Abeona Therapeutics(US:ABEO)2024-11-14 12:30Financial Performance - The net loss for the three months ended September 30, 2024, was $30.269 million, compared to a loss of $11.836 million for the same period in 2023, reflecting a 156% increase in losses[12]. - The net loss for the nine months ended September 30, 2024 and 2023, respectively, was $54.4 million and $37.6 million, with an accumulated deficit of approximately $804.0 million as of September 30, 2024[26]. - The basic and diluted loss per common share for the three months ended September 30, 2024, was $(0.63), compared to $(0.48) for the same period in 2023[12]. - The company has incurred significant operating losses and negative cash flows from operations since inception, which are expected to continue for the foreseeable future[25]. - The company has incurred recurring losses since inception and expects to continue generating operating losses for the foreseeable future[26]. Assets and Liabilities - As of September 30, 2024, total current assets increased to $112.657 million from $55.737 million as of December 31, 2023, representing a 102% increase[9]. - Total liabilities rose to $74.819 million from $49.176 million, marking a 52% increase[10]. - The total stockholders' equity increased significantly to $45.773 million from $14.826 million, representing a 208% increase[11]. - Total assets measured at fair value as of September 30, 2024, were $109,168 million, an increase from $72,305 million as of December 31, 2023[51]. - Total liabilities measured at fair value as of September 30, 2024, were $38,789 million, up from $31,352 million as of December 31, 2023[55]. Cash Flow and Investments - Cash and cash equivalents increased to $15.726 million as of September 30, 2024, from $14.473 million as of December 31, 2023, a rise of 9%[9]. - As of September 30, 2024, the Company had cash, cash equivalents, restricted cash, and short-term investments totaling $110.0 million, expected to fund operations for at least the next 12 months[26]. - The total cash, cash equivalents, and restricted cash at the end of the period is $16,064,000, compared to $5,050,000 at the end of the prior year[20]. - Total available-for-sale short-term investments amounted to $93.975 million as of September 30, 2024, with unrealized losses primarily due to changes in interest rates[42]. Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $25.366 million, up from $23.712 million in the same period of 2023, indicating a 7% increase[12]. - The company is developing pz-cel, an autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB)[21]. - The reimbursement of development and transition costs from Ultragenyx is recognized as a reduction of research and development costs[109]. Stock and Equity - The company issued 12,285,056 shares of common stock in connection with an underwritten offering, net of offering costs, during the reporting period[16]. - The Company sold 1,902,376 shares under the ATM Agreement during the nine months ended September 30, 2024, resulting in net proceeds of $10.0 million[84]. - The Company sold 3,284,407 shares and pre-funded warrants for an aggregate purchase price of $25.0 million gross on July 6, 2023[89]. - The Company sold 12,285,056 shares and pre-funded warrants for an aggregate purchase price of $75.0 million gross on May 7, 2024[90]. Revenue and Licensing - The company reported no license and other revenues for the three months ended September 30, 2024, compared to $3.5 million for the same period in 2023[12]. - The Company recognized no revenue from the sublicense agreements for the three and nine months ended September 30, 2024 and 2023[103]. - The transaction price for the sublicense agreement related to CLN1 disease includes $7.0 million of fixed consideration and up to $56.0 million of variable consideration[102]. - Under the Ultragenyx License Agreement, the Company is eligible to receive tiered royalties from mid-single-digit up to 10% on net sales and up to $30.0 million in commercial milestone payments[108]. Risks and Future Outlook - The company has highlighted potential risks including the timing and outcome of the FDA's review of its Biologics License Application for pz-cel, which could materially affect performance[7]. - The Company resubmitted its Biologics License Application (BLA) for pz-cel on October 28, 2024, with a target action date of April 29, 2025, set by the FDA[110]. - The BLA resubmission follows a Type A meeting with the FDA in August 2024, aligning on additional information required for Chemistry Manufacturing and Controls (CMC)[111]. Operating Costs and Expenses - Total operating lease costs for the nine months ended September 30, 2024, were $1,308 million, a decrease from $1,379 million in the same period of 2023[68]. - The Company incurred stock-based compensation expense of $4,673,000 for the nine months ended September 30, 2023, compared to $3,254,000 for the same period in 2022[20]. - Total stock-based compensation expense for the three months ended September 30, 2024 was $1.804 million, compared to $1.557 million for the same period in 2023[95].