Investors Attention Alert: Atara Biotherapeutics, Inc. (NASDAQ: ATRA)

On Thursday Atara Biotherapeutics, Inc. (NASDAQ: ATRA) shares price traded between $35.46 and $38.13 during the last trading session upbeat/downbeat with -6.24 percent at $-2.38. Over the one year trading period, the stock has a peak price of $54.45 and its down is recorded at $12.65. The short ratio in the stock is 9.01 and the short float is around of 23.09 percent.

Atara Biotherapeutics, Inc. (ATRA) recently stated financial results for the second quarter of 2018 and recent operational highlights.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel™ (tabelecleucel)

• Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel™ (tabelecleucel) in patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).

  • 11 clinical sites for the MATCH and 13 for the ALLELE studies are now open for enrollment in the U.S. with additional sites predictable to open in the U.S. and other geographies.

• Presented positive long-term outcomes including durable remissions and encouraging safety findings from two Phase 2 studies of tab-cel™ in EBV+ PTLD at the 23rd Congress of the European Hematology Association (EHA).

  • One- and three-year overall survival (OS) for tab-cel™ treated patients with EBV+ PTLD following HCT who failed rituximab (n=35) was 68% and 55%, respectively. Median OS was not reached after a median of 23.3 months of follow-up in this patient group.
  • In patients with EBV+ PTLD following SOT who failed rituximab, the one- and three-year OS after treatment with tab-cel™ (n=14) was 64% and 43%, respectively. Median survival in this patient group was 21.3 months.
  • None of the EBV+ PTLD patients who had complete or partial responses (CR or PR) after treatment with tab-cel™ died of EBV+ PTLD.  Two-year OS for these responding patients was 83% and 86% following HCT (n=24) and SOT (n=7), respectively.
  • Tab-cel™ was associated with durable objective response rate (CR plus PR) of 69% and 50% in patients with EBV+ PTLD following HCT and SOT, respectively, who have failed rituximab.

• S. Food and Drug Administration (FDA) accepted IND to initiate a Phase 1/2 clinical study of tab-cel™ in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) that Atara plans to initiate in the second half of 2018.
• Expect to present updated tab-cel™ results in patients with EBV+ cancers in the second half of 2018.

ATA188 & ATA190 for Multiple Sclerosis (MS)

• Reported publication of new research findings advancing the understanding of Epstein-Barr Virus (EBV) infection in the MS-affected brain.

  • The findings were stated in an article online and published in the July 2018 print issue of Neurology: Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.

• A Phase 1 clinical study to evaluate off-the-shelf, allogeneic ATA188 in patients with progressive MS is also underway across clinical sites in the U.S. and Australia.

  • The primary objective of the Phase 1 study is to assess the safety of ATA188 in patients followed for at least one year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale (EDSS) and annualized relapse rate (ARR), as well as MRI imaging.
  • The first results from the ongoing ATA188 Phase 1 study in patients with progressive MS are predictable in the first half of 2019.
  • Plan to initiate a randomized autologous ATA190 study in progressive MS patients in 2019.

Development Pipeline

• Plan to rapidly advance novel gene-edited CAR T development programs from recently expanded T-cell immunotherapy alliance with Memorial Sloan Kettering Cancer Center (MSK), leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities.
• Expect to start Phase 1 study for ATA621 targeting both JC and BK viruses in 2019.

Corporate

• Commenced operations at Atara T Cell Operations & Manufacturing (ATOM) facility in the second quarter of 2018, with completion to support clinical production predictable in 2019.
• Designated Utpal Koppikar as Chief Financial Officer. Utpal has an completed track record in global biotechnology financial operations.
• In June 2018 we exercised our option under a license contract with QIMR Berghofer to an exclusive, worldwide license to develop and commercialize additional T-cell immunotherapy programs including ATA190, as well as the option to license additional technology.

Second Quarter 2018 Financial Results

• Cash, cash equivalents and short-term investments as of June 30, 2018 totaled $417.0M, which we believe will enable us to expand our near-term pipeline and accelerate pre-commercial activities as well as fund our before planned operations to mid-2020.  In the second quarter of 2018, we sold about 1.0M shares of ordinary stock pursuant to our “at-the-market” (ATM) facility for net proceeds of $47.6M, after deducting commissions and other offering expenses.
• We stated net losses of $50.9M, or $1.15 per share, for the second quarter of 2018, as contrast to $27.4M, or $0.94 per share, for the same period in 2017.
• Research and development expenses were $33.4M for the second quarter of 2018, as contrast to $18.3M for the same period in 2017. The raise in the second quarter of 2018 was Because of costs associated with our continuing expansion of research and development activities, including:

  • clinical trial, manufacturing and outside service costs related to the two Phase 3 clinical trials of tab-cel™ in patients with EBV+ PTLD and the Phase 1 clinical trial of allogeneic ATA188 in patients with MS;
  • higher payroll and related costs from raised headcount, and
  • an raise in allocated facilities and information technology expenses.

• Research and development expenses include $3.4M and $2.0M of non-cash stock-based compensation expenses in the second quarters of 2018 and 2017, respectively.
• General and administrative expenses were $19.2M for the second quarter of 2018, as contrast to $9.6M for the same period in 2017. The raise in the second quarter of 2018 was primarily Because of raises in professional services costs and payroll and related costs driven by raised headcount to support the Company’s expanding operations. General and administrative expenses include $4.6M and $3.7M of non-cash stock-based compensation expenses in the second quarters of 2018 and 2017, respectively.

The company jumped 0.65 percent in past week and declined -10.57 percent in one month. During the past three month period the stock dropped -8.75 percent and decreased -9.44 percent in past six month. During the twelve month it added 150.14 percent and year to date performance of 97.62 percent.