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THOUSAND OAKS, Calif. - Atara Biotherapeutics, Inc. (NASDAQ:ATRA), currently trading at $9.23 and showing a significant 7.6% return over the past week, has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have received at least one prior therapy.
The resubmission addresses manufacturing facility observations outlined in a Complete Response Letter received in January 2025. If approved, tab-cel would be the first FDA-approved therapy for this indication and would trigger a $40 million milestone payment to Atara from its partner, Pierre Fabre Laboratories.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by data from over 430 patients, including the pivotal ALLELE study that demonstrated a 48.8% objective response rate.
"We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the U.S.," said Cokey Nguyen, President and CEO of Atara, according to the press release.
The therapy has previously received Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease and orphan drug designation for EBV-positive PTLD.
Atara is finalizing the transfer of clinical studies associated with tab-cel to Pierre Fabre Laboratories, which will assume substantially all operational activities and associated costs while Atara maintains BLA sponsorship.
The company reported it had approximately $22 million in cash, cash equivalents, and short-term investments as of June 30, 2025, which it believes will fund operations into the first quarter of 2026. According to InvestingPro analysis, the company is currently burning through cash rapidly, with a current ratio of 0.57 indicating short-term obligations exceed liquid assets. In addition to the potential milestone payment upon approval, Atara is eligible to receive double-digit tiered royalties on net sales and additional commercial sales milestones. Analysts tracked by InvestingPro expect the company to become profitable this year, with an EPS forecast of $4.45 for FY2025. InvestingPro subscribers have access to 8 additional key insights about Atara’s financial health and market position.
In other recent news, Atara Biotherapeutics has announced the pricing of a new stock and warrant offering. The company plans to offer 834,237 shares of common stock at a price of $6.61 each, along with pre-funded warrants to purchase 1,587,108 shares at $6.6099 per share. These warrants are exercisable immediately at a nominal price of $0.0001 per share and are targeted at a select group of existing institutional investors. The transaction is expected to close around May 16, 2025, subject to customary closing conditions, with Atara aiming to raise $16 million in gross proceeds. These funds are intended for the ongoing development of tab-cel, a candidate for biologics license application approval, as well as for general corporate purposes and working capital. TD Cowen is acting as the sole bookrunner for this offering, which is conducted under a shelf registration statement filed with the U.S. Securities and Exchange Commission. Further information will be detailed in a prospectus supplement to be filed with the SEC. This offering complies with legal requirements and is not an offer to sell or solicit an offer to buy in jurisdictions where such actions would be unlawful before registration or qualification under local securities laws.
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