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Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLOTM (tabelecleucel)

1. Atara received FDA CRL due to third-party manufacturer inspection issues. 2. No clinical efficacy or safety concerns were raised by FDA in the CRL. 3. Atara plans to resubmit BLA after compliance issues are resolved, expecting approval in six months. 4. Non-binding term sheet signed for $15 million funding to support EBVALLO approval activities. 5. Strategic alternatives are being explored to ensure long-term value for shareholders.

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FAQ

Why Neutral?

Despite FDA's CRL, lack of safety data issues suggests future approval is possible.

How important is it?

FDA's response affects approval timeline; funding situation impacts operational capacity.

Why Short Term?

Timeframe for approval is highlighted as approximately six months post-resubmission.

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Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLOTM (tabelecleucel)

Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer

CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval

Atara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to patients in the U.S.

Atara has engaged a well-known financial advisor to support exploration of all strategic options

Atara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders

Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval

THOUSAND OAKS, Calif.--()--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy...

The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO...

“We are working closely with our partner Pierre Fabre Laboratories, the FDA, and the third-party manufacturer...

“We are disappointed by the delay and are willing to work with Atara on appropriate next steps to bring EBVALLO...

EBVALLO, which was granted marketing authorization by the European Commission in December of 2022...

Corporate Updates

Review of Strategic Alternatives: The Board regularly reviews Atara’s strategic plan...

Preservation of Future EBVALLO Milestone and Royalty Income Value to Shareholders: Atara remains eligible to receive a $60 million milestone payment...

If a strategic resolution is not reached to provide funding for its CAR-T development programs in Q1 2025...

Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding...

Financial Update

  • Cash, cash equivalents and short-term investments as of year-end 2024 totaled approximately $43 million
  • Entered into non-binding term sheet with Redmile Group to provide up to $15 million in available capital...
  • Several additional options are under consideration as part of the exploration of financial and strategic alternatives

This estimate of our cash, cash equivalents and short-term investments as of December 31, 2024...

About Atara Biotherapeutics, Inc.

Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies...

Forward-Looking Statements

This press release contains or may imply "forward-looking statements" within the meaning...

Contacts

Investor and Media Relations
Jason Awe, Ph.D.
Head of Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com

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