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

Rocket One Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1711786 · All filings on SEC.gov

Everything below is quoted or computed from Rocket One Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

11 / 9risk-factor paragraphs added / removed in latest 10-K
1new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-27 (period ending 2025-12-31) with 10-K filed 2025-03-28 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

11new paragraphs
9removed paragraphs
16reworded paragraphs
19,790 → 20,681words in section

New heading “Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.”

Removed heading “The Restatement of our financial statements may affect shareholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.”

Removed heading “We identified a material weakness in our internal control over financial reporting, which resulted in the restatement of our consolidated financial statements for several prior annual and quarterly and year-to-date periods. If remediation of this material weakness is not effective, or if we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or operating results, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.”

Removed heading “The restatement of our prior quarterly financial statements may affect investor confidence and raise reputational issues and may subject us to additional risks and uncertainties, including increased professional costs and the increased possibility of legal proceedings and regulatory inquiries.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: restatement, investigation, sanction
“The Restatement of our financial statements may affect shareholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.”
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Removed text topics: material weakness, restatement
“We identified a material weakness in our internal control over financial reporting, which resulted in the restatement of our consolidated financial statements for several prior annual and quarterly and year-to-date periods. If remediation of this material weakness is not effective, or if we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or operating results, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.”
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Removed text topics: restatement, investigation, sanction, liquidity
“We have incurred, and may continue to incur, substantial unanticipated costs for accounting and legal fees in connection with, or related to, the Restatement. The Restatement could also subject us to other risks and uncertainties, including the increased possibility of legal proceedings and inquiries, sanctions, or investigations by the SEC or other regulatory authorities relating to the Restatement. …”
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Removed text topics: restatement
“The restatement of our prior quarterly financial statements may affect investor confidence and raise reputational issues and may subject us to additional risks and uncertainties, including increased professional costs and the increased possibility of legal proceedings and regulatory inquiries.”
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New text topics: going concern
“Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.”
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Removed text topics: restatement, litigation
“As discussed in Note 8 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we determined to restate our previously issued audited consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and our unaudited condensed consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and for each of the quarterly and year to date periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023, after we identified material amounts …”
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Full comparison: every changed paragraph (36)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Reworded

We were incorporated in May 2017 and have a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the development and expansion of a new business enterprise. Since inception, we have incurred losses and expect to continue to operate at a net loss for at least the next several years as we continue our research and development efforts, conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities. Our net losses for the years ended December 31, 31,2025 and 2024 and 2023 were $8.2 $12.5 million and $8.1$8.2 million, respectively, and our accumulated deficit as of December 31, 20242025 and 20232024 was $60.4 $72.9 million and $52.2$60.4 million, respectively. There can be no assurance that the products under development by us will be approved for sale in the U.S. or elsewhere. Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability, we may be unable to continue our operations.

Reworded

The capital markets have been unpredictable in the recent past for unprofitable companies such as ours. The amount of capital that a company such as ours is able to raise often depends on variables that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued viability will be materially adversely affected.

Added

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.

Added

Our financial statements as of December 31, 2025 have been prepared under the assumption that we will continue as a going concern for the next twelve months. Our independent registered public accounting firm included in its opinion for the year ended December 31, 2025 an explanatory paragraph referring to our recurring losses and negative cash flows from operations and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available. Our ability to continue as a going concern is dependent upon our ability to obtain additional funding through strategic relationships, public or private equity or debt financings, grants or other arrangements. Our financial statements as of December 31, 2025 did not include any adjustments that might result from the outcome of this uncertainty. The reaction of investors to the inclusion of a going concern statement by our auditors, and our potential inability to continue as a going concern, in future years could materially adversely affect our share price and our ability to raise new capital or enter into strategic alliances. Furthermore, we also could be required to seek funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us.

Removed

The Restatement of our financial statements may affect shareholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.

Removed

We have incurred, and may continue to incur, substantial unanticipated costs for accounting and legal fees in connection with, or related to, the Restatement. The Restatement could also subject us to other risks and uncertainties, including the increased possibility of legal proceedings and inquiries, sanctions, or investigations by the SEC or other regulatory authorities relating to the Restatement. Any of the foregoing may adversely affect our reputation, the accuracy and timing of our financial reporting, or our business, results of operations, liquidity, and financial condition, or cause shareholders and investors to lose confidence in the accuracy and completeness of our financial reports or cause the market price of our common stock to decline. Any such legal proceedings or regulatory inquiries, sanctions, or investigation, whether successful or not, could adversely affect our business, financial condition, and results of operations.

Reworded

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such trials are being conducted, by an independent Safety Review Board for such trial or by the FDA, Therapeutics Goods Administration (“TGA”), European Medicines Agency (“EMA”),EMA, or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, TGA, or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Added

If one or more of our product candidates receives marketing approval, the commercial success of such product may depend in part on our ability to obtain and maintain periods of regulatory exclusivity under the FDCA. However, there can be no assurance that our product candidates will qualify for or retain any such exclusivity.

Reworded

RegulatoryWe have orphan drug designation from the FDA for HT-KIT for the treatment of mastocytosis and we may seek orphan drug designation for other product candidates. As discussed above, 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 drug candidate as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug product available in the United States for the type of disease or condition will be recovered from sales of the product. ODD entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers; however, the orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process. Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, as codified by the Consolidated Appropriations Act of 2026. This means that the FDA may not approve any other applications to market the same drug or biological product for the same “same approved use or indication within such rare disease or condition” for seven years, except in certain circumstances, including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care) to the product with orphan exclusivity.

Added

We may not obtain any future orphan drug designations that we apply for. Orphan drug designations do not guarantee that we will be able to successfully develop our product candidates, and there is no guarantee that we will be able to maintain any orphan drug designations that we receive. For instance, orphan drug designations may be revoked if the FDA determines that our request for orphan drug designation was materially defective, if the FDA determines that the product candidate was not eligible for designation at the time of the submission of the request, or if we are unable to assure sufficient quantities of the commercial product for which the designation was granted to meet the needs of patients.

Added

Moreover, even if we are able to receive and maintain orphan drug designations, we may ultimately not receive any period of regulatory exclusivity if our product candidates are approved. For instance, exclusive marketing rights in the United States may be limited if we 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. Orphan exclusivity may further be lost if we are unable to assure a sufficient quantity of the product to meet the needs of patients with the rare disease or condition.

Added

Even if we obtain orphan exclusivity for any of our current or future product candidates, that exclusivity may not effectively protect the product from competition as different products can be approved for the same condition or products that are the same as ours can be approved for different conditions. Even after an orphan product is approved, competitors may receive approval of different products for the indication for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which the orphan product has exclusivity. If another sponsor receives FDA approval for such product before we do, we would be prevented from launching our product in the United States for the orphan indication for a period of at least seven years, unless we can demonstrate clinical superiority. Moreover, third-party payors may reimburse for products off-label even if not indicated for the orphan condition.

Added

Further, our product candidates may not be able to obtain and/or maintain NCE exclusivity. The FDA may determine that a product candidate does not contain a new active moiety if the active ingredient has been previously approved, if the molecule is determined to be a salt, ester, metabolite, or other derivative of a previously approved active moiety, or if the FDA otherwise interprets the statutory requirements in a manner that limits the availability of NCE exclusivity. If the FDA determines that our product candidates are not eligible for NCE exclusivity, competing applicants could submit abbreviated applications that rely on our safety and efficacy data earlier than would be permitted if we do obtain NCE exclusivity.

Added

Our product candidates may also not be able to obtain and/or maintain NCI exclusivity. The FDA may determine that the clinical studies supporting approval do not qualify as “new clinical investigations” within the meaning of the statute or that the studies were not essential to approval. In addition, as discussed above, NCI exclusivity protects only the specific conditions of approval supported by the qualifying studies and does not prevent the FDA from approving competing products that rely on our data for other conditions of use or that rely on independently generated data. As a result, even if we obtain NCI exclusivity, competitors may still be able to obtain approval for competing products.

Added

Our product candidates may also not be able to obtain and/or maintain pediatric exclusivity. As discussed above, pediatric exclusivity is granted only if the FDA issues a written request for pediatric studies and we complete those studies in accordance with the request and within the required timeframes. There can be no assurance that the FDA will issue such a request, that we will be able to complete the required studies within the specified timelines, that the studies will be deemed responsive to the written request, or that we will otherwise satisfy the regulatory requirements necessary to obtain pediatric exclusivity. In addition, pediatric exclusivity relies on our ability to obtain some other exclusivity period or patent protection, as it extends existing exclusivity periods and/or patent protection but does not create an independent exclusivity period if no underlying exclusivity or patent protection exists.

Added

Finally, any exclusivity that we obtain could be subject to challenge, reinterpretation, or limitation by the FDA, legislative changes, or judicial decisions. Changes in law, regulation, or FDA policy regarding the scope or availability of regulatory exclusivity could also reduce the period of protection afforded to our product candidates. If we fail to obtain or maintain regulatory exclusivity for any approved product, competitors may be able to rely on our clinical and nonclinical data to support approval of competing products earlier than if we had obtained exclusivity, which could materially adversely affect our business, financial condition, and results of operations.

Removed

ODD entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity. This means that the FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except in certain circumstances, including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care) to the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which the orphan product has exclusivity. In addition, exclusive marketing rights in the United States may be limited if we 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.

Reworded

In JanuaryOn 2024,December 18, 2025, the BIOSECURE Act (H.R. 7085) was introducedsigned into inlaw, theas House of Representatives and a substantially similar bill (S.3558) was introduced in the Senate. Although the House of Representativespart of the priorFY Congress2026 (theNational 118thDefense Congress) passed the BIOSECUREAuthorization Act on(“NDAA”).Under Septemberthis 9, 2024,law, the legislationU.S. ultimatelygovernment did not become law in the 118th Congress. It is unclear whether the current Congress (the 119th Congress) will introduce the BIOSECURE Act or similar legislation in this congressional session. If these bills became law, or similar laws are passed, they would havehas the potential to severely restrict the ability of U.S. biopharmaceutical companies to contract with certain Chinese biotechnology companies “of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government. Unlike previous versions of the bill, the BIOSECURE Act, as enacted, does not name specific companies as “companies of concern;” but, rather, treats any company on the Department of Defense (now “Department of War”) 1260H list of “Chinese military companies” as “companies of concern.” We do business with companies in China and it is possible some of our contractual counterparties counterparties could be impacted by this legislation.

Reworded

Current and future legislation legislationand other regulatory reform measures may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates andcandidates, affect the prices we may obtain for such product candidates.candidates and may have a negative impact on our business and results of operations.

Reworded

In the United States, the Medicare Modernization Act (“MMA”) changed the way Medicare covers and pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices for drugs. In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that will be covered in any therapeutic class. As a result of this legislation and the expansion of federal coverage of drug products, we expect that there will be additional pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that we receive for our product candidates and could seriously harm our business. Additionally, in 2025, the IRA implemented several key changes to Medicare Part D drug coverage, which could also impact coverage and the price that we receive for our product candidates, including, but not limited to (i) a $2,000 annual cap for brand-name and generic drugs, (ii) elimination of the “coverage gap” phase during which Medicare beneficiaries previously had to pay for 100% of drug cost, (iii) monthly payments options, and (iv) mandated manufacturer discounts on brand-name and generic drugs. While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.

Added

Furthermore, on July 4, 2025, the OBBBA was signed into law which is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing Federal funding, and limiting provider taxes used to fund the program. OBBBA also narrows access to Affordable Care Act, marketplace exchange enrollment and declines to extend the Affordable Care Act enhanced advanced premium tax credits, which expired on December 31, 2025, which, among other provisions in the law, have reduced the number of Americans with health insurance and led to significantly higher, often doubled, premiums for 2026 coverage. In addition, there have been actions and proposals from the Trump administration that include: reducing agency workforce and cutting programs; directing The U.S. Department of Health and Human Services and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products; imposing tariffs on imported pharmaceutical products; and directing certain federal agencies to enforce existing law regarding hospital and plan price transparency and by standardizing prices across hospitals and health plans. Although any proposed measures will require authorization through additional legislation to become effective (and Congress and the current administration have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs), each of these initiatives has been implemented to some degree through executive orders regarding the same. For example, the president’s 2026 Federal Budget, which is being incrementally enacted through a series of "minibus" spending bills, proposed significant reductions to federal agency staffing from 2024/2025 levels, which were already significantly reduced due to agency actions based on an executive order mandating the same. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or successfully commercialize our drugs.

Reworded

In the United States, there have been, and continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future results of pharmaceutical manufactures’ operations. In particular, there have been and continue to be a number of initiatives at the federal and state levels that seek to reduce healthcare costs. On the federal level, the Affordable Care Act (“ACA”) was enacted in March 2010, and continues includedto be amended by subsequent legislation, and includes measures to significantly change the way healthcare is financed by both governmental and private insurers. Among the provisions of the ACAACA, as amended, that have been of greatest importance to the pharmaceutical and biotechnology industry are the following:

Reworded

Although there have been legal and political challenges to certain aspects of the ACA, the Biden Administration affirmed support for the law and, entered its own executive orders to enforce and strengthen it. Because of the volatility surrounding the implementation and enforcement of the ACA since its passage, and at this time, the full effect that the ACA would have on a pharmaceutical manufacturer remains unclear. This uncertainty is heightened by actions taken under the Trump Administration. On January 20, 2025, President Trump issued Executive Order 14148, which revoked Executive Order 14009 issued by President Biden on January 28, 2021, that had initiated a special enrollment period for purposes of obtaining health insurance coverage coverage through the ACA marketplace. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear what additional healthcare reform measures will be implemented by the Trump Administration, but significant changes are anticipated.possible. The potential changes in patient coverage by government funded insurance may impact our pricing.

Reworded

The first Trump Administration, on July 24, 2020 and September 13, 2020, announced several executive orders related to prescription drug pricing. As a result, the FDA concurrently released a final rule and guidance in September 20202020, which are still in effect, providing pathways for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, the HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. The implementation of the rule was delayed until 2032 by the Inflation Reduction Act of 2022. On November 20, 2020, CMS issued an interim final rule implementing President Trump’s Most Favored Nation executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries. The Most Favored Nation regulations mandate participation by identified Medicare Part B providers and will apply in all U.S. states and territories for a seven-year period beginning January 1, 2021, and ending December 31, 2027. As a result of litigation challenging the Most Favored Nation model, on December 27, 2021 CMS published a final rule that rescinds the Most Favored Nation model interim final rule. Further, in July 2021, the Biden administration released an executive order that included multiple provisions aimed at prescription drugs. In response to President Biden’s executive order, on September 9, 2021, the HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform. The plan sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. Now, under the current administration, CMS has proposed two rules to implement alternative drug pricing models, both of which aim to expand the Trump Administration’s Most Favored Nation drug pricing policies, as set forth in Executive Order 14297. No legislation or administrative actions have been finalized to implement these principles. ItThe first proposed rule would establish the mandatory Global Benchmark for Efficient Drug Pricing (“GLOBE”) Model, which would utilize a benchmark derived from manufacturer-reported international pricing (rather than domestic drug pricing), and would run from October 1, 2026 to September 30, 2033. The second proposed rule would establish the mandatory Guarding U.S. Medicare Against Rising Drug Costs (“GUARD”) Model, which would test how changes to the Part D inflation rebate impact costs for the Medicare program, and would run from January 1, 2027 to December 31, 2035. The comment period for both rules ended on February 23, 2026, and reflected significant push-back from industry participants. Accordingly, if and when CMS issues the final rules later in 2026, legal challenges are expected. Additionally, in February 2026, the Administration launched TrumpRx, a platform aimed at reducing high prescription drug costs by allowing users to access, via TrumpRx.gov, discounted, brand-name, and specialty medications. TrumpRx serves as a search tool and hub directing consumers to manufacturer websites or pharmacy coupons, bypassing traditional insurance to provide lower, international-style pricing. In January 2026, the HHS Office of Inspector General (“OIG”) issued a bulletin designating the TrumpRx program as “low risk” under federal fraud and abuse laws; however, industry participants have raised concerns, which indicate that legal challenges to the TrumpRx program are possible. Although it is unclear how the current Trump Administration will further address drug pricing.pricing, the Administration has continues to tout it as a key priority.

Reworded

In August 2022, the Inflation Reduction Act of 2022 was signed into law by President Biden. The new legislation has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage. Among other things, the Inflation Reduction Act of 2022 requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The Inflation Reduction Act of 2022 permits the Secretary of the HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. There is uncertainty surrounding this program with the new administration, especially in light of the administration’s budget cuts which impact an agency’s ability to regulate through guidance. Further, it is unclear how the new leadership of HHS, CMS, etc. will approach the issue of drug pricing. However, CMS pricing.has already implemented several of the IRA’s key changes to Medicare Part D drug coverage, through rule and/or guidance, including (i) the $2,000 annual cap for brand-name and generic drugs, (ii) elimination of the “coverage gap” phase under Medicare Part D, and (iii) creation of the Medicare Part D Manufacturer Discount Program, which mandates manufacturer discounts on brand-name and generic drugs and provides beneficiaries with monthly payment options.

Reworded

Further, there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA. The FDA has issued several guidance documents, but no implementing regulations, on biosimilars.biosimilars (although the Trump Administration continues to tout its commitment to making it “faster and less costly to develop biosimilar medicines”). A number of biosimilar applications have been approved over the past few years.years, including one as recently as January 2026. The regulations regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical manufacturers manufacturers conduct their business and may require changes to current strategies. A biosimilar is a biological product that is highly similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

Reworded

The global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, inflationary pressure and interest rate changes, increases in unemployment rates and uncertainty about economic stability. The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, terrorism or other geopolitical events. Sanctions imposed by the United States and other countries in response to such conflicts, may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. Moreover, the 2023 closures of Silicon Valley Bank and Signature Bank and their placement into receivership with the Federal Deposit Insurance Corporation (“FDIC”) created bank-specific and broader financial institution liquidity risk and concerns. Although the Department of the Treasury, the Federal Reserve, and the FDIC jointly released a statement that depositors at SVB and Signature Bank would have access to their funds, even those in excess of the standard FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term working capital needs, and create additional market and economic uncertainty. We have significant cash balances at financial institutions which, throughout the year, regularly exceed the federally insured limit of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on our financial condition, results of operations, and cash flow.

Reworded

Our Articles of Incorporation, Amended and Restated Bylaws, and Nevada law could make it more difficult for a third-party to acquire us, even if closing such a transaction would be beneficial to our shareholders. We are authorized to issue up to 10,000,000 shares of preferred stock, none of which are outstanding as of March 28,26, 2025.2026. This preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our board of directors without further action by shareholders. The terms of any series of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions. As of March 28,26, 2025,2026, 5,000,000 shares of our preferred stock have been designated as Series A Preferred Stock of which 3,102,480 shares of Series A Preferred Stock were previously issued and converted into common stock at the time of our initial public offering and 1,897,520 shares of Series A Preferred Stock remain authorized. As of March 28,26, 2025,2026, 2,000,000 shares of our preferred stock have been designated as Series B Preferred Stock of which 2,000,000 shares of Series B Preferred Stock were previously issued and redeemed. The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore reduce the value of our common stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third-party and thereby preserve control by the present management.

Reworded

The trading market for our common stock will rely relies in part on the research and reports that industry or financial analysts publish about us, our business, our markets and our competitors. We do not control these analysts. If securities analysts do not cover our common stock, the lack of research coverage may adversely affect the market price of our common stock. Furthermore, if one or more of the analysts who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price would likely decline. If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose visibility in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline and may also impair our ability to expand our business with existing customers and attract new customers.

Reworded

As a publicly traded company we incur significant legal, accounting and other expenses. The obligations of being a public company in the United States require significant expenditures and places significant demands on our management and other personnel, including costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance practices, including those under Sarbanes-Oxley, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing requirements of Nasdaq. These rules require the establishment and maintenance of effective disclosure and financial controls and procedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules that are often difficult to implement, monitor and maintain compliance with. Moreover, despite reforms made possible by the JOBS Act, the reporting requirements, rules, and regulations will make some activities more time-consuming and costly, since we are no longer an “emerging growth company.” Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted, among other potential problems.

Removed

We identified a material weakness in our internal control over financial reporting, which resulted in the restatement of our consolidated financial statements for several prior annual and quarterly and year-to-date periods. If remediation of this material weakness is not effective, or if we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or operating results, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.

Removed

We identified a material weakness in our internal control over financial reporting as of March 21, 2025. As defined in the standards established by the U.S. Public Company Accounting Oversight Board, a “material weakness” is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

Removed

The material weakness identified related to the proper classification of research and development expenses, which impacted our previously issued consolidated financial statements and condensed consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and for each of the quarterly and year to date periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023. As further described in Note 8 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, there were material amounts inappropriately classified as research and development expense which should have been classified as prepaid assets and other assets. We are taking steps to remediate the material weakness and are in the process of supplementing our existing internal controls related to the proper classification of research and development expenses. In response to the material weakness, we are enhancing our review procedures over significant contracts with contract manufacturing organizations and contract research organizations, augmenting existing staff and strengthening our review process. The incremental internal controls created to respond to this material weakness are being integrated into our internal controls testing plan and they will be tested during 2025 and beyond.

Removed

Although we plan to complete the above remediation process and associated evaluation and testing as quickly as possible, we may not be able to do so and our initiatives may prove not to be successful. If our remedial measures are insufficient to address the material weakness, or if additional material weaknesses or significant deficiencies in our internal control over financial reporting are discovered during the evaluation and testing process, we will be unable to assert that our internal control over financial reporting is effective and our independent registered public accounting firm will be unable to express an opinion on the effectiveness of our internal control. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.

Removed

The restatement of our prior quarterly financial statements may affect investor confidence and raise reputational issues and may subject us to additional risks and uncertainties, including increased professional costs and the increased possibility of legal proceedings and regulatory inquiries.

Removed

As discussed in Note 8 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we determined to restate our previously issued audited consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and our unaudited condensed consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021, and for each of the quarterly and year to date periods ended March 31, 2024 and 2023, June 30, 2024 and 2023, and September 30, 2024 and 2023, after we identified material amounts inappropriately classified as research and development expense which should have been classified as prepaid assets and other assets. As a result of this error and the resulting restatement of our consolidated financial statements and condensed consolidated financial statements for the impacted periods, we have incurred, and may continue to incur, unanticipated costs for accounting and legal fees in connection with or related to the restatement and have become subject to a number of additional risks and uncertainties, including the increased possibility of litigation and regulatory inquiries. Any of the foregoing may affect investor confidence in the accuracy of our financial disclosures and may raise reputational risks for our business, both of which could harm our business and financial results.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

6new paragraphs
9removed paragraphs
6reworded paragraphs
3,053 → 3,100words in section

Removed heading “Income Taxes (Topic 740)”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: fine
“During the year ended December 31, 2024, we issued 2,500,000 shares (the “Warrant Shares”) of our common stock upon the exercise of the 2,500,000 January 2023 Existing Warrants (as defined herein) for net proceeds of approximately $3.7 million, after deducting placement agent fees and other offering expenses of approximately $0.4 million. …”
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“Income Taxes (Topic 740)”
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New text
“In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to provide more detailed disaggregation of expenses in the income statement, focusing on the nature of the expenses rather than their function. The new disclosures will require entities to separately present expenses for significant line items, including but not limited to, depreciation, amortization, and employee compensation. …”
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New text
“During the year ended December 31, 2025, the increase in general and administrative expenses of approximately $1,449,000 was primarily attributed to an increase in compensation and related expenses of $590,000, primarily attributable to the issuance of 800,000 shares of common stock to our Chief Executive Officer valued at $968,000 and an increase in other compensation and related expenses of $196,000, which were offset by a decrease in stock-based compensation of approximately $574,000 in connection with the issuance of stock options during the year ended December 31, 2025 as compared to …”
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Paragraph as it now reads, with added and removed wording marked:

On November 8, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) under which we maycould offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager pursuant to our effective shelf registration statement on Form S-3, including an accompanying prospectusS-3 (File No. 333-272620), including an accompanying base prospectus and and a prospectus supplement dated November 8, 2024. Sales of shares of the Company’s common stock through Wainwright, if any, will be be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended.Act. Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time to time, based on instructions from us (including any price, time or size limits or other parameters or conditions we may impose). We will pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection with the ATM Agreement. On February 7, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $5,000,000 pursuant to a prospectus supplement dated February 7, 2025. On November 13, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $2,439,256 pursuant to a prospectus supplement dated November 13, 2025 for a current offering up to $4,821,200. The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant to the ATM Agreement, of shares having an aggregate offering price of $2,700,000$10,139,256 and (2) the termination of the ATM Agreement by either us or Wainwright, as set forth therein. FromDuring Novemberthe 8,year 2024 toended December 31, 20242025 we issued 1,137,250an aggregate of 2,782,309 shares of our common stock for net proceeds of approximately $4.1 $1.0million, millionafter deducting approximately $142,000 in sales agent commissions and other offering expenses payable by us pursuant to the ATM Agreement.
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New text
“For the year ended December 31, 2025, research and development expenses were approximately $5.9 million. Specifically, during the year ended December 31, 2025, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $3,646,000 related to manufacturing and clinical activities; (ii) HT-KIT, approximately $753,000 related to manufacturing and preclinical activities; (iii) HT-VA, approximately $137,000, and (iv) HT-ALZ, approximately $12,000 related to preclinical studies. …”
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Full comparison: every changed paragraph (21)

Green = added, red = removed. Unchanged paragraphs, 3 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Added

For the year ended December 31, 2025, research and development expenses were approximately $5.9 million. Specifically, during the year ended December 31, 2025, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $3,646,000 related to manufacturing and clinical activities; (ii) HT-KIT, approximately $753,000 related to manufacturing and preclinical activities; (iii) HT-VA, approximately $137,000, and (iv) HT-ALZ, approximately $12,000 related to preclinical studies. In addition to the foregoing, we also incurred fees of approximately $131,000 payable to members of our scientific advisory board for services and recorded approximately $1,268,000 of in-process research and development expenses in connection with the acquisition of patent applications.

Removed

For the year ended December 31, 2023, research and development expenses were approximately $3.9 million. Specifically, during the year ended December 31, 2023, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $2.0 million related to manufacturing and clinical activities; (ii) HT-KIT, approximately $1.6 million related to manufacturing and preclinical activities; (iii) HT-ALZ, approximately $65,000 related to preclinical studies; (iv) BioLexa, approximately $56,000 related to manufacturing; and (v) HT-004, approximately $59,000 related to sponsored research. In addition to the foregoing, we also incurred fees of approximately $0.2 million payable to members of our scientific advisory board for services.

Added

During the year ended December 31, 2025, the increase in general and administrative expenses of approximately $1,449,000 was primarily attributed to an increase in compensation and related expenses of $590,000, primarily attributable to the issuance of 800,000 shares of common stock to our Chief Executive Officer valued at $968,000 and an increase in other compensation and related expenses of $196,000, which were offset by a decrease in stock-based compensation of approximately $574,000 in connection with the issuance of stock options during the year ended December 31, 2025 as compared to the year ended December 31, 2024. Additionally, during the year December 31, 2025, professional and consulting expenses increased by approximately $892,000 which was primarily attributable to an increase in legal and consulting fees of approximately $538,000, an increase in stock-based professional fees of $333,000 an increase in directors’ fees of approximately $21,000, and an increase in rent expense of $1,000. These increases were offset by a decrease in other general and administrative expenses of approximately $34,000.

Removed

During the year ended December 31, 2024, the increase in general and administrative expenses of approximately $754,000 was primarily attributed to an increase other general and administrative expenses of approximately $246,000, which primarily consisted of an increase in conference fees of approximately $154,000, and an increase in travel expenses of approximately $32,000, an increase in compensation and related expenses of approximately $681,000, comprising of an increase in stock-based compensation of approximately $612,000 related to the issuance of stock options to executives and board of director members and an increase in health insurance, and an increase in rent of approximately $14,000, offset by a decrease in professional and consulting expenses of approximately $187,000.

Reworded

For the year ended December 31, 2024, net2025, other expense, incomenet was approximately $27,000,$108,000, which primarily resulted from $27,000the recording of dividendan andunrealized interestloss income.of crypto assets of $109,000.

Reworded

For the year ended December 31, 2023,2024, other income, net other expenses werewas approximately $0.1 million, $27,000, which primarily resulted from $0.2 million of unrealized losses on marketable securities, partially offset by approximately $0.1 million$27,000 of dividend and interest income.

Reworded

For the yearyears ended December 31, 20242025 and 2023, 2024, we incurred a net loss of approximately $8.2$12.5 million, or $1.28 per common share (basic and diluted), and $8.1 million, or $2.38$0.90 per common share (basic and diluted), and $8.2 million, or $1.28 per common share (basic and diluted), respectively.

Reworded

To date we have funded our operations primarily through the sale of equity and debt securities. As of December 31, 2024,2025, we had approximately $7.0$6.2 million in cash and cash equivalents, working capital of approximately $6.8$5.2 million and an accumulated deficit of approximately $60.4$72.9 million. Net cash used in operating activities was $7.0$9.8 million and $8.4$7.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. We incurred net losses of approximately $8.2 $12.5 million and $8.1$8.2 million for the years ended December 31, 20242025 and 2023,2024, respectively. We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future as we continue our pre-clinical and clinical development of our product candidates. We have not yet commercialized any products and have never generated any revenue from product sales. We do not believe that our existing cash as of December 31, 2024 plus cash proceeds we received of $5,625,000 from exercise of warrants in January 2025 and cash proceeds we received of $1,470,435 from the sale of our common shares under the ATM Agreement during the period from January 7, 2025 to March 28, 2025 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date that our auditedconsolidated financial statements are available to be issued.

Removed

During the year ended December 31, 2024, we issued 2,500,000 shares (the “Warrant Shares”) of our common stock upon the exercise of the 2,500,000 January 2023 Existing Warrants (as defined herein) for net proceeds of approximately $3.7 million, after deducting placement agent fees and other offering expenses of approximately $0.4 million. The Warrant Shares were issued as a result of a March 27, 2024 inducement offer agreement, which closed on April 1, 2024, with a holder (the “Holder”) of certain of our existing warrants (“January 2023 Existing Warrants”) to immediately exercise, for cash, an aggregate of 2,500,000 January 2023 Existing Warrants to purchase shares of our common stock at a reduced exercise price of $1.6775 per share.

Reworded

On November 8, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) under which we maycould offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager pursuant to our effective shelf registration statement on Form S-3, including an accompanying prospectusS-3 (File No. 333-272620), including an accompanying base prospectus and and a prospectus supplement dated November 8, 2024. Sales of shares of the Company’s common stock through Wainwright, if any, will be be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended.Act. Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time to time, based on instructions from us (including any price, time or size limits or other parameters or conditions we may impose). We will pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection with the ATM Agreement. On February 7, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $5,000,000 pursuant to a prospectus supplement dated February 7, 2025. On November 13, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $2,439,256 pursuant to a prospectus supplement dated November 13, 2025 for a current offering up to $4,821,200. The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant to the ATM Agreement, of shares having an aggregate offering price of $2,700,000$10,139,256 and (2) the termination of the ATM Agreement by either us or Wainwright, as set forth therein. FromDuring Novemberthe 8,year 2024 toended December 31, 20242025 we issued 1,137,250an aggregate of 2,782,309 shares of our common stock for net proceeds of approximately $4.1 $1.0million, millionafter deducting approximately $142,000 in sales agent commissions and other offering expenses payable by us pursuant to the ATM Agreement.

Added

For the year ended December 31, 2025, net cash used in operating activities was approximately $9.8 million, which primarily resulted from a net loss of approximately $12.5 million and an increase in prepaid expenses and other current assets of approximately $460,000 and an increase in accounts payable and accrued expenses of approximately $644,000, offset by approximately $850,000 of non-cash research and development-acquired patent, $1.5 million in stock-based compensation and professional fees, and unrealized loss on crypto assets of $109,000.

Removed

For the year ended December 31, 2023, net cash used in operating activities was approximately $8.4 million, which primarily resulted from a net loss of approximately $8.1 million, a $0.3 million gain on termination of license agreement, offset by $0.2 million unrealized loss on marketable securities, $0.2 million stock-based compensation and changes in operating assets and liabilities of approximately $0.5 million.

Added

During the year ended December 31, 2025, the Company purchased $300,000 in crypto assets.

Reworded

The Company did not have any cash flows from investing activities for the yearsyear ended December 31, 2024 or December 31, 2023.2024.

Added

For the year ended December 31, 2025, net cash provided by financing activities was approximately $9.3 million, which primarily resulted from net proceeds from the issuance of common stock of approximately $4.1 million and proceeds from the exercise of warrants of approximately $5.6 million, offset by the payment of taxes related to the net share settlement of an equity award of $376,000.

Removed

For the year ended December 31, 2023, net cash provided by financing activities was approximately $11.3 million, which primarily resulted from net proceeds from the issuance of common stock, common stock warrants, and prefunded warrants.

Added

In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to provide more detailed disaggregation of expenses in the income statement, focusing on the nature of the expenses rather than their function. The new disclosures will require entities to separately present expenses for significant line items, including but not limited to, depreciation, amortization, and employee compensation. Entities will also be required to provide a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively, disclose the total amount of selling expenses and, in annual reporting periods, provide a definition of what constitutes selling expenses. This pronouncement is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company does not expect the adoption of this new guidance to have a material impact on its consolidated financial statements.

Removed

Income Taxes (Topic 740)

Removed

In December 2023, the Financial Accounting Standards Board (“FASB”) issued guidance within Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in the ASU are intended to provide more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The ASU requires disclosure in the rate reconciliation of specific categories as well as additional information for reconciling items that meet a quantitative threshold.

Removed

The ASU requires disclosure of the following information about income taxes paid on an annual basis:

Removed

The ASU is effective for annual periods beginning after December 15, 2024. The amendments should be applied on a prospective basis. The Company is evaluating the impact that the adoption of this ASU will have on the Company’s consolidated financial statements, as it may require additional disclosures in the notes to our condensed consolidated financial statements.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-14 (period ending 2026-06-30) with 10-Q filed 2026-05-15 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

31new paragraphs
0removed paragraphs
1reworded paragraphs
169 → 2,975words in section

New heading “Risks Related to the Company”

New heading “Our technologies are based on early-stage technologies that have not been demonstrated at commercial scale, and if we are unable to advance these technologies beyond their current developmental stage, our business, financial condition, and prospects could be materially adversely affected.”

New heading “Many of our initiatives, including those to develop our nanomagnetic matrix multiplier, skyrmion-mediated spintronic memory, and Swarm Stage AI, may involve significant technical complexity, unproven technologies, or technologies that do not exist or may require significant advancement, and such initiatives may not achieve commercial viability.”

New heading “Our products are dependent on the market for commercial satellite manufacturing, launch and data services for satellites which is not well established, is still emerging and may not achieve the growth potential we expect or may grow more slowly than expected.”

New heading “Any delays in the development and manufacture of satellites and related technology may adversely impact our business, financial condition and results of operations.”

New heading “Developing AI can be capital intensive and we operate in a nascent and rapidly evolving market in which the potential of AI remains uncertain.”

New heading “The semiconductor industry is highly cyclical and has experienced severe downturns that have materially adversely affected, and may continue to materially adversely affect, our business in the future.”

New heading “Our products may be subject to security vulnerabilities that could have a material adverse effect on us.”

New heading “If essential equipment, materials, or manufacturing processes are not available to manufacture our products, we could be materially adversely affected.”

New heading “Risk Relating to Government Regulations”

New heading “Our business is subject to a wide variety of extensive and evolving government laws and regulations. Failure to comply with such laws and regulations could have a material adverse effect on our business.”

New heading “Issues related to the responsible use of AI may result in reputational, competitive and financial harm and liability.”

New heading “Risks Related to Our Intellectual Property Rights”

New heading “If we fail to adequately protect our proprietary intellectual property rights, including our rights under our exclusive license agreements, our competitive position could be impaired and we may lose valuable assets and incur costly litigation to protect our rights.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: export control, artificial intelligence, regulation, labor
“We are subject to a wide variety of laws and regulations relating to various aspects of our business, including with respect to export controls, defense procurement and contracting, intellectual property, semiconductor development and manufacturing, employment and labor, tax, privacy and data security, health and safety, and environmental issues. …”
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New text topics: litigation
“If we fail to adequately protect our proprietary intellectual property rights, including our rights under our exclusive license agreements, our competitive position could be impaired and we may lose valuable assets and incur costly litigation to protect our rights.”
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New text topics: regulation
“Our business is subject to a wide variety of extensive and evolving government laws and regulations. Failure to comply with such laws and regulations could have a material adverse effect on our business.”
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New text topics: lawsuit, penalt
“Failure to comply with these laws, such as with respect to obtaining and maintaining licenses, certificates, authorizations and permits critical for the operation of our business, may result in civil penalties or private lawsuits, or the suspension or revocation of licenses, certificates, authorizations or permits, which would prevent us from operating our business. …”
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New text topics: ai
“Developing AI can be capital intensive and we operate in a nascent and rapidly evolving market in which the potential of AI remains uncertain.”
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New text
“Many of our initiatives, including those to develop our nanomagnetic matrix multiplier, skyrmion-mediated spintronic memory, and Swarm Stage AI, may involve significant technical complexity, unproven technologies, or technologies that do not exist or may require significant advancement, and such initiatives may not achieve commercial viability.”
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Full comparison: every changed paragraph (32)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Reworded

Risk factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 27, 2026 (“Annual Report”), as subsequently updated, amended or superseded by our other filings made with the SEC. ThereExcept as otherwise set forth herein, there have been no material changes in our risk factors from those previously disclosed in our Annual Report and other filings made with the SEC. You should carefully consider the risks in our filings with the SEC which could materially affect our business, financial condition or future results. The risks in our SEC filings are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results. If any of the risks actually occur, our business, financial condition, and/or results of operations could be negatively affected.

Added

Risks Related to the Company

Added

Our technologies are based on early-stage technologies that have not been demonstrated at commercial scale, and if we are unable to advance these technologies beyond their current developmental stage, our business, financial condition, and prospects could be materially adversely affected.

Added

Our three core platforms — the nanomagnetic matrix multiplier, skyrmion-mediated spintronic memory, and Swarm Stage AI — are at early stages of development. We license our intellectual property Virginia Commonwealth University and our technologies have only been validated in laboratory or simulation environments, not in commercial products. Our development path depends on advancing device simulation, chip architecture modeling, and experimental device characterization through sponsored university research, and we currently lack our own manufacturing capabilities. There can be no assurance that these technologies, which operate on potentially novel principles, can be successfully translated into commercially viable, manufacturable products Even if these technologies are commercially viable, there is no guarantee that they will achieve market acceptance.. If we are unable to advance these technologies beyond their current developmental stage, our business, financial condition, and prospects could be materially adversely affected.

Added

Many of our initiatives, including those to develop our nanomagnetic matrix multiplier, skyrmion-mediated spintronic memory, and Swarm Stage AI, may involve significant technical complexity, unproven technologies, or technologies that do not exist or may require significant advancement, and such initiatives may not achieve commercial viability.

Added

Our initiatives to develop our nanomagnetic matrix multiplier, skyrmion-mediated spintronic memory, and Swarm Stage AI are in developmental stages of conception, design and development and have not yet been proven at commercial scale, or at all, and may ultimately be unsuccessful. In particular, the timeline for these initiatives, may be difficult or impossible to determine. These efforts require substantial and ongoing investments of financial, technical, and human resources over extended time horizons, including, but not limited to, research and development, testing, infrastructure, regulatory approvals, and mission execution. The technologies, systems, and operational capabilities required for each of these initiatives involve significant technical complexity and are subject to design, engineering, and performance risks, many of which may only become apparent as development and testing progress. Many of these technologies, systems and operational capabilities are novel and untested, and we expect to incur significant capital expenditures before our products and services and other strategic initiatives become profitable, which may never occur. We may be required to devote financial, technical, human or other resources in excess of our current expectations, and there can be no assurance that these investments will generate adequate revenue, which could adversely affect our business, financial condition, results of operations, and future prospects.

Added

-3434--

Added

Our products are dependent on the market for commercial satellite manufacturing, launch and data services for satellites which is not well established, is still emerging and may not achieve the growth potential we expect or may grow more slowly than expected.

Added

The market for in-space infrastructure services, in particular commercial satellite manufacturing, launch and data services for small satellites, has not been well established and is still emerging. Sales of our future products and technology will be dependent on this market. Our estimates for the total addressable market are based on several internal and third-party estimates and while we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the accuracy of these underlying factors. As a result, our estimates of the total addressable market for our future products and services, as well as the expected growth rate for the total addressable market for our future products and services, may prove to be incorrect.

Added

Any delays in the development and manufacture of satellites and related technology may adversely impact our business, financial condition and results of operations.

Added

We may, in the future, experience delays or other complications in the design, manufacture, launch, production, delivery and servicing ramp of satellites and related technology. Our ability to sell our products and generate revenue may be impacted by delays in the manufacturing of satellites and related technology. If delays like this arise or recur, we could experience issues in sustaining sales of our products which could result in adverse publicity and damage to our brand and reputation, all of which could have a material adverse effect on our business and results of operations.

Added

Developing AI can be capital intensive and we operate in a nascent and rapidly evolving market in which the potential of AI remains uncertain.

Added

AI is a nascent and rapidly evolving technology, and although we believe AI holds significant promise for consumers and enterprises, its long-term impact will depend on the degree to which AI products and services prove to be broadly useful in real-world applications. There can be no assurance that demand for AI solutions will develop or be sustained at the levels we anticipate, or at all. While industry interest in AI has grown substantially, the commercial value proposition of AI models remains largely unproven, and long-term market acceptance of the use of AI in our products and services is uncertain. Developing, training, and providing inference for AI models requires substantial and growing capital expenditures, including investments in specialized computing hardware, data center infrastructure, energy procurement, and technical personnel, and we expect these costs to continue to increase for the foreseeable future. Furthermore, the continued improvement of AI model capabilities has historically depended in part on scaling laws, the empirical observation that model performance improves with increased compute, data, and model size, but there is uncertainty as to how long these scaling relationships will continue to hold. As a result of these factors, the use of AI in our products may not achieve the growth or returns we expect.

Added

The semiconductor industry is highly cyclical and has experienced severe downturns that have materially adversely affected, and may continue to materially adversely affect, our business in the future.

Added

The semiconductor industry is highly cyclical and has experienced significant downturns, often alongside constant and rapid technological change, wide fluctuations in supply and demand, continuous new product introductions, price erosion and declines in general economic conditions. The growth of AI is further creating pressure on the semiconductor industry to timely design, manufacture and deliver semiconductor products and solutions to meet customer demand for computing power and AI infrastructure. Furthermore, global economic uncertainty and weakness have in the past impacted the semiconductor market as consumers and businesses have deferred purchases, which may negatively impact demand for our products. Our financial performance may in the future be negatively affected by these downturns.

Added

-3535--

Added

Our products may be subject to security vulnerabilities that could have a material adverse effect on us.

Added

The products that we intend to sell will be complex and may be subject to security vulnerabilities that could result in, among other things, the loss, corruption, theft or misuse of confidential data or system performance issues. Our efforts to prevent and address security vulnerabilities may decrease performance, be only partially effective or not successful at all. We may depend on vendors to create mitigations to their technology that we incorporate into our products and they may delay or decline to make such mitigations. We may also depend on third parties, such as customers and end-users, to deploy our mitigations alone or as part of their own mitigations, and they may delay, decline or modify the implementation of such mitigations. Our relationships with our customers could be adversely affected as some of our customers may stop purchasing our products, reduce or delay future purchases of our products, or use competing products. Any of these actions by our customers could adversely affect our revenue. In addition, we may be subject to claims and litigation related to security vulnerabilities. Actual or perceived security vulnerabilities of our products may subject us to adverse publicity, damage to our brand and reputation, and could materially harm our business or results of operations.

Added

If essential equipment, materials, or manufacturing processes are not available to manufacture our products, we could be materially adversely affected.

Added

We may purchase equipment and materials for manufacturing use and our operations depend upon obtaining deliveries of adequate supplies of equipment and materials of acceptable quality on a timely basis. In addition, if our products increase in technical complexity, we may rely on third-party suppliers to update their processes to meet our back-end manufacturing needs. There is currently an industry-wide memory shortage as the demand for such components has outpaced supply. The price of memory has also increased as a result of the shortage. If we are unable to procure a stable supply of memory, equipment or materials of acceptable quality on an ongoing basis and at reasonable costs to meet our production requirements, we could experience a shortage in memory, equipment materials or supply or an increase in production costs, which could have a material adverse effect on our business. Because some of the equipment and materials that we may purchase may be complex, it may be difficult to substitute one equipment or materials supplier for another.

Added

From time to time, suppliers may extend lead times, limit supply or increase prices due to capacity constraints or other factors. Also, some of these materials and components may be subject to rapid changes in price, quality and availability. Interruption of supply or increased demand in the industry could cause shortages and price increases in various essential materials. If we are unable to procure certain of these materials for our back-end manufacturing operations, or our third-party manufacturers are unable to procure materials for manufacturing our products, our business would be materially adversely affected.

Added

Risk Relating to Government Regulations

Added

Our business is subject to a wide variety of extensive and evolving government laws and regulations. Failure to comply with such laws and regulations could have a material adverse effect on our business.

Added

We are subject to a wide variety of laws and regulations relating to various aspects of our business, including with respect to export controls, defense procurement and contracting, intellectual property, semiconductor development and manufacturing, employment and labor, tax, privacy and data security, health and safety, and environmental issues. Laws and regulations at the foreign, federal, state, and local levels frequently change, especially in relation to new and emerging industries such as artificial intelligence, and we cannot always reasonably predict the impact from, or the ultimate cost of compliance with, current or future regulatory or administrative changes. We monitor these developments and intend to devote a significant amount of management’s time and external resources towards compliance with these laws, regulations and guidelines, and anticipate that such compliance will place a significant burden on management’s time and other resources, and it may limit our ability to expand into certain jurisdictions. Moreover, changes in law, the imposition of new or additional regulations or the enactment of any new or more stringent legislation that impacts our business could require us to change the way we operate and could have a material adverse effect on our sales, profitability, cash flows and financial condition.

Added

Failure to comply with these laws, such as with respect to obtaining and maintaining licenses, certificates, authorizations and permits critical for the operation of our business, may result in civil penalties or private lawsuits, or the suspension or revocation of licenses, certificates, authorizations or permits, which would prevent us from operating our business. For example, deploying space assets such as satellites in the United States require licenses and permits from certain agencies of the Department of Transportation, including the Federal Aviation Administration and review by other agencies of the U.S. Government, including the National Oceanic and Atmospheric Administration, the Department of Defense, Department of State, NASA, Federal Communications Commission and the International Telecommunications Union. License approval includes an interagency review of safety, operational, national security, and foreign policy and international obligations implications, as well as a review of foreign ownership. Delays in licensing and approvals allowing us to deploy our commercial satellites could adversely affect our ability to operate our business and our financial results.

Added

-3636-- Moreover, regulation of our industry is still evolving, and new or different laws or regulations could affect our operations, increase direct compliance costs for us or cause any third-party suppliers or contractors to raise the prices they charge us because of increased compliance costs. Application of these laws to our business may negatively impact our performance in various ways, limiting the collaborations we may pursue, further regulating the export and re-export of our products, services, and technology from the United States and abroad, and increasing our costs and the time necessary to obtain required authorization. The adoption of a multi-layered regulatory approach to any one of the laws or regulations to which we are or may become subject, particularly where the layers are in conflict, could require alteration of our manufacturing processes or operational parameters which may adversely impact our business. We may not be in complete compliance with all such requirements at all times and, even when we believe we are in complete compliance, a regulatory agency may determine that we are not.

Added

Issues related to the responsible use of AI may result in reputational, competitive and financial harm and liability.

Added

We intend to offer products that include capabilities to support AI deployment. As with many new emerging technologies, AI presents risks and challenges and increasing legal, social and ethical concerns relating to its responsible use that could affect the adoption of AI, and thus our business. Third-party misuse of AI applications, models, or solutions, or ineffective or inadequate AI development or deployment practices by us or our customers, could cause harm to individuals or society and impair the public’s acceptance of AI. Moreover, we may be subject to competitive harm, regulatory action and legal liability as a result of new and proposed legislation regulating AI, as well as new applications of existing data protection, privacy and intellectual property and other laws. Such regulations and changes thereto could cause us to incur greater compliance costs, could impact our ability to sell or the ability of our customers and users worldwide to acquire, deploy and use systems that include our AI-related products and services and reduce the number of customers, which could negatively impact our business and financial results. As there continues to be an increasing focus on risks related to AI technologies, there may be an increasing focus on regulatory restrictions that target products and services that enable or facilitate AI and that may negatively impact some of our AI-related products and services. If the AI-related products that we offer have unintended consequences, infringe intellectual property rights or rights of publicity, or are misused by our customers or are otherwise controversial due to their perceived or actual impact on human rights, privacy, cybersecurity, employment or other social, economic or political issues the public’s acceptance of AI may be impaired and this may also result in reputational, competitive and financial harm and liability to our business.

Added

Risks Related to Our Intellectual Property Rights

Added

If we fail to adequately protect our proprietary intellectual property rights, including our rights under our exclusive license agreements, our competitive position could be impaired and we may lose valuable assets and incur costly litigation to protect our rights.

Added

Our success depends, in part, on our ability to protect our proprietary intellectual property rights, including our exclusive licenses from Virginia Commonwealth University. To date, we have relied primarily on our exclusive license agreements and other intellectual property laws to protect our intellectual property and intend to continue to rely on these and other means, including patent protection, in the future. However, the steps we take to protect our intellectual property may be inadequate, and we may choose not to pursue or maintain protection for our intellectual property in the United States or foreign jurisdictions. We will not be able to protect our intellectual property if we are unable to enforce our rights or if we do not detect unauthorized use of our intellectual property. Despite our precautions, it may be possible for unauthorized third parties to copy our technology and use information that we regard as proprietary to create technology that competes with ours.

Added

Further, the laws of some countries do not protect proprietary rights to the same extent as the laws of the United States, and mechanisms for enforcement of intellectual property rights in some foreign countries may be inadequate. To the extent we expand our international activities, our exposure to unauthorized copying and use of our technologies and proprietary information may increase. Accordingly, despite our efforts, we may be unable to prevent third parties from infringing upon, misappropriating or otherwise violating our technology and intellectual property.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

24new paragraphs
7removed paragraphs
17reworded paragraphs
3,527 → 3,751words in section

New heading “General and Administrative Expenses”

New heading “Comparison of Our Results of Operations for the Six Months Ended June 30, 2026 and 2025”

New heading “Operating Costs and Expenses”

New heading “Research and Development Expenses”

Removed heading “Recent Developments”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Reworded topics: going concern

Paragraph as it now reads, with added and removed wording marked:

Our unaudited condensed consolidated financial financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Our ability to continue as a going concern is dependent on our ability to raise additional capital to fund our research and development (“R&D”) activities and meet our obligations on a timely basis. To date we have funded our operations primarily through the sale of equity and debt securities. As of March 31,June 30, 2026, we had approximately $4,047,000 $7,892,000 in cash and cash equivalents, working capital of approximately $3,425,000$7,197,000 and an accumulated deficit of approximately $75,572,000.$79,406,000. Net cash used in operating activities was $3,050,000$6,019,000 and $2,788,000$5,161,000 for the three six months ended MarchJune 31,30, 2026 and 2025, respectively. We incurred net losses of approximately $2,692,000$6,527,000 and $3,476,000$5,675,000 for the three six months ended March,June 30, 2026 and 2025, respectively. We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future as we continue to execute our pre-clinicallonger-term business plans and clinical development of our product candidates.development. We have not yet commercialized any products and have never generated any revenue from product sales. We do not believe that our existing cash as of MarchJune 31,30, 2026 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date that our unaudited condensed consolidated financial statements are are available to be issued. If funding is not available, or not available on terms acceptable to the Company, our current development plan and plans for expansion of our general and administrative infrastructure may be curtailed. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these consolidated financial statements are issued. Our unaudited condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary in the event the Company can no longer continue as a going concern.
see in full comparison
Removed text topics: fine
“On November 8, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) under which we could offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager pursuant to our effective shelf registration statement on Form S-3 (File No. 333-272620), including an accompanying base prospectus and a prospectus supplement dated November 8, 2024. …”
see in full comparison
New text topics: artificial intelligence, ai
“In May 2026, we announced a strategic repositioning pursuant to which we are now pursuing opportunities in artificial intelligence (“AI”) infrastructure, next-generation semiconductor technologies, and ultra-low-power AI computing. Specifically, we are an AI semiconductor infrastructure company building nanomagnetic and spintronic computing for ultra-low-power AI, resilient edge, defense, and space. We are also focused on developing (i) a nanomagnetic matrix multiplier; (ii) Skyrmion Spintronic memory; and (iii) Swarm Stage AI. …”
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New text
“Comparison of Our Results of Operations for the Six Months Ended June 30, 2026 and 2025”
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“General and Administrative Expenses”
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“Research and Development Expenses”
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Full comparison: every changed paragraph (48)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Added

In May 2026, we announced a strategic repositioning pursuant to which we are now pursuing opportunities in artificial intelligence (“AI”) infrastructure, next-generation semiconductor technologies, and ultra-low-power AI computing. Specifically, we are an AI semiconductor infrastructure company building nanomagnetic and spintronic computing for ultra-low-power AI, resilient edge, defense, and space. We are also focused on developing (i) a nanomagnetic matrix multiplier; (ii) Skyrmion Spintronic memory; and (iii) Swarm Stage AI. Additionally, we also continue to have preclinical and clinical assets that will developed under our wholly owned subsidiary, Hoth Therapeutics LLC, for (i) a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001); (ii) a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT); (iii) a treatment for obesity, and obesity-related diseases and conditions (HT-VA); and (iv) a treatment for Alzheimer’s Disease (HT-ALZ).

Removed

We are a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. We are focused on developing (i) a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001); (ii) a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT); and (iii) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ). We also have assets being developed for (i) atopic dermatitis (also known as eczema) (BioLexa); (ii) a treatment for asthma and allergies using inhalational administration (HT-004); and (iii) a treatment for obesity, and obesity-related diseases and conditions (HT-VA).

Removed

Recent Developments

Removed

On April 1, 2026, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to which the Company agreed to sell to such investors 2,857,144 shares of common stock of the Company at a purchase price of $0.70 per share of common stock. For each share of common stock purchased by the investors, the Company, in a private placement pursuant to the Purchase Agreement, concurrently issued to such investors an unregistered warrant (each a “Warrant” and, collectively, the “Warrants”) to purchase one share of common stock at an exercise price of $0.85 per share. The Warrants are exercisable six months from the date of issuance (the “Initial Exercise Date”) for a period of five-years from the Initial Exercise Date. In connection with the offering, gross proceeds were approximately $2,000,000, and the Company received net proceeds of $1,611,879, after deducting placement agent’s fees and other offering expenses paid by the Company of $388,121. Additionally, in connection with the offering, the Company issued placement agent warrants to the designees of the placement agent, Wainwright, to purchase up to 142,857 shares of common stock (the “Placement Agent Warrants”). The Placement Agent Warrants are immediately exercisable at an exercise price of $0.875 per share and expire on April 1, 2031.

Reworded

Comparison of Our Results of Operations for the Three Months Ended MarchJune 31,30, 2026 and 2025

Removed

For the three months ended March 31, 2026, research and development expenses were approximately $1,519,000. Specifically, during the three months ended March 31, 2026, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $1,431,000 related to manufacturing and clinical activities; (ii) HT-KIT, approximately $12,000 related to manufacturing and preclinical activities; and (iii) HT-VA approximately $45,000 related to preclinical studies. In addition to the foregoing, we also incurred fees of approximately $31,000 payable to members of our scientific advisory board for services.

Reworded

For the three months ended MarchJune 31,30, 2025,2026, research and development expenses were approximately $1,959,000.$1,955,000. Specifically, during the three months ended MarchJune 31,30, 2025,2026, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $459,000$1,634,000 related to manufacturing and clinical activities; and (ii) HT-KIT,HT-VA approximately $198,000 related to manufacturing and preclinical activities; and (iii) HT-ALZ, approximately $12,000$35,000 related to preclinical studies. In addition to the foregoing, we also incurred fees of approximately $37,000 $29,000 payable to members of our scientific advisory board for servicesservices, $47,000 in licensing fees, and recorded approximately $1,253,000$210,000 of in-process research and development expenses in connection with the acquisition of patentsoftware applications.and other technologies.

Added

For the three months ended June 30, 2025, research and development expenses were approximately $1,040,000. Specifically, during the three months ended June 30, 2025, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $652,000 related to manufacturing and clinical activities; and (ii) HT-KIT, approximately $351,000 related to manufacturing and preclinical activities. In addition to the foregoing, we also incurred fees of approximately $31,000 payable to members of our scientific advisory board for services.

Added

We expect our research and development activities to continue to increase as we develop our existing product candidates and potentially acquire new product candidates, reflecting increasing costs associated with the following:

Added

-2727--

Added

General and Administrative Expenses

Added

For the three months ended June 30, 2026, general and administrative expenses amounted to approximately $1,879,000 as compared to $1,160,000 for the three months ended June 30, 2025, an increase of $719,000, or 62.0%. For the three months ended June 30, 2026 and 2025, general and administrative expenses consisted of the following (rounded to the nearest $1,000):

Added

During the three months ended June 30, 2026, the increase in general and administrative expenses of approximately $719,000 was primarily attributed to an increase in compensation and related expenses of $668,000 primarily attributable to an increase in stock-based compensation of approximately $625,000 in connection with the issuance of stock options during the three months ended June 30, 2026 as compared to none during the three months ended June 30, 2025, as well as an increase in other compensation and related expenses of $43,000 and an increase in professional and consulting expenses of approximately $119,000 which was primarily attributable to an increase in legal and consulting fees of approximately $51,000, an increase in accounting fees of approximately $45,000, and an increase in directors’ fees of approximately $27,000 offset by a decrease in rent expense of $7,000 and a decrease in other general and administrative expenses of $61,000, primarily attributable to a decrease in travel expense.

Added

We anticipate that our general and administrative expenses will continue to increase in future periods, reflecting continued and increasing costs associated with:

Added

Other Income

Added

For the three months ended June 30, 2026 and 2025, other income was approximately $149 and $173, respectively, which resulted from interest income.

Added

Net Loss

Added

For the three months ended June 30, 2026 and 2025, we incurred a net loss of approximately $3,835,000, or $0.19 per common share (basic and diluted), and $2,199,000, or $0.17 per common share (basic and diluted), respectively.

Added

Comparison of Our Results of Operations for the Six Months Ended June 30, 2026 and 2025

Added

Operating Costs and Expenses

Added

Research and Development Expenses

Added

For the six months ended June 30, 2026, research and development expenses were approximately $3,474,000. Specifically, during the six months ended June 30, 2026, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $3,065,000 related to manufacturing and clinical activities; (ii) HT-KIT, approximately $12,000 related to manufacturing and preclinical activities; and (iii) HT-VA approximately $80,000 related to preclinical studies. In addition to the foregoing, we also incurred fees of approximately $60,000 payable to members of our scientific advisory board for services, $47,000 in licensing fees, and $210,000 of in-process research and development expenses in connection with the acquisition of software and other technologies.

Added

-2828-- For the six months ended June 30, 2025, research and development expenses were approximately $2,998,000. Specifically, during the six months ended June 30, 2025, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $1,110,000 related to manufacturing and clinical activities; (ii) HT-KIT, approximately $549,000 related to manufacturing and preclinical activities; and (iii) HT-ALZ, approximately $12,000 related to preclinical studies. In addition to the foregoing, we also incurred fees of approximately $69,000 payable to members of our scientific advisory board for services and recorded approximately $1,258,000 of in-process research and development expenses in connection with the acquisition of patent applications.

Reworded

For the threesix months ended MarchJune 31,30, 2026, general and administrative expenses amounted to approximately $1,129,000$3,009,000 as compared to $1,517,000$2,677,000 for the threesix months ended MarchJune 31,30, 2025, an a decreaseincrease of $388,000,$332,000, or 25.6%.12.4%. For the threesix months ended MarchJune 31,30, 2026 and 2025, general and administrative expenses consisted of the the following (rounded to the nearest $1,000):

Reworded

During the threesix months ended MarchJune 31,30, 2026, the the decreaseincrease in general and administrative expenses of approximately $388,000$332,000 was primarily attributed to (1)an a decreaseincrease in compensation and and related expenses of $256,000,$412,000 primarily attributable to aan decreaseincrease in stock-based compensation of approximately $220,000$406,000 in connection with the issuance of stock options during the threesix months ended MarchJune 31,30, 20252026 as compared none duringto the threesix months ended MarchJune 31, 2026,30, 2025, and a decreasean increase in other compensation and related expenses of $33,000,$6,000, (2)offset duringby thea threedecrease monthsin endedrent Marchexpense 31,of 2026,$9,000, professional and consultinga decrease in other general and administrative expenses decreasedof by approximately $118,000 which was$71,000, primarily attributable to a decrease in legaltravel and consulting fees of approximately $48,000 and a decrease in accounting fees of approximately $76,000, offset by an increase in directors’ fees of approximately $6,000, (3) a decrease in rent expense of $3,000, and (4) a decrease in other general and administrative expenses of $11,000.expense.

Added

-2929--

Reworded

For the threesix months ended MarchJune 31,30, 2026, other expense, net was approximately $44,000, which resulted from the recording of a realized loss of crypto assets of $44,000.

Reworded

For the threesix months ended MarchJune 31,30, 2025, other income, net was approximately $181,$354, which resulted from $354 of interest income.

Reworded

For the threesix months ended MarchJune 31,30, 2026 and 2025, 2025, we incurred a net loss of approximately $2,692,000,$6,527,000, or $0.17$0.36 per common share (basic and diluted), and $3,476,000,$5,675,000, or $0.27$0.44 per common common share (basic and diluted), respectively.

Reworded

Our unaudited condensed consolidated financial financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Our ability to continue as a going concern is dependent on our ability to raise additional capital to fund our research and development (“R&D”) activities and meet our obligations on a timely basis. To date we have funded our operations primarily through the sale of equity and debt securities. As of March 31,June 30, 2026, we had approximately $4,047,000 $7,892,000 in cash and cash equivalents, working capital of approximately $3,425,000$7,197,000 and an accumulated deficit of approximately $75,572,000.$79,406,000. Net cash used in operating activities was $3,050,000$6,019,000 and $2,788,000$5,161,000 for the three six months ended MarchJune 31,30, 2026 and 2025, respectively. We incurred net losses of approximately $2,692,000$6,527,000 and $3,476,000$5,675,000 for the three six months ended March,June 30, 2026 and 2025, respectively. We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future as we continue to execute our pre-clinicallonger-term business plans and clinical development of our product candidates.development. We have not yet commercialized any products and have never generated any revenue from product sales. We do not believe that our existing cash as of MarchJune 31,30, 2026 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date that our unaudited condensed consolidated financial statements are are available to be issued. If funding is not available, or not available on terms acceptable to the Company, our current development plan and plans for expansion of our general and administrative infrastructure may be curtailed. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these consolidated financial statements are issued. Our unaudited condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary in the event the Company can no longer continue as a going concern.

Added

On November 8, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) under which we could offer and sell shares of our common stock through Wainwright. We have agreed to pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of our stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection with the ATM Agreement. The aggregate market value of the shares of common stock eligible for sale is currently $5,257,000. From November 8, 2024 through August 13, 2026, the Company sold 9,825,684 shares of common stock through the ATM Agreement which resulted in approximately $13.56 million in gross proceeds. During the three and six months ended June 30, 2026, we sold an aggregate of 3,436,991 and 4,193,178 shares of common stock for net proceeds of $5,145,579 and $5,847,063, respectively. Furthermore, from July 1 to August 13, 2026, pursuant to the ATM Agreement, we issued an aggregate of 1,712,947 shares of common stock for net proceeds of $1,938,593.

Added

On April 1, 2026, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to which we agreed to sell to such investors 2,857,144 shares of common stock at a purchase price of $0.70 per share. For each share of common stock purchased by the investors, in a private placement pursuant to the Purchase Agreement, we concurrently issued to such investors an unregistered warrant (each a “April Warrant” and, collectively, the “April Warrants”) to purchase one share of common stock at an exercise price of $0.85 per share. The April Warrants are exercisable six months from the date of issuance (the “Initial Exercise Date”) for a period of five years from the Initial Exercise Date. We received gross proceeds of approximately $2,000,000, and net proceeds of approximately $1,611,880, after deducting placement agent’s fees and other offering expenses paid by us of $388,121. Additionally, in connection with the offering, we issued placement agent warrants to the designees of the placement agent, Wainwright, to purchase up to 142,857 shares of common stock (the “April Placement Agent Warrants”). The April Placement Agent Warrants are immediately exercisable at an exercise price of $0.875 per share and expire on April 1, 2031.

Removed

On November 8, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) under which we could offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager pursuant to our effective shelf registration statement on Form S-3 (File No. 333-272620), including an accompanying base prospectus and a prospectus supplement dated November 8, 2024. Sales of shares of the Company’s common stock through Wainwright, if any, will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time to time, based on instructions from us (including any price, time or size limits or other parameters or conditions we may impose). We will pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection with the ATM Agreement. On February 7, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $5,000,000 pursuant to a prospectus supplement dated February 7, 2025. On November 13, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased by $2,439,256 pursuant to a prospectus supplement dated November 13, 2025 for a current offering up to $4,821,200. The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant to the ATM Agreement, of shares having an aggregate offering price of $7,790,780 and (2) the termination of the ATM Agreement by either us or Wainwright, as set forth therein. During the three months ended March 31, 2026, we issued an aggregate of 756,187 shares of our common stock for net proceeds of approximately $701,000, after deducting sales agent commissions and other offering expenses payable by us pursuant to the ATM Agreement. On April 16, 2026, the amount that the Company could offer and sell pursuant to the ATM Agreement was updated pursuant to a prospectus supplement to a registration statement on Form S-3 (File No. 333-291566) dated April 16, 2026 for a current offering up to approximately $1,555,000. The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant to the ATM Agreement, of shares having an aggregate offering price of $7,790,780 and (2) the termination of the ATM Agreement by either the Company or Wainwright, as set forth therein.

Reworded

-3030-- We have entered into certain license, sublicense, sponsored research and option agreements with third parties. Pursuant to such agreements, we may be required to make certain: (i) license maintenance fee payments; (ii) out-of-pocket expense payments, including, but not limited to, payments related to intellectual property and research related expenses; (iii) development and commercialization expense payments; (iv) annual and quarterly minimum payments; (v) diligence expense payments; and (vi) revenue interest payments. In addition, subject to the achievement of certain development and/or commercialization events, we may also be required to make certain: (i) minimum royalty payments, ranging from middle to high five figures, (ii) sales-based royalties and running royalties, ranging from low single digits to low double digits; and (iii) milestone payments, of of up to approximately $25$29 million (if all milestones in all of our current agreements are achieved).

Reworded

Additional funding will be necessary to fund our future clinicalbusiness and pre-clinicaldevelopment activities. We may obtain additional financing through sales of our equity and debt securities or entering into strategic partnership arrangements, or a combination of the foregoing. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of the economic downturn. If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.

Reworded

For the threesix months ended MarchJune 31,30, 2026, net cash cash used in operating activities was approximately $3,050,000,$6,019,000, which primarily resulted from a net loss of approximately $2,692,000, $6,527,000, an increase in prepaid expenses and other current assets of approximately $387,000$149,000, a decrease in accounts payable and accrued expenses of approximately $14,000, and a decrease in lease costs of $1,000, $64,000, offset by approximately $44,000 of realized loss on crypto assets.assets and $677,000 in stock-based compensation and professional fees.

Added

.

Reworded

For the threesix months ended MarchJune 31,30, 2025, net cash cash used in operating activities was approximately $2,788,000,$5,161,000, which primarily resulted from a net loss of approximately $3,476,000,$5,675,000, an increase in prepaid expenses and other current assets of approximately $155,000 and a decrease in accounts payable and accrued expenses of approximately $460,000, offset by approximately $851,000 of non-cash research and development-acquired patent, $220,000and $275,000 in stock-based compensation and aprofessional lease costs of $4,000, an increase in prepaid expenses and other current assets of $371,000 and a decrease in accounts payable and accrued expenses of $16,000.fees.

Reworded

During the threesix months ended MarchJune 31,30, 2026, the the Company received proceeds of approximately $147,000 from the sale of crypto assets.

Reworded

The Company did not have any cash flows from investing activities for the threesix months ended MarchJune 31,30, 2025.

Removed

For the three months ended March 31, 2026, net cash provided by financing activities was approximately $701,000, which resulted from net proceeds from the issuance of common stock of approximately $701,000.

Reworded

For the threesix months ended MarchJune 31,30, 2025,2026, net cash cash provided by financing activities was approximately $7,067,000,$7,516,000, which resulted from net proceeds from the issuance of common stock of $1,442,000approximately $5,847,000 and from net proceeds from the exerciseissuance of common stock and warrants of approximately $5,625,000.$1,669,000.

Added

For the six months ended June 30, 2025, net cash provided by financing activities was approximately $7,133,000, which primarily resulted from net proceeds from the issuance of common stock of approximately $1,508,000 and proceeds from the exercise of warrants of $5,625,000.

Reworded

We plan to pursue our plans with respect to the research and development of our technology products, as well as our pre-clinical productsproducts, which will require resources beyond those that we currently have, ultimately requiring additional capital from third-party sources. We currently do not expect to generate any revenue.

Added

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Added

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Reworded

In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to provide more detailed disaggregation of expenses in the income statement, focusing on the nature of the expenses rather than their function. The new disclosures will require entities to separately present expenses for significant line items, includingincluding, but not limited to, depreciation, amortization, and employee compensation. Entities will also be required to provide a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively, disclose the total amount of selling expenses and, in annual reporting periods, provide a definition of what constitutes selling expenses. This pronouncement is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted.

Removed

The Company does not expect the adoption of this new guidance to have a material impact on its consolidated financial statements.

RKTO insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

No Form 4 stock transactions in this period.

Well-known investors holding RKTO (13F)

None of the 59 investors we track reported a position in their latest 13F.

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