On November 4, 2016 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, reported financial results for the third quarter ended September 30, 2016 and recent operational highlights (Press release, Atara Biotherapeutics, NOV 4, 2016, View Source [SID1234516329]).
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"We are pleased to report that for our lead product candidate, EBV-CTL, we have received feedback from FDA on our approach to comparing material manufactured by our CMO with material previously produced at MSK and have commenced manufacturing to support our Phase 3 trials," said Isaac Ciechanover, Chief Executive Officer and President of Atara Bio. "We have also submitted our Phase 3 trial protocols to FDA, and we look forward to the initiation of these trials by year end."
Recent Highlights and Anticipated Upcoming Milestones
EBV-CTL
Submitted Phase 3 protocols to the U.S. Food and Drug Administration (FDA) incorporating its feedback on two trials of allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (EBV-CTL) in patients with rituximab refractory EBV-post transplant lymphoproliferative disorder (PTLD) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).
Phase 3 trials are expected to initiate by year end.
Completed manufacturing process transfer for EBV-CTL to our contract manufacturing organization (CMO).
Developed end-to-end supply chain and logistics to support manufacturing and distribution of EBV-CTL.
Received feedback from FDA regarding our comparability protocol designed to compare EBV-CTL material manufactured by our CMO with material previously produced at Memorial Sloan Kettering (MSK).
Commenced production of full scale EBV-CTL lots for the expanded access protocol (EAP) and the Phase 3 trials.
Granted access to priority medicines (PRIME) regulatory support by the European Medicines Agency (EMA) for allogeneic EBV-CTL for the treatment of EBV-PTLD after HCT.
Scientific Advice meeting with the EMA and health technology assessment groups (HTAs) scheduled in the 4th quarter of 2016 to discuss potential pathways for submission of a marketing authorization application (MAA) for EBV-CTL in the treatment of rituximab refractory EBV-PTLD after HCT.
First patient dosed in multi-center EAP trial of EBV-CTL in patients with rituximab refractory EBV-PTLD.
We plan to broaden our EAP trial to include enrollment of patients with other EBV-associated hematologic malignancies and solid tumors.
CMV-CTL
Conducted an end of Phase 2 meeting with the FDA to discuss late-stage development of allogeneic cytomegalovirus (CMV)-specific CTL (CMV-CTL) for the treatment of anti-viral refractory or resistant CMV infection following either HCT or SOT.
We expect to initiate a Phase 3 trial in 2017, once we have completed discussions with the FDA on trial design.
Received positive opinion from the EMA on orphan drug designation for the treatment of CMV infection in patients with impaired immune systems.
CTL Platform Expansion
Expanded our relationship with the Queensland Institute of Medical Research (QIMR Berghofer) including the development of allogeneic CTLs targeting human papilloma virus (HPV) and BK virus (BKV).
HPV is associated with a number of solid tumors including head and neck cancer, cervical cancer, and anal cancer.
BKV is a challenging clinical problem in kidney transplant patients and is a potential cause of organ loss.
Third Quarter 2016 Financial Results
Cash and investments as of September 30, 2016 totaled $278.1 million, which the Company believes will be sufficient to fund its planned operations through 2018.
The Company reported a net loss of $25.4 million, or $0.88 per share, for the third quarter of 2016, as compared to a net loss of $11.9 million, or $0.43 per share, for the third quarter of 2015.
Total research and development expenses were $18.8 million for the third quarter of 2016, compared to $8.1 million for the third quarter of 2015, including $2.6 million and $0.9 million of non-cash stock-based compensation expenses, respectively. The increase was primarily due to an increase in our clinical trial, research, regulatory and manufacturing expenses associated with our T-cell programs of $10.9 million and increased headcount related costs to support these activities of $4.4 million, offset by a decrease in costs associated with our other molecular programs of $4.6 million.
General and administrative expenses were $7.1 million for the third quarter of 2016, compared to $4.1 million for the third quarter of 2015, including $2.7 million and $1.3 million of non-cash stock-based compensation expenses, respectively. The increase was primarily due to a $1.4 million increase in non-cash stock-based compensation driven by new award grants, a $0.9 million increase in compensation-related expenses driven by increased headcount, and to a lesser extent, higher consulting and outside services costs.