Atara Biotherapeutics Announces First Quarter 2024 Financial Results and Operational Progress
Atara Biotherapeutics announced its first-quarter 2024 financial results and operational progress, highlighting key advancements in its lead CAR T program, ATA3219, for oncology and autoimmune diseases. The company plans to submit a BLA for tab-cel in Q2 2024 and initiate studies for lupus nephritis and non-Hodgkin’s lymphoma. Atara's cash runway extends into 2027, enabling key pipeline readouts.
Successful advancement of lead CAR T program, ATA3219, for oncology and autoimmune diseases
Plans to submit BLA for tab-cel in Q2 2024, with promising data and regulatory approvals
Initiation of studies for lupus nephritis and non-Hodgkin’s lymphoma, with anticipated clinical data in 2024-2025
Cash runway extended into 2027, ensuring key pipeline readouts
Net losses of $31.8 million reported for Q1 2024
Reduction in force announced in January 2024, impacting approximately 25% of employees
Operating expenses expected to decrease by 35% in 2024
Insights
The Q1 2024 financial results of Atara Biotherapeutics indicate a strategic repositioning with a focus on key pipeline readouts and a partnership that has started to yield financial benefits. Specifically, the receipt of a $20 million milestone payment and the anticipation of further payments upon BLA acceptance and approval signify a bolstering of the company's financial position. The reported net losses have narrowed to $31.8 million from $74.8 million YoY, a substantial improvement partly driven by a decrease in operating expenses, which are expected to fall by an additional 35% throughout 2024.
The company's cash runway projection into 2027 should provide investor confidence in its financial stability, as it includes not only cash on hand but also expected milestone payments and operational efficiencies. This extended runway is critical given that biotech firms like Atara often require extended periods of capital to support research and development before reaching profitability. Investors should note, however, the reliance on the successful acceptance and approval of the tab-cel BLA for part of this runway prediction.
The progression of Atara's lead CAR T therapy, ATA3219, is notable for the development of treatments in both oncology and autoimmune diseases. The initiation of several studies, including for lupus nephritis and a non-Hodgkin’s lymphoma study, signal significant steps in the clinical development pathway. The mention of a 48.8% Objective Response Rate (ORR) for tab-cel in a pivotal study suggests a favorable efficacy profile, an important factor in the drug's commercial potential and future approval prospects.
Furthermore, the strategic decision to initiate a new cohort for severe systemic lupus erythematosus without lymphodepletion could indicate an advancement toward a more patient-friendly treatment regimen with potential differentiators in safety and efficacy. This approach, if successful, could give Atara a competitive edge in the marketplace. The emphasis on Atara's proprietary EBV T-cell platform also underscores the company's commitment to leverage its unique technology to fulfill unmet medical needs.
The partnership with Pierre Fabre points to Atara's strategic efforts to expand the global commercial potential of its products. Such alliances are key in the pharmaceutical industry, often leading to enhanced market penetration and risk-sharing. This is evident in the upfront payment of approximately $27 million and the potential for substantial future payments, which can underwrite Atara's R&D while waiting for product revenue.
The Swissmedic approval for Ebvallo (tab-cel®) extends Atara's reach into the European market and may serve as a precursor to further regulatory successes in additional geographies. This expansion is promising but comes with the inherent challenge of navigating diverse regulatory landscapes. The company's financial results reflect a significant increase in revenue year-over-year, which is primarily attributed to the Pierre Fabre partnership, a positive indicator of Atara's ability to monetize its pipeline advancements and collaborations.
Tab-cel®
Initiation of ATA3219 Lupus Nephritis Study Expected in Q4 2024, with Initial Clinical Data Expected in H1 2025
Initiation of New ATA3219 Cohort Without Lymphodepletion in Severe Systemic Lupus Erythematosus Planned for Q4 2024, with Initial Clinical Data Expected in H2 2025
Enrolling ATA3219 Non-Hodgkin’s Lymphoma Study, with Initial Clinical Data Expected in Q4 2024
Cash Runway Into 2027 Enables Key Pipeline Readouts
"Our lead CAR T program, ATA3219, is advancing as a promising new therapeutic option for oncology and autoimmune diseases, where it is positioned to benefit from the unique characteristics of our proven allogeneic EBV T-cell platform,” said Pascal Touchon, President and Chief Executive Officer of Atara. “This is anticipated to provide multiple near-term clinical milestones for ATA3219, including initial non-Hodgkin’s lymphoma data expected in the fourth quarter 2024, and initial lupus nephritis data in the first half of 2025, with plans to expand into a new SLE cohort without lymphodepletion. In addition, our partnership with Pierre Fabre continues to generate value, as we received our first milestone payment related to tab-cel regulatory progress in the
Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD)
- Atara plans to submit a Biologics License Application (BLA) in Q2 2024 for tab-cel indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate
- The data package for the filing includes pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases
-
The BLA will include the latest pivotal ALLELE study data-cut that demonstrated a statistically significant
48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses -
Ebvallo received regulatory approval from Swissmedic, the regulatory authority in
Switzerland , further expanding its potential inEurope -
Atara continues to advance the Pierre Fabre Laboratories expanded global partnership, which included approximately
$27 million $640 million $100 million
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]) in Q4 2024 with initial clinical data anticipated in H1 2025
- The Phase 1 open-label, dose-escalation study is designed to evaluate safety, preliminary efficacy, pharmacokinetics, and biomarkers of a single dose of ATA3219 administered to LN subjects refractory to one or more lines of treatment. Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells. Each dose level is designed to enroll 3-6 patients
- Atara is positioned to potentially expand ATA3219 Phase 1 study into additional autoimmune indications via the same Investigational New Drug (IND) application previously cleared for the LN study
- Preclinical data supporting the potential of ATA3219 in SLE will be presented in poster presentation at the International Society for Cell & Gene Therapy meeting, which is being held May 29-June 1, 2024. The data demonstrate that ATA3219 CAR T cells led to complete CD19-specific B-cell depletion against SLE or multiple sclerosis patient peripheral blood mononuclear cells
- Additional preclinical data also presented in the poster show that ATA3219 CAR T cells, which use the next-generation 1XX costimulatory domain, release lower levels of pro-inflammatory cytokines while maintaining cytotoxic function as potent as observed with autologous CAR T controls in response to stimulation with CD19+ target cells. Mitigating inflammatory cytokine release that is typically seen with standard CD19 CAR T signaling may lead to reduced toxicity and better tolerability if confirmed in clinical trials
ATA3219: CD19 Program in Severe Systemic Lupus Erythematosus (SLE) Without Lymphodepletion
- Atara plans to expand the Phase 1 LN study of ATA3219 and add a new cohort in severe SLE without lymphodepletion (LD) in Q4 2024 with initial clinical data anticipated in H2 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
- There is compelling clinical and scientific rationale supporting the potential to eliminate the need for LD based on the EBV T-cell backbone and unique features of ATA3219, including: 1) low alloreactivity risk and favorable safety in over 600 patients treated without LD, due to T-cell receptor EBV specificity and partial human leukocyte antigen matching; 2) expansion and persistence data without LD correlating to efficacy in patients treated with tab-cel; and 3) the inclusion of clinically validated features into ATA3219 such as the 1XX costimulatory domain and memory phenotype that increase potency and persistence
ATA3219: CD19 Program in Non-Hodgkin’s Lymphoma (NHL)
- Atara initiated enrollment of a multi-center, Phase 1 open-label, dose-escalation clinical trial of ATA3219 in NHL, including large B-cell lymphomas, follicular lymphoma, and mantle cell lymphoma, with initial clinical data anticipated in Q4 2024
- Study designed to evaluate safety, preliminary efficacy, pharmacokinetics, and biomarkers. Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells. Each dose level is designed to enroll 3-6 patients
- Previously presented preclinical data demonstrated superior in vivo persistence and CD19-specific anti-tumor efficacy compared to an autologous CD19 CAR T benchmark with no observed toxicity or alloreactivity
ATA3431: CD19/CD20 Program for B-Cell Malignancies
- Preclinical data presented at ASH 2023 demonstrated early evidence of potent antitumor activity, long-term persistence, and superior tumor growth inhibition compared to an autologous CD19/CD20 CAR T benchmark
- Dual CD19 and CD20 targeting designed to address CD19 escape and tumor variability and may provide additional efficacy in lymphoma
- Atara is progressing toward an IND submission in H2 2025
First Quarter 2024 Financial Results
-
Cash, cash equivalents and short-term investments as of March 31, 2024 totaled
$46.2 million $51.7 million -
Q1 2024 accounts receivable totaled
$35.8 million $20 million $12 million $20 million $12 million -
Together, cash, cash equivalents, short-term investments, and accounts receivable as of March 31, 2024 totaled
$82.1 million -
Net cash used in operating activities was
$29.6 million $38.4 million -
Q1 2024 net cash used in operating activities included 2023 annual employee bonus payments and cash disbursements related to the November 2023 and January 2024 reductions in force of approximately
$13 million
-
Q1 2024 net cash used in operating activities included 2023 annual employee bonus payments and cash disbursements related to the November 2023 and January 2024 reductions in force of approximately
-
Total revenues were
$27.4 million $1.2 million $26.2 million -
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of
$9.8 million $13.0 million -
Total costs and operating expenses include restructuring expense of
$4.8 million 25% to 170 employees -
Research and development expenses were
$45.5 million $62.2 million -
Research and development expenses include
$4.7 million $6.8 million
-
Research and development expenses include
-
General and administrative expenses were
$11.1 million $13.9 million -
General and administrative expenses include
$3.7 million $5.0 million
-
General and administrative expenses include
-
Atara reported net losses of
$31.8 million $0.23 $74.8 million $0.72
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 is expected to begin in Q2 2024 and continue for the remainder of the year
-
Atara expects that cash, cash equivalents, short-term investments, and accounts receivable as of March 31, 2024, plus the items noted below, in total will enable funding of planned operations into 2027:
-
anticipated payments of
$20 million $60 million - 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
-
anticipated payments of
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 (SLE) with kidney involvement (lupus nephritis [LN]). 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 costimulatory 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 promote 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 costimulatory 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.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases. Atara is headquartered in
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel®, including a potential BLA and potential indications, the potential characteristics and benefits of tab-cel®, and the progress and results of, and prospects for, the expanded global partnership with Pierre Fabre Laboratories involving tab-cel®, and the potential financial benefits to Atara as a result of the expanded global partnership with Pierre Fabre Laboratories, including the receipt, timing and amount of any payments thereunder; (2) the development, timing and progress of Atara’s AlloCAR-T programs (including ATA3219 and ATA3431), including the timing of the start of any clinical trials, the timing of submissions of regulatory applications, and the potential benefits, safety and efficacy of such product candidates or product candidates emerging from such programs; (3) Atara’s cash runway, the timing and receipt of potential milestone payments, and operating expenses, including Atara’s ability to fund its planned operations into 2027; and (4) Atara’s planned transition of substantially all activities relating to tab-cel at the time of the BLA transfer to Pierre Fabre and the timing thereof. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the COVID-19 pandemic and the wars in
ATARA BIOTHERAPEUTICS, INC. |
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Consolidated Balance Sheets |
||||||||
(Unaudited) |
||||||||
(In thousands) |
||||||||
|
|
March 31, |
|
December 31, |
||||
|
|
2024 |
|
2023 |
||||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
35,087 |
|
|
$ |
25,841 |
|
Short-term investments |
|
|
11,152 |
|
|
|
25,884 |
|
Restricted cash |
|
|
146 |
|
|
|
146 |
|
Accounts receivable |
|
|
35,834 |
|
|
|
34,108 |
|
Inventories |
|
|
16,084 |
|
|
|
9,706 |
|
Other current assets |
|
|
8,131 |
|
|
|
6,184 |
|
Total current assets |
|
|
106,434 |
|
|
|
101,869 |
|
Property and equipment, net |
|
|
2,989 |
|
|
|
3,856 |
|
Operating lease assets |
|
|
51,981 |
|
|
|
54,935 |
|
Other assets |
|
|
3,868 |
|
|
|
4,844 |
|
Total assets |
|
$ |
165,272 |
|
|
$ |
165,504 |
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity (deficit) |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,854 |
|
|
$ |
3,684 |
|
Accrued compensation |
|
|
5,707 |
|
|
|
11,519 |
|
Accrued research and development expenses |
|
|
15,928 |
|
|
|
17,364 |
|
Deferred revenue |
|
|
123,154 |
|
|
|
77,833 |
|
Other current liabilities |
|
|
33,047 |
|
|
|
31,826 |
|
Total current liabilities |
|
|
180,690 |
|
|
|
142,226 |
|
Deferred revenue - long-term |
|
|
719 |
|
|
|
37,562 |
|
Operating lease liabilities - long-term |
|
|
42,197 |
|
|
|
45,693 |
|
Liability related to the sale of future revenues - long-term |
|
|
35,573 |
|
|
|
34,623 |
|
Other long-term liabilities |
|
|
4,401 |
|
|
|
4,631 |
|
Total liabilities |
|
$ |
263,580 |
|
|
$ |
264,735 |
|
|
|
|
|
|
|
|
||
Stockholders’ (deficit) equity: |
|
|
|
|
|
|
||
Common stock |
|
|
12 |
|
|
|
11 |
|
Additional paid-in capital |
|
|
1,902,637 |
|
|
|
1,870,112 |
|
Accumulated other comprehensive loss |
|
|
(55 |
) |
|
|
(204 |
) |
Accumulated deficit |
|
|
(2,000,902 |
) |
|
|
(1,969,150 |
) |
Total stockholders’ (deficit) equity |
|
|
(98,308 |
) |
|
|
(99,231 |
) |
Total liabilities and stockholders’ (deficit) equity |
$ |
165,272 |
$ |
165,504 |
||||
ATARA BIOTHERAPEUTICS, INC. |
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Consolidated Statements of Operations and Comprehensive Loss |
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(Unaudited) |
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(In thousands, except per share amounts) |
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|
|
|
||||
|
|
Three Months Ended March 31, |
||||||
|
|
2024 |
|
2023 |
||||
Commercialization revenue |
|
$ |
27,357 |
|
|
$ |
884 |
|
License and collaboration revenue |
|
|
— |
|
|
|
342 |
|
Total revenue |
|
|
27,357 |
|
|
|
1,226 |
|
Costs and operating expenses: |
|
|
|
|
||||
Cost of commercialization revenue |
|
|
1,985 |
|
|
|
216 |
|
Research and development expenses |
|
|
45,506 |
|
|
|
62,156 |
|
General and administrative expenses |
|
|
11,113 |
|
|
|
13,872 |
|
Total costs and operating expenses |
|
|
58,604 |
|
|
|
76,244 |
|
Loss from operations |
|
|
(31,247 |
) |
|
|
(75,018 |
) |
Interest and other income (expense), net |
|
|
(481 |
) |
|
|
269 |
|
Loss before provision for income taxes |
|
|
(31,728 |
) |
|
|
(74,749 |
) |
Provision for income taxes |
|
|
24 |
|
|
|
22 |
|
Net loss |
|
$ |
(31,752 |
) |
|
$ |
(74,771 |
) |
Other comprehensive gain (loss): |
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale securities |
|
|
149 |
|
|
|
830 |
|
Comprehensive loss |
|
$ |
(31,603 |
) |
|
$ |
(73,941 |
) |
|
|
|
|
|
||||
Basic and diluted net loss per common share |
|
$ |
(0.23 |
) |
|
$ |
(0.72 |
) |
|
|
|
|
|
||||
Basic and diluted weighted-average shares outstanding |
|
|
140,587 |
|
|
|
103,969 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240509763182/en/
Investor and Media Relations:
Jason Awe, Ph.D.
Senior Director, Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com
Source: Atara Biotherapeutics, Inc.
FAQ
When does Atara plan to submit a BLA for tab-cel?
What are the key upcoming milestones for Atara in 2024?
What is the cash runway for Atara extending into?
