On November 12, 2024 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, reported financial results for the third quarter 2024, recent business highlights, and key upcoming milestones (Press release, Atara Biotherapeutics, NOV 12, 2024, View Source [SID1234648156]).
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"With the first patient now enrolled in our Phase 1 NHL trial of ATA3219, we have taken an important step in applying our proven Epstein-Barr virus platform to the significant opportunity in allogeneic CAR T," said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. "The first quarter of 2025 is positioned to be transformational for the company, with the potential for FDA approval of tab-cel and transition of this business to our partner Pierre Fabre, repositioning Atara as a fully focused allogeneic CAR-T company with multiple near-term data milestones for our lead program in oncology and autoimmune indications."
Tabelecleucel (tab-cel or EbvalloTM) for Post-Transplant Lymphoproliferative Disease (PTLD)
Tab-cel biologics license application (BLA) is on track with Priority Review and a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025
A U.S. Food and Drug Administration (FDA) advisory committee meeting is not planned
Atara has the potential to receive an additional $60 million milestone payment from Pierre Fabre contingent upon FDA approval of the tab-cel BLA
ATA3219: CD19 Program in Non-Hodgkin’s Lymphoma (NHL)
First patient treated in ongoing Phase 1 clinical study of ATA3219 for NHL, including large B-cell lymphomas, follicular lymphoma, and mantle cell lymphoma
Study designed to evaluate safety, preliminary efficacy, pharmacokinetics, and biomarkers
Initial clinical data anticipated in Q1 2025
ATA3219: CD19 Program in Lupus Nephritis (LN)
Atara expects to initiate a Phase 1 study of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]) by end of year with initial clinical data anticipated in mid-2025
ATA3219: CD19 Program in Extrarenal Systemic Lupus Erythematosus (ERL) Without Lymphodepletion (LD)
Atara expanded the Phase 1 LN study of ATA3219 with an additional cohort in ERL without LD, and expects initiation by end of year with initial clinical data anticipated in mid-2025
The elimination of LD is designed to further simplify the treatment regimen and to potentially provide a differentiated safety profile to patients without comprising efficacy, which may improve patient access
ATA3431: CD19/CD20 Program for B-Cell Malignancies
Atara is progressing toward an IND submission in Q4 2025
Leadership and Board of Directors Update
As previously announced, on September 9, 2024, Cokey Nguyen, Ph.D. became President and CEO and Pascal Touchon assumed the role of Chairman of the Board of Directors
Greg Ciongoli, founder and managing partner of Adiumentum Capital Management, joined Atara’s Board of Directors
Eric Hyllengren has been appointed to serve as the Company’s Chief Operating Officer, in addition to his role as Chief Financial Officer
Third Quarter 2024 Financial Results
Cash, cash equivalents and short-term investments as of September 30, 2024 totaled $67.2 million, as compared to $35.3 million as of June 30, 2024. This includes a $20 million milestone payment related to the tab-cel BLA acceptance that was received from Pierre Fabre in August 2024, $15.5 million from Pierre Fabre for the purchase of certain existing tab-cel intermediate inventory in September 2024, and gross proceeds of $36 million from a registered direct offering completed in September 2024. The financing was led by existing top institutional investors with participation from a new strategic investor and was completed at a 15% premium to Atara’s 7-day volume-weighted average price
Net cash used in operating activities was $4.0 million for the third quarter 2024, as compared to $51.3 million in the same period in 2023
Q3 2024 net cash used in operating activities included a $6.0 million sub-licensing fee payment, which was paid to Memorial Sloan Kettering Cancer Center (MSK) under protest, as Atara does not believe it owes this under the terms of its license agreements with MSK. Atara is entering into evaluative non-binding mediation to potentially resolve this disagreement
Total revenues were $40.2 million for the third quarter 2024, as compared to $2.1 million for the same period in 2023. Total revenues increased by $38.1 million year over year, primarily due to revenue recognized as a result of additional obligations for the expanded partnership with Pierre Fabre and accelerated recognition of existing deferred revenue due to the planned transition of substantially all activities relating to tab-cel at the time of BLA approval and transfer to Pierre Fabre
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $7.7 million for the third quarter 2024, as compared to $12.4 million for the same period in 2023
Research and development expenses were $43.9 million for the third quarter 2024, as compared to $56.9 million for the same period in 2023
Research and development expenses include a $6.0 million sub-licensing fee, which was paid to MSK under protest, whereas third quarter 2023 had no such comparable expense
Research and development expenses also include $2.9 million of non-cash stock-based compensation expenses for the third quarter 2024, as compared to $6.8 million for the same period in 2023
General and administrative expenses were $10.4 million for the third quarter 2024, as compared to $12.2 million for the same period in 2023
General and administrative expenses include $3.5 million of non-cash stock-based compensation expenses for the third quarter 2024, as compared to $4.4 million for the same period in 2023
Atara reported net losses of $21.9 million, or $2.93 per share, for the third quarter 2024, as compared to $69.8 million, or $16.40 per share, for the same period in 2023
2024 Outlook and Cash Runway
Atara expects full year 2024 operating expenses to decrease by approximately 35% from 2023
The large majority of the year-over-year operating expense reduction began in Q2 2024 and is expected to continue for the remainder of the year
Atara expects that cash, cash equivalents, short-term investments, and accounts receivable as of September 30, 2024, plus the items noted below, in total will enable funding of planned operations into 2027:
additional $60 million approval milestone from Pierre Fabre contingent upon the approval of the tab-cel BLA;
additional anticipated purchases of tab-cel inventory through the manufacturing transfer date by Pierre Fabre;
anticipated reimbursement for tab-cel global development costs through the BLA transfer by Pierre Fabre;
operating efficiencies resulting from completed workforce reductions;
the planned transition of substantially all activities relating to tab-cel at the time of the BLA transfer to Pierre Fabre potentially as early as Q1 2025, which will further reduce quarterly operating expenses; and
anticipated royalties from sales of tab-cel by Pierre Fabre in the U.S. post BLA approval
About ATA3219
ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus. ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. It incorporates multiple clinically validated technologies including a modified CD3ζ signaling domain (1XX) that optimizes expansion and mitigates exhaustion, enrichment during manufacturing for a less differentiated phenotype for robust expansion and persistence and retains the endogenous T-cell receptor without gene editing as a key survival signal for T cells contributing to persistence.
About ATA3431
ATA3431 is an allogeneic, bispecific CAR directed against CD20 and CD19, built on Atara’s EBV T-cell platform. The design consists of a tandem CD20-CD19 design, with binders oriented to optimize potency. Dual targets address the limitations of single antigen loss and tumor variability. ATA3431 features a novel 1XX signaling domain, memory phenotype, and retained, unedited T-cell receptor. Preclinical data have demonstrated early evidence of antitumor activity, long-term persistence, and superior tumor growth inhibition compared to an autologous CD19/CD20 CAR T benchmark.
Next-Generation Allogeneic CAR T Approach
Atara is focused on applying Epstein-Barr virus (EBV) T-cell biology, featuring experience in over 600 patients treated with allogeneic EBV T cells, and novel chimeric antigen receptor (CAR) technologies to meet the current limitations of autologous and allogeneic CAR therapies head-on by advancing a potential best-in-class CAR T pipeline in oncology and autoimmune disease. Unlike gene-edited approaches aimed at inactivating T-cell receptor (TCR) function to reduce the risk for graft-vs-host disease, Atara’s allogeneic platform maintains expression of the native EBV TCR that promotes in vivo functional persistence while also demonstrating inherently low alloreactivity due to their recognition of defined viral antigens and partial human leukocyte antigen (HLA) matching. A molecular toolkit of clinically-validated technologies—including the 1XX signaling domain designed for better cell fitness and less exhaustion while maintaining stemness—offers a differentiated approach to addressing significant unmet need with the next generation CAR T.