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Item 2. Management’s Discussion and Analysis

2025-05-14 compared with 2024-11-14 · 129 added, 224 removed, 176 unchanged (67% 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 nine months ended September 30, 2024 (“Quarterly Report”) and the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2023 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, 2023, (“Annual Report”), filed with the Securities and Exchange Commission, (“SEC”), on March 5, 2024.

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 months ended March 31, 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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Commercial Adoption of Offerings for OGM Systems

In executing on our commercialization strategy, we expanded the utilization of our OGM systems and:

• Grew our installed base to 368 as of September 30, 2024, an increase of approximately 22% from a total installed base of 301 as of September 30, 2023.

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 379 as of March 31, 2025, an increase of approximately 9% from a total installed base of 347 as of March 31, 2024.

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

• Sold 7,835 flowcells in the three-month period ended September 30, 2024, an increase of approximately 27% from 6,176 flowcells sold in the same quarter of 2023.

Sold 22,249 flowcells in the nine-month period ended September 30, 2024, an increase of approximately 20% from 18,464 flowcells sold in the same period of 2023.The OGM cartridge is the consumable that packages nanochannel arrays for DNA linearization.

• Sold 6,994 flowcells in the three-month period ended March 31, 2025, a decrease of approximately 15% from 8,249 flowcells sold in the same quarter of 2024.

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

In its current form, the OGM cartridge can comprise - one, two or three flowcells per cartridge.

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Macroeconomic and Geopolitical Developments

We are subject to additional risks and uncertainties as a result of adverse geopolitical and macroeconomic developments, such as recent and potential future bank failures, the ongoing conflict between Ukraine and Russia and in the Middle East, related sanctions, and any effects of global pandemics and uncertain market conditions, including inflation and supply chain disruptions, which could continue to have a material impact on our business and financial results.

For example, we are

anticipating a potential protracted slowdown in our Asia Pacific business due to funding headwinds in the region, which are negatively impacting these manufacturing partners who are reliant on government funding, and are awaiting approval from the NMPA.

We are subject to additional risks and uncertainties as a result of adverse geopolitical and macroeconomic developments, such as recent and potential future bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East, related sanctions, any effects of global pandemics and uncertain market conditions, including inflation and supply chain disruptions, and international trade policies (including trade protection measures, such as tariffs, sanctions and other trade barriers), changes

in monetary and fiscal policy, United States political developments and other sources of instability which, have not had a material impact on our business and financial results to date, but could result in a material impact to our business or financial results in the future.

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.

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

and global financial markets experienced volatility, which has led to disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity globally.

In response to the invasion, the United States, UK and EU, along with others, imposed significant new sanctions and export controls against Russia, Russian banks and certain Russian individuals and may implement additional sanctions or take further punitive actions in the future.

The full economic and social impact of the sanctions imposed on Russia and possible future punitive measures that may be implemented, as well as the counter measures imposed by Russia, in addition to the ongoing military conflict between Ukraine and Russia, which could conceivably expand into the surrounding region, remains uncertain;

however, both the conflict and related sanctions have resulted, and could continue to result, in disruptions to trade, commerce, pricing stability, credit availability, supply chain continuity and reduced access to liquidity on acceptable terms, in both Europe and globally, and has introduced significant uncertainty into global markets.

As a result, our business and results of operations may be adversely affected by the ongoing conflict between Ukraine and Russia and related sanctions, particularly to the extent it escalates to involve additional countries, further economic sanctions or wider military conflict.

We closely monitor and comply with various applicable guidelines and legal requirements in the jurisdictions in which we operate.

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 nine months ended September 30, 2024, we did not experience material increases in our supply chain costs, but we may experience such increases in future fiscal periods.

During the three months ended March 31, 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

In March 2024 and September 2024, we announced restructuring plans that aim to reduce annualized operating expenses by approximately $35.0 to $40.0 million starting in the second half of 2024, and by an additional $25.0 million to $30.0 million beginning in the fourth quarter of 2024, respectively.

As part of the plans, we reduced our overall headcount by approximately 120 and 83 employees, respectively.

The Company has substantially completed the reductions in force as of September 30, 2024.

In addition, as of September 30, 2024, we have phased out the offering by Bionano Laboratories of certain testing services related to neurodevelopmental disorders, including autism spectrum disorders and other disorders of childhood development.

These measures were incremental to the cost saving initiatives previously announced in May 2023 and October 2023.

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

As part of the plans we have also made a change in our business strategy and refocused our efforts on the current installed base of OGM systems with less emphasis on new placements of OGM systems and more emphasis on ensuring customers are able to maximize their utilization of the OGM systems.

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.

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

The payments are intended to create a deposit for inventory Bionano may purchase above the 2025 minimum order quantity and guarantee the availability of certain raw materials previously purchased by the contract manufacturer to build instruments.

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.

Financial Overview

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Consumable revenue consists of sales of reagents and chips necessary to process a sample.

Sales of our VIA software, which provides customers with solutions for analysis, interpretation and reporting of genomic data, are made on a subscription basis.

Sales of our VIA software, which provides customers with solutions for analysis, interpretation and reporting of genomics data, are made on a subscription basis.

We generate service revenue from the sale of diagnostic testing services through Bionano Laboratories, as well as services performed related to customer sample evaluations using an OGM system.

Other revenue consists of warranty and other service-based revenue, including support, repair and maintenance services.

We anticipate that our change in 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 would slow the pace of our revenue growth when compared to historical growth rates.

We expect service and other revenue to continue to decrease over the remainder of 2024 as a result of phasing out Bionano Laboratories offerings.

The following table presents our revenue for the periods indicated:

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

2024 2023 2024 2023

Three Months Ended March 31,

Product revenue $ 6,004,000 $ 6,828,000

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

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

2024 2023 2024 2023

$ % $ % $ % $ %

Three Months Ended March 31,

Americas $ 3,058,000 47 % $ 4,690,000 53 %

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We have incurred losses in each year since our inception.

Our net loss was $44.2 million and $91.9 million for the three and nine months ended September 30, 2024, respectively.

As of September 30, 2024, we had an accumulated deficit of $673.1 million.

Our net loss was $3.1 million for the three months ended March 31, 2025.

As of March 31, 2025, we had an accumulated deficit of $696.3 million.

While we have 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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• incur increased costs as a result of operating as a public company.

Accordingly, based on recurring losses from operations incurred since inception, the expectation of continued operating losses, and the need to raise additional capital to finance our future operations, we determined that there is substantial doubt about our ability to continue as a going concern within 12 months after the date that the financial statements included in this Quarterly Report are issued.

ability to continue as a going concern within 12 months after the date that the financial statements included in this Quarterly Report are issued.

We will continue to seek to raise additional capital, but without sufficient additional financing in the very near term we will not be able to continue as a going concern.

If we are unable to continue as a going concern, we may have to reorganize or liquidate our business and may receive less than the value at which those assets are carried on our consolidated financial statements, and investors may lose all or a part of their investment.

The board of directors (the “Board”) has established a strategy committee to work with the Company and outside advisors in evaluating our options and considering alternatives that we believe will maximize stakeholder value, including any of the following or a combination thereof:

The board of directors has established a strategy committee to work with the Company and outside advisors in evaluating our options and considering alternatives that we believe will maximize stakeholder value, including any of the following or a combination thereof:

debt financing, equity investments, combinations with other companies, or the sale of all or part of the company.

There can be no assurances that any transactions will be available to us or completed and if we are not able to raise sufficient additional capital in the very near term to fund our operation, we may seek relief available under applicable insolvency laws.

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

Comparison of the Three Months Ended September 30, 2024 and 2023

The following table sets forth our results of operations for the three months ended September 30, 2024 and 2023:

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

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 March 31, 2025 and 2024

The following table sets forth our results of operations for the three months ended March 31, 2025 and 2024:

Three Months Ended March 31, Period-to-Period Change

Product revenue $ 6,004,000 $ 6,828,000 $ (824,000) (12) %

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Selling, general and administrative 9,033,000 19,088,000 (10,055,000) (53) %

Goodwill impairment

— 77,280,000 (77,280,000) (100) %

Intangible assets and other long-lived assets impairment

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Loss before income taxes (3,095,000) (31,440,000) 28,345,000 (90) %

Provision for income taxes (24,000) (39,000) 15,000 (38) %

Net loss $ (44,246,000) $ (112,566,000) $ 68,320,000 (61) %

Product revenue decreased by $0.4 million, or 7%, to $6.0 million for the three months ended September 30, 2024 compared to $6.5 million for the same period in 2023.

The decrease in product revenue was driven by a $0.9 million or 39% decrease in instrument revenue, a $0.4 million or 23% decrease in software revenue, and partially offset by an increase of $0.9 million or 35% in consumables revenue.

In September 2024 Bionano announced a change in its business strategy which would allow the company to become a more capital-efficient business.

Our focus is on driving utilization and adoption of OGM from our

existing installed base, with less emphasis on new placements of our OGM systems.

We anticipate that this change in strategy would slow the pace of our revenue growth when compared to historical growth rates.

Service and other revenue decreased by $2.8 million, or 98%, to $0.1 million for the three months ended September 30, 2024 when compared to the same period in 2023 which is the result of discontinuing sales of certain clinical service offerings from Bionano Laboratories effective March 2024.

We expect service and other revenue to continue to decrease over the remainder of 2024 as a result of phasing out these offerings.

Cost of Revenue

Cost of product revenue increased by 179%, to $14.3 million for the three months ended September 30, 2024, compared to $5.1 million for the three months ended September 30, 2023.

The increase 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 .

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

Cost of service and other revenue decreased by $1.2 million, or 82%, to $0.3 million for the three months ended September 30, 2024, compared to $1.5 million for the three months ended September 30, 2023.

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.

We expect cost of service and other revenue to decrease over the remainder of 2024 as a result of our decision to phase out certain clinical service offerings from Bionano Laboratories.

Gross Profit, and Gross Margin

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

Gross profit (loss):

Product $ (8,230,000) $ 1,351,000 $ (9,581,000) (709)%

Service and other (216,000) 1,398,000 (1,614,000) (115)%

Total gross profit $ (8,446,000) $ 2,749,000 $ (11,195,000) (407)%

Gross margin:

Product (137) % 21 %

Service and other (415) % 49 %

Total gross margin (139) % 30 %

Product gross profit decreased by $9.6 million, or 709%, to $8.2 million for the three months ended September 30, 2024, compared to $1.4 million for the three months ended September 30, 2023.

The decrease 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 .

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

Service and other gross profit decreased by $1.6 million, or 115%, to $0.2 million for the three months ended September 30, 2024, compared to $1.4 million for the three months ended September 30, 2023.

The decrease 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.

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

We expect service and other gross profit to decrease over the remainder of 2024 as a result of our decision to phase out certain clinical service offerings from Bionano Laboratories.

Research and Development Expenses

Research and development (“R&D”) expenses decreased by $9.1 million, or 66%, to $4.7 million for the three months ended September 30, 2024 compared to $13.8 million for the same period in 2023.

The decrease was partially due to decreases of $4.6 million in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024, and of $2.6 million in professional and consulting fees including decreases in costs incurred to support clinical research studies, Stratys development, foundry expenses, and cloud computing.

We also reduced our internal consumption of inventory, materials and supplies by $1.4 million.

We anticipate that R&D expenses will decrease for the remainder of 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 $15.4 million, or 62%, to $9.5 million for the three months ended September 30, 2024 compared to $24.9 million for the same period in 2023.

The decrease was primarily due to a $6.3 million decrease in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024, a $6.1 million decrease in the gain/loss recorded on fair value of the contingent consideration due for BioDiscovery and Purigen milestones, a $3.2 million decrease in professional and consulting fees which is primarily marketing, software and legal expenses, and $0.6 million decrease in travel and entertainment.

We anticipate that SG&A expenses will decrease for the remainder of 2024 as a result of our restructuring initiatives announced in March and September 2024.

Goodwill impairment

Goodwill of $77.3 million was fully impaired during the three months ended September 30, 2023.

Intangible assets and other long-lived assets impairment

The Company recognized a $19.5 million loss on intangible assets and other long-lived assets impairment during the three months ended September 30, 2024 due to our restructuring initiatives and change in business strategy.

The Company recognized no additional impairment losses during the three months ended September 30, 2023.

See Note 1 (Organization and Basis of Presentation) 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 quarter.

Restructuring Costs

Restructuring costs were $1.8 million for the three months ended September 30, 2024, as a result of our cost saving initiatives announced in March and September 2024.

We had no expenses that were classified as restructuring costs during the same period in 2023.

Interest Income

Interest income was $0.4 million for the three months ended September 30, 2024, as compared to $0.7 million for the same period in 2023.

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

Other income (expense)

Other income (expense) was $0.7 million for the three months ended September 30, 2024, as compared to $45,000 for the same period in 2023.

The increase is primarily driven by an increase in the change in fair value (net gain) of $0.6 million for the convertible debentures.

See Note 5 (Debt) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for further discussion on debt transactions that took effect during the year.

Comparison of the Nine Months Ended September 30, 2024 and 2023

The following table sets forth our results of operations for the nine months ended September 30, 2024 and 2023:

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

Product revenue $ 19,359,000 $ 18,512,000 $ 847,000 5 %

Service and other revenue 3,254,000 6,883,000 (3,629,000) (53) %

Total revenue 22,613,000 25,395,000 (2,782,000) (11) %

Cost of revenue:

Cost of product revenue 23,858,000 13,714,000 10,144,000 74 %

Cost of service and other revenue 1,792,000 4,553,000 (2,761,000) (61) %

Total cost of revenue 25,650,000 18,267,000 7,383,000 40 %

Operating expenses:

Research and development 21,329,000 42,331,000 (21,002,000) (50) %

Selling, general and administrative 40,109,000 77,809,000 (37,700,000) (48) %

Goodwill impairment

— 77,280,000 (77,280,000) (100) %

Intangible assets and other long-lived assets impairment

19,951,000 — 19,951,000 100 %

Restructuring costs

7,616,000 — 7,616,000 100 %

Total operating expenses 89,005,000 197,420,000 (108,415,000) (55) %

Loss from operations (92,042,000) (190,292,000) 98,250,000 (52) %

Other income (expenses):

Interest income 1,876,000 2,122,000 (246,000) (12) %

Other income (expenses)

Benefit (provision) for income taxes

(7,000) 18,000 (25,000) (139) %

Total other income (expenses) 182,000 1,788,000 (1,606,000) (90) %

Loss before income taxes (91,860,000) (188,504,000) 96,644,000 (51) %

Provision for income taxes (32,000) (98,000) 66,000 (67) %

Net loss $ (3,102,000) $ (31,422,000) $ 28,320,000 (90) %

Product revenue increased by $0.8 million, or 5%, to $19.4 million for the nine months ended September 30, 2024, compared to $18.5 million for the same period in 2023.

The increase in product revenue was driven by a $1.7 million or 22% increase in sales of consumables and an increase of $0.5 million or 13% of software, partially offset by a $1.4 million or 21% decrease in instrument sale s.

In September 2024, we announced a change in its business strategy which would allow the company to become a more capital-efficient business.

Our focus is on driving utilization and adoption of OGM from our existing installed base, with less emphasis on new placements of our OGM systems.

We anticipated that this change in strategy would slow the pace of our revenue growth when compared to historical growth rates.

Service and other revenue decreased by $3.6 million or 53% for the nine months ended September 30, 2024, compared to the same period in 2023 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 $1.7 million in revenues for the nine months ended September 30, 2024 compared to $5.1 million for the same period in 2023.

We expect service and other revenue to continue to decrease over the remainder of 2024 as a result of phasing out these offerings.

Product revenue decreased by $0.8 million, or 12%, to $6.0 million for the three months ended March 31, 2025, as compared to $6.8 million for the same period in 2024.

The decrease in product revenue was driven by a decrease of $0.9 million or 57% in instrument sales and a $0.2 million or 6% decrease in consumable sales, partially offset by an increase of $0.3 million or 18% 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 anticipated that this change in strategy would slow the pace of our revenue growth when compared to historical growth rates and that the reduced pace of our revenue growth will continue in 2025.

Service and other revenue decreased by $1.5 million or 77% for the three months ended March 31, 2025, 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 to no revenues for the three months ended March 31, 2025, as compared to $1.4 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 increased by $10.1 million, or 74%, to $23.9 million for the nine months ended September 30, 2024, compared to $13.7 million for the same period in 2023.

The increase in cost of product revenue was due to higher sales of consumables offset by lower sales of instruments.

In addition, during the three months ended September 30, 2024, $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 .

Cost of product revenue decreased by $1.9 million, or 38%, to $3.1 million for the three months ended March 31, 2025, as compared to $4.9 million for the same period in 2024.

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

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

Cost of service and other revenue decreased by $2.8 million, or 61%, to $1.8 million for the nine months ended September 30, 2024, compared to $4.6 million for the same period in 2023.

Cost of service and other revenue decreased by $0.6 million, or 55%, to $0.5 million for the three months ended March 31, 2025, compared to $1.0 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.

We expect cost of service and other revenue to decrease over the remainder of 2024 as a result of our decision to phase out certain clinical service offerings from Bionano Laboratories.

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

Gross Profit, and Gross Margin

Nine Months Ended September 30,

Period-to-Period Change Period-to-Period Percentage Change

Three Months Ended March 31,

Period-to-Period Change

Gross profit (loss):

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Total gross margin 46 % 32 %

Product gross profit decreased by $9.3 million, or 194%, to $4.5 million for the nine months ended September 30, 2024, compared to $4.8 million for the same period in 2023.

Service and other gross profit decreased by $0.9 million, or 37%, to $1.5 million for the nine months ended September 30, 2024, compared to $2.3 million for the same period in 2023.

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

We expect service and other gross profit to decrease over the remainder of 2024 as a result of our decision to phase out certain clinical service offerings from Bionano Laboratories.

Product gross profit increased by $1.0 million, or 53%, to $3.0 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024.

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

Service and other gross profit (loss) decreased by $0.9 million, or 101%, to $(0.01) million for the three months ended March 31, 2025, as compared to $0.9 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.

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

R&D expenses decreased by $21.0 million, or 50%, to $21.3 million for the nine months ended September 30, 2024 compared to $42.3 million for the same period in 2023.

The decrease was partially due to decreases of $11.1 million in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024 and $6.2 million in professional and consulting fees, including decreases in costs incurred to support clinical research studies, Stratys development, foundry expenses, and cloud computing.

Research and development (“R&D”) expenses decreased by $7.4 million, or 76%, to $2.4 million for the three months ended March 31, 2025 compared to $9.8 million for the same period in 2024.

The decrease was primarily due to a decrease of $4.4 million in salaries, wages and benefits driven by headcount reductions announced throughout 2023 and 2024 and $1.4 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 $0.1 million, and we reduced our internal consumption of inventory, materials and supplies by $1.4 million.

We anticipate that R&D expenses will decrease for the remainder of 2024 as a result of our cost saving initiatives announced in March and September 2024.

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.

Selling, General and Administrative Expenses

SG&A expenses decreased by $37.7 million, or 48%, to $40.1 million for the nine months ended September 30, 2024 compared to $77.8 million for the same period in 2023.

The decrease was primarily due to a $16.1 million decrease in salaries, wages and benefits driven by headcount reductions announced in 2023 and 2024, a $13.4 million decrease in the gain/loss recorded on fair value of the contingent consideration due for Purigen and BioDiscovery milestones, a $7.4 million decrease in professional and consulting fees which is primarily marketing, software, and legal expenses, and a $1.7 million decrease in travel and entertainment.

We anticipate that SG&A expenses will decrease for the remainder of 2024 as a result of our cost saving initiatives announced in March and September 2024.

Goodwill impairment

Goodwill of $77.3 million was fully impaired during the nine months ended September 30, 2023.

Selling, general and administrative (“SG&A”) expenses decreased by $10.1 million, or 53%, to $9.0 million for the three months ended March 31, 2025 compared to $19.1 million for the same period in 2024.

The decrease was primarily due to a $5.8 million decrease in salaries, wages and benefits driven by headcount reductions announced in 2023 and 2024, a $0.6 million decrease in the gain/loss recorded on fair value of the contingent consideration due for Purigen milestones, a $2.6 million decrease in professional and consulting fees which is primarily marketing, software, and legal expenses, and a $0.7 million decrease in travel and entertainment.

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.

Intangible assets and other long-lived assets impairment

The Company recognized $20.0 million in impairment losses on intangible assets and other long-lived assets during the nine months ended September 30, 2024 due to our restructuring initiatives and change in business strategy.

The Company recognized no additional impairment losses during the nine months ended September 30, 2023.

The Company recognized no impairment losses on intangible assets and other long-lived assets during the three months ended March 31, 2025, as compared to $0.4 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 quarter.

Restructuring Costs

Restructuring costs were $7.6 million for the nine months ended September 30, 2024, as a result of our cost saving initiatives announced in March and September 2024.

We had no expenses that were classified as restructuring costs during the same period in 2023.

The Company had no expenses that were classified as restructuring costs during the three months ended March 31, 2025, as compared to $4.6 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 $1.9 million for the nine months ended September 30, 2024, as compared to $2.1 million for the same period in 2023.

Interest income was $0.3 million for the three months ended March 31, 2025, as compared to $1.0 million for the same period in 2024.

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

Other income (expense)

Other expense was $1.7 million for the nine months ended September 30, 2024 compared to $0.3 million for the same period in 2023.

The decrease was driven by a net gain on the extinguishment of the High Trail Note and Purchase Option of $4.0 million, offset by a loss recorded on the issuance of the JGB Debentures of $1.9 million, an increase in the change in fair value (net gain) of $2.0 million for the convertible notes, purchase option, and convertible debentures, and an increase in interest expense of $1.5 million.

Other income was $5.1 million for the three months ended March 31, 2025 compared to other expense of $1.4 million for the same period in 2024.

The increase to other income was primarily driven by a $6.2 million increase (net gain) in the total change in fair value adjustments, principal redemptions and interest payments of the convertible High Trail Notes and purchase option outstanding as of March 31, 2024, as compared to the total change in fair value adjustments, principal redemptions and interest payments of the convertible debentures payable outstanding as of March 31, 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.

Liquidity and Capital Resources

Since our inception, we have incurred recurring net losses from operations, negative cash flows from operating activities and accumulated deficit.

We have primarily generated cash flows from sales of equity securities and debt financings.

We incurred net losses of $91.9 million and $188.6 million for the nine months ended September 30, 2024 and 2023, respectively.

As of September 30, 2024, we had an accumulated deficit of $673.1 million, cash and cash equivalents of $8.8 million, $11.4 million in restricted cash and short-term investments of $3.2 million.

In connection with the Debentures (as defined below), 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.

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

We incurred net losses of $3.1 million and $31.4 million, and used $2.8 million and $28.1 million of cash from our operating activities for the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025, we had an accumulated deficit of $696.3 million, cash and cash equivalents of $3.6 million, $14.6 million in short-term investments and $11.0 million in restricted short-term investments.

Sources of Liquidity and Capital Resources

In the nine months ended September 30, 2024, we incurred negative cash flows from operating activities of $62.4 million.

In the three months ended March 31, 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.

See Note 6 (Stockholder’s Equity and Stock-Based Compensation) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for a discussion of our recent equity activity for more information.

On October 13, 2023, we completed a registered offering (the “October 2023 Registered Offering”) of senior secured convertible notes payable due 2025 (the “High Trail Registered Notes”) and warrants (the “Registered Warrants”) and a concurrent private placement (the “October 2023 Private Placement” and together with the October 2023 Registered Offering, the “October 2023 Offering”) of senior secured convertible notes payable due 2025 (the “High Trail Private Placement Notes” and, together with the High Trail Registered Notes, the “High Trail Notes”) and warrants (the “Private Placement Warrants” and, together with the Registered Warrants, the “Warrants”) and received net proceeds from the sale of the High Trail Notes and the Registered Warrants of approximately $75.6 million, after deducting the offering expenses and placement agent fees.

On February 27, 2024, we entered into a letter agreement (the “Letter Agreement”) and an Amendment to the Registered Notes (the “Amendment”), with the purchaser of the High Trail Registered Notes which provided reduction (i) of the minimum liquidity covenant from $50.0 million, and (ii) of the restricted cash covenant from $35.0 million, to the amount equal to the sum of (iii) the outstanding principal amount of the High Trail Registered Notes plus (iv) approximately $0.7 million, which will be further reduced as the remaining principal on the High Trail Registered Notes are retired.

We also redeemed the outstanding $17.0 million of the High Trail Private Placement Notes for a redemption payment of approximately $19.6 million and a retirement fee of $3.2 million paid concurrently and $10.7 million of the High Trail Registered Notes for a redemption payment of approximately $12.3 million.

On March 1, 2024, we redeemed $27.7 million aggregate principal amount of the High Trail Notes at a redemption price of 115% of the outstanding principal (the “Repayment Price”) or $31.8 million, and for the period January 1, 2024 through May 1, 2024, redeemed an additional $18.0 million aggregate principal amount of the High Trail Notes at the holders’ option at the Repayment Price for an aggregate of $20.7 million.

See Note 5 (Debt) and 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 a discussion of our recent debt and equity activity.

On May 24, 2024, we entered into a securities purchase agreement with certain accredited investors (the “Holders”) and JGB Collateral LLC, as collateral agent for the Holders, for the sale by the Company in a private placement (the “JGB Debentures Offering”) of:

• 2.25 million shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and

• 38,000 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and

• Senior Secured Convertible Debentures in the aggregate principal amount of $20.0 million (the “Debentures”), for an aggregate purchase price of $18.0 million.

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The Company used the proceeds received to fully redeem the outstanding balance due under the High Trail Note of approximately $17.6 million, as amended (see further discussion below).

On May 23, 2024, in connection with the JGB Debentures Offering, the Company entered into a redemption agreement with High Trail (“HT Agreement”).

Pursuant to the HT Agreement, the Company agreed to redeem the entire outstanding principal amount of $15.3 million under the High Trail Note at a redemption price of 115% for a total redemption payment of $17.6 million (the “Redemption Payment”).

Upon High Trail’s receipt of the Redemption Payment on May 24, 2024, the High Trail Note and related Option were cancelled.

On May 23, 2024, in connection with the JGB Debentures Offering, the Company entered into a redemption agreement with High Trail (“High Trail Agreement”).

Pursuant to the High Trail Agreement, the Company agreed to redeem the entire outstanding principal amount of $15.3 million under the High Trail Note at a redemption price of 115% for a total redemption payment of $17.6 million (the “Redemption Payment”).

Upon High Trail’s receipt of the Redemption Payment on May 24, 2024, the High Trail Note and related Purchase Option to purchase additional High Trail Notes at fair value were cancelled.

In addition, the Company agreed to pay High Trail a retirement fee of $2.2 million and to reimburse High Trail for all of its reasonable and documented out-of-pocket expenses incurred with the release and termination of security interests relating to the High Trail Note.

As of September 30, 2024, the Company reported $15.0 million of Debentures at fair value, which is classified as current on the unaudited condensed consolidated balance sheet.

Through September 30, 2024, the Company paid $0.8 million in interest and $3.0 million in principal redemption amounts on the Debentures.

As of September 30, 2024, the Company may be required to redeem up to $3.0 million of principal and expects to pay an additional $0.4 million in interest on the Debentures in the fourth quarter of 2024.

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

On April 4, 2024, we entered into a securities purchase agreement (the “April Purchase Agreement”) with certain institutional investors, pursuant to which we agreed to issue and sell, in a registered direct offering priced at-the-market consistent with the rules of the Nasdaq Stock Market (the “April 2024 Registered Direct Offering”):

(i) an aggregate of 6.5 million shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate of 2.2 million shares of common stock and (iii) warrants to purchase up to 8.7 million shares of common stock.

The combined purchase price of each share of common Stock and accompanying warrant was $1.15 per share.

The combined purchase price of each pre-funded warrant and accompanying warrant was $1.14 (equal to the combined purchase price per share of common stock and accompanying warrant, minus $0.001).

We received gross proceeds from the April 2024 Registered Direct Offering of approximately $10.0 million, before deducting placement agent fees and other offering expenses of $0.7 million.

On July 4, 2024, we entered into a securities purchase agreement (the “July 2024 Purchase Agreement”) with certain institutional investors, pursuant to which we agreed to issue and sell, (i) in a registered direct offering priced at-the-market consistent with the rules of the Nasdaq Stock Market (the “July 2024 Registered Direct Offering”):

(a) an aggregate of 11.7 million shares of our common stock, and (b) pre-funded warrants to purchase up to an aggregate of 5.8 million shares of Common Stock, and (ii) in a concurrent private placement (the “Private Placement” and together with the Registered Direct Offering, the “July 2024 Offering”), Series A warrants to purchase up to an aggregate of 17.5 million shares of Common Stock (the “Series A Warrants”) and Series B warrants to purchase up to an aggregate of 17.5 million shares of Common Stock (the “Series B Warrants”, and together with the Series A Warrants, the “Purchase Warrants”).

Each share of Common Stock and each Pre-Funded Warrant sold pursuant to the Purchase Agreement will be accompanied by one Series A Warrant and one Series B Warrant.

The combined purchase price of each share of Common Stock and accompanying Purchase Warrants is $0.571 per share.

The combined purchase price of each Pre-Funded Warrant and accompanying Purchase Warrants is $0.571 (equal to the combined purchase price per share of Common Stock and accompanying Purchase Warrants, minus $0.001).

We received gross proceeds from the July 2024 Offering of approximately $10.0 million (excluding up to $20.0 million of aggregate gross proceeds that may be received in the future upon the cash exercise of the Purchase Warrants issued in the Private Placement which is contingent upon stockholder approval), before deducting placement agent fees and other offering expenses of $0.7 million.

On October 30, 2024, the Company entered into a securities purchase agreement (the “October 2024 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 (the “October 2024 Offering”):

(i) an aggregate of approximately 9.9 million shares (the “Shares”) of the Company’s common stock, (ii) Series C warrants to purchase up to an aggregate of approximately 9.9 million shares of the Company’s common stock (the “Series C Warrants”) and (iii) Series D warrants to purchase up to an aggregate of approximately 9.9 million shares of the Company’s common stock (the “Series D Warrants”, and together with the Series C Warrants, the (“October Purchase Warrants”).

Each share of common stock sold pursuant to the October 2024 Purchase Agreement will be accompanied by one Series C Warrant to purchase one share of common stock and one Series D Warrant to purchase one share of common stock .

The Shares and the October Purchase Warrants are immediately separable and will be issued separately.

The combined purchase price of each Share and accompanying October Purchase Warrants is $0.304 per share.

The gross proceeds to the Company from the October 2024 Offering are expected to be approximately $3.0 million (excluding up to approximately $6.0 million of aggregate gross proceeds that may be received in the future upon the cash exercise of the October Purchase Warrants, which is contingent upon stockholder approval), before deducting placement agent fees and other offering expenses payable by the Company.

On December 31, 2024, the Company entered into an amendment of the Debentures (the “Amendment”) with the Selling Securityholders.

Pursuant to the Amendment, the parties agreed that (i) no amortization payment would be paid in December 2024;

(ii) the maximum monthly amortization payments due between January 2025 and July 2025 would be reduced from $1.0 million per month to $0.5 million per month;

(iii) the maximum monthly amortization payments due from August 2025 through repayment in full of the principal aggregate amount would be $1.4 million per month;

(iv) the conversion price of the Debentures would be reduced from $120.00 to $16.20;

and (v) the Debentures will become non-callable by the Company until August 2025.

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 March 31, 2025, the Company reported $13.0 million of Debentures at fair value, which is classified as current on the unaudited condensed consolidated balance sheet.

For the three months ended March 31, 2025, the Company paid $0.4 million in interest and $1.5 million in principal redemption amounts on the Debentures.

As of March 31, 2025, the Company may be required to redeem up to $8.9 million of principal and expects to pay an additional $0.9 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.

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 (the “January 2025 Offering”) (i) an aggregate of approximately 382,000 shares of the Company’s common stock (as adjusted for the reverse stock split) , (ii) pre-funded warrants to purchase up to an aggregate of approximately 280,000 shares of common stock (as adjusted for the reverse stock split) (the “January Pre-Funded Warrants”) and (iii) warrants to purchase up to an aggregate of approximately 661,000 shares of common stock (as adjusted for the reverse stock split) (the “January Purchase Warrants”).

Each share of common stock and each January Pre-Funded Warrant sold pursuant to the January 2025 Purchase Agreement were accompanied by a January Purchase Warrant.

Both the shares of common stock and the accompanying January Purchase Warrants, and the January Pre-Funded Warrants and the accompanying January Purchase Warrants were immediately separable and were issued separately.

The combined purchase price of each share of common stock and accompanying January Purchase Warrant was $15.120 per share (as adjusted for the reverse stock split) .

The combined purchase price of each January Pre-Funded Warrant and accompanying January Purchase Warrant was $15.119 (equal to the combined purchase price per share of common stock and accompanying January Purchase Warrant, minus $0.001) (as adjusted for the reverse stock split) .

The gross proceeds to the Company from the January 2025 Offering were approximately $10.0 million (excluding up to approximately $10.0 million of aggregate gross proceeds that may be received in the future upon the cash exercise of the January Purchase Warrants which is contingent upon stockholder approval), before deducting placement agent fees and other offering expenses payable by the Company.

Each January Purchase Warrant is exercisable for one share of common stock at an exercise price of $15.120 per share beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the January Purchase Warrants (the “Stockholder Approval”).

The January Purchase Warrants will expire on the five-year anniversary of the Stockholder Approval.

The January Pre-Funded Warrants were immediately exercisable and were exercised in full in January 2025.

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.

Based on our current business plans, we will continue to require additional capital in the very near term to fund our operating expenses and capital expenditure requirements, or we may need to further curtail or cease operations and seek protection by filing a voluntary petition for relief under the United States Bankruptcy Code.

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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.

Future Capital Requirements

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

As of September 30, 2024, we had $8.8 million in cash and cash equivalents, $3.2 million in short-term investments and $11.4 million in restricted cash and investments.

As of March 31, 2025, we had $3.6 million in cash and cash equivalents, $14.6 million in short-term investments and $11.0 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.

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In addition, our estimate as to the sufficiency of our current cash, cash equivalents and short-term investments and our current operating plan as discussed above are based on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we currently anticipate.

See Note 1 (Organization and Basis of Presentation) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for more information.

The Board has established a strategy committee to work with the Company and outside advisors in evaluating our options and considering alternatives that we believe will maximize stakeholder value, including any of the following or a combination thereof:

debt financing, equity investments, combinations with other companies, or the sale of all or part of the company.

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

The following table sets forth the cash flow from operating, investing and financing activities for the periods presented:

Net cash provided by (used in):

Nine Months Ended September 30,

Three Months Ended March 31,

Operating activities $ (2,764,000) $ (28,131,000)

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We derive cash flows from operations primarily from the sale of our products and services.

Our cash flows from operating activities are also significantly influenced by our use of cash for operating expenses to support our business.

Our cash flows from operating activities are also significantly influenced by our use of cash for operating expenses to support the growth of our business.

We have historically experienced negative cash flows from operating activities as we have developed our technology, expanded our business and built our infrastructure, and this may continue in the future.

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We expect to seek to raise additional capital to fulfill our operating and capital requirements for at least 12 months through equity or debt financings, however, we may not be able to secure such financing in a timely manner or on favorable terms, if it all, and if we are unable to raise sufficient additional capital in the very near term, we may need to further curtail or cease operations and seek protection by filing a voluntary petition for relief under the United States Bankruptcy Code.

See Note 5 (Debt) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for a discussion of our recent debt financing.

Our recent restructuring activities are anticipated to reduce the cash used in operating activities over the next 12 months;

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 $62.4 million during the nine months ended September 30, 2024 as compared to $95.4 million during the same period in 2023.

The decrease in cash used in operating activities of $33.0 million was primarily attributed to a decrease in our net loss and a decrease in cash used for inventory purchases over that time, consistent with the cost saving initiatives that were initiated in May of 2023

Net cash used in operating activities was $2.8 million during the three months ended March 31, 2025 as compared to $28.1 million during the same period in 2024.

The decrease in cash used in operating activities of $25.4 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.

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 nine months ended September 30, 2024, cash provided by investing activities was $70.8 million, as compared to $79.5 million provided by investing activities during the same period in 2023.

The decrease in cash provided by investing activities of $8.7 million was primarily attributed to the maturity of $285.3 million in available for sale securities which was offset by a purchase of available for sale securities of $214.3 million during the nine months ended September 30, 2024, compared to the maturity of $84.9 million in available for sale securities offset by a purchase of $4.5 million of available for sale securities during the same period in 2023.

During the three months ended March 31, 2025, net cash used in investing activities was $14.1 million, as compared to $47.6 million provided by investing activities during the same period in 2024.

The decrease in cash provided by investing activities of $61.7 million was primarily attributed to the maturity of $50.7 million in available for sale securities which was offset by a higher purchase of available for sale securities of $64.8 million during the three months ended March 31, 2025, as compared to the maturity of $158.2 million in available for sale securities offset by a purchase of $110.6 million of available for sale securities during the same period in 2024.

Financing Activities

Net cash used in financing activities was $17.6 million during the nine months ended September 30, 2024 as compared to net cash provided by financing activities of $45.3 million during the same period in 2023, a decrease of $62.9 million.

During the nine months ended September 30, 2024, the Company made principal payments of $61.0 million and payments on debt extinguishment costs of $5.4 million towards the High Trail convertible notes payable which was offset by approximately $18.0 million in gross proceeds from the issuance of the JGB convertible debentures and $37.7 million in gross proceeds from executing sales under our at-the-market facility with Cowen and Company, LLC (“Cowen”) as compared to $46.4 million during the same period in 2023.

Net cash provided by financing activities was $10.9 million during the three months ended March 31, 2025 as compared to net cash used in financing activities of $21.6 million during the same period in 2024, an increase of $32.5 million.

During the three months ended March 31, 2025, the Company made principal payments of $1.5 million towards the convertible debentures payable, as compared to principal payments of $36.7 million towards the convertible High Trail Notes payable during the same period in 2024, and $13.3 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 three months ended March 31, 2025, as compared to $15.4 million during the same period in 2024.

Capital Resources

As of September 30, 2024, we had approximately $8.8 million in cash and cash equivalents, $3.2 million in short-term investments , $11.4 million in restricted cash and restricted investments and working capital of $14.0 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.

We have in place a Sales Agreement with Cowen (the “Cowen ATM”), as amended, pursuant to which we may offer and sell from time to time up to $200.0 million of shares from the date of the amendment going forward through or to Cowen, acting as sales agent or principal.

During the nine months ended September 30, 2024, we sold approximately 14.2 million shares of common stock under the Cowen ATM and received gross proceeds of approximately $17.7 million before deducting offering costs of $0.4 million.

Contingent Consideration

As part of the merger agreement related to the acquisition of Purigen, we agreed to pay two independent milestone payments up to an aggregate of $32.0 million.

The fair value of the Purigen milestones is reassessed on a quarterly basis using a probability weighted model and a Monte Carlo Simulation.

We determined the fair value of the milestone consideration using a scenario-based technique, as the trigger for payment is event driven.

For the second milestone, we performed a Monte Carlo Simulation to determine the likelihood that

the milestone will be achieved and was applied to the milestone consideration payment.

As of September 30, 2024, the Company concluded that the probability of achievement of the two independent milestones was 0% which resulted in a reduction in the contingent consideration liability to zero.

As of March 31, 2025, we had approximately $3.6 million in cash and cash equivalents, $14.6 million in short-term investments , $11.0 million in restricted short-term investments and working capital of $18.5 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).

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.

We also previously had in place a Sales Agreement with Cowen (the “Cowen ATM”), as amended, pursuant to which we were permitted to offer and sell from time to time shares of our common stock having an aggregate offering price of up to $200.0 million through or to Cowen, acting as sales agent or principal, pursuant to the Shelf Registration Statement.

In January 2025, the Company sold approximately 0.1 million shares of common stock under the Cowen ATM and received gross proceeds of approximately $1.9 million before deducting offering costs of $0.05 million.

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

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.

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.

On March 31, 2025, upon filing our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, we became subject to the offering limits in General Instruction I.B.6 of Form S-3.

Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell shares of our common stock under our Shelf Registration Statement with a value of more than one-third of our public float in any 12-month period, so long as our public float is less than $75.0 million.

On April 2, 2025, we filed an amendment to the prospectus dated May 10, 2023 and the prospectus supplement, dated February 21, 2025, relating to the ATM Agreement with Wainwright (the “ATM Prospectus”), to update 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.

Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell shares of our common stock pursuant to the ATM Prospectus, as amended, with a value of more than one-third of our public float in any 12-month period, so long as our public float is less than $75.0 million.

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.

Contractual Obligations

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

Change in Accounting Estimates

The Company reviews the estimated useful life of its fixed assets on an ongoing basis.

This review indicated that the actual lives of the Company’s Saphyr and Stratys instruments were longer than the estimated useful lives used for depreciation purposes in the Company’s unaudited condensed consolidated financial statements.

We first assessed several qualitative and quantitative factors as part of our review including an analysis of the product life cycle, continued product support, customer commitments, technical durability, and compatibility of the Company’s Saphyr and Stratys instruments.

As described further in Note 1, (Organization and Basis of Presentation) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, effective January 1, 2024, the Company changed its estimates of the useful lives of the Company’s Saphyr and Stratys instruments to better reflect the estimated period during which these assets will remain in service.

During the nine months ended September 30, 2024, there have been no changes to our critical accounting policies and estimates as described in our Annual Report.

During the three months ended March 31, 2025, there have been no changes to our critical accounting policies and estimates as described in our Annual Report.

Recent Accounting Pronouncements

See Note 1 (Organization and Basis of Presentation) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for information concerning recent accounting pronouncements.

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 information concerning recent accounting pronouncements.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company, we are not required to provide the information required by this Item.

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