ATA188

A board to discuss future MS therapies in early stage (Phase I or II) trials.
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NHE
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Re: ATA188

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Atara Biotherapeutics Announces 1-for-25 (1:25) Reverse Stock Split

https://www.businesswire.com/news/home/ ... tock-Split

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-25 (the "Reverse Stock Split"). The Reverse Stock Split will become effective at 12:01 a.m. Eastern Time, on June 20, 2024 (the “Effective Time”). The Company's common stock will begin trading on a post-split basis at the market open on June 20, 2024. The Reverse Stock Split is part of the Company's plan to regain compliance with the minimum bid price requirement of $1.00 per share required to maintain continued listing on The Nasdaq Global Select Market, among other benefits.

The Reverse Stock Split was approved by the Company's stockholders at the Company's Annual Meeting of Stockholders held on June 10, 2024 (the "Annual Meeting") to be effected at the Board's discretion within approved parameters. Following the Annual Meeting, the final ratio was approved by the Company's Board on June 10, 2024.

The Reverse Stock Split reduces the number of shares of the Company's outstanding common stock from 122,606,575 shares to 4,904,263 shares, subject to adjustment due to the payment of cash in lieu of fractional shares. This does not include the Company’s outstanding 32,153,085 pre-split (1,286,123 post-split, subject to adjustment due to payment of cash in lieu of fractional warrants) pre-funded common stock warrants as of the Effective Time. As a result of the Reverse Stock Split, proportionate adjustments will be made to the number of shares of the Company's common stock underlying the Company's outstanding equity awards and the number of shares issuable under the Company's equity incentive plans and other existing agreements, as well as the exercise or conversion price, as applicable. There will be no change to the number of authorized shares or the par value per share.

Information for ATRA Stockholders

As a result of the reverse stock split, every 25 pre-split shares of common stock outstanding will become one share of common stock. The Company's transfer agent, Computershare Trust Company, N.A., will serve as the exchange agent for the reverse stock split.

Registered stockholders holding pre-split shares of the Company's common stock electronically in book-entry form are not required to take any action to receive post-split shares. Those stockholders who hold their shares in brokerage accounts or in "street name" will have their positions automatically adjusted to reflect the reverse stock split, subject to each broker's particular processes, and will not be required to take any action in connection with the reverse stock split. Stockholders holding shares of the Company's common stock in certificate form, if any, will receive a transmittal letter from Computershare with instructions as soon as practicable after the effective date.

No fractional shares will be issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive fractional shares will receive a cash payment in lieu of such fractional shares.
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NHE
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Re: ATA188

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Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219

U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL)

https://www.businesswire.com/news/home/ ... d-EBVALLO™

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara’s active Investigational New Drug (IND) applications. These INDs include the EBVALLOTM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, an allogeneic CD19-targeted CAR-T therapy, for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus. Specifically identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocols. Screening and enrollment of new participants in both programs have been paused.

The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was announced on January 16, 2025. While ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL. These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California. The FDB facility remains a critical component of Atara’s long-term manufacturing strategy for both assets.

Atara and FDA have discussed and agreed upon the actions necessary to release the clinical holds. The FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to resolve the clinical holds.

“We intend to work closely with the FDA to address these issues as expeditiously as possible,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “We are encouraged with ongoing correspondence with the Agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs.”

[Continued]
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