Atara Biotherapeutics(ATRA) - 2025 Q1 - Quarterly Results

Q1 2025 Financial Results and Operational Progress The company secured new financing and implemented major cost reductions to extend its cash runway while focusing resources on its lead program, tab-cel - Atara secured $16 million in financing, which is expected to extend its cash runway through the first quarter of 2026[2][7][13] - The company is implementing significant cost reductions, including workforce and program cuts, and expects to reduce operating expenses by approximately 65% year-over-year in 2025[1][6][13] - All manufacturing responsibilities and costs for its lead candidate, tabelecleucel, have been transferred to partner Pierre Fabre Laboratories[1][4] - Development of the company's CAR T programs (ATA3219 and ATA3431) has been discontinued to focus resources on tabelecleucel[3] Operational Highlights & Pipeline Update Atara is advancing tab-cel® by addressing FDA feedback and transferring manufacturing, while discontinuing CAR T programs to conserve resources Tabelecleucel (tab-cel® or EbvalloTM) The company is actively working with the FDA to advance its lead program, tab-cel®, towards a Biologics License Application resubmission - The FDA has lifted the clinical holds on EBVALLOTM studies, and Atara plans to resume enrollment in its Phase 3 and Phase 2 studies[4] - A Type A meeting with the FDA is scheduled for Q2 2025 to discuss the path for resubmitting the EBVALLOTM Biologics License Application (BLA)[4] - As of March 2025, all worldwide manufacturing responsibility for tab-cel has been transferred to partner Pierre Fabre Laboratories[4] - Atara remains eligible for significant milestone payments and royalties from Pierre Fabre upon potential FDA approval and commercial sales of EBVALLOTM[4] CAR T Programs Development of the company's CAR T programs has been paused to prioritize resources for its lead asset - Atara has paused the development of its CAR T programs (ATA3219 and ATA3431), with wind-down activities expected to be completed in the second quarter of 2025[3] Corporate and Financial Updates The company executed a strategic restructuring and secured new financing, resulting in a significant Q1 2025 revenue increase and a return to profitability Corporate Updates The company undertook a major restructuring, including workforce reductions and new financing, to strengthen its financial position - In May 2025, Atara implemented a strategic restructuring that resulted in a 30% workforce reduction, retaining approximately 23 essential personnel[6] - The company entered into an underwriting agreement for an offering with expected gross proceeds of $16 million to fund activities towards tab-cel BLA approval and for general corporate purposes[7] - Atara has paused its review of strategic options, such as a merger or sale, pending the outcome of the Type A meeting with the FDA scheduled for Q2 2025[5] First Quarter 2025 Financial Results Q1 2025 saw a dramatic revenue increase and a shift to net income, driven by the Pierre Fabre agreement Q1 2025 Financial Highlights | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenues | $98.1M | $27.4M | +$70.7M | | R&D Expenses | $27.4M | $45.5M | -$18.1M | | G&A Expenses | $11.5M | $11.1M | +$0.4M | | Net Income (Loss) | $38.0M | $(31.8)M | +$69.8M | | Diluted EPS | $3.50 | $(5.65) | +$9.15 | - The significant increase in total revenues was primarily due to revenue recognized from the Pierre Fabre agreement following the transfer of manufacturing responsibilities[8] - Cash, cash equivalents, and short-term investments totaled $13.8 million as of March 31, 2025, compared to $42.5 million as of December 31, 2024[8] 2025 Outlook and Cash Runway Atara projects a 65% reduction in 2025 operating expenses and has extended its cash runway into Q1 2026 with recent financing - The company projects that its cash position as of March 31, 2025, combined with the $16M gross proceeds from the May 2025 offering, will fund planned operations into the first quarter of 2026[13] - Full-year 2025 operating expenses are expected to decrease by approximately 65% from 2024, with the largest reduction anticipated in Q2 2025[1][13] - The company has reduced its headcount by approximately 85% since December 31, 2024, as part of its cost reduction initiatives[13] Financial Statements This section provides the unaudited Consolidated Balance Sheets and Statements of Operations as of and for the period ended March 31, 2025 Consolidated Balance Sheets The balance sheet reflects a decrease in total assets and a significant reduction in liabilities, primarily from deferred revenue recognition Consolidated Balance Sheet Summary | Balance Sheet Item (In thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $13,841 | $25,030 | | Total current assets | $27,182 | $64,894 | | Total assets | $62,038 | $109,098 | | Liabilities & Equity | | | | Deferred revenue (current) | $15,983 | $95,092 | | Total current liabilities | $47,892 | $134,574 | | Total liabilities | $117,110 | $206,381 | | Total stockholders' (deficit) equity | $(55,072) | $(97,283) | - Total assets decreased to $62.0 million as of March 31, 2025, from $109.1 million at December 31, 2024[15] - Total liabilities decreased significantly to $117.1 million from $206.4 million, primarily due to a reduction in deferred revenue from $95.1 million to $16.0 million[15] Consolidated Statements of Operations The company achieved a significant net income of $38.0 million in Q1 2025, a stark contrast to the net loss in the prior-year period Consolidated Statement of Operations Summary | Statement of Operations (In thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Commercialization revenue | $98,149 | $27,357 | | Total costs and operating expenses | $59,347 | $58,604 | | Income (loss) from operations | $38,802 | $(31,247) | | Net income (loss) | $38,010 | $(31,752) | - The company reported a net income of $38.0 million for Q1 2025, a significant turnaround from a net loss of $31.8 million in Q1 2024[9][17] - Diluted net income per common share was $3.50 for Q1 2025, compared to a diluted net loss per share of $5.65 in the same period of 2024[9][17]