What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-31 compared with 2025-03-25 · 135 added, 169 removed, 79 unchanged (79% of the section changed)

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Company Overview

We are a neurotechnology company focused on neurological wellness.

Our purpose is to develop, license or acquire non-implantable technologies targeted at reducing symptoms of neurological disease or trauma.

We are a listed digital asset treasury (“DAT”) dedicated to acquiring and holding Solana tokens (“SOL”).

Our DAT objective is to maximize SOL per share through strategic use of capital markets and onchain opportunities, offering public market investors direct exposure to Solana.

Strategic digital asset reserves like SOL lay the groundwork for a future where global payments, credentialing, and personalized learning can be powered by decentralized infrastructure, enhancing how we grow our company.

We believe that SOL represents a uniquely scalable, high-performance blockchain platform that aligns with our long-term vision of integrating innovative technologies into our services.

By investing in and participating in the SOL ecosystem, we aim to both enhance our digital asset treasury strategy and create strategic optionality for product innovation in our core business.

We are, to a lesser extent, also a neurotechnology company focused on neurological wellness.

Our product, known as the Portable Neuromodulation Stimulator, or PoNS®, is an innovative non-implantable medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and chronic balance deficit.

PoNS Therapy® is integral to the overall PoNS solution and is the physical therapy applied by patients during use of the PoNS neuromodulation stimulator.

PoNS Therapy® is integral to the overall PoNS solution and is the physical therapy applied by patients during use of the PoNS device.

PoNS has marketing clearance in the U.S.

for use in the U.S.

as a short-term treatment of gait deficit due to mild-to-moderate symptoms for MS and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

for use as a short-term treatment of gait deficit due to mild-to-moderate symptoms for multiple sclerosis (“MS’) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

We began accepting prescriptions for PoNS in the U.S.

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PoNS is authorized for sale in Canada for three indications:

(i) as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury, or mmTBI, and is to be used in conjunction with physical therapy;

(i) as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy;

(ii) as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and it is to be used in conjunction with physical therapy;

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Recent Developments

In March 2026, the SEC and CFTC issued the Release indicating that certain digital assets, including SOL, may be characterized as “digital commodities” and that certain related activities, including staking and secondary market transactions, may not constitute securities transactions under specified circumstances.

However, the Release does not constitute formal rulemaking and does not have the force of law, and the regulatory characterization of SOL and related activities therefore remains subject to ongoing development.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, making various amendments to the Internal Revenue Code.

Based on our ongoing assessment, the Company does not expect OBBBA to have a material impact on its consolidated financial statements.

Corporate Updates

On August 9, 2024, we received written notice (the “Notification Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the Company was not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market.

Nasdaq Listing Rule 5550(a)(2) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days.

Based on the closing bid price of the Company’s Class A common stock (“Common Stock”) for the 30 consecutive business days prior to the date of the Notification Letter, the Company did not meet the minimum closing bid price requirement.

To regain compliance, the closing bid price of the Company’s Common Stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to February 5, 2025.

There can be no assurance that we will be able to regain compliance with the minimum bid price requirement and other Nasdaq listing criteria.

If we fail to meet the applicable continued listing requirements for the Nasdaq Capital Market, Nasdaq may delist our Common Stock.

If such delisting should occur, it would likely have a negative effect on the price of our Common Stock and would impair an investor’s ability to sell or purchase our Common Stock when desired.

In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements.

Additionally, Nasdaq rules allow an expedited delisting of securities of companies that have had one or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period.

Under these rules, if a company falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any compliance periods and Nasdaq will instead require the issuance of a Staff delisting determination, which is appealable to a hearings panel.

Our ability to remain listed on Nasdaq may be negatively impacted by this Nasdaq rule.

On February 7, 2025, we received a determination letter from Nasdaq notifying us that because we did not comply with the $5 million minimum stockholders’ equity initial listing requirement for The Nasdaq Capital Market, we were not eligible for a second 180-day period.

On February 14, 2025, we requested an appeal of this determination and will submit a plan to regain compliance.

The Company had a hearing with the Nasdaq Hearing Panel on March 18, 2025.

At the hearing, we presented our plan for regaining compliance with the Minimum Bid Price Requirement and requested a further extension so that we may complete the execution of our plan.

Although we believe our plan will be sufficient to enable us to regain compliance, no assurance can be provided that Nasdaq will ultimately accept our plan or that we will ultimately regain compliance with the Minimum Bid Price Requirement.

As of the date of this report, we have not received a determination from the hearings panel.

Our common stock will remain listed and eligible for trading on Nasdaq pending the ultimate conclusion of the hearing process.

On March 11, 2025, we established Revelation Neuro to pursue the development of a new gold standard of care for personalized neurorehabilitation using a non-implantable AI powered brain computer interface combining our newly developed intellectual property with Helius’ existing intellectual property.

On January 21, 2025, the Company entered into warrant exercise inducement offer letters with certain holders of existing Series A warrants and Series B warrants generating gross proceeds of $3.7 million as discussed further in Note 15 in our consolidated financial statements.

Presently, PoNS Therapy is not reimbursed under contract by any third-party payers in the U.S.

We are pursuing commercial insurance coverage for PoNS within the Durable Medical Equipment benefit category.

On February 29, 2024, CMS assigned HCPCS Level II codes to the PoNS controller and PoNS mouthpiece, effective April 1, 2024.

On May 2, 2024, CMS published a proposed fee schedule payment rates for the PoNS controller and PoNS mouthpiece to be discussed at CMS' bi-annual Healthcare Common Procedure Coding System (“HCPCS”) public meeting to be held on May 29, 2024.

For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a capped fee of $1,206.53.

For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the previously offered, temporary, cash pay price of $4,500, resulting in a total capped payment of $3,075.53.

The Company subsequently provided CMS additional information to support reimbursement economics and presented that information at the public meeting with CMS on May 29, 2024 for consideration by CMS for determination of the final reimbursement amount for each of the PoNS controller and mouthpiece.

On October 7, 2024, CMS posted the final payment rate for the PoNS Mouthpiece (HCPCS code A4594) at $2,963.30, which will be effective January 1, 2025 and deferred final national determination of the payment rate for the PoNS Controller (HCPCS Code A4593) to the next payment cycle.

At the Company’s request, Company management subsequently met with CMS in December 2024 prior to PoNS Mouthpiece pricing taking effect on January 1, 2025 to request that they revisit the starting point for the gap filling process to more appropriately use the market pricing established through negotiation with the VA and an insurance carrier.

On October 8, 2024, CMS published the preliminary rate for the PoNS Controller (HCPCS Code A4593) at the capped total payment of $519.80, based on its view that the product is comparable to devices reported with HCPCS code E0730 (transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation) to be effective April 1, 2025.

On January 13, 2025, CMS posted final Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies fee schedule payment rates for the PoNS Controller (HCPCS Code A4593) at the capped total payment of $532.27 and no changes to the previous final determination for the PoNS Mouthpiece (HCPCS code A4594) were made.

During the first quarter of 2024, the Company partnered with Lovell Government Services (“Lovell”), an SBA-certified Service-Disabled Veteran-Owned Small Business, to make the PoNS device available to federal healthcare systems.

In May 2024, PoNS became available on the Veteran Affairs Federal Supply Schedule and General Services Administration Advantage Contracts at $23,843.72 for the PoNS device and $7,344.97 for the PoNS mouthpiece.

In July 2024, PoNS became available to the Department of Defense and U.S.

Military facilities on the Distribution and Pricing Agreement at $23,724.50 for the PoNS device and $7,308.25 for the PoNS mouthpiece.

In December 2024, the first PoNS System sale to the VA Healthcare System through Lovell was delivered at the contracted price of $23,844, comprised of $16,499 for the PoNS Controller and $7,345 for the PoNS Mouthpiece.

As discussed further in Note 8 to our consolidated financial statements, in May 2024, the Company closed on a registered public offering of its Common Stock and warrants and received net proceeds of approximately $5.5 million.

On April 4, 2024, the Company received written notice from Nasdaq stating that the Company no longer complied with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) for continued listing on Nasdaq because the Company’s stockholders' equity, as reported in our 2023 10-K, had fallen below $2.5 million.

The notice also indicated that the Company did not meet the alternative compliance standards.

Under applicable Nasdaq rules, the Company had 45 calendar days from the date of the notice, or until May 20, 2024, to submit a plan to regain compliance.

On May 31, 2024, the Company received formal notification from Nasdaq confirming that, following the consummation of a registered public offering on May 9, 2024, the Company regained compliance with the minimum stockholders’ equity requirement, and that the Company satisfied all other applicable criteria for continued listing on Nasdaq.

During the second quarter of 2024, the Company received the first third-party reimbursement from a major insurance carrier at a 7% rebate, which resulted in pricing of $23,900 for the PoNS device, comprised of $16,554 for the PoNS controller and $7,347 for the PoNS mouthpiece, exclusive of rounding.

In June 2024, the Company began establishing sales representative agreements with organizations and individuals to sell PoNS devices to Veterans Affairs (“VA”) facilities in the U.S.

The Company has since established agreements with representatives covering facilities in Texas and east of the Mississippi with plans to expand west.

During the first quarter of 2024, leveraging the Breakthrough Designation, the Company reached alignment with the FDA on the registrational program to evaluate the therapeutic benefit of PoNS on gait and balance deficits in chronic stroke subjects, which originally included two initial studies.

The first was an investigator-initiated randomized placebo-controlled trial (“MUSC-RCT”) in approximately 60 subjects, led by Dr.

Steven Kautz at the Medical University of South Carolina (“MUSC”) and Dr.

Mark Bowden at Brooks Rehabilitation.

The second study was a company-sponsored open-label study (“HMI-OLS”), in approximately 30 subjects.

Following guidance from FDA, Helius added, in May 2024, a third company-sponsored randomized placebo-controlled trial (“HMI-RCT”) in approximately 60 subjects, as the pivotal study, along with the OLS, for the registrational program.

All three studies shared the same design and endpoints, including primary outcomes on gait and balance improvement, as well as key secondary endpoints with Type 1 error of reduced risk of falling and maintenance of effect at 12 weeks post-treatment.

Enrollment of the stroke registrational studies started at MUSC for the MUSC-RCT in August 2023 and, at Brooks Rehabilitation, in August 2024.

In June 2024, Helius started enrollment of the HMI-OLS at five U.S.

Centers of Excellence for Neurorehabilitation including Shepherd Center, MGH-IHP, REHABOLOGYM, Brooks Rehabilitation and New England Neurological Center.

Enrollment continued, with the HMI-RCT, in July 2024 at Neuro-Concept Rehabilitation Center, Neuphysio, Synaptic Health, Bergin Motion in Canada and REHABOLOGYM in the U.S.

The Company has completed and far exceeded the initial 90-subject target enrollment for its stroke registrational program enrolling 128 participants by December 31, 2024.

With maximum enrollment of over 150 participants achieved at the end of January 2025, the Company is on track to submit for FDA authorization for stroke in the second quarter of 2025, with the plan to achieve FDA authorization by the end of 2025.

During the fourth quarter of 2024, the Company completed the transition of the manufacturing of PoNS device controllers and mouthpieces to Minnetronix, Inc.

from its previous contract manufacturer, Key Tronic Corporation.

We also intend to provide broad access and reimbursement for the PoNS Therapy over time through commercial insurers.

Prior to broad commercial payer coverage, we anticipate the primary source of sales will be self-pay and VA patients.

We expect to support the cost of the PoNS Therapy by working with advocacy groups and charitable organizations to help self-pay patients access our technology.

In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers from the date that the HCPCS codes became effective.

Strategic Digital Asset Treasury

In connection with the closing of our private placement offerings in September 2025 (“2025 PIPE Offerings”), we implemented a DAT strategy to acquire SOL, the native cryptocurrency of the Solana blockchain.

SOL will serve as our primary treasury reserve asset.

Solana has historically been the fastest growing blockchain, leading the industry in transaction revenue and processing more than 3,500 transactions per second.

The network is also the most widely adopted, averaging about 3.7 million daily active wallets and surpassing 23 billion transactions year to date.

SOL is financially productive by design, offering a ~7% native staking yield, whereas assets like Bitcoin are non-yield-bearing.

We intend to leverage the native yield-generating properties of Solana's architecture and capture opportunities in DeFi and broader onchain activity.

Advisory Agreements

On September 15, 2025, we entered into a Strategic Advisor Agreement (the “Strategic Advisor Agreement) with Pantera Capital and Summer (the “Advisors”), pursuant to which we engaged each of Pantera and Summer to provide strategic advice and guidance relating to the Company’s business, operations, growth initiatives and industry trends in the crypto technology sector for an initial term of two (2) years, which term automatically renews for successive periods of one (1) year each.

Either the Company or the Advisors may terminate the Strategic Advisor Agreement upon written notice of a material breach by the other party that has not been cured within thirty (30) days of receipt of the written notice.

The Strategic Advisor Agreement also contains customary representations and warranties, confidentiality provisions and limitations on liability.

Refer to Note 8 for details on the terms of the Advisor Warrants we issued and Note 11 for expenses reimbursed to the Advisors during the year ended December 31, 2025 in connection with the Strategic Advisor Agreement.

Additionally, on September 15, 2025, we entered into a Trading Advisory Agreement (the “Trading Advisory Agreement”) with Pantera, pursuant to which we engaged Pantera to manage the investment of substantially all of our digital assets, digital asset derivatives, cash and other assets for an initial term of ten (10) years, which term automatically renews for successive periods of one (1) year each, subject to the mutual agreement of us and Pantera.

The management fees pursuant to the Trading Advisory Agreement shall be equal to:

(a) 1.0%, if the Company’s Assets Under Management (as defined in the Trading Advisory Agreement) is less than or equal to $1 billion, (b) 0.75% per annum of assets under management (“ AUM ”) if AUM is more than $1 billion but less than or equal to $5 billion and (c) 0.50% per annum of AUM if AUM is more than $5 billion.

Refer to Note 11 for details of the fees expensed by us during the year ended December 31, 2025, under the Trading Advisory Agreement.

Master Loan Agreement

In connection with the closing of the 2025 PIPE Offerings, as discussed in more detail in Note 8 to our consolidated financial statements, we agreed to use the net proceeds from the sale to fund the acquisition of SOL, and the establishment of a SOL treasury operation, as well as pay transaction fees and expenses, and for working capital and general corporate purposes.

To advance the our planned SOL treasury operation, on September 14, 2025, Marvel Operations Corp., a Delaware limited liability company and our wholly-owned subsidiary of the Company, entered into a Master Loan Agreement with a third-party lender (the “Master Loan Agreement”) to provide a short-term loan to make initial purchases of SOL.

As of December 31, 2025, Marvel Operations Corp., had no outstanding loans with the third-party lender under the Master Loan Agreement.

Financing and Stock

On September 18, 2025, we completed the issuance and sale of an aggregate of 38,049,663 shares of our Class A common stock at an offering price of $6.881 and accompanying pre-funded warrants to purchase up to 36,261,239 shares of Class A common stock at a price of $6.881 less $0.001 and stapled warrants to purchase up to 73,941,196 shares of Class A common stock at an exercise price of $10.134.

We also issued warrants to our Advisors to purchase up to 7,394,119 shares of Class A common stock at an exercise price of $0.001 subject to shareholder approval.

In connection with the 2025 PIPE Offerings, we received total gross proceeds of approximately $518.4 million before

deducting estimated placement agent fees and offering expenses.

On November 17, 2025, certain provisions of the stapled warrants related to adjustments of the Black-Scholes inputs in determining the warrant value in the event of a fundamental transaction were amended to align treatment of stapled warrant holders and Class A common stockholders in the event of a fundamental transaction.

On September 15, 2025, we entered into a Sales Agreement (the “2025 Sales Agreement”) with Clear Street LLC (“Clear Street”) and Maxim Group LLC (“Maxim”), as co-sales agents, pursuant to which we may offer and sell shares of our Class A common stock from time to time having an aggregate offering price of up to $92.8 million (the “2025 ATM”).

During the year ended December 31, 2025, we issued and sold shares 1,347,916 shares with net proceeds of $24.2 million under the 2025 ATM.

On June 23, 2025, we entered into a sales agreement with Roth Capital Partners, LLC (“Roth”), pursuant to which we may offer and sell shares of our Class A common stock.

On July 7, 2025, we filed an updated prospectus supplement for the offer and sale of up to $25 million of shares of Class A common stock through Roth pursuant to the sales agreement.

In September 2025, we terminated the sales agreement with Roth in connection with our 2025 Sales Agreement with Clear Street and Maxim.

During the year ended December 31, 2025, we sold 379,040 shares generating net proceeds after commissions of $5.1 million.

On June 6, 2025, we completed the issuance and sale of an aggregate of 55,372 shares of our Class A common stock and accompanying common warrants to purchase up to 55,372 shares of Class A common stock at an offering price of $163.50 per share of Class A common stock and accompanying common warrants generating gross proceeds of $9.1 million before repayment of the previously issued promissory notes of $1.56 million and cash issuance costs of $1.2 million (the “2025 Offering”).

We also issued warrants to the placement agent to purchase 2,769 shares of Class A common stock on the same terms as the common stock warrants.

See Note 8 in our consolidated financial statements for more details.

On May 23, 2025, our stockholders approved a potential reverse stock split in a ratio of 1-to-2 to 1-to-250.

The Board of Directors subsequently approved a reverse split at a ratio of 1-for-50, which became effective July 1, 2025 (the “July 2025 Reverse Stock Split”) as discussed further in Note 8 in our consolidated financial statements.

On April 24, 2025, we sold, in a private placement, unsecured 20% original issue discount promissory notes (the “Notes”) and issued 1,760 shares of our Class A common stock generating gross proceeds of $1.3 million with cash share issuance costs of $0.1 million for net proceeds of $1.2 million as discussed further in Note 8 in our consolidated financial statements.

On April 21, 2025, our stockholders approved a potential reverse stock split in a ratio of 1-to-2 to 1-to-30.

The Board of Directors subsequently approved a reverse split at a ratio of 1-for-15, which became effective May 2, 2025 (the “May 2025 Reverse Stock Split”) as discussed further in Note 8 in our consolidated financial statements.

On January 21, 2025, we entered into warrant exercise inducement offer letters with certain holders of existing Series A warrants and Series B warrants (together, the “Existing Warrants”) to exercise their Existing Warrants in exchange for the issuance of new Series C warrants and Series D warrants on substantially the same terms as the Existing Warrants generating gross proceeds of $3.7 million as discussed further in Note 8 in our consolidated financial statements.

Share Repurchase Program

On November 3, 2025, our board of directors approved a stock repurchase program for the purchase of up to $100 million of our outstanding Class A common stock.

Repurchases of Class A common stock may be made in the open market (including through Rule 10b-18 compliant transactions), in privately negotiated transactions, in block trades, through one or more accelerated share repurchase transactions, through one or more trading plans intended to comply with Rule 10b5-1, through tender offers, or by any combination of the foregoing.

As of December 31, 2025, no stock repurchases had occured.

As of March 27, 2026, the Company has repurchased 1,531,032 shares of its Class A common stock (“Repurchased Shares”) at a weighted-average purchase price of $2.21 per share.

Repurchased Shares are held in treasury.

Material Trends and Uncertainties

Global Economic Conditions

Generally, worldwide economic conditions remain uncertain, in part due to supply chain disruptions, labor shortages, global conflicts, increased inflation and unpredictable trade policies, including tariffs, customs regulations and other trade restriction.

The general economic and capital market conditions both in the U.S.

and worldwide, have been volatile in recent years and at times have adversely affected our access to capital and have increased the cost of capital.

The capital and credit markets may not be available to support future capital raising activity on favorable terms.

If economic conditions continue to remain volatile or decline, our future cost of equity or debt capital and access to the capital markets could be adversely affected.

Our operating results could be materially impacted by changes in the overall macroeconomic environment and other economic factors.

Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, global conflicts such as the conflicts in Ukraine and in the Middle East, and steps taken by governments and central banks as well as other stimulus and spending programs have led to higher inflation, which has led to an increase in costs and has caused changes in fiscal and monetary policy, including increased interest rates.

Although we may take measures to

mitigate these impacts, if these measures are not effective, our business, financial condition, results of operations, and liquidity could be materially adversely affected.

Other Trends and Uncertainties

To successfully commercialize, we need to continue to build infrastructure necessary to grow our business including adding headcount and implementing or upgrading business systems.

Competition for talent in today’s labor market may impact our ability to add headcount and to recruit talent with the expertise we need to develop our commercial infrastructure.

Our historical financial condition and results of operations for the periods presented may not be comparable, either from period to period or going forward, due to the recent deployment of our new blockchain-native treasury management

business, primarily with Solana tokens.

As a result, the periods presented in our historical financial statements may not be comparable to one another and our future results of operations and financial results may differ.

Our treasury management business is expected to be heavily dependent on the price of SOL, which has historically experienced significant volatility.

As of December 31, 2025, our total SOL exposure that we held directly in our accounts or had exposure to 2,360,083 SOL, valued at $293.7 million based on a market price of $124.45 per token.

SOL is valued at fair value at the end of each reporting period, with changes in fair value recognized in net income.

Refer to Note 3 in the consolidated financial statements for more details on the breakout of our SOL holdings.

As a result, fluctuations in the price of SOL may significantly impact our results of operations.

The price per SOL as of March 27, 2026 (midnight UTC) was $83.05, a 33% decline as compared to December 31, 2025.

We have not adjusted the carrying value of digital assets as of December 31, 2025, in the consolidated financial statements because this decline relates to conditions arising after the balance sheet date.

Results of Operations

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Years Ended December 31,

Product sales, net:

United States

Total product sales, net

Other revenue

Staking revenue

Product sales and other revenue

Total revenue

Cost of revenue

Gross (loss) profit

Gross profit (loss)

Operating expenses

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Research and development expenses

Amortization expense

Fixed asset impairment

Unrealized loss on digital assets and digital assets receivable

Realized loss on digital assets

Unrealized loss on digital assets fund investment

Realized gain on digital asset derivatives

Total operating expenses

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Nonoperating income

Interest (expense) income, net

Interest expense, net

Foreign exchange gain (loss) and other income

Change in fair value of derivative liability

Foreign exchange (loss) gain

Other income, net

Loss on derivative liability

Financing costs

Nonoperating income, net

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Year Ended December 31, 2025 Compared to Year Ended December 31, 2024

The decrease in total net product sales was primarily attributable to a decrease in unit volumes for U.S.

sales of PoNS systems due to the termination of our Patient Therapy Access Program (“PTAP”) on June 30, 2023 as well as the termination of the previously offered temporary cash pay pricing in May 2024.

Staking revenue

We began staking our SOL holdings in September 2025, earning staking rewards of $5.5 million in SOL during the year ended December 31, 2025.

Product sales and other revenue

Product sales and other revenue for 2025 compared to the same period in the prior year remained flat as a result of a decrease in product sales offset by a one-time recognition of deferred revenue.

Cost of Revenue

The cost of revenue for 2024 as compared to the same period in the prior year remained relatively flat year to year due to decreased unit volumes sold offset by increases in certain inventory reserve adjustments, warranty and fixed employee costs.

Gross (Loss) Profit

Gross loss for the year ended December 31, 2024 was $62,000 compared to gross profit of $61,000 for the same period in the prior year.

Decreased revenues in 2024 with cost of revenues remaining flat from the prior year were the primary reasons for the year-to-year variance.

The cost of revenue for 2025 as compared to the same period in the prior year decreased year to year due to decreased unit volumes sold resulting in lower product costs and a decrease in certain inventory adjustments offset by increases in fixed employee costs and staking costs related to our new Solana treasury strategy.

Selling, General and Administrative Expenses

The increase in selling, general and administrative expenses was primarily from a $0.7 million increase in non-cash stock-based compensation expense, a $0.3 million in increased legal costs partially offset by a $0.2 million decrease in insurance costs and a $0.1 million decrease in franchise taxes.

Refer to Note 9 to our consolidated financial statements for detailed information about stock-based compensation.

The increase in selling, general and administrative expenses was the result of the implementation of our Solana treasury strategy and was primarily from a $6.9 million increase in non-cash stock-based compensation expense, a $2 million increase in employee wages and benefits, a $1.3 million increase in digital asset management and custodian fees, a $1.0 million in increased legal costs, a $0.6 million in increased professional fees, a $0.6 million increase in filing costs, a $0.3 million increase in advertising costs, a $0.3 million increase in franchise taxes, and a $0.2 million increase in directors’ and officers’ insurance partially offset by a $0.2 million decrease in contract manufacturer transition costs.

Research and Development Expenses

The increase in research and development expenses was primarily from increases in clinical trial related costs of $0.4 million, an increase in non-cash employee stock compensation expense of $0.2 million and product development costs of $0.1 million.

Refer to Note 9 to our consolidated financial statements for detailed information about stock-based compensation.

Amortization Expense

Amortization expense is primarily comprised of the amortization of acquired finite-lived intangible assets.

The decrease in amortization expense is primarily due to the remaining unamortized intangible assets becoming fully amortized during the year ended December 31, 2024.

Refer to Note 6 to our consolidated financial statements for additional information about the composition of intangible assets.

Fixed Asset Impairment

During the fourth quarter of 2024, we recorded an impairment of $40,000 for certain software used with our enterprise resource planning system.

Refer to Note 3 to our consolidated financial statements for additional information.

Nonoperating Income

Interest (Expense) Income, Net

Net interest expense for the year ended December 31, 2024 was primarily attributable to interest expense related to the Company’s insurance premium financing and lower interest income earned on investments of excess cash in an unrestricted money market savings account year to year due to lower current year cash balances and a shift to excess cash being primarily invested in money market mutual funds earning dividend income in the current year, versus interest bearing securities in the prior year.

The decrease in research and development expenses was primarily from increases in clinical trial related costs of $0.3 million and an increase in product development costs of $0.3 million offset by a decrease in non-cash employee stock compensation expense of $0.2 million and a decrease in employee wages of $0.5 million.

Unrealized loss on digital assets and digital assets receivable

The unrealized loss on digital assets and digital assets receivable represents the unrealized mark-to-market for our digital asset holdings to record digital assets at fair value due to the decline in value of SOL.

Realized loss on digital assets

The realized loss on digital assets represents the loss realized on sales of SOL with proceeds utilized to acquire digital assets receivable, which consists of underlying restricted SOL assets for which we have the right to receive unrestricted SOL in the future at a discounted price relative to unrestricted SOL.

Unrealized loss on digital assets fund investment

The unrealized loss on digital assets fund investment represents the unrealized mark-to-market for our digital asset fund investment holdings to record digital asset investment fund at fair value due to the decline in value of SOL.

Realized gain on digital asset derivatives

The realized gain on digital assets represents the gain on a SOL put option that expired during the year ended December 31, 2025.

Nonoperating income (expense)

Interest Expense

Net interest expense for the year ended December 31, 2025 was primarily attributable to interest expense related to short-term borrowing and to a lesser extent interest expense from our insurance premium financing.

See Note 8 in the consolidated financial statements for more detail on the short-term borrowing that was repaid in 2025.

Foreign exchange gain (loss) and other income

Foreign exchange gain (loss) and other income for the year ended December 31, 2025 was primarily attributable to dividend income earned on investments of excess cash in money market mutual funds and foreign exchange gain due to fluctuations in the Canadian to U.S.

dollar exchange rates.

Loss on Derivative Liability

Loss on derivative liability for the years ended December 31, 2025 was primarily attributable to a charge in the third quarter as the result of the gross proceeds allocation from the 2025 PIPE Offerings to the derivative liability from the related stapled warrants.

See Note 8 in the consolidated financial statements for more detail on the stapled warrant derivative liability.

Change in Fair Value of Derivative Liability

As discussed in more detail in Note 8 to our consolidated financial statements, the warrants issued in connection with the August 2022 Public Offering are being accounted for as a derivative liability instrument.

The change in fair value of derivative liability for the year ended December 31, 2024 of $3.0 million is the result of the decrease in our stock price offset partially by reduced outstanding warrant exposure due to warrant exercises during the year.

Foreign Exchange (Loss) Gain

The foreign exchange loss for the year ended December 31, 2024 was primarily due to higher Canadian to U.S.

dollar exchange rates in 2024.

Other Income, Net

Other income was primarily attributable to dividend income earned on investments of excess cash in a money market mutual fund.

As discussed in more detail in Note 8 to our consolidated financial statements, the stapled warrants issued in connection with the 2025 PIPE Offerings completed on September 18, 2025 were accounted for as a derivative liability instrument.

The gain from the change in fair value of derivative liability primarily results from the change in fair value of the stapled warrant derivative liability for the year ended December 31, 2025 of $943.6 million, which was primarily due to a decrease in our stock price and was partially offset by a $6.1 million loss from the change in fair value relating to the June 2025 common warrants.

Due to the change in classification of the stapled warrants, no further impact to change in fair value of derivative liability occurred after November 17, 2025.

Financing Costs

Financing costs consist of $0.5 million in warrant-related costs from the June 2025 Offering, $14.9 million of cash financing costs from the 2025 PIPE Offerings and non-cash financing costs from the issuance of advisory warrants and the issuance of Class A common stock to the placement agent of $179.8 million.

Liquidity and Capital Resources

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Working capital

Our available capital resources have been primarily used to expand our U.S.

commercialization efforts, fund manufacturing activities for the PoNS device, conduct clinical trials and for working capital and general corporate purposes.

Our primary sources of cash and cash equivalents have been proceeds from public and private offerings of our common stock which most recently included $5.5 million in net proceeds we received from a public offering of our common stock and warrants completed in May 2024 (“May 2024 Public Offering”) as discussed in more detail in Note 8 to our consolidated financial statements.

As discussed in more detail in Note 8 to our consolidated financial statements, the Company entered into a sales agreement related to our at-the-market offering program (“ATM”) under which we may offer and sell shares having gross proceeds up to $2.0 million.

During the year ended December 31, 2024, the Company issued and sold shares with gross proceeds of $1.3 million under the ATM.

In addition, the Company received gross proceeds of $0.2 million from the issuance of shares upon the exercise of warrants for the year ended December 31, 2024.

On January 21, 2025, the Company entered into warrant exercise inducement offer letters and new warrant issuance which generated $3.4 million in net proceeds as discussed in more detail in Note 15 to our consolidated financial statements.

Prior to the 2025 PIPE Offering, which included $374.9 million in net cash proceeds as discussed in more detail in Note 8 to our consolidated financial statements, our operations were primarily financed through sales of Class A common stock in private placement and public offering transactions.

As previously disclosed, we had expressed substantial doubt about our ability to continue as a going concern due to recurring losses and negative operating cash flows.

Since September 2025, our available capital resources have been primarily used to increase our digital asset holdings and for working capital and general corporate purposes.

We may have to dispose of liquid SOL assets or future liquid SOL earned from staking within the next twelve months to fund these expenses With the successful completion of the 2025 PIPE Offerings and sales pursuant to the 2025 ATM, cash and liquid SOL assets as of December 31, 2025, we believe that substantial doubt about our ability to continue as a going concern has been alleviated for at least the next twelve months from the date of filing of this Form 10-K.

As discussed in more detail in Note 8 to our consolidated financial statements, we entered into a sales agreement related to the 2025 ATM under which we may offer and sell shares of our Class A common stock from time to time having an

aggregate offering price of up to $92.8 million.

During the year ended December 31, 2025, we issued and sold shares with net proceeds of $24.2 million under the 2025 ATM.

As discussed in more detail in Note 8 to our consolidated financial statements, we entered into a sales agreement related to our at-the-market offering program (the “2023 ATM”) under which we may offer and sell shares o f our Class A common stock having an aggregate offering price of up to $2.0 million.

In July 2025, we updated the prospectus supplement to increase the capacity under the 2023 ATM to $25.0 million.

In September 2025, we terminated the sales agreement with Roth in connection with our 2025 Sales Agreement with Clear Street and Maxim.

During the year ended December 31, 2025 and 2024, we issued and sold shares with net proceeds of $5.1 million and $1.3 million, respectively, under the 2023 ATM.

In 2025, we received $7.9 million in net proceeds from a public offering of our Class A common stock and warrants completed in June 2025 (the “June 2025 Public Offering”) as discussed in more detail in Note 8 to our consolidated financial statements.

On April 24, 2025, we sold, in a private placement, unsecured 20% original issue discount promissory notes and issued 1,760 shares of our Class A common stock generating gross proceeds of $1.3 million with cash share issuance costs of $0.1 million for net proceeds of $1.2 million as discussed further in Note 8 in our consolidated financial statements.

On January 21, 2025, we entered into warrant exercise inducement offer letters and new warrant issuance which generated $3.4 million in net proceeds as discussed in more detail in Note 8 to our consolidated financial statements.

In 2024, the Company received $5.5 million in net proceeds from a public offering of our Class A common stock and warrants completed in May 2024 (“May 2024 Public Offering”) as discussed in more detail in Note 8 to our consolidated financial statements

Statement of Cash Flows

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Effect of foreign exchange rate changes on cash

Net decrease in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Net Cash used in Operating Activities

The higher level of cash used in operating activities in 2024 primarily resulted from increases in selling, general and administrative expenses and research and development expenses as compared to 2023.

The higher level of cash used in operating activities in the year ended December 31, 2025 primarily resulted from increases in selling, general and administrative expenses as compared to 2024.

Net Cash Used in Investing Activities

Our investing activities are primarily related to the purchase of property and equipment.

Our investing activities in the year ended December 31, 2025 primarily related to the strategic acquisition of SOL.

Net Cash Provided by Financing Activities

During the year ended December 31, 2024, we received net proceeds of $1.3 million from the issuance and sale of shares under the ATM.

In addition, we received $0.2 million in net proceeds from the exercise of warrants.

During the year ended December 31, 2024, we received net proceeds of $5.5 million from the sale of shares primarily from our May 2024 Public Offering, as described in Note 8 to our consolidated financial statements.

Cash Requirements

Our ability to generate product revenues sufficient to achieve profitability will depend heavily on the successful commercialization of PoNS Therapy in the U.S.

Our net loss was $11.7 million and $8.9 million for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, we had an accumulated deficit of $171.7 million.

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

These and other factors indicate substantial doubt about our ability to continue as a going concern.

Refer to Note 1 to our consolidated financial statements for additional discussion about our going concern uncertainty.

We intend to use our available capital resources primarily to expand our U.S.

commercialization efforts, fund manufacturing activities for the PoNS device, conduct clinical trials and for working capital and general corporate purposes.

We believe that our existing capital resources, including the $0.1 million of additional net proceeds from the ATM and $3.4 million in net proceeds from warrant inducements in 2025 through the date of this filing, will be sufficient to fund our operations into the second quarter of 2025, but we will be required to seek additional funding through the sale of equity or debt financing to continue to fund our operations thereafter.

We will need additional funding for our ongoing clinical trials for stroke.

The amount required to fund operations thereafter will depend on various factors, including timing of approval of clinical trials, duration and result of clinical trials and other factors that affect the cost of the clinical trial, manufacturing costs of product, development of our product for new indications and demand for our authorized products in the market.

There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us.

If we are unable to raise sufficient additional capital, we may be compelled to reduce the scope of our operations and planned capital expenditure or sell certain assets, including intellectual property, and we may be forced to cease or wind down operations, seek protection under the provisions of the U.S.

Bankruptcy Code, or liquidate and dissolve our company.

Critical Accounting Policies and Estimates

During the year ended December, 2025, we generated $3.4 million in net proceeds from entering into a warrant inducement with current warrant holders, net proceeds of $5.1 million from issuance and sales of shares under the 2023 ATM, net proceeds of $24.2 million from issuance and sales of shares under the 2025 ATM, we sold, in the April 2025 Private Placement, promissory notes and issued shares of our Class A common stock generating net proceeds of $1.2 million, we generated, in the June 2025 Public Offering, $7.9 million in net proceeds from an offering of Class A

common stock and warrants, and in the September 2025 PIPE Offerings, the Company issued shares of Class A common stock generating net cash proceeds of $374.9 million and $34.3 million of USDC.

We repaid the promissory notes of $1.6 million.

Critical Accounting Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our financial statements that have been prepared in accordance with U.S.

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revenue recognition, stock-based compensation, derivative financial instruments and accounting for warrants.

Revenue Recognition

The Company generates nearly all of its revenue from product sales directly to patients, its e-commerce partner in the United States and to clinics in Canada.

Revenue from product sales is recognized at a point in time as the performance obligation is satisfied and when the customer obtains control at the established transaction price.

Taxes that the Company collects concurrent with revenue-producing activities are excluded from revenue.

The Company requires some customers in the United States to prepay the full product selling price, net of cash discount, prior to shipment.

The Company records a contract liability for any customer prepayment received for which delivery had not yet occurred as of the end of the period.

Accounting and Valuation of Warrants

We have issued and may continue to issue warrants to purchase shares of common stock through our public and private offerings.

We account for such warrants in accordance with ASC 480 Distinguishing Liabilities from Equity, which identifies three categories of freestanding financial instruments that are required to be accounted for as a liability.

We have issued and may continue to issue warrants to purchase shares of Class A common stock through our public and private offerings.

We account for such warrants in accordance with Accounting Standard Codification (“ASC”) 480 Distinguishing Liabilities from Equity, which identifies three categories of freestanding financial instruments that are required to be accounted for as a liability.

If determined to be classified as a liability, we will remeasure the fair value of the warrants at each balance sheet date.

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This model uses Level 3 inputs in the fair value hierarchy established by ASC 820 - Fair Value Measurement.

As of December 31, 2024, our derivative financial instruments accounted for in accordance with ASC 815 were comprised of warrants issued in connection with our August 2022 public offering as discussed in more detail in Note 8 to our Consolidated Financial Statements.

We account for income taxes using the asset and liability method.

The asset and liability method provide that deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for operating loss and tax credit carryforwards.

Deferred tax assets and liabilities are measured using the currently enacted tax rates and laws that will be in effect when the differences are expected to reverse.

We record a valuation allowance to reduce deferred tax assets to the amount that is believed more likely than not to be realized.

Going Concern

Because we have generated limited revenues from commercialization, our operations to date have been principally financed through public and private offerings of our common stock and convertible debt and exercises of options and

There are a number of conditions that we must satisfy before we will be able to generate sufficient revenue to fund our operations, including but not limited to the successful commercialization of the PoNS device in the U.S.

These factors raise substantial doubt about our ability to continue as a going concern through at least 12 months from the date of this Form 10-K.

While we had $1.1 million of cash as of December 31, 2024, we do not currently have sufficient resources to accomplish all of the above conditions necessary for us to generate sufficient revenues to achieve profitability, and we expect that we will require additional financing to continue to fund our operations.

There is no guarantee that such funding will be available at all or in sufficient amounts to satisfy our required expenditures.

In reviewing this filing, you should carefully consider this uncertainty, the risks described in the section entitled “Item 1A.

Risk Factors” and other risks described throughout this Form 10-K.

Recently Issued Accounting Pronouncements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis