Abeona Therapeutics(ABEO) - 2024 Q3 - Quarterly Results

Financial Performance - Abeona Therapeutics reported a net loss of $30.3 million for Q3 2024, compared to a net loss of $11.8 million in Q3 2023, reflecting an increase in losses due to higher expenses[8]. - Abeona's total expenses for Q3 2024 were $15.3 million, compared to $11.3 million in Q3 2023, indicating a significant increase in operational costs[12]. - Research and development expenses for Q3 2024 were $8.9 million, up from $7.1 million in the same period of 2023, while general and administrative expenses rose to $6.4 million from $4.2 million[8]. - Total stockholders' equity increased to $45,773 million as of September 30, 2024, compared to $14,826 million as of December 31, 2023[15]. - Accumulated deficit rose to $(803,965) million from $(749,524) million[15]. - Total liabilities and stockholders' equity reached $120,592 million, up from $64,002 million[15]. - Additional paid-in capital increased to $849,388 million from $764,151 million[15]. - Accumulated other comprehensive loss increased to $(84) million from $(66) million[15]. - Total shares issued and outstanding remained at 26,523,878 as of September 30, 2024, unchanged from December 31, 2023[15]. Cash Position - As of September 30, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash totaling $110.0 million, down from $123.0 million as of June 30, 2024[6]. - Abeona's current cash resources are estimated to fund operations into 2026, excluding potential revenue from pz-cel sales[7]. Product Development and Regulatory Progress - The FDA accepted the resubmission of Abeona's Biologics License Application (BLA) for pz-cel, with a target action date set for April 29, 2025[1][4]. - Abeona has made significant progress in commercial readiness for pz-cel, including discussions with payors and onboarding treatment centers[2][4]. - The Centers for Medicare and Medicaid Services (CMS) assigned a product-specific procedure code for pz-cel, facilitating higher reimbursement levels for the therapy[3]. - The company has received new patents related to pz-cel, which are expected to enhance its intellectual property position in the market[3]. Operational Expansion - The company entered a lease agreement for additional manufacturing space in Cleveland, Ohio, to expand its production capacity[3].