What changed in this filing

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Item 1. Financial Statements

2025-11-13 compared with 2025-08-14 · 174 added, 103 removed, 741 unchanged (27% of the section changed)

2 unchanged sentences

Condensed Consolidated Balance Sheets

September 30,

2025 December 31,

32 unchanged sentences

Preferred stock, $ 0.0001 par value;

10,000,000 shares authorized at June 30, 2025 and December 31, 2024;

no shares issued and outstanding at June 30, 2025 and December 31, 2024

Common stock, $ 0.0001 par value, 400,000,000 shares authorized at June 30, 2025 and December 31, 2024;

3,909,400 and 1,865,400 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively

10,000,000 shares authorized at September 30, 2025 and December 31, 2024;

no shares issued and outstanding at September 30, 2025 and December 31, 2024

Common stock, $ 0.0001 par value, 400,000,000 shares authorized at September 30, 2025 and December 31, 2024;

9,730,400 and 1,865,400 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital 761,479,000 728,573,000

Accumulated deficit ( 711,687,000 ) ( 693,225,000 )

Accumulated other comprehensive income (loss)

( 10,000 ) 27,000

Accumulated other comprehensive income

Total stockholders’ equity $ 49,799,000 $ 35,375,000

4 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2025 2024 2025 2024

30 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2025 2024 2025 2024

3 unchanged sentences

1,000 10,000 ( 2,000 ) 12,000

Change in fair value attributable to instrument-specific credit risk

— 1,503,000 — 1,503,000

Foreign currency translation adjustments 15,000 24,000 ( 19,000 ) ( 4,000 )

27 unchanged sentences

1,179,600 $ — $ 709,192,000 $ ( 628,854,000 ) $ ( 3,000 ) $ 80,335,000

Stock-based compensation expense — — 2,202,000 — — 2,202,000

Issue common stock, net of issuance costs 197,800 — 9,034,000 — — 9,034,000

Issue stock for warrant exercises 96,900 — 2,000 — — 2,000

Issuance of common stock due to the vesting of restricted stock units, net of shares withheld to cover taxes 200 — — — — —

Net loss — — — ( 44,246,000 ) — ( 44,246,000 )

Other comprehensive income

— — — — 1,537,000 1,537,000

Balance at September 30, 2024

1,474,500 $ — $ 720,430,000 $ ( 673,100,000 ) $ 1,534,000 $ 48,864,000

Balance at January 1, 2025

20 unchanged sentences

3,909,400 $ — $ 748,568,000 $ ( 703,184,000 ) $ ( 10,000 ) $ 45,374,000

Stock-based compensation expense — — 941,000 — — 941,000

Issue common stock, net of issuance costs 5,771,000 1,000 11,970,000 — — 11,971,000

Issue stock for warrant exercises 50,000 — — — — —

Net loss — — — ( 8,503,000 ) — ( 8,503,000 )

Other comprehensive income

— — — — 16,000 16,000

Balance at September 30, 2025

9,730,400 $ 1,000 $ 761,479,000 $ ( 711,687,000 ) $ 6,000 $ 49,799,000

See accompanying notes to the unaudited condensed consolidated financial statements.

1 unchanged sentence

Condensed Consolidated Statements of Cash Flows

Six Months Ended

Nine Months Ended

September 30,

Operating activities:

2 unchanged sentences

Depreciation and amortization expense 7,190,000 11,624,000

Inventory write-offs

Amortization of financing lease right-of-use asset 153,000 153,000

12 unchanged sentences

Gain on High Trail extinguishment — ( 3,965,000 )

Disposal of internal-use software

Intangible assets and other long-lived assets impairment

Loss on ROU asset impairment

Disposal of property and equipment

31 unchanged sentences

— ( 1,444,000 )

Payments of retirement fees for redemption of High Trail Notes

— ( 5,375,000 )

Net cash provided by/(used in) financing activities

1 unchanged sentence

Effect of exchange rates on cash, cash equivalents and restricted cash ( 18,000 ) ( 3,000 )

Net increase (decrease) in cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

( 6,508,000 ) ( 9,154,000 )

43 unchanged sentences

The Company has experienced recurring net losses from operations and negative cash flows from operating activities since its inception, has a significant accumulated deficit and expects to continue to incur net losses into the foreseeable future.

As of June 30, 2025, the Company had approximately $ 3.6 million in cash and cash equivalents, $ 12.9 million in short-term investments, $ 11.0 million in restricted short-term investments and working capital of $ 18.5 million.

As of September 30, 2025, the Company had approximately $ 3.1 million in cash and cash equivalents, $ 18.5 million in short-term investments, $ 10.3 million in restricted short-term investments and working capital of $ 25.8 million.

The amount the Company is required to hold as restricted cash or investments is equal to the lesser of (a) $ 11.0 million and (b) the then outstanding principal balance of the Debentures (as defined in Note 5 (Debt) in these notes accompanying the unaudited condensed consolidated financial statements).

As of June 30, 2025, the Company had $ 12.1 million of principal outstanding under the Debentures (see Note 5 (Debt) to our unaudited condensed consolidated financial statements) and an accumulated deficit of $ 703.2 million.

During the six months ended June 30, 2025, the Company used $ 6.3 million of cash in operations.

As of September 30, 2025, the Company had $ 10.3 million of principal outstanding under the Debentures (see Note 5 (Debt) to our unaudited condensed consolidated financial statements) and an accumulated deficit of $ 711.7 million.

During the nine months ended September 30, 2025, the Company used $ 12.2 million of cash in operations.

Management expects operating losses and negative cash flows to continue for at least the next year as the Company continues to incur costs related to product development and commercialization efforts.

Management has prepared cash flows forecasts which indicate that based on the Company’s expected operating losses and negative cash flows, there is substantial doubt about the Company’s ability to continue as a going concern within 12 months after the date that the unaudited condensed consolidated financial statements for the six months ended June 30, 2025, are issued.

Management’s ability to continue as a going concern is dependent upon its ability to raise additional funding.

Management’s plans to raise additional capital to fulfill its operating and capital requirements for at least 12 months include public or private equity or debt financings.

However, the Company may not

be able to secure such financing in a timely manner or on favorable terms, if at all, and if the Company is unable to raise sufficient additional capital in the very near term, it may need to further curtail or cease operations and seek protection by filing a voluntary petition for relief under the United States Bankruptcy Code.

Company may not be able to secure such financing in a timely manner or on favorable terms, if at all, and if the Company is unable to raise sufficient additional capital in the very near term, it may need to further curtail or cease operations and seek protection by filing a voluntary petition for relief under the United States Bankruptcy Code.

Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders.

1 unchanged sentence

Significant Accounting Policies

During the three and six months ended June 30, 2025, there were no material changes to the Company’s significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

During the three and nine months ended September 30, 2025, there were no material changes to the Company’s significant accounting policies as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Restructuring Expenses

12 unchanged sentences

See Note 7 (Commitments and Contingencies in these notes accompanying the unaudited condensed consolidated financial statements) for additional information.

Disposal of In-Process Internal-Use Software

In September 2024, Bionano announced a change in its business strategy to focus on driving utilization and adoption of OGM from the Company’s existing installed base, with less emphasis on new placements of the Company’s OGM systems, which resulted in a change in the manner in which the Company’s in-process internally developed software would be used;

therefore, it became probable that the software would not be placed into service.

The Company disposed of the project, and recorded a loss of $ 1.3 million included in selling, general and administrative expense on the unaudited condensed consolidated statement of operations during the three and nine months ended September 30, 2024.

No material disposals of internal-use software were recorded during the three and nine months ended September 30, 2025.

The Company’s in-process internal-use software was recorded in prepaid expenses and other current assets on the unaudited condensed consolidated balance sheets.

Impairment of Long-Lived Assets (including Finite-Lived Intangible Assets)

8 unchanged sentences

The Company recognized an impairment loss of $ 0.4 million during the three months ended March 31, 2024.

No impairment losses were recorded during the six months ended June 30, 2025.

During the three months ended September 30, 2024, the Company experienced a triggering event and identified indicators of impairment in all of its asset groups as a result of the restructuring initiatives and change in business strategy announced in September 2024.

The Company assessed the recoverability of each asset group and concluded the legacy OGM Bionano and Purigen asset groups were not recoverable.

Therefore, the Company was required to perform an impairment analysis to determine the fair value of the legacy OGM Bionano and Purigen asset groups as further described below.

The Company evaluated the fair value of the finite-lived assets of the legacy OGM Bionano asset group.

The Company evaluated the fair value of the reagent rental instruments based on the expected sales volume or usage and recorded an impairment loss of $ 2.6 million during the three and nine months ended September 30, 2024.

The estimates and assumptions used in the assessment of the reagent rental instrument impairments represent Level 2 measurements because they are supported by executed sales transactions.

The impairment loss associated with these reagent rental instruments was recorded to cost of product revenue in the Company’s unaudited condensed consolidated statement of operations.

The Company estimated the fair value of the right-of-use assets and related office equipment and leasehold improvements for the San Diego facilities (Nancy Ridge and 9640 Towne Center Drive) and recorded an impairment loss of $ 0.4 million and $ 0.2 million, respectively during the three and nine months ended September 30, 2024.

The fair value of the right-of-use asset and related office equipment and leasehold improvements was estimated using the discounted future cash flow methods, which includes estimates and assumptions for future sublease rental rates that reflect current sublease market conditions as well as discount rates.

The estimates and assumptions used in the assessment of right-of-use assets impairments represent Level 3 measurements because they are supported by little or no market activity and reflect the Company’s assumptions in measuring fair value.

The impairment losses were recognized in intangible assets and other long-lived assets impairment in the consolidated statement of operations.

The Company evaluated the fair value of the finite-lived intangible assets of the Purigen asset group, consisting of the Purigen trade name, customer relationships and developed technology, as well as the operating lease right-of-use asset and related office equipment and leasehold improvements.

To estimate the fair value of the intangible assets, the Company utilized the discounted cash flow method to estimate the fair value of the asset group.

The Company identified that no projected after-tax cash flows would be generated from the Purigen intangible assets and that the cost to maintain and sell the Purigen products exceeded the expected revenue to be generated from the asset group.

The carrying value of the Purigen intangible assets therefore exceeded its fair value and the Company recorded an impairment loss of $ 17.3 million for the intangible assets during the three and nine months ended September 30, 2024.

The Company estimated the fair value of the right-of-use asset and related office equipment and leasehold improvements for the Pleasanton, California facility and recorded an impairment loss of $ 0.8 million during the three and nine months ended September 30, 2024.

The Company also recorded $ 0.1 million of leasehold improvements and office equipment impairments related to the Pleasanton, California facility during the three and nine months ended September 30, 2024.

The estimates and assumptions used in the assessment of intangible assets, right-of-use assets and related office equipment and leasehold improvement impairments represent Level 3 measurements because they are supported by little or no market activity and reflect the Company’s assumptions in measuring fair value.

The impairment losses were recognized in intangible assets and other long-lived assets impairment in the unaudited condensed consolidated statement of operations.

No impairment losses were recorded during the three and nine months ended September 30, 2025.

The Company reviews its inventories for classification purposes.

The value of inventories not expected to be realized in cash, sold or consumed during the next 12 months are classified as non-current within other long-term assets.

As of June 30, 2025, $ 1.7 million of inventories were included in other long-term assets.

As of September 30, 2025, $ 1.4 million of inventories were included in other long-term assets.

During the three and nine months ended September 30, 2024, the Company recorded a $ 7.2 million write-off of its Saphyr instrument spare parts and other excess or obsolete inventory as a result of the Company’s restructuring initiatives and change in business strategy announced in September 2024.

Loss on disposal of property and equipment

Loss on disposal of property and equipment includes the net book value of assets that have been abandoned or retired and consists primarily of our leasehold improvements, furniture, equipment and fixtures that were abandoned and disposed of in the normal course of business.

We recorded a $ 0.3 million loss on disposal of property and equipment during the six months ended June 30, 2025 and $ 0.4 million during the six months ended June 30, 2024.

We recorded a $ 0.3 million loss on disposal of property and equipment during the nine months ended September 30, 2025 and $ 1.4 million during the three and nine months ended September 30, 2024.

Change in depreciable lives of property and equipment

4 unchanged sentences

The effect of this change in estimate reduced depreciation expense by $ 1.8 million for the fiscal year 2024.

There were no changes to the depreciable lives of property and equipment during the six months ended June 30, 2025.

There were no changes to the depreciable lives of property and equipment during the nine months ended September 30, 2025.

Segment Reporting

9 unchanged sentences

In November 2023, the FASB issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures , which updates reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses for all public entities, including public entities with a single reportable segment.

Improvements to Reportable Segment Disclosures , which updates reportable segment disclosure requirements primarily through

enhanced disclosures about significant segment expenses for all public entities, including public entities with a single reportable segment.

On an annual and interim basis, entities are required to disclose significant segment expenses that are regularly provided to the CODM.

7 unchanged sentences

ASU 2023-09 is effective for annual periods beginning after December 15, 2024 on a prospective basis.

Early adoption is

Early adoption is permitted.

The Company is currently evaluating the impact of this accounting standard update on the Company’s consolidated financial statements and related disclosures.

9 unchanged sentences

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

The Company is currently evaluating the impact of OBBBA on the Company’s consolidated financial statements and related disclosures.

The provisions of OBBBA did not have a material impact on the Company’s unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2025.

The Company will continue to evaluate the impact of OBBBA on the Company’s consolidated financial statements and related disclosures for the year ending December 31, 2025.

Net Loss Per Share

5 unchanged sentences

Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive were as follows (in common stock equivalent shares):

2025 June 30,

September 30,

2025 September 30,

Common stock options

2 unchanged sentences

12,105,500 1,091,000

Convertible debentures and High Trail Notes

Convertible debentures

634,000 142,000

3 unchanged sentences

Revenue by Source

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

6 unchanged sentences

Revenue by Geographic Location

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

8 unchanged sentences

Asia Pacific includes China, Japan, South Korea, Singapore, India and Australia.

For the three months ended June 30, 2025 and 2024, the United States represented 38.9 % and 38.6 % of total revenue, respectively.

For the six months ended June 30, 2025 and 2024, the United States represented 38.7 % and 40.7 % of total revenue, respectively.

No other countries represented greater than 10% of total revenue during the three and six months ended June 30, 2025 and 2024.

For the three months ended September 30, 2025 and 2024, the United States represented 33.4 % and 32.3 % of total revenue, respectively.

For the nine months ended September 30, 2025 and 2024, the United States represented 36.8 % and 38.3 % of total revenue, respectively.

No other countries represented greater than 10% of total revenue during the three and nine months ended September 30, 2025 and 2024.

Remaining Performance Obligations

As of June 30, 2025, the estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied was approximately $ 1.4 million.

As of September 30, 2025, the estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied was approximately $ 1.4 million.

These remaining performance obligations primarily relate to extended warranty, support and maintenance obligations, as well as obligations related to software under hosting arrangements.

1 unchanged sentence

Warranty revenue is included in service and other revenue.

The Company recognized revenue of approximately $ 0.4 million and $ 0.4 million during the three months ended June 30, 2025 and 2024, respectively, which was included in the contract liability balance at the end of the year preceding each period.

The Company recognized revenue of approximately $ 1.0 million and $ 1.0 million during the six months ended June 30, 2025 and 2024, respectively, which was included in the contract liability balance at the end of the year preceding each period.

The Company recognized revenue of approximately $ 0.2 million and $ 0.2 million during the three months ended September 30, 2025 and 2024, respectively, which was included in the contract liability balance at the end of the year preceding each period.

The Company recognized revenue of approximately $ 1.2 million and $ 1.3 million during the nine months ended September 30, 2025 and 2024, respectively, which was included in the contract liability balance at the end of the year preceding each period.

Balance Sheet Account Details

Accounts Receivable and Allowance for Credit Losses

September 30,

2025 December 31,

4 unchanged sentences

$ 4,526,000 $ 4,752,000 $ 9,319,000

Changes to the allowance for credit losses during the six months ended June 30, 2025 and 2024 were as follows:

Changes to the allowance for credit losses during the nine months ended September 30, 2025 and 2024 were as follows:

Allowance for Credit Losses

2 unchanged sentences

Provision for expected credit loss ( 9,000 )

Balance as of June 30, 2024

Balance as of September 30, 2024

$ ( 204,000 )

2 unchanged sentences

Provision for expected credit loss —

Balance as of June 30, 2025

$ ( 108,000 )

Balance as of September 30, 2025

The Company’s analysis included an assessment of aged trade receivables balances and their underlying credit risk characteristics.

1 unchanged sentence

The components of inventories are as follows:

September 30,

2025 December 31,

10 unchanged sentences

Intangible assets that are subject to amortization consisted of the following for the periods presented:

June 30, 2025

September 30, 2025

December 31, 2024

4 unchanged sentences

Intangibles, net $ 26,800,000 $ ( 21,217,000 ) $ 5,583,000 $ 26,800,000 $ ( 17,197,000 ) $ 9,603,000

Intangible assets not subject to amortization totaled $ 0.1 million at June 30, 2025 and December 31, 2024, and related to the Company’s domain name.

See Note 1 (Organization and Basis of Presentation) in these notes accompanying the unaudited condensed consolidated financial statements for further discussion on the impairment charges impacting the Company’s intangible assets in the period.

Intangible assets not subject to amortization totaled $ 0.1 million at September 30, 2025 and December 31, 2024, and related to the Company’s domain name.

Accrued Expenses

Accrued expenses consist of the following:

September 30,

2025 December 31,

18 unchanged sentences

The Debentures mature on May 24, 2026, and have an interest rate of 11 % per annum payable monthly on the last business day of each calendar month.

During the six months ended June 30, 2025, the Company paid the Holders $ 0.8 million in interest, which is included in the change in fair value within other income (expense), net.

During the nine months ended September 30, 2025, the Company paid the Holders $ 1.1 million in interest, which is included in the change in fair value within other income (expense), net.

The Company recorded the Debentures at their fair value at issuance of $ 19.9 million, per the fair value option under ASC 825 (refer to Note 8 (Investments and Fair Value Measurements)) and they will be measured on a recurring basis and adjusted through other income and expense, net.

3 unchanged sentences

The Holders of the Debentures requested that the Company redeem up to $ 1.0 million per calendar month of its Debentures and may request redemption up to $ 0.5 million per calendar month beginning in January 2025 to July 2025, and up to $ 1.4 million from August 2025 onward.

The table below shows the amount of potential redemptions each year until the maturity of the Debentures as of June 30, 2025.

The table below shows the amount of potential redemptions each year until the maturity of the Debentures as of September 30, 2025.

The Company may redeem the Debentures, subject to certain Equity Conditions (as defined in the Debentures), at any time after August 2025 by paying an amount equal to the entire outstanding principal amount of the Debenture, plus all accrued and unpaid interest, plus the applicable Company Redemption Premium (as defined in the Debentures, the “Premium”) plus any other amounts due and payable under the Debentures.

15 unchanged sentences

declared immediately due and payable, including certain types of bankruptcy or insolvency events of default involving the Company and its subsidiaries, and in the event of a change of control or fundamental transaction as defined in the Debentures.

As of June 30, 2025, the Company had $ 12.1 million of principal outstanding, including $ 0.5 million of the “Fill-Up Amount” (as defined in the JGB Amendment (as defined below)).

As of September 30, 2025, the Company had $ 10.3 million of principal outstanding, including $ 0.5 million of the “Fill-Up Amount” (as defined in the JGB Amendment (as defined below)).

The Fill-Up Amount represents the shares issuable to adjust for stock price volatility between the date of the settlement agreement and the effective date of the resale registration statement registering such shares for issuance.

1 unchanged sentence

Refer to Note 8 (Investments and Fair Value Measurements), for fair value measurements and additional discussion.

The activity for the six months ended June 30, 2025 was as follows:

The activity for the nine months ended September 30, 2025 was as follows:

Principal balance, January 1, 2025

1 unchanged sentence

( 4,875,000 )

Debentures principal balance, June 30, 2025

Debentures principal balance, September 30, 2025

JGB Amendment

26 unchanged sentences

The April 2024 payment was delayed to April 20, 2024, under the Note Amendment as discussed above.

As of June 30, 2025, the Company had no principal outstanding under the High Trail Notes (refer to Note 8 (Investments and Fair Value Measurements), for fair value measurements and additional discussion).

As of September 30, 2025, the Company had no principal outstanding under the High Trail Notes (refer to Note 8 (Investments and Fair Value Measurements), for fair value measurements and additional discussion).

Other Income (Expense), Net

The following is a summary of the charges included within other income (expense), net on the unaudited condensed consolidated statement of operations:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

27 unchanged sentences

The Company agreed to pay Wainwright a commission of up to 3.0 % of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Wainwright with customary indemnification and contribution rights.

In February and March 2025, the Company sold approximately 0.4 million shares of common stock under the ATM Agreement at an average share price of $ 3.84 per share and received gross proceeds of approximately $ 1.4 million before deducting offering costs of $ 0.05 million.

In the three months ended June 30, 2025, the Company sold approximately 0.8 million shares of common stock under the ATM Agreement at an average share price of $ 3.83 per share and received gross proceeds of approximately $ 3.1 million before deducting offering costs of $ 0.1 million.

In July and August 2025, the Company sold approximately 0.8 million shares of common stock under the ATM Agreement at an average share price of $ 3.43 per share, and received gross proceeds of approximately $ 2.7 million before deducting offering costs of $ 0.09 million.

From February 24, 2025 to September 30, 2025, the Company sold approximately 2.0 million shares of common stock under the ATM Agreement at an average share price of $ 3.68 per share and received gross proceeds of approximately $ 7.4 million before deducting offering costs of $ 0.2 million.

In October and November 2025, the Company sold approximately 0.6 million shares of common stock under the ATM Agreement at an average share price of $ 1.86 per share, and received gross proceeds of approximately $ 1.1 million before deducting offering costs of $ 0.04 million.

Stock Warrants

A summary of the Company’s warrant activity during the six months ended June 30, 2025 was as follows:

A summary of the Company’s warrant activity during the nine months ended September 30, 2025 was as follows:

Shares of Stock under Warrants Weighted-

6 unchanged sentences

Canceled ( 200 ) 198.00 — —

Outstanding at June 30, 2025

Outstanding at September 30, 2025

12,105,500 $ 13.19 3.10 $ 43,000

In connection with the registered direct offerings (as described under the heading “Registered Direct Offerings” below) the Company issued warrants to purchase shares of the Company’s common stock.

In connection with the registered direct offering and public offering (as described under the heading “Registered Direct Offering” and “September 2025 Public Offering” below) the Company issued warrants to purchase shares of the Company’s common stock.

Stock Options

A summary of the Company’s stock option activity during the six months ended June 30, 2025 was as follows:

A summary of the Company’s stock option activity during the nine months ended September 30, 2025 was as follows:

Shares of Stock under Stock Options Weighted-

6 unchanged sentences

Canceled ( 12,000 ) 404.67 —

Outstanding and expected to vest at June 30, 2025

Outstanding and expected to vest at September 30, 2025

191,000 $ 249.79 8.89 $ —

Vested and exercisable at June 30, 2025

Vested and exercisable at September 30, 2025

49,000 $ 868.94 7.42 $ —

For the three and six months ended June 30, 2025, the weighted-average grant date fair value of stock options granted was $ 3.14 and $ 3.16 per share, respectively.

For the three and nine months ended September 30, 2025, the weighted-average grant date fair value of stock options granted was $ 3.23 and $ 3.17 per share, respectively.

Stock-Based Compensation

1 unchanged sentence

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2025 2024 2025 2024

6 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2025 2024 2025 2024

4 unchanged sentences

Restricted Stock Units and Performance Stock Units

The following table summarizes RSU activity during the six months ended June 30, 2025:

The following table summarizes RSU activity during the nine months ended September 30, 2025:

Stock Units Weighted- Average Grant Date Fair Value per Share

3 unchanged sentences

Forfeited ( 670 ) 219.79

Outstanding at June 30, 2025

Outstanding at September 30, 2025

3,590 $ 290.64

The total fair value of the RSUs that vested during the six months ended June 30, 2025 was $ 0.5 million, determined as of the date of vesting.

The weighted average remaining contractual term for the RSUs was 2.4 years as of June 30, 2025.

The following table summarizes PSU activity during the six months ended June 30, 2025:

The total fair value of the RSUs that vested during the nine months ended September 30, 2025 was $ 0.5 million, determined as of the date of vesting.

The weighted average remaining contractual term for the RSUs was 2.4 years as of September 30, 2025.

The following table summarizes PSU activity during the nine months ended September 30, 2025:

Stock Units Weighted- Average Grant Date Fair Value per Share

3 unchanged sentences

Forfeited — —

Outstanding at June 30, 2025

Outstanding at September 30, 2025

During the year ended December 31, 2023, the Company reassessed the implicit service period on its performance-based stock units relative to specified revenue targets and determined that the performance conditions were met from an accounting perspective, but subject to certain certifications and approval from the compensation committee (the “Compensation Committee”) of the board of directors;

6 unchanged sentences

The shares subject to the stock options shall vest monthly over 48 months beginning on the one-month anniversary of their respective grant dates, such that the stock options shall be fully vested and exercisable on the four-year anniversary of their respective grant dates.

Registered Direct Offerings

Registered Direct Offering

On January 3, 2025, the Company entered into a securities purchase agreement (the “January 2025 Purchase Agreement”) with certain institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market consistent with the rules of the Nasdaq Stock Market (i) an aggregate of approximately 382,000 shares of the Company’s common stock, (ii) pre-funded warrants to purchase up to an aggregate of approximately 280,000 shares of common stock (the “January Pre-Funded Warrants”) and (iii) warrants to purchase up to an aggregate of approximately 661,000 shares of common stock (the “January Purchase Warrants”).

8 unchanged sentences

On January 15, 2025, the Company held a Special Meeting of Stockholders (the “2025 Special Meeting”), and obtained stockholder approval for the issuance of the shares of common stock issuable upon exercise of the Series C warrants and Series D warrants issued in a registered direct offering on October 30, 2024 pursuant to that certain securities purchase agreement and among the Company and certain institutional investors and approval, at the discretion of the Company’s board of directors, of a reverse stock split of the Company’s common stock at a ratio of between 1-for-25 and 1-for-75.

On January 15, 2025, the Company’s board of directors approved a reverse stock split at a ratio of 1-for-60, and on January 24, 2025, the Company filed a certificate of amendment to effect the reverse split ratio chosen by the Company’s board of directors as further described above under the section “Reverse Stock Split.”

On January 15, 2025, the Company’s board of directors approved a reverse stock split at a ratio of 1-for-60, and on January 24, 2025, the Company filed

a certificate of amendment to effect the reverse split ratio chosen by the Company’s board of directors as further described above under the section “Reverse Stock Split.”

On June 11, 2025, the Company held its 2025 Annual Meeting of Stockholders (the “Annual Meeting”) and obtained stockholder approval, in compliance with Nasdaq Listing Rule 5635(d), for the issuance of the shares of common stock issuable upon exercise of the January Purchase Warrants issued in a registered direct offering on January 3, 2025.

September 2025 Public Offering

On September 16, 2025, the Company commenced a best efforts public offering (the “September 2025 Offering”) of an aggregate of (i) 4.9 million shares of its common stock, (ii) pre-funded warrants (the “September Pre-Funded Warrants”) to purchase up to an aggregate of 75,000 shares of common stock, (iii) Series E warrants (the “Series E Warrants”) to purchase up to an aggregate of 5.0 million shares of common stock, and (iv) Series F warrants (the “Series F Warrants,” to purchase up to an aggregate of 5.0 million shares of common stock.

Each share of common stock or September Pre-Funded Warrant was sold together with one Series E Warrant to purchase one share of common stock and one Series F Warrant to purchase one share of common stock.

The combined public offering price for each share of common stock and accompanying Series E and Series F Warrant was $ 2.00 , and the combined public offering price for each September Pre-Funded Warrant and accompanying Series E and Series F Warrant was $ 1.9999 .

The September Pre-Funded Warrants have an exercise price of $ 0.0001 per share, are exercisable immediately upon issuance and will expire when exercised in full.

50,000 of the 75,000 September Pre-Funded Warrants were exercised in full at time of closing on September 16, 2025.

The remaining 25,000 September Pre-Funded Warrants were exercised in full on November 5, 2025.

Each Series E and Series F Warrant have an exercise price of $ 2.00 per share and is exercisable immediately upon issuance.

The Series E warrants will expire on the five-year anniversary of the date of issuance and the Series F warrants will expire on the eighteen-month anniversary of the date of issuance.

The gross proceeds to the Company from the September 2025 Offering were approximately $ 10.0 million (excluding up to approximately $ 20.0 million of aggregate gross proceeds that may be received in the future upon the cash exercise of the Series E and Series F Warrants), before deducting placement agent fees and other offering expenses payable by the Company.

The September 2025 Pre-Funded Warrants, Series E Warrants, and Series F Warrants qualified for classification as equity instruments.

Commitments and Contingencies

The Company has entered into various operating lease agreements and a finance lease agreement, primarily relating to our office, laboratory, and manufacturing space.

The future minimum payments under non-cancellable operating and finance leases as of June 30, 2025, are as follows:

The future minimum payments under non-cancellable operating and finance leases as of September 30, 2025, are as follows:

Operating Leases Finance Lease

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In June 2025, the Company executed an amendment to its headquarters facility to extend the lease term through December 2030.

The Company accounted for the lease amendment as a lease modification and recorded a gain of $ 0.1 million during the three and six months ended June 30, 2025.

The Company accounted for the lease amendment as a lease modification and recorded a gain of $ 0.1 million during the three and nine months ended September 30, 2025.

Purchase Commitments

The Company is currently negotiating an agreement with its instrument contract manufacturer under which it would make weekly deposits for future inventory purchases through November 21, 2025.

The Company is currently operating under an agreement with its instrument contract manufacturer under which it would make weekly deposits for future inventory purchases through November 21, 2025.

Total payments in 2025 are expected to range from approximately $ 1.7 million to $ 2.0 million.

1 unchanged sentence

The Company will continue to evaluate the financial impact of this commitment and assess the need for future disclosures or accruals in accordance with ASC 450.

As of June 30, 2025, the Company did not accrue any amounts related to this agreement as it was not probable that the amounts would be incurred.

As of September 30, 2025, the Company did not accrue any amounts related to this agreement as it was not probable that the amounts would be incurred.

Restructuring

The 2024 Workforce Reductions described in Note 1 (Organization and Basis of Presentation) comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California Worked Adjustment and Retraining Notification (WARN) Act.

There were no restructuring charges incurred for the three and six months ended June 30, 2025.

The following is a summary of restructuring charges associated with the reduction in force for the three and six months ended June 30, 2024 including severance and other exit related costs:

Three Months Ended June 30, Six Months Ended June 30,

There were no restructuring charges incurred for the three and nine months ended September 30, 2025.

The following is a summary of restructuring charges associated with the reduction in force for the three and nine months ended September 30, 2024 including severance and other exit related costs:

Three Months Ended September 30, Nine Months Ended September 30,

$ 1,050,000 $ 5,475,000

1 unchanged sentence

720,000 1,767,000

500,000 1,047,000

Total restructuring charges including in operating expenses

4 unchanged sentences

$ 1,909,000 $ 7,773,000

The following restructuring liability activity was recorded in connection with the reductions in force for the six months ended June 30, 2025 included within accrued expenses on the unaudited condensed consolidated financial statements:

The following restructuring liability activity was recorded in connection with the reductions in force for the nine months ended September 30, 2025 included within accrued expenses on the unaudited condensed consolidated financial statements:

Accrued restructuring as of January 1, 2025

1 unchanged sentence

Cash payments

Accrued restructuring as of June 30, 2025

Accrued restructuring as of September 30, 2025

From time to time, the Company may be subject to potential liabilities under various claims and legal actions that are pending or may be asserted.

9 unchanged sentences

The investment service provider values the securities using a hierarchical security pricing model that relies primarily on valuations provided by an industry-recognized valuation service.

Such valuations may be based on trade prices in active markets for identical assets or liabilities (Level 1 inputs) or valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curves, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, and broker and dealer quotes, as well as other relevant economic measures.

The following table presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024:

June 30, 2025

Such valuations may be based on trade

prices in active markets for identical assets or liabilities (Level 1 inputs) or valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curves, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, and broker and dealer quotes, as well as other relevant economic measures.

The following table presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024:

September 30, 2025

Total Fair Value and Carrying Value on Balance Sheet Fair Value Measurement Category

1 unchanged sentence

$ 18,516,000 $ — $ 18,516,000 $ —

government agencies

$ 9,716,000 — $ 9,716,000 —

Money market funds classified as cash equivalents

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JGB Convertible debentures payable, High Trail convertible notes payable and purchase option liability

The fair value of the JGB convertible debentures maturing in 2026, which were issued on May 24, 2024, and the High Trail convertible notes payable that were issued in October 2023, were estimated using a scenario-based analysis as of June 30, 2025 and June 30, 2024, respectively.

The fair value was estimated using a lattice model.

1 unchanged sentence

Convertible Debentures Payable High Trail Convertible Notes Payable

June 30, 2025

September 30, 2025

December 31, 2024 December 31, 2023

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In connection with the High Trail Notes, the purchaser was granted an option (the “Purchase Option”) which expired on the maturity date of the High Trail Notes to purchase up to an additional $ 25.0 million aggregate principal amount of private placement notes (the “Subsequently Purchased Notes”) and warrants (refer to Note 5 (Debt)).

The estimated fair value of the Purchase Option as of the valuation date was assessed as the difference in the aggregate indicated value of the Subsequently Purchased Notes and the consideration to be paid upon exercising the option which was estimated to be $ 8.5 million at December 31, 2023.

The estimated fair value of the Purchase Option as of the valuation date was assessed as the difference in the aggregate indicated value of the Subsequently

Purchased Notes and the consideration to be paid upon exercising the option which was estimated to be $ 8.5 million at December 31, 2023.

The outstanding amount of the High Trail Notes was redeemed on May 24, 2024, and the Purchase Option rights no longer exist.

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Equity discount rate

Changes in estimated fair value of convertible debentures payable in the six months ended June 30, 2025 are as follows:

Changes in estimated fair value of convertible debentures payable in the nine months ended September 30, 2025 are as follows:

Debentures Payable (Level 3 Measurement)

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( 4,875,000 )

Balance as of June 30, 2025

Changes in estimated fair value of contingent consideration liability, convertible debentures payable, convertible High Trail notes payable and option liability in the six months ended June 30, 2024 is as follows:

Balance as of September 30, 2025

Changes in estimated fair value of contingent consideration liability, convertible debentures payable, convertible High Trail notes payable and option liability in the nine months ended September 30, 2024 is as follows:

Consideration

4 unchanged sentences

$ 10,890,000 $ — $ 69,803,000 $ 8,534,000

Issuance of convertible debentures payable, convertible notes payable and option

Issuance of convertible debentures payable, convertible notes payable and option liability

— 19,890,000 — —

2 unchanged sentences

— ( 434,000 ) ( 4,524,000 ) ( 3,474,000 )

Change in fair value attributable to instrument-specific credit risk recorded in other comprehensive income (loss)

— ( 1,503,000 ) — —

Cash payments

4 unchanged sentences

— — 1,095,000 ( 5,060,000 )

Balance as of June 30, 2024

Balance as of September 30, 2024

$ — $ 14,953,000 $ — $ —

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Moreover, the Company continues to receive payments of interest and principal as they become due, and our expectation is that those payments will continue to be received timely.

Based on this evaluation, as of June 30, 2025 and December 31, 2024, the Company determined that unrealized losses of the below securities were primarily attributable to changes in interest rates and non-credit related factors.

Based on this evaluation, as of September 30, 2025 and December 31, 2024, the Company determined that unrealized losses of the below securities were primarily attributable to changes in interest rates and non-credit related factors.

As such, no allowances for credit losses were recorded during these periods.

As of June 30, 2025 and December 31, 2024, the Company held 8 and 1 securities, respectively, which have been in an unrealized loss position for a period of less than 12 months.

As of June 30, 2025 and December 31, 2024, the Company held no securities, which have been in an unrealized loss position for a period of greater than 12 months.

As of September 30, 2025 and December 31, 2024, the Company held seven and one securities, respectively, which have been in an unrealized loss position for a period of less than 12 months.

As of September 30, 2025 and December 31, 2024, the Company held no securities, which have been in an unrealized loss position for a period of greater than 12 months.

Realized gains and losses are calculated using the specific identification method and recorded in other income (expense) in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss.

The Company has the ability, if necessary, to liquidate any of its cash equivalents and marketable securities to meet its liquidity needs in the next 12 months.

During the six months ended June 30, 2025, there were no sales of the Company’s available for sale securities.

During the nine months ended September 30, 2025, the Company sold one of its available for sale securities and received proceeds of $ 1.4 million.

During the nine months ended September 30, 2025, the Company recognized an immaterial loss in other income relating to the sale of its security.

Amounts are reclassified out of accumulated other comprehensive income into earnings using the specific identification method when sales are realized.

Interest receivable as of June 30, 2025 and December 31, 2024 was immaterial .

Interest receivable as of September 30, 2025 and December 31, 2024 was immaterial .

Interest receivable is recorded as a component of prepaid expenses and other current assets on the unaudited condensed consolidated balance sheets.

As of June 30, 2025, the following table summarizes the amortized cost and the unrealized gains (losses) of the available for sale securities presented within investments:

As of September 30, 2025, the following table summarizes the amortized cost and the unrealized gains (losses) of the available for sale securities presented within investments:

Remaining Contractual Maturity (in years) Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value

Less than 1 $ 18,517,000 $ — $ ( 1,000 ) $ 18,516,000

government agencies Less than 1 9,717,000 — ( 1,000 ) 9,716,000

Total maturity less than 1 year $ 18,517,000 $ — $ ( 1,000 ) $ 18,516,000

As of June 30, 2025, the following table summarizes the amortized cost and the unrealized gains (losses) of the available for sale securities presented within restricted investments:

As of September 30, 2025, the following table summarizes the amortized cost and the unrealized gains (losses) of the available for sale securities presented within restricted investments:

Remaining Contractual Maturity (in years) Amortized Cost Unrealized Gains Unrealized Losses Aggregate Estimated Fair Value

9 unchanged sentences

Total maturity less than 1 year $ 11,000,000 $ — $ — $ 11,000,000

As of June 30, 2025, the following table summarizes available-for-sale securities in an unrealized loss position:

As of September 30, 2025, the following table summarizes available-for-sale securities in an unrealized loss position:

Less Than 12 Months 12 Months or Greater Total

3 unchanged sentences

$ 18,516,000 $ ( 1,000 ) $ — $ — $ 18,516,000 $ ( 1,000 )

government agencies 9,716,000 ( 1,000 ) — — 9,716,000 ( 1,000 )

Total $ 18,516,000 $ ( 1,000 ) $ — $ — $ 18,516,000 $ ( 1,000 )

As of June 30, 2025, the available-for-sale securities listed as restricted investments in an unrealized loss position was zero .

As of September 30, 2025, the available-for-sale securities listed as restricted investments in an unrealized loss position was zero .

As of December 31, 2024, the following table summarizes available-for-sale securities in an unrealized loss position:

8 unchanged sentences

The following table presents financial information with respect to the Company’s single operating segment, including significant segment expenses, which are regularly provided to the CODM and included within consolidated operating loss:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

15 unchanged sentences

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