What changed in this filing

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Item 1. Financial Statements

2025-08-06 compared with 2025-05-07 · 115 added, 91 removed, 456 unchanged (31% of the section changed)

4 unchanged sentences

(in thousands, except per share amounts)

March 31, 2025 December 31, 2024

June 30, 2025 December 31, 2024

Current Assets:

26 unchanged sentences

Operating lease liability 2,086 2,129

Acquisition-related contingent consideration obligation 16,981 —

Total current liabilities 42,350 33,483

20 unchanged sentences

(in thousands, except per share amounts)

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

NET REVENUES:

14 unchanged sentences

OTHER INCOME 1,135 3,066 2,913 6,557

Loss before income taxes ( 15,972 ) ( 3,602 )

INCOME TAX BENEFIT ( 456 ) ( 18 )

(Loss) income before income taxes and equity investment ( 16,891 ) 326 ( 32,863 ) ( 3,276 )

INCOME TAX EXPENSE 2,000 381 1,544 363

LOSS BEFORE EQUITY INVESTMENT ( 18,891 ) ( 55 ) ( 34,407 ) ( 3,639 )

LOSS ON EQUITY INVESTMENT ( 802 ) ( 560 ) ( 1,326 ) ( 560 )

11 unchanged sentences

(in thousands)

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

NET LOSS $ ( 19,693 ) $ ( 615 ) $ ( 35,733 ) $ ( 4,199 )

7 unchanged sentences

(in thousands)

For the Three Months Ended March 31,

For the Six Months Ended June 30,

OPERATING ACTIVITIES:

26 unchanged sentences

Purchases of property and equipment ( 2,356 ) ( 3,196 )

Net cash provided by (used in) in investing activities 370 ( 46,528 )

Net cash used in investing activities ( 1,566 ) ( 40,865 )

FINANCING ACTIVITIES:

1 unchanged sentence

Proceeds from exercise of stock options — 214

Withholding and retirement of common stock ( 941 ) ( 1,462 )

Repurchase of common stock ( 5,000 ) —

Payment of taxes related to net share settlement of equity awards ( 1,725 ) ( 3,446 )

Net cash used in financing activities ( 6,751 ) ( 3,339 )

22 unchanged sentences

These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results of operations expected for the full year.

Results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results of operations expected for the full year.

Summary of Significant Accounting Policies

1 unchanged sentence

Change in Accounting Principle

During the three months ended March 31, 2025, the Company changed its methodology for valuing certain inventories to the average cost method from the first-in, first-out ("FIFO") cost method.

Effective January 1, 2025, the Company changed its methodology for valuing certain inventories to the average cost method from the first-in, first-out ("FIFO") cost method.

The change was applicable to all inventories.

1 unchanged sentence

The effect of this change in accounting principle was immaterial.

Therefore, retroactive application was not determined to be necessary and a cumulative adjustment of $ .08 million was recorded in the statement of operations for the three months ended March 31, 2025.

Therefore, retroactive application was not determined to be necessary and a cumulative adjustment of $ .08 million was recorded in the statement of operations for the six months ended June 30, 2025.

Cash Equivalents & Short-Term Investments

5 unchanged sentences

When evaluating an investment for impairment, the Company reviews factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments will continue to be made.

The Company had no available-for-sale securities as of March 31, 2025 and December 31, 2024.

The Company had no available-for-sale securities as of June 30, 2025 and December 31, 2024.

The Company maintains cash balances in the United States in excess of the federally insured limits.

1 unchanged sentence

Fair Value of Financial Instruments

As of March 31, 2025 and December 31, 2024, the carrying values of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their respective fair values based on their short-term nature.

As of June 30, 2025 and December 31, 2024, the carrying values of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their respective fair values based on their short-term nature.

Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:

5 unchanged sentences

Therefore, the degree of judgment exercised in determining fair value is greatest for assets or liabilities categorized in Level 3.

March 31, December 31,

June 30, December 31,

Level 2025 2024

1 unchanged sentence

Contingent consideration:

All of the Company's guaranteed investment certificates are measured as Level 1 instruments as of March 31, 2025.

Included in cash and cash equivalents at March 31, 2025 and December 31, 2024 was $ 66.5 million and $ 66.6 million, respectively, of guaranteed investment certificates.

Also included in cash and cash equivalents at March 31, 2025 and December 31, 2024 was $ 119.8 million and $ 118.5 million, respectively, invested in money market funds.

Current portion 16,981 —

Long-term portion 7,140 22,910

$ 24,121 $ 22,910

All of the Company's guaranteed investment certificates are measured as Level 1 instruments as of June 30, 2025.

Included in cash and cash equivalents at June 30, 2025 and December 31, 2024 was $ 68.4 million and $ 66.6 million, respectively, of guaranteed investment certificates.

Also included in cash and cash equivalents at June 30, 2025 and December 31, 2024 was $ 121.1 million and $ 118.5 million, respectively, invested in money market funds.

These money market funds have investments in U.S.

4 unchanged sentences

The assets of the plan are held in mutual funds and company stock.

The fair value of the plan assets as of March 31, 2025 and December 31, 2024 was $ 0.8 million and $ 0.7 million, respectively, and was calculated using the quoted market prices of the assets as of those dates.

The fair value of the plan assets as of June 30, 2025 and December 31, 2024 was $ 0.5 million and $ 0.7 million, respectively, and was calculated using the quoted market prices of the assets as of those dates.

All investments in the plan are classified as trading securities and measured as Level 1 financial instruments.

6 unchanged sentences

The fair value methodology for royalty payments is based on a discounted cash flow model.

Significant quantitative unobservable inputs are internally developed future expected cash flows, discount rate and probability achievement of a

milestone of a regulatory approval.

Significant quantitative unobservable inputs are internally developed future expected cash flows, discount rate and probability achievement of a milestone of a regulatory approval.

The royalty payments represent a mid-single digit percentage of the net sales through 2034 associated with the acquired in-process and research developed intangible asset.

There was an increase of $ 0.5 million in the fair value of the Company's contingent consideration from date of acquisition to March 31, 2025.

There was an increase of $1.2 million in the fair value of the Company's contingent consideration from date of acquisition to June 30, 2025.

Equity Method Investee

2 unchanged sentences

Through this relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic tests and molecular sample management solutions to the Company's customers globally.

As of March 31, 2025, the Company had funded $ 30.0 million for its interest in Sapphiros.

As of June 30, 2025, the Company had funded $ 30.0 million for its interest in Sapphiros.

The Company recorded the investment using the equity method in accordance with Accounting Standards Codification ("ASC") Topic 323, Investments—Equity Method and Joint Ventures—Overall.

1 unchanged sentence

The Company has elected as its accounting policy to recognize its share of any income or loss in Sapphiros on a three-month lag.

The investment in Sapphiros of $ 27.8 million as of March 31, 2025 is included in the investment in equity method investee line of the Company's balance sheet and is measured as a Level 3 investment.

The investment in Sapphiros of $ 27.0 million as of June 30, 2025 is included in the investment in equity method investee line of the Company's balance sheet and is measured as a Level 3 investment.

The Company has no unconditional obligations or guarantees to, or in support of, its equity method investee and its operations.

In conjunction with the preparation of the Company's March 31, 2025 financial statements, the Company considered whether the carrying value of the investment in Sapphiros was impaired and concluded that no such impairment existed.

In conjunction with the preparation of the Company's June 30, 2025 financial statements, the Company considered whether the carrying value of the investment in Sapphiros was impaired and concluded that no such impairment existed.

The Company's investment in Sapphiros was valued at $ 28.3 million as of December 31, 2024.

Foreign Currency Transactions

Net foreign exchange gains and (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $( 0.4 ) million and $ 0.2 million for the three months ended March 31, 2025 and 2024, respectively.

Net foreign exchange gains (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $( 0.9 ) million and $ 0.1 million for the three months ended June 30, 2025 and 2024, respectively.

Net foreign exchange gains (losses) resulting from foreign currency transactions for the six months ended June 30, 2025 and 2024 were $( 1.3 ) million and $ 0.3 million respectively.

Accumulated Other Comprehensive Loss

3 unchanged sentences

Other comprehensive gain 6,989 6,989

Balance at March 31, 2025 $ ( 24,122 ) $ ( 24,122 )

Balance at June 30, 2025 $ ( 17,371 ) $ ( 17,371 )

Uncertain Tax Positions

Assets and liabilities are established for uncertain tax positions taken or positions expected to be taken in income tax returns when such positions fail to meet the "more likely than not" threshold based on the technical merits of the positions.

We assess whether previously unrecognized tax benefits may be recognized when tax positions is (1) more likely than not of being sustained based on its technical merits, (2) effectively settled through examination, negotiation or litigation, or (3) settled through actual expiration of the relevant tax statures.

The assessment of an uncertain tax position requires significant judgement.

Recent Accounting Pronouncements

1 unchanged sentence

2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures .

The purpose of the update was to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information.

paid information.

The amendments in this ASU are effective for annual periods beginning after December 15, 2024.

5 unchanged sentences

The amendments in the ASU are effective for all public business entities for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted.

The amendments are to be applied either prospectively to financial statements issued for reporting periods after the effective date of the update or retrospectively to

any or all prior periods presented in the financial statements.

The amendments are to be applied either prospectively to financial statements issued for reporting periods after the effective date of the update or retrospectively to any or all prior periods presented in the financial statements.

Management is evaluating the impact on the Company's consolidated financial statements.

6 unchanged sentences

Inventories (in thousands)

March 31, December 31,

June 30, December 31,

Raw materials $ 15,334 $ 17,002

3 unchanged sentences

Property, Plant and Equipment, net (in thousands)

March 31, December 31,

June 30, December 31,

Land $ 1,118 $ 1,118

8 unchanged sentences

Accrued Expenses and Other Current Liabilities (in thousands)

March 31, December 31,

June 30, December 31,

Payroll and related benefits $ 9,028 $ 11,147

8 unchanged sentences

The charges for termination benefits included in the Company's consolidated statements of operations are as follows (in thousands):

For the Three Months Ended March 31,

For the Six Months Ended June 30,

Cost of products and services sold $ 231

2 unchanged sentences

General and administrative 17

As of March 31, 2025, the Company had fully paid the $ 0.4 million related to the reduction in workforce.

As of June 30, 2025, the Company had fully paid the $ 0.4 million related to the reduction in workforce.

This reduction in workforce was completed by December 31, 2024.

2 unchanged sentences

This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations .

As of March 31, 2025 the Company had $ 0.3 million accrued and had paid $ 1.3 million related to the reduction in workforce.

No additional expense was incurred during the three months ended March 31, 2025.

For the Six Months Ended June 30,

Cost of products and services sold $ 889

Research and development 478

Sales and marketing 125

General and administrative 160

As of June 30, 2025 the Company had $ 0.3 million accrued and had paid $ 1.4 million related to the reduction in workforce.

No additional expense was incurred during the six months ended June 30, 2025.

The Company expects this plan to be completed by September 2025.

3 unchanged sentences

This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations .

As of March 31, 2025 the Company had $ 0.7 million accrued and had paid $ 0.5 million related to the reduction in workforce.

No additional expense was incurred during the three months ended March 31, 2025.

As of June 30, 2025 the Company had $ 0.5 million accrued and had paid $ 0.7 million related to the reduction in workforce.

No additional expense was incurred during the six months ended June 30, 2025.

The Company expects this plan to be completed by the third quarter of 2026.

1 unchanged sentence

The following table represents total net revenues by product line (in thousands):

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

HIV $ 14,398 $ 13,652 $ 27,298 $ 27,032

Sample Management Solutions (1)

9,855 12,609 18,965 23,431

HCV 4,126 4,734 8,459 7,734

Risk Assessment Testing (2)

446 2,308 1,866 4,352

Other product and services revenues (3)

994 897 1,767 1,429

28 18,939 489 42,067

Molecular Services — 810 — 1,683

1 unchanged sentence

Non-product and services revenues (5)

1,395 386 2,329 739

Net revenues $ 31,242 $ 54,335 $ 61,173 $ 108,467

6 unchanged sentences

The following table represents total net revenues by geographic area, based on the location of the customer (in thousands):

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

United States $ 19,852 $ 44,386 $ 40,187 $ 89,597

5 unchanged sentences

The following table represents customer concentration risk:

For the Three Months Ended March 31,

Non-commercial customer N/A 40 %

March 31, December 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

Non-commercial customer N/A 33 % N/A 37 %

June 30, December 31,

Accounts Receivable

Commercial customer 19 % 10 %

Commercial customer (1)

(1) Each commercial customer is different.

Vendor Concentration.

5 unchanged sentences

The Company records deferred revenue when funds are received prior to the recognition of the associated revenue.

Deferred revenue as of March 31, 2025 and December 31, 2024 was comprised of customer prepayments of $ 2.5 million and $ 3.0 million, respectively.

Deferred revenue as of June 30, 2025 and December 31, 2024 was comprised of customer prepayments of $ 2.4 million and $ 3.0 million, respectively.

The following table represents deferred revenue recognized:

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

Deferred Revenue Recognized 2025 2024 2025 2024

Accrued at beginning of period $ 974 $ 774 $ 1,461 $ 1,194

From current period 1,333 834

The components of income tax expense are as follows (in thousands):

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

The components of income tax expense benefit are as follows (in thousands):

For the Three Months Ended March 31,

Federal income tax expense $ 157 $ — $ 165 $ —

2 unchanged sentences

$ 2,000 $ 381 $ 1,544 $ 363

During the three months ended March 31, 2025 and 2024, the Company recorded an income tax benefit of $ 0.5 million and $ 0.02 million, respectively.

The three months ended March 31, 2025 net tax benefit increase is due to having a U.S.

and foreign pretax loss in 2025 compared to a U.S.

pretax loss and foreign pretax income for the three months ended March 31, 2024.

During the three months ended June 30, 2025 and 2024, the Company recorded income tax expense of $ 2.0 million and $ 0.4 million, respectively.

During the six months ended June 30, 2025 and 2024, the Company recorded income tax expense of $ 1.5 million and $ 0.4 million, respectively.

The net tax expense increase in both periods is largely due to recording an uncertain tax position for certain tax matters, including penalties and interest.

Income tax expense reflects taxes due to the taxing authorities and the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting and tax purposes, and net operating loss and tax credit carryforwards.

The significant components of the Company's total deferred tax asset as of March 31, 2025 and at December 31, 2024 relate to the tax effects of the basis difference of acquired intangible assets.

The significant components of the Company's total deferred tax asset as of June 30, 2025 and at December 31, 2024 relate to the tax effects of the basis difference of acquired intangible assets.

A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.

A full valuation allowance was recorded on the Company’s U.S.

deferred tax assets as of March 31, 2025 and December 31, 2024.

deferred tax assets as of June 30, 2025 and December 31, 2024.

As of December 31, 2024 and June 30, 2025, uncertain tax positions were approximately $ 0.0 million and $ 2.5 million.

The Company’s uncertain tax position relates to U.S.

federal and other jurisdictions.

Due to various factors, including the inherent complexities and uncertainties of the judicial, administrative, and regulatory processes in certain jurisdictions, the timing of the resolution of income tax controversies is highly uncertain, and the amounts ultimately paid, if any, upon resolution of the issues raised by the taxing authorities may differ from the amounts accrued.

Any assessments or settlements could result in changes to our contingencies related to positions on prior years’ tax filings.

On July 4, 2025, Congress enacted the One Big Beautiful Bill Act (“OBBBA”), which includes several changes to the Internal Revenue Code which may result in changes to the Company’s income tax expense.

The Company is currently evaluating the impacts of the OBBBA but does not believe that changes in tax law will materially affect the Company’s operating performance or financial position.

Income (Loss) Per Share

3 unchanged sentences

Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.

For the three months ended March 31, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 689 shares and 1,697 shares, respectively, were excluded from the computation of diluted loss per share.

For the three months ended June 30, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 581 shares and 1,010 shares, respectively, were excluded from the computation of diluted loss per share.

For the six months ended June 30, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 618 shares and 1,333 shares, respectively, were excluded from the computation of diluted loss per share.

Stockholders’ Equity

1 unchanged sentence

The amount and timing of share repurchases under the Repurchase Program may be carried out at the discretion of the Company's management through various methods in compliance with applicable state and federal securities laws.

The Company did not repurchase any shares of the Company's common stock under the Repurchase Program during the three months ended March 31, 2025.

The reconciliation of the changes in stockholders' equity for the three months ended March 31, 2025 and 2024 is as follows (in thousands):

The Company repurchased 1.8 million shares of its common stock under the Repurchase Program during the six months ended June 30, 2025.

The reconciliation of the changes in stockholders' equity for the three and six months ended June 30, 2025 and 2024 is as follows (in thousands):

Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total

7 unchanged sentences

Balance at March 31, 2025 75,114 $ — $ 539,875 $ ( 24,122 ) $ ( 119,471 ) $ 396,282

Vesting of restricted stock and performance stock units 713 — — — — —

Purchase and retirement of common shares ( 271 ) — ( 784 ) — — ( 784 )

Stock-based compensation — — 3,165 — — 3,165

Repurchase of common stock ( 1,821 ) — ( 5,000 ) — — ( 5,000 )

Net loss — — — — ( 19,693 ) ( 19,693 )

Currency translation adjustments — — — 6,751 — 6,751

Balance at June 30, 2025 73,735 $ — $ 537,256 $ ( 17,371 ) $ ( 139,164 ) $ 380,721

Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total

8 unchanged sentences

Balance at March 31, 2024 73,959 $ — $ 531,263 $ ( 17,497 ) $ ( 87,515 ) $ 426,251

Vesting of restricted stock and performance stock units 1,033 — — — — —

Purchase and retirement of common shares ( 424 ) — ( 1,984 ) — — ( 1,984 )

Stock-based compensation — — 3,322 — — 3,322

Net loss — — — — ( 615 ) ( 615 )

Currency translation adjustments — — — ( 1,134 ) — ( 1,134 )

Balance at June 30, 2024 74,568 $ — $ 532,601 $ ( 18,631 ) $ ( 88,130 ) $ 425,840

Business Segment Information

The Company is organized on the basis of products and services into a single reportable segment.

All products and services reside under the same reporting hierarchy.

Historically, there was separate management leading the Company's Diagnostics and Molecular Solutions businesses.

In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across the Diagnostics and Molecular Solutions businesses into one operating segment with sales, marketing, product development and research teams covering all product lines and reporting to a Chief Product Officer ("CPO").

The Company's reportable segment derives its revenues from the sale of diagnostics products and sample management solutions, as described in Note 1 Summary of Significant Accounting Policies.

9 unchanged sentences

The following table represents total long-lived assets by geographic area:

March 31, December 31,

June 30, December 31,

United States $ 38,418 $ 40,286

4 unchanged sentences

The following table represents reported segment revenues, segment loss, and significant segment expenses:

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

Net revenues 31,242 54,335 61,173 108,467

3 unchanged sentences

Research and development (2)

11,401 6,599 21,004 14,337

Sales and marketing (2)

6,375 7,931 13,234 16,379

General and administrative (2)

3 unchanged sentences

Gain on sale of assets — — ( 993 ) —

Operating loss ( 17,750 ) ( 7,093 )

Operating (loss) income ( 18,026 ) ( 2,740 ) ( 35,776 ) 58,587

Other (expense) income — ( 43 ) ( 16 ) 241

1 unchanged sentence

Other segment items (1)

Loss before income taxes ( 15,972 ) ( 3,602 )

Income tax benefit ( 456 ) ( 18 )

( 938 ) 78 ( 1,299 ) 264

(Loss) income before income taxes ( 16,891 ) 326 ( 32,863 ) ( 3,276 )

Income tax expense 2,000 381 1,544 363

Loss on equity investment ( 802 ) ( 560 ) ( 1,326 ) ( 560 )

2 unchanged sentences

(2) The following tables represent additional significant segment expense categories:

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

Stock-based Compensation

4 unchanged sentences

$ 3,165 $ 3,322 $ 5,852 $ 6,290

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

2025 2024 2025 2024

Depreciation and Amortization

67 unchanged sentences

Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisition been consummated as of January 1, 2024.

For the Three Months Ended March 31,

For the Three Months Ended June 30, For the Six Months Ended June 30,

Net revenues $ 54,575 $ 109,038

3 unchanged sentences

In management’s opinion, the outcomes of such actions, either individually or in the aggregate, are not expected to have a material adverse effect on the Company's future financial position or results of operations.

In March 2021, the Company filed a complaint against Spectrum Solutions, LLC (“Spectrum”) in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG.

Spectrum filed an answer asserting that its device does not infringe the Company’s patent and that the Company’s patent is invalid.

In August 2021, the Company amended its complaint to add a second patent to this litigation.

Spectrum responded to the Company’s amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office (“PTO”), which was granted by the PTO.

The District Court issued multiple pretrial orders, resolving the infringement, antitrust, and inequitable conduct claims without trial.

First, the District Court granted Spectrum’s motion for summary judgment of noninfringement.

Second, the Court denied Spectrum’s motion to supplement its allegations of alleged antitrust violations, finding that if such an amendment were allowed, Spectrum’s claims would not survive a motion for summary judgment.

Spectrum thereafter withdrew its antitrust and inequitable conduct counterclaims.

Spectrum did not appeal the District Court’s denial of its motion to amend.

The Company appealed the grant of summary judgment to the Court of Appeals on June 8, 2023.

On February 14, 2025, the Court of Appeals affirmed the District Court’s judgment.

The Court of Appeals mandate issued on March 24, 2025.

On February 7, 2024, the PTO issued a Final Written Decision regarding the second patent in the litigation, holding that claims 1, 3–8, 11, and 12 of U.S.

11,002,646 B2 are unpatentable.

On March 8, 2024, the Company filed a Request for Rehearing by the Director of the PTO of the Final Written Decision.

On March 27, 2024, the Company’s Request for Rehearing was denied.

On September 15, 2023, Spectrum filed a separate petition for inter partes review of a third patent, which DNAG did not assert in the District Court.

On March 26, 2024, the PTO issued a Decision Granting Institution of Inter Partes Review.

On July 2, 2024, the Company filed a Motion to Amend the claims of the third patent and oral argument in this IPR took place on January 24, 2025.

On February 19, 2025, the PTO issued a Final Written Decision regarding the third patent in the litigation, granting the Company’s Motion to Amend as to cancelling the original claims, but denying the Company’s Motion to Amend as to adding proposed substitute claims.

On November 14, 2024 the Company filed a complaint against NowDiagnostics, Inc.

6 unchanged sentences

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

What changed 10-Q

Item 1. Financial Statements