RKTO 10-K & 10-Q changes, risk factors and insider trading
Rocket One Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1711786 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
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
“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.”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“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.”see in full comparison
“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.”see in full comparison
“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 …”see in full comparison
Full comparison: every changed paragraph (36)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
Removed heading “Income Taxes (Topic 740)”
Largest changes
“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. …”see in full comparison
“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. …”see in full comparison
“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 …”see in full comparison
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 wesee in full comparisonmaycould 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 FormS-3, including an accompanying prospectusS-3 (File No. 333-272620), including an accompanying base prospectus andanda prospectus supplement dated November 8, 2024. Sales of shares of the Company’s common stock through Wainwright, if any, will bebemade by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the SecuritiesAct 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.FromDuringNovemberthe8,year2024 toended December 31,20242025 we issued1,137,250an 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.
“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. …”see in full comparison
Full comparison: every changed paragraph (21)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
During the year ended December 31, 2025, the Company purchased $300,000 in crypto assets.
The
Company did not have any cash flows from investing activities for
the yearsyear ended December 31, 2024 or December 31, 2023.2024.
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.
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.
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.
Income
Taxes (Topic 740)
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.
The
ASU requires disclosure of the following information about income taxes paid on an annual basis:
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
Risk Factors
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
“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. …”see in full comparison
“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.”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“Developing AI can be capital intensive and we operate in a nascent and rapidly evolving market in which the potential of AI remains uncertain.”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (32)
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.
Risks Related to the Company
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.
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.
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.
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.
-3434--
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.
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.
Any delays in the development and manufacture of satellites and related technology may adversely impact our business, financial condition and results of operations.
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.
Developing AI can be capital intensive and we operate in a nascent and rapidly evolving market in which the potential of AI remains uncertain.
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.
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.
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.
-3535--
Our products may be subject to security vulnerabilities that could have a material adverse effect on us.
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.
If essential equipment, materials, or manufacturing processes are not available to manufacture our products, we could be materially adversely affected.
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.
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.
Risk Relating to Government Regulations
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.
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.
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.
-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.
Issues related to the responsible use of AI may result in reputational, competitive and financial harm and liability.
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.
Risks Related to Our Intellectual Property Rights
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.
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.
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)
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
Our unaudited condensed consolidated financialsee in full comparisonfinancialstatements 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 ofMarch31,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 thethreesix months endedMarchJune31,30, 2026 and 2025, respectively. We incurred net losses of approximately$2,692,000$6,527,000 and$3,476,000$5,675,000 for thethreesix months endedMarch,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 ourpre-clinicallonger-term business plans andclinical development of our product candidates.development. We have not yet commercialized any products and have never generated any revenue from product sales. Wedo notbelieve that our existing cash as ofMarchJune31,30, 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 areareavailable 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.
“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
“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. …”see in full comparison
“Comparison of Our Results of Operations for the Six Months Ended June 30, 2026 and 2025”see in full comparison
Full comparison: every changed paragraph (48)
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).
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).
Recent Developments
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.
Comparison of Our Results of Operations for the Three Months Ended
MarchJune 31,30, 2026 and 2025
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.
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.
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.
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:
-2727--
General and Administrative Expenses
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):
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.
We anticipate that our general and administrative expenses will continue to increase in future periods, reflecting continued and increasing costs associated with:
Other Income
For the three months ended June 30, 2026 and 2025, other income was approximately $149 and $173, respectively, which resulted from interest income.
Net Loss
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.
Comparison of Our Results of Operations for the Six Months Ended June 30, 2026 and 2025
Operating Costs and Expenses
Research and Development Expenses
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.
-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.
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):
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.
-2929--
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.
For the threesix months ended MarchJune 31,30, 2025, other
income, net was approximately $181,$354, which resulted from $354 of interest income.
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.
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.
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.
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.
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.
-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).
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.
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.
.
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.
During the threesix months ended MarchJune 31,30, 2026, the
the Company received proceeds of approximately $147,000 from the sale of crypto assets.
The Company did not have any cash flows from investing activities for
the threesix months ended MarchJune 31,30, 2025.
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.
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.
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.
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.
-3131--
-3232--
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.
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.