What changed in this filing

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Item 1. Financial Statements

2024-08-08 compared with 2024-05-09 · 147 added, 111 removed, 465 unchanged (36% of the section changed)

3 unchanged sentences

CONSOLIDATED BALANCE SHEETS

March 31, 2024

June 30, 2024

December 31, 2023

29 unchanged sentences

5,000,000 shares authorized;

0 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

Common stock, $ 0.001 par value;

100,000,000 shares authorized;

36,127,096 shares issued and 31,278,418 shares outstanding as of March 31, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023

36,759,680 shares issued and 31,911,002 shares outstanding as of June 30, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023

Treasury stock, at cost;

4,848,678 shares held as of March 31, 2024 and December 31, 2023, respectively

4,848,678 shares held as of June 30, 2024 and December 31, 2023, respectively

( 15,575,795 )

Additional paid-in capital

1 unchanged sentence

Accumulated earnings (deficit)

( 12,313,195 )

Total stockholders’ equity

4 unchanged sentences

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Product revenue

11 unchanged sentences

( 11,994,439 )

( 17,939,349 )

( 21,945,089 )

Other income, net

1 unchanged sentence

Realized gain on investments

Gain on remeasurement of acquisition contingencies

Gain on disposition of assets

Gain (loss) on remeasurement of acquisition contingencies

Gain (loss) on equity method investment in joint venture

3 unchanged sentences

( 11,157,145 )

( 16,868,007 )

( 19,172,347 )

Income tax provision (benefit)

2 unchanged sentences

$ ( 7,599,318 )

$ ( 8,918,825 )

$ ( 16,911,361 )

$ ( 14,674,216 )

Other comprehensive loss

4 unchanged sentences

$ ( 8,811,459 )

$ ( 16,686,853 )

$ ( 14,388,229 )

Loss per common share:

6 unchanged sentences

CONSOLIDATED STATEMENTS OF CASH FLOWS

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows from operating activities

9 unchanged sentences

(Gain) loss from equity method investment

Gain on disposition of assets

Deferred income taxes

16 unchanged sentences

( 13,699,301 )

Net cash provided by (used in) investing activities

( 65,296,809 )

Net cash provided by investing activities

Cash flows from financing activities

Repurchases of common stock

( 1,037,930 )

Net cash used in financing activities

Net increase (decrease) in cash and cash equivalents

( 1,037,930 )

Net decrease in cash and cash equivalents

( 1,058,012 )

( 9,142,957 )

Cash and cash equivalents at beginning of period

3 unchanged sentences

Supplemental disclosure of non-cash investing and financing transactions

Inventory moved to property, plant and equipment

Right-of-use assets obtained in exchange for new operating lease liabilities

3 unchanged sentences

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Preferred Stock

Other Comprehensive

Accumulated Earnings

Stockholders’

Convertible Preferred Stock

Additional Paid-in

Accumulated Other Comprehensive

Total Stockholders’

Balance as of December 31, 2023

7 unchanged sentences

( 4,713,877 )

Preferred Stock

Other Comprehensive

Stockholders’

Balance as of December 31, 2022

Stock-based compensation

Other comprehensive income, net of tax

( 7,599,318 )

Balance as of June 30, 2024

$ ( 15,575,795 )

$ ( 12,313,195 )

Convertible Preferred Stock

Additional Paid-in

Accumulated Other Comprehensive

Total Stockholders’

Balance as of December 31, 2022

$ ( 14,211,866 )

$ 114,519,994

Stock-based compensation

6 unchanged sentences

( 14,694,062 )

Stock-based compensation

Repurchases of common stock

Other comprehensive income, net of tax

( 8,918,825 )

Balance as of June 30, 2023

$ ( 15,249,796 )

$ 103,432,378

$ ( 15,249,796 )

$ 103,432,378

accompanying notes to unaudited condensed consolidated financial statements

9 unchanged sentences

The Company also uses its proprietary technology to design specific

tests for its Co-Dx PCR platform and to locate genetic markers for use in applications other than infectious disease.

In connection with

the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems.

tests for its Co-Dx™ platform and to locate genetic markers for use in applications other than infectious disease.

In connection

with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems.

Condensed Consolidated Financial Statements

12 unchanged sentences

been included.

Operating results for the three months ended March 31, 2024 are not necessarily indicative of the results that may be

expected for the year ending December 31, 2024.

These statements should be read in conjunction with the Company’s audited financial

statements and related notes for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with

the SEC on March 14, 2024.

The Company’s significant accounting policies are set forth in Note 2 to the consolidated financial

statements in its Annual Report on Form 10-K for the year ended December 31, 2023.

Operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results that

may be expected for the year ending December 31, 2024.

These statements should be read in conjunction with the Company’s audited

financial statements and related notes for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K

filed with the SEC on March 14, 2024.

The Company’s significant accounting policies are set forth in Note 2 to the consolidated

financial statements in its Annual Report on Form 10-K for the year ended December 31, 2023.

preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates

18 unchanged sentences

written off are recorded when collected.

At March 31, 2024 total accounts receivable was $ 620,548 with an allowance for uncollectable

At June 30, 2024 total accounts receivable was $ 710,898 with an allowance for uncollectable

accounts of $ 159,394 resulting in a net amount of $ 551,504 .

4 unchanged sentences

average cost in accordance with ASC 330-10-30-12.

At March 31, 2024, the Company had $ 1,549,812 in inventory, of which $ 674,142 was finished

At June 30, 2024, the Company had $ 1,463,960 in inventory, of which $ 620,825 was finished

goods and $ 843,135 was raw materials.

3 unchanged sentences

useful or scrap values.

The Company recognized $ 311,339 and $ 43,717 related to the change in inventory reserves during the three months

ended March 31, 2024 and 2023, respectively.

The Company recognized $ 24,333 and $ 287,006 related to the change in inventory reserves during the three and

six months ended June 30, 2024, respectively, compared to $ 198,978 and $ 242,695 during the three and six months ended June 30, 2023 respectively.

Company generates revenue from customers from product and license sales.

19 unchanged sentences

obligations as deferred revenue in the consolidated balance sheets if the conditions or performance obligations have not yet been met.

The Company recognized grant funding revenue of $ 0.2 million and $ 0 during the three months ended March 31, 2024 and 2023, respectively.

At March 31, 2024, the Company has also recorded $ 0.3 million of deferred revenue related to grant funding for which the cash was received,

but the underlying conditions or performance obligations have not yet been met.

Cash received from federal grants, contracts, and awards

can be subject to audit by the grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.

The Company recognized grant funding revenue of $ 2,495,738 and $ 2,710,847 during the three and six months ended June 30, 2024, respectively,

compared to $ 0 during the three and six months ended June 30, 2023, respectively.

At June 30, 2024, the Company has also recorded $ 127,710

of deferred revenue related to grant funding for which the cash was received, but the underlying conditions or performance obligations

have not yet been met.

Cash received from federal grants, contracts, and awards can be subject to audit by the grantor and, if the examination

results in a disallowance of any expenditure, repayment could be required.

Company accounts for income taxes in accordance with the liability method of accounting for income taxes.

18 unchanged sentences

Risk and Significant Customers

Company had certain customers which were each responsible for generating 10 % or more of the total revenue for the three months ended

March 31, 2024.

One customer accounted for approximately 26 % of product revenue, and one granting agency accounted for all of the grant

revenue recognized during the three months ended March 31, 2024.

Two customers accounted for approximately 44 % of product revenue for

the three months ended March 31, 2023.

customers accounted for more than 10 % of accounts receivable at March 31, 2024 and three customers accounted for more than 10 % of accounts

Company had certain customers which were each responsible for generating 10 % or more of the total revenue for the three and six months

ended June 30, 2024.

Two customers accounted for approximately 37 % of product revenue, and two granting agencies accounted for approximately

94 % of the grant revenue recognized during the three months ended June 30, 2024.

One customer accounted for approximately 29 % of product

revenue, and two granting agencies accounted for approximately 94 % of grant revenue recognized during the six months ended June 30, 2024.

Three customers accounted for approximately 44 % of product revenue and two customers accounted for approximately 33 % of product revenue

recognized for the three and six months ended June 30, 2023, respectively.

customers accounted for more than 10 % of accounts receivable at June 30, 2024 and three customers accounted for more than 10 % of accounts

receivable at December 31, 2023.

These customers together accounted for approximately 90 % and 97 % of accounts receivable at March 31,

These customers together accounted for approximately 89 % and 97 % of accounts receivable at June 30,

2024 and December 31, 2023, respectively.

15 unchanged sentences

of Cash, Cash Equivalents and Marketable Investment Securities

March 31, 2024

June 30, 2024

treasury securities

2 unchanged sentences

treasury securities

investment securities held as of March 31, 2024 mature over the next 12 months.

investment securities held as of June 30, 2024 mature over the next 12 months.

4 – Fair Value Measurements

7 unchanged sentences

Unobservable inputs that are not corroborated by market data.

following table summarizes the assets and liabilities measured at fair value on a recurring basis as of March 31, 2024 and December 31,

following table summarizes the assets and liabilities measured at fair value on a recurring basis as of June 30, 2024 and December 31,

2023, by level within the fair value hierarchy:

of Fair Value Assets and Liabilities

March 31, 2024

June 30, 2024

Cash equivalents

15 unchanged sentences

treasury bills and notes as

of March 31, 2024 and December 31, 2023.

of June 30, 2024 and December 31, 2023.

fair value of contingent consideration is calculated using a discounted probability weighted valuation model.

6 unchanged sentences

Change in fair value of contingent consideration issued for business acquisitions

Fair value as of March 31, 2024

Fair value as of June 30, 2024

fair value of the contingent consideration is based on the fair value of the contingent consideration-common stock and contingent consideration-warrants.

6 unchanged sentences

of Contingent Consideration Common Stock and Warrants

March 31, 2024

June 30, 2024

December 31, 2023

8 unchanged sentences

of Intangible Assets, Net

March 31, 2024

June 30, 2024

Weighted-Average

12 unchanged sentences

on weighted-average useful life established as of the acquisition date.

expected future annual amortization expense of the Company’s intangible assets held as of March 31, 2024 is as follows:

expected future annual amortization expense of the Company’s intangible assets held as of June 30, 2024 is as follows:

of Future Amortization Expense

Year Ending December 31,

Amortization Expense

2024 (remainder)

1 unchanged sentence

of Revenue by Geographic Area

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

United States

10 unchanged sentences

Rest of World

in the Company’s deferred revenue balance for the three months ended March 31, 2024 were as follows:

in the Company’s deferred revenue balance for the six months ended June 30, 2024 were as follows:

of Deferred Revenue

1 unchanged sentence

Revenue recognized included in deferred revenue balance at the beginning of the period

Balance as of March 31, 2024

Increase due to prepayments from customers

Balance as of June 30, 2024

7 – Loss Per Share

following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for three months ended

March 31, 2024 and 2023, respectively:

following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for three and six months

ended June 30, 2024 and 2023, respectively:

of Basis and Diluted Earnings Per Share

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Net loss, as reported

1 unchanged sentence

$ ( 8,918,825 )

$ ( 16,911,361 )

$ ( 14,674,216 )

Weighted average shares, basic

Dilutive effect of stock options, warrants and RSUs

Shares used to compute diluted loss per share

Shares used to compute diluted earnings per share

Basic loss per share

Diluted loss per share

computation of diluted loss per share for the three months ended March 31, 2024 and 2023, respectively, also excludes approximately 1.4

million shares of common stock and approximately 465,000 warrants to purchase shares of common stock that are contingent upon the achievement

of certain milestones.

a result of incurring a net loss for the three months ended March 31, 2024 and 2023, respectively, no potentially dilutive securities

computation of diluted loss per share for the three and six months ended June 30, 2024 and 2023, respectively, also excludes approximately

1.4 million shares of common stock and approximately 465,000 warrants to purchase shares of common stock that are contingent upon the

achievement of certain milestones.

a result of incurring a net loss for the three and six months ended June 30, 2024 and 2023, respectively, no potentially dilutive securities

are included in the calculation of diluted loss per share because such effect would be anti-dilutive.

The Company had potentially dilutive

securities as of March 31, 2024, consisting of:

securities as of June 30, 2024, consisting of:

(i) 1,758,323 restricted stock units and (ii) 532,112 options and warrants.

had potentially dilutive securities as of March 31, 2023, consisting of:

had potentially dilutive securities as of June 30, 2023, consisting of:

(i) 2,890,985 restricted stock units and (ii) 512,112 options

9 unchanged sentences

The number of awards available for issuance under

the Incentive Plan was 4,492,462 at March 31, 2024.

following table summarizes option activity during the three months ended March 31, 2024:

the Incentive Plan was 2,987,694 at June 30, 2024.

following table summarizes option activity during the six months ended June 30, 2024:

of Option Activity

1 unchanged sentence

Forfeited/Cancelled

Outstanding at March 31, 2024

Exercisable at March 31, 2024

aggregate intrinsic value of outstanding options at March 31, 2024 was approximately $ 0.1 million.

Outstanding at June 30, 2024

Exercisable at June 30, 2024

aggregate intrinsic value of outstanding options at June 30, 2024 was approximately $ 0.2 million.

compensation cost is measured at the grant date based on the fair value of the award granted and recognized as expense over the vesting

1 unchanged sentence

The Company uses the Black-Scholes model to value options granted.

As of March 31, 2024, there

As of June 30, 2024, there

were no unvested options and no unrecognized stock-based compensation expense related to options.

2 unchanged sentences

The following table sets forth the outstanding

RSUs and related activity for the three months ended March 31, 2024:

RSUs and related activity for the six months ended June 30, 2024:

of Outstanding Restricted Stock Units and Related Party

4 unchanged sentences

Forfeited/Cancelled

Unvested at March 31, 2024

of March 31, 2024, there was approximately $ 7.6 million of unrecognized stock-based compensation expense related to outstanding RSUs

which is expected to be recognized over a weighted-average period of 1.5 years.

Unvested at June 30, 2024

of June 30, 2024, there was approximately $ 7.5 million of unrecognized stock-based compensation expense related to outstanding RSUs which

is expected to be recognized over a weighted-average period of 1.7 years.

Company has issued warrants related to financings, acquisitions and as compensation to third parties for services provided.

2 unchanged sentences

the fair value of issued warrants using a vesting schedule based on the terms and conditions of each warrant if granted for services.

following table summarizes warrant activity during the three months ended March 31, 2024:

following table summarizes warrant activity during the six months ended June 30, 2024:

of Warrant Activity

1 unchanged sentence

Forfeited/Cancelled

Outstanding at March 31, 2024

The aggregate intrinsic value of outstanding

warrants at March 31, 2024 was approximately $ 0 .

total number of warrants exercisable at March 31, 2024 is 20,000 .

Outstanding at June 30, 2024

aggregate intrinsic value of outstanding warrants at June 30, 2024 was $ 0 .

total number of warrants exercisable at June 30, 2024 is 20,000 .

The ability to exercise the remaining 465,000 warrants issued in connection

4 unchanged sentences

of Recognized Stock-based Compensation Expense

Three Months Ended

Three Months Ended June 30,

Six Months Ended June 30,

Cost of revenue

4 unchanged sentences

9 – Income Taxes

the three months ended March 31, 2024, the Company recognized expense from income taxes of $ 22,764 ,

representing an effective tax rate of - 0.2 %.

the three months ended June 30, 2024, the Company recognized expense from income taxes of $ 20,590 , representing an effective tax rate

For the six months ended June 30, 2024, the Company recognized expense from income taxes of $ 43,354 , representing an effective

tax rate of ( 0.3 %).

The Company’s effective tax rate will generally differ from the U.S.

Federal statutory rate of 21.0 %,

primarily due to the full valuation allowance as well as state taxes, permanent items, and discrete items.

For the three months

ended March 31, 2023, the Company recognized a benefit from income taxes of $ 2,259,811 .

Federal statutory rate of 21.0 %, primarily

due to the full valuation allowance as well as state taxes, permanent items, and discrete items.

For the three and six months ended June

30, 2023, the Company recognized a benefit from income taxes of $ 2,238,320 and $ 4,498,131 , respectively.

10 – Commitments and Contingencies

3 unchanged sentences

expedient elected.

the three months ended March 31,2024, components of lease expense are summarized as follows:

components of lease expense are summarized as follows:

of Lease Expense

March 31, 2024

Three Months Ended June 30,

Six Months Ended June 30,

Operating lease costs

1 unchanged sentence

Total lease costs

of March 31, 2024, the maturities of the Company’s lease liabilities are as follows:

of June 30, 2024, the maturities of the Company’s lease liabilities are as follows:

of Maturities on Company Lease Liabilities

7 unchanged sentences

of Other Information Related to Operating Lease

Three Months Ended

March 31, 2024

Six Months Ended

June 30, 2024

Cash paid for operating leases included in operating cash flows

5 unchanged sentences

are expensed as incurred.

Company is a defendant in two class action claims and three derivative actions claiming that the Company promulgated false and misleading

Company is a defendant in two class action claims and four derivative actions claiming that the Company promulgated false and misleading

press releases to increase the price of our stock to improperly benefit the officers and directors of the Company.

1 unchanged sentence

compensatory damages sustained as a result of the Company’s alleged wrongdoing in an amount to be proven at trial.

is also a party to two civil actions, one in the US and the other in the United Kingdom.

is also a party to three civil actions, one in the US and the other in the United Kingdom.

Each of the civil actions is based on breach

14 unchanged sentences

regulatory requirements, and general market conditions.

accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the

applicable trade.

accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the applicable

Such repurchased shares are held in treasury and are presented using the cost method.

These shares are not retired

and are considered issued but not outstanding.

No shares were repurchased during the three months ended March 31, 2024.

These shares are not retired and are considered

issued but not outstanding.

No shares were repurchased during the three or six months ended June 30, 2024.

12 – Related Party Transactions

2023, the Company entered into a services agreement with CoSara, the Company’s equity method investment, under which CoSara provides

certain research and development consulting and support services.

During the three months ended March 31, 2024, the Company recognized

$ 0.1 million of expense related to this agreement.

13 – Subsequent Events

October 2023, the Company was awarded grant funding of a total of approximately $ 9.0 million, contingent on the attainment of certain

The first $ 3.5 million of funding under this grant was received by the Company at the time the grant was awarded in October

In April 2024, a milestone under this grant was met and accepted, which resulted in the disbursement of an additional $ 2.0 million

of funding per the grant agreement.

These funds were received by the Company in April 2024.

2023, the Company entered into a services agreement with CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture for manufacturing

in India, under which CoSara provides certain research and development consulting and support services.

The Company recognized $ 74,040

and $ 179,965 of expense related to this agreement during the three and six months ended June 30, 2024, respectively.

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