Myomo (NYSE: MYO) lifts Q2 2026 revenue 21% to $11.7M and narrows loss
Myomo, Inc. reported higher revenue and improved margins for the quarter ended June 30, 2026. Revenue grew to $11.7 million from $9.7 million a year earlier, and six‑month revenue rose to $21.8 million from $19.5 million. Gross margin expanded to 72.1% from 62.7% as higher average selling prices and manufacturing efficiencies outweighed increased clinical costs.
Operating expenses were essentially flat at $10.7 million for the quarter, with lower research and development spending and slightly higher general and administrative costs. Operating loss narrowed to $2.3 million from $4.6 million, and net loss improved to $4.0 million, or $0.09 per share, from $4.6 million, or $0.11 per share. For the first half, net loss was $7.0 million versus $8.1 million, while Adjusted EBITDA loss improved to $3.1 million from $6.8 million.
Cash, cash equivalents and short‑term investments totaled $13.5 million at June 30, 2026, with working capital of $13.9 million and operating cash use reduced to $4.1 million in the first half from $11.5 million a year earlier. A $17.5 million term‑loan facility with Avenue adds committed capital but increases interest expense and introduces derivative‑related fair value volatility, and carries covenants on minimum cash, revenue and cash burn. Revenue is driven mainly by direct billing to patients, U.S. and international O&P channels and the MyoConnect referral program, and remains highly dependent on Medicare and other insurance reimbursement, including updated CMS fee schedules for MyoPro devices.
Positive
- None.
Negative
- None.
Filing Explained
Myomo has not issued shares from these warrants, but 3,763,258 remain exercisable and Avenue retains additional conversion rights that could dilute existing holders.
The filing updates Myomo’s equity-linked financing: at
Each pre-funded warrant is exercisable for one common share at
Separately, Avenue’s warrant covers up to
The filing states that no pre-funded warrants were exercised during the three or six months ended
The Avenue warrant expires on
Key Figures
Key Terms
Adjusted EBITDA financial
compound derivative liability financial
Healthcare Common Procedure Coding System regulatory
MyoConnect program other
pre-funded warrants financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
How did Myomo (MYO) perform financially in Q2 2026?
What were Myomo (MYO)’s margins and profitability trends in the first half of 2026?
What is Myomo (MYO)’s cash position and liquidity as of June 30, 2026?
How is Myomo (MYO) financing its operations and what are key term‑loan features?
How dependent is Myomo (MYO) on Medicare and CMS reimbursement?
What are the main revenue channels for Myomo (MYO)?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
or
For the transition period from to .
Commission File Number
(Exact name of Registrant as Specified in its Charter)
|
||
(State or Other Jurisdiction of |
|
(I.R.S. Employer |
Incorporation or Organization) |
|
Identification No.) |
|
|
|
|
||
(Address of principal executive offices) |
|
(Zip Code) |
(
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
☐ |
|
Accelerated filer |
☐ |
☒ |
|
Smaller reporting company |
||
Emerging growth company |
|
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
At July 31, 2026, the registrant has
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q includes forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms or other comparable terminology.
You should not place undue reliance on forward looking statements. The cautionary statements set forth in this Quarterly Report on Form 10-Q, including in “Risk Factors” and those contained in our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission on March 9, 2026 and elsewhere, identify important factors which you should consider in evaluating our forward-looking statements. These factors include, among other things:
Although the forward-looking statements in this Quarterly Report on Form 10-Q and those contained in our Annual Report on the Form 10-K for the year ended December 31, 2025, are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this Quarterly Report on Form 10-Q or otherwise make public statements updating our forward-looking statements.
TABLE of CONTENTS
PART I. FINANCIAL INFORMATION |
|
|
|
|
|
|
|||
Item 1. Financial Statements (interim periods unaudited) |
|
|
1 |
|
|
|
|||
Condensed Consolidated Balance Sheets at June 30, 2026 and December 31, 2025 |
|
|
1 |
|
|
|
|||
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2026 and 2025 |
|
|
2 |
|
|
|
|
|
|
Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2026 and 2025 |
|
|
3 |
|
|
|
|||
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2026 and 2025 |
|
|
4 |
|
|
|
|||
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025 |
|
|
5 |
|
|
|
|||
Notes to Unaudited Condensed Consolidated Financial Statements |
|
|
6 |
|
|
|
|||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
|
|
19 |
|
|
|
|||
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
|
|
25 |
|
|
|
|||
Item 4. Controls and Procedures |
|
|
25 |
|
|
|
|||
PART II. OTHER INFORMATION |
|
|
|
|
|
|
|||
Item 1. Legal Proceedings |
|
|
27 |
|
|
|
|||
Item 1A. Risk Factors |
|
|
28 |
|
|
|
|||
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities |
|
|
28 |
|
|
|
|||
Item 5. Other Information |
|
|
28 |
|
|
|
|
||
Item 6. Exhibits |
|
|
29 |
|
|
|
|||
Signatures |
|
|
30 |
|
Part 1. FINANCIAL INFORMATION
Item 1. Financial statements
MYOMO, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
|
|
(unaudited) |
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
||
Current Assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Short-term investments |
|
|
|
|
|
|
||
Accounts receivable, net |
|
|
|
|
|
|
||
Inventories |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Total Current Assets |
|
|
|
|
|
|
||
Restricted Cash |
|
|
|
|
|
|
||
Operating lease assets with right of use, net |
|
|
|
|
|
|
||
Equipment, net |
|
|
|
|
|
|
||
Software development costs, net |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Total Assets |
|
$ |
|
|
$ |
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current Liabilities: |
|
|
|
|
|
|
||
Accounts payable and accrued expenses |
|
|
|
|
|
|
||
Current operating and financing lease liability |
|
|
|
|
|
|
||
Taxes payable |
|
|
|
|
|
|
||
Deferred revenue |
|
|
|
|
|
|
||
Warrant derivative liability |
|
|
|
|
|
|
||
Current portion long term debt, net of discount of $ |
|
|
|
|
|
|
||
Total Current Liabilities |
|
|
|
|
|
|
||
Non-current operating and financing lease liability |
|
|
|
|
|
|
||
Long-term debt, net of discount of $ |
|
|
|
|
|
|
||
Total Liabilities |
|
|
|
|
|
|
||
Commitments and Contingencies |
|
|
|
|
|
|
||
Stockholders’ Equity: |
|
|
|
|
|
|
||
Preferred stock, $ |
|
|
|
|
|
|
||
Common stock par value $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated other comprehensive income |
|
|
|
|
|
|
||
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Treasury stock, |
|
|
( |
) |
|
|
( |
) |
Total Stockholders’ Equity |
|
|
|
|
|
|
||
Total Liabilities and Stockholders’ Equity |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.
1
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, clinical and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other expense (income), net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (income), net |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Change in fair value of derivative liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Loss before income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Income tax expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.
2
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Foreign currency translation adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain on short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Comprehensive loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.
3
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (unaudited)
|
For the Three and Six Months Ended June 30, 2026 and 2025 |
|||||||
|
Common stock |
Additional |
Accumulated Comprehensive |
Accumulated |
Treasury Stock |
Total |
||
|
Shares |
Amount |
Capital |
(Loss) Income |
Deficit |
Shares |
Amount |
Equity |
Balance, January 1, 2026 |
$ |
$ |
$ |
$( |
$( |
$ |
||
Common stock issued upon vesting of restricted stock units |
( |
— |
— |
— |
— |
— |
||
Stock-based compensation |
— |
— |
— |
— |
— |
— |
||
Unrealized income on foreign currency adjustments |
— |
— |
— |
— |
— |
— |
||
Net loss |
— |
— |
— |
— |
( |
— |
— |
( |
Balance, March 31, 2026 |
$ |
$ |
$ |
$( |
$( |
$ |
||
|
|
|
|
|
|
|
|
|
Common stock issued upon vesting of restricted stock units, net of |
( |
— |
— |
— |
— |
( |
||
Stock-based compensation |
— |
— |
— |
— |
— |
— |
||
Unrealized income on foreign currency adjustments |
— |
— |
— |
— |
— |
— |
||
Net loss |
— |
— |
— |
— |
( |
— |
— |
( |
Balance, June 30, 2026 |
( |
( |
||||||
|
|
|
|
|
|
|
|
|
Balance, January 1, 2025 |
$ |
$ |
$( |
$( |
$( |
$ |
||
Common stock issued upon vesting of restricted stock units |
( |
— |
— |
— |
— |
— |
||
Common stock issued upon vesting of incentive stock options |
— |
— |
— |
— |
— |
— |
— |
|
Stock-based compensation |
— |
— |
— |
— |
— |
— |
||
Unrealized loss on foreign currency adjustments |
— |
— |
— |
( |
— |
— |
— |
( |
Net loss |
— |
— |
— |
— |
( |
— |
— |
( |
Balance, March 31, 2025 |
$ |
$ |
$( |
$( |
$( |
$ |
||
Common stock issued upon vesting of restricted stock units |
( |
— |
— |
— |
— |
— |
||
Stock-based compensation |
|
|
— |
— |
— |
— |
||
Common stock issued upon vesting of incentive stock options |
— |
— |
— |
— |
— |
— |
— |
|
Exercise of pre-funded warrants |
— |
— |
— |
— |
— |
|||
Unrealized income on foreign currency adjustments |
— |
— |
— |
— |
— |
— |
||
Net loss |
— |
— |
— |
|
( |
— |
— |
( |
Balance, June 30, 2025 |
$ |
$ |
$ |
$( |
$( |
$ |
||
The accompanying notes are an integral part of the consolidated unaudited financial statements.
4
MYOMO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
For the Six Months Ended June 30, |
|
2026 |
|
|
2025 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operations: |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Accretion of discount on short-term investments |
|
|
( |
) |
|
|
( |
) |
Credit losses |
|
|
|
|
|
|
||
Amortization of debt discounts |
|
|
|
|
|
|
||
Amortization of right-of-use assets |
|
|
|
|
|
|
||
Change in fair value of derivative liabilities |
|
|
|
|
|
|
||
Other non-cash changes |
|
|
|
|
|
( |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
( |
) |
|
|
( |
) |
Inventories |
|
|
|
|
|
( |
) |
|
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
( |
) |
Other assets |
|
|
|
|
|
( |
) |
|
Accounts payable and accrued expenses |
|
|
|
|
|
( |
) |
|
Operating and financing lease liabilities |
|
|
( |
) |
|
|
|
|
Deferred revenue |
|
|
( |
) |
|
|
|
|
Income taxes payable |
|
|
( |
) |
|
|
( |
) |
Tenant improvement allowance |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
||
Purchases of equipment |
|
|
( |
) |
|
|
( |
) |
Purchases of software development costs |
|
|
( |
) |
|
|
( |
) |
Purchases of short-term investments |
|
|
|
|
|
( |
) |
|
Maturities of short-term investments |
|
|
|
|
|
|
||
Net cash provided by (used in) investing activities |
|
|
|
|
|
( |
) |
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
||
Deferred debt origination costs |
|
|
|
|
|
( |
) |
|
Net proceeds from issuance of debt |
|
|
|
|
|
|
||
Taxes paid for net share settlement of restricted stock units |
|
|
( |
) |
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
||
Effect of foreign exchange rate changes on cash |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
||
Net change in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash beginning of period |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash end of period |
|
$ |
|
|
$ |
|
||
Cash paid during the period for income taxes |
|
$ |
|
|
$ |
|
||
Cash paid during the period for interest |
|
$ |
|
|
$ |
|
||
Non-cash financing and investing activities |
|
|
|
|
|
|
||
Right of use assets obtained in exchange for lease obligations |
|
$ |
|
|
|
|
||
Unrealized gain from mark to market on short-term investments |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.
5
MYOMO, INC.
NOTES TO CONDENSED CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
Note 1 — Description of Business
Myomo Inc. (“Myomo” or the “Company”) is a wearable medical robotics platform company that develops, designs, and produces myoelectric orthotics for people with neuromuscular disorders. The MyoPro ® myoelectric upper limb orthosis product is registered with the U.S. Food and Drug Administration as a Class II medical device. The Company sells its products directly to patients, to Orthotics and Prosthetics ("O&P") providers around the world, the Veterans Health Administration, and distributors in Europe and Australia. The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Burlington, Massachusetts.
Note 2 — Liquidity
The Company had cash, cash equivalents and short-term investments of approximately $
Based upon its current cash, cash equivalents, and short-term investments, as well as the future expected cash flows, the Company believes that its available cash, cash equivalents, and short-term investments will fund its operations for at least the next twelve months from the issuance date of these financial statements.
The Company has historically funded its operations through financing activities, including raising equity and debt. On November 4, 2025, the Company entered into a Loan and Security Agreement with Avenue Capital Management II, L.P. as administrative agent and collateral agent and Avenue Venture Opportunities Fund II, L.P., as a lender, which provided the Company $
Management's operating plans are primarily focused on growing revenues from recurring sources, including expanding its MyoConnect program to generate referrals in rehab clinics and stroke centers around the country, continued growth in revenues in the O&P channel, as well as International operations, while reducing the cost of patient acquisition (measured as cost per pipeline add) and minimizing the growth in fixed expenses. In addition, the Company believes that it has access to capital resources through possible public or private equity offerings, or other means.
Note 3 — Summary of Significant Accounting Policies
Interim Financial Statements
The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of June 30, 2026 and for the three and six months ended June 30, 2026 and 2025. The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2026, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2025 and 2024 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
6
Basis of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH. All significant intercompany balances and transactions are eliminated.
Comprehensive Loss
Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short-term investments. There were no reclassifications out of accumulated other comprehensive loss to other (income) expense related to realized gains or losses on short-term investments in the three and six months ended June 30, 2026 and 2025, respectively.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from these estimates. The Company’s estimates include assertion of collectability with payers as it relates to timing of revenue recognition and transaction pricing and the valuation of derivative liabilities.
Cash, Cash Equivalents and Short-Term Investments
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at June 30, 2026 and December 31, 2025.
The Company considers all investments with an original maturity of greater than three months but less than one year to be short-term investments. Short-term investments as of June 30, 2026 and December 31, 2025 consist of U.S. Treasury Bills and Commercial Paper, which are classified as available for sale, totaling approximately $
The Company's cash balances as of June 30, 2026 and December 31, 2025 consist of the following:
|
|
June 30, |
|
|
December 31, |
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash |
|
|
|
|
|
|
||
Total cash, cash equivalents, and restricted cash |
|
$ |
|
|
$ |
|
||
Accounts Receivable and Allowance for Credit Losses
The Company reports accounts receivable at invoiced amounts less an allowance for credit losses accounts. The Company evaluates its accounts receivable on a continuous basis and, if necessary, establishes an allowance for credit losses based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At June 30, 2026, and December 31, 2025, the Company’s balance for allowance for credit losses was approximately $
Revenue Recognition
The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all the related amendments (Topic 606). Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement and are evaluated using a five-step model. Generally, the Company recognizes revenue at a point in time.
The Company recognizes revenue after applying the following five steps:
7
Revenue is recognized when control of these services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services.
The Company derives the majority of its revenue from direct billing. The Company also derives revenue from the sale of its products to O&P providers in the United States and internationally and the Veterans' Administration (the “VA”). Under direct billing, the Company recognizes revenue when all of the following criteria are met:
The transaction price associated with the MyoPro for direct to patient revenue is generally determined by the insurance payer. For patients with Medicare Part B, the transaction price is based on the published fees for our billing codes L8701 and L8702. Medicare pays
For revenue derived from patients under Medicare Part B, the Company recognizes revenue once it has obtained sufficient medical documentation to demonstrate medical necessity and when control of the device has passed to the patient. Patients with Medicare Part B insurance coverage represented
Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended June 30, 2026 and 2025, the Company recognized revenue of approximately $
For revenues derived from O&P providers and the VA, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable.
The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue.
Software Development
The Company accounts for costs incurred to develop internal-use software in accordance with ASC 350-40, Internal-Use Software. Costs incurred during the preliminary project stage and post-implementation stage are expensed as incurred. Once an application has reached the development stage and it is probable that the software will be completed and used for its intended purpose, internal and external direct costs incurred to develop the software are capitalized. Capitalized costs consist of third-party costs directly attributable to the development of the software. Capitalized software development costs are amortized on a straight-line basis over the estimated useful life of five years. The Company evaluates capitalized internal-use software for impairment whenever events or changes in circumstances indicate that the carrying
8
amount may not be recoverable. Costs related to internal-use software capitalized during the period were approximately $
Contract Balances
The timing of revenue recognition may differ from the timing of payment by customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. The Company had deferred revenue of approximately $
Disaggregated Revenue from Contracts with Customers
The following table presents revenue by major source:
|
|
For the Three Months |
|
|
For the Six Months |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Direct to patient |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Clinical/Medical providers |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue from contracts with customers |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Geographic Data
The Company generated
During the six months ended June 30, 2026, the Company generated
Cost of Revenue
In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company ships the MyoPro, and provides the device directly to patients, pending reimbursement from third party payers, after which revenue is recognized. For the three and six months ended June 30, 2026, the Company recorded cost of goods sold of approximately $
Advertising
The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Foreign exchange translation gains and losses from the Euro to U.S. dollars are included in other comprehensive loss. The Company recorded a comprehensive gain of approximately $
Net Loss per Share
Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Restricted stock, restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive.
9
The Company reported a net loss for the three and six months ended June 30, 2026 and 2025, and as a result, all potentially dilutive common shares are considered antidilutive for these periods.
Potential dilutive common shares issuable consist of the following at:
|
|
June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Stock options |
|
|
|
|
|
|
||
Restricted stock units |
|
|
|
|
|
|
||
Other warrants |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Due to their nominal exercise price of $
Recently Adopted Accounting Standards
In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by June 30, 2027. The Company currently complies with these disclosure requirements as applicable under Regulation S-X or Regulation S-K and will adopt these new standards depending on timing of when they become effective, which is not expected to have a material impact on its financial position and results of operations.
In November 2024, the FASB issued ASU 2024-03 “Disaggregation of Income Statement Expenses (Subtopic 220-40) Disaggregation of Income Statement Expenses.” The update requires public business entities to provide enhanced disclosures in the note to the financial statements about the nature of expenses included in income statement captions. The new disclosures will require entities to disaggregate relevant expense captions and present these in a tabular format. In January 2025, the FASB issued ASU 2025-01 which clarified the effective date of ASU 2024-03. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within fiscal years beginning after December 15, 2027. Early adoption is permitted, which is not expected to have a material impact on the Company’s financial position and results of operations.
Note 4 — Inventories
Inventories consist of the following at:
|
|
June 30, |
|
|
December 31, |
|
||
Finished goods |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Parts and subassemblies |
|
|
|
|
|
|
||
Inventories |
|
$ |
|
|
$ |
|
||
Note 5 — Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820, “Fair Value Measurement” (“ASC 820”), which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements.
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
10
The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, accounts receivable and accounts payable, approximate fair value due to the short-term nature of these instruments. Cash equivalents consist of money market funds that limit their investments to only short-term U.S. Treasury Securities and repurchase agreements related to these securities. Short-term investments primarily consist of commercial paper and U.S. Treasury Bills and are carried on the condensed consolidated balance sheets at amortized cost which approximates fair value.
The Company considers all investments with an original maturity of greater than three months to be short-term investments. Short-term investments are carried on the consolidated balance sheets at fair value. Short-term investments as of June 30, 2026 and December 31, 2025 consisted of U.S. Treasury Bills, which are classified as available for sale, agency bonds and commercial paper totaling approximately $
Cash equivalents and short-term investments measured at fair value on a recurring basis at June 30, 2026 were as follows:
|
|
In Active |
|
|
Significant |
|
|
Significant |
|
|
Total |
|
||||
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Short-term investments |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Warrant liability |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Compound derivative liability |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2025 were as follows:
|
|
In Active |
|
|
Significant |
|
|
Significant |
|
|
Total |
|
||||
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Commercial paper |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Short-term investments |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Warrant liability |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Compound derivative liability |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the periods ended June 30, 2026 and December 31, 2025, respectively:
|
|
Warrant Liability |
|
|
Compound |
|
|
Total |
|
|||
Balance – December 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Change in fair value of derivative liabilities |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance – March 31, 2026 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Change in fair value of derivative liabilities |
|
|
|
|
|
|
|
|
|
|||
Balance – June 30, 2026 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
11
Compound derivative liability is presented in long term debt, net of discount on the Condensed Consolidated Balance sheets as of June 30, 2026 and December 31, 2025.
Valuation assumptions utilized in the valuations of Level 3 liability under the Monte Carlo model for warrants as of June 30, 2026 and December 31, 2025 were as follows:
|
|
June 30, 2026 |
|
December 31, 2025 |
Risk-free interest rate |
|
|
||
Stock price |
|
|
$ |
|
Initial exercise price - Warrants |
|
$ |
|
$ |
Volatility |
|
|
||
Dividend yield |
|
|
||
Remaining term - Warrants |
|
|
The expected stock price volatility for the Company’s warrant liability was based on the Company's historical volatility. Risk free interest rates were obtained from U.S. Treasury rates for the applicable periods. The expected term used is the contractual life of the instrument being valued. The Company has historically not paid any dividends and does not have any intention to do so in the future.
The valuation assumptions for the compound derivative liability under the Monte Carlo model are based on determining the fair value of the debt, excluding warrants with and without the derivative features, which include the conversion option for a portion of the debt, the default interest provision and acceleration of the debt upon an event of default.
|
|
June 30, 2026 |
|
December 31, 2025 |
Remaining term - loan |
|
|
||
Credit spread |
|
|
||
Implied debt yield |
|
|
||
Annualized risk-free rate |
|
|
Note 6 - Accounts Payable and Other Accrued Expenses
Accounts Payable and Other Accrued Expenses consist of the following at:
|
|
June 30, |
|
|
December 31, |
|
||
Trade payables |
|
$ |
|
|
$ |
|
||
Accrued compensation and benefits |
|
|
|
|
|
|
||
Accrued professional services |
|
|
|
|
|
|
||
Warranty reserve |
|
|
|
|
|
|
||
Customer deposits |
|
|
|
|
|
|
||
Accrued insurance |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
.
Note 7 — Debt
On November 4, 2025 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”), with Avenue Capital Management II, L.P., as administrative agent and collateral agent (the “Agent”) and Avenue Venture Opportunities Fund II, L.P., as a lender ("Avenue", or the "Lender"). Also on November 4, 2025, the Company entered into a Supplement to the Loan and Security Agreement (the “Supplement” and together with the Loan and Security Agreement, the “Loan Agreement”) with the Agent and the Lender.
The Loan Agreement provides for committed term loans in an aggregate principal amount of up to $
12
The Company is making interest only payments on the Loans until the 18-month anniversary of the Closing Date, subject to a 6-month extension if the funding of Tranche 2 has occurred. The Loan principal is repayable in equal monthly installments from the end of interest only period to the Maturity Date.
Pursuant to the Loan Agreement, the Company is subject to certain financial covenants requiring the Company to (i) maintain at all times $
Pursuant to the Loan Agreement, the Lender also has the right to convert up to $
The Company recorded approximately $
Concurrent with the closing of the Loan Agreement, the Company repaid $
Including the aforementioned amounts, the Company recorded interest expense of approximately $
Long-term debt as of June 30, 2026 and December 31, 2025 are as follows;
13
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||
Long-term debt |
|
$ |
|
|
$ |
|
||
Compound derivative |
|
|
|
|
|
|
||
Discount |
|
|
( |
) |
|
|
( |
) |
Total debt |
|
|
|
|
|
|
||
Short-term debt, net of discount |
|
|
( |
) |
|
|
|
|
Long term debt, net of discount |
|
$ |
|
|
$ |
|
||
Note 8 —Common Stock and Warrants
Pursuant to an amended and restated certificate of incorporation, the Company is authorized to issue up to
In conjunction with entering into the Loan Agreement (See Note 7), the Company issued to Avenue a warrant to purchase up to $
In addition, upon a change of control, Avenue is entitled to receive the shares of common stock underlying the Warrant without payment of the exercise price. Avenue may exercise the warrant at any time, or from time to time up to and including the Expiration Date, by making a cash payment equal to the exercise price multiplied by the quantity of shares. Avenue may also exercise the warrant on a cashless basis by receiving a net number of shares calculated pursuant to the formula set forth in the warrant. The warrant is subject to anti-dilution adjustments for stock dividends, stock splits, and reverse stock splits.
The Company is accounting for the warrant as a derivative liability, which is recorded at fair value. At inception, the Company recorded a derivative liability of approximately $
As of June 30, 2026,
.
During the three and six months ended June 30, 2026
During the six months ended June 30, 2025,
There were
Note 9 — Stock Award Plans and Stock-Based Compensation
As of June 30, 2026, there were
Recipients of awards of restricted stock units typically sell shares in the open market to cover their individual tax liabilities and remit the proceeds to the Company, which offsets withholding taxes paid by the Company. In certain circumstances, stock awards may be net share settled upon vesting to cover the required employee statutory withholding taxes and the remaining amount is converted into shares based upon their share-value on the date the award vests. In such instances, these payments of employee withholding taxes are presented in the statements
14
of cash flows as a financing activity. There were
During the three months ended June 30, 2026 and 2025,
Share-Based Compensation Expense
The Company accounts for stock awards to employees and non-employees based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award.
The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period.
The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Cost of goods sold |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, clinical, and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As of June 30, 2026, there was
As of June 30, 2026, there was approximately $
Note 10 — Commitments and Contingencies
Litigation
The Company may be involved from time to time in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There are no material claims, assessments, or litigation against the Company as of June 30, 2026.
Operating and Financial Leases
The Company entered into a new financial lease for its 3D printing machines in May of 2026. The initial lease liability was for approximately $
As of June 30, 2026, total lease assets were approximately $
15
|
|
|
|
|
|
|
|
|
|
Total |
|
|||
|
|
|
|
Operating Lease |
|
|
Financing Lease |
|
|
June 30, 2026 |
|
|||
2026 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
2027 |
|
|
|
|
|
|
|
|
|
|
|
|||
2028 |
|
|
|
|
|
|
|
|
|
|
|
|||
2029 |
|
|
|
|
|
|
|
|
|
|
|
|||
Thereafter |
|
|
|
|
|
|
|
|
|
|
|
|||
Total future minimum lease payments |
|
|
|
|
|
|
|
|
|
|
|
|||
Less imputed interest |
|
|
|
|
|
|
|
|
|
|
|
|||
Total lease liabilities |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Included in the condensed consolidated balance sheet: |
|
|
|
|
|
|
|
|
|
|
|
|||
Current lease liabilities |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Non-current lease liabilities |
|
|
|
|
|
|
|
|
|
|
|
|||
Total lease liabilities |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
For the three and six months ended June 30, 2026 and 2025, the total lease cost is comprised of the following amounts:
|
|
For the Three Months |
|
|
For the Six Months |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Operating lease expense |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
||||
Financing lease expense |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Short-term lease expense |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
||||
Total lease expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following summarizes additional information related to operating and financial leases:
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
|
||
Weighted-average remaining operating lease term (in years) |
|
|
|
|
|
|
|
||
Weighted-average discount rate operating lease |
|
|
% |
|
|
% |
|
||
Weighted-average remaining financing lease term (in years) |
|
|
|
|
|
— |
|
|
|
Weighted-average discount rate financing lease |
|
|
% |
|
|
% |
|
||
Insurance Obligations
The Company finances the insurance policies of its directors and officers, which requires the Company to make a down payment, followed by equal payments over a defined term. The Company then entered into a financing arrangement covering the twelve-month period ending in June 2025. Under this financing arrangement, the Company made a down payment of approximately $
The Company also finances its property and casualty insurance policies, which require the Company to make a down payment, followed by equal payments over a defined term. During the three months ended September 30, 2025, the Company entered in a new financing arrangement for its 2025-2026 policy covering the twelve months ended July 2026. The Company made a down payment of $
Changes in the Company's supplier finance obligations were as follows:
16
|
|
Six Months Ended |
|
|||||
|
|
June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Opening January 1 |
|
$ |
|
|
$ |
|
||
Payments |
|
|
— |
|
|
|
— |
|
Expensed |
|
|
( |
) |
|
|
( |
) |
Balance March 31, |
|
$ |
|
|
$ |
|
||
Increase |
|
|
|
|
|
|
||
Expensed |
|
|
( |
) |
|
|
( |
) |
Balance June 30, |
|
$ |
|
|
$ |
|
||
No assets are pledged as security under this arrangement.
Note 11 — Segment Reporting and Major Customers
Segment Reporting
ASC 280, “Segment Reporting” establishes standards for reporting information about operating segments on a basis consistent with the Company’s internal organization structure as well as information about products, business segments, and major customers in financial statements. The Company conducts its business in one operating segment, and sells products in one family, which are versions of the MyoPro. While the Company has several sales channels and operates in different geographies, the Chief Executive Officer, who is the Company's chief operating decision-maker, and is responsible for allocating resources and assessing the performance of the Company, manages the Company's business on a consolidated basis, focusing on revenue, gross margin, certain operating expenses, loss from operations, other expenses (income), Income Tax, and Net loss.
|
|
Three Months Ended |
For The Six Months Ended |
|
||||||||||||
|
|
June 30, |
June 30, |
|
||||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross margin |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Payroll and benefits expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Advertising |
|
|
|
|
|
|
|
|
|
|
|
|
||||
All other segment operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Payroll and benefits expense in cost of revenue |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Other expense (income) |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Change in fair value of derivatives liabilities |
|
|
|
|
|
|
|
|
|
|
||||||
Tax Expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net Loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Major Customers
For the three and six months ended June 30, 2026 and 2025, there were no customers which accounted for more than
17
At June 30, 2026, CMS accounted for approximately
For the three and six months ended June 30, 2026, approximately
Note 12 — Subsequent Events
The Company evaluated subsequent events through the date the financial statements were issued, and determined that there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the unaudited condensed consolidated financial statements.
18
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our condensed consolidated financial statements and the related notes contained elsewhere in this Quarterly Report on Form 10-Q and in our other Securities and Exchange Commission filings. The following discussion may contain predictions, estimates, and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors”, “Cautionary Statement Regarding Forward-Looking Statements” and elsewhere in this Quarterly Report on Form 10-Q and those described under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2025. These risks could cause our actual results to differ materially from any future performance suggested below.
Overview
We are a wearable medical robotics platform company, specializing in myoelectric braces, or orthotics, for people with neuromuscular disorders. We develop and market the MyoPro product line, which is a myoelectric-controlled upper limb brace, or orthosis. The orthosis is a rigid brace used for the purpose of supporting a patient’s weak or deformed arm to enable and improve functional activities of daily living (“ADLs”), in the home and community. It is custom constructed by a trained professional during a custom fabrication process for each individual user to meet their specific needs. Our products are designed to help regain function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders.
We advertise on television and through social media. In addition, we perform in-services for therapists and physicians to generate referrals under a new program we refer to as MyoConnect, and we directly educate and inform those individuals who are potential candidates for our products. Once the prospective patient contacts us or is referred to us through our MyoConnect program, either our trained clinical staff or a trained O&P provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are often initially conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate. Prior to obtaining authorizations from commercial insurance companies or delivering to a patient with Medicare Part B, the patient’s medical records are collected and reviewed to make sure the device is medically necessary for their condition and a prescription is always obtained from a physician. Once these documents are obtained, if the patient has Medicare Advantage or other commercial insurance, a pre-authorization request is submitted to the patient’s insurer. If we receive a pre-authorization, we proceed to measure the patient’s arm, a process we call “shape capture”. In many cases, shape capture is done using a remote measurement kit supplied to the patient. If the patient is covered by Medicare Part B, no pre-authorization is required, and we can move directly to taking measurements of the patient's arm. We then use those measurements to 3D print orthotic parts, which are used to fabricate the MyoPro, and then deliver it to the patient. Since we are directly providing the device to the patient and then billing insurance ourselves, we refer to this process as direct billing. We also call on hospitals and O&P practices in the United States, Europe and Australia that provide our products to their patients as well as generate indirect sales. The MyoPro product line has been approved by the VA system for impaired veterans, and over 130 VA facilities have ordered devices for their patients.
Our myoelectric orthoses have been clinically shown in peer reviewed published research studies to help regain the ability to complete functional tasks by supporting the affected joint and enabling individuals to self-initiate and control movement of their partially paralyzed limbs by using their own muscle signals. Our technology was originally developed at MIT in collaboration with medical experts affiliated with Harvard Medical School. Myomo was incorporated in 2004.
Other historical milestones include:
19
Recent Developments
Term Loan Facility
On November 4, 2025 (“the Closing Date”), we entered into a Loan and Security Agreement with Avenue Capital Management II, L.P., as administrative agent and collateral agent and Avenue Venture Opportunities Fund II, L.P., as a lender (together "Avenue"), which provides us $17.5 million in committed funding under two tranches. The first tranche of $12.5 million was funded on the Closing Date. The remaining $5.0 million becomes available at our discretion between 12 and 18 months from the Closing Date, subject to maintaining compliance with covenants. We are paying interest only on the term loan for a period of 18 months from the Closing Date, which could be extended to 24 months if we borrowed under the second tranche. After the expiration of the interest-only period, we will re-pay the principal balance in 24 equal monthly installments. The term loan matures on June 1, 2029. Proceeds from this loan were used to repay the outstanding borrowings under the credit facility with Silicon Valley Bank and to pay fees and expenses, with the remainder being used for general corporate purposes.
China Joint Venture
In November 2025, we were notified that Ryzur Medical filed for bankruptcy in China and is in the process of being liquidated. As a result, the operations of the JV Company are now severely limited. Efforts to find another lead investor have not materialized. As a result, we notified the parties on July 24, 2026 that we are terminating the joint venture. We do not expect to receive any proceeds from liquidation of the JV Company and there is no impact to our financial statements from the termination of the joint venture for the three and six months ended June 30, 2026.
Results of Operations
We have been growing revenues while incurring net losses and negative cash flows from operations since inception and anticipate this to continue in 2026. Our financial performance in 2025 reflected our ability to be reimbursed by Medicare for providing the MyoPro to their beneficiaries, as well as challenges around marketing efficiency and patient acquisition which increased cost per pipeline add. Our plan for 2026 is to begin to pivot away from relying on direct to patient advertising to generate revenues and invest in generating revenues from recurring patient sources, including the MyoConnect referral program and from O&P providers in the U.S. and Germany, while implementing marketing initiatives to reduce cost per pipeline add in the direct billing channel and minimizing the growth of fixed expenses.
The following table sets forth our revenue, cost of revenue, gross profit and gross margin for each of the periods presented.
|
For the Three Months |
Period- |
For the Six Months |
Period- |
||||
|
2026 |
2025 |
$ |
% |
2026 |
2025 |
$ |
% |
Revenue |
$11,704,565 |
$9,652,234 |
$2,052,331 |
21% |
$21,817,853 |
$19,484,048 |
2,333,805 |
12% |
Cost of revenue |
3,262,017 |
3,600,061 |
(338,044) |
(9)% |
6,473,698 |
6,822,246 |
(348,548) |
(5)% |
Gross profit |
$8,442,548 |
$6,052,173 |
$2,390,375 |
39% |
$15,344,155 |
$12,661,802 |
$2,682,353 |
21% |
Gross margin % |
72.1% |
62.7% |
|
9.4% |
70.3% |
65.0% |
|
5.3% |
20
Revenues
We derive revenue primarily from providing devices directly to patients and billing insurance companies or Medicare directly. We also sell our products to O&P providers in the U.S., Europe and Australia, to the VA, and to rehabilitation hospitals. Though we increasingly provide devices directly to patients, we sometimes utilize the clinical services of O&P providers for which they are paid a fee.
We expect that our revenues will continue to grow in 2026, primarily as a result of investments to grow revenues from recurring patient sources, including generating patient referrals under our MyoConnect program, as well as from O&P practices in the U.S. and Germany, which we expect to increase operating leverage and reduce our dependence on advertising-driven direct-to-patient revenues.
Total revenue increased by approximately $2.1 million and $2.3 million, or 21% and 12%, for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025. Higher revenues in the three and six months ended June 30, 2026 were due to a higher number of revenue units and a higher average sales price. Revenues by channel for the three and six months ended June 30, 2026 and 2025 were as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Direct billing |
|
$ |
8,175,345 |
|
|
$ |
7,420,904 |
|
|
$ |
15,343,823 |
|
|
$ |
15,228,681 |
|
International |
|
|
1,955,707 |
|
|
|
1,479,783 |
|
|
|
3,962,569 |
|
|
|
2,792,549 |
|
U.S. O&P |
|
|
1,224,283 |
|
|
|
531,472 |
|
|
|
2,066,666 |
|
|
|
1,003,192 |
|
VA |
|
|
349,230 |
|
|
|
220,075 |
|
|
|
444,795 |
|
|
|
459,626 |
|
Total revenue |
|
$ |
11,704,565 |
|
|
$ |
9,652,234 |
|
|
$ |
21,817,853 |
|
|
$ |
19,484,048 |
|
Cost of Revenue and Gross Margin
Cost of revenue consists of direct costs for the manufacturing, printing of orthotic parts, fabrication and fitting of our products, changes in inventory and warranty reserves, and overhead costs allocated to cost of revenue.
Gross margin was 72.1% and 70.3% for the three and six months ended June 30, 2026, respectively, compared to 62.7% and 65.0% for the three and six months ended June 30, 2025, respectively. The increases in gross margin were primarily due to a higher average selling price and manufacturing cost reductions, partially offset by higher clinical costs allocated to cost of sales.
Operating Expenses
The following table sets forth our operating expenses for each of the periods presented.
|
|
For the Three Months |
|
Period-to-Period |
|
For the Six Months |
Period-to-Period |
||||||||
|
|
2026 |
|
2025 |
|
$ |
|
% |
|
2026 |
|
2025 |
$ |
|
% |
Research and development |
|
$1,720,463 |
|
$2,001,331 |
|
$(280,868) |
|
(14)% |
|
$3,343,623 |
|
$3,791,355 |
$(447,732) |
|
(12)% |
Selling, clinical and marketing |
|
5,264,090 |
|
5,233,885 |
|
30,205 |
|
1% |
|
10,080,849 |
|
9,629,689 |
$451,160 |
|
5% |
General and administrative |
|
3,712,481 |
|
3,407,277 |
|
305,204 |
|
9% |
|
7,331,221 |
|
7,351,332 |
(20,111) |
|
0% |
Total operating expenses |
|
$10,697,034 |
|
$10,642,493 |
|
$54,541 |
|
1% |
|
$20,755,693 |
|
$20,772,376 |
$(16,683) |
|
0% |
Research and development
Research and development (“R&D”) expenses consist of costs for our engineering and R&D personnel, including salaries, benefits, bonuses and stock-based compensation, product development costs, clinical studies, and the cost of certain third-party contractors and travel expense. R&D costs are expensed as they are incurred. We intend to manage R&D expenses in 2026, while maintaining the pace of our R&D efforts as cash flows allow, as well as to fund a randomized controlled trial being conducted by the University of Utah.
R&D expenses decreased by approximately $0.3 million and $0.4 million, or 14% and 12%, during the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025. The decreases were primarily due to lower labor expense in project management, engineering, and research.
Selling, clinical and marketing
Selling, clinical, and marketing (“SC&M”) expenses consist of costs for our business development, customer experience, field sales and clinical staff, clinical training organization, and marketing personnel, including salaries, benefits, bonuses, stock-based compensation and sales
21
commissions, costs of advertising, marketing and promotional events, corporate communications, product marketing and travel expenses. Variable compensation for personnel engaged in sales and marketing activities is generally earned and recorded as expense when the product is delivered. We expect the growth rate in selling, clinical and marketing expenses to be lower in 2026. In addition to gaining leverage on our 2025 investments, we intend to make investments in our MyoConnect referral program, including clinical sales personnel, our international operations and support for the O&P channel, as we execute our strategy to reduce our dependence on advertising-driven direct billing revenues.
SC&M expenses increased by less than $0.1 million and $0.5 million or 1% and 5%, during the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025. The increases were primarily due to expenses associated with our new clinical sales personnel and higher incentive compensation, partially offset by higher clinical costs allocated to cost of revenues, and in the second quarter of 2026, lower advertising expense.
General and administrative
General and administrative (“G&A”) expenses consist primarily of costs for administrative, reimbursement, and finance personnel, including salaries, benefits, bonuses and stock-based compensation, professional fees associated with legal matters, consulting expenses, costs for pursuing insurance reimbursements for our products and costs required to comply with the regulatory requirements of the SEC and Medicare accreditation, as well as costs associated with accounting systems, insurance premiums and other corporate expenses. We intend to reduce the growth rate in general and administrative expenses in 2026.
G&A increased by $0.3 million, or 9% in the second quarter of 2026 compared to the same period in 2025 due primarily to higher legal expenses. G&A expenses for the six months ended June 30, 2026 were flat compared with the same period in 2025.
Other expense (income), net
The following table sets forth our other income, net for each of the periods presented:
|
|
For the Three Months |
|
|
Period-to-Period |
|
For the Six Months |
|
|
Period-to-Period |
||||||||||||||||||
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
% |
|
2026 |
|
|
2025 |
|
|
$ |
|
|
% |
||||||
Interest expense (income), net |
|
$ |
535,744 |
|
|
$ |
(106,549 |
) |
|
$ |
642,293 |
|
|
N/M |
|
|
1,040,440 |
|
|
|
(298,540 |
) |
|
|
1,338,980 |
|
|
N/M |
Change in fair value of derivative liabilities |
|
|
1,199,726 |
|
|
|
- |
|
|
|
1,199,726 |
|
|
N/M |
|
|
360,662 |
|
|
|
- |
|
|
|
360,662 |
|
|
N/M |
Total other income, net |
|
$ |
1,735,470 |
|
|
$ |
(106,549 |
) |
|
$ |
1,842,019 |
|
|
N/M |
|
$ |
1,401,102 |
|
|
$ |
(298,540 |
) |
|
$ |
1,699,642 |
|
|
N/M |
Other expense (income), net was $1.7 million and $1.4 million for the three and six months ended June 30, 2026, respectively, compared to income of $0.1 million and $0.3 million for the same periods in 2025, respectively. The increase in other expense was due to the change in fair value of derivative liabilities related to our term loan with Avenue, driven primarily by an increase in our stock price and market volatility. This was offset higher interest expense due to our term loan with Avenue entered into in November 2025.
Income tax expense
Income tax expense recorded during the three and six months ended June 30, 2026 and 2025 represents the provision for income taxes for our wholly-owned subsidiary, Myomo Europe GmbH. Income tax expense decreased by $0.1 million and $0.1 million in the three and six months ended June 30, 2026, respectively, as compared with the same periods in 2025 due to lower taxable income in each period.
Adjusted EBITDA
We believe that the presentation of Adjusted EBITDA, a non-GAAP financial measure, provides investors with additional information about our financial results. Adjusted EBITDA is an important supplemental measure used by our board of directors and management to evaluate our operating performance from period-to-period on a consistent basis and as a measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.
We define Adjusted EBITDA as earnings before interest, taxes, depreciation and amortization adjusted for, stock-based compensation and other unusual items.
Adjusted EBITDA is not in accordance with, or an alternative to, measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. As a non-GAAP measure, Adjusted EBITDA has
22
limitations in that it does not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP. In particular:
Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures including net income (loss) and our financial results presented in accordance with U.S. GAAP.
The following table provides a reconciliation of net loss to Adjusted EBITDA for each of the periods indicated:
|
|
For the Three Months |
|
|
For the Six Months |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
GAAP net loss |
|
$ |
(4,021,360 |
) |
|
$ |
(4,631,972 |
) |
|
$ |
(7,030,759 |
) |
|
$ |
(8,097,030 |
) |
Adjustments to reconcile to Adjusted EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (income), net |
|
|
535,744 |
|
|
|
(106,549 |
) |
|
|
1,040,440 |
|
|
|
(298,540 |
) |
Depreciation expense |
|
|
384,539 |
|
|
|
190,798 |
|
|
|
676,129 |
|
|
|
349,240 |
|
Stock-based compensation |
|
|
1,042,665 |
|
|
|
394,889 |
|
|
|
1,639,913 |
|
|
|
935,093 |
|
Change in fair value of derivative liabilities |
|
|
1,199,726 |
|
|
|
— |
|
|
|
360,662 |
|
|
|
— |
|
Income tax expense |
|
|
31,404 |
|
|
|
148,201 |
|
|
|
218,119 |
|
|
|
284,996 |
|
Adjusted EBITDA |
|
$ |
(827,282 |
) |
|
$ |
(4,004,633 |
) |
|
$ |
(3,095,496 |
) |
|
$ |
(6,826,241 |
) |
Liquidity and Capital Resources
Liquidity
We measure our liquidity in a number of ways, including the following:
|
|
June 30, |
|
|
December 31, |
|
||
Cash and cash equivalents |
|
$ |
11,219,217 |
|
|
$ |
14,132,027 |
|
Short-term investments |
|
|
2,233,141 |
|
|
|
4,261,782 |
|
Total |
|
|
13,452,358 |
|
|
|
18,393,809 |
|
Working capital |
|
$ |
13,915,560 |
|
|
$ |
19,211,756 |
|
As of June 30, 2026, we had working capital of approximately $13.9 million and stockholders’ equity of approximately $5.8 million. We used approximately $4.4 million in cash for operating activities during the six months ended June 30, 2026.
We have historically funded our operations through financing activities, including raising equity and debt capital. On November 4, 2025, we entered into a Loan and Security Agreement with Avenue, which provides us $17.5 million in committed funding under two tranches. The first tranche of $12.5 million was funded on the Closing Date. The remaining $5.0 million becomes available at our discretion between 12 and 18 months from the Closing Date, subject to maintaining compliance with covenants. We are paying interest only on the term loan for a period of 18 months from the Closing Date, which could be extended to 24 months if we borrowed under the second tranche. After the expiration of the interest-only period, we will re-pay the principal balance in 24 equal monthly installments. The term loan matures on June 1, 2029. We have to meet certain debt covenants under the loan, including (i) a minimum cash balance of $2,500,000; (ii) minimum trailing three months revenue equal to 75% of budgeted revenues for such months, measured monthly; and (iii) maximum trailing six months cash burn equal to the greater of 150% of the budgeted cash burn for such months, or $2,000,000, measured quarterly. Non-compliance with covenants may impact access to liquidity. Proceeds from this loan were used to repay the outstanding borrowings under the credit facility with Silicon Valley Bank and to pay fees and expenses, with the remainder being used for general corporate purposes. Considering our cash balance, our debt service and our operating plans discussed below, we believe there will be sufficient cash to fund our operations and capital expenditures for the next 12 months from the date of this report.
23
Our operating plans are primarily focused on growing revenues from recurring sources, including expanding our MyoConnect program to generate referrals in rehab clinics and stroke centers around the country, continued growth in revenues in the U.S. O&P channel, as well as International operations, while reducing the cost of patient acquisition (measured as cost per pipeline add) in the direct billing channel and minimizing the growth in fixed expenses.
Our business is dependent upon reimbursement of our products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and by statutory health insurance plans in Germany, which could prevent our revenues from growing to the level necessary to return to cash flow breakeven on a sustaining basis. We believe that we have access to capital resources, if necessary, through potential public or private equity offerings, debt financings, or other means. If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. We may also explore strategic alternatives for the purpose of maximizing stockholder value. There can be no assurance we will be successful in implementing our plans to sustain our operations and continue to conduct our business.
|
|
Six Months Ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(4,141,768 |
) |
|
$ |
(11,542,175 |
) |
Net cash provided by/(used in) investing activities |
|
|
1,528,080 |
|
|
|
(2,653,446 |
) |
Net cash (used in)/provided by financing activities |
|
|
(243,709 |
) |
|
|
3,963,494 |
|
Effect of foreign change rate changes on cash |
|
|
(55,413 |
) |
|
|
100,186 |
|
Net (decrease) in cash, cash equivalents and restricted |
|
$ |
(2,912,810 |
) |
|
$ |
(10,131,941 |
) |
Operating Activities. The net cash used in operating activities for the six months ended June 30, 2026 was primarily used to fund a net loss of approximately $7.0 million, adjusted for non-cash expenses in the aggregate amount of approximately $3.6 million and by approximately $0.7 million of cash used by net changes in the levels of operating assets and liabilities, primarily related to increases in prepaid expenses and accounts receivable, partially offset by an increase in accounts payable and accrued expenses, due primarily to an increase in incentive compensation during the six months ended June 30, 2026.
Net cash used in operating activities for the six months ended June 30, 2025 was primarily used to fund a net loss of approximately $8.1 million, adjusted for non-cash expenses in the aggregate amount of approximately $1.8 million and by approximately $5.3 million of cash used by net changes in the levels of operating assets and liabilities, primarily related to increases in accounts receivable due primarily to a payment hold by CMS, increases in inventory and prepaid expenses and other current assets, and a decrease in accounts payable and accrued expenses, due primarily to the payment of incentive compensation during the three months ended June 30, 2025.
Investing Activities. During the six months ended June 30, 2026, cash provided by investing activities of $1.5 million was primarily related to maturities of our short-term investments partially offset by purchases of equipment. During the six months ended June 30, 2025, cash used in investing activities of $2.7 million was primary related to purchases related to software development and purchases of short-term investments.
Financing Activities. There was approximately $244,000 of cash used for financing activities in the six months ended June 30, 2026 to satisfy employees' statutory tax withholding obligations related to the sale of restricted stock units. There was $4.0 million in cash generated from financing activities during the six months ended June 30, 2025. Cash generated in the six months ended June 30, 2025 was due to borrowings under our previous line of credit and term loan facility with Silicon Valley Bank.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Materially different results can occur if circumstances change and additional information becomes known. Actual results may differ from these estimates. Refer to Note 3 - Summary of Significant Accounting Policies. Our most critical accounting estimates include the timing and amount of revenue recognition based on assertions, revenue recognition based on transaction pricing estimated from payments from certain insurance payers and valuation of derivative liabilities
Timing and Amount of Revenue Recognition
The timing and amount of revenue recognized is determined based on certain estimates. For revenue derived from patients with Medicare Part B, we determined we had sufficient payment history in order to determine transaction price and recognize revenue upon delivery of the device
24
to the patient based on the published fees by CMS. With respect to patients with Medicare Advantage or other commercial insurance, except for a small number of payers, we do not have contracts to establish pricing or provide evidence of an arrangement, however we are able to rely on a history of payments after receiving an insurance authorization, delivery of the device and submission of a claim as evidence of an arrangement. For these payers, payment history is also used to estimate how much we expect to be paid upon delivery of our device and submission of an insurance claim, which determines how much revenue we recognize. The transaction pricing for these providers is based on the expected value method, based on previous history. For the majority of Medicare Advantage and other commercial insurance payers, we have determined that we do not have sufficient collection history with the payer to assert evidence of an arrangement and collectability. For these payers, revenue is recognized at payment, which is when we can determine how much we will be paid for the device.
Valuation of Derivative Liabilities
Our derivative liabilities are recorded at fair value on the basis of both observable and unobservable inputs. With respect to the derivative liability for the warrant issued to Avenue, these inputs include our stock price, expected volatility of our stock price, remaining term of the warrant and assumptions around the probability of an equity financing resulting in an adjustment to the warrant exercise price. Our derivative liability for the compound derivative feature in the term loan with Avenue is based on similar assumptions, but also including the credit spread and remaining term of the debt.
Recent Accounting Standards
Information regarding new accounting standards is included in Note 3 — Recently Adopted Accounting Standards to our unaudited condensed consolidated financial statements contained in Item 1 of this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
This item is not applicable to us as a smaller reporting company.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer, our principal executive officer, and our Chief Financial Officer, our principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026, the end of the period covered by this Quarterly Report on Form 10-Q.
Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of such date at the reasonable assurance level.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Our management assessed the effectiveness of our internal control over financial reporting as of June 30, 2026. In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control - Integrated Framework (2013). Based on our assessment, we believe that as of June 30, 2026, our internal control over financial reporting was effective at the reasonable assurance level.
25
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the evaluation of our internal control that occurred during the quarter ended June 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
26
Part II. OTHER INFORMATION
Item 1. Legal Proceedings
The Company may be involved in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There is no material litigation against the Company at this time that is required to be disclosed under Item 103 of Regulation S-K.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes to our risk factors from those disclosed in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025.
Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations and U.S. customs regulations, and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control and the U.S. Department of State. Export controls and trade sanctions laws and regulations may restrict or prohibit altogether the provision, sale, or supply of our products to certain governments, persons, entities, countries, and territories, including those that are the target of comprehensive sanctions or an embargo. While it has not had a material impact on our business to date, we sell our products in countries throughout the world and import materials into the United States. Significant political, trade, or regulatory developments in the jurisdictions in which we may sell our products are difficult to predict and may have a material adverse effect on us. These developments may include export controls, tariffs or changes in reimbursement policies for Medicaid and Medicare. For example, the United States has imposed tariffs on certain imports from China and other countries, and these tariffs may continue to escalate, depending on the status of trade negotiations. Historically, tariffs have led to increased trade and political tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. Though the United States has reached trade agreements with certain countries and the U.S. Supreme Court has struck down the legal basis for some of the implemented tariffs, significant uncertainty around future tariff policies remains. The United States is conducting investigations and renegotiating the U.S.-Mexico-Canada Agreement, which could result in higher or modified tariffs. While we estimate that tariffs assessed on our imports are expected to have less than a 100 basis point (1%) impact on gross margin in 2026, we cannot provide any assurance that the final tariffs actually imposed, changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, will not have a material adverse effect on our financial condition or results of operations.
If we fail to properly manage our anticipated growth, including in O&P channel and international markets, our business could suffer.
As we grow our revenues from Medicare Part B patients and expand the number of locations which provide the MyoPro products, including O&P practices in the United States, and future planned international distribution, we expect that it will place significant strain on our management team and on our financial resources. Failure to manage our growth effectively could cause us to mis-allocate management or financial resources and result in losses or weaknesses in our infrastructure, systems, processes and controls, which could materially adversely affect our business. Additionally, our anticipated growth will increase the demands placed on our suppliers, resulting in an increased need for us to manage our suppliers and monitor for quality assurance.
Moreover, there are significant costs and risks inherent in selling our products, particularly in international markets, including: (a) time and difficulty in building a widespread network of distribution partners; (b) increased shipping and distribution costs, which could increase our expenses and reduce our margins; (c) potentially lower margins in some regions; (d) longer collection cycles in some regions; (e) compliance with foreign laws and regulations; (f) compliance with anti-bribery, anti-corruption, sanctions, export controls, import and customs, and anti-money laundering laws, such as the Foreign Corrupt Practices Act and the Office of Foreign Assets Control regulations, by us, our employees, and our business partners; (g) currency exchange rate fluctuations and related effects on our results of operations; (h) economic weakness, including inflation, or political instability in foreign economies and markets; (i) compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; (j) workforce uncertainty in countries where labor unrest is more common than in the United States; (k) business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, typhoons, floods and fires; and (l) other costs and risks of doing business internationally, such as new tariffs which may be imposed. These and other factors could harm our ability to implement planned growth in international operations and, consequently, harm our business, results of operations, and financial condition. Further, we may incur significant operating expenses as a result of our planned expansion activities, and they may not be successful. We have limited experience with regulatory environments and market practices internationally, and we may not be able to penetrate or successfully operate in new markets. We may also encounter difficulty growing the O&P channel while simultaneously being a direct provider to patients in the United States. and expanding into international markets because of limited brand recognition. These factors may lead to delayed or limited acceptance of our products by patients in these markets. Accordingly, if we are unable to expand O&P
27
channel revenues in the United States, expand internationally or manage our international operations successfully, we may not achieve the expected benefits of this expansion and our financial condition and results of operations could be harmed.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities
None.
Item 5. Other Information
28
Item 6. Exhibits
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibits Index, which is incorporated by reference.
Exhibits Index
Exhibit No. |
|
Exhibit Description |
3.1 |
|
Eighth Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 2.3 contained in the Registrant’s Form 1-A filed on January 6, 2017) |
|
|
|
3.2 |
|
Amended and Restated Bylaws (Incorporated by reference to Exhibit 2.4 contained in the Registrant’s Form 1-A filed on January 6, 2017) |
|
|
|
3.3 |
|
Certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on January 30, 2020 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on January 30, 2020) |
|
|
|
3.4 |
|
Second certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on June 10, 2021 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on June 15, 2021) |
|
|
|
3.5 |
|
Third certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on June 25, 2026 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K/A filed on June 29, 2026) |
|
|
|
10.1 |
|
Amendment No. 3 to the Myomo 2018 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 contained in the Registrant’s Form 8-K/A filed on June 29, 2026) |
|
|
|
31.1* |
|
Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2* |
|
Certification of Chief Financial Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1+ |
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2+ |
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101.INS* |
|
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document with embedded linkbase documents. |
104* |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
+ The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
29
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date August 5, 2026
|
Myomo, Inc. |
|
|
|
/s/ David A. Henry |
|
David A. Henry |
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
30