Atara Biotherape Stock Price, News & Analysis

Atara Biotherapeutics (NASDAQ: ATRA), a T-cell immunotherapy company, has appointed two new members to its Board of Directors following the completion of their $16 million offering. James Huang, Founder and Managing Partner of Panacea Venture, brings 37 years of biotech experience, including leadership roles at Kleiner Perkins China, Vivo Ventures, and various pharmaceutical companies. Nachi Subramanian, currently Managing Director at Redmile Group, joins with extensive financial experience from his fourteen-year tenure at J.P. Morgan and background in Institutional Equities.

Atara Biotherapeutics (ATRA) reported Q1 2025 financial results and operational updates. The company reported net income of $38.0 million ($3.53 basic EPS), compared to a net loss of $31.8M in Q1 2024. Total revenues increased to $98.1 million, up from $27.4M YoY. Atara has transferred all manufacturing responsibilities of tabelecleucel to Pierre Fabre Laboratories and implemented significant cost-cutting measures, including an 85% workforce reduction since December 2024. The company secured $16 million in new financing through a stock and warrant offering. The FDA has lifted clinical holds on EBVALLO™ studies and granted a Type A meeting in Q2 2025 to discuss the Complete Response Letter issues. Atara expects to reduce operating expenses by 65% in 2025 and projects its cash runway to extend into Q1 2026.

Atara Biotherapeutics (NASDAQ: ATRA) has announced the pricing of an underwritten registered direct offering to select institutional investors, including Adiumentum Capital Management, EcoR1 Capital, Panacea Venture, and Redmile Group. The offering consists of 834,237 common stock shares at $6.61 per share and 1,587,108 pre-funded warrants at $6.6099 per warrant with a $0.0001 exercise price.

The offering, expected to close around May 16, 2025, aims to raise $16 million in gross proceeds. The funds will be used to support the company's biologics license application (BLA) approval process for tab-cel and general corporate purposes. TD Cowen is serving as the sole bookrunner for this offering.

Atara Biotherapeutics (NASDAQ: ATRA) announced that the FDA has lifted the clinical hold on its EBVALLO™ (tabelecleucel) program, which was imposed in January 2025 due to GMP compliance issues at a third-party manufacturing facility. The company can now resume its Phase 3 ALLELE study for EBV+ PTLD patients and Phase 2 label-expansion study. Additionally, the FDA has granted a Type A meeting to discuss addressing issues from the January 2025 Complete Response Letter (CRL) and the path forward for BLA resubmission. Atara has temporarily paused its strategic options evaluation process, which includes potential acquisition, merger, or sale considerations, pending clarity on the BLA resubmission timeline.

Atara Biotherapeutics (NASDAQ: ATRA) reported its Q4 and full year 2024 financial results, facing significant operational changes. The company received a Complete Response Letter (CRL) from FDA for EBVALLO in January 2025, leading to a clinical hold due to third-party manufacturing facility issues.

Key financial metrics include:

• Q4 2024 net loss of $12.7 million ($1.19 per share)
• Full year 2024 net loss of $85.4 million ($11.41 per share)
• Cash position of $42.5 million as of December 31, 2024

The company implemented a 50% workforce reduction and paused its CAR-T programs (ATA3219 and ATA3431) to preserve resources. Atara secured potential funding of up to $15 million through an equity line of credit with Redmile Group and is exploring strategic alternatives including potential merger or acquisition options.

Atara Biotherapeutics (Nasdaq: ATRA), a leader in T-cell immunotherapy, has granted 1,350 restricted stock units to one newly hired employee. The grant was approved by the company's Compensation Committee under the 2018 Inducement Plan, effective February 3, 2025. The stock units will vest over a four-year period, with 25% vesting after the first anniversary and the remaining portions vesting in 12 quarterly installments over the following three years, contingent on continuous employment. This grant was made in accordance with Nasdaq Listing Rule 5635(c)(4) as an inducement for employment.

Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on its active Investigational New Drug (IND) applications for EBVALLO™ (tabelecleucel) and ATA3219 programs. The hold affects EBVALLO's treatment for EBV+ PTLD and ATA3219's therapy for non-Hodgkin's lymphoma and systemic lupus erythematosus.

The clinical hold stems from unresolved GMP compliance issues at a third-party manufacturing facility, which were previously identified in a Complete Response Letter (CRL) on January 16, 2025. While current participants showing potential clinical benefits may continue treatment, new enrollment has been paused.

The issues specifically affect one third-party facility and do not impact Atara's second manufacturer, FUJIFILM Diosynth Biotechnologies facility. Atara and FDA have agreed on necessary actions to release the holds, with FDA committing to work collaboratively for resolution.

Atara Biotherapeutics (NASDAQ: ATRA) received a Complete Response Letter (CRL) from the FDA regarding EBVALLO™ (tabelecleucel). The CRL solely relates to inspection findings at a third-party manufacturer and did not identify any issues with clinical efficacy, safety data, or manufacturing process. No new clinical trials were requested.

The company is working with Pierre Fabre Laboratories and the manufacturer to address the feedback and expects potential approval within six months of resubmission. EBVALLO, already approved in Europe, demonstrated a 50% Objective Response Rate in the pivotal ALLELE study.

Atara has secured a potential $15 million funding through an equity line of credit from Redmile Group to support BLA approval activities. The company reported approximately $43 million in cash and equivalents as of year-end 2024. Atara remains eligible for a $60 million milestone payment upon FDA approval and double-digit tiered royalties from Pierre Fabre.

Atara Biotherapeutics (Nasdaq: ATRA), a pioneer in T-cell immunotherapy focusing on EBV T-cell platform for cancer and autoimmune disease treatments, has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. Cokey Nguyen, Ph.D., President and CEO, will engage in a fireside chat on Tuesday, December 3, 2024, at 3:50 p.m. EST. The presentation will be accessible via live webcast in the Investors and Media section of atarabio.com, with a replay available for 30 days afterward.