Mobia Medical, Inc.

Previous wording

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our condensed unaudited interim financial statements (the condensed financial statements) and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2025, included in our prospectus dated May 7, 2026, filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended on May 8, 2026.

Current wording

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our condensed unaudited interim financial statements (the condensed financial statements) and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2025, included in our prospectus dated May 7, 2026, filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 8, 2026 pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Securities Act”).

Previous wording

We are a commercial-stage medical device company redefining stroke recovery for survivors living with life-altering motor impairments. Our Vivistim Paired Vagus Nerve Stimulation (Paired VNS) System is the first and only clinically-validated, FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. Stroke is one of the leading causes of long-term disability in the United States. While advancements in acute stroke care over the past decade have significantly reduced mortality, innovation for chronic stroke recovery has lagged, resulting in a growing number of stroke survivors living with meaningful impairments. Our breakthrough Vivistim Paired VNS System (Vivistim System) addresses this unmet need. The Vivistim System includes an implanted pulse generator and lead that deliver stimulation to the vagus nerve when activated. During treatment (Vivistim Therapy), intentional bursts of stimulation are delivered during functional movement to increase neuroplasticity and durably restore motor function. Clinical data have demonstrated that Vivistim Therapy delivers meaningful improvements in upper limb function, which can help stroke survivors regain critical capabilities and independence and restore quality of life, regardless of the time elapsed since the patient’s stroke. In July 2026, two-year follow-up data from the VNS-REHAB pivotal trial were published in Neurology. The publication reported that improvements observed following Vivistim Therapy in upper-limb motor impairment and function and certain patient-reported measures were sustained for at least two years. We believe we are setting a new standard of care in chronic stroke recovery, facilitating a new treatment pathway for chronic ischemic stroke survivors with moderate to severe upper extremity impairments.

Current wording

We are a commercial-stage medical device company redefining stroke recovery for survivors living with life-altering motor impairments. Our Vivistim Paired Vagus Nerve Stimulation (Paired VNS) System is the first and only clinically-validated, FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. Stroke is one of the leading causes of long-term disability in the United States. While advancements in acute stroke care over the past decade have significantly reduced mortality, innovation for chronic stroke recovery has lagged, resulting in a growing number of stroke survivors living with meaningful impairments. Our breakthrough Vivistim Paired VNS System (Vivistim System) addresses this unmet need. The Vivistim System includes an implanted pulse generator and lead that deliver stimulation to the vagus nerve when activated. During treatment (Vivistim Therapy), intentional bursts of stimulation are delivered during functional movement to increase neuroplasticity and durably restore motor function. Clinical data have demonstrated that Vivistim Therapy delivers meaningful improvements in upper limb function, which can help stroke survivors regain critical capabilities and independence and restore quality of life, regardless of the time elapsed since the patient’s stroke. In July 2026, two-year follow-up data from the VNS-REHAB pivotal trial were published in Neurology. The publication reported that improvements observed following Vivistim Therapy in upper-limb motor impairment and function and certain patient-reported measures were sustained for at least two years. We believe we are setting a new standard of care in chronic stroke recovery, facilitating a new treatment pathway for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. In August 2026, the American Heart Association and American Stroke Association updated their Guideline for Adult Stroke Rehabilitation and Recovery to state that vagus nerve stimulation paired with high-dose, task-specific training may be considered to improve upper-limb impairment and function in eligible patients.

Previous wording

Our commercial strategy is designed to encourage Vivistim Therapy adoption at stroke centers and therapy sites through a coordinated, evidence-based approach. We sell the Vivistim System to customers, primarily stroke hospitals, in the United States, and our commercial organization is responsible for driving adoption of the Vivistim System through customer outreach, education, and relationship management activities. Our team includes Territory Managers (TMs), who support initial customer onboarding efforts at stroke centers and maintain commercial relationships with physicians and administrators, and Therapy Development Specialists (TDSs), who focus on outreach to therapy sites and provide general educational information regarding the clinical use of the Vivistim System. These activities are intended to facilitate customer adoption and utilization of the Vivistim System. Our commercial efforts are currently focused on primary and comprehensive stroke centers, which are hospitals that have cross-functional teams with the capabilities to treat acute stroke at the highest level of care and in compliance with AHA guidelines. These centers see significant volumes of acute stroke patients and are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure necessary for efficient implementation of Vivistim Therapy. We work with these stroke centers to establish Vivistim Therapy as a treatment option for stroke survivors. Over time, we believe these centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use

Current wording

Our commercial strategy is designed to encourage Vivistim Therapy adoption at stroke centers and therapy sites through a coordinated, evidence-based approach. We sell the Vivistim System to customers, primarily stroke hospitals, in the United States, and our commercial organization is responsible for driving adoption of the Vivistim System through customer outreach, education, and relationship management activities. Our team includes Territory Managers (TMs), who support initial customer onboarding efforts at stroke centers and maintain commercial relationships with physicians and administrators, and Therapy Development Specialists (TDSs), who focus on outreach to therapy sites and provide general educational information regarding the clinical use of the Vivistim System. These activities are intended to facilitate customer adoption and utilization of the Vivistim System. Our commercial efforts are currently focused on primary and comprehensive stroke centers, which are hospitals that have cross-functional teams with the capabilities to treat acute stroke at the highest level of care and in compliance with AHA guidelines. These centers see significant volumes of acute stroke patients and are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure necessary for efficient implementation of Vivistim Therapy. We work with these stroke centers to establish Vivistim Therapy as a treatment option for stroke survivors. Over time, we believe these centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use Vivistim Therapy. According to data from the stroke center accreditation organizations, there were approximately 1,500 primary and comprehensive stroke centers in the United States as of December 2025. In addition, according to stroke claims data, approximately 70% of acute strokes in the United States are seen at 900 hospitals.

Previous wording

To date, our primary sources of capital have been private placements of preferred stock, debt financing arrangements, revenue from sales of our Vivistim System and net proceeds from our initial public offering in May 2026 (the “IPO”). For the six months ended June 30, 2026, we generated revenue of $25.6 million, with a gross margin of 82.8%, and had a net loss of $38.8 million, compared to revenue of $12.3 million, with a gross margin of 82.2%, and a net loss of $21.1 million for the six months ended June 30, 2025. As of June 30, 2026, we had cash and cash equivalents of $177.1 million and an accumulated deficit of approximately $196.6 million. In May 2026, we completed our IPO and received net proceeds of approximately $134.0 million.

Current wording

To date, our primary sources of capital have been private placements of preferred stock, debt financing arrangements, revenue from sales of our Vivistim System and net proceeds from our initial public offering in May 2026 (the “IPO”). For the nine months ended September 30, 2026, we generated revenue of $41.2 million, with a gross margin of 83.0%, and had a net loss of $56.1 million, compared to revenue of $21.3 million, with a gross margin of 81.1%, and a net loss of $32.6 million for the nine months ended September 30, 2025. As of September 30, 2026, we had cash and cash equivalents of $160.7 million and an accumulated deficit of approximately $213.9 million. In May 2026, we completed our IPO and received net proceeds of approximately $134.0 million.

Previous wording

Growing our commercial organization. To promote awareness and utilization, we expect to continue to efficiently invest in and grow our commercial organization. For example, our selling, general and administrative expenses were $26.9 million for the three months ended June 30, 2026 compared to $14.5 million for the three months ended June 30, 2025. We intend to continue to make significant investments in our commercial organization by scaling our team, which we believe will broaden our geographic reach, drive penetration, and increase access to our products. We seek to scale deliberately and efficiently using our scalable commercial model, which initially targets a highly concentrated group of high-volume primary and comprehensive stroke centers. These stroke centers are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure for efficient implementation of Vivistim Therapy. Historically, substantially all Vivistim System implants have been performed at primary and comprehensive stroke centers. While we aim to expand strategically and efficiently, the rate at which we grow our commercial organization and the speed at which newly hired personnel become effective will impact our revenue growth and our costs incurred in anticipation of such growth.

Current wording

Growing our commercial organization. To promote awareness and utilization, we expect to continue to efficiently invest in and grow our commercial organization. For example, our selling, general and administrative expenses were $29.0 million for the three months ended September 30, 2026 compared to $16.8 million for the three months ended September 30, 2025. We intend to continue to make significant investments in our commercial organization by scaling our team, which we believe will broaden our geographic reach, drive penetration, and increase access to our products. We seek to scale deliberately and efficiently using our scalable commercial model, which initially targets a highly concentrated group of high-volume primary and comprehensive stroke centers. These stroke centers are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure for efficient implementation of Vivistim Therapy. Historically, substantially all Vivistim System implants have been performed at primary and comprehensive stroke centers. While we aim to expand strategically and efficiently, the rate at which we grow our commercial organization and the speed at which newly hired personnel become effective will impact our revenue growth and our costs incurred in anticipation of such growth.

Previous wording

We currently generate all of our revenue from the sale of our Vivistim System to customers, mainly primary and comprehensive stroke centers, in the United States. Our customers typically purchase an initial stocking order and then reorder replenishment product as procedures are performed. No single customer accounted for 10% or more of our revenue for the three and six months ended June 30, 2026 and 2025. We expect revenue to increase as we expand our commercial organization and sales territories, add customers and expand patient and customer awareness. We have expanded our commercial organization to help us drive and support revenue growth and intend to continue this expansion. We also expect that demand, and thus revenue growth, will be positively impacted by, and to the extent that, we obtain additional positive coverage policies with payors. While we have experienced strong revenue growth, our revenue may fluctuate from quarter to quarter due to a variety of factors.

Current wording

We currently generate all of our revenue from the sale of our Vivistim System to customers, mainly primary and comprehensive stroke centers, in the United States. Our customers typically purchase an initial stocking order and then reorder replenishment product as procedures are performed. No single customer accounted for 10% or more of our revenue for the three and nine months ended September 30, 2026 and 2025. We expect revenue to increase as we expand our commercial organization and sales territories, add customers and expand patient and customer awareness. We have expanded our commercial organization to help us drive and support revenue growth and intend to continue this expansion. We also expect that demand, and thus revenue growth, will be positively impacted by, and to the extent that, we obtain additional positive coverage policies with payors. While we have experienced strong revenue growth, our revenue may fluctuate from quarter to quarter due to a variety of factors.

Previous wording

Selling, general and administrative expenses primarily consist of compensation for personnel, including salaries, employee benefits, stock-based compensation, commissions associated with our commercial organization, spending related to sales and marketing, finance, information technology and human resource functions, expenses related to clinical studies and our registry for our current clinical indication, legal expenses related to regulatory matters, and training. Other expenses include travel expenses, advertising, conferences, trade shows, consulting and professional services fees, insurance costs, and general corporate expenses, including facilities-related expenses. The activities of our TMs and TDSs to facilitate customer adoption and utilization of the Vivistim System, and of our in-house market access team in facilitating the administrative prior authorization process, are included in selling, general and administrative expenses and do not represent contractual obligations or services provided to customers after product delivery. We expect selling, general and administrative expenses to continue to increase in absolute dollars as we expand our commercial organization, including with respect to TMs and TDSs, to both drive and support our planned growth in revenue, fund clinical studies and our registry for our current clinical indication, and incur additional expenses associated with operating as a public company, including costs related to legal, accounting, insurance, compliance with exchange listing and Securities and Exchange Commission requirements, and investor relations. We also expect an increase in our stock-based compensation expense with the establishment of the new equity plan in connection with our IPO and related grants thereunder. However, we expect selling, general and administrative expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.

Current wording

Selling, general and administrative expenses primarily consist of compensation for personnel, including salaries, employee benefits, stock-based compensation, commissions associated with our commercial organization, spending related to sales and marketing, finance, information technology and human resource functions, expenses related to clinical studies and our registry for our current clinical indication, legal expenses related to regulatory matters, and training. Other expenses include travel expenses, advertising, conferences, trade shows, consulting and professional services fees, insurance costs, and general corporate expenses, including facilities-related expenses. The activities of our TMs and TDSs to facilitate customer adoption and utilization of the Vivistim System, and of our in-house market access team in facilitating the administrative prior authorization process, are included in selling, general and administrative expenses and do not represent contractual obligations or services provided to customers after product delivery. We expect selling, general and administrative expenses to continue to increase in absolute dollars as we expand our commercial organization, including with respect to TMs and TDSs, to both drive and support our planned growth in revenue, fund clinical studies and our registry for our current clinical indication, and incur additional expenses associated with operating as a public company, including costs related to legal, accounting, insurance, compliance with exchange listing and SEC requirements, and investor relations. We also expect an increase in our stock-based compensation expense with the establishment of the new equity plan in connection with our IPO and related grants thereunder. However, we expect selling, general and administrative expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.

Previous wording

Revenue. Revenue increased by $6.8 million, or 102.4%, to $13.5 million for the three months ended June 30, 2026, compared to $6.7 million for the three months ended June 30, 2025. The increase was driven primarily by higher adoption of the Vivistim System, as units of IPGs sold, a primary component of the Vivistim System, increased comparably during the period. This revenue growth reflects our continued efforts to increase awareness and expand our commercial organization while maintaining a consistent average selling price of the Vivistim System.

Current wording

Revenue. Revenue increased by $6.6 million, or 73.3%, to $15.6 million for the three months ended September 30, 2026, compared to $9.0 million for the three months ended September 30, 2025. The increase was driven primarily by higher adoption of the Vivistim System, as units of IPGs sold, a primary component of the Vivistim System, increased comparably during the period. This revenue growth reflects our continued efforts to increase awareness and expand our commercial organization while maintaining a consistent average selling price of the Vivistim System.

Previous wording

Cost of goods sold and gross margin. Cost of goods sold increased by $2.2 million, or 100.1%, to $4.4 million for the six months ended June 30, 2026, compared to $2.2 million for the six months ended June 30, 2025. While the cost per unit of the underlying product remained relatively consistent year over year, the increase in cost of goods sold was primarily driven by higher sales volume of Vivistim Systems and higher product warranty costs. Gross margin increased to 82.8% for the six months ended June 30, 2026, compared to 82.2% for the six months ended June 30, 2025. The increase was primarily attributable to inbound freight and tariff costs recognized in cost of goods sold during the period.

Current wording

Cost of goods sold and gross margin. Cost of goods sold increased by $0.8 million, or 42.5%, to $2.6 million for the three months ended September 30, 2026, compared to $1.8 million for the three months ended September 30, 2025. The increase was primarily driven by higher sales volume of Vivistim Systems, partially offset by lower inbound freight and tariff costs and lower inventory write-offs compared to the prior-year period. Gross margin increased to 83.2% from 79.6% primarily due to lower inbound freight and tariff costs recognized in cost of goods sold during the period and the lower inventory write-offs compared to the prior-year period.

Previous wording

Research and development costs. Research and development costs increased by $0.9 million, or 60.6%, to $2.3 million for the three months ended June 30, 2026, compared to $1.4 million for the three months ended June 30, 2025. The increase was primarily due to a $0.6 million increase in personnel-related expenses associated with increased headcount and a $0.3 million increase in product development efforts, including external development services.

Current wording

Research and development costs. Research and development costs increased by $0.9 million, or 58.8%, to $2.5 million for the three months ended September 30, 2026, compared to $1.6 million for the three months ended September 30, 2025. The increase was primarily due to a $0.4 million increase in personnel-related expenses associated with increased headcount and a $0.4 million increase in product development efforts, including external development services.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $12.4 million, or 85.0%, to $26.9 million for the three months ended June 30, 2026, compared to $14.5 million for the three months ended June 30, 2025. The increase was primarily due to an increase of $7.6 million in personnel-related expenses as a result of increased headcount primarily in our commercial organization, as well as higher commissions related to increased sales of Vivistim Systems. The increase also included $1.7 million in travel, meeting, marketing and branding expenses and $1.9 million in share-based compensation and professional fees.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $12.2 million, or 72.2%, to $29.0 million for the three months ended September 30, 2026, compared to $16.8 million for the three months ended September 30, 2025. The increase was primarily due to an increase of $6.7 million in personnel-related expenses, driven by increased headcount, particularly within our commercial organization, and higher sales commissions resulting from increased sales of Vivistim Systems. The increase was additionally driven by $1.9 million in additional share-based compensation expense, $1.3 million in higher travel, meeting, marketing and branding expenses, and $1.3 million in increased professional fees and IT-related expenses.

Previous wording

Total other income (expense), net. Total other expense, net was $3.1 million for the three months ended June 30, 2026, compared to total other expense, net of $28,000 for the three months ended June 30, 2025. The increase in total other expenses was primarily attributable to a $4.1 million loss from the change in the fair value of our Convertible Notes, partially offset by $0.7 million of higher interest income resulting from a higher average cash balance and a $0.2 million gain from changes in the fair value of warrant liabilities.

Current wording

Total other income (expense), net. Total other income, net was $1.2 million for the three months ended September 30, 2026, compared to total other expense, net of $0.2 million for the three months ended September 30, 2025. The increase in total other income, net was primarily attributable to $1.3 million of higher interest income resulting from a higher average cash balance.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025.

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025.

Previous wording

Revenue. Revenue increased by $13.2 million, or 107.4%, to $25.6 million for the six months ended June 30, 2026, compared to $12.3 million for the six months ended June 30, 2025. The increase was driven primarily by higher adoption of the Vivistim System, as units of IPGs sold, a primary component of the Vivistim System, increased comparably during the period. This revenue growth reflects our continued efforts to increase awareness and expand our commercial organization while maintaining a consistent average selling price of the Vivistim System.

Current wording

Revenue. Revenue increased by $19.8 million, or 93.0%, to $41.2 million for the nine months ended September 30, 2026, compared to $21.3 million for the nine months ended September 30, 2025. The increase was driven primarily by higher adoption of the Vivistim System, as units of IPGs sold, a primary component of the Vivistim System, increased comparably during the period. This revenue growth reflects our continued efforts to increase awareness and expand our commercial organization while maintaining a consistent average selling price of the Vivistim System.

Previous wording

Cost of goods sold and gross margin. Cost of goods sold increased by $1.1 million, or 91.5%, to $2.3 million for the three months ended June 30, 2026, compared to $1.2 million for the three months ended June 30, 2025. While the cost per unit of the underlying product remained relatively consistent year over year, the increase in cost of goods sold was primarily driven by higher sales volume of Vivistim Systems. Gross margin increased to 83.2% in the current period, from 82.3% in the three months ended June 30, 2025. The increase was primarily attributable to inbound freight and tariff costs recognized in cost of goods sold during the period, partially offset by other changes in product and warranty costs.

Current wording

Cost of goods sold and gross margin. Cost of goods sold increased by $3.0 million, or 73.9%, to $7.0 million for the nine months ended September 30, 2026, compared to $4.0 million for the nine months ended September 30, 2025. While the cost per unit of the underlying product remained relatively consistent year over year, the increase in cost of goods sold was primarily driven by higher sales volume of Vivistim Systems and higher product warranty costs, partially offset by lower inventory write-offs and inbound freight and tariff costs. Gross margin increased to 83.0% from 81.1%, primarily due to lower inbound freight and tariff costs recognized in cost of goods sold and lower inventory write-offs compared to the prior-year period.

Previous wording

Research and development costs. Research and development costs increased by $1.2 million, or 43.2%, to $4.0 million for the six months ended June 30, 2026, compared to $2.8 million for the six months ended June 30, 2025. The increase was primarily due to an increase of $0.8 million in personnel related expenses associated with increased headcount and a $0.4 million increase in product and related software development expenses, including external development services.

Current wording

Research and development costs. Research and development costs increased by $2.1 million, or 48.9%, to $6.5 million for the nine months ended September 30, 2026, compared to $4.4 million for the nine months ended September 30, 2025. The increase was primarily due to an increase of $1.0 million in personnel related expenses associated with increased headcount, a $0.6 million increase in product and related software development expenses, including external development services, and a $0.5 million increase in share-based compensation expense.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $23.9 million, or 85.1%, to $52.1 million for the six months ended June 30, 2026, compared to $28.1 million for the six months ended June 30, 2025. The increase was primarily due to a $15.1 million increase in compensation and benefits and share-based compensation associated with increased headcount, primarily in our commercial organization, and higher commissions related to increased sales of Vivistim Systems. The increase also included $4.2 million in travel, meeting, marketing and branding expenses, including costs associated with our name change, and $2.5 million in audit, legal and other professional fees.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $36.1 million, or 80.3%, to $81.1 million for the nine months ended September 30, 2026, compared to $45.0 million for the nine months ended September 30, 2025. The increase was primarily attributable to a $23.8 million increase in compensation and benefits expense, including $3.0 million of share-based compensation expense, driven by increased headcount, particularly within our commercial organization, and higher sales commissions resulting from increased sales of Vivistim Systems. The increase was also driven by $5.9 million in higher audit, legal and other professional fees and IT-related expenses, as well as $4.0 million in additional travel, meeting, marketing and branding expenses, including costs associated with our corporate name change.

Previous wording

Total other income (expense), net. Total other expense, net was $3.9 million for the six months ended June 30, 2026, compared to total other expense, net of $0.4 million for the six months ended June 30, 2025. The increase was primarily attributable to a $4.9 million loss from changes in the fair value of our Convertible Notes and $0.1 million of higher interest expense, partially offset by $0.9 million of higher interest income resulting from a higher average cash balance and a $0.2 million gain from changes in the value of warrant liabilities.

Current wording

Total other income (expense), net. Total other expense, net was $2.7 million for the nine months ended September 30, 2026, compared to total other expense, net of $0.5 million for the nine months ended September 30, 2025. The increase was primarily attributable to a $4.9 million loss from changes in the fair value of our Convertible Notes, partially offset by $2.2 million of higher interest income resulting from a higher average cash balance.

Previous wording

To date, our primary sources of capital have been private placements of preferred stock, debt financing arrangements, revenue from sales of our Vivistim System, and net proceeds from our IPO in May 2026. As of June 30, 2026, we had cash and cash equivalents of $177.1 million and an accumulated deficit of approximately $196.6 million. During the three months ended March 31, 2026, we issued Convertible Promissory Notes in an aggregate principal amount of $40.0 million. In May 2026, we completed our IPO and received proceeds of approximately $134.0 million.

Current wording

To date, our primary sources of capital have been private placements of preferred stock and convertible promissory notes, debt financing arrangements, revenue from sales of our Vivistim System, and net proceeds from our IPO in May 2026. As of September 30, 2026, we had cash and cash equivalents of $160.7 million and an accumulated deficit of approximately $213.9 million. During the three months ended March 31, 2026, we issued convertible promissory notes in an aggregate principal amount of $40.0 million, which converted into shares of our common stock in connection with the IPO. In May 2026, we completed our IPO and received net proceeds of approximately $134.0 million.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025:

Previous wording

Net cash used in operating activities was $33.4 million for the six months ended June 30, 2026, compared to $20.7 million for the six months ended June 30, 2025. Net cash used in operating activities for the six months ended June 30, 2026 was primarily due to our net loss of $38.8 million, as well as increases in accounts receivable, inventory, and other assets of $1.2 million, $1.5 million, and $1.0 million, respectively. These uses of cash were partially offset by non-cash adjustments for the change in fair value of convertible notes payable of $4.9 million and share-based compensation of $2.0 million, as well as increases in accounts payable and accrued liabilities and other of $2.1 million. Net cash used for the six months ended June 30, 2025 was primarily due to our net loss of $21.1 million and increases in inventory of $1.1 million, partially offset by non-cash adjustments for share-based compensation of $0.6 million, as well as other changes in operating assets and liabilities.

Current wording

Net cash used in operating activities was $46.3 million for the nine months ended September 30, 2026, compared to $32.3 million for the nine months ended September 30, 2025. Net cash used in operating activities for the nine months ended September 30, 2026 was primarily due to our net loss of $56.1 million, as well as increases in inventory, accounts receivable, and other assets of $2.9 million, $2.6 million, and $0.7 million, respectively. These uses of cash were partially offset by non-cash adjustments for the change in fair value of convertible notes payable of $4.9 million and share-based compensation of $4.6 million, as well as increases in accounts payable and accrued liabilities and other of $6.2 million. Net cash used for the nine months ended September 30, 2025 was primarily due to our net loss of $32.6 million and increases in accounts receivable and inventory of $1.8 million and $1.5 million, respectively, partially offset by non-cash adjustments for share-based compensation of $1.0 million, as well as increases in accounts payable and accrued liabilities and other of $2.3 million.

Previous wording

Net cash used in investing activities was $1.6 million for the six months ended June 30, 2026, compared to $23.0 thousand for the six months ended June 30, 2025. Net cash used in investing activities in each case consisted of purchases of property and equipment.

Current wording

Net cash used in investing activities was $1.6 million for the nine months ended September 30, 2026, compared to $0.3 million for the nine months ended September 30, 2025. Net cash used in investing activities in each case consisted of purchases of property and equipment.

Previous wording

Net cash provided by financing activities was $178.5 million for the six months ended June 30, 2026, attributable primarily to $139.5 million in proceeds from the issuance of common stock in our initial public offering, net of underwriting discounts and commissions, $40.0 million in aggregate proceeds from the issuance of Convertible Notes, including $25.9 million from related parties, $0.5 million received upon the exercise of common stock options, and $0.4 million received upon the cash exercise of redeemable convertible preferred stock warrants. The proceeds were offset by the payments of $2.0 million of deferred offering costs.

Current wording

Net cash provided by financing activities was $175.1 million for the nine months ended September 30, 2026, attributable primarily to $134.0 million in proceeds from the issuance of common stock in our initial public offering, net of underwriting discounts and commissions and offering costs, $40.0 million in aggregate proceeds from the issuance of Convertible Notes, including $25.9 million from related parties, $0.7 million received upon the exercise of common stock options, and $0.4 million received upon the cash exercise of redeemable convertible preferred stock warrants.

Previous wording

Net cash provided by financing activities was $32.4 million for the six months ended June 30, 2025, attributable primarily to $29.6 million in net proceeds from the issuance of Series F redeemable convertible preferred stock, $2.6 million in net proceeds from the related party issuance of Series F redeemable convertible preferred stock, and $0.2 million received upon the exercise of common stock options.

Current wording

Net cash provided by financing activities was $32.5 million for the nine months ended September 30, 2025, attributable primarily to $29.6 million in net proceeds from the issuance of Series F redeemable convertible preferred stock, $2.6 million in net proceeds from the related party issuance of Series F redeemable convertible preferred stock, and $0.3 million received upon the exercise of common stock options.

Previous wording

Pursuant to the Loan and Security Agreement, we are required to issue a warrant to purchase shares of our securities in the event that we draw down a tranche following satisfaction of the applicable conditions. In connection with our draw down of the first tranche under the Loan and Security Agreement, we issued first tranche warrants to purchase such number of securities representing an aggregate of $262,500 to Horizon. The first tranche warrants are exercisable, at the election of Horizon, for (i) shares of Series E-2 redeemable convertible preferred stock at an exercise price of $2.5443 per share or (ii) shares of Series F redeemable convertible preferred stock at an exercise price of $2.6317 per share, and expire ten years from the date of issuance.

Current wording

Pursuant to the Loan and Security Agreement, we are required to issue a warrant to purchase shares of our securities in the event that we draw down a tranche following satisfaction of the applicable conditions. In connection with our draw down of the first tranche under the Loan and Security Agreement, we issued first tranche warrants to purchase such number of securities representing an aggregate of $262,500 to Horizon. The first tranche warrants are exercisable, at the election of Horizon, for (i) shares of Series E-2 redeemable convertible preferred stock at an exercise price of $2.5443 per share or (ii) shares of Series F redeemable convertible preferred stock at an exercise price of $2.6317 per share, and expire ten years from the date of issuance. The warrants allow for settlement in shares and are transferable at the holder’s discretion. The value of the warrants is capped at $2.5443 per share, a total of $262,500, but the number of shares is not limited. Immediately prior to the completion of the IPO, the warrants automatically converted into warrants to purchase 29,620 shares of common stock with an average exercise price of $8.8618 per share. As of September 30, 2026, these warrants remain outstanding.

Previous wording

We are required to make a final payment of $131,250 for each loan funded on the earlier of (i) the date that we prepay all of the outstanding principal of such loan, (ii) the date of acceleration of the balance of such loan by the Lender, and (iii) the maturity.

Current wording

We are required to make a final payment of $131,250 for each loan funded on the earliest of (i) the date that we prepay all of the outstanding principal of such loan, (ii) the date of acceleration of the balance of such loan by Horizon, and (iii) the maturity date.

Previous wording

We rely on third-party contract manufacturers and suppliers and enter into purchase commitments in the ordinary course of business. These arrangements are generally executed through purchase orders and, in certain cases, include non-cancelable purchase commitments and binding forecast obligations. As of June 30, 2026, we had approximately $9.3 million of outstanding non-cancelable purchase commitments expected to be fulfilled within the next twelve months. For additional information, see Note 13 –Commitments and Contingencies to our condensed financial statements included in this Quarterly Report.

Current wording

We rely on third-party contract manufacturers and suppliers and enter into purchase commitments in the ordinary course of business. These arrangements are generally executed through purchase orders and, in certain cases, include non-cancelable purchase commitments and binding forecast obligations. As of September 30, 2026, we had approximately $16.8 million of outstanding non-cancelable purchase commitments expected to be fulfilled within the next twelve months. For additional information, see Note 13 –Commitments and Contingencies to our condensed financial statements included in this Quarterly Report.

Previous wording

The preparation of our financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires us to make estimates and judgments that affect the amounts reported in the financial statements and related notes thereto. Critical accounting estimates are those estimates that, in accordance with GAAP, involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial statements. Management has determined that our most critical accounting estimates are those relating to share-based compensation. Although we believe that the estimates we use are reasonable, due to the inherent uncertainty involved in making these estimates, actual results reported in future periods could differ materially from those estimates. For further discussion about our accounting policies, see Note 3 to our condensed financial statements included in this Quarterly Report and the section titled “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” in our prospectus dated May 7, 2026. There have been no significant or material changes in our critical accounting policies since December 31, 2025, except that, following our IPO, the fair value of our common stock is based on its publicly quoted market price and is no longer determined using valuation methodologies applicable to a privately held company.

Current wording

The preparation of our financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires us to make estimates and judgments that affect the amounts reported in the financial statements and related notes thereto. Critical accounting estimates are those estimates that, in accordance with GAAP, involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial statements. Management has determined that our most critical accounting estimates are those relating to share-based compensation. Although we believe that the estimates we use are reasonable, due to the inherent uncertainty involved in making these estimates, actual results reported in future periods could differ materially from those estimates. For further discussion about our accounting policies, see Note 3 to our condensed financial statements included in this Quarterly Report and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our prospectus dated May 7, 2026. There have been no material changes in our critical accounting policies since December 31, 2025, except that, following our IPO, the fair value of our common stock is based on its publicly quoted market price and is no longer determined using valuation methodologies applicable to a privately held company.

Previous wording

The JOBS Act permits EGCs such as us to take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an EGC to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for any other new or revised accounting standards during the period in which we remain an EGC; however, we may adopt certain new or revised accounting standards early. As a result, we will not be subject to the same new or revised accounting standards as other public companies that are not EGCs and our financial statements may not be comparable to other public companies that comply with new or revised accounting pronouncements as of public company effective dates.

Current wording

The JOBS Act permits EGCs such as us to take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an EGC to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for new or revised accounting standards during the period in which we remain an EGC; however, we may adopt certain new or revised accounting standards early. As a result, we will not be subject to the same new or revised accounting standards as other public companies that are not EGCs and our financial statements may not be comparable to other public companies that comply with new or revised accounting pronouncements as of public company effective dates.