Adaptimmune(ADAP)
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Adaptimmune(ADAP) - 2024 Q2 - Quarterly Report
2024-08-12 11:23
Drug Approvals and Clinical Trials - Tecelra received FDA approval on August 1, 2024, for the treatment of advanced synovial sarcoma, showing an overall response rate (ORR) of 43% in a trial with 44 patients[115] - The median duration of response for Tecelra was 6 months, with 39% of responsive patients maintaining a response for 12 months or longer[115] - Lete-cel, targeting the NY-ESO antigen, reported an ORR of 40% in the IGNYTE-ESO trial, with a median duration of response of approximately 11 months[116] - The company is focusing on developing T-cell therapies directed to PRAME and CD70, with preclinical testing ongoing for ADP-600 and ADP-520[119] Financial Performance - Revenue increased by $123.1 million to $128.2 million for the three months ended June 30, 2024, compared to $5.1 million for the same period in 2023, primarily due to the termination of the Genentech collaboration[161] - The company reported a profit of $69.5 million for the period ended June 30, 2024, compared to a loss of $21.4 million in the same period in 2023, marking a 425% improvement[160] - Revenue increased by $81.2 million to $133.9 million for the six months ended June 30, 2024, primarily due to the termination of the Genentech collaboration, resulting in a cumulative catch-up adjustment of $101.3 million[175] - Operating loss for the six months ended June 30, 2024, was $19.4 million, a significant improvement compared to an operating loss of $43.3 million for the same period in 2023[174] Research and Development Expenses - Research and development expenses rose by 35% to $40.4 million for the three months ended June 30, 2024, compared to $30.0 million in the same period in 2023[160] - Research and development expenses for the six months ended June 30, 2024, increased by 36% to $75.7 million from $55.5 million in the same period in 2023[177] - The net increase in research and development expenses for the six months ended June 30, 2024, was primarily driven by a $9.4 million increase in salaries and related costs due to the acquisition of TCR2[179] - Subcontracted costs for the three months ended June 30, 2024, were $14.0 million, compared to $9.5 million in the same period of 2023, including $9.7 million directly associated with afami-cel, lete-cel, and uza-cel T-cells[167] Collaborations and Agreements - A clinical collaboration agreement with Galapagos NV includes an upfront payment of $70 million and potential milestone payments of up to $465 million for the TCR T-cell therapy candidate uza-cel[123] - The company expects to receive initial payments of $100 million from the Galapagos collaboration, including $70 million upfront and $30 million for research and development funding[138] - The company will recognize revenue from the Galapagos collaboration based on the percentage of completion of the proof-of-concept trial[139] - The company received an upfront payment of £7.5 million from Adaptimmune as part of the GSK Termination and Transfer Agreement[135] Cash Flow and Liquidity - The company had cash and cash equivalents of $211.8 million and Total Liquidity of $214.8 million as of June 30, 2024[187] - Net cash provided by operating activities was $15.4 million for the six months ended June 30, 2024, compared to a net cash used of $81.0 million for the same period in 2023[189] - The increase in net cash provided by operating activities was primarily due to $30.8 million in research and development credits, an $85 million upfront payment from Galapagos, and a $7.7 million milestone payment from GSK[189] - Net cash provided by financing activities was $53.7 million for the six months ended June 30, 2024, compared to $0.2 million for the same period in 2023[192] Tax and Corporate Costs - The U.K. corporation tax rate is 25% for the year ended December 31, 2024, impacting the company's tax strategy[152] - The company benefits from the U.K. SME R&D Tax Credit Scheme, allowing for a payable tax credit of up to approximately 18.6% of eligible R&D expenditures[142] - Income tax expense for the period was $1.0 million, reflecting taxable profits generated by Adaptimmune LLC in the United States[172] - The company experienced an increase of $1.8 million in other corporate costs due to higher accounting, legal, and professional fees[186] Strategic Changes and Collaborations - The termination of the Astellas Collaboration Agreement resulted in a contract modification with a transaction price of $42.4 million recognized in March 2023[130] - The termination of the Genentech collaboration led to a cumulative catch-up adjustment of $101.3 million due to the loss of future payments[134] - The gain on bargain purchase from the strategic combination with TCR2 Therapeutics Inc. occurred in June 2023[171] General and Administrative Expenses - General and administrative expenses decreased by 5% to $19.1 million for the three months ended June 30, 2024, down from $20.1 million in the same period in 2023[168] - General and administrative expenses for the six months ended June 30, 2024, decreased by 4% to $38.8 million from $40.5 million in the same period in 2023[182]
Adaptimmune(ADAP) - 2024 Q2 - Quarterly Results
2024-08-12 11:05
[Key Highlights](index=1&type=section&id=Key%20Highlights) Adaptimmune secured FDA accelerated approval for Tecelra®, its first solid tumor cell therapy, and reported **$214.8 million** liquidity at Q2 2024 end - Received U.S. FDA accelerated approval for Tecelra® (afami-cel), the first approved engineered T-cell therapy for a solid tumor[1](index=1&type=chunk) - The company is prepared for commercial launch, with biomarker testing available and systems ready to receive orders for Tecelra®[1](index=1&type=chunk)[2](index=2&type=chunk) Liquidity Position | Metric | Amount | As of | | :--- | :--- | :--- | | Total Liquidity | $214.8 million | End of Q2 2024 | [Business and Pipeline Updates](index=1&type=section&id=Business%20and%20Pipeline%20Updates) The company focuses on commercializing its Tecelra®-led sarcoma franchise and advancing clinical and preclinical pipelines via strategic collaborations and financing [Sarcoma Franchise (Tecelra® and lete-cel)](index=1&type=section&id=Sarcoma%20Franchise%20(Tecelra%C2%AE%20and%20lete-cel)) FDA-approved Tecelra® is launching commercially for sarcoma, with a lete-cel BLA planned for 2025, targeting **$400 million** peak U.S. sales for the franchise - Tecelra® is the first engineered cell therapy approved for solid tumors and the first new treatment for synovial sarcoma in over a decade[2](index=2&type=chunk) Tecelra® SPEARHEAD-1 Trial Efficacy | Metric | Result | | :--- | :--- | | Overall Response Rate (ORR) | 43% | | Complete Response Rate | 4.5% | | Median Duration of Response | 6 months | | Patients with ≥12 month response | 39.0% | - Based on successful IGNYTE-ESO trial results (**40% ORR**), Adaptimmune plans to initiate a rolling Biologics License Application (BLA) for lete-cel in 2025 for MRCLS and synovial sarcoma[3](index=3&type=chunk) [Clinical Pipeline](index=3&type=section&id=Clinical%20pipeline) The clinical pipeline advances with a Galapagos collaboration for uza-cel in head & neck cancer, ongoing SURPASS-3 enrollment for ovarian cancer, and SURPASS Phase 1 trial conclusion - Entered a clinical collaboration with Galapagos to evaluate uza-cel in head & neck cancer using Galapagos' decentralized manufacturing platform[3](index=3&type=chunk) - The SURPASS-3 Phase 2 trial investigating uza-cel for platinum-resistant ovarian cancer is currently enrolling patients[3](index=3&type=chunk) - Enrollment for the SURPASS Phase 1 trial will cease shortly as screening has stopped[3](index=3&type=chunk) [Preclinical Pipeline](index=3&type=section&id=Preclinical%20pipeline) The wholly-owned allogeneic pipeline progresses with process optimization, advancing ADP-600 (PRAME) and ADP-520 (CD70) programs toward IND-enabling activities - The wholly-owned allogeneic pipeline is progressing with continued process optimization[4](index=4&type=chunk) - IND-enabling activities are ongoing for the ADP-600 (PRAME) and ADP-520 (CD70) programs[4](index=4&type=chunk) [Corporate Updates](index=3&type=section&id=Business%20and%20corporate%20updates) Adaptimmune secured **$100 million** from a Galapagos collaboration and a **$125 million** loan facility with Hercules Capital, enhancing financial flexibility for commercial launch and pipeline development - Under the Galapagos agreement, Adaptimmune will receive **$100 million** in initial payments (**$70M** upfront, **$30M** R&D funding), with potential for up to **$465 million** in milestones plus royalties[5](index=5&type=chunk) - Entered into a loan and security agreement with Hercules Capital for up to **$125.0 million**. Following Tecelra's FDA approval, the company is eligible to draw down a **$25.0 million** tranche[5](index=5&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) Adaptimmune reported a significant Q2 2024 revenue increase to **$128.2 million** and a **$69.5 million** net profit, driven by terminated collaboration revenue, ending the quarter with **$214.8 million** liquidity [Financial Performance Summary (Q2 2024)](index=4&type=section&id=Financial%20Performance%20Summary%20(Q2%202024)) Q2 2024 revenue significantly increased to **$128.2 million** (from **$5.1 million**), driven by a **$101.3 million** Genentech adjustment, resulting in a **$69.5 million** net profit (vs. **$21.3 million** net loss in Q2 2023), with R&D expenses rising to **$40.4 million** Q2 Financial Performance (Three Months Ended June 30, in millions, except per share data) | Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | $128.2M | $5.1M | +2414% | | R&D Expenses | $40.4M | $30.0M | +34.7% | | G&A Expenses | $19.1M | $20.1M | -5.0% | | Net Profit/(Loss) | $69.5M | $(21.3)M | Profit vs Loss | | EPS (Diluted) | $0.04 | $(0.02) | Profit vs Loss | - The significant increase in revenue in 2024 is primarily due to recognizing the majority of remaining deferred income from the terminated Genentech collaboration, including a **$101.3 million** cumulative catch-up adjustment[7](index=7&type=chunk) - R&D expenses increased due to a higher number of employees, increased subcontracted expenditures, and in-process R&D costs[7](index=7&type=chunk) [Financial Position and Liquidity](index=4&type=section&id=Financial%20Position%20and%20Liquidity) As of June 30, 2024, Adaptimmune's total liquidity stood at **$214.8 million**, a notable increase from **$146.9 million** at the end of 2023. This non-GAAP measure, comprising cash, cash equivalents, and marketable securities, reflects the company's enhanced capital position to support its operational and commercial activities Total Liquidity (in thousands) | Component | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $211,810 | $143,991 | | Marketable securities | $2,979 | $2,947 | | **Total Liquidity** | **$214,789** | **$146,938** | [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Statement of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $128,231 | $133,909 | | Total operating expenses | $(59,531) | $(114,470) | | Operating profit/(loss) | $68,700 | $19,439 | | Net profit/(loss) | $69,521 | $21,018 | | Net profit/(loss) per share (Diluted) | $0.04 | $0.01 | [Balance Sheet](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (in thousands) | Metric | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $211,810 | $143,991 | | Total current assets | $253,770 | $207,552 | | **Total assets** | **$321,702** | **$282,616** | | Total current liabilities | $82,073 | $72,788 | | **Total liabilities** | **$225,428** | **$243,103** | | **Total stockholders' equity** | **$96,274** | **$39,513** | [Cash Flow Statement](index=9&type=section&id=Condensed%20Consolidated%20Cash%20Flow%20Statement) Cash Flow Highlights (Six Months Ended June 30, in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by/(used in) operating activities | $15,449 | $(81,045) | | Net cash (used in)/provided by investing activities | $(1,101) | $51,035 | | Net cash provided by financing activities | $53,747 | $210 | | **Net increase/(decrease) in cash** | **$67,659** | **$(29,402)** |
Adaptimmune Reports Q2 2024 Financial and Business Updates
Newsfile· 2024-08-12 11:00
Core Insights - Adaptimmune received U.S. FDA accelerated approval for Tecelra® (afami-cel), marking it as the first engineered cell therapy approved for solid tumors, specifically for advanced MAGE-A4+ synovial sarcoma in adults [2][3] - The company reported significant financial growth, with Q2 2024 revenue reaching $128.2 million, a substantial increase from $5.1 million in Q2 2023, primarily due to the recognition of deferred income from a terminated collaboration with Genentech [8][11] - Adaptimmune plans to expand its sarcoma franchise with a rolling Biologics License Application (BLA) submission for lete-cel in 2025 and a commercial launch anticipated in 2026, projecting peak U.S. sales of $400 million for the sarcoma franchise [2][3] Company Updates - Tecelra® is expected to be available in 6-10 U.S. authorized treatment centers shortly, allowing patients to begin their treatment journey [2][3] - The approval of Tecelra® was based on the SPEARHEAD-1 trial, which demonstrated an overall response rate (ORR) of 43% and a median duration of response of 6 months [3] - Adaptimmune has entered a clinical collaboration with Galapagos to evaluate uza-cel for head and neck cancer, further diversifying its clinical pipeline [4] Financial Performance - As of June 30, 2024, Adaptimmune reported total liquidity of $214.8 million, up from $146.9 million at the end of 2023 [8][10] - The company recorded a net profit of $69.5 million for Q2 2024, compared to a loss of $21.3 million in Q2 2023, indicating a significant turnaround in financial performance [8][11] - Research and development expenses increased to $40.4 million for Q2 2024, reflecting the company's investment in expanding its clinical programs [8][11] Future Outlook - Adaptimmune is set to initiate a rolling BLA submission for lete-cel in 2025, targeting advanced or metastatic myxoid/round cell liposarcoma and synovial sarcoma [3] - The company anticipates that its sarcoma franchise will redefine treatment options in advanced soft tissue sarcoma, with a projected peak sales potential of $400 million in the U.S. [2][3] - The ongoing SURPASS-3 Phase 2 trial for uza-cel in platinum-resistant ovarian cancer is currently enrolling patients, showcasing the company's commitment to addressing unmet medical needs [5]
Adaptimmune to Report Q2 2024 Financial and Business Updates on Monday, August 12, 2024
Newsfile· 2024-08-05 12:00
Core Insights - Adaptimmune Therapeutics plc is set to report its financial results and business updates for Q2 2024 on August 12, 2024, before US markets open [2] - The company specializes in cell therapies aimed at treating solid tumor cancers, utilizing a unique engineered T-cell receptor (TCR) platform [3] Financial Reporting - The financial results will cover the second quarter ended June 30, 2024, and will be announced before the market opens on August 12, 2024 [2] - A live webcast will follow the announcement at 8:00 a.m. EDT, providing an opportunity for stakeholders to engage with the company [2] Company Overview - Adaptimmune is a clinical-stage biopharmaceutical company focused on developing cell therapies to improve cancer treatment outcomes [3] - The company's TCR platform is designed to engineer T-cells that specifically target and destroy various solid tumor types [3]
ADAP: Initiating Coverage of Adaptimmune, a Leading T-Cell Therapy Company
Benzinga· 2024-06-17 18:05
Core Viewpoint - Adaptimmune Therapeutics plc is positioned for significant growth with a 12-month price target of $3.00, driven by its innovative T-cell receptor (TCR) platform aimed at treating various solid tumor cancers [1][8]. Group 1: Unique T-cell Therapy - Adaptimmune's mission is to revolutionize cancer treatment by engineering TCRs to recognize specific cancer biomarkers, enhancing the immune response to target cancer cells while sparing healthy cells [1][5]. - The company has developed a proprietary technology platform over 15 years that allows for the genetic engineering of TCRs from a patient's own T-cells (autologous) or from stem cells (allogeneic) [1][5]. Group 2: Commercialization Inflection Point - The anticipated launch of afami-cel, pending FDA approval, signifies Adaptimmune's transition from a clinical-stage to a commercial-stage company [3][4]. - The FDA has accepted the Biologics License Application (BLA) for afami-cel, with a Prescription Drug User Fee Act (PDUFA) date set for August 4, 2024, and plans for an initial launch at six to ten Authorized Treatment Centers (ATCs) [4][6]. Group 3: Robust Product Pipeline - Adaptimmune has a diversified pipeline that includes late-stage programs and a deep preclinical pipeline for various autologous and allogeneic cell therapies targeting multiple cancer types [5][6]. - Collaborations with cancer centers of excellence are in place to advance clinical and preclinical studies for T-cell therapies across various indications [5][6]. Group 4: Economic Opportunity - While net losses are expected in the near term, the ramp-up of afami-cel sales post-FDA approval is crucial for future profitability, with projected gross sales of approximately $80 million in 2025 and peak sales of $400 million for the sarcoma franchise [6][7]. - Adaptimmune's current liquidity and funding arrangements, including a $125 million term loan facility and a $200 million at-the-market facility, are expected to support operations into late 2025 [7]. Group 5: Valuation Insights - A probability-weighted DCF model indicates significant upside potential for Adaptimmune's stock, based on three late-stage clinical programs and a near-term eligible patient population of approximately 4,600 per year [8].
Galapagos and Adaptimmune sign clinical collaboration agreement with an option to exclusively license Adaptimmune's TCR T-cell therapy candidate, uza-cel, in head & neck cancer and potential future solid tumor indications
Newsfilter· 2024-05-30 20:01
Core Insights - Adaptimmune and Galapagos have entered a clinical collaboration agreement to evaluate the safety and efficacy of uza-cel, a next-generation TCR T-cell therapy targeting MAGE-A4 in head & neck cancer [1][3] - Uza-cel has shown an overall response rate of 80% in a Phase 1 trial, with partial responses in four out of five patients [2][3] - Galapagos will utilize its decentralized manufacturing platform to produce uza-cel, which may enhance the efficacy and durability of the treatment [2][6] Financial Terms - Adaptimmune will receive an initial payment of $100 million, including $70 million upfront and $30 million for R&D funding [1][5] - Additional payments could reach up to $465 million in development and sales milestones, along with tiered royalties on net sales [1][5] - Galapagos has the option to exclusively license uza-cel for global development and commercialization, with a maximum option fee of $100 million [1][4] Manufacturing and Development - Galapagos' decentralized manufacturing platform allows for a median vein-to-vein time of seven days, facilitating rapid access to treatment for patients [2][6] - Adaptimmune will manage the clinical proof-of-concept trial and supply the vector for manufacturing, while Galapagos will deliver the fresh product [3][4] Strategic Vision - The partnership aligns with Galapagos' strategic vision to advance novel cell therapies and expand its oncology portfolio [3] - Adaptimmune aims to leverage the collaboration to enhance the effectiveness of its TCR T-cell therapy for patients with late-stage cancers [3][4]
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, ...