Atara Biotherapeutics(ATRA)

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Atara Biotherapeutics(ATRA) - 2019 Q2 - Earnings Call Transcript
2019-08-09 04:04
Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q2 2019 Results Earnings Conference Call August 8, 2018 8:00 AM ET Company Participants John Craighead - Vice President of Investor Relations and Corporate Communications Pascal Touchon - President and Chief Executive Officer AJ Joshi - Chief Medical Officer Chris Haqq - Chief Scientific Officer Conference Call Participants Anupam Rama - JP Morgan John Newman - Canaccord Genuity Salim Syed - Mizohu Americas Matt Phipps - William Blair Philip Nadeau - Cowen and C ...
Atara Biotherapeutics(ATRA) - 2019 Q2 - Quarterly Report
2019-08-08 11:51
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the period ended June 30, 2019, detail the company's financial position, operational results, and cash flows, showing a significant increase in net loss driven by higher research and development and general administrative expenses, a decrease in cash and short-term investments, and increased cash usage in operations Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,159 | $60,698 | | Short-term investments | $130,976 | $248,933 | | Total current assets | $201,139 | $321,489 | | Total assets | $274,144 | $391,839 | | **Liabilities & Equity** | | | | Total current liabilities | $25,803 | $39,979 | | Total liabilities | $41,865 | $52,982 | | Total stockholders' equity | $232,279 | $338,857 | | Total liabilities and stockholders' equity | $274,144 | $391,839 | Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $52,251 | $33,387 | $100,919 | $61,847 | | General and administrative | $23,284 | $19,236 | $42,507 | $33,228 | | Loss from operations | ($75,535) | ($52,623) | ($143,426) | ($95,075) | | Net loss | ($74,328) | ($50,883) | ($140,585) | ($92,326) | | Basic and diluted net loss per share | ($1.60) | ($1.15) | ($3.04) | ($2.20) | Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($124,789) | ($74,256) | | Net cash provided by (used in) investing activities | $117,849 | ($253,794) | | Net cash provided by financing activities | $5,401 | $352,030 | | (Decrease) increase in cash, cash equivalents and restricted cash | ($1,539) | $23,980 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business strategy, pipeline progress, financial results, and liquidity, highlighting the advancement of tab-cel® through **Phase 3** trials, significant increases in operating expenses, and the expectation that a July **2019** public offering will fund operations into **2021** Overview and Pipeline Atara is a leading **allogeneic T-cell immunotherapies** company with a platform focused on cancer, autoimmune, and viral diseases, advancing tab-cel® in **Phase 3** for EBV+ PTLD with a planned **BLA submission** in the second half of **2020**, and developing ATA188/190 for multiple sclerosis and a next-generation CAR T program - The company's lead product, tab-cel®, is in **Phase 3** development for EBV+ PTLD, with plans to initiate a Biologics License Application (**BLA submission**) in the second half of **2020**[91](index=91&type=chunk)[92](index=92&type=chunk) - The pipeline includes ATA188 (allogeneic) and ATA190 (autologous) for multiple sclerosis, with initial efficacy results for ATA188 expected in the second half of **2019**[96](index=96&type=chunk) - Atara is advancing a next-generation CAR T program, with an **IND planned** for autologous ATA2271 in advanced mesothelioma in **2020**[97](index=97&type=chunk)[98](index=98&type=chunk) Results of Operations For the three and six months ended June 30, 2019, operating expenses increased significantly compared to 2018, with research and development expenses rising to **$52.3 million** for the quarter and **$100.9 million** for the six-month period, driven by higher costs for tab-cel® **Phase 3** studies, ATA188/190 MS programs, and **increased headcount** Research and Development Expenses by Program (in thousands) | Program | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Tab-cel® expenses | $11,252 | $8,089 | $22,891 | $17,134 | | ATA188, ATA190 and other | $9,102 | $6,855 | $15,208 | $11,179 | | Employee and overhead | $31,897 | $18,443 | $62,820 | $33,534 | | **Total R&D Expenses** | **$52,251** | **$33,387** | **$100,919** | **$61,847** | - General and administrative expenses increased to **$42.5 million** for the six months ended June 30, **2019**, from **$33.2 million** in the prior-year period, primarily due to **increased headcount** and related **compensation costs**[116](index=116&type=chunk) Liquidity and Capital Resources As of June 30, 2019, Atara had **$190.1 million** in cash, cash equivalents, and short-term investments, with management expecting that existing cash combined with **$140.6 million** in **net proceeds** from a July **2019** **underwritten public offering** will be **sufficient to fund planned operations** into **2021** - The company completed an **underwritten public offering** in July **2019**, raising aggregate **net proceeds** of approximately **$140.6 million**[119](index=119&type=chunk) - Management expects that cash, cash equivalents, and short-term investments as of June 30, **2019**, together with the proceeds from the July **2019** offering, will be **sufficient to fund planned operations** into **2021**[121](index=121&type=chunk)[129](index=129&type=chunk) - During the first six months of **2019**, the company sold **359,234** shares under its **ATM Facility** for **gross proceeds** of **$8.0 million**[118](index=118&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that there were no **material changes** to its market risk disclosures, including interest rate risk and foreign currency exchange rate risk, during the six months ended June 30, 2019, from what was reported in its **2018** Annual Report on Form **10-K** - There were **no material changes** to the company's market risk disclosures regarding interest rate and foreign currency exchange rate risk during the six months ended June 30, **2019**[138](index=138&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's **disclosure controls and procedures** and concluded they were **effective** as of June 30, 2019, with no changes in **internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, these controls - The Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures** were **effective** as of June 30, **2019**[139](index=139&type=chunk) - No changes in **internal control over financial reporting** occurred during the six months ended June 30, **2019**, that have **materially affected**, or are reasonably likely to materially affect, internal controls[142](index=142&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is **not currently involved** in any **material legal proceedings** - The company reports **no material legal proceedings**[144](index=144&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks that could materially harm the company's business, including a history of **substantial financial losses** and the **need for additional capital**, the **unproven nature** of its T-cell immunotherapy platform, reliance on third parties for manufacturing, challenges in protecting intellectual property, and significant competition - Financial risks include a history of **substantial losses** (**$667.6 million** **accumulated deficit** as of June 30, **2019**) and the **need for substantial additional financing** to achieve goals[147](index=147&type=chunk)[154](index=154&type=chunk) - Development risks center on the novel and **unproven nature** of T-cell immunotherapy, which could result in **heightened regulatory scrutiny**, **clinical trial delays**, or **failure to receive approval**[170](index=170&type=chunk) - The company faces **manufacturing risks** related to **scaling up complex cellular therapy processes**, **potential contamination**, and **reliance on a limited number of contract manufacturing organizations (CMOs)**[210](index=210&type=chunk)[213](index=213&type=chunk) - Commercialization success depends on gaining **market acceptance**, securing **adequate reimbursement** from payors, and **competing with established therapies** and companies with **greater resources**[258](index=258&type=chunk)[260](index=260&type=chunk)[272](index=272&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports **no unregistered sales** of equity securities during the period - **None reported**[323](index=323&type=chunk) [Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports **no defaults** upon senior securities - **None reported**[323](index=323&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is **not applicable** to the company - **Not applicable**[324](index=324&type=chunk) [Other Information](index=61&type=section&id=Item%205.%20Other%20Information) The company reports **no other information** for this period - **None reported**[324](index=324&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form **10-Q**, including the company's amended and restated certificate of incorporation and bylaws, executive employment agreements, and certifications by the CEO and CFO
Atara Biotherapeutics(ATRA) - 2019 Q1 - Earnings Call Transcript
2019-05-12 16:00
Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q1 2019 Earnings Conference Call May 9, 2019 8:30 AM ET Company Participants John Craighead - Vice President of Investor Relations and Corporate Communications Isaac Ciechanover - President and Chief Executive Officer Dietmar Berger - Global Head of Research and Development Utpal Koppikar - Chief Financial Officer Conference Call Participants Anupam Rama - JPMorgan John Newman - Canaccord Salim Syed - Mizuho Matt Phipps - William Blair Maryana Breitman - Goldman Sac ...
Atara Biotherapeutics(ATRA) - 2019 Q1 - Quarterly Report
2019-05-09 12:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36548 | --- | --- | |------------------------------------------------------------------------------|--------------------------------------- ...
Atara Biotherapeutics(ATRA) - 2018 Q4 - Annual Report
2019-02-26 13:47
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36548 | --- | --- | |-------------------------------------------------------------------------------------------------|-------------- ...