24 unchanged sentences
General research and development costs
−Removed: The overall increase in research and development expense of approximately $7,445,000, or 73%, was primarily a result of an increase in clinical project costs primarily related to our WM pivotal study of approximately $7,050,000 and general research and development cost of approximately $360,000.
−Removed: Manufacturing and related costs remained relatively consistent.
+Added: * Prior period amounts have been reclassified to conform with current period presentation.
+Added: The overall increase in research and development expense of approximately $1,634,000, or 9%, was primarily a result of an increase in manufacturing and related costs related to production sourcing and pre-clinical costs.
+Added: This increase was partially offset by reduced clinical project costs of approximately $160,000, driven by the timing of the activities related to our pivotal trial, and a reduction in general research and development costs of approximately $305,000.
General and Administrative.
General and administrative expense for the year ended December 31, 2022 was approximately $9,594,000, compared to approximately $6,545,000 in 2021.
−Removed: The increase of $1,395,000, or 27%, in general and administrative costs was primarily a result of an increase in professional fees and insurance, personnel costs and stock-based compensation expense.
+Added: The increase of $3,049,000, or 47%, in general and administrative costs was primarily driven by increased professional fees, a portion of which are non-recurring, as well as travel and personnel costs.
Other income (expense), net .
Interest income, net, for the year ended December 31, 2022 was approximately $153,000, as compared to approximately $2,000 for the year ended December 31, 2021.
−Removed: The decrease is a result of decreased returns on investments.
+Added: The increase is a result of increased returns on investments.
Other income for the year ended December 31, 2021 was approximately $7,000.
−Removed: Other income for the year ended December 31, 2020 was approximately $185,000 because of a gain on extinguishment of debt related to the forgiveness of our loan and accrued interest obtained under the Paycheck Protection Program (PPP).
−Removed: The PPP was established as part of the Coronavirus Aid, Relief and Economic Security Act which provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business.
−Removed: The loans and accrued interest are forgivable after 24 weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels.
−Removed: The amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the 24-week period.
+Added: The year ended December 31, 2022 did not have other income.
Liquidity and Capital Resources
Year ended December 31, 2022, Compared to Year Ended December 31, 2021
−Removed: As of December 31, 2021, we had cash, cash equivalents and restricted cash of $35.7 million, compared to $57.2 million as af December 31, 2020.
+Added: As of December 31, 2022, we had cash and cash equivalents of $19.9 million, compared to $35.7 million as of December 31, 2021, a decrease of $15.8 million.
This decrease was primarily a result of research and development expense and general and administrative expenses.
The cash used in operating activities during the twelve months ended December 31, 2022 was approximately $25,222,000.
+Added: Net cash proceeds from the issuance of common stock, pre-funded warrants and common warrants during 2022 was approximately $9,611,000.
Our cash requirements have historically been for our research and development activities, finance and administrative costs, capital expenditures and overall working capital.
3 unchanged sentences
We have incurred losses since inception in devoting substantially all of our efforts toward research and development.
−Removed: During the year ended December 31, 2021, we generated a net loss of approximately $24.1 million, and used approximately $22.6 million in cash from operations.
+Added: During the year ended December 31, 2022, we generated a net loss of approximately $28.6 million, and used approximately $25.2 million in cash for operations.
We expect that we will continue to generate operating losses for the foreseeable future.
As of December 31, 2022, our consolidated cash balance was approximately $19.9 million.
−Removed: We believe our cash balance as of December 31, 2021 is adequate to fund our basic budgeted operations for at least 12 months from the filing of these financial statements.
+Added: We believe our cash balance as of December 31, 2022 is adequate to fund our basic budgeted operations into the fourth quarter of 2023.
Our ability to execute our operating plan beyond that time depends on our ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or otherwise.
26 unchanged sentences
Right-Of-Use Asset and Lease Liability.
−Removed: A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification.
−Removed: Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases.
+Added: A lessee is required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification.
+Added: Leases with a term of twelve months or less will be expensed when paid for operating leases.
Stock-based Compensation .
We account for stock-based compensation by measuring the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award, using the Black-Scholes option-pricing model.
−Removed: The cost of non-performance-based awards is recognized over the period during which an employee is required to provide service in exchange for the award, the requisite service period (usually the vesting period).
+Added: The cost of service-based awards is recognized over the period during which an employee is required to provide service in exchange for the award, the requisite service period (usually the vesting period).
For stock options with performance-based vesting provisions, recognition of compensation expense commences if and when the achievement of the performance criteria is deemed probable and is recognized over the relevant performance period.
5 unchanged sentences
Fair value measurements.
−Removed: We account for certain financial assets at fair value, defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., exit price) in the principal, most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
+Added: We account for certain financial assets at fair value, defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., exit price) in the principal, most advantageous market for the asset or liability in an orderly
+Added: transaction between market participants on the measurement date.
As such, fair value is a market-based measurement that is determined based on assumptions that a market participant would use in pricing an asset or liability.
−Removed: In conjunction with our financing in June 2020, we allocated the common stock, warrants and pre-funded warrants separately based on the respective estimated relative fair value.
−Removed: In conjunction with our financing in December 2020, we allocated the common stock and preferred stock separately based on the respective estimated relative fair value.
+Added: In conjunction with our financing in October 2022, we allocated the common stock, warrants and pre-funded warrants separately based on the respective estimated relative fair value.
If management made different assumptions or judgments, material differences in measurements of fair value could occur.
10 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.