What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-07 compared with 2024-08-08 · 106 added, 88 removed, 154 unchanged (56% of the section changed)

92 unchanged sentences

rapidly screen millions of possible options to pinpoint the optimum design.

The intellectual property we use in our business, consisting

of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represents a major

The intellectual property we use in our business consists

of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major

advance in PCR testing systems.

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OF OPERATIONS

Three Months Ended June 30, 2024 Compared to the Three Months ended June 30, 2023

the three months ended June 30, 2024, we generated revenues of $2,656,840, compared to revenues of $197,806 for the three months ended

June 30, 2023.

Grant revenue accounted for $2,495,738 of revenue for the three months ended June 30, 2024, compared to $0 for the three

months ended June 30, 2023.

The increase in grant revenue was primarily due to the achievement of certain milestones under various grants

the Company was awarded.

recorded cost of revenues of $212,148 for the three months ended June 30, 2024, compared to $459,095 for the three months ended June

The decrease in cost of revenues of $246,947 is primarily due to lower inventory obsolescence reserves recorded in the current

incurred total operating expenses of $10,124,654 for the three months ended June 30, 2024, compared to total operating expenses of $11,733,150

for the three months ended June 30, 2023.

The decrease in operating expenses was primarily due to decreased stock-based compensation

expense, bad debt expense, and expense related to clinical trials for the Co-Dx PCR platform.

These decreases were partially offset by

increased legal expenses.

sales and marketing expenses for the three months ended June 30, 2024 were $1,041,243, compared to $1,732,966 for the three months ended

June 30, 2023.

The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, and

website development expenses.

and administrative expenses were $3,132,385 for the three months ended June 30, 2024, compared to $3,713,895 for the three months ended

June 30, 2023.

The decrease in general and administrative expenses was primarily due to decreases in stock-based compensation expense,

bad debt expense, and insurance expense, partially offset by increased legal and professional services expenses.

research and development expenses were $5,612,691 for the three months ended June 30, 2024, compared to $5,981,043 for the three months

ended June 30, 2023.

The decrease was primarily a result of decreased expenses related to clinical trials for the Co-Dx PCR platform

and stock-based compensation expense, partially offset by increases in personnel related expenses.

the three months ended June 30, 2024 we had total other income of $101,234, compared to total other income of $837,294 for the three

months ended June 30, 2023.

The decrease in other income is primarily due to a change in the fair value of contingent consideration liabilities

and decreased realized gains from investments in marketable securities, partially offset by increased interest income.

realized a net loss for the three months ended June 30, 2024 of $7,599,318, compared to a net loss for the three months ended June 30,

2023 of $8,918,825.

The smaller net loss was primarily the result of an increase in grant revenue, combined with a decrease in operating

expenses, as well as changes in the fair value of acquisition contingencies and income related to investments in marketable securities.

Additionally, we recorded income tax expense of $20,590 for the three months ended June 30, 2024, compared to an income tax benefit of

$2,238,320 for the three months ended June 30, 2023.

The primary reason for the change in the provision for income taxes is a result

of the Company now being in a full valuation allowance.

Six Months Ended June 30, 2024 Compared to the Six Months ended June 30, 2023

the six months ended June 30, 2024, we generated revenues of $3,124,694, compared to revenues of $799,763 for the six months ended June

Grant revenue accounted for $2,710,847 of revenue for the six months ended June 30, 2024, compared to $0 for the six months

ended June 30, 2023.

The decrease in product revenue of $385,916 was primarily due to lower sales of our Logix Smart COVID-19 throughout

The increase in grant revenue was primarily due to the achievement of certain milestones under various grants the Company

recorded cost of revenues of $446,653 for the six months ended June 30, 2024, compared to $961,336 for the six months ended June 30,

The decrease in cost of revenues of $514,683 is primarily due to lower inventory obsolescence reserves being recorded in the current

incurred total operating expenses of $20,617,390 for the six months ended June 30, 2024, compared to total operating expenses of $21,783,516

for the six months ended June 30, 2023.

The decrease in operating expenses was primarily due to decreased stock-based compensation expense,

bad debt expense and expense related to clinical trials for the Co-Dx PCR platform.

Three Months Ended September 30, 2024 Compared to the Three Months ended September 30, 2023

the three months ended September 30, 2024, we generated revenues of $641,141, compared to revenues of $2,457,098 for the three months

ended September 30, 2023.

Grant revenue accounted for $434,265 of revenue for the three months ended September 30, 2024, compared to

$2,320,565 for the three months ended September 30, 2023.

The decrease in grant revenue was primarily due to the timing of the achievement

of certain milestones under various grants the Company was awarded.

recorded cost of revenues of $297,403 for the three months ended September 30, 2024, compared to $255,772 for the three months ended

September 30, 2023.

The increase in cost of revenues is primarily due to higher inventory obsolescence costs recorded in

the current quarter versus the prior year comparable period.

incurred total operating expenses of $10,578,675 for the three months ended September 30, 2024, compared to total operating expenses

of $11,137,277 for the three months ended September 30, 2023.

The decrease in operating expenses was primarily due to decreased stock-based

compensation expense, and expense related to clinical trials for the Co-Dx PCR platform.

These decreases were partially offset by increased

personnel related expenses and legal expenses.

sales and marketing expenses for the six months ended June 30, 2024 were $2,604,925, compared to $3,439,297 for the six months ended

June 30, 2023.

The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, and

website development expenses.

and administrative expenses were $6,051,188 for the six months ended June 30, 2024, compared to $6,727,860 for the six months ended June

The decrease in general and administrative expenses was primarily due to decreases in stock-based compensation expense, bad

debt expense, and insurance expense, partially offset by increased legal and professional services expenses.

research and development expenses were $11,292,369 for the six months ended June 30, 2024, compared to $10,995,103 for the six months

ended June 30, 2023.

The primary increase in expenses was a result of increased personnel related expenses, partially offset by decreased

expenses related to clinical trials for the Co-Dx PCR platform and stock-based compensation expense.

the six months ended June 30, 2024 we had total other income of $1,071,342, compared to total other income of $2,772,742 for the six

months ended June 30, 2023.

The decrease in other income is primarily due to a change in the fair value of contingent consideration liabilities,

an increased loss related to the Company’s joint venture investment, and decreased realized gains from investments in marketable

securities, partially offset by increased interest income.

realized a net loss for the six months ended June 30, 2024 of $16,911,361, compared to a net loss for the six months ended June 30, 2023

legal expenses.

sales and marketing expenses for the three months ended September 30, 2024 were $1,059,745, compared to $1,904,395 for the three months

ended September 30, 2023.

The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses,

and outside consulting and professional services expenses.

and administrative expenses were $4,287,380 for the three months ended September 30, 2024, compared to $3,147,753 for the three months

ended September 30, 2023.

The increase in general and administrative expenses was primarily due to increased legal expenses, partially

offset by decreases in stock-based compensation expense and professional services expenses.

research and development expenses were $4,880,315 for the three months ended September 30, 2024, compared to $5,788,789 for the three

months ended September 30, 2023.

The decrease was primarily a result of decreased expenses related to development of and clinical trials

for the Co-Dx PCR platform and stock-based compensation expense, partially offset by increases in consulting and professional

services expenses.

the three months ended September 30, 2024 we had total other income of $560,671, compared to total other income of $840,176 for the three

months ended September 30, 2023.

The decrease in other income is primarily due to a change in the fair value of contingent consideration

liabilities and decreased realized gains from investments in marketable securities.

realized a net loss for the three months ended September 30, 2024 of $9,696,455, compared to a net loss for the three months ended September

30, 2023 of $5,982,194.

The larger net loss was primarily the result of changes in the fair value of acquisition contingencies and income taxes,

partially offset by an increase in grant revenue combined with a decrease in operating expenses.

We recorded income tax expense of $43,354

for the six months ended June 30, 2024, compared to an income tax benefit of $4,498,131 for the six months ended June 30, 2023.

reason for the change in the provision for income taxes is a result of the Company now recording a full valuation allowance.

The increase in net loss was primarily the result of a decrease in grant revenue, partially offset by a decrease

in operating expenses, as well as changes in the fair value of acquisition contingencies and income related to investments in marketable

Additionally, we recorded income tax expense of $22,189 for the three months ended September 30, 2024, compared to an income

tax benefit of $2,113,581 for the three months ended September 30, 2023.

The primary reason for the change in the provision for income

taxes is a result of the Company now being in a full valuation allowance.

Nine Months Ended September 30, 2024 Compared to the Nine Months ended September 30, 2023

the nine months ended September 30, 2024, we generated revenues of $3,765,835, compared to revenues of $3,256,861 for the nine months

ended September 30, 2023.

Grant revenue accounted for $3,145,112 of revenue for the nine months ended September 30, 2024, compared to

$2,320,565 for the nine months ended September 30, 2023.

The decrease in product revenue of $315,573 was primarily due to lower sales

of our Logix Smart COVID-19 test throughout the world.

The increase in grant revenue was primarily due to the achievement of certain

milestones under various grants the Company was awarded.

recorded cost of revenues of $744,056 for the nine months ended September 30, 2024, compared to $1,217,108 for the nine months ended

September 30, 2023.

The decrease in cost of revenues of $473,052 is primarily due to lower inventory obsolescence reserves being recorded

in the current year versus the prior year comparable period.

incurred total operating expenses of $31,196,065 for the nine months ended September 30, 2024, compared to total operating expenses of

$32,920,793 for the nine months ended September 30, 2023.

The decrease in operating expenses was primarily due to decreased stock-based

compensation expense, bad debt expense and expense related to development of and clinical trials for the Co-Dx PCR platform.

These decreases

were partially offset by increased personnel related expenses and legal expenses.

sales and marketing expenses for the nine months ended September 30, 2024 were $3,664,670, compared to $5,343,692 for the nine months

ended September 30, 2023.

The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses,

website development expenses and personnel related expenses.

and administrative expenses were $10,338,568 for the nine months ended September 30, 2024, compared to $9,875,613 for the nine months

ended September 30, 2023.

The increase in general and administrative expenses was primarily due to increased legal expenses, partially

offset by decreases in stock-based compensation expense, bad debt expense, professional services expense and insurance expense.

research and development expenses were $16,172,684 for the nine months ended September 30, 2024, compared to $16,783,892 for the nine

months ended September 30, 2023.

The decrease was primarily a result of decreased expenses related to development of and clinical trials

for the Co-Dx PCR platform and stock-based compensation expense, partially offset by increases in personnel, consulting and professional

services expenses.

the nine months ended September 30, 2024, we had total other income of $1,632,013, compared to total other income of $3,612,918 for the

nine months ended September 30, 2023.

The decrease in other income is primarily due to a change in the fair value of contingent consideration

liabilities, an increased loss related to the Company’s joint venture investment, and decreased realized gains from investments

in marketable securities, partially offset by increased interest income.

realized a net loss for the nine months ended September 30, 2024 of $26,607,816, compared to a net loss for the nine months ended September

30, 2023 of $20,656,410.

The larger net loss was primarily the result of changes in the fair value of acquisition contingencies and income

taxes, partially offset by an increase in grant revenue combined with a decrease in operating expenses.

We recorded income tax expense

of $65,543 for the nine months ended September 30, 2024, compared to an income tax benefit of $6,611,712 for the nine months ended September

The primary reason for the change in the provision for income taxes is a result of the Company now recording a full valuation

and Capital Resources

June 30, 2024, we had cash and cash equivalents of $13,858,866.

September 30, 2024, we had cash and cash equivalents of $10,797,630.

Additionally, we had $26,864,571 of marketable investment securities

that could readily be converted into cash if needed.

Additionally, our total current assets of June 30, 2024, were $48,219,239 compared

Additionally, our total current assets of September 30, 2024, were $40,103,158 compared

to total current liabilities of $5,797,977.

cash used in operating activities during the six months ended June 30, 2024 was $13,694,532, compared to $11,538,068 for the six months

ended June 30, 2023.

The increase in cash used in operating activities was primarily due to increased operating expenses and the impact

of non-cash items.

cash provided by investing activities during the six months ended June 30, 2024 was $12,636,520, primarily from maturities of marketable

investment securities, compared to $3,433,041 during the six months ended June 30, 2023.

cash used in financing activities was $0 for the six months ended June 30, 2024, compared to $1,037,930 for the same period in the prior

This is due to the repurchase of outstanding common shares during the prior period, compared to no such repurchases in the current

cash used in operating activities during the nine months ended September 30, 2024 was $20,924,039, compared to $17,303,239 for the

nine months ended September 30, 2023.

The increase in cash used in operating activities was primarily due to a decrease in cash

collections from customers and granting agencies and the impact of non-cash items.

cash provided by investing activities during the nine months ended September 30, 2024 was $16,804,791, primarily from maturities of marketable

investment securities, compared to $5,773,590 during the nine months ended September 30, 2023.

cash used in financing activities was $0 for the nine months ended September 30, 2024, compared to $1,204,256 for the same period in

the prior year.

This is due to the repurchase of outstanding common shares during the prior period, compared to no such repurchases in

the current period.

commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the purchase

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shares of our common stock, having an aggregate offering price of up to $50.0 million through Piper, as agent.

The Company is subject

to General Instruction I.B.6 of Form S-3 which limits the amounts that we may sell under the Equity Distribution Agreement over a 12-month

period to an amount equal to or less than one-third of our public float.

On October 18, 2024, the Company filed a Prospectus Supplement

with the SEC reducing the amount available for sale under the Equity Distribution Agreement to $17.1 million.

No shares have been sold

under the distribution agreement as of June 30, 2024.

We may not be able to secure financing in a timely manner or on favorable terms,

under the distribution agreement as of September 30, 2024.

We may not be able to secure financing in a timely manner or on favorable

terms, if at all.

Sheet Arrangements

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis