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Adaptimmune(ADAP) - 2024 Q1 - Quarterly Report
2024-05-15 20:05
[PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q1 2024, reflecting a significant revenue decrease, increased net loss, and cash inflows from financing activities. [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2024, shows total assets decreased to **$258.0 million** from **$282.6 million** at year-end 2023, with total stockholders' equity declining to **$24.4 million**. Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $140,670 | $143,991 | | Total current assets | $186,903 | $207,552 | | Total assets | $258,010 | $282,616 | | **Liabilities & Equity** | | | | Total current liabilities | $66,411 | $72,788 | | Total liabilities | $233,635 | $243,103 | | Total stockholders' equity | $24,375 | $39,513 | | Total liabilities and stockholders' equity | $258,010 | $282,616 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2024, revenue significantly decreased to **$5.7 million** from **$47.6 million** in the prior-year period, resulting in a net loss of **$48.5 million** compared to a **$1.0 million** net profit in Q1 2023. Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Revenue | $5,678 | $47,601 | | Research and development | $(35,207) | $(25,548) | | General and administrative | $(19,732) | $(20,397) | | Operating (loss)/profit | $(49,261) | $1,656 | | Net (loss)/profit | $(48,503) | $1,036 | | Net (loss)/profit per share - Basic & Diluted | $(0.03) | $0.00 | [Unaudited Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$32.0 million** for Q1 2024, with financing activities providing **$29.2 million**, leading to a **$3.5 million** decrease in total cash, cash equivalents, and restricted cash. Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(31,950) | $(37,283) | | Net cash (used in)/provided by investing activities | $(358) | $48,341 | | Net cash provided by financing activities | $29,235 | $196 | | Net (decrease)/increase in cash | $(3,489) | $11,842 | | Cash, cash equivalents and restricted cash at end of period | $143,528 | $121,444 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed explanations of accounting policies, revenue recognition, the Genentech agreement termination, the TCR2 business combination, and the establishment of a new loan facility. - The collaboration and license agreement with Genentech was terminated in April 2024, with **$146.3 million** in deferred revenue expected to be recognized in the remainder of 2024[93](index=93&type=chunk)[115](index=115&type=chunk) - In Q1 2024, the company sold 27,278,176 ADSs under its At-The-Market (ATM) sales agreement, generating net proceeds of **$29.1 million**[76](index=76&type=chunk) - On May 14, 2024, the company entered into a loan and security agreement for a term loan facility of up to **$125.0 million**, with an initial tranche of **$25.0 million** drawn on the closing date[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity, the afami-cel BLA under FDA priority review, and financial results, attributing the significant revenue decline to a prior-year one-time recognition. [Overview](index=27&type=section&id=Overview) Adaptimmune is transitioning to a commercial-stage company, anticipating its first marketing approval for afami-cel in 2024, with a pipeline including lete-cel and uza-cel, and a preclinical focus on T-cell therapies. - The company's lead product, afami-cel, has a Biologics License Application (BLA) under priority review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of **August 4, 2024**[98](index=98&type=chunk) - Commercial launch preparations for afami-cel are underway, with plans to engage up to **30 authorized treatment centers** (ATCs), focusing on sarcoma centers of excellence[98](index=98&type=chunk) - The clinical pipeline includes lete-cel for synovial sarcoma and MRCLS, with plans for a U.S. commercial launch in 2026, and the SURPASS trials for uza-cel in ovarian and other cancers[97](index=97&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Q1 2024 revenue decreased by **88%** ($41.9 million) primarily due to a one-time recognition of **$42.4 million** from the terminated Astellas agreement in Q1 2023, while research and development expenses increased by **38%**. Comparison of Results of Operations (in thousands) | Line Item | Q1 2024 | Q1 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $5,678 | $47,601 | $(41,923) | (88)% | | Research and development expenses | $(35,207) | $(25,548) | $(9,659) | 38% | | General and administrative expenses | $(19,732) | $(20,397) | $665 | (3)% | | Operating (loss)/profit | $(49,261) | $1,656 | $(50,917) | (3,075)% | | Net (loss)/profit | $(48,503) | $1,036 | $(49,539) | (4,782)% | - The decrease in revenue was primarily due to the termination of the Astellas collaboration in Q1 2023, which resulted in the recognition of **$42.4 million** in deferred revenue during that period[137](index=137&type=chunk) - The **$9.7 million** increase in R&D expenses was mainly due to a **$5.9 million** rise in employee-related costs following the TCR2 acquisition and a **$0.9 million** increase in manufacturing facility expenditure[140](index=140&type=chunk)[141](index=141&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company had **$140.7 million** in cash and cash equivalents and **$143.7 million** in total liquidity, with management believing current funds and a new debt facility are sufficient to fund operations into late 2025. Total Liquidity (Non-GAAP, in thousands) | Component | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $140,670 | $143,991 | | Marketable securities | $2,982 | $2,947 | | **Total Liquidity** | **$143,652** | **$146,938** | - The company believes its cash runway extends into late 2025, supported by current liquidity, expected revenues from afami-cel, and a new debt facility with Hercules Capital[148](index=148&type=chunk) - Net cash used in operating activities decreased to **$32.0 million** in Q1 2024 from **$37.3 million** in Q1 2023, partly due to the receipt of **$30.8 million** in R&D credits[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports no material changes to its market risk exposure during Q1 2024, referring to the more detailed disclosures in its Annual Report on Form 10-K for the year ended December 31, 2023. - There have been no material changes to the Company's market risk during the first quarter of 2024[158](index=158&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2024, with no material changes to internal control over financial reporting. - Based on an evaluation as of March 31, 2024, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[159](index=159&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[160](index=160&type=chunk) [PART II — OTHER INFORMATION](index=45&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that as of March 31, 2024, it was not a party to any material legal proceedings. - As of March 31, 2024, the company was not involved in any material legal proceedings[161](index=161&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes from the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2023. - There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023[163](index=163&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=45&type=section&id=Other%20Items) This section covers other required disclosures, reporting no unregistered sales of equity securities, no defaults upon senior securities, no mine safety disclosures, and no Rule 10b5-1 trading plan changes by directors or officers. - Item 2: No unregistered sales of equity securities and use of proceeds were reported[163](index=163&type=chunk) - Item 5: No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter[165](index=165&type=chunk)
Adaptimmune(ADAP) - 2024 Q1 - Earnings Call Transcript
2024-05-15 14:07
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q1 2024 Earnings Conference Call May 15, 2024 8:00 AM ET Company Participants Juli Miller - Investor Relations Adrian Rawcliffe - Chief Executive Officer Gavin Wood - Chief Financial Officer Dennis Williams - Head of Late Stage Development Cintia Piccina - Chief Commercial Officer John Lunger - Chief Patient Supply Officer Elliot Norry - Chief Medical Officer Conference Call Participants Jonathan Chang - Leerink Partners Marc Frahm - TD Cowen Tony Butler - Rodman & ...
Adaptimmune(ADAP) - 2024 Q1 - Quarterly Results
2024-05-15 11:39
Exhibit 99.1 Adaptimmune Reports Q1 2024 Financial and Business Updates Afami-cel commercial and regulatory update presented at Company’s Investor Day (replay HERE); FDA review and inspections progressing with PDUFA date of August 4th, 2024 Commercial and manufacturing infrastructure in place to support afami-cel commercial launch upon approval Data from SPEARHEAD-1 pivotal trial with afami-cel published in The Lancet; data from a planned interim analysis of pivotal lete-cel IGNYTE-ESO trial to be presented ...
Garry Menzel joins GHO Capital as Operating Partner
Newsfilter· 2024-04-23 11:45
Garry Menzel joins GHO Capital as Operating Partner Former CEO of TCR² Therapeutics with significant investment and operating experience to support deal origination and provide best in class services to pioneering healthcare companies London, UK – 23 April 2024: Global Healthcare Opportunities, or GHO Capital Partners LLP ("GHO"), the European specialist investor in global healthcare, is pleased to announce the appointment of Dr. Garry Menzel as Operating Partner. Garry brings a unique blend of scientific, ...
Adaptimmune (ADAP) Down on End of Collaboration With Roche
Zacks Investment Research· 2024-04-15 19:16
Core Viewpoint - Adaptimmune Therapeutics plc's strategic collaboration with Roche's Genentech has been terminated, leading to a 10% drop in ADAP shares, indicating investor disappointment and a setback for the company [1][2]. Company Developments - The collaboration, initiated in 2021, aimed to develop allogeneic cell therapies for multiple oncology indications, including two components: allogeneic T-cell therapies for shared cancer targets and personalized allogeneic T-cell therapies [1]. - Adaptimmune received an upfront payment of $150 million and was entitled to additional payments of $150 million over five years, along with milestone payments exceeding $3 billion in total value [1]. - Despite the setback, management remains optimistic about the long-term potential of its iPSC-based allogeneic platform and is focused on launching afami-cel, its first product in the sarcoma franchise, pending FDA approval [2]. Product Pipeline - Afami-cel is intended for the treatment of advanced synovial sarcoma, with a target action date set by the FDA for August 4, 2024, and is expected to be the first engineered T-cell therapy for solid tumors to receive commercial approval in the U.S. [2]. - The second product in the sarcoma franchise, lete-cel, is currently being investigated in the IGNYTE-ESO study [2][3]. Market Context - Year-to-date, Adaptimmune shares have risen by 46.3%, contrasting with a 7.9% decline in the industry, reflecting a strong performance despite recent challenges [2]. - Roche continues to collaborate with Poseida Therapeutics on allogeneic CAR-T therapies targeting hematological malignancies, indicating ongoing interest in cell therapy development within the industry [4].
Adaptimmune(ADAP) - 2023 Q4 - Earnings Call Transcript
2024-03-06 14:29
Financial Data and Key Metrics Changes - The company completed a corporate restructuring and a merger with TCR Squared in 2023, marking a year of transformation [4] - The submission of the Biologics License Application (BLA) for Afamicel is a significant milestone, being the first BLA for an engineered cell therapy for a solid tumor indication [5] - The company estimates peak sales of up to $400 million for its sarcoma franchise, indicating substantial commercial potential [5][12] Business Line Data and Key Metrics Changes - Afamicel is positioned as the first product in the sarcoma franchise, with a focus on innovative cell therapy products in the solid tumor space [5] - Letecel has been recovered from GSK, with its pivotal trial having met its primary endpoint for efficacy [11] - The company anticipates infusing its first patients with Afamicel in Q4 2024, contingent on FDA approval [10] Market Data and Key Metrics Changes - The addressable patient population for the sarcoma franchise is estimated to be a little over 1,000 patients per year in the U.S. for synovial sarcoma and myxoid round cell liposarcoma [12] - The company plans to establish treatment centers across the U.S., starting with 6 to 10 centers and expanding to 30 within two years [36] Company Strategy and Development Direction - The company aims to transition into a fully integrated commercial stage company, focusing on discovering, developing, and delivering cell therapy products [6] - The launch preparedness for Afamicel includes a comprehensive infrastructure plan, with a sponsored testing plan and patient support systems [10] - The company is actively recruiting a commercial team to support the launch of Afamicel and Letecel [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial reality of cell therapy for solid tumors in 2024, with Afamicel and Iovance's Lifileucel as key products [29] - The company is focused on leveraging existing referral networks within the sarcoma community to maximize patient access to Afamicel [23] - Management highlighted the importance of the FDA's review process and the anticipated PDUFA date for Afamicel in August [7] Other Important Information - The company has bolstered its manufacturing team to meet the commercial demand for Afamicel, with in-house production capabilities [9] - The maximum internal manufacturing capacity is around 600 to 700 patients per year, sufficient to meet anticipated clinical and commercial needs [26] Q&A Session Summary Question: Can you walk us through the assumptions around the $400 million U.S. peak sales opportunity for the sarcoma franchise? - Management clarified that the $400 million figure pertains to U.S. sales for specific indications and is based on patient incidence and HLA restrictions [15][16] Question: Can you provide any additional color on the cash runway guidance? - The CFO detailed three sources of income, including payments from GSK and Genentech, projecting a cash runway exceeding $300 million [18][19] Question: How many patients can be expected to be reached in the initial treatment centers? - Management estimated that over 40% of total patients could be treated in the initial 6 to 10 centers, with plans to expand rapidly [22][23] Question: What are the implications of Iovance's TIL-based cell therapy approval? - Management expressed optimism that Iovance's approval would facilitate the commercial adoption of cell therapies, while noting the differences in their respective markets [29] Question: How is the company assessing the competitive landscape in PRAME? - The Chief Scientific Officer highlighted the competitive nature of the PRAME target but expressed confidence in their TCR's safety and efficacy profile [33]
Adaptimmune(ADAP) - 2023 Q4 - Annual Results
2024-03-05 16:00
Exhibit 99.1 Adaptimmune Reports Q4 /Full Year 2023 Financial Results and Business Updates U.S. FDA accepted BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024 Confirmatory evidence for afami-cel full approval agreed with FDA; will use data from Cohort 2 of pivotal SPEARHEAD-1 trial, which is fully enrolled Company is targeting launch of afami-cel upon receipt of FDA approval with commercial, manufacturing, and supply chain teams prepar ...
Adaptimmune(ADAP) - 2023 Q4 - Annual Report
2024-03-05 16:00
PART I [Business](index=5&type=section&id=Item%201.%20Business) Adaptimmune is a clinical-stage biopharmaceutical company transitioning to commercialization in 2024, focusing on engineered T-cell therapies for solid tumors with a lead product, afami-cel, under FDA review and a pipeline of clinical and preclinical assets [Overview and Strategy](index=5&type=section&id=Overview%20and%20Strategy) - Adaptimmune is transitioning to a commercial-stage cell therapy company in 2024, with its first product, afami-cel for synovial sarcoma, expecting marketing approval and launch[8](index=8&type=chunk) - The company filed a Biologics License Application (BLA) for afami-cel in December 2023, which was accepted by the FDA with a PDUFA target action date of August 4, 2024[11](index=11&type=chunk)[12](index=12&type=chunk) - On June 1, 2023, Adaptimmune combined with TCR² Therapeutics Inc. in an all-stock transaction, integrating TCR²'s operations and expanding its T-cell therapy pipeline[21](index=21&type=chunk) - Key business strategies include building a commercial franchise in sarcoma with afami-cel and lete-cel, progressing the SURPASS-3 Phase 2 trial for ovarian cancer, and advancing preclinical PRAME (ADP-600) and CD-70 (ADP-520) therapies into the clinic[22](index=22&type=chunk)[23](index=23&type=chunk) [Product Pipeline](index=12&type=section&id=Product%20Pipeline) Afami-cel (SPEARHEAD-1 Trial) Clinical Data | Metric | Value | Source Chunk | | :--- | :--- | :--- | | **Indication** | Synovial Sarcoma | 36 | | **Overall Response Rate (ORR)** | ~39% | 36 | | **Median Duration of Response** | ~50 weeks | 36 | | **2-Year Survival (Responders)** | 70% | 39 | | **Median Overall Survival (All Patients)** | ~17 months | 39 | Lete-cel (IGNYTE-ESO Trial) Interim Data | Metric | Value | Source Chunk | | :--- | :--- | :--- | | **Indications** | Synovial Sarcoma & MRCLS | 41 | | **Overall Response Rate (ORR)** | 40% (18/45 patients) | 42 | | **Median Duration of Response** | 10.6 months | 43 | | **First-Line Setting ORR (Sub-study 1)** | 80% (4/5 patients) | 14, 44 | ADP-A2M4CD8 (SURPASS Trial) Clinical Data | Metric | Value | Source Chunk | | :--- | :--- | :--- | | **Overall Response Rate (ORR)** | 35% (43 evaluable patients) | 46 | | **ORR in Ovarian, Urothelial, Head & Neck** | 50% | 46 | | **ORR in Ovarian Cancer (Phase 1)** | 40% (15 patients) | 48 | - The preclinical pipeline is focused on a T-cell therapy for the PRAME target (ADP-600) and a TRuC T-cell therapy for the CD70 target (ADP-520)[18](index=18&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk) - The company is developing an allogeneic iPSC platform to create 'off-the-shelf' cell therapies, which involves gene-editing iPSCs to express engineered TCRs and differentiating them into T-cells[54](index=54&type=chunk)[55](index=55&type=chunk) [Collaborations and Intellectual Property](index=22&type=section&id=Collaborations%20and%20Intellectual%20Property) - Adaptimmune has a strategic collaboration with Genentech to develop allogeneic T-cell therapies for up to five shared cancer targets and a personalized allogeneic platform. The agreement includes a **$150 million** upfront payment, up to **$150 million** in additional payments over five years, and significant potential milestones and royalties[60](index=60&type=chunk)[61](index=61&type=chunk) - Following the termination of a collaboration with GSK, Adaptimmune is transitioning the NY-ESO program (lete-cel) back in-house, with the full transition expected by mid-2024. The agreement includes milestone-based payments to Adaptimmune totaling **£30 million**[19](index=19&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) - The company holds multiple patent families covering its key products. The afami-cel (ADP-A2M4) composition of matter patents are expected to expire in 2037, while the lete-cel (NY-ESO) patents expire in 2025, with next-generation patents extending to 2043[66](index=66&type=chunk)[67](index=67&type=chunk) [Competition and Regulation](index=27&type=section&id=Competition%20and%20Regulation) - The company faces intense competition from large pharmaceutical companies and other biotech firms in areas including other autologous cell therapies (CAR-T, TIL), other TCR T-cell therapies (e.g., Immatics), different cell-based immunotherapies (NK-cells, dendritic cells), and allogeneic approaches[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - The company's products are subject to extensive government regulation in the U.S. by the FDA and in other jurisdictions like the EU and U.K. The approval process involves preclinical studies, an Investigational New Drug (IND) application, and adequate and well-controlled clinical trials to establish safety and effectiveness before a Biologics License Application (BLA) can be approved[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - Adaptimmune has received several expedited program designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) for afami-cel and ADP-A2M4CD8, and Orphan Drug designation for afami-cel, which provides benefits like a seven-year marketing exclusivity period in the U.S. for the designated indication[39](index=39&type=chunk)[100](index=100&type=chunk)[105](index=105&type=chunk) - Commercial success is dependent on pricing and reimbursement from third-party payors, including government programs like Medicare and Medicaid. The company will be subject to regulations such as the Medicaid Drug Rebate program and pricing pressures from the Inflation Reduction Act (IRA)[129](index=129&type=chunk)[130](index=130&type=chunk)[134](index=134&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including historical net losses, the need for further financing, dependence on regulatory approval and market acceptance of its lead products, complex manufacturing, and intense competition [Risks Related to Financial Condition and Capital Requirements](index=57&type=section&id=Risks%20Related%20to%20Financial%20Condition%20and%20Capital%20Requirements) - The company has incurred net losses every year since its 2008 inception, with an accumulated deficit of **$1,023.1 million** as of December 31, 2023, and expects to continue incurring losses[174](index=174&type=chunk)[175](index=175&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$146.9 million** (as of Dec 31, 2023) are expected to fund operations into early 2026, but additional financing will be required to complete development and commercialization[182](index=182&type=chunk) - The company benefits from the U.K. R&D tax credit regime, but changes to the rules or the company no longer qualifying as an SME could reduce future cash rebates and increase funding needs[187](index=187&type=chunk)[188](index=188&type=chunk) [Risks Related to Commercialization and Marketing](index=64&type=section&id=Risks%20Related%20to%20Commercialization%20and%20Marketing) - The company is heavily dependent on the successful commercialization of afami-cel and lete-cel, which requires FDA approval and sufficient market uptake. There is no guarantee of approval or that it will occur on the anticipated Q3 2024 timeline for afami-cel[193](index=193&type=chunk)[194](index=194&type=chunk) - As an organization, Adaptimmune has no experience in marketing or supplying commercial products and must transition from an R&D focus to a company capable of supporting commercial activities, which presents significant challenges[216](index=216&type=chunk)[217](index=217&type=chunk) - Successful sales depend on obtaining coverage and adequate reimbursement from third-party payors like Medicare, Medicaid, and private insurers, which is a time-consuming and uncertain process[226](index=226&type=chunk)[228](index=228&type=chunk) - Commercialization requires regulatory approval of a companion diagnostic to screen patients for MAGE-A4 and HLA-type. The company relies on a third party for this development, and any delays could impact the product launch[206](index=206&type=chunk)[209](index=209&type=chunk)[212](index=212&type=chunk) [Risks Related to Clinical Development](index=79&type=section&id=Risks%20Related%20to%20Clinical%20Development) - The company's ability to secure additional financing is heavily reliant on positive data from ongoing clinical trials, particularly the ADP-A2M4CD8 (SURPASS) trials. Negative results could hinder funding and delay all programs[237](index=237&type=chunk) - T-cell therapy is a novel approach with significant risks of side effects, including cytokine release syndrome (CRS), neurotoxicity, and pancytopenia. Unacceptable toxicities could lead to the suspension or termination of clinical programs[247](index=247&type=chunk)[248](index=248&type=chunk)[250](index=250&type=chunk) - Clinical trials may face substantial delays due to difficulties in patient recruitment, as patients must have the specific HLA-type and antigen expression, and competition for patients at clinical sites[262](index=262&type=chunk)[263](index=263&type=chunk) [Risks Related to Manufacturing and Supply](index=96&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Supply) - The manufacturing process for autologous cell therapies is complex, patient-specific, and costly. Delays or failures can result from process errors, sterility failures, or variability in patient starting material, potentially preventing a patient from receiving treatment[291](index=291&type=chunk)[292](index=292&type=chunk)[293](index=293&type=chunk) - The company's Navy Yard facility is the sole source of supply for afami-cel and ADP-A2M4CD8. Any shutdown due to contamination or other issues would halt supply for clinical trials and commercial launch[293](index=293&type=chunk) - The company relies on third parties for critical components, such as the lentiviral vector for afami-cel and lete-cel, and for the manufacture of the lete-cel cell therapy itself. It also has a sole-source supplier (ThermoFisher) for the Dynabeads® technology used in its process[168](index=168&type=chunk)[371](index=371&type=chunk) [Unresolved Staff Comments](index=136&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[434](index=434&type=chunk) [Cybersecurity](index=136&type=section&id=Item%201C.%20Cybersecurity) The company integrates cybersecurity into its overall risk management, overseen by the Audit Committee, and has not identified any material threats to date - The company's cybersecurity policies and processes are integrated into its overall risk management program, which is overseen by the Audit Committee of the board of directors[433](index=433&type=chunk)[438](index=438&type=chunk) - The company has not identified any cybersecurity threats that have materially affected its ability to conduct business or its financial standing[437](index=437&type=chunk) [Properties](index=138&type=section&id=Item%202.%20Properties) As of December 31, 2023, the company leases four primary facilities in the UK and US for corporate, R&D, and manufacturing, deemed adequate for near-term needs Leased Facilities Summary (as of Dec 31, 2023) | Location | Approx. Square Feet | Primary Usage | Lease Expiration | | :--- | :--- | :--- | :--- | | Abingdon, UK | 67,140 | Corp. HQ, R&D, Manufacturing, Admin | Oct 2041 | | Abingdon, UK | 46,017 | Manufacturing, Process Dev, Research | Oct 2041 | | Philadelphia, PA | 47,700 | Manufacturing, Process Dev, Research | Oct 2031 | | Cambridge, MA | 22,890 | R&D, Process Development | Jun 2025 | [Legal Proceedings](index=139&type=section&id=Item%203.%20Legal%20Proceedings) As of December 31, 2023, the company was not a party to any material legal proceedings - As of December 31, 2023, we were not a party to any material legal proceedings[442](index=442&type=chunk) [Mine Safety Disclosures](index=139&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[442](index=442&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=139&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's ADSs trade on Nasdaq under 'ADAP', with no unregistered securities sold or equity repurchases made in 2023 - The company's ADSs trade on The Nasdaq Global Select Market under the symbol "ADAP". Each ADS represents six ordinary shares[442](index=442&type=chunk) - As of March 4, 2024, there were approximately 27 holders of record of ordinary shares and 16 holders of record of ADSs. The closing price per ADS on December 31, 2023 was **$0.793**[442](index=442&type=chunk) - The company did not repurchase any of its equity securities during the year ended December 31, 2023[443](index=443&type=chunk) [Reserved](index=140&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=140&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2023, the company reported increased revenue of **$60.3 million** and a reduced net loss of **$113.9 million**, ending the year with **$146.9 million** in liquidity expected to fund operations into early 2026 [Results of Operations](index=153&type=section&id=Results%20of%20Operations) Comparison of Years Ended December 31, 2023 and 2022 (in thousands) | Line Item | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $60,281 | $27,148 | $33,133 | 122% | | **Research and development expenses** | ($126,509) | ($127,726) | $1,217 | (1)% | | **General and administrative expenses** | ($73,513) | ($63,387) | ($10,126) | 16% | | **Operating loss** | ($139,741) | ($163,965) | $24,224 | (15)% | | **Gain on bargain purchase** | $22,049 | $0 | $22,049 | N/A | | **Loss for the period** | ($113,871) | ($165,456) | $51,585 | (31)% | - Revenue increased by **$33.1 million** in 2023 primarily due to the termination of the Astellas collaboration, which resulted in the recognition of remaining deferred income[488](index=488&type=chunk) - R&D expenses decreased slightly by **$1.2 million** in 2023, mainly due to a **$14.7 million** decrease in R&D tax credits receivable and lower subcontracted expenditures, offset by costs from the TCR² acquisition[489](index=489&type=chunk)[491](index=491&type=chunk)[493](index=493&type=chunk) - G&A expenses increased by **$10.1 million** in 2023, largely due to higher corporate costs, including legal and professional fees related to the TCR² merger, and severance costs for former TCR² leadership[495](index=495&type=chunk)[496](index=496&type=chunk)[498](index=498&type=chunk) [Liquidity and Capital Resources](index=162&type=section&id=Liquidity%20and%20Capital%20Resources) Total Liquidity (Non-GAAP, in thousands) | Component | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $143,991 | $108,033 | | Marketable securities | $2,947 | $96,572 | | **Total Liquidity** | **$146,938** | **$204,605** | - The company believes its total liquidity of **$146.9 million** as of December 31, 2023, is sufficient to fund operations into early 2026[517](index=517&type=chunk) - Net cash used in operating activities was **$140.9 million** for 2023, a slight decrease from **$141.8 million** in 2022, reflecting lower operating expenditure from restructuring, offset by costs from the TCR² acquisition and lower R&D tax credit receipts during the year[518](index=518&type=chunk)[519](index=519&type=chunk) - As of December 31, 2023, the company had material cash requirements including **$25.2 million** in operating lease obligations and **$13.7 million** in non-cancellable purchase commitments for clinical materials and contract manufacturing[536](index=536&type=chunk)[537](index=537&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=177&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks include interest rate, foreign currency (GBP/USD), and credit risk, managed through diversified holdings without hedging, with no material inflation impact in 2023 - The company is exposed to foreign currency risk, particularly between the pound sterling and the U.S. dollar, as its U.K. subsidiary incurs significant costs in U.S. dollars[561](index=561&type=chunk)[563](index=563&type=chunk) - Credit risk is managed by holding cash with multiple banks and adhering to an investment policy that limits investments to certain types of instruments and specifies minimum credit ratings[565](index=565&type=chunk) - The company does not believe an immediate one percentage point change in interest rates would materially affect its portfolio's fair market value or operating results[562](index=562&type=chunk) [Financial Statements and Supplementary Data](index=179&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section lists consolidated financial statements and an index of exhibits, noting the omission of financial statement schedules [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=179&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[568](index=568&type=chunk) [Controls and Procedures](index=179&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes reported - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[568](index=568&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[571](index=571&type=chunk) [Other Information](index=181&type=section&id=Item%209B.%20Other%20Information) The company reports that during the fourth quarter of 2023, none of its directors or officers adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement - During the three-month period ended December 31, 2023, none of our directors or officers adopted, modified or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement"[573](index=573&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=181&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[574](index=574&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=181&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The information required for this item, concerning directors, executive officers, and corporate governance, is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Shareholders [Executive Compensation](index=182&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item, concerning executive compensation, is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Shareholders [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=182&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item, concerning security ownership, is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Shareholders [Certain Relationships and Related Transactions, and Director Independence](index=182&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item, concerning related transactions and director independence, is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Shareholders [Principal Accountant Fees and Services](index=182&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The information required for this item, concerning principal accountant fees and services, is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Shareholders PART IV [Exhibits and Financial Statement Schedules](index=182&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists consolidated financial statements and an index of exhibits, noting the omission of financial statement schedules [Form 10-K Summary](index=191&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary - None[592](index=592&type=chunk)
Adaptimmune (ADAP) Surges More Than 80% in a Month: Here's Why
Zacks Investment Research· 2024-01-16 17:47
Adaptimmune Therapeutics (ADAP) is a clinical-stage biopharmaceutical company focused on developing novel T-cell therapies targeting cancer indications.The most advanced candidate in the company’s pipeline is afamitresgene autoleucel (or afami-cel), an engineered T-cell therapy for advanced synovial sarcoma, a malignant tumor that affects the tissue around the joints.Since the past month, shares of Adaptimmunehave soared 83.1% compared with the industry’s 7.0% rise. The upside can be attributed to the compl ...
Adaptimmune(ADAP) - 2023 Q3 - Earnings Call Transcript
2023-11-08 16:45
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q3 2023 Earnings Conference Call November 8, 2023 8:00 AM ET Company Participants Juli Miller – Investor Relations Adrian Rawcliffe – Chief Executive Officer Dennis Williams – Senior Vice President-Late Stage Development Elliot Norry – Chief Medical Officer Jo Brewer – Chief Scientific Officer Gavin Wood – Chief Financial Officer Conference Call Participants Jerry Gong – Mizuho Securities Marc Frahm – TD Cowen Dylan Drakes – Leerink Partners Yanan Zhu – Wells Fargo ...