31, 2025, our ownership interest in LipoMedix was approximately 95%. As needed, we provide debt or equity funding to LipoMedix to support its development and clinical efforts. LipoMedix is currently exploring strategic options for its lead candidate, including potential licensing opportunities, collaborations with industry partners,partners and investigator-initiated studies.

In 2019, we established Barer, originally as a preclinical cancer metabolism research operation, to focus on developing a pipeline of novel therapeutic compounds, including compounds designed to regulate cancer metabolism with potentially broader application in other indications beyond cancer. Barer was comprised of scientists and academic advisors that are experts in cancer metabolism, chemistry,chemistry and drug development. In addition to its own internal discovery efforts, Barer pursued collaborative research agreements and in-licensing opportunities with leading scientists from top academic institutions. Barer’s majority owned subsidiary, Farber Partners, LLC (“Farber”), was formed around one such agreement with Princeton University’s Office of Technology Licensing (“Princeton”) for technology from the laboratory of Dr. Joshua Rabinowitz, in the Department of Chemistry, Princeton University, for an exclusive worldwide license to its SHMT (serine hydroxymethyltransferase) inhibitor program. In November 2022, we resolved to curtail its early-stage development efforts, including pre-clinical research at Barer and has, since that date, ceased almost all of such activity. Since then, we have sought partners for Farber programs and has entered into a license agreement for one of its technologies that is in the pre-clinical research stage with the Ludwig Institute of Cancer Research and has transferred majority ownership of another one of its technologies, SHMT, to a new company, Forme Therapeutics, that is being managed by Dr. Joshua Rabinowitz with the goal of developing SHMT while seeking out external investment and partnerships. Going forward, we expect that Barer will primarily operate as an entity holding interest in these two cancer-focused opportunities.

In January 2024, we entered into a series of transactions with Day Three and certain of its shareholders, acquiring a controlling interest in Day Three and subsequently consolidating Day Three’s results (the “Day Three Acquisition”). On March 14, 2025, Day Three Labs Manufacturing, a majority ownedmajority-owned subsidiary of Day Three, entered into an Asset Purchase Agreement and Licensing Agreement, pursuant to which they sold assets and licensed certain applications of their Unlokt™ technology used in their cannabinoid ingredient manufacturing business.

Our business consists of three reportable segments - Healthcare, Infusion Technology,Technology and Real Estate. We evaluate the performance of our Healthcare segment based primarily on results of clinical trials and loss from operations, and the Infusion Technology and Real Estate segments based primarily on revenues and income (loss) from operations. Accordingly, the income and expense line items below loss from operations are only included in the discussion of consolidated results of operations.

The Healthcare segment is comprised of the activities of Barer, LipoMedix, Farber, Cornerstone, Cyclo,Cyclo and Rafael Medical Devices. As of JanuaryApril 31,30, 2026, we held a 100% interest in Barer and Cyclo, a 95% interest in LipoMedix, a 93% interest in Farber, a 67% interest in Cornerstone,Cornerstone and a 73% interest in Rafael Medical Devices.

Product revenue. Total revenue for the Healthcare segment for the three and sixnine months ended JanuaryApril 31,30, 2026, increasedwas approximately $89 thousand and $368 thousand, respectively, compared to $0.1$243 million and $0.3 million, respectively, compared to $0thousand for the three and sixnine months ended JanuaryApril 31,30, 2025. ThisProduct increaserevenue is dueprimarily attributed to theCyclo’s inclusionspecialty chemicals of product revenue generated by Cyclo following the Merger in March 2025 as well as product sales generated by RMD following the FDA’s clearance of the VECTR System.business.

Cost of product revenue. Cost of product revenue for the Healthcare segment for the three and sixnine months ended JanuaryApril 31,30, 2026, increasedwas from$8 $—thousand duringand $29 thousand, respectively, compared to $9 thousand for the three and six nine months ended JanuaryApril 31, 2025 due to the inclusion of cost of product revenue generated by Cyclo following the Merger in March30, 2025.

General and administrative expenses. General and administrative expenses consist mainly of payroll, stock-based compensation expense, benefits, facilities, consulting and professional fees. The decrease in general and administrative expenses during the three months ended JanuaryApril 31,30, 2026 compared to the three months ended endedApril January 31,30, 2025 is primarily due to decreases: in payroll expenses of $0.1 million; in stock-based compensation expense of $0.2 million; in professional fees of $0.4 million; and in other expenses of $0.3 million. The decrease in general and administrative expenses for the nine months ended April 30, 2026 compared to the nine months ended April 30, 2025 is primarily attributable to decreases: in payroll expense of $0.6 million; in stock based compensation expense of $0.1$0.4 million; in professional fees of $0.5$0.8 million; and in other general and administrative expenses of $0.1 $0.4 million. ThisThe decreasedecreases waswere partially offset by the inclusion ofincrease in Cyclo’s general and administrative expenses of $0.8$1.5 million in the fiscal 2026 period. The increase in general and administrative expenses in the six months ended January 31, 2026 compared to the six months ended January 31, 2025 is primarily attributable to the inclusion of Cyclo’s general and administrative expenses of $1.7 million in the fiscal 2026 period. This increase was partially offset by decreases of: $0.6 million of payroll due to terminations; $0.3 million in stock based compensation; and $0.5 million in professional fees.million.

Research and development expenses. Research and development expenses are derived from activity at Cyclo, Barer, LipoMedix, Farber, Cornerstone,Cornerstone and Rafael Medical Devices. Research and development expenses have increased for the three and sixnine months ended JanuaryApril 31,30, 2026 compared to the three and sixnine months ended April January 31,30, 2025. For the three months ended JanuaryApril 31,30, 2026, the increase was attributable to Cyclo’s research and development expenses of $4.0$2.5 million,million offset by decreases: in R&D payroll expense of $0.3 million; and in clinical trial expenses and other expenses, excluding Cycloexpenses of $0.1 $0.2 million. For the sixnine months ended JanuaryApril 31,30, 2026, the increase was attributable to the increase in Cyclo’s research and development expenses which which amounted to $10.4$12.8 million,million plusas well as an increase in stockR&D basedstock-based compensation expense of $0.4 million, partiallymillion offset by a $0.5 million decreasedecreases: in R&D payroll dueof to$0.9 terminationsmillion; and a $0.3 million decrease in clinical trial and other expenses,expenses excludingof Cyclo.$0.5 million.

The Infusion Technology segment is comprised of our majority equity interest in Day Three, which was acquired in January 2024. Revenues associated with the Infusion Technology segment consist of Infusion Technology revenue derived from Day Three’s Unlokt™ technology. Cost of Infusion Technology revenue includes supplies, materials, production labor,labor and travel costs. General and administrative expenses for the Infusion Technology segment consist mainly of payroll, insurance, software,software and licenses. Research and development expenses for the Infusion Technology segment include costs related to the development of new products and services.

Due to reductions in certain operationsoperations, including a layoff within the Company’s Infusion Technology segment, the Companywe concluded that a triggering event occurred during theNovember three months ended January 31, 2025 under ASC 350 and ASC 3602024, that required the Company us to assess if there was an impairment.impairment Theunder CompanyASC 350 and ASC 360. We completed an analysis pursuant to ASC 360 and determined that the expected undiscounted cash flows of the asset group exceeded its carrying amount, indicating that the long-lived assets were not impaired. In accordance with ASC 350, the Companywe performed a quantitative goodwill impairment test, which indicated that the carrying amount of the reporting unit exceeded the estimated fair value of the reporting unit, indicating that the goodwill of the reporting unit was impaired. The CompanyWe recorded an impairment charge of $3.1 million related to the Infusion Technology segment’s goodwill during the threenine months ended JanuaryApril 31,30, 2025.

On March 14, 2025, Day Three Labs Manufacturing entered into the DTLM Sale Agreement, pursuant to which they sold assets and licensed certain applications of their Unlokt™ technology used in Infusion Technology services, causing an overall reduction in revenues and operating expenses during the three and sixnine months ended JanuaryApril 31,30, 2026 compared to the prior year periods.

General and administrative expenses. General and administrative expenses consist mainly of real estate taxes, payroll, accounting and legal fees, as well as building operating and office expenses. The decrease in general and administrative expenses during the three and six months ended January 31, 2026 compared to the three and six months ended January 31, 2025 is primarily the result of a decrease in real estate taxes.

Interest income. We recorded interest income of $0.3 million and $0.5 million for the three months ended January 31,April 30, 2026 and 2025, respectively, and interest income of $0.7 $1.0 million and $1.1$1.5 million for for the sixnine months ended JanuaryApril 31,30, 2026 and 2025, respectively. In November 2024, we sold our investments in available-for-sale securities securities and cash equivalents to reallocate assets to better align with our strategic goals. Accordingly, interest income has decreased due to a lower interest rate and decreased interest income earning balances.

Realized gain on available-for-sale securities. We recognized a realized loss on available-for-sale securities of $16 thousand for the three months ended January 31, 2025 and a gain on available-for-sale securities of $0.2 million for the sixnine months ended JanuaryApril 31,30, 2025, related to sale and maturity activity. TheNo realized gains were recognized during the three and nine months ended April 30, 2026 or the three months ended April 30, 2025 as the available-for-sale portfolio was sold in November 2024.

Unrealized loss on investment - Cyclo. Unrealized gains and losses on investment - Cyclo arewere recognized as a result of changes in the fair value of our investments in Cyclo common stock and warrants which fluctuated due to the volatility of the market price of Cyclo common stock leading up to the Cyclo Merger. We recorded an unrealized gain of $0.6 million for the three months ended January 31, 2025 and an unrealized loss of $3.8 million for the six months ended January 31, 2025.

Unrealized loss on convertible notes receivable, due from Cyclo. We recorded an unrealized gain of $0.5$0.4 million for the three months ended JanuaryApril 31,30, 2025 and an unrealized loss of of $1.1$0.7 million for the sixnine months ended JanuaryApril 31,30, 20252025, related to the change in fair value of our convertible notes receivable due from from Cyclo, which were forgiven as part of the MergerCyclo and therefore not held during the six months ended January 31, 2025.merger.

Gain on settlement of accounts payable and convertible notes payable. We recorded a gain of $0.2$3.7 million for the three months ended April 30, 2026 and sixa gain of $4.0 million for the nine months ended JanuaryApril 31,30, 20262026, related to settlements between Cornerstone and various vendors and convertible notes holders.

Other (loss) income, net. We recorded other income, income, net of an insignificant amount for the three months ended JanuaryApril 31,30, 2026 and other income, net of $0.1 million for the sixnine months ended JanuaryApril 31,30, 2026. TheOther incomeincome, net was primarily$0.1 relatedmillion and an insignificant amount for the three and nine months ended April 30, 2025, respectively, due to the gain on the sale of CornerstoneCornerstone’s fixed assets. For the three and six months ended January 31, 2025, we recorded other loss, net of $0.1 million primarily due to the loss on sale of Day Three fixed assets.IPR&D.

Net income (loss) attributable to noncontrolling interests. The change in the net income (loss) attributable to noncontrolling interests is primarily attributed to lower net losses at certain majority-owned subsidiaries during the three and sixnine months ended JanuaryApril 31,30, 2026 as compared to the three and sixnine months ended January 31,April 30, 2025.

As of JanuaryApril 31,30, 2026, we held cash and cash cash equivalents of approximately $37.8$30.5 million. We expect the balance of cash and cash equivalents to be sufficient to meet our obligations for at least the next 12 months from the filing of this Quarterly Report on Form 10-Q.

For the sixnine months ended JanuaryApril 31,30, 2025,2026, cash used in operating activities was $5.4$21.6 million,million impacted by a net loss of $14.5$19.0 million adjusted for non-cash items totaling $8.6$2.7 million. Cash usedgenerated from operating assets and liabilities primarily included the collection of $0.2other receivables of $1.2 million ofand accounts receivable and $0.5 million of interest receivables as well as an increase in accrued non-current expenses of $0.3 million, offset by an increase in prepaid clinical trials of $0.7 million, a decrease in accounts payable and accrued expenses of $0.2 million and accrued expensesexpenses, noncurrent of $0.4 million.

Cash used in investing activities for the sixnine months ended JanuaryApril 31,30, 2026 of $0.7 million was primarily due to the purchase of investmentspreferred inshares from Nina Medical Ltd. for $0.8 million, offset by proceeds of $0.1 million from the sale of property and equipment.

Cash provided by investing activities for the sixnine months ended JanuaryApril 31,30, 2025 of $43.9 million was primarily due to proceeds of $80.7 million from sales and maturities of available-for-sale securities securities and $2.3 million in proceeds from Hedgehedge Funds of $2.3,funds, offset by purchases of available-for-sale securities of approximately $16.9 million, andpurchases payments forof $15.0$19.5 million in convertible notes receivable, due from Cyclo.Cyclo, and cash paid in the Cyclo Merger, net of cash acquired, of $2.3 million.

Cash used in financing activities for the sixnine months ended JanuaryApril 31,30, 2026 was primarily related to $60 thousand of paymentspayment for taxes onrelated to shares withheld for employee taxes.taxes of $79 thousand and cash paid to settle convertible notes payable of $11 thousand.

Cash used in financing activities for the sixnine months ended JanuaryApril 31,30, 2025 was primarily related to thea $75 thousand of paymentspayment for taxes onrelated to shares withheld for employee taxes.taxes of $108 thousand and offset by proceeds from sale of RMD membership units of $44 thousand.

The application of critical accounting policies requires that we make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. These estimates and assumptions are based on historical and other factors believed to be reasonable under the circumstances. We evaluate these estimates and assumptions on an ongoing basis and may retain outside consultants to assist in our evaluation. If actual results ultimately differ from previous estimates, the revisions are included in results of operations in the period in which the actual amounts become known. The critical accounting policies that involve the most significant management judgments and estimates used in preparation of our consolidated financial statements, or are the most sensitive to change from outside factors, are discussed in the Critical Accounting Estimates section in Item 7 of the Annual Report on Form 10-K for fiscal year 2025.2025 as filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 29, 2025 (the “2025 Form 10-K”).