SI 10-K & 10-Q changes, risk factors and insider trading
Shoulder Innovations, Inc. · NYSE · Surgical & Medical Instruments & Apparatus · CIK 1699350 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Comparison not available: Not available: fewer than two 10-K filings on EDGAR to compare (only one so far)..
What changed in the latest 10-Q
Risk Factors
Investing in our common stock involves a high degree of risk. Risk factors describing the major risks to our business can be found under Part I, Item 1A, “Risk Factors” in the Company’s 2025 Annual Report. You should consider carefully the risks and uncertainties described therein, together with all of the other information in this Quarterly Report, including Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed financial statements and related notes, before deciding whether to purchase shares of our common stock. Our business, financial condition, results of operations and prospects could also be harmed by risks and uncertainties that are not presently known to us or that we currently believe are not material. If any of these risks actually occur, our business, financial condition, results of operations and prospects could be materially and adversely affected. Unless otherwise indicated, references in these risk factors to our business being harmed will include harm to our business, reputation, brand, financial condition, results of operations, and prospects. In such event, the market price of shares of our common stock could decline, and you could lose all or part of your investment.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Change in Fair Value of Series E Purchase Option”
New heading “Loss on Extinguishment of Debt”
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
Largest changes
“The Trinity Loan Agreement also includes customary affirmative and negative covenants and events of default. Upon the occurrence and continuance of an event of default the Agent may demand immediate repayment of all principal and unpaid interest under the Trinity Loan Agreement, and exercise remedies against us and the collateral securing the Trinity Loan Agreement. …”see in full comparison
“The Term Loan and Revolving Facility may be prepaid at any time and without penalty, except that any prepayment of the aggregate principal amount of borrowings outstanding under the Term Loan made prior to June 26, 2027 is subject to a prepayment premium equal to 1.00% of the aggregate principal amount of borrowings outstanding under the Term Loan immediately prior to such prepayment. The Term Loan matures on June 1, 2031, and the Revolving Facility matures on June 26, 2029.”see in full comparison
•Continued investments in product development, innovation and growth. We expect to continue to focus on long-term revenue growth through investments in our ecosystem and expansion of our operations. In research and development, we continually invest in improving our technologies, developing new products and further expanding our cleared indications. For example, we began using ProVoyance in 2021 and have developed a product line to include certain fracture indications and commercially launched the InSet 70 in September of 2025. In December 2025, the Company announced the development of a robotics platform to design a transformative shoulder-specific micro-robotic solution designed to further enhance shoulder surgical precision, workflow efficiency, and enable exciting, new clinical approaches in the aTSA and rTSA markets. The roboticsee in full comparisonsolutionsolution, known as InSet Neo, is designed to be integrated with the Company’s ProVoyance platform to deliver a comprehensive technology solution. We are planning FDA submission for InSet Neo in the first half of 2027. We are also evaluating expansion into adjacent areas in shoulder surgical care, which may include sports medicine and shoulder trauma markets. In January 2026, we received FDA 510(k) clearance for products designed for patients with metal sensitivity and products that expand our I-Series humeral stem product line to include additional fracture indications. In April 2026, we announced the full commercial launch of the InSet™ I-135RFX Humeral Stem. We have filed a 510(k) with the FDA related to additive manufacturing of certain products, which will add additional supply chain capacity and cost reductions of up to 30% on certain products beginning in 2027. Beginning in the third quarter of 2026, the InSet Clutch guide system for anatomic and reverse glenoid procedures will be available to surgeons, and we also expect a limited user release for a new subscapularis sparing technique initiative. We expect the first surgical cases using our streamlined InSet anatomic glenoid implant, the InSet Go, in the fourth quarter of 2027 which will further reduce surgical steps. Additionally, we are targeting FDA submission in 2027 for a new concept for reverse procedures, branded InSet One. We anticipate we will continue to invest significantly in product development, including with respect to our supporting technologies, in order to further bolster our ecosystem. While research and development are time consuming and costly and therefore negatively impact our results of operations in the near term, we believe expanding into new areas, implementing product improvements and continuing to demonstrate the efficacy, safety and cost effectiveness of our products through clinical data and surgeon education are all critical to increasing the adoption of our implant systems and to the success of our business over the long term. Our clinical data collection efforts within the registry are ahead of our expectations. As we expand our operations in line with our anticipated growth, we will be required to maintain sufficient levels of inventory and instrumentation to meet our estimated demand, which we expect will increase expenses.
Full comparison: every changed paragraph (60)
We have experienced significant growth in recent years, primarily driven by growth in our net revenue from the sale of our advanced implant systems sold.systems.
•Continued investments in product development, innovation and growth. We expect to continue to focus on long-term revenue growth through investments in our ecosystem and expansion of our operations. In research and development, we continually invest in improving our technologies, developing new products and further expanding our cleared indications. For example, we began using ProVoyance in 2021 and have developed a product line to include certain fracture indications and commercially launched the InSet 70 in September of 2025. In December 2025, the Company announced the development of a robotics platform to design a transformative shoulder-specific micro-robotic solution designed to further enhance shoulder surgical precision, workflow efficiency, and enable exciting, new clinical approaches in the aTSA and rTSA markets. The robotic solutionsolution, known as InSet Neo, is designed to be integrated with the Company’s ProVoyance platform to deliver a comprehensive technology solution. We are planning FDA submission for InSet Neo in the first half of 2027. We are also evaluating expansion into adjacent areas in shoulder surgical care, which may include sports medicine and shoulder trauma markets. In January 2026, we received FDA 510(k) clearance for products designed for patients with metal sensitivity and products that expand our I-Series humeral stem product line to include additional fracture indications. In April 2026, we announced the full commercial launch of the InSet™ I-135RFX Humeral Stem. We have filed a 510(k) with the FDA related to additive manufacturing of certain products, which will add additional supply chain capacity and cost reductions of up to 30% on certain products beginning in 2027. Beginning in the third quarter of 2026, the InSet Clutch guide system for anatomic and reverse glenoid procedures will be available to surgeons, and we also expect a limited user release for a new subscapularis sparing technique initiative. We expect the first surgical cases using our streamlined InSet anatomic glenoid implant, the InSet Go, in the fourth quarter of 2027 which will further reduce surgical steps. Additionally, we are targeting FDA submission in 2027 for a new concept for reverse procedures, branded InSet One. We anticipate we will continue to invest significantly in product development, including with respect to our supporting technologies, in order to further bolster our ecosystem. While research and development are time consuming and costly and therefore negatively impact our results of operations in the near term, we believe expanding into new areas, implementing product improvements and continuing to demonstrate the efficacy, safety and cost effectiveness of our products through clinical data and surgeon education are all critical to increasing the adoption of our implant systems and to the success of our business over the long term. Our clinical data collection efforts within the registry are ahead of our expectations. As we expand our operations in line with our anticipated growth, we will be required to maintain sufficient levels of inventory and instrumentation to meet our estimated demand, which we expect will increase expenses.
In addition to our results and measures of performance determined in accordance with U.S. GAAP, we believe that non-GAAP financial measures can be useful in evaluating and comparing our financial and operational performance over multiple periods, identifying trends affecting our business, formulating business plans and making strategic decisions. We use and present Adjusted EBITDA for these purposes. We define Adjusted EBITDA as net loss before interest (income) expense, net, income tax expense, loss on extinguishment of debt, depreciation and amortization, and stock-based compensation expense.
We currently derive our net revenue from the sale of our aTSA and rTSA implant systems, which generally consist of our InSet Glenoid and humeral stem products. We sell our implants to hospitals, outpatient centers and ASCs in the United States through a dedicated commercial leadership team and a network of external independent distributors. Net revenue is recognized when the performance obligation to deliver these implant systems to our customers is satisfied and we transfer control of the implants to our customers, which is generally when we have received a purchase order and appropriate notification that the procedure has been used or implanted. Revenue is recognized in the amount of the consideration received net of any sales taxes that we expect to collect from customers. We also record shipping and handling costs as revenue. Our average sales price for our implant systems was $7,650$7,674 and $7,022$7,330 for the three months ended MarchJune 31,30, 2026 and 2025, respectively. Our average sales price for our implant systems was $7,662 and $7,179 for the six months ended June 30, 2026 and 2025, respectively. No single customer accounted for more than 10% of our net revenue during the three or six months ended MarchJune 31,30, 2026 and 2025, respectively. We expect our net revenue to increase for the foreseeable future as we expand our commercial organization, add new customers, expand our sales territories, introduce new products, as existing customers perform more procedures using our systems and as we generally expand awareness of our systems with new and existing customers. While industry trends have resulted in increased downward pricing pressure on medical services and products, we have not experienced a material impact on our net revenue to date; however, we cannot assure you that our net revenue will not be impacted in the future by these industry trends. Our net revenue may fluctuate from quarter to quarter due to a variety of factors, such as the size and success of our dedicated commercial leadership team, the number of hospitals and physicians who are aware of and use our systems and seasonality.
Cost of goods sold consists primarily of the cost of components, packaging and sterilization, and obsolete inventory adjustments. Our systems are manufactured to our specifications primarily by third-party suppliers in the United States and are generally ordered on a purchase order basis. Cost of goods sold is recognized at the time the related revenue is recognized. Prior to use in surgery, the cost of our products is recorded as inventories, net of obsolescence reserve on our condensed balance sheets. Cost of goods sold does not include depreciation expense for instruments, which is included in selling, general and administrative expenses. Depreciation expense for instruments was $1,057$1,086 thousand and $593$623 thousand for the three months ended MarchJune 31,30, 2026 and 2025, respectively. See Note 87 to our unaudited condensed financial statements included elsewhere in this Quarterly Report for additional information. We expect cost of goods sold to increase as our net revenue increases and more of our implant systems are sold.
Our other (income) expense consists of (i) interest (income) expense, net, (ii) change in fair value of Series E purchase option, (iii) loss on extinguishment of debt, and (iiiv) other (income) expense, net.
Interest (income) expense, net consists of interest expense related to our term loan facility (the “Trinity Loan Agreement”) with Trinity Capital Inc. (“Trinityas Capital”defined below), the Loan Agreement (as defined below), interest expense related to our convertible notes, and non-cash interest related to the amortization of debt discount, issuance costs and deferred interest associated with our indebtedness, as well as interest income earned on our cash, cash equivalents and marketable securities.
Change in Fair Value of Series E Purchase Option
Change in fair value of warrant liabilities consists of gains and losses resulting from the remeasurement of the fair value of our warrant liabilities at each balance sheet date. During the third quarter of 2025 and upon completion of the Company’s IPO, a final remeasurement of the fair value of the warrant liability was made and the warrants were reclassified to equity within the additional paid-in capital line item.
Loss on Extinguishment of Debt
Loss on extinguishment of debt consists of unamortized deferred financing fees, prepayment premium, and unrecognized end of term payment amount under the Trinity Loan Agreement.
Other (Income) Expense, Net
Other (income) expense, net consists primarily of adjustment in the fair market value of marketable securities and change in fair value of warrant liabilities.
Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025
_______________ (1)Includes stock-based compensation expense of $726$1,081 thousand and $127$190 thousand for the three months ended MarchJune 31,30, 2026 and 2025, respectively.
Net Revenue. Net revenue increased $6,576$6,162 thousand, or 64.9%,56.0%, to $16,708$17,175 thousand for the three months ended MarchJune 31,30, 2026, compared to $10,132$11,013 thousand for the three months ended MarchJune 31,30, 2025. The increase in net revenue was due to an increase in the number of implant systems sold, as well as an increase in the number of customers.
Cost of Goods Sold and Gross Margin. Cost of goods sold increased $1,381$1,114 thousand, or 59.0%,42.5%, to $3,722$3,734 thousand for the three months ended MarchJune 31,30, 2026, compared to $2,341$2,620 thousand for the three months ended MarchJune 31,30, 2025. This increase in cost of goods sold was primarily due to the increase in the number of our systems sold. Gross margin for the three months ended MarchJune 31,30, 2026 increased to 77.7%,78.3%, compared to 76.9%76.2% for the three months ended MarchJune 31,30, 2025.
Selling, General and Administrative Expenses. Selling, general and administrative expenses increased $7,706$7,237 thousand, or 73.4%,56.3%, to $18,208$20,086 thousand for the three months ended MarchJune 31,30, 2026, compared to $10,502$12,849 thousand for the three months ended MarchJune 31,30, 2025. This increase in selling, general and administrative expenses was primarily due to a $3,246$3,066 thousand increase in personnel-related expenses as a result of increased headcount of our commercial organization, a $2,170$2,079 thousand increase in commissions and sales related costs due to higher sales of our systems, a $1,228$891 thousand increase in stock-based compensation expense, a $736 thousand increase in general corporate costs such as information technology, business development and insurance costs including costs associated with becoming a public company, a $598 thousand increase in stock-based compensation expense,company and a $464$465 thousand increase in depreciation primarily of surgical instruments.
Research and Development Expenses. Research and development expenses increased $2,171$1,985 thousand, or 137.1%,141.2%, to $3,754$3,391 thousand for the three months ended MarchJune 31,30, 2026, compared to $1,583$1,406 thousand for three months ended MarchJune 31,30, 2025. The increase in research and development expenses was due to our investment in new product development efforts, including an increase in external consulting fees of $2,279$1,499 thousand primarily related to the robotic platform strategic partnership.
Interest (Income) Expense, Net. Interest expense, net decreased $803$889 thousand, or 218.8%,411.6%, to interest income, net of $436$673 thousand for the three months ended MarchJune 31,30, 2026, compared to interest expense, net of $367$216 thousand for the three months ended MarchJune 31,30, 2025. This decrease in interest expense, net was due to higher interest earned on marketable securities.
Change in Fair Value of Series E Purchase Option. Change in fair value of Series E purchase option was $0 for the three months ended June 30, 2026, compared to $11,719 thousand for the three months ended June 30, 2025. The Series E purchase option was issued in connection with the Company’s Series E preferred stock financing entered into during the first quarter of 2025 and the increase resulted from recognition of the fair value change between issuance and the exercise of the Series E preferred stock purchase option in June 2025.
Loss on Extinguishment of Debt. Loss on extinguishment of debt was $589 thousand for the three months ended June 30, 2026 and resulted from repaying the Trinity Loan Agreement. There was no loss on extinguishment of debt in 2025.
Other (Income) Expense, Net. Other expense, net decreased by $162$1,198 thousandthousand, or 85.6%, to other income, net of $161$201 thousand for the three months ended MarchJune 31,30, 2026, compared to other expense, net of $1$1,399 thousand for the three months ended MarchJune 31,30, 2025. This decrease in other expense, net was due to a decrease of $1,415 thousand related to changes in the fair value of our preferred stock warrant liability offset by an increase of $162$217 thousand in gainloss on marketable securities.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table sets forth the components of our statements of operations for the periods presented below:
_______________ (1)Includes stock-based compensation expense of $1,807 thousand and $317 thousand for the six months ended June 30, 2026 and 2025, respectively.
*Not meaningful
Net Revenue. Net revenue increased $12,738 thousand, or 60.2%, to $33,883 thousand for the six months ended June 30, 2026, compared to $21,145 thousand for the six months ended June 30, 2025. The increase in net revenue was due to an increase in the number of implant systems sold, as well as an increase in the number of customers.
Cost of Goods Sold and Gross Margin. Cost of goods sold increased $2,495 thousand, or 50.3%, to $7,456 thousand for the six months ended June 30, 2026, compared to $4,961 thousand for the six months ended June 30, 2025. This increase in cost of goods sold was primarily due to the increase in the number of our systems sold. Gross margin for the six months ended June 30, 2026 increased to 78.0%, compared to 76.5% for the six months ended June 30, 2025.
Selling, General and Administrative Expenses. Selling, general and administrative expenses increased $14,943 thousand, or 64.0%, to $38,294 thousand for the six months ended June 30, 2026, compared to $23,351 thousand for the six months ended June 30, 2025. This increase in selling, general and administrative expenses was primarily due to a $6,312 thousand increase in personnel-related expenses as a result of increased headcount of our commercial organization, a $4,250 thousand increase in commissions and sales related costs due to higher sales of our systems, a $1,960 thousand increase in general corporate costs such as information technology, business development and insurance costs, a $1,491 thousand increase in stock-based compensation expense and a $930 thousand increase in depreciation primarily of surgical instruments.
Research and Development Expenses. Research and development expenses increased $4,156 thousand, or 139.0%, to $7,145 thousand for the six months ended June 30, 2026, compared to $2,989 thousand for the six months ended June 30, 2025. The increase in research and development expenses was due to our investment in new product development efforts, including an increase in external consulting fees of $3,778 thousand primarily related to the robotic platform strategic partnership.
Interest (Income) Expense, Net. Interest expense, net decreased $1,692 thousand, or 290.2%, to interest income, net of $1,109 thousand for the six months ended June 30, 2026, compared to interest expense, net of $583 thousand for the six months ended June 30, 2025. This decrease in interest expense, net was due to higher interest earned on marketable securities.
Change in Fair Value of Series E Purchase Option. Change in fair value of Series E purchase option was $0 for the six months ended June 30, 2026, compared to $11,719 thousand for the six months ended June 30, 2025. The Series E purchase option was issued in connection with the Company’s Series E preferred stock financing entered into during the first quarter of 2025 and the increase resulted from recognition of the fair value change between issuance and the exercise of the Series E preferred stock purchase option in June 2025.
Loss on Extinguishment of Debt. Loss on extinguishment of debt was $589 thousand for the six months ended June 30, 2026 and resulted from repaying the Trinity Loan Agreement. There was no loss on extinguishment of debt in 2025.
Other Expense, Net. Other expense, net decreased by $1,360 thousand, or 97.1%, to $40 thousand for the six months ended June 30, 2026, compared to other expense, net of $1,400 thousand for the six months ended June 30, 2025. This decrease in other expense, net was due to a decrease of $1,415 thousand related to changes in the fair value of our preferred stock warrant liability offset by an increase of $55 thousand in loss on marketable securities.
To date, our primary sources of capital have been from net revenue received from the sale of our implant systems, the sale of common stock in our IPO, proceeds from private placements of our convertible preferred stock and debt financing arrangements. On August 1, 2025, we completed our IPO, selling 5,000,000 shares of our common stock at $15.00 per share. Upon completion of our IPO, we received net proceeds of approximately $64,212 thousand, after deducting underwriting discounts and commissions and offering expenses. Since inception, we have raised a total of $114,600 thousand in net proceeds from private placements of our convertible preferred stock. As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $108,538$98,993 thousand and $15,000 thousand of principal outstanding under our Trinitythe Loan Agreement.
We have generated losses from our operations since our inception as reflected in our accumulated deficit of $105,779$115,932 thousand as of MarchJune 31,30, 2026. Our losses primarily resulted from the costs incurred in the development, sales, and marketing of our systems and providing support for our operations. We expect to continue to incur losses for the foreseeable future and to expend significant amounts of cash for the foreseeable future as we continue to scale our business, increase selling, general and administrative expenses to support the expansion of our commercial organization and efforts, increase general and administrative expenses to support being a publicly-traded company and invest in research and development activities.
On June 26, 2026 the Company entered into a Loan and Security Agreement (the “Loan Agreement”), by and between the Company, as borrower, and Stifel Bank, as lender (the “Lender”). The Loan Agreement provides for (i) a senior secured term loan in the aggregate principal amount of $15,000 thousand (the “Term Loan”) and (ii) a senior secured asset-based revolving line of credit in the aggregate principal amount of $30,000 thousand, which, subject to certain conditions, may be increased by $5,000 thousand at the Company’s request (the “Revolving Facility”). Proceeds from the Loan Agreement were used to pay off the term loan outstanding under the Trinity Loan and Security Agreement (the “Trinity Loan Agreement”). The Trinity Loan Agreement was terminated on June 26, 2026.
Availability under the Revolving Facility is subject to a borrowing base consisting of specified percentages of eligible accounts receivable, subject to adjustments established by the Lender; provided that, up to $15,000 thousand of the Revolving Facility is available on a non-formula basis so long as the Company meets certain liquidity requirements.
The aggregate principal amount of borrowings outstanding under the Term Loan accrue interest at a rate per annum equal to the greater of (i) 0.75% below the prime rate and (ii) 5.00%. The aggregate principal amount of borrowings outstanding under the Revolving Facility will accrue interest at a rate per annum equal to the greater of: (i) the prime rate and (ii) 5.00%.
The Company’s obligations under the Loan Agreement are secured by substantially all assets of the Company, except for any copyrights, patents, trademarks, service marks and applications now owned or hereafter acquired by the Company or any claims for damages by way of any past, present and future infringement of any of the foregoing intellectual property.
The Term Loan and Revolving Facility may be prepaid at any time and without penalty, except that any prepayment of the aggregate principal amount of borrowings outstanding under the Term Loan made prior to June 26, 2027 is subject to a prepayment premium equal to 1.00% of the aggregate principal amount of borrowings outstanding under the Term Loan immediately prior to such prepayment. The Term Loan matures on June 1, 2031, and the Revolving Facility matures on June 26, 2029.
The Loan Agreement contains customary affirmative and negative covenants and covenants limiting the ability of the Company to, among other things, incur debt, grant liens, pay dividends and distributions on capital stock, and make investments and acquisitions, in each case subject to exceptions customary for secured financings.
On August 7, 2023, we entered into the Trinity Loan Agreement, as amended on July 21, 2025, with Trinity Capital, as administrative agent and collateral agent (in such capacities, the “Agent”) and as a lender, and the other lenders from time to time party thereto, providing for term loans of up to an aggregate principal amount of $45,000 thousand, available in three tranches: (i) a $15,000 thousand tranche that was fully funded on the August 7, 2023, (ii) a $15,000 thousand tranche that expired on December 31, 2025 and (iii) a $15,000 thousand tranche available through December 31, 2026. The availability of the second tranche is subject to, among other things, our achievement of at least $30,000 thousand of annualized trailing 6-month revenue by December 31, 2025. The availability of the third tranche is subject to, among other things, our achievement of at least $45,000 thousand of annualized trailing six-month revenue by December 31, 2026. In connection with the Trinity Loan Agreement, as amended on July 21, 2025, we issued a warrant to purchase 87,157 shares of our Series D convertible preferred stock to Trinity Capital. Upon completion of the Company’s IPO the warrants converted to warrants to purchase shares of the Company’s common stock. The warrant has an exercise price of $10.33 per share and expires ten years from the date of its issuance. As of March 31, 2026, the aggregate outstanding principal balance under the Trinity Loan Agreement was $15,000 thousand. The second tranche expired on December 31, 2025, prior to the Company drawing on the tranche.
The term loans under the Trinity Loan Agreement bear interest at an annual rate equal to the greater of the prime rate plus 3.50% and 11.00%. Under the terms of the Trinity Loan Agreement, the prime rate is equal to the greater of 8.0% per year and the prime rate as reported in The Wall Street Journal. We are required to make monthly payments of interest only through maturity of the term loans on September 1, 2028 (“Maturity Date”). The unpaid balance of principal and accrued interest is due on the Maturity Date. The Trinity Loan Agreement provides that we can at any time prepay the term loans, in whole or in part, subject to a prepayment premium equal to: (i) 2.50% of the then-outstanding principal amount of the term loans, if such prepayment occurs on or prior to the first anniversary of the Trinity Loan Agreement; (ii) 1.50% of the then-outstanding principal amount of the advance, if such prepayment occurs after the first anniversary of the Trinity Loan Agreement and on or prior to the second anniversary of the Trinity Loan Agreement; and (iii) 1.00% of the then-outstanding principal amount of the advance, if such prepayment occurs after the second anniversary of the Trinity Loan Agreement and prior to the Maturity Date. We are required to make an end of term payment equal to 3.00% of the aggregate principal amount of the term loans funded on the earlier of (i) the Maturity Date, (ii) the date that we prepay all of the outstanding principal in full or (iii) the date of acceleration of the balance of the outstanding term loans by the Agent. The term loans are secured by substantially all our assets, including intellectual property.
The Trinity Loan Agreement also includes customary affirmative and negative covenants and events of default. Upon the occurrence and continuance of an event of default the Agent may demand immediate repayment of all principal and unpaid interest under the Trinity Loan Agreement, and exercise remedies against us and the collateral securing the Trinity Loan Agreement. Events of default under the Trinity Loan Agreement include, among other things: (i) insolvency, bankruptcy or similar proceedings subject to a certain grace period in respect of any involuntary insolvency, bankruptcy or similar proceedings; (ii) failure to pay any debts due under the Trinity Loan Agreement or other loan documents on a timely basis; (iii) failure to observe any covenant or secured obligation under the Trinity Loan Agreement, subject to a certain cure period; (iv) occurrence of a material adverse change; (v) material misrepresentations; (vi) occurrence of any default under any material agreement (or termination thereof) or any other agreement resulting in a right by the applicable third party to accelerate debt in excess of $500 thousand; (vii) entry of certain final, non-appealable judgments against us in excess of $500 thousand not paid or bonded within 10 days of such entry; (viii) a change of control unless as a condition to the closing of such change of control all outstanding term loans will be paid in full; and (ix) certain changes in the composition of board of directors.
As of MarchJune 31,30, 2026, wethe wereCompany was in compliance with all covenants contained in the Trinity Loan Agreement.
As of June 30, 2026, there was $15,000 thousand in outstanding borrowings under the Term Loan and no outstanding borrowings under the Revolving Facility.
Based on our current operating plan, we believe that the expected cash generated from the sale of our systems, our existing cash, cash equivalents and marketable securities and amounts under our Trinity Loan Agreement, will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least 12 months from the date hereof. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. We may experience lower than expected cash generated from operating activities or greater than expected capital expenditures, cost of goods sold, or operating expenses, and may need to raise additional capital to fund operations, increase our commercial organization and efforts, further research and development activities, or acquire, invest in, or in-license other businesses, assets, or technologies.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we are unable to satisfy our liquidity requirements, including because of the risks described in Part I, “Risk Factors” included in “Risk Factors” contained in Part I, Item 1A of the Company’s 2025 Annual Report, we may seek to raise any necessary additional capital through public or private equity offerings or debt financings, credit or loan facilities or a combination of one or more of these or other funding sources. Additional funds may not be available to us on acceptable terms or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, we could be forced to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will suffer dilution and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. If we raise additional capital through collaborationscollaboration agreements, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights, future revenue streams, research programs or product or grant licenses that may not be favorable to us. Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.
For the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $12,358$19,750 thousand, consisting primarily of a net loss of $8,379$18,532 thousand and net cash used by changes in our operating assets and liabilities of $5,846$6,311 thousand, partially offset by non-cash charges of $1,867$5,093 thousand. The non-cash charges primarily consisted of depreciation and amortization expense of $1,132$2,265 thousand andthousand, stock-based compensation expense of $726$1,807 thousand and loss on extinguishment of debt of $589 thousand. Net cash used by changes in our operating assets and liabilities primarily consisted of an increase of $2,857 thousand in trade accounts receivable, a decrease of $3,219$2,222 thousand in accounts payable, an increase of $2,389 thousand in trade accounts receivable, an increase of $238$1,329 thousand to inventory, and an increase of $187$811 thousand in prepaid expenses, partially offset by an increase of $187$908 thousand in other current liabilities.
For the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities was $6,477$11,274 thousand, consisting primarily of a net loss of $4,662$23,858 thousand and net cash used by changes in our operating assets and liabilities of $2,511$2,270 thousand, partially offset by non-cash charges of $696$14,854 thousand. The non-cash charges primarily consisted of changes in the fair value of our preferred stock warrant liability and Series E purchase option of $13,134 thousand, depreciation and amortization expense of $668$1,385 thousand and stock-based compensation expense of $127$317 thousand, partially offset by realized gain on marketable securities of $162$207 thousand. Net cash used by changes in operating assets and liabilities primarily consisted of aan decreaseincrease of $2,122$3,126 thousand in accounts payableinventory and an increase in accounts receivable of $1,459$1,820 thousand, partially offset by aan decreaseincrease of $851$1,954 thousand in inventory.other current liabilities and an increase of $982 thousand in accounts payable.
For the threesix months ended MarchJune 31,30, 2026, net cash usedprovided inby investing activities was $3,122$17,322 thousand, consisting primarily of proceeds of $40,384 thousand from sales of our marketable securities, partially offset by purchases of $18,170 thousand in marketable securities and $2,735$4,892 thousand in fixed assets purchases, partially offset by proceeds of $17,783 thousand from sales of our marketable securities.purchases.
For the threesix months ended MarchJune 31,30, 2025, net cash used in investing activities was $13,070$5,879 thousand, consisting primarily of purchases of $20,060$20,477 thousand in marketable securities and $843$2,311 thousand in fixed assets purchases, partially offset by cash proceeds of $7,833$16,909 thousand from sales of our marketable securities.
For the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was $101$17 thousand, resulting from proceeds receivedof $15,000 thousand from thedebt issuance and proceeds of $524 thousand from exercise of common stock options.options, partially offset by payments of $15,000 thousand of payments of long-term debt and $507 thousand of payments of debt issuance and extinguishment costs.
For the threesix months ended MarchJune 31,30, 2025, net cash provided by financingsfinancing activities was $19,794$38,084 thousand, consisting of proceeds of $19,632$39,553 thousand from the issuance and sale of shares of our Series E convertible preferred stock, proceeds of $130$362 thousand from the exercise of warrants for our Series Seed preferred stock and proceeds of $32$151 thousand from the exercise of common stock options.options, partially offset by $1,982 thousand of payments of deferred IPO costs.
Our contractual commitments will have an impact on our future liquidity. These commitments include future payments on our Trinity Loan Agreement, future payments on facility leases and certain royalty obligations. Where applicable, we calculate our obligation based on termination fees that can be paid to exit the contract.
The principal outstanding under our Trinitythe Loan Agreement was $15,000 thousand as of MarchJune 31,30, 2026, however, we are required to make monthly payments of interest only through theJuly Maturity1, Date2029 followed by twenty-four equal monthly installments of theprincipal termplus loans.accrued interest. The unpaid balance of principal and accrued interest is due on the Maturitymaturity Date.date.
We have entered into an operating lease for office space in Michigan. The lease has a five-year term, which commenced in July 2021 and is renewable for one additional five-year term upon expiration, and was renewed in April 2026. We have also entered into an operating lease for warehouse space in California. The lease has a three-year term, which commenced in March 2025 and is renewable for one additional one-year term upon expiration. In April 2026, we entered into a new lease, which includes the construction of a new commercial building in Michigan that is expected to be substantially completed around the fourth quarter of 2027, which we intend to use as our corporate headquarters. As of MarchJune 31,30, 2026, the operating lease obligations under these operating leases were $93$71 thousand.
On October 22, 2020, we entered into a software license agreement with Genesis Software Innovations, LLC (“Genesis Software”), which was amended and restated on January 1, 20232023, and subsequently amended and restated on June 10, 2025 (as amended and restated, the “License Agreement”), pursuant to which we are required to pay Genesis Software certain payments, including royalty payments, until such time we have paid Genesis Software an aggregate of $7,000 thousand under the License Agreement. As of MarchJune 31,30, 2026, we have paid an aggregate of $6,262$7,000 thousand of the total $7,000 thousand, including royalties of $575$666 thousand and $343$398 thousand in the three months ended MarchJune 31,30, 2026 and 2025, respectively.
SI insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 8 filings (3 insiders, 15 trade dates, 247,243 shares, about $5.5M; 2 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -247,243 (purchases minus sales); net value about -$5.5M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-10-05 | Tansey Casey M |
Grant/award | 733 | $19.60 | $14.4K |
| 2026-10-05 | Sidow Kevin K. |
Grant/award | 892 | $19.60 | $17.5K |
| 2026-10-05 | Hykes Andrew |
Grant/award | 669 | $19.60 | $13.1K |
| 2026-10-05 | Buckman Paul |
Grant/award | 1,275 | $19.60 | $25.0K |
| 2026-09-14 | Ball Robert Joseph |
Open-market sale | 10,175 | $18.45 | $187.7K |
| 2026-09-14 | Ball Robert Joseph |
Option exercise | 89,233 | $2.10 | $187.4K |
| 2026-08-26 | Gilde Healthcare Holding B.v. |
Open-market sale | 1,196 | $22.60 | $27.0K |
| 2026-08-24 | Gilde Healthcare Holding B.v. |
Open-market sale | 681 | $22.62 | $15.4K |
| 2026-08-21 | Gilde Healthcare Holding B.v. |
Open-market sale | 20,516 | $22.61 | $463.9K |
| 2026-08-20 | Gilde Healthcare Holding B.v. |
Open-market sale | 3,900 | $22.60 | $88.1K |
| 2026-08-18 | Ahearn Matthew Fraser |
Open-market sale |
1,600 | $21.38 | $34.2K |
| 2026-08-18 | Ahearn Matthew Fraser |
Open-market sale |
12,586 | $20.94 | $263.6K |
| 2026-08-17 | Ahearn Matthew Fraser |
Open-market sale |
8,314 | $20.10 | $167.1K |
| 2026-08-14 | Ahearn Matthew Fraser |
Gift |
2,500 | — | — |
| 2026-08-06 | Gilde Healthcare Holding B.v. |
Open-market sale | 2,095 | $22.60 | $47.3K |
| 2026-08-05 | Gilde Healthcare Holding B.v. |
Open-market sale | 7,338 | $22.64 | $166.1K |
| 2026-08-04 | Gilde Healthcare Holding B.v. |
Open-market sale | 99,812 | $22.77 | $2.3M |
| 2026-08-03 | Gilde Healthcare Holding B.v. |
Open-market sale | 10,751 | $22.71 | $244.2K |
| 2026-07-31 | Gilde Healthcare Holding B.v. |
Open-market sale | 20,034 | $22.73 | $455.4K |
| 2026-07-30 | Gilde Healthcare Holding B.v. |
Open-market sale | 28,245 | $23.36 | $659.8K |
| 2026-06-26 | Tansey Casey M |
Grant/award | 5,046 | — | — |
| 2026-06-26 | Sidow Kevin K. |
Grant/award | 5,046 | — | — |
| 2026-06-26 | Hykes Andrew |
Grant/award | 5,046 | — | — |
| 2026-06-26 | Buckman Paul |
Grant/award | 5,046 | — | — |
| 2026-06-26 | Buchholz Richard |
Grant/award | 5,046 | — | — |
| 2026-06-15 | Ahearn Matthew Fraser |
Open-market sale |
1,644 | $18.20 | $29.9K |
| 2026-06-15 | Ahearn Matthew Fraser |
Open-market sale |
2,500 | $19.26 | $48.1K |
| 2026-06-12 | Ahearn Matthew Fraser |
Open-market sale |
15,856 | $18.68 | $296.2K |
| 2026-04-30 | Ball Robert Joseph |
Option exercise | 10,000 | $2.48 | $24.8K |
| 2026-04-20 | Ahearn Matthew Fraser |
Option exercise | 7,421 | $2.48 | $18.4K |
| 2026-04-20 | Ahearn Matthew Fraser |
Option exercise | 14,243 | $2.86 | $40.7K |
Well-known investors holding SI (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 193,942 | $2.8M | — | Sold out |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 36,795 | $746.2K | 0.0% | Added 172% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 22,920 | $464.8K | 0.0% | New position |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 19,775 | $401.0K | 0.0% | New position |