Mirati Therapeutics to Present New Research From its Innovative Oncology Pipeline at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer

On October 4, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported new clinical and preclinical research will be presented at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 7 – 10, 2021 (Press release, Mirati, OCT 4, 2021, View Source [SID1234590773]).

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The Company will present preclinical data evaluating MRTX1719, the selected clinical candidate from our MTA-cooperative PRMT5 inhibitor program, in MTAP-deleted cancer models.

In addition, the Company will present a summary of the discovery and characterization of initial formulations of MRTX1133, a KRASG12D inhibitor, including in pancreatic cancer models. The presentation will also include preliminary new clinical data from a cohort of the KRYSTAL-1 study evaluating adagrasib in previously-treated patients with KRASG12C-mutated pancreatic cancer.

Learn more about Mirati’s development of therapies that target the genetic and immunological drivers of cancers at Mirati.com/science.

Mirati studies at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference include:
All times noted are U.S. Eastern Time (ET)

Presentation Title: MRTX1719: A First-in-class MTA-cooperative PRMT5 Inhibitor that Selectively Elicits Antitumor Activity in MTAP/CDKN2A Deleted Cancer Models
Author: Peter Olson, Ph.D., Mirati Therapeutics, Inc.
Session: Poster
Session Date/Time: Thursday, October 7, 9:00 a.m. and on-demand throughout conference

Presentation Title: Discovery and Characterization of MRTX1133, a Selective Non-Covalent Inhibitor of KRASG12D*
Author: James G. Christensen, Ph.D., Mirati Therapeutics, Inc.
Session: Plenary Session 5: Drugging Difficult Targets
Session Date/Time: Saturday, October 9, 12:05 – 1:55 p.m.

*Presentation to include preliminary clinical data from a cohort of the KRYSTAL-1 trial evaluating adagrasib in previously treated patients with KRASG12C-mutated pancreatic cancer.

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

About MRTX1133
MRTX1133 is an investigational, highly selective and potent small molecule inhibitor of KRASG12D. In preclinical studies, MRTX1133 exhibited a long half-life, an ability to bind the KRASG12D protein in both active and inactive states, and selective inhibition of KRAS G12D mutant cancer cells. In G12D mutant tumor models, MRTX1133 showed dose-dependent selective inhibition of the KRAS pathway and tumor regression. Increased activity was also shown when combined with rational combination therapies. MRTX1133 is in Investigational New Drug-enabling studies and has the potential to be a first-in-class therapeutic. For more information visit Mirati.com/science.

About MRTX1719
Mirati is developing MRTX1719, an internally discovered, synthetic lethal PRMT5 inhibitor for the treatment of methylthioadenosine phosphoylase (MTAP)-deleted cancers. PRMT5 is an enzyme critical to the survival of both healthy and cancer cells and is partially inhibited by methylthioadenosine (MTA), which accumulates in MTAP-deleted cancers. MRTX1719 has shown in preclinical models to selectively target the PRMT5/MTA complex in MTAP-deleted cancer cells while sparing healthy cells. MTAP gene deletion occurs in approximately 9% of all cancers including pancreatic, lung, and bladder cancers, as well as other patient populations that have limited treatment options. MRTX1719 is in Investigational New Drug-enabling studies and has the potential to be a first-in-class therapeutic.

Centessa Pharmaceuticals Announces $300 Million Financing Agreement with Oberland Capital

On October 4, 2021 Centessa Pharmaceuticals plc ("Centessa" or "Company") (Nasdaq: CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, reported that it has entered into a $300 million financing agreement with funds managed by Oberland Capital Management LLC ("Oberland Capital") (Press release, Centessa Pharmaceuticals, OCT 4, 2021, View Source [SID1234590748]).

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Oberland Capital will purchase up to $300 million of 6-year, interest-only, senior secured notes ("Notes") from the Company under the following terms:

•$75 million funded October 4, 2021 ("First Purchase Date")
•$125 million available to be funded in tranches of $75 million and $50 million within 24 months of First Purchase Date at the option of the Company
•$100 million available to fund M&A, in-licensing, or other strategic transactions, at the option of the Company and Oberland Capital
•The Notes are interest-only for the full 6-year term; principal on the Notes will be due
October 4, 2027, with certain contingent and capped payments due up to ten years from First Purchase Date
•Flexible structure with no financial covenants

This $300 million facility, combined with the Company’s existing cash balance as of June 30, 2021, provides access to over $900 million to advance the Company’s pipeline of clinical and pre-clinical programs and enable the Company to pursue strategic business development opportunities.

"Our ability to secure such a flexible, long-term financing arrangement with a 6-year, interest-only period is directly enabled by our broad portfolio of uncorrelated programs based on compelling biology. On the heels of our recent positive Phase 2 readout of SerpinPC and upcoming registrational trial for lixivaptan, this financing will allow us to further scale up our development activities and provide enhanced balance sheet flexibility for pipeline expansion," said Gregory Weinhoff, MD, MBA, Chief Financial Officer of Centessa.

"We are excited to be partnering with Centessa to help bring their portfolio of innovative product candidates to patients as quickly as possible," said Andrew Rubinstein, Managing Partner of Oberland Capital. "Our flexible financing structure is designed to allow the Centessa team to maintain maximum optionality as their pipeline matures, with two programs entering potential registrational studies next year and multiple INDs expected."

Additional details regarding the financing are available in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission today. The foregoing summary of certain terms of the financing agreement and related agreements is qualified in its entirety by reference to the full text of such agreements, which will be filed as exhibits to our next Form 10-Q.

Himalaya Therapeutics Announces Submission in Mainland China of IND Applications for its CAB-AXL-ADC to treat sarcomas and NSCLC, its CAB-ROR2-ADC to treat melanoma and NSCLC

On October 4, 2021 Himalaya Therapeutics ("Himalaya"), a clinical-stage biopharmaceutical company focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment of solid tumor cancer, which are based on the Conditionally Active Biologics ("CAB") technology platform, reported that it has submitted four investigational new drug (IND) applications to the Center for Drug Evaluation (CDE) of the China National Medical Products Association (NMPA) (Press release, Himalaya Therapeutics, OCT 4, 2021, View Source [SID1234590776]).

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Himalaya submitted one IND for HTBA3011, its CAB-antibody drug conjugate (ADC) targeting AXL, a protein expressed on many tumor cells, for soft tissue and bone sarcomas, one for HTBA3011 for non-small cell lung cancer (NSCLC), one for HTBA3021, its CAB-ADC targeting ROR2, another protein expressed on many tumor cells, for melanoma, and one for HTBA3021 for NSCLC. AXL and ROR2 are both well-validated targets, where high expression has been correlated with aggressive disease in multiple cancer types and have both also been shown to be a common escape mechanism following PD-1, PD-L1, ALK and EGFR treatment.

"Although our Taiwan and Hong Kong sites are already part of the ongoing registrational global trials for these product candidates, adding Mainland China to our global trials as well will be a key milestone in our goal of providing treatment to patients in China for these deadly cancers for which availability of effective, novel treatments has been limited" said Brian Zhang, Himalaya’s CEO.

"This IND submission reflects our ability to operate quickly and efficiently in China by working closely with the regulatory authorities to advance its clinical candidates here" said Howe Li, Himalaya’s CMO. "This is an affirmation of the hard work, support and close coordination among not only our team members, but also our local and global partners, and BioAtla, our collaboration partner."

Entry into a Material Definitive Agreement

On October 4, 2021 Inspyr Therapeutics, Inc,. a Delaware corporation ("Inspyr"), reported that it is implementing a holding company reorganization pursuant to an Agreement and Plan of Merger (the "Merger Agreement"), dated as of September 28, 2021, among Inspyr, Rebus Holdings, Inc. a Delaware corporation ("Holding Company"), and Rebus Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Holding Company ("Merger Sub"), which will result in the Holding Company becoming the direct parent company of Inspyr and replacing Inspyr as the public company trading on the OTC Markets ("OTC") (the "Reorganization")(Filing, 8-K, Inspyr Therapeutics, OCT 4, 2021, View Source [SID1234590819]).

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Pursuant to the Merger Agreement, Merger Sub will merge with Inspyr pursuant to the filing of a certificate of merger (the "Certificate of Merger"), with Inspyr surviving as a direct, wholly-owned subsidiary of Holding Company (the "Merger"). At the effective time of the Merger (the "Effective Time"), subject to the approval of the Financial Industry Regulatory Authority or FINRA:

(i) Each outstanding share of Inspyr common stock, par value $0.0001 per share ("Inspyr Common Stock"), will automatically be converted into one share of common stock, par value $0.0001 per share, of Holding Company ("Holding Company Common Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Common Stock immediately prior to the Reorganization;

(ii) Each outstanding share of Inspyr Series A Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series A Stock"), will automatically be converted into one share of Series A Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series A Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series A Stock immediately prior to the Reorganization;

(iii) Each outstanding share of Inspyr Series B Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series B Stock"), will automatically be converted into one share of Series B Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series B Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series B Stock immediately prior to the Reorganization;

(iv) Each outstanding share of Inspyr Series C Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series C Stock"), will automatically be converted into one share of Series C Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series C Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series C Stock immediately prior to the Reorganization;

(v) Each outstanding share of Inspyr Series D Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series D Stock"), will automatically be converted into one share of Series D Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series D Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series D Stock immediately prior to the Reorganization;

(vi) Each outstanding share of Inspyr Series E Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series E Stock"), will automatically be converted into one share of Series E Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series E Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series E Stock immediately prior to the Reorganization; and

(vii) Each outstanding share of Inspyr Series F Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series F Stock"), will automatically be converted into one share of Series F Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series F Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series F Stock immediately prior to the Reorganization.

Accordingly, upon consummation of the Reorganization (and the Reverse Stock Split as defined below), Inspyr stockholders will automatically became stockholders of Holding Company, on a one-for-one basis, with the same number and approximate ownership percentage of shares of the same class as they held in Inspyr immediately prior to the Effective Time. The Reorganization is intended to be a tax-free transaction for U.S. federal income tax purposes for Inspyr stockholders.

The Reorganization is being conducted pursuant to Section 251(g) of the General Corporation Law of the State of Delaware (the "DGCL"), which provides for the formation of a holding company without a vote of the stockholders of the constituent corporation. The conversion of stock will occur automatically without an exchange of stock certificates. In addition, at the Effective Time:

● Each outstanding and unexpired option to purchase Inspyr Common Stock will automatically be converted into one share of Holding Company Common Stock;

● Each outstanding warrant to purchase Inspyr Common Stock ("Inspyr Warrant"), whether or not vested, will automatically be converted into and become a warrant to purchase Holding Company Common Stock ("Holding Company Warrant") and Holding Company will assume each Inspyr Warrant in accordance with the terms of each Inspyr Warrant, and such Holding Company Warrant will have the same number of shares, the same exercise price (subject to adjustments), the same restrictions on exercise, and any other provisions contained in the Inspyr Warrants; and

● Each outstanding convertible debt instrument of Inspyr, including but not limited to, promissory notes or debentures that are convertible into Inspyr Common Stock ("Inspyr Convertible Notes") will automatically be converted into, assumed, and become the convertible debt instruments of the Holding Company ("Holding Company Convertible Notes").

As a result of the Reorganization, the Holding Company will become the successor issuer to Inspyr pursuant to Rule 12g-3(a) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and as a result, shares of Holding Company Common Stock are deemed registered under Section 12(g) of the Exchange Act as the common stock of the successor issuer.

Reverse Stock Split

As previously disclosed in the Definitive Proxy Statement filed by Inspyr on September 3, 2021, pursuant to a written consent, Inspyr’s shareholders approved a proposal authorizing the board of directors of Inspyr ("Board") to effect a reverse stock split of the Company’s common stock, par value $0.0001 (the "Common Stock").

On September 1, 2021, the Board approved a one-for-seventy-five (1-for-75) reverse stock split of the Inspyr Common Stock ("Reverse Stock Split"). In furtherance of the Reverse Stock Split, Inspyr has filed an amended and restated certificate of incorporation ("Amended and Restated Certificate of Incorporation") with the Secretary of State of Delaware to effect the Reverse Stock Split effective as of 4:59 p.m. Eastern Time on October 5, 2021, but the trading post Reverse Stock Split will not occur until FINRA approval is received ("Reverse Split Effective Time").

As a result, at the Reverse Split Effective Time (and just prior to the completion of the Reorganization, subject to FINRA approval of each), each of the holders of Inspyr Common Stock will receive one (1) new share of Inspyr Common Stock for every seventy-five (75) shares such shareholder held immediately prior to the Reverse Split Effective Time. The Reverse Stock Split will also affect the Company’s outstanding stock options, warrants and other exercisable or convertible instruments and will result in the shares underlying such instruments being reduced and the exercise price being increased proportionately to the Reverse Stock Split ratio. No fractional shares will be issued as a result of the Reverse Stock Split. Any fractional shares that would have otherwise resulted from the Reverse Stock Split will be rounded up to the next whole number of shares.

As a result of the Reverse Stock Split, the number of issued and outstanding shares of Common Stock will be adjusted from 718,202,289 (assuming no change in issued and outstanding until such date) shares to approximately 9,576,030 shares. Additionally, pursuant to the terms of their Certificates of Designation, each Series of Inspyr preferred stock will have the conversion price at which shares of such applicable preferred stock may be converted into shares of Inspyr Common Stock proportionately adjusted to reflect the Reverse Stock Split. Additionally, all outstanding options, warrants and convertible debt of Inspyr will be adjusted proportionately pursuant to the Reverse Stock Split.

Upon the completion of the Reorganization immediately after, each shareholder will have such number of shares of Holding Company Common Stock and Holding Company Preferred Stock as the shareholder would have held of Inspyr immediately following the Reverse Stock Split.

Post Reverse Stock Split and Reorganization Information

Following the completion of the (i) Reverse Stock Split and (ii) the Reorganization, the Holding Company Common Stock will begin trading on post Reverse Stock Split and post Reorganization basis on Pink Sheets of the OTC Markets Group upon completion and approval of the FINRA review and confirmation of a new trading symbol, which we expect to receive soon after the filing of this Current Report. We will announce the new trading symbol and CUSIP via press release prior to the date when such trading begins on a post Reverse Stock Split and Reorganization basis.

At the Effective Time, the officers and members of the Board of Inspyr will become the officers and members of the board of directors of the Holding Company.

Immediately after the consummation of the Reorganization, the Holding Company will have, on a consolidated basis, the same assets, businesses, and operations as Inspyr will have had immediately prior to the consummation of the Reorganization.

The foregoing does not purport to be a complete description of the Reverse Stock Split and the subsequent Reorganization and each are qualified in their entirety by reference to (i) the Amended and Restated Certificate of Incorporation effecting the Reverse Stock Split, (ii) the Merger Agreement, and (iii) the Certificate of Merger, a copy of each of which is filed as Exhibit 3.01(i), 2.01, and 3.02(i), respectively, to this Current Report on Form 8-K and each are incorporated by reference herein.

Item 3.03 Material Modification of Rights of Security Holders.

At the Effective Time of the Merger, each share of capital stock of Inspyr issued and outstanding immediately prior to the Effective Time will automatically convert into a share of the same class or series designation of the Holding Company, having the same designations, rights, powers, and preferences and the qualifications, limitations, and restrictions as such applicable share of Inspyr capital stock immediately prior to the Effective Time.

The information set forth in Item 1.01 under the heading "Adoption of Agreement and Plan of Merger and Consummation of Reorganization" and in Item 5.03 is hereby incorporated by reference in this Item 3.03.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

The information set forth in Item 1.01 under the heading "Post Reverse Stock Split and Reorganization Information" is hereby incorporated by reference in this Item 5.02.

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

As described in Item 1.01 above under the heading "Reverse Stock Split", Inspyr filed the Amended and Restated Certificate of Incorporation effecting the Reverse Stock Split.

Upon consummation of the Reorganization, the Amended and Restated Certificate of Incorporation of Inspyr will be amended and restated through the Certificate of Merger to (i) decrease the authorized number of shares of Inspyr Common Stock from one billion thirty million (1,030,000,000) shares to one thousand (1,000) shares; (ii) remove the authorized number of shares of Preferred Stock; (iii) add a provision, which is required by Section 251(g) of the DGCL, that provides that any act or transaction by or involving Inspyr, other than the election or removal of directors, that requires for its adoption under the DGCL or the Amended and Restated Certificate of Incorporation, the approval of the stockholders of Inspyr shall require the approval of the stockholders of the Holding Company by the same vote as is required by the DGCL and/or the Amended and Restated Certificate of Incorporation; and (iv) add and remove provisions as appropriate for a wholly-owned subsidiary.

In addition, the Amended and Restated Bylaws of Inspyr, dated January 6, 2010, were amended and restated (as amended and restated, the "Inspyr Bylaws") to add and remove provisions as appropriate for a wholly-owned subsidiary.

The foregoing descriptions of the (i) Amended and Restated Certificate of Incorporation, (ii) amendment to the Amended and Restated Certificate of Incorporation as contained in the Certificate of Merger, and (iii) Inspyr Bylaws do not purport to be complete and are qualified in their entirety by reference to the Certificate of Merger and the Bylaws, copies of which are filed as Exhibit 3.01(i), Exhibit 3.02(i), and Exhibit 3.03(ii) respectively, to this Current Report on Form 8-K and incorporated by reference herein.

Atara Biotherapeutics and Pierre Fabre Enter Strategic Collaboration to Commercialize Tabelecleucel (Tab-cel®)

On October 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre reported an exclusive commercialization agreement for tabelecleucel (tab-cel) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers (Press release, Atara Biotherapeutics, OCT 4, 2021, View Source [SID1234590749]). Atara will retain full rights to tab-cel in other major markets, including North America, Asia Pacific, and Latin America.

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Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre.

Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

"Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships," commented Pascal Touchon, President and CEO of Atara. "Our Companies’ complementary capabilities will expand access to tab-cel, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers."

Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology.

"Tab-cel is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,’" said Eric Ducournau, CEO of Pierre Fabre. "We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients."

PJT Partners served as the exclusive financial advisor to Atara.

Atara Conference Call
In connection with this announcement, Atara will host a webcast and conference call today at 8:30 a.m. EDT. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13723585. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company’s website for 30 days.

About Tabelecleucel
Tabelecleucel (tab-cel) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.

Tab-cel is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.

Tab-cel has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel has orphan drug designation in the U.S. and EU.