Financial Performance - The company reported a net loss of 24.6millionfortheyearendedDecember31,2024,adecreaseof31.6 million compared to a net loss of 56.2millionin2023[424].−Thecompanyhasaccumulatedadeficitof134.8 million as of December 31, 2024, and expects to incur losses for the foreseeable future[413]. - Interest income decreased by 0.3millionfortheyearendedDecember31,2024,attributedtolowercashandcashequivalentbalances[427].−Financingcostswere1.9 million for the year ended December 31, 2024, compared to no financing costs in 2023, due to issuance costs and changes in derivative fair value[428]. - The change in fair value of warrants resulted in a gain of 3.6millionfortheyearendedDecember31,2024,comparedtoalossof11.8 million in 2023[429]. - As of December 31, 2024, the company's cash and cash equivalents totaled 10.6million,indicatingongoingliquiditychallenges[431].−Cashusedinoperatingactivitieswas21.9 million for the year ended December 31, 2024, a decrease from 40.0millionin2023,reflectingreducedclinicalactivity[448].−Cashprovidedbyfinancingactivitieswas26.7 million for the year ended December 31, 2024, primarily from common stock and warrant issuances[450]. - The company expects to incur significant operating losses for the foreseeable future as it ramps up clinical development programs[441]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory requirements, with substantial doubt regarding the ability to continue as a going concern within one year[440]. Research and Development - Research and development expenses decreased to 20.0millionin2024from38.8 million in 2023, reflecting a reduction of 18.8million[424].−ThePhase3PDStudywascompletedonDecember4,2023,withtoplineefficacydatareleasedonJuly2,2024,showingsignificantcognitiveimprovementsin1218.8 million for the year ended December 31, 2024, compared to 2023, primarily due to the completion of major clinical trials[425]. - Research and development expenses for the year ended December 31, 2024, were 3.8million,comparedto4.6 million for 2023, indicating a decrease of approximately 17.4%[461]. Administrative Expenses - General and administrative expenses increased slightly to 6.7millionin2024from6.2 million in 2023, an increase of 0.5million[424].−Generalandadministrativeexpensesincreasedby0.5 million for the year ended December 31, 2024, mainly due to warrant exercise commissions[426]. Stock-Based Compensation - As of December 31, 2024, the company had 2.4millionofunrecognizedstock−basedcompensationexpense,whichwillberecognizedoveraremainingweighted−averageperiodof1.0years[461].−Stock−basedcompensationexpensewasrecordedas3.8 million for 2024, reflecting the company's ongoing investment in employee incentives[461]. - Stock-based compensation awards are recognized in the statements of operations based on their grant date fair values, with forfeitures recognized as they occur[457]. Accounting and Reporting - The company adopted ASU 2023-07 for segment reporting, effective January 1, 2024, which requires public entities to disclose significant expenses and other segment items annually[463]. - The company has not determined the impact of ASU 2023-09 on its financial statement disclosures but does not expect material impacts[465]. - The company has irrevocably elected not to take advantage of the JOBS Act exemption, thus adhering to the same new or revised accounting standards as other public companies[467]. - The fair value of Common Stock Warrant Liabilities is determined using a Black-Scholes option-pricing model, which requires considerable judgment and may lead to significant differences in reported values[462]. - The assumptions used in the Black-Scholes option-pricing model include expected term, expected volatility, risk-free interest rate, and expected dividends, which are inherently subjective[459].
