What changed in this filing

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Item 1. Financial Statements

2025-11-06 compared with 2025-08-05 · 91 added, 64 removed, 333 unchanged (32% of the section changed)

2 unchanged sentences

(In thousands, except share and per share data)

September 30,

Current assets:

17 unchanged sentences

Stockholders’ equity:

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

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

26,193,733 and 25,324,684 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

7 unchanged sentences

Three months ended

Six months ended

Nine months ended

September 30,

Cost of goods sold

17 unchanged sentences

stockholders’

Balances as of March 31, 2024

Balances as of June 30, 2025

Exercise of stock options

Proceeds from Employee Stock Purchase Plan

Employee stock compensation

Net loss for the three months ended June 30, 2025

Issuance of common stock

Net loss for the three months ended September 30, 2025

Cumulative translation adjustment

Balances as of September 30, 2025

Balances as of June 30, 2024

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

Net loss for the three months ended September 30, 2024

Cumulative translation adjustment

Balances as of September 30, 2024

comprehensive

5 unchanged sentences

Issuance of common stock

Net loss for the six months ended June 30, 2025

Net loss for the nine months ended September 30, 2025

Cumulative translation adjustment

Balances as of June 30, 2025

Balances as of September 30, 2025

Balances as of December 31, 2023

4 unchanged sentences

Issuance of common stock upon net exercise of common warrants

Net loss for the six months ended June 30, 2024

Net loss for the nine months ended September 30, 2024

Cumulative translation adjustment

Balances as of June 30, 2024

Balances as of September 30, 2024

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

1 unchanged sentence

(In thousands)

Six months ended

Nine months ended

September 30,

Cash flows from operating activities:

16 unchanged sentences

Proceeds from the issuance of common stock

Proceeds from debt financing

Debt financing costs

Net cash provided by financing activities

33 unchanged sentences

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

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.

As of September 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 September 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

38 unchanged sentences

Inventory consists of the following at:

September 30,

(in thousands)

2 unchanged sentences

Property and equipment, net consists of the following at:

September 30,

(in thousands)

7 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 $ 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.

Depreciation expense was $ 194,000 and $ 169,000 for the three months ended September 30, 2025 and 2024, respectively, and $ 571,000 and $ 441,000 for the nine months ended September 30, 2025 and 2024, respectively.

Accrued expenses consist of the following at:

September 30,

(in thousands)

Paid time off

Customer rebates

Accrued interest payable

Operating lease liability, current portion

Customer rebates

Employee stock purchase plan

Clinical trial and other professional fees

1 unchanged sentence

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 June 30, 2025.

W e had $ 50.0 million in outstanding Term Loans under the Loan Agreement as of September 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.

5 unchanged sentences

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 June 30, 2025.

We were in compliance with these covenants as of September 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.

The annual principal maturities of debt under the Loan Agreement are as follows:

September 30,

(in thousands)

11 unchanged sentences

The following table presents the lease balances within the condensed consolidated balance sheets:

September 30,

(in thousands)

5 unchanged sentences

Total operating lease liabilities

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

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

September 30,

(in thousands)

2 unchanged sentences

Present value of lease liability

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.

As of September 30, 2025, the remaining lease term was 2.9 years, and the weighted average discount rate was 7.1 %.

The operating cash outflows from our operating lease were $ 0.5 million and $ 0.4 million for the nine months ended September 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 outstanding at June 30, 2025 and December 31, 2024.

We had common stock warrants exercisable for 102,718 shares of common stock upon conversion at a weighted average exercise price of $ 12.66 per share outstanding and 103,349 shares of common stock upon conversion at a weighted average exercise price of $ 12.92 per share outstanding at September 30, 2025 and December 31, 2024, respectively.

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 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 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.

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

On November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025.

In connection with the filing of this Quarterly Report on Form 10-Q, we expect to file a new registration statement on Form S-3 to replace our existing registration statement on Form S-3 that is scheduled to expire on November 15, 2025 and subsequently enter into a new sales agreement to permit continued ATM offering activity in the future.

Stock-based compensation

9 unchanged sentences

Awards granted under the 2021 Plan will have such vesting schedules and other terms as determined by the Compensation Committee and stock options and stock appreciation rights have a maximum term of 10 years from the grant date.

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

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

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

As of September 30, 2025, there were 1,407,814 shares available for future issuance under the 2021 Plan.

Stock Options

Options are granted at exercise prices not less than the fair market value (as determined by the Board of Directors) of our common stock on the date of grant.

During the years 2008 through the initial public offering (the “IPO”), the Board of Directors authorized the grant of stock options for the purchase of shares of common stock to the employers of certain non-employee directors.

Options are granted at exercise prices not less than the fair market value of our common stock on the date of grant.

Prior to our initial public offering (the “IPO”), the fair market value of our common stock was determined

by our Board of Directors, and following our IPO, the fair market value of our common stock is based on the closing price of our common stock on the date of grant.

During the years 2008 through the IPO, the Board of Directors authorized the grant of stock options for the purchase of shares of common stock to the employers of certain non-employee directors.

The options were not granted under the 2001 Plan or the 2021 Plan, but terms are substantially the same as our standard form of option agreement for non-employee directors as they have an exercise price not less than the fair market value on the grant date and vest over 48 months from the date of grant.

3 unchanged sentences

Cancelled / Forfeited

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.

Balance as of September 30, 2025

Options exercisable as of September 30, 2025

As of September 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 September 30, 2025, the weighted average remaining contractual life was 6.8 years.

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

As of September 30, 2025, unrecognized compensation expense related to unvested stock-based compensation arrangements for stock options was $ 20.8 million.

As of September 30, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 2.6 years.

Restricted Stock Units

5 unchanged sentences

Cancelled / Forfeited

Unvested Balance as of June 30, 2025

Unvested Balance as of September 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 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.

No RSUs were vested as of September 30, 2025.

As of September 30, 2025, the unrecognized compensation expense related to unvested stock-based compensation arrangements for RSUs was $ 3.8

As of September 30, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 3.4 years.

Employee Stock Purchase Plan

1 unchanged sentence

The number of shares of common stock initially reserved for issuance under the ESPP was 278,170 .

The shares available for issuance under the ESPP automatically increase on the first day of each year, commencing January 1, 2022, and ending on (and including) January 1, 2031, in an amount equal to 1 % of the total number of shares of our common stock outstanding on the last day of the calendar month before the

date of each automatic increase, or such lesser number of shares as determined by the Board of Directors.

The annual increase resulted in an additional 253,246 shares being reserved for issuance under the ESPP as of January 1, 2025.

1 unchanged sentence

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 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.

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

As of September 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 six months ended June 30, 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 nine months ended September 30, 2025 and 2024:

September 30,

Weighted average fair value of options granted

8 unchanged sentences

3.67 % 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 six months ended June 30, 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 nine months ended September 30, 2025 and 2024:

September 30,

Weighted average fair value per ESPP purchase right

1 unchanged sentence

Expected volatility

112.3 % to 133.4

74.0 % to 96.9

Expected dividend yield

Risk-free interest rate

4.25 % to 4.29

5.24 % to 5.37

We review these assumptions on a periodic basis and adjust them, as necessary.

2 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

Nine months ended

September 30,

(in thousands)

7 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 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 .

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

As of September 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 September 30, 2025 was $ 3,000 and provision for income taxes for the three months ended September 30, 2024 was $ 47,000 .

Benefit for income taxes for the nine months ended September 30, 2025 was $ 11,000 and provision for income taxes for the nine months ended September 30, 2024 was $ 126,000 .

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.

8 unchanged sentences

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.

We 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

Nine months ended

September 30,

Weighted average common shares outstanding — basic and diluted

3 unchanged sentences

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:

Six months ended

Nine months ended

September 30,

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 June 30, 2025 or December 31, 2024.

There have been no contingent liabilities requiring accrual or disclosure as of September 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 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.

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

We recorded an expense for matching contributions of $ 0.9 million for each of the nine months ended September 30, 2025 and 2024.

Segment, geographic information, and revenue disaggregation

8 unchanged sentences

Three months ended

Six months ended

Nine months ended

September 30,

Other countries

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

As of September 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