
Financial Performance - Operating loss for the three months ended September 30, 2024, was $3,282,087, a decrease from $5,749,674 for the same period in 2023[10] - Net loss for the three months ended September 30, 2024, was $3,231,604, compared to a net loss of $5,979,054 for the same period in 2023[10] - The net loss for the three months ended September 30, 2023, was $5,979,054, compared to a net loss of $16,600,250 for the nine months ended September 30, 2023[16] - The company incurred a net loss of $9,413,758 for the nine months ended September 30, 2024, compared to $16,600,250 for the same period in the previous year[16] - The accumulated deficit increased to $(102,357,201) as of September 30, 2024, from $(92,943,443) on December 31, 2023, reflecting a rise of approximately 10%[8] - The company reported a net cash used in operating activities of $14,371,857 for the nine months ended September 30, 2024[16] - The company reported interest and other income of $50,483 for the three months ended September 30, 2024, compared to an expense of $(229,380) in the same period of 2023, indicating a positive shift[10] Assets and Liabilities - Total current assets increased significantly to $11,343,611 as of September 30, 2024, compared to $578,594 at the end of December 31, 2023[8] - Cash and cash equivalents decreased to $10,040,149 as of September 30, 2024, from $52,416 at the end of December 31, 2023[8] - Total liabilities decreased to $1,542,541 as of September 30, 2024, from $10,360,865 at the end of December 31, 2023[8] - Total stockholders' equity increased to $12,037,563 as of September 30, 2024, from a deficit of $(6,869,429) at the end of December 31, 2023[8] - Accrued expenses totaled $402,152 as of September 30, 2024, significantly down from $1,651,518 as of December 31, 2023, reflecting a decrease of approximately 75.7%[30] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $5,116,582, down from $10,508,395 in the same period of 2023[10] - Research and development expenses for the three months ended September 30, 2024, were $1,428,504, down from $3,923,852 in the same period of 2023, reflecting a decrease of about 64%[10] - The company plans to develop and commercialize product candidates, with ongoing clinical trials for CTx-1301, CTx-1302, and CTx-2103[6] - The company is targeting a New Drug Application (NDA) for its ADHD treatment CTx-1301 in mid-2025, with ongoing clinical requirements[18] - The company has a third product, CTx-2103, in the formulation stage for treating anxiety[18] Stock and Financing - The company raised approximately $24.4 million from the issuance of common stock and pre-funded common stock purchase warrants during the nine months ended September 30, 2024[16] - The company issued common stock in connection with various offerings, raising a total of approximately $11,791,624 during the three months ended September 30, 2024[14] - The Company completed a public offering on February 2, 2024, resulting in gross proceeds of $7.5 million before deducting $750,950 in fees[51] - The Company sold 902,300 shares of common stock under the ATM Agreement for net proceeds of $5,804,393 during the three months ended September 30, 2024[48] - The Company sold 1,092,337 shares under the Lincoln Park Purchase Agreement during the three months ended September 30, 2024, for net proceeds of $6,081,814[50] Stock-Based Compensation - Stock-based compensation expense for the three months ended September 30, 2023, was $236,251[13] - Stock-based compensation expense was recorded at $812,691 for the nine months ended September 30, 2024, compared to $658,105 for the same period in 2023[56] - The fair value of stock options granted during the three months ended September 30, 2024, was $5.04, while the range for the nine months ended September 30, 2024, was from $4.00 to $14.00[61] - As of September 30, 2024, there was $1,219,737 of unrecognized compensation cost related to nonvested share-based compensation arrangements, expected to be recognized over the next one to four years[56] Tax and Valuation - The Company recorded a valuation allowance for deferred tax assets totaling $16,121,058 as of September 30, 2024, compared to $12,631,033 at December 31, 2023[74] - No deferred income tax benefit or expense was recorded for the three-month periods ended September 30, 2024 and 2023, or for the nine-month periods ended September 30, 2024 and 2023[71] - The total income tax expense for the nine months ended September 30, 2024, was $0, consistent with the previous year[72] - The Company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of September 30, 2024[76] Corporate Actions - The company completed a one-for-twelve reverse stock split on August 9, 2024, reducing the number of issued and outstanding shares[41] - The Company has authorized 240,000,000 shares of common stock and 10,000,000 shares of preferred stock, with 3,044,165 shares of common stock issued and outstanding as of September 30, 2024[38] - The maximum aggregate offering price of shares under the ATM Agreement was increased from $15.2 million to $19.7 million[78] - The Company approved an amendment to the 2021 Plan, increasing the number of shares authorized for issuance by 104,167 shares to a total of 125,577 shares[55]