Atara Biotherapeutics Announces Third Quarter 2024 Financial Results and Operational Progress
Atara Biotherapeutics (ATRA) reported Q3 2024 financial results and operational progress. The company's tab-cel® BLA is on track with a PDUFA date of January 15, 2025. Total revenues were $40.2 million, up from $2.1 million in Q3 2023. Net loss was $21.9 million ($2.93 per share). Cash position was $67.2 million as of September 30, 2024.
The company dosed its first patient in the ATA3219 Non-Hodgkin's Lymphoma study, with initial data expected Q1 2025. Atara expects to initiate studies for Lupus Nephritis and Extrarenal Systemic Lupus Erythematosus by year-end. The company projects its cash runway into 2027, supported by potential milestone payments and operational efficiencies.
Atara Biotherapeutics (ATRA) ha riportato i risultati finanziari e i progressi operativi per il terzo trimestre del 2024. La BLA del tab-cel® è in linea con la data PDUFA fissata per il 15 gennaio 2025. Le entrate totali sono state di 40,2 milioni di dollari, rispetto ai 2,1 milioni nel terzo trimestre del 2023. La perdita netta è stata di 21,9 milioni di dollari (2,93 dollari per azione). La posizione di cassa era di 67,2 milioni di dollari al 30 settembre 2024.
La società ha somministrato il primo trattamento al paziente nello studio sull'Linfoma Non-Hodgkin, con dati iniziali previsti per il primo trimestre del 2025. Atara prevede di avviare studi per la Nefrite Lupica e l'Eritema Sistemico Lupico Extrarenale entro la fine dell'anno. La società prevede di mantenere la liquidità fino al 2027, supportata da potenziali pagamenti per traguardi e da efficienze operative.
Atara Biotherapeutics (ATRA) informó sobre los resultados financieros y el progreso operacional del tercer trimestre de 2024. La BLA del tab-cel® está en camino con una fecha PDUFA del 15 de enero de 2025. Los ingresos totales fueron de 40,2 millones de dólares, en comparación con los 2,1 millones en el tercer trimestre de 2023. La pérdida neta fue de 21,9 millones de dólares (2,93 dólares por acción). La posición de efectivo era de 67,2 millones de dólares al 30 de septiembre de 2024.
La compañía administró su primer tratamiento en el estudio de Linfoma No Hodgkin, con datos iniciales esperados para el primer trimestre de 2025. Atara espera iniciar estudios para Nefritis Lúpica y Lupus Eritematoso Sistémico Extrarrenal para fin de año. La empresa proyecta que su liquidez se extenderá hasta 2027, respaldada por posibles pagos por hitos y eficiencias operativas.
Atara Biotherapeutics (ATRA)는 2024년 3분기 재무 결과 및 운영 진행 상황을 보고했습니다. 회사의 tab-cel® BLA는 2025년 1월 15일로 예정된 PDUFA 날짜에 맞춰 진행되고 있습니다. 총 수익은 4020만 달러로, 2023년 3분기의 210만 달러에서 증가했습니다. 순손실은 2190만 달러(주당 2.93달러)였습니다. 2024년 9월 30일 현재 현금 보유액은 6720만 달러였습니다.
회사는 ATA3219 비호지킨 림프종 연구에서 첫 번째 환자에게 치료를 진행했으며, 초기 데이터는 2025년 1분기에 예상됩니다. Atara는 연말까지 루푸스 신염 및 외부 신체 루푸스 연구를 시작할 계획입니다. 회사는 이정표 지급 및 운영 효율성을 통해 2027년까지 현금 유동성을 유지할 것으로 예상합니다.
Atara Biotherapeutics (ATRA) a rapporté les résultats financiers et les avancées opérationnelles du troisième trimestre 2024. La BLA de tab-cel® est sur la bonne voie avec une date PDUFA prévue au 15 janvier 2025. Les revenus totaux se sont élevés à 40,2 millions de dollars, contre 2,1 millions de dollars au troisième trimestre 2023. La perte nette s'est élevée à 21,9 millions de dollars (2,93 dollars par action). La position de liquidités était de 67,2 millions de dollars au 30 septembre 2024.
L'entreprise a traité son premier patient dans l'étude ATA3219 sur le lymphome non hodgkinien, avec des données initiales attendues pour le premier trimestre 2025. Atara prévoit de lancer des études sur la néphrite lupique et le lupus érythémateux systémique extrarénal d'ici la fin de l'année. L'entreprise prévoit une trésorerie suffisante jusqu'en 2027, soutenue par des paiements potentiels d'étapes et des économies opérationnelles.
Atara Biotherapeutics (ATRA) hat die finanziellen Ergebnisse und den operativen Fortschritt für das dritte Quartal 2024 veröffentlicht. Die BLA für tab-cel® ist auf Kurs mit einem PDUFA-Datum vom 15. Januar 2025. Die Gesamterlöse betrugen 40,2 Millionen Dollar, im Vergleich zu 2,1 Millionen Dollar im dritten Quartal 2023. Der Nettoverlust betrug 21,9 Millionen Dollar (2,93 Dollar pro Aktie). Die Liquidität betrug zum 30. September 2024 67,2 Millionen Dollar.
Das Unternehmen verabreichte dem ersten Patienten in der ATA3219-Studie zu Non-Hodgkin-Lymphom eine Behandlung, wobei initiale Daten für das erste Quartal 2025 erwartet werden. Atara plant, bis zum Jahresende Studien zu Lupusnephritis und extrarenalem systemischem Lupus erythematodes zu initiieren. Das Unternehmen prognostiziert seine finanzielle Laufzeit bis 2027, unterstützt durch potenzielle Meilensteinzahlungen und betriebliche Effizienz.
- Revenue increased significantly to $40.2M from $2.1M YoY
- Net loss decreased to $21.9M from $69.8M YoY
- Operating expenses expected to decrease by 35% from 2023
- Cash runway extended into 2027
- Potential $60M milestone payment upon FDA approval
- Net loss of $21.9M in Q3 2024
- $6.0M sub-licensing fee paid under protest to MSK
- Cash position of $67.2M requires additional funding sources for long-term operations
Insights
The Q3 2024 financial results and operational updates reveal significant progress and improved financial position. Total revenues surged to
The company's cash position strengthened to
The pipeline progress shows strong potential for near-term value creation. Tab-cel's BLA review is advancing with Priority Review status and a January 15, 2025 PDUFA date, notably without a planned FDA advisory committee meeting, suggesting a potentially smoother approval path. The initiation of ATA3219 trials in both NHL and lupus indications demonstrates pipeline diversification.
The expansion into autoimmune diseases, particularly lupus nephritis and extrarenal lupus without lymphodepletion, represents a strategic move into high-value markets. The lymphodepletion-free approach could offer a significant competitive advantage in terms of safety and accessibility. Multiple data readouts expected in 2025 could serve as major catalysts for the company's transition into a focused allogeneic CAR-T player.
Tab-cel®
First Patient Dosed for ATA3219 Non-Hodgkin’s Lymphoma Study; Initial Clinical Data Expected Q1 2025
ATA3219 Lupus Nephritis and Extrarenal Systemic Lupus Erythematosus Study Initiation Expected by End of Year; Initial Clinical Data Expected Mid-2025
Cash Runway Into 2027 Enables Key Pipeline Readouts
“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
milestone payment from Pierre Fabre contingent upon FDA approval of the tab-cel BLA$60 million
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
, as compared to$67.2 million as of June 30, 2024. This includes a$35.3 million milestone payment related to the tab-cel BLA acceptance that was received from Pierre Fabre in August 2024,$20 million from Pierre Fabre for the purchase of certain existing tab-cel intermediate inventory in September 2024, and gross proceeds of$15.5 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$36 million 15% premium to Atara’s 7-day volume-weighted average price -
Net cash used in operating activities was
for the third quarter 2024, as compared to$4.0 million in the same period in 2023$51.3 million -
Q3 2024 net cash used in operating activities included a
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$6.0 million
-
Q3 2024 net cash used in operating activities included a
-
Total revenues were
for the third quarter 2024, as compared to$40.2 million for the same period in 2023. Total revenues increased by$2.1 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$38.1 million -
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of
for the third quarter 2024, as compared to$7.7 million for the same period in 2023$12.4 million -
Research and development expenses were
for the third quarter 2024, as compared to$43.9 million for the same period in 2023$56.9 million -
Research and development expenses include a
sub-licensing fee, which was paid to MSK under protest, whereas third quarter 2023 had no such comparable expense$6.0 million -
Research and development expenses also include
of non-cash stock-based compensation expenses for the third quarter 2024, as compared to$2.9 million for the same period in 2023$6.8 million
-
Research and development expenses include a
-
General and administrative expenses were
for the third quarter 2024, as compared to$10.4 million for the same period in 2023$12.2 million -
General and administrative expenses include
of non-cash stock-based compensation expenses for the third quarter 2024, as compared to$3.5 million for the same period in 2023$4.4 million
-
General and administrative expenses include
-
Atara reported net losses of
, or$21.9 million per share, for the third quarter 2024, as compared to$2.93 , or$69.8 million per share, for the same period in 2023$16.40
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
approval milestone from Pierre Fabre contingent upon the approval of the tab-cel BLA;$60 million - 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
-
additional
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.
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 the BLA and potential indications, the potential characteristics and benefits of tab-cel®, and the progress and results of, and prospects for, the global partnership with Pierre Fabre Laboratories involving tab-cel®, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre Laboratories, including the receipt, timing and amount of any payments to be received by Atara 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 the availability of data from such clinical trials, the timing of submissions of regulatory applications, and the potential benefits, characteristics, 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 and other 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
Financials
ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) |
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September 30, |
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December 31, |
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2024 |
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2023 |
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Assets |
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Current assets: |
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|
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|
Cash and cash equivalents |
|
$ |
46,453 |
|
|
$ |
25,841 |
|
Short-term investments |
|
|
20,736 |
|
|
|
25,884 |
|
Restricted cash |
|
|
146 |
|
|
|
146 |
|
Accounts receivable |
|
|
1,335 |
|
|
|
34,108 |
|
Inventories |
|
|
13,980 |
|
|
|
9,706 |
|
Other current assets |
|
|
9,205 |
|
|
|
6,184 |
|
Total current assets |
|
|
91,855 |
|
|
|
101,869 |
|
Property and equipment, net |
|
|
1,661 |
|
|
|
3,856 |
|
Operating lease assets |
|
|
45,833 |
|
|
|
54,935 |
|
Other assets |
|
|
3,357 |
|
|
|
4,844 |
|
Total assets |
|
$ |
142,706 |
|
|
$ |
165,504 |
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|
|
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|
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Liabilities and stockholders’ equity (deficit) |
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Current liabilities: |
|
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|
|
|
|
|
|
Accounts payable |
|
$ |
2,146 |
|
|
$ |
3,684 |
|
Accrued compensation |
|
|
7,768 |
|
|
|
11,519 |
|
Accrued research and development expenses |
|
|
6,077 |
|
|
|
17,364 |
|
Deferred revenue |
|
|
116,344 |
|
|
|
77,833 |
|
Other current liabilities |
|
|
23,644 |
|
|
|
31,826 |
|
Total current liabilities |
|
|
155,979 |
|
|
|
142,226 |
|
Deferred revenue - long-term |
|
|
470 |
|
|
|
37,562 |
|
Operating lease liabilities - long-term |
|
|
35,243 |
|
|
|
45,693 |
|
Liability related to the sale of future revenues - long-term |
|
|
37,584 |
|
|
|
34,623 |
|
Other long-term liabilities |
|
|
3,969 |
|
|
|
4,631 |
|
Total liabilities |
|
$ |
233,245 |
|
|
$ |
264,735 |
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|
|
|
|
|
|
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Stockholders’ (deficit) equity: |
|
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|
|
|
|
|
|
Common stock |
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|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
1,951,298 |
|
|
|
1,870,123 |
|
Accumulated other comprehensive loss |
|
|
22 |
|
|
|
(204 |
) |
Accumulated deficit |
|
|
(2,041,860 |
) |
|
|
(1,969,150 |
) |
Total stockholders’ (deficit) equity |
|
|
(90,539 |
) |
|
|
(99,231 |
) |
Total liabilities and stockholders’ (deficit) equity |
|
$ |
142,706 |
|
|
$ |
165,504 |
|
ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts) |
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Three Months Ended
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Nine Months Ended
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2024 |
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2023 |
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2024 |
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|
2023 |
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Commercialization revenue |
|
$ |
40,190 |
|
|
$ |
2,020 |
|
|
$ |
96,187 |
|
|
$ |
3,697 |
|
License and collaboration revenue |
|
|
— |
|
|
|
118 |
|
|
|
— |
|
|
|
624 |
|
Total revenue |
|
|
40,190 |
|
|
|
2,138 |
|
|
|
96,187 |
|
|
|
4,321 |
|
Costs and operating expenses: |
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Cost of commercialization revenue |
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7,602 |
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|
2,615 |
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|
|
14,214 |
|
|
|
5,726 |
|
Research and development expenses |
|
|
43,924 |
|
|
|
56,888 |
|
|
|
122,762 |
|
|
|
175,185 |
|
General and administrative expenses |
|
|
10,421 |
|
|
|
12,247 |
|
|
|
30,446 |
|
|
|
39,454 |
|
Total costs and operating expenses |
|
|
61,947 |
|
|
|
71,750 |
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|
|
167,422 |
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|
|
220,365 |
|
Loss from operations |
|
|
(21,757 |
) |
|
|
(69,612 |
) |
|
|
(71,235 |
) |
|
|
(216,044 |
) |
Interest and other income (expense), net |
|
|
(169 |
) |
|
|
(204 |
) |
|
|
(1,468 |
) |
|
|
372 |
|
Loss before provision for (benefit from) income taxes |
|
|
(21,926 |
) |
|
|
(69,816 |
) |
|
|
(72,703 |
) |
|
|
(215,672 |
) |
Provision for (benefit from) income taxes |
|
|
(17 |
) |
|
|
(19 |
) |
|
|
7 |
|
|
|
4 |
|
Net loss |
|
$ |
(21,909 |
) |
|
$ |
(69,797 |
) |
|
$ |
(72,710 |
) |
|
$ |
(215,676 |
) |
Other comprehensive gain (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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36 |
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|
|
362 |
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|
|
226 |
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|
|
1,496 |
|
Comprehensive loss |
|
$ |
(21,873 |
) |
|
$ |
(69,435 |
) |
|
$ |
(72,484 |
) |
|
$ |
(214,180 |
) |
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Basic and diluted net loss per common share |
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$ |
(2.93 |
) |
|
$ |
(16.40 |
) |
|
$ |
(11.34 |
) |
|
$ |
(51.27 |
) |
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Basic and diluted weighted-average shares outstanding |
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|
7,466 |
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|
|
4,256 |
|
|
|
6,414 |
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|
|
4,207 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112342526/en/
Investor and Media Relations:
Jason Awe, Ph.D.
Head of Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com
Source: Atara Biotherapeutics, Inc.
FAQ
What was Atara Biotherapeutics (ATRA) revenue in Q3 2024?
When is the PDUFA date for Atara's (ATRA) tab-cel?
What is Atara's (ATRA) cash runway projection?