Adaptimmune(ADAP)

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Adaptimmune(ADAP) - 2020 Q4 - Earnings Call Transcript
2021-02-25 19:07
Adaptimmune Therapeutics PLC (NASDAQ:ADAP) Q4 2020 Earnings Conference Call February 25, 2020 8:00 AM ET Company Participants Juli Miller - Senior Director, IR Adrian Rawcliffe - CEO Elliot Norry - Senior VP and Chief Medical Officer Helen Tayton-Martin - Co-Founder and Chief Business Officer Conference Call Participants Tony Butler - ROTH Capital Kenneth Atkins - Cowen & Company Mohit Bansal - Citi Group Michael Smith - Guggenheim Nick Abbott - Wells Fargo Operator Ladies and gentlemen, thank you for stand ...
Adaptimmune Therapeutics (ADAP) Presents At SITC Virtual Annual Meeting 2020 - Slideshow
2020-11-10 23:59
Efficacy - Two patients achieved RECIST responses, one with esophagogastric junction (EGJ) cancer and another with head and neck cancer[5, 27] - Initial tumor reductions were observed in 5 out of 6 patients[5, 25, 27] - The data supports further investigation of ADP-A2M4CD8 as an active product[4, 27] Safety - All 6 patients (100%) experienced adverse events (AEs), with all 6 (100%) having Grade ≥3 AEs[14] - Common AEs (any grade) included leukopenia, lymphopenia/lymphocyte decrease, and neutropenia/neutrophil decrease, each occurring in 6 patients (100%)[14] - Other frequent AEs (any grade) were anemia/red blood cell decrease (4 patients, 67%), cytokine release syndrome (4 patients, 67%), fatigue (4 patients, 67%), headache (4 patients, 67%), and nausea (4 patients, 67%)[14] - One serious adverse event (SAE) of cytokine release syndrome was reported in a patient in Cohort 2 and was considered related to the T-cell infusion[15] - Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or cancer immunotherapy[5, 15, 26] Trial Design and Next Steps - The SURPASS trial is a first-in-human dose-escalation trial[8] - The trial is focusing on enrolling patients with gastroesophageal, head and neck, lung, and bladder cancers[5, 7, 28] - A Phase 2 trial is planned for 2021 with ADP-A2M4CD8 in patients with gastroesophageal cancers[5, 7, 17, 28]
Adaptimmune(ADAP) - 2020 Q3 - Earnings Call Transcript
2020-11-06 03:18
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q3 2020 Earnings Conference Call November 5, 2020 8:30 AM ET Company Participants Juli Miller - Senior Director, IR Adrian Rawcliffe - CEO Elliot Norry - Senior VP and Chief Medical Officer Helen Tayton-Martin - Co-Founder and Chief Business Officer Conference Call Participants Tony Butler - ROTH Capital David Ruch - SVB Leerink Gabriel Fung - Mizuho Securities Operator Ladies and gentlemen, thank you for standing by, and welcome to Adaptimmune's Third Quarter 2020 ...
Adaptimmune(ADAP) - 2020 Q3 - Quarterly Report
2020-11-05 21:18
PART I [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed consolidated financial statements for Q3 2020 reveal significant asset growth and a narrowed net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $78,466 | $50,412 | | Marketable securities | $321,442 | $39,130 | | **Total Assets** | **$479,022** | **$181,543** | | **Liabilities & Equity** | | | | Total liabilities | $102,816 | $57,905 | | Total stockholders' equity | $376,206 | $123,638 | | **Total Liabilities & Equity** | **$479,022** | **$181,543** | Condensed Consolidated Statement of Operations Highlights (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Revenue | $2,456 | $394 | | Research and development | $(65,791) | $(77,147) | | General and administrative | $(32,557) | $(32,662) | | **Operating loss** | **$(95,892)** | **$(109,415)** | | **Net loss** | **$(93,479)** | **$(107,801)** | | Net loss per share | $(0.11) | $(0.17) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(24,375) | $(99,979) | | Net cash (used in) provided by investing activities | $(286,532) | $71,262 | | Net cash provided by financing activities | $339,929 | $366 | | **Net increase (decrease) in cash** | **$27,999** | **$(28,749)** | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, collaboration revenue recognition, and public offering impact on stockholders' equity - The company entered a collaboration agreement with Astellas on January 13, 2020, receiving a **$50.0 million** non-refundable upfront payment for co-development of T-cell therapies for up to three targets[41](index=41&type=chunk) - Deferred revenue increased from **$2.1 million** at the start of 2020 to **$49.8 million** at September 30, 2020, primarily due to the upfront payment from the Astellas collaboration[39](index=39&type=chunk) - The company raised net proceeds of **$90.5 million** from a public offering in January 2020 and **$243.8 million** from another public offering in June 2020[65](index=65&type=chunk)[66](index=66&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results of operations, covering business overview, performance analysis, and liquidity [Overview](index=21&type=section&id=Overview) The company, a leader in engineered T-cell therapies for solid tumors, aims for a 2022 commercial launch of ADP-A2M4 and advances other clinical programs and collaborations - The company aims to commercially launch its lead product, **ADP-A2M4**, in 2022, subject to successful completion of the SPEARHEAD-1 study and FDA approval[71](index=71&type=chunk) - Enrollment is ongoing in the SURPASS Phase 1 trial for the next-generation SPEAR T-cell, **ADP-A2M4CD8**, which has shown partial responses in patients with EGJ and head and neck cancers[73](index=73&type=chunk) - The company is collaborating with Astellas to co-develop and co-commercialize up to three targets for "off-the-shelf" allogeneic cell therapies[77](index=77&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section analyzes financial results for the three and nine months ended September 30, 2020 and 2019, noting increased revenue and decreased R&D expenses Comparison of Results for the Nine Months Ended September 30 (in thousands) | Line Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $2,456 | $394 | $2,062 | 523% | | R&D Expenses | $(65,791) | $(77,147) | $11,356 | (15)% | | G&A Expenses | $(32,557) | $(32,662) | $105 | (0)% | | **Operating Loss** | **$(95,892)** | **$(109,415)** | **$13,523** | **(12)%** | - The decrease in R&D expenses for the nine-month period was primarily driven by a **$5.0 million** decrease in accrued purchase commitments and a **$3.7 million** decrease in in-process R&D costs compared to the same period in 2019[121](index=121&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity significantly strengthened to **$399.9 million** by September 30, 2020, primarily from public offerings and collaboration payments, sufficient for operations into 2022 Total Liquidity (Non-GAAP, in thousands) | Component | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $78,466 | $50,412 | | Marketable securities | $321,442 | $39,130 | | **Total Liquidity** | **$399,908** | **$89,542** | - Financing activities in the first nine months of 2020 provided **$339.9 million** in cash, primarily from net proceeds of **$334.4 million** from public offerings[136](index=136&type=chunk) - Net cash used in operating activities decreased significantly to **$24.4 million** for the nine months ended Sep 30, 2020, from **$100.0 million** in the prior year, largely due to the receipt of the **$50.0 million** upfront payment from Astellas[133](index=133&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Adaptimmune is not required to provide the information requested in this item - The company is exempt from this disclosure requirement due to its status as a smaller reporting company[143](index=143&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2020, with no material changes in internal control over financial reporting - The CEO and CFO concluded that as of September 30, 2020, the company's disclosure controls and procedures were effective[144](index=144&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[145](index=145&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) As of September 30, 2020, the company was not a party to any material legal proceedings [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including the COVID-19 pandemic, financial condition, development of cell therapies, and reliance on third parties [Risks Related to the COVID-19 pandemic](index=44&type=section&id=Risks%20Related%20to%20the%20COVID-19%20pandemic) The COVID-19 pandemic poses material risks, potentially delaying clinical trials, disrupting supply chains, and impacting workforce effectiveness - The pandemic has delayed the company's ability to obtain data from clinical trials and will extend the time required to complete enrollment[151](index=151&type=chunk) - Work-from-home policies and social distancing requirements limit workforce effectiveness and may cause delays in manufacturing, development, and research activities[150](index=150&type=chunk) [Risks Related to Financial Condition and Capital Requirements](index=46&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company has a history of net losses and requires substantial future financing, with failure to raise capital potentially impacting development and commercialization efforts - The company has incurred net losses every year since inception and expects to continue incurring them, with an accumulated deficit of **$549.1 million** as of September 30, 2020[158](index=158&type=chunk)[159](index=159&type=chunk) - Although current liquidity is believed to be sufficient into 2022, the company will require additional capital for further development and commercialization of its cell therapies[162](index=162&type=chunk)[168](index=168&type=chunk) [Risks Related to the Development of Our Cell Therapies](index=51&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Cell%20Therapies) The company's business is highly dependent on novel, unproven SPEAR T-cell candidates, facing risks including cross-reactivity, complex manufacturing, and uncertain clinical trial outcomes with reported serious adverse events - The business is highly dependent on its wholly-owned SPEAR T-cell candidates (**ADP-A2M4**, **ADP-A2M4CD8**, **ADP-A2AFP**), which require significant additional clinical testing[172](index=172&type=chunk) - Manufacturing and administering cell therapies is complex, costly, and subject to potential failures in process, logistics, or starting materials, which can delay trials and affect patient outcomes[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk) - Serious adverse events (SAEs) have been reported across trials, including **CRS**, neurotoxicity, and pancytopenia, with two treatment-related fatal SAEs in the **ADP-A2M4** pilot trial[213](index=213&type=chunk)[262](index=262&type=chunk) [Risks Related to Reliance Upon Third Parties](index=106&type=section&id=Risks%20Related%20to%20Our%20Reliance%20Upon%20Third%20Parties) The company heavily relies on third parties for collaborations, technology, manufacturing, and supply, with their performance largely outside the company's control and critical to clinical and commercial plans - The company's collaboration with GSK is subject to GSK's decisions on progressing targets, and GSK can terminate the agreement or specific programs with 60 days' notice[362](index=362&type=chunk)[363](index=363&type=chunk) - The collaboration with Universal Cells (Astellas) is critical for developing allogeneic 'off-the-shelf' therapies, but milestone payments and program progression are not guaranteed[368](index=368&type=chunk)[370](index=370&type=chunk) - The company relies on a limited number of third-party manufacturers for clinical trial supplies, exposing it to risks of supply disruption, quality issues, and regulatory compliance failures at these external sites[382](index=382&type=chunk)[383](index=383&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=141&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period [Defaults Upon Senior Securities](index=141&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities [Other Information](index=141&type=section&id=Item%205.%20Other%20Information) The company reported no other information [Exhibits](index=142&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and financial data in iXBRL format
Adaptimmune(ADAP) - 2020 Q2 - Earnings Call Transcript
2020-08-09 11:51
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q2 2020 Earnings Conference Call August 6, 2020 8:00 AM ET Company Participants Juli Miller - Senior Director, IR Adrian Rawcliffe - CEO Elliot Norry - Senior VP and Chief Medical Officer Helen Tayton-Martin - Co-Founder and Chief Business Officer John Lunger - Chief Patient Supply Officer Conference Call Participants Marc Frahm - Cowen and Company Tony Butler - ROTH Capital Mohit Bansal - Citigroup Kelsey Goodwin - Guggenheim Securities Nick Abbott - Wells Fargo S ...