What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-13 compared with 2025-08-14 · 123 added, 93 removed, 302 unchanged (42% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2025 (“Quarterly Report”) and the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2024, (“Annual Report”), filed with the Securities and Exchange Commission, (“SEC”), on March 31, 2025.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2025 (“Quarterly Report”) and the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2024, (“Annual Report”), filed with the Securities and Exchange Commission (“SEC”), on March 31, 2025.

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” refer to Bionano Genomics, Inc.

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In executing on our commercialization strategy, we expanded the utilization of our OGM systems (our Saphyr system and our Stratys system) and:

• Grew our installed base to 378 as of June 30, 2025, an increase of approximately 4% from a total installed base of 363 as of June 30, 2024.

• Grew our installed base to 384 as of September 30, 2025, an increase of approximately 4% from a total installed base of 368 as of September 30, 2024.

Installed base represents the global number of OGM instruments installed at end-customer locations and therefore having the technology to process OGM.

• Sold 7,233 flowcells in the three-month period ended June 30, 2025, an increase of approximately 17% from 6,165 flowcells sold in the same period of 2024.

Sold 14,227 flowcells in the six-month period ended June 30, 2025, a decrease of approximately 1% from 14,414 flowcells sold in the same period of 2024.

• Sold 8,390 flowcells in the three-month period ended September 30, 2025, an increase of approximately 7% from 7,835 flowcells sold in the same period of 2024.

Sold 22,617 flowcells in the nine-month period ended September 30, 2025, an increase of approximately 2% from 22,249 flowcells sold in the same period of 2024.

The OGM cartridge is the consumable that packages nanochannel arrays for DNA linearization.

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Additionally, we have experienced a slowdown in our Asia Pacific business, including as a result of headwinds in the region, which negatively impacted our manufacturing partners who are reliant on government funding.

While our manufacturing partners in the Asia Pacific region have obtained some approvals from the National Medical Products Administration (“NMPA”), and are waiting on more, we do not anticipate that the funding headwinds will change in the near term.

While our manufacturing partners in the Asia Pacific region have obtained some approvals from the National Medical Products Administration, and are waiting on more, we do not anticipate that the funding headwinds will change in the near term.

Following the invasion of Ukraine by Russia, the U.S.

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In the past, we have experienced supply chain challenges, attributable to such adverse geopolitical and macroeconomic developments including increased costs to secure certain component parts in our products and to produce our products at our contract manufacturers.

During the six months ended June 30, 2025, we did not experience material increases in our supply chain costs, but we may experience such increases in future fiscal periods.

During the nine months ended September 30, 2025, we did not experience material increases in our supply chain costs, but we may experience such increases in future fiscal periods.

We expect our costs to remain high for the foreseeable future.

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Recent Developments

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

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

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See Note 7 (Commitments and Contingencies - Purchase Commitments) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Government Shutdown

federal government’s new fiscal year began October 1, 2025, without the passage of appropriation acts or a continuing resolution (“CR”) and the government began its shutdown procedures, to include furloughing government civilian employees.

It is unclear at this time when either a CR or appropriations act will be enacted.

Federal agencies have published guidance for identifying those functions that may continue to be carried out in the absence of available appropriations.

At this time, we do not anticipate the shutdown as having a material effect on our business;

however, we are closely monitoring the known and potential impact of any short-term or extended shutdown which may negatively impact our manufacturing partners and customers who may be reliant on government funding.

Additionally, a prolonged shutdown may impact our ability to timely deliver and service our products.

Financial Overview

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The following table presents our revenue for the periods indicated:

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

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

2025 2024 2025 2024

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

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

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

2025 2024 2025 2024

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We have incurred losses in each year since our inception.

Our net loss was $6.9 million and $10.0 million for the three and six months ended June 30, 2025, respectively.

As of June 30, 2025, we had an accumulated deficit of $703.2 million.

Our net loss was $8.5 million and $18.5 million for the three and nine months ended September 30, 2025, respectively.

As of September 30, 2025, we had an accumulated deficit of $711.7 million.

While we implemented restructuring plans in March and September 2024, we expect to continue to incur significant expenses and operating losses as we:

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We do not intend to make further announcements regarding this process unless and until the board of directors approves a specific transaction or otherwise determines that further disclosure is appropriate.

Comparison of the Three Months Ended June 30, 2025 and 2024

The following table sets forth our results of operations for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30, Period-to-Period Change

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table sets forth our results of operations for the three months ended September 30, 2025 and 2024:

Three Months Ended September 30, Period-to-Period Change

Product revenue $ 6,934,000 $ 6,021,000 $ 913,000 15 %

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Selling, general and administrative 9,064,000 9,464,000 (400,000) (4) %

Intangible assets and other long-lived assets impairment

— 19,504,000 (19,504,000) (100) %

Restructuring costs

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Loss from operations (8,538,000) (43,901,000) 35,363,000 (81) %

Other income:

Other income (expense):

Interest income 268,000 376,000 (108,000) (29) %

Other expense

(219,000) (697,000) 478,000 (69) %

Total other income

Total other income (expense)

49,000 (321,000) 370,000 (115) %

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Net loss $ (8,503,000) $ (44,246,000) $ 35,743,000 (81) %

Product revenue decreased by $0.2 million, or 3%, to $6.3 million for the three months ended June 30, 2025 as compared to $6.5 million for the same period in 2024.

The decrease in product revenue was driven by a decrease of $0.9 million or 38% in instrument sales and a $0.05 million or 3% decrease in software sales, partially offset by an increase of $0.7 million or 28% in consumables sales.

Product revenue increased by $0.9 million, or 15%, to $6.9 million for the three months ended September 30, 2025 as compared to $6.0 million for the same period in 2024.

The increase in product revenue was driven by an increase of $0.2 million or 14% in instrument sales, an increase of $0.4 million or 13% in consumables sales, and an increase of $0.27 million or 22% increase in software sales.

In September 2024, we announced a change in our business strategy to focus on driving utilization and adoption of OGM from our existing installed base, with less emphasis on new placements of our OGM systems.

We expected that this change in strategy would slow the pace of our revenue growth when compared to historical growth rates, and we anticipate that the reduced pace of our revenue growth will continue in the remainder of 2025.

Service and other revenue decreased by $0.8 million, or 66%, to $0.4 million for the three months ended June 30, 2025, as compared to the same period in 2024 which is the result of discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

Such clinical service offerings from Bionano Laboratories contributed no revenues for the three months ended June 30, 2025, as compared to $0.7 million for the same period in 2024.

We expect service and other revenue to decline in 2025 relative to 2024 as these service offerings were fully phased out as of December 31, 2024.

Service and other revenue increased by $0.4 million, or 733%, to $0.4 million for the three months ended September 30, 2025, as compared to the same period in 2024.

For the three months ended September 30, 2024, service and other revenue included a $0.5 million write-down of aged receivables tied to discontinued clinical services products.

The write-down was treated as a reversal of revenue.

Such clinical service offerings from Bionano Laboratories contributed no revenues for the three months ended September 30, 2025, as compared to no revenues and a $0.5 million write-down for the same period in 2024.

Cost of Revenue

Cost of product revenue decreased by $1.6 million or 33% , to $3.2 million for the three months ended June 30, 2025, as compared to $4.7 million for the three months ended June 30, 2024.

The decrease in cost of product revenue was primarily due to lower sales of instruments and software, partially offset by higher sales of consumables.

Cost of product revenue decreased by $10.4 million or 73%, to $3.8 million for the three months ended September 30, 2025, as compared to $14.3 million for the three months ended September 30, 2024.

The decrease in cost of product revenue was primarily due to $9.8 million in total expenses recognized in the three months September 30, 2024.

This included a $7.2 million write-off of excess Saphyr instrument spare parts and other obsolete inventory as well as a $2.6 million disposition expense for reagent rentals that were underutilized.

We expect cost of product revenue to fluctuate with the volume of product sales.

Cost of service and other revenue decreased by $0.4 million , or 78%, to $0.1 million for the three months ended June 30, 2025, as compared to $0.5 million for the three months ended June 30, 2024.

Cost of service and other revenue decreased by $0.1 million, or 42%, to $0.2 million for the three months ended September 30, 2025, as compared to $0.3 million for the three months ended September 30, 2024.

The decrease in cost of service and other revenue was primarily due to discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

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Gross Profit, and Gross Margin

Three Months Ended June 30, Period-to-Period Change

Three Months Ended September 30, Period-to-Period Change

Gross profit:

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Total gross margin 46 % (139) %

Product gross profit increased by $1.4 million, or 75% , to $3.2 million for the three months ended June 30, 2025, compared to $1.8 million for the three months ended June 30, 2024.

The increase in product gross profit was primarily due to an increase in consumable sales.

Product gross profit increased by $11.3 million, or 138% , to $3.1 million for the three months ended September 30, 2025, compared to $(8.2) million for the three months ended September 30, 2024.

The increase in product gross profit was primarily due to $9.8 million in total expenses recognized to write-off excess Saphyr instrument spare parts and other obsolete inventory for $7.2 million, as well as dispose of reagent rentals that were underutilized for $2.6 million during the three months ended September 30, 2024 .

We expect cost of product revenue to fluctuate with the volume of product sales.

Service and other gross profit decreased by $0.5 million, or 59%, to $0.3 million for the three months ended June 30, 2025, compared to $0.8 million for the three months ended June 30, 2024.

The decrease in service and other gross profit was primarily due to discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

Service and other gross profit increased by $0.5 million, or 229%, to $0.3 million for the three months ended September 30, 2025, compared to $(0.2) million for the three months ended September 30, 2024.

The increase in service and other gross profit was impacted by a $0.5 million write-down of aged receivables tied to discontinued clinical service offerings from Bionano Laboratories during the three months ended September 30, 2024.

The write-down was treated as a reversal of revenue.

We expect service and other gross profit to remain relatively flat in 2025 as these service offerings were fully phased out as of December 31, 2024.

Research and Development Expenses

Research and development (“R&D”) expenses decreased by $3.9 million, or 57%, to $2.9 million for the three months ended June 30, 2025 compared to $6.8 million for the same period in 2024.

The decrease was primarily due to a decrease of $2.4 million in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024, and a decrease of $1.1 million in professional and consulting fees including decreases in costs incurred to support clinical research studies, development of the Stratys system, foundry expenses, and cloud computing.

We also reduced our internal consumption of inventory, materials and supplies by $0.4 million.

We anticipate that R&D expenses will continue to decrease throughout 2025 as a result of our cost saving initiatives announced in March and September 2024.

Research and development (“R&D”) expenses decreased by $1.9 million, or 40%, to $2.8 million for the three months ended September 30, 2025 compared to $4.7 million for the same period in 2024.

The decrease was primarily due to a decrease of $1.6 million in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024, and a decrease of $0.2 million in foundry expenses.

We anticipate that R&D expenses will decrease throughout 2025, in comparison to the same period in 2024, as a result of our cost saving initiatives announced in March and September 2024.

Selling, General and Administrative Expenses

Selling, general and administrative (“SG&A”) expenses decreased by $3.2 million, or 28%, to $8.3 million for the three months ended June 30, 2025, as compared to $11.6 million for the same period in 2024.

Selling, general and administrative (“SG&A”) expenses decreased by $0.4 million, or 4%, to $9.1 million for the three months ended September 30, 2025, as compared to $9.5 million for the same period in 2024.

The decrease was primarily due to a $2.4 million decrease in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024;

a $2.1 million decrease in professional and consulting fees, which is primarily marketing, software and legal expenses;

a $1.8 million decrease in professional and consulting fees, which was primarily marketing, software and legal expenses;

a $0.1 million decrease in travel and entertainment;

and a $0.3 million decrease in information technology and rent and facility costs.

These decreases were offset by a $4.5 million gain recorded on the fair value of the contingent consideration due for the Purigen milestones during the same period in 2024 as compared to no gain recorded for the three months ended June 30, 2025 .

We anticipate that SG&A expenses will continue to decrease throughout 2025 as a result of our restructuring initiatives announced in March and September 2024.

a $0.4 million decrease in information technology and rent and facility costs;

and a $0.5 million decrease in depreciation and amortization.

These decreases were offset by a $5.8 million gain recorded on the fair value of the contingent consideration due for the Purigen milestones during the same period in 2024 as compared to no gain recorded for the three months ended September 30, 2025 .

We anticipate that SG&A expenses will decrease throughout 2025, in comparison to the same period in 2024, as a result of our cost saving initiatives announced in March and September 2024.

Intangible Assets and Other Long-lived Assets Impairment

The Company recognized no impairment losses on intangible assets and other long-lived assets during the three months ended September 30, 2025, as compared to $19.5 million for the same period in 2024.

These losses were due to our restructuring initiatives and change in business strategy announced in 2024.

See Note 1 (Organization and Basis of Presentation) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion on the impairment charges that were recorded during the prior period.

Restructuring Costs

The Company had no expenses that were classified as restructuring costs during the three months ended June 30, 2025, as compared to $1.2 million during the same period in 2024.

The Company had no expenses that were classified as restructuring costs during the three months ended September 30, 2025, as compared to $1.8 million during the same period in 2024.

These restructuring costs were the result of our cost saving initiatives announced in 2024.

Interest Income

Interest income was $0.3 million for the three months ended June 30, 2025, as compared to $0.5 million for the same period in 2024.

Interest income was $0.3 million for the three months ended September 30, 2025, as compared to $0.4 million for the same period in 2024.

The decrease was primarily the result of a reduction in investments, partially offset by higher returns.

Other income was $0.7 million for the three months ended June 30, 2025, as compared to $0.4 million for the same period in 2024.

The increase was primarily driven by a loss recorded on the issuance of the JGB Debentures of $1.9 million during the three months ended June 30, 2024, debt issuance costs recorded in connection with the debt instruments of $1.4 million during the three months ended June 30, 2024 , and an increase in other income of $1.8 million primarily related to an Employee

Retention Credit (“ERC”) refundable tax credit received during the three months ended June 30, 2025 from the Internal Revenue Services (“IRS”) for eligible businesses affected by the COVID-19 pandemic.

These increases were offset by a net gain on the extinguishment of the High Trail Note and Purchase Option of $4.0 million during the three months ended June 30, 2024 , and a change in fair value (net loss) of $0.9 million for the convertible High Trail Notes, Purchase Option, and convertible debentures during the three months ended June 30, 2025 .

See Note 5 (Debt) and Note 8 (Investments and Fair Value Measurements) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion.

Comparison of the Six Months Ended June 30, 2025 and 2024

The following table sets forth our results of operations for the six months ended June 30, 2025 and 2024:

Six Months Ended June 30, Period-to-Period Change

Other Expense

Other expense was $0.2 million for the three months ended September 30, 2025, as compared to $0.7 million for the same period in 2024.

The decrease in other expense was primarily driven by a change in fair value (net loss) of $0.4 million for the convertible debentures during the three months ended September 30, 2025.

See Note 5 (Debt) and Note 8 (Investments and Fair

Value Measurements) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion.

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following table sets forth our results of operations for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30, Period-to-Period Change

Product revenue $ 19,248,000 $ 19,359,000 $ (111,000) (1) %

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Net loss $ (18,462,000) $ (91,892,000) $ 73,430,000 (80) %

Product revenue decreased by $1.0 million, or 8%, to $12.3 million for the six months ended June 30, 2025, as compared to $13.3 million for the same period in 2024.

Product revenue decreased by $0.1 million, or 1%, to $19.2 million for the nine months ended September 30, 2025, as compared to $19.4 million for the same period in 2024.

The decrease in product revenue was driven by a decrease of $1.6 million or 30% in instrument sales, partially offset by increases of $0.9 million, or 10%, in consumable sales and $0.5 million, or 12%, in software sales.

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Service and other revenue decreased by $2.3 million, or 73%, for the six months ended June 30, 2025, as compared to the same period in 2024, which is the result of discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

Such clinical service offerings from Bionano Laboratories contributed no revenues for the six months ended June 30, 2025, as compared to $2.2 million for the same period in 2024.

Service and other revenue decreased by $1.9 million, or 60%, for the nine months ended September 30, 2025, as compared to the same period in 2024, which is the result of discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

Such clinical service offerings from Bionano Laboratories contributed no revenues for the nine months ended September 30, 2025, as compared to $1.7 million for the same period in 2024.

We expect service and other revenue to decline in 2025 relative to 2024 as these service offerings were fully phased out as of December 31, 2024.

Cost of Revenue

Cost of product revenue decreased by $3.4 million, or 35%, to $6.2 million for the six months ended June 30, 2025, as compared to $9.6 million for the same period in 2024.

The decrease in cost of product revenue was primarily due to lower sales of instruments, partially offset by higher sales of software and consumables.

Cost of product revenue decreased by $13.8 million, or 58%, to $10.0 million for the nine months ended September 30, 2025, as compared to $23.9 million for the same period in 2024.

The decrease in cost of product revenue was primarily due to $9.8 million in total expenses recognized to write-off excess Saphyr instrument spare parts and other obsolete inventory for $7.2 million as well as dispose of reagent rentals that were underutilized for $2.6 million during the nine months ended September 30, 2024 .

In addition, the decrease in cost of product revenue was due to lower sales of instruments, partially offset by higher sales of software and consumables during the nine months ended September 30, 2025.

We expect cost of product revenue to fluctuate with the volume of product sales.

Cost of service and other revenue decreased by $1.0 million, or 62%, to $0.6 million for the six months ended June 30, 2025, compared to $1.5 million for the same period in 2024.

Cost of service and other revenue decreased by $1.1 million, or 59%, to $0.7 million for the nine months ended September 30, 2025, compared to $1.8 million for the same period in 2024.

The decrease in cost of service and other revenue was primarily due to discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

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Gross Profit, and Gross Margin

Six Months Ended June 30,

Nine Months Ended September 30,

Period-to-Period Change

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Total gross margin 48 % (13) %

Product gross profit increased by $2.4 million, or 64%, to $6.1 million for the six months ended June 30, 2025, as compared to $3.7 million for the same period in 2024.

The increase in product gross profit was primarily due to an increase in consumable and software sales.

Service and other gross profit decreased by $1.4 million, or 82%, to $0.3 million for the six months ended June 30, 2025, as compared to $1.7 million for the same period in 2024.

Product gross profit increased by $13.7 million, or 305%, to $9.2 million for the nine months ended September 30, 2025, as compared to $(4.5) million for the same period in 2024.

The increase in product gross profit was primarily due to an increase in consumable and software sales and due to $9.8 million in total expenses recognized to write-off excess Saphyr instrument spare parts and other obsolete inventory for $7.2 million, as well as dispose of reagent rentals that were underutilized for $2.6 million during the three months ended September 30, 2024 .

We expect cost of product revenue to fluctuate with the volume of product sales .

Service and other gross profit decreased by $0.9 million, or 60%, to $0.6 million for the nine months ended September 30, 2025, as compared to $1.5 million for the same period in 2024.

The decrease in service and other gross profit was primarily due to discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

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Research and Development Expenses

R&D expenses decreased by $11.3 million, or 68%, to $5.3 million for the six months ended June 30, 2025, as compared to $16.6 million for the same period in 2024.

R&D expenses decreased by $13.2 million, or 62%, to $8.1 million for the nine months ended September 30, 2025, as compared to $21.3 million for the same period in 2024.

The decrease was primarily due to a decrease of $8.4 million in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024 and a decrease of $2.7 million in professional and consulting fees, including decreases in costs incurred to support clinical research studies, development of the Stratys system, foundry expenses, and cloud computing.

Lastly, we reduced information technology and rent and facility costs by $0.3 million, and we reduced our internal consumption of inventory, materials and supplies by $1.7 million.

We anticipate that R&D expenses will continue to decrease throughout 2025 as a result of our cost saving initiatives announced in March and September 2024.

We anticipate that R&D expenses will decrease throughout 2025, in comparison to the same period in 2024, as a result of our cost saving initiatives announced in March and September 2024.

Selling, General and Administrative Expenses

SG&A expenses decreased by $13.3 million, or 43%, to $17.4 million for the six months ended June 30, 2025, as compared to $30.6 million for the same period in 2024.

SG&A expenses decreased by $13.7 million, or 34%, to $26.4 million for the nine months ended September 30, 2025, as compared to $40.1 million for the same period in 2024.

The decrease was primarily due to a $12.5 million decrease in salaries, wages and benefits driven by headcount reductions announced in 2023 and 2024;

a $4.8 million decrease in professional and consulting fees which is primarily marketing, software, and legal expenses;

a $6.5 million decrease in professional and consulting fees which was primarily marketing, software, and legal expenses;

a $1.0 million decrease in travel and entertainment;

a $1.2 million decrease in information technology and rent and facility costs;

a $0.9 million decrease in depreciation and amortization and a $0.4 million gain on lease modification.

These decreases were offset by a $5.1 million gain recorded on the fair value of the contingent consideration due for the Purigen milestones during the same period in 2024 as compared to no gain recorded for the six months ended June 30, 2025.

We anticipate that SG&A expenses will continue to decrease throughout 2025 as a result of our cost saving initiatives announced in March and September 2024.

a $1.4 million decrease in depreciation and amortization;

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

and a $0.4 million change in the gain on lease modification.

These decreases were offset by a $10.9 million gain recorded on the fair value of the contingent consideration due for the Purigen milestones during the same period in 2024 as compared to no gain recorded for the nine months ended September 30, 2025.

We anticipate that SG&A expenses will decrease throughout 2025,in comparison to the same period in 2024, as a result of our cost saving initiatives announced in March and September 2024.

Intangible Assets and Other Long-lived Assets Impairment

The Company recognized no impairment losses on intangible assets and other long-lived assets during the six months ended June 30, 2025, as compared to $0.4 million for the same period in 2024.

The Company recognized no impairment losses on intangible assets and other long-lived assets during the nine months ended September 30, 2025, as compared to $20.0 million for the same period in 2024.

These losses were due to our restructuring initiatives and change in business strategy announced in 2024.

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Restructuring Costs

The Company had no expenses that were classified as restructuring costs during the six months ended June 30, 2025, as compared to $5.8 million during the same period in 2024.

The Company had no expenses that were classified as restructuring costs during the nine months ended September 30, 2025, as compared to $7.6 million during the same period in 2024.

These restructuring costs were the result of our cost saving initiatives announced in 2024.

Interest Income

Interest income was $0.6 million for the six months ended June 30, 2025, as compared to $1.5 million for the same period in 2024.

Interest income was $0.8 million for the nine months ended September 30, 2025, as compared to $1.9 million for the same period in 2024.

The decrease is primarily the result of a reduction in investments, partially offset by higher returns.

Other Income (Expense)

Other income was $5.8 million for the six months ended June 30, 2025, as compared to other expense of $1.0 million for the same period in 2024.

The change was primarily driven by a loss recorded on the issuance of the JGB Debentures of $1.9 million during the six months ended June 30, 2024 , debt issuance costs recorded in connection with the debt instruments of $1.4 million during the six months ended June 30, 2024, an increase in the change in fair value (net gain) of $5.3 million for the convertible High Trail Notes, Purchase Option, and convertible debentures during the six months ended June 30, 2025, and an increase in other income of $2.0 million primarily related to an ERC refundable tax credit received during the six months ended June 30, 2025 from the IRS for eligible businesses affected by the COVID-19 pandemic.

These changes were offset by a net gain on the extinguishment of the High Trail Note and Purchase Option of $4.0 million during the six months ended June 30, 2025.

Other income was $5.5 million for the nine months ended September 30, 2025, as compared to other expense of $1.7 million for the same period in 2024.

The change was primarily driven by a loss recorded on the issuance of the JGB Debentures of $1.9 million during the nine months ended September 30, 2024 , debt issuance costs recorded in connection with the debt instruments of $1.4 million during the nine months ended September 30, 2024, an increase in the change in fair value (net gain) of $5.7 million for the convertible High Trail Notes, Purchase Option, and convertible debentures during the nine months ended September 30, 2025, and an increase in other income of $2.1 million primarily related to an ERC refundable tax credit received during the nine months ended September 30, 2025 from the IRS for eligible businesses affected by the COVID-19 pandemic.

These changes were offset by a net gain on the extinguishment of the High Trail Note and Purchase Option of $4.0 million during the nine months ended September 30, 2024.

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Since our inception, we have incurred net losses and negative cash flows from operations.

We incurred net losses of $10.0 million and $47.6 million, and used $6.3 million and $49.1 million of cash from our operating activities for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $703.2 million, cash and cash equivalents of $3.6 million, $12.9 million in short-term investments and $11.0 million in restricted short-term investments.

We incurred net losses of $18.5 million and $91.9 million, and used $12.2 million and $62.4 million of cash from our operating activities for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $711.7 million, cash and cash equivalents of $3.1 million, $18.5 million in short-term investments and $10.3 million in restricted short-term investments.

Sources of Liquidity and Capital Resources

In the six months ended June 30, 2025, we have generated cash flows from sales of common stock and other equity instruments.

In the nine months ended September 30, 2025, we have generated cash flows from sales of common stock and other equity instruments.

We anticipate that future sources of liquidity will principally come from sales of common stock and other equity instruments, borrowings from credit facilities and revenue from our commercial operations.

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As consideration for the Amendment, the Company issued to the Selling Securityholders approximately 83,000 shares of its common stock (the “Private Placement Shares”).

As of June 30, 2025, the Company reported $11.8 million of Debentures at fair value, which is classified as current on the unaudited condensed consolidated balance sheet.

For the six months ended June 30, 2025, the Company paid $0.8 million in interest and $3.0 million in principal redemption amounts on the Debentures.

As of June 30, 2025, the Company may be required to redeem up to $7.4 million of principal and expects to pay an additional $0.6 million in interest on the Debentures for the remainder of 2025.

As of September 30, 2025, the Company reported $9.8 million of Debentures at fair value, which is classified as current on the unaudited condensed consolidated balance sheet.

For the nine months ended September 30, 2025, the Company paid $1.1 million in interest and $4.9 million in principal redemption amounts on the Debentures.

As of September 30, 2025, the Company may be required to redeem up to $4.1 million of principal and expects to pay an additional $0.3 million in interest on the Debentures for the remainder of 2025.

See Note 5 (Debt) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further information.

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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.

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.

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.

See Note 6 (Stockholder’s Equity and Stock-Based Compensation) in the accompanying notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further information.

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Our existing cash and cash equivalents and short-term investments will not be sufficient for us to achieve cash-flow break even, and we expect to need to seek additional capital.

Based on the Company’s current business plans we believe we will be able to fund our operating expenses and capital expenditure requirements into the first quarter of 2026.

Based on the Company’s current business plans we believe we will be able to fund our operating expenses and capital expenditure requirements into the third quarter of 2026.

Future Capital Requirements

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We expect such expenditures to continue throughout the balance of 2025.

As of June 30, 2025, we had $3.6 million in cash and cash equivalents, $12.9 million in short-term investments and $11.0 million in restricted short-term investments.

As of September 30, 2025, we had $3.1 million in cash and cash equivalents, $18.5 million in short-term investments and $10.3 million in restricted short-term investments.

The amount we are required to hold as restricted cash or restricted investments is equal to the lesser of (a) $11.0 million and (b) the then outstanding principal balance of the Debentures.

As of September 30, 2025, the Company had $10.3 million of principal outstanding under the Debentures.

Based on recurring losses from operations incurred since inception and the expectation of continued operating losses, we anticipate our available cash balance will not be sufficient to operate our business for the next twelve months from the issuance of this Quarterly Report.

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Net cash provided by (used in):

Six Months Ended June 30,

Nine Months Ended September 30,

Operating activities $ (12,170,000) $ (62,418,000)

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however, our financial condition may result in certain additional restructuring or advisory expenses which may result in our corporate expenditures increasing, potentially materially, and we may observe fluctuations in the cash used in operating activities on a quarterly basis to sustain our current commercial offerings.

Net cash used in operating activities was $6.3 million during the six months ended June 30, 2025, as compared to $49.1 million during the same period in 2024.

The decrease in cash used in operating activities of $42.9 million was primarily attributed to a decrease in our net loss and a decrease in our working capital usage as a result of our cost saving initiatives that were initiated in 2024.

Net cash used in operating activities was $12.2 million during the nine months ended September 30, 2025, as compared to $62.4 million during the same period in 2024.

The decrease in cash used in operating activities of $50.2 million was primarily attributed to a decrease in our net loss as a result of our cost saving initiatives that were initiated in 2024.

Investing Activities

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We expect to continue to incur additional costs for capital expenditures related to these efforts in future periods.

During the six months ended June 30, 2025, net cash used in investing activities was $12.1 million, as compared to $76.2 million provided by investing activities during the same period in 2024.

The decrease in cash provided by investing activities of $88.3 million was primarily attributed to the maturity of $104.6 million in available for sale securities, which was offset by a higher purchase of available for sale securities of $116.6 million during the six months ended June 30, 2025, as compared to the maturity of $227.9 million in available for sale securities, which was partially offset by a purchase of $151.6 million of available for sale securities during the same period in 2024.

During the nine months ended September 30, 2025, net cash used in investing activities was $16.8 million, as compared to $70.8 million provided by investing activities during the same period in 2024.

The decrease in cash provided by investing activities of $87.6 million was primarily attributed to the maturity of $160.8 million in available for sale securities, which was offset by a higher purchase of available for sale securities of $177.5 million during the nine months ended September 30, 2025, as compared to the maturity of $285.3 million in available for sale securities, which was partially offset by a purchase of $214.3 million of available for sale securities during the same period in 2024.

Financing Activities

Net cash provided by financing activities was $12.4 million during the six months ended June 30, 2025 as compared to net cash used in financing activities of $23.6 million during the same period in 2024, an increase of $36.0 million.

During the six months ended June 30, 2025, the Company made principal payments of $3.0 million towards the convertible debentures payable, as compared to principal payments of $62.4 million towards the convertible High Trail Notes payable and the convertible debentures payable, $5.4 million incurred for the debt issuance costs recorded from the issuance of the convertible debentures, which was partially offset by approximately $18.0 million in gross proceeds received from the issuance of the convertible debentures during the same period in 2024, and $16.4 million in gross proceeds from executing sales under our at-the-market facilities with Cowen and Company, LLC (“Cowen”) and H.C.

Wainwright & Co., LLC (“Wainwright”) during the six months ended June 30, 2025, as compared to $27.6 million during the same period in 2024.

Net cash provided by financing activities was $22.4 million during the nine months ended September 30, 2025 as compared to net cash used in financing activities of $17.6 million during the same period in 2024, an increase of $40.0 million.

During the nine months ended September 30, 2025, the Company made principal payments of $4.9 million towards the convertible debentures payable, as compared to principal payments of $64.0 million towards the convertible High Trail Notes payable and the convertible debentures payable, $1.4 million incurred for the debt issuance costs recorded from the issuance of the convertible debentures, which was partially offset by approximately $18.0 million in gross proceeds received from the issuance of the convertible debentures during the same period in 2024, and $29.3 million in gross proceeds from executing sales under our at-the-market facilities with Cowen and Company, LLC (“Cowen”) and H.C.

Wainwright & Co., LLC (“Wainwright”) during the nine months ended September 30, 2025, as compared to $37.7 million in gross proceeds from executing sales under our at-the-market facilities with Cowen during the same period in 2024.

Capital Resources

As of June 30, 2025, we 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, we 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 we are required to hold as restricted cash or restricted 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) to our unaudited condensed consolidated financial statements).

As of September 30, 2025, the Company had $10.3 million of principal outstanding under the Debentures.

In order to fund our future operations, on March 10, 2023, we filed a universal shelf registration statement (the “Shelf Registration Statement”) with the SEC, which provides for aggregate offerings of up to $400.0 million of common stock, preferred stock, debt securities and warrants or any combination thereof.

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On February 4, 2025, the Company provided notice of its termination, effective February 14, 2025, of the Cowen ATM.

stock having an aggregate offering price of up to $75.0 million, through or to Wainwright, acting as sales agent or principal, pursuant to the Shelf Registration Statement.

In February and March 2025, the Company sold approximately 0.4 million shares of common stock under the ATM Agreement 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 for gross proceeds of approximately $3.1 million before deducting offering costs of $0.09 million.

On February 21, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Wainwright, pursuant to which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $75.0 million, through or to Wainwright, acting as sales agent or principal, pursuant to the Shelf Registration Statement.

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.

On March 31, 2025, the date we filed our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our public float was less than $75 million, As a result, we became subject to the offering limits in General Instruction I.B.6 of Form S-3.

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If our public float increases or decreases, the number of securities we may sell under our shelf registration statements in accordance with General Instruction I.B.6 of Form S-3 will also increase or decrease, respectively.

Consequently, based on an increase in our current public float for our common stock, on October 17, 2025, we filed a prospectus supplement to amend and supplement the information in the prospectus dated May 10, 2023 and the prospectus supplements, dated April 2, 2025 and February 21, 2025, relating to the ATM Prospectus, to increase the amount of shares of our common stock we are eligible to sell under General Instruction I.B.6 of Form S-3, as described above, and pursuant to the ATM Agreement.

If our public float increases above $75.0 million such that we may sell additional amounts under the ATM Agreement and the ATM Prospectus, we will file another amendment to the ATM Prospectus prior to making additional sales in excess of the limitations of General Instruction I.B.6 of Form S-3.

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Historically, revisions to our estimates have not resulted in a material change to our financial statements.

During the six months ended June 30, 2025, there have been no changes to our critical accounting policies and estimates as described in our Annual Report.

During the nine months ended September 30, 2025, there have been no changes to our critical accounting policies and estimates as described in our Annual Report.

Recent Accounting Pronouncements

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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 2. Management’s Discussion and Analysis