What changed in this filing

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Item 1. Financial Statements

2024-11-07 compared with 2024-08-08 · 144 added, 116 removed, 496 unchanged (34% of the section changed)

3 unchanged sentences

CONSOLIDATED BALANCE SHEETS

June 30, 2024

September 30, 2024

December 31, 2023

29 unchanged sentences

5,000,000 shares authorized;

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

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

Common stock, $ 0.001 par value;

100,000,000 shares authorized;

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

36,778,430 shares issued and 31,929,752 shares outstanding as of September 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 June 30, 2024 and December 31, 2023, respectively

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

( 15,575,795 )

10 unchanged sentences

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Product revenue

16 unchanged sentences

Realized gain on investments

Gain on disposition of assets

Gain (loss) on disposition of assets

Gain (loss) on remeasurement of acquisition contingencies

29 unchanged sentences

CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities

8 unchanged sentences

Realized gain on investments

( 1,254,718 )

(Gain) loss from equity method investment

Gain on disposition of assets

(Gain) loss on disposition of assets

Deferred income taxes

17 unchanged sentences

( 83,604,933 )

Investment in joint venture

Net cash provided by investing activities

10 unchanged sentences

Supplemental disclosure of cash flow information

Income taxes paid

Cash paid (received) for income taxes

Supplemental disclosure of non-cash investing and financing transactions

25 unchanged sentences

( 12,313,195 )

Stock-based compensation

Other comprehensive income, net of tax

( 9,696,455 )

Balance as of September 30, 2024

$ ( 15,575,795 )

$ 100,924,241

$ ( 22,009,650 )

Convertible Preferred Stock

1 unchanged sentence

Accumulated Other Comprehensive

Accumulated Earnings

Total Stockholders’

18 unchanged sentences

( 15,249,796 )

Stock-based compensation

Repurchases of common stock

Other comprehensive income, net of tax

( 5,982,194 )

Balance as of September 30, 2023

$ ( 15,416,122 )

accompanying notes to unaudited condensed consolidated financial statements

26 unchanged sentences

been included.

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.

Operating results for the three and nine months ended September 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

23 unchanged sentences

written off are recorded when collected.

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

At September 30, 2024 total accounts receivable was $ 384,643 with an allowance for uncollectable

accounts of $ 206,400 resulting in a net amount of $ 178,243 .

4 unchanged sentences

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

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

At September 30, 2024, the Company had $ 1,266,016 in inventory, of which $ 566,186 was

finished goods and $ 699,830 was raw materials.

At December 31, 2023, the Company had $ 1,664,725 in inventory, of which $ 700,467 was finished

goods and $ 964,258 was raw materials.

At December 31, 2023, the Company had $ 1,664,725 in inventory, of which $ 700,467 was finished goods

and $ 964,258 was raw materials.

The Company establishes reserves to reduce low-moving, obsolete, or unusable inventories to their estimated

useful or scrap values.

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.

The Company establishes reserves to reduce low-moving, obsolete, or unusable inventories to their

estimated useful or scrap values.

The Company recognized $ 72,872 and $ 214,134 related to the change in inventory reserves during the

three and nine months ended September 30, 2024, respectively, compared to $ 152,274 and $ 96,073 during the three and nine months ended

September 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 $ 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.

The Company recognized grant funding revenue of $ 434,265 and $ 3,145,112 during the three and nine months ended September 30, 2024, respectively,

compared to $ 2,320,565 during the three and nine months ended September 30, 2023, respectively.

At September 30, 2024, the Company has

also recorded $ 40,856 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 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 89 % and 97 % of accounts receivable at June 30,

2024 and December 31, 2023, respectively.

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

ended September 30, 2024.

Three customers accounted for approximately 61 % of product revenue, and one granting agency accounted for 100 %

of the grant revenue recognized during the three months ended September 30, 2024.

Two customers accounted for approximately 31 % of product

revenue, and two granting agencies accounted for approximately 95 % of grant revenue recognized during the nine months ended September

Three customers accounted for approximately 47 % of product revenue and two customers accounted for approximately 28 % of product

revenue recognized for the three and nine months ended September 30, 2023, respectively.

One granting agency accounted for 100 % of grant

revenue recognized during the three and nine months ended September 30, 2023, respectively.

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

for more than 10 % of accounts receivable at December 31, 2023.

These customers together accounted for approximately 92 % and 97 % of accounts

receivable at September 30, 2024 and December 31, 2023, respectively.

Issued Accounting Standards

13 unchanged sentences

following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:

of Cash, Cash Equivalents and Marketable Investment Securities

June 30, 2024

Schedule of Cash, Cash Equivalents and Marketable Investment Securities

September 30, 2024

Adjusted Cost

Total Unrealized Gains / (Losses)

Cash and Cash Equivalents

Marketable Investment Securities

treasury securities

2 unchanged sentences

treasury securities

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

investment securities held as of September 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 June 30, 2024 and December 31,

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

31, 2023, by level within the fair value hierarchy:

of Fair Value Assets and Liabilities

June 30, 2024

September 30, 2024

Cash equivalents

15 unchanged sentences

treasury bills and notes as

of June 30, 2024 and December 31, 2023.

of September 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 June 30, 2024

Fair value as of September 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

June 30, 2024

September 30, 2024

December 31, 2023

7 unchanged sentences

assets, net consisted of the following:

of Intangible Assets, Net

June 30, 2024

Schedule of Intangible Assets, Net

September 30, 2024

Weighted-Average

2 unchanged sentences

Non-competition agreements

( 1,018,333 )

Total intangible assets

8 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 June 30, 2024 is as follows:

of Future Amortization Expense

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

Schedule of Future Amortization Expense

Year Ending December 31,

1 unchanged sentence

following table sets forth revenue by geographic area:

of Revenue by Geographic Area

Three Months Ended June 30,

Six Months Ended June 30,

Summary of Revenue by Geographic Area

Three Months Ended September 30,

Nine Months Ended September 30,

United States

10 unchanged sentences

Rest of World

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

of Deferred Revenue

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

Schedule of Deferred Revenue

Balance as of December 31, 2023

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

Increase due to prepayments from customers

Balance as of June 30, 2024

Balance as of September 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 and six months

ended June 30, 2024 and 2023, respectively:

of Basis and Diluted Earnings Per Share

Three Months Ended June 30,

Six Months Ended June 30,

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

ended September 30, 2024 and 2023, respectively:

Schedule of Basis and Diluted Earnings Per Share

Three Months Ended September 30,

Nine Months Ended September 30,

Net loss, as reported

8 unchanged sentences

Diluted loss per share

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

computation of diluted loss per share for the three and nine months ended September 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 June 30, 2024, consisting of:

a result of incurring a net loss for the three and nine months ended September 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 September 30, 2024, consisting of:

(i) 1,598,891 restricted stock units and (ii) 532,112 options and warrants.

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

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

and warrants.

The Company had potentially dilutive securities as of September 30, 2023, consisting of:

(i) 2,750,302 restricted stock units and (ii)

512,112 options and warrants.

8 – Stock-Based Compensation

7 unchanged sentences

The number of awards available for issuance under

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

the Incentive Plan was 2,939,242 at September 30, 2024.

following table summarizes option activity during the nine months ended September 30, 2024:

Schedule of Option Activity

Outstanding at December 31, 2023

Forfeited/Cancelled

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.

Outstanding at September 30, 2024

Exercisable at September 30, 2024

aggregate intrinsic value of outstanding options at September 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 June 30, 2024, there

As of September 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 six months ended June 30, 2024:

of Outstanding Restricted Stock Units and Related Party

RSUs and related activity for the nine months ended September 30, 2024:

Schedule of Outstanding Restricted Stock Units and Related Party

Number of RSUs

Weighted Average

Grant Date Fair

Weighted Average Grant Date Fair Value

Unvested at December 31, 2023

Forfeited/Cancelled

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.

Unvested at September 30, 2024

of September 30, 2024, there was approximately $ 6.2 million of unrecognized stock-based compensation expense related to outstanding RSUs

which is expected to be recognized over a weighted-average period of 1.6 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 six months ended June 30, 2024:

of Warrant Activity

following table summarizes warrant activity during the nine months ended September 30, 2024:

Schedule of Warrant Activity

Outstanding at December 31, 2023

Forfeited/Cancelled

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

with acquisitions in prior years is contingent upon the achievement of certain development and revenue milestones on or before January

Outstanding at September 30, 2024

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

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

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

connection with acquisitions in prior years is contingent upon the achievement of certain development and revenue milestones on or before

January 1, 2027.

There was no unrecognized stock-based compensation expense related to warrants.

1 unchanged sentence

Company recognized stock-based compensation expense as follows:

of Recognized Stock-based Compensation Expense

Three Months Ended June 30,

Six Months Ended June 30,

Schedule of Recognized Stock-based Compensation Expense

Three Months Ended September 30,

Nine Months Ended September 30,

Cost of revenue

4 unchanged sentences

9 – Income Taxes

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 three months ended September 30, 2024, the Company recognized expense from income taxes of $ 22,189 , representing an effective tax

rate of ( 0.2 %).

For the nine months ended September 30, 2024, the Company recognized expense from income taxes of $ 65,543 , representing

an effective tax rate of ( 0.2 %).

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 and six months ended June

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

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 nine

months ended September 30, 2023, the Company recognized a benefit from income taxes of $ 2,113,581 and $ 6,611,712 , respectively.

10 – Commitments and Contingencies

4 unchanged sentences

components of lease expense are summarized as follows:

of Lease Expense

Three Months Ended June 30,

Six Months Ended June 30,

Schedule of Lease Expense

Three Months Ended

September 30,

Nine Months Ended

September 30,

Operating lease costs

1 unchanged sentence

Total lease costs

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

of Maturities on Company Lease Liabilities

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

Schedule of Maturities on Company Lease Liabilities

2024 (remainder)

5 unchanged sentences

information related to operating leases was as follows:

of Other Information Related to Operating Lease

Six Months Ended

June 30, 2024

Schedule of Other Information Related to Operating Lease

Nine Months Ended September 30, 2024

Cash paid for operating leases included in operating cash flows

9 unchanged sentences

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 three civil actions, one in the US and the other in the United Kingdom.

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

Each of the civil actions is based on breach

18 unchanged sentences

issued but not outstanding.

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

No shares were repurchased during the three or nine months ended September 30, 2024.

12 – Related Party Transactions

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.

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.

recognized $ 181,878

and $ 361,843

of expense related to this agreement during the three and nine months ended September 30, 2024, respectively.

The Company recognized $ 70,000 of expense for the three and nine months ended September 30, 2023.

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