What changed in this filing

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Item 1. Financial Statements

2025-08-05 compared with 2025-05-09 · 81 added, 57 removed, 316 unchanged (30% of the section changed)

21 unchanged sentences

Stockholders’ equity:

Common stock, $ 0.01 par value, 200,000,000 authorized as of March 31, 2025 and December 31, 2024;

26,051,992 and 25,324,684 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

Common stock, $ 0.01 par value, 200,000,000 authorized as of June 30, 2025 and December 31, 2024;

26,145,951 and 25,324,684 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

7 unchanged sentences

Three months ended

Six months ended

Cost of goods sold

17 unchanged sentences

stockholders’

Balances as of March 31, 2024

Exercise of stock options

Proceeds from Employee Stock Purchase Plan

Employee stock compensation

Net loss for the three months ended June 30, 2025

Cumulative translation adjustment

Balances as of June 30, 2025

Balances as of March 31, 2023

Exercise of stock options

Proceeds from Employee Stock Purchase Plan

Employee stock compensation

Issuance of common stock

Net loss for the three months ended June 30, 2024

Balances as of June 30, 2024

comprehensive

stockholders’

Balances as of December 31, 2024

Exercise of stock options

Proceeds from Employee Stock Purchase Plan

Employee stock compensation

Issuance of common stock

Net loss for the three months ended March 31, 2025

Net loss for the six months ended June 30, 2025

Cumulative translation adjustment

Balances as of March 31, 2025

Balances as of June 30, 2025

Balances as of December 31, 2023

Exercise of stock options

Proceeds from Employee Stock Purchase Plan

Employee stock compensation

1 unchanged sentence

Issuance of common stock upon net exercise of common warrants

Net loss for the three months ended March 31, 2024

Net loss for the six months ended June 30, 2024

Cumulative translation adjustment

Balances as of March 31, 2024

Balances as of June 30, 2024

The accompanying notes are an integral part of these condensed consolidated financial statements.

1 unchanged sentence

(In thousands)

Three months ended

Six months ended

Cash flows from operating activities:

14 unchanged sentences

Proceeds from the exercise of common stock options

Proceeds from Employee Stock Purchase Plan

Proceeds from the issuance of common stock

34 unchanged sentences

Cash and cash equivalents include highly liquid investments with an original maturity of three months or less.

As of March 31, 2025 and December 31, 2024, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value.

Additionally, as of March 31, 2025 and December 31, 2024, a majority of our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits.

As of June 30, 2025 and December 31, 2024, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value.

Additionally, as of June 30, 2025 and December 31, 2024, a majority of our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits.

Accounts Receivable

4 unchanged sentences

Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis.

We regularly review inventory quantities in consideration of actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate.

We regularly review inventory quantities based on actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate.

Operating leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses, and operating lease liability – non-current portion in our balance sheets.

44 unchanged sentences

Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or the term of the lease.

Depreciation expense was $ 184,000 and $ 131,000 for the three months ended March 31, 2025 and 2024, respectively.

Depreciation expense was $ 193,000 and $ 141,000 for the three months ended June 30, 2025 and 2024, respectively, and $ 377,000 and $ 272,000 for the six months ended June 30, 2025 and 2024, respectively.

Accrued expenses consist of the following at:

2 unchanged sentences

Accrued interest payable

Employee stock purchase plan

Operating lease liability, current portion

3 unchanged sentences

On October 31, 2022, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Innovatus Life Sciences Fund I, LP, as the collateral agent and a lender, allowing us to borrow, subject to our achievement of certain milestones, up to a total of $ 50.0 million in a series of term loans (collectively, the “Term Loans”).

W e had $ 50.0 million in outstanding Term Loans under the Loan Agreement as of March 31, 2025.

W e had $ 50.0 million in outstanding Term Loans under the Loan Agreement as of June 30, 2025.

The Loan Agreement initially requires interest only payments through November 2027, followed by three monthly principal and interest payments, of which a principal payment of $ 16.7 million is due in December 2027 and two principal payments of $ 16.7 million each are due in January 2028.

A final payment of $ 2.3 million, equal to 4.5 % of the original borrowed principal, is due in January 2028.

The Term Loans bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 5.50 % plus (b) 2.65 %.

A final payment of $ 2.3 million, equal to 4.5 % of the funded amount, is due in January 2028.

The Term Loans bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 5.50 %;

plus (b) 2.65 %.

The Term Loans are secured by substantially all of our personal property.

1 unchanged sentence

The Loan Agreement requires the payment of certain penalties if the Term Loans are paid off prior to maturity for any reason, including pursuant to an acceleration clause, and includes various restrictive covenants, including a restriction on the payment of dividends or making other distributions or payments on our capital stock, subject to limited exceptions.

We were in compliance with these covenants as of March 31, 2025.

We were in compliance with these covenants as of June 30, 2025.

In connection with the Loan Agreement, we recorded $ 1.1 million of debt issuance costs and discounts as a reduction of long-term debt.

4 unchanged sentences

We lease 35,183 square feet of office space in Minneapolis, Minnesota, which houses our principal executive offices and our manufacturing facility.

We lease this space under an operating lease agreement that commenced December 1, 2008.

On April 21, 2023, we extended the operating lease for our office space in Minneapolis, Minnesota for an additional 49 consecutive months through August 31, 2028.

On November 7, 2023, we expanded our existing office space with the addition of 7,615 square feet of property adjacent to our principal executive offices and our manufacturing facility.

The term on this expanded property is for 57 consecutive months that will run concurrently with the term on the existing lease.

We lease this space under an operating lease agreement that commenced December 1, 2008, which has been amended to expand the leased space and extend the term of the lease, which expires August 31, 2028.

Most recently, on May 20, 2025, we expanded our existing office space with an additional 3,678 square feet of property adjacent to our principal executive offices and our manufacturing facility.

The term on this expanded property is for 39 consecutive months and runs concurrently with the term on the existing lease.

We intend to add new facilities as we grow, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

11 unchanged sentences

Total operating lease liabilities

Maturities of our lease liability for our operating lease are as follows as of March 31, 2025:

Maturities of our lease liability for our operating lease are as follows as of June 30, 2025:

(in thousands)

2 unchanged sentences

Present value of lease liability

As of March 31, 2025, the remaining lease term was 3.4 years, and the weighted average discount rate was 6.7 %.

The operating cash outflows from our operating lease were $ 0.1 million for each of the three months ended March 31, 2025 and 2024.

As of June 30, 2025, the remaining lease term was 3.2 years, and the weighted average discount rate was 7.1 %.

The operating cash outflows from our operating lease were $ 0.3 million for each of the six months ended June 30, 2025 and 2024.

Stockholders’ equity

Common Stock Warrants

We had common stock warrants exercisable for 103,349 shares of common stock upon conversion at a weighted average exercise price of $ 12.92 per share and 716,131 shares of common stock upon conversion at a weighted average exercise price of $ 2.39 per share outstanding at March 31, 2025 and December 31, 2024, respectively.

We had common stock warrants exercisable for 103,349 shares of common stock upon conversion at a weighted average exercise price of $ 12.92 per share outstanding at June 30, 2025 and December 31, 2024.

Johnson & Johnson Innovation – JJDC, Inc.

had common stock warrants exercisable for

607,725 shares of our common stock with an exercise price of $ 0.16 per share that were all exercised through a net exercise transaction for 604,000 shares of common stock during the three months ended March 31, 2024.

had common stock warrants exercisable for 607,725 shares of our common stock with an exercise price of $ 0.16 per share that were all exercised through a net exercise transaction for 604,000 shares of common stock during the six months ended June 30, 2024.

At-the-Market (“ATM”) Offering

In January 2024, we commenced an ATM offering, which allows us to issue and sell shares of our common stock having an aggregate offering price of up to $ 50.0 million .

We issued 543,462 shares of common stock for gross proceeds of $ 9.5 million under the ATM offering during the three months ended March 31, 2025.

We issued 543,462 shares of common stock for gross proceeds of $ 9.5 million under the ATM offering during the six months ended June 30, 2025.

We have remaining capacity to issue and sell up to approximately $ 6.7 million of additional shares of common stock under this ATM offering.

11 unchanged sentences

No further awards can be made under the 2001 Plan following the adoption of the 2021 Plan.

As of March 31, 2025, there were 1,454,590 shares available for future issuance under the 2021 Plan.

As of June 30, 2025, there were 1,392,926 shares available for future issuance under the 2021 Plan.

Stock Options

6 unchanged sentences

Cancelled / Forfeited

Balance as of March 31, 2025

Options exercisable as of March 31, 2025

As of March 31, 2025, stock options outstanding included 4,402 options that were not granted under the 2001 Plan or the 2021 Plan.

For options outstanding as of March 31, 2025, the weighted average remaining contractual life was 7.2 years.

For options exercisable as of March 31, 2025, the weighted average remaining contractual life was 5.7 years.

As of March 31, 2025, unrecognized compensation expense related to unvested stock-based compensation arrangements for stock options was $ 25.9 million.

As of March 31, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 2.8 years.

Balance as of June 30, 2025

Options exercisable as of June 30, 2025

As of June 30, 2025, stock options outstanding included 4,402 options that were not granted under the 2001 Plan or the 2021 Plan.

For options outstanding as of June 30, 2025, the weighted average remaining contractual life was 7.0 years.

For options exercisable as of June 30, 2025, the weighted average remaining contractual life was 5.6 years.

As of June 30, 2025, unrecognized compensation expense related to unvested stock-based compensation arrangements for stock options was $ 23.2 million.

As of June 30, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 2.7 years.

Restricted Stock Units

5 unchanged sentences

Cancelled / Forfeited

Unvested Balance as of March 31, 2025

Unvested Balance as of June 30, 2025

The aggregate intrinsic value of unvested RSUs is based on our closing stock price on the last trading day of the period.

No RSUs were vested as of March 31, 2025.

As of March 31, 2025, the unrecognized compensation expense related to unvested stock-based compensation arrangements for RSUs was $ 4.2 million.

As of March 31, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 3.9 years.

No RSUs were vested as of June 30, 2025.

As of June 30, 2025, the unrecognized compensation expense related to unvested stock-based compensation arrangements for RSUs was $ 4.0 million.

As of June 30, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 3.7 years.

Employee Stock Purchase Plan

6 unchanged sentences

employees to purchase shares of our common stock at a price per share not less than 85 % of the lower of (i) the closing market price per share of our common stock on the first day of the applicable purchase period or (ii) the closing market price per share of our common stock on the purchase date at the end of the applicable six-month purchase period.

For the three months ended March 31, 2025, there were no shares of common stock purchased under the ESPP.

As of March 31, 2025, there were 886,053 shares available for issuance under the ESPP.

For the six months ended June 30, 2025, 71,942 shares of common stock were purchased under the ESPP for $ 0.4 million of employee contributions.

As of June 30, 2025, there were 814,111 shares available for issuance under the ESPP.

Stock-based compensation expense

5 unchanged sentences

We account for forfeitures as they occur.

The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the Black-Scholes option pricing model for the three months ended March 31, 2025 and 2024:

The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the Black-Scholes option pricing model for the six months ended June 30, 2025 and 2024:

Weighted average fair value of options granted

8 unchanged sentences

3.95 % to 4.71

The following table provides the weighted average fair value of ESPP purchase rights and the related assumptions used in the Black-Scholes option pricing model for the three months ended March 31, 2025 and 2024:

The following table provides the weighted average fair value of ESPP purchase rights and the related assumptions used in the Black-Scholes option pricing model for the six months ended June 30, 2025 and 2024:

Weighted average fair value per ESPP purchase right

7 unchanged sentences

The expected dividend yield is assumed to be zero , as we have never paid dividends and have no current plans to do so.

The risk-free interest rate is based on the yield on U.S.

The risk-free interest rate is based

on the yield on U.S.

Treasury securities for a period approximating the expected term of the options being valued.

1 unchanged sentence

Three months ended

Six months ended

(in thousands)

Stock options

Employee Stock Purchase Plan

Restricted Stock

Total stock-based compensation expense

5 unchanged sentences

Additionally, the option agreements were modified so that the options may be exercised, to the extent vested, by our former Chief Executive Officer until the earlier of (a) five years following his retirement date, or (b) the applicable option expiration date.

The modification of these option awards resulted in an additional $ 8.4 million of non-cash stock-based compensation expense recognized during the three months ended March 31, 2024.

As of March 31, 2025 and December 31, 2024, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position.

Benefit for income taxes for the three months ended March 31, 2025 was $ 5,000 and provision for income taxes for the three months ended March 31, 2024 was $ 38,000 .

The modification of these option awards resulted in an additional $ 8.4 million of non-cash stock-based compensation expense recognized during the six months ended June 30, 2024.

As of June 30, 2025 and December 31, 2024, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position.

Benefit for income taxes for the three months ended June 30, 2025 was $ 3,000 and provision for income taxes for the three months ended June 30, 2024 was $ 41,000 .

Benefit for income taxes for the six months ended June 30, 2025 was $ 8,000 and provision for income taxes for the six months ended June 30, 2024 was $ 79,000 .

As of December 31, 2024, we had federal and state net operating loss carryforwards (“NOLs”) of approximately $ 429.7 million and $ 8.1 million, respectively.

5 unchanged sentences

Such a change of ownership would limit our utilization of the NOLs and could be triggered by subsequent sales of securities by us or our stockholders.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S.

The OBBBA includes significant tax-related provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions, including the capitalization of certain R&D costs.

The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.

are currently evaluating the potential impact of the OBBBA on our consolidated financial statements and related disclosures.

Loss Per Share

1 unchanged sentence

Three months ended

Six months ended

Weighted average common shares outstanding — basic and diluted

Net loss per share attributable to common stockholders — basic and diluted

Our potentially dilutive securities, which include stock options, restricted stock units, and warrants to purchase shares of common stock, have been excluded from the computation of diluted net loss per share attributable to common stockholders, as the effect would be to reduce the net loss per share attributable to common stockholders.

Our potentially dilutive securities, which include stock options, RSUs, and warrants to purchase shares of common stock, have been excluded from the computation of diluted net loss per share attributable to common stockholders, as the effect would be to reduce the net loss per share attributable to common stockholders.

Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.

We excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

Three months ended

Restricted stock units

Six months ended

Commitments and contingencies

1 unchanged sentence

We accrue a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated.

There have been no contingent liabilities requiring accrual or disclosure as of March 31, 2025 or December 31, 2024.

There have been no contingent liabilities requiring accrual or disclosure as of June 30, 2025 or December 31, 2024.

Employee benefit plans

3 unchanged sentences

Beginning January 1, 2024, we adopted a policy to match a portion of employee contributions for all qualified employees participating in the 401(k) plan.

We recorded an expense for matching contributions of $ 0.3 million and $ 0.2 million for the three months ended March 31, 2025 and 2024, respectively.

We recorded an expense for matching contributions of $ 0.3 million for each of the three months ended June 30, 2025 and 2024.

We recorded an expense for matching contributions of $ 0.6 million for each of the six months ended June 30, 2025 and 2024.

Segment, geographic information, and revenue disaggregation

2 unchanged sentences

Our chief operating decision maker is our Chief Executive Officer.

Our Chief Executive Officer evaluates performance based primarily on

revenue in the geographic locations in which the Company operates and consolidated net loss.

Our Chief Executive Officer evaluates performance based primarily on revenue in the geographic locations in which the Company operates and consolidated net loss.

The Chief Executive Officer reviews financial information presented on a consolidated basis, including consolidated net loss, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance.

3 unchanged sentences

Three months ended

Six months ended

Other countries

As of March 31, 2025 and December 31, 2024, substantially all our long-lived assets were located in the U.S.

As of June 30, 2025 and December 31, 2024, substantially all our long-lived assets were located in the U.S.

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

What changed 10-Q

Item 1. Financial Statements