7 unchanged sentences
Our product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
−Removed: The CLR 1900 Series is being targeted for solid tumors with a payload that inhibits mitosis (cell division), a validated pathway for treating cancers.
+Added: The CLR 1900 Series targets for solid tumors with a payload that inhibits mitosis (cell division), a validated pathway for treating cancers.
Results of Operations
9 unchanged sentences
Research and development expense for the year ended December 31, 2023 was approximately $28,211,000, compared to approximately $19,220,000 for the year ended December 31, 2022.
−Removed: The following table is a comparison summary of research and development costs for the years ended December 31, 2022 and December 31, 2021:
+Added: The following table provides a summary of research and development costs by category for the years ended December 31, 2023 and December 31, 2022:
Clinical project costs
2 unchanged sentences
General research and development costs
−Removed: * Prior period amounts have been reclassified to conform with current period presentation.
−Removed: 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.
−Removed: 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.
+Added: The overall increase in research and development expense of approximately $8,991,000, or 47%, was primarily a result of an increase in manufacturing and related costs related to greater production sourcing necessary to support clinical trials and establish commercial production capabilities of approximately $5,103,000 and clinical project costs of approximately $2,168,000, driven by the timing of the activities related to our pivotal and pediatric trials and an increase in general research and development costs of approximately $1,668,000 primarily attributable to an increase in personnel-related costs.
General and Administrative.
General and administrative expense for the year ended December 31, 2023 was approximately $10,749,000, compared to approximately $9,594,000 in 2022.
−Removed: 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.
+Added: The increase of $1,155,000, or 12% in general and administrative costs was primarily driven by an increase in personnel costs partially offset by a reduction in professional fees.
Other income (expense), net .
Interest income, net, for the year ended December 31, 2023 was approximately $387,000, as compared to approximately $153,000 for the year ended December 31, 2022.
−Removed: The increase is a result of increased returns on investments.
−Removed: Other income for the year ended December 31, 2021 was approximately $7,000.
−Removed: The year ended December 31, 2022 did not have other income.
+Added: The increase is a result of increased returns on money market cash equivalents.
+Added: Other income was approximately $530,000 was the result of a gain from the valuation of the outstanding warrants issued in September 2023, partially offset by warrant issuance costs.
Liquidity and Capital Resources
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The cash used in operating activities during the twelve months ended December 31, 2023 was approximately $32,377,000.
−Removed: Net cash proceeds from the issuance of common stock, pre-funded warrants and common warrants during 2022 was approximately $9,611,000.
+Added: Net cash proceeds from the issuance of common stock, preferred stock, warrants during 2023 was approximately $22,939,000.
Our cash requirements have historically been for our research and development activities, finance and administrative costs, capital expenditures and overall working capital.
6 unchanged sentences
As of December 31, 2023, our consolidated cash balance was approximately $9.6 million.
−Removed: We believe our cash balance as of December 31, 2022 is adequate to fund our basic budgeted operations into the fourth quarter of 2023.
+Added: We believe our cash balance as of December 31, 2023, when combined with funds generated by the exercise of warrants in January 2024 (see Note 13 to our audited financial statements in Item 8 below), is adequate to fund our basic budgeted operations into the fourth quarter of 2024.
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.
14 unchanged sentences
fees paid to vendors in conjunction with the manufacturing of clinical materials;
−Removed: and professional service fees, such as for lawyers and accountants.
+Added: and professional
+Added: service fees, such as for lawyers and accountants.
In connection with such service fees, our estimates are most affected by our understanding of the status and timing of services provided relative to the actual levels of services incurred by such service providers.
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We make these judgments based on the facts and circumstances known to us, in accordance with GAAP.
−Removed: Long-Lived Assets.
−Removed: Long-lived assets include property, equipment, and right-of-use assets.
−Removed: We periodically evaluate long-lived assets for potential impairment.
−Removed: Whenever events or circumstances change, an assessment is made as to whether there has been impairment to the value of long-lived assets by determining whether projected undiscounted cash flows generated by the applicable asset exceed its net book value as of the assessment date.
−Removed: There were no long-lived asset impairment charges recorded during the years ended December 31, 2022 or 2021.
−Removed: Right-Of-Use Asset and Lease Liability.
−Removed: 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.
−Removed: Leases with a term of twelve months or less will be expensed when paid for operating leases.
−Removed: Stock-based Compensation .
−Removed: 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 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).
−Removed: 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.
−Removed: We account for transactions in which services are received from non-employees in exchange for equity instruments based on the fair value of such services received or of the equity instruments issued (using the Black-Scholes option-pricing model), whichever is more reliably measured.
−Removed: The measurement of stock-based compensation for non-employees is subject to periodic adjustments as the options vest, and the expense is recognized over the period during which a non-employee is required to provide services for the award (usually the vesting period).
−Removed: Accounting for equity instruments granted or sold by us under accounting guidance requires fair-value estimates of the equity instrument granted or sold.
−Removed: If our estimates of the fair value of these equity instruments are too high or too low, our expenses may be over- or understated.
−Removed: For equity instruments granted or sold in exchange for the receipt of goods or services, we estimate the fair value of the equity instruments based on consideration of factors that we deem to be relevant at that time.
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
−Removed: 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 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 October 2022, we allocated the common stock, warrants and pre-funded warrants separately based on the respective estimated relative fair value.
+Added: In conjunction with our financing in September 2023, we allocated the preferred stock and 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.
−Removed: Contingencies.
−Removed: From time to time, we may become involved in legal disputes regarding our products in development, intellectual property rights, stockholder claims or other matters.
−Removed: We assess each matter to determine if a contingent liability should be recorded.
−Removed: In making this assessment, we may consult, depending on the nature of the matter, with external legal counsel and technical experts.
−Removed: Based on the information we obtain, combined with our judgment regarding all the facts and circumstances of each matter, we determine whether it is probable that a contingent loss may be incurred and whether the amount of such loss can be reasonably estimated.
−Removed: Should a loss be probable and reasonably estimable, we record a loss.
−Removed: In determining the amount of the loss, we consider advice received from experts in the specific matter, current status of legal proceedings, if any, prior case history and other factors.
−Removed: Should the judgments and estimates made by us be incorrect, we may need to record additional contingent losses that could materially adversely impact the results of operations and financial conditions.
+Added: We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”).
+Added: The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of our control, among other conditions for equity classification.
+Added: This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
+Added: If these instruments are initially classified as liabilities and subsequently meet the requirements for equity classification, we reclassify the fair value to equity.
+Added: Preferred Stock.
+Added: We accounts for preferred stock based upon their specific terms and the authoritative guidance in ASC 480 and ASC 815, including whether they are freestanding instruments, whether any redemption or conversion aspects exist and how they are required to be settled (particularly if there is a cash settlement aspect), whether they contain characteristics that are predominantly debt-like or equity-like, whether they have embedded derivatives, and if they have redemption features.
+Added: Based upon analysis of these criteria, the preferred stock will be classified as either debt, temporary (or “mezzanine”) equity, or permanent equity.
+Added: The resultant classification is then evaluated quarterly to determine whether any change to the classification is required.
Quantitative and Qualitative Disclosures About Market Risk.
1 unchanged sentence
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.