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ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress
Prnewswire· 2025-06-12 10:30
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b trial, showing a 93.3% overall response rate (ORR) and an 86.7% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with ZYNLONTA® and glofitamab [1][3][4] Efficacy Data - Among 30 efficacy evaluable patients, 28 achieved an overall response, with 26 achieving complete responses [3] - 25 out of 26 patients who achieved CR remained in CR at the data cut-off [1][3] - Median time to CR was 80 days for the 120 µg/kg dose and 42 days for the 150 µg/kg dose [3] - 12 patients converted from stable disease or partial response to CR over time [3] - Of 6 patients previously treated with CAR-T, 5 achieved CR [3] Safety Profile - The combination treatment was generally well tolerated, with no dose-limiting toxicities (DLTs) reported [3] - Among 41 safety evaluable patients, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (24.4%), anemia (9.8%), and increased liver enzymes [3] - Cytokine release syndrome (CRS) was observed in 23.8% of patients at the 150 µg/kg dose, all Grade 1, while 55% experienced CRS at the 120 µg/kg dose [3] Study Expansion - The company is expanding enrollment for the LOTIS-7 trial to 100 patients at the 150 µg/kg dose of ZYNLONTA [1][4] - The updated data will be presented at the European Hematology Association 2025 Congress and the 18th International Conference on Malignant Lymphoma [4] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy [9][13] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
ADC Therapeutics (ADCT) 2025 Conference Transcript
2025-05-21 15:30
Summary of ADC Therapeutics Conference Call Company Overview - ADC Therapeutics is an antibody drug conjugate company with capabilities from research to commercialization, focusing on two main pillars: ZIMMANTA and an early-stage solid tumor pipeline targeting PSMA and Claudine six [3][4] Market Performance and Strategy - ZIMMANTA is approved as a monotherapy in the third line plus setting for DLBCL, capturing approximately 10% market share, which translates to 25% of the broadly accessible therapies segment [7][8] - The market for DLBCL therapies is segmented into complex therapies (60% market share) and broadly accessible therapies (40% market share) [6][7] - ADC Therapeutics aims to expand ZIMMANTA's use into earlier lines of therapy, with ongoing studies showing promising results [14][19] Clinical Data and Studies - The LOTUS five study, combining ZIMMANTA with rituximab, has shown a 50% complete response (CR) rate in early safety run-in data, with expectations for top-line results by early next year [14][24] - The LOTUS seven study, combining ZIMMANTA with glafitamab, reported an overall response rate of over 95% and a CR rate of 91% in the first 22 evaluable patients [15][19] - The company plans to engage with the FDA regarding the LOTUS studies and potential phase three designs in the second half of the year [20][27] Financial Projections - The potential market opportunity for ZIMMANTA in the second line setting is estimated at $200 million to $300 million, with a total opportunity (including LOTUS five and current indications) projected to reach $500 million to $800 million [25][27] - The company reported a cash position of $196 million, providing a runway until the second half of 2026, with a quarterly cash burn of $30 million to $35 million [39][41] Expansion Opportunities - ADC Therapeutics is exploring additional indications in indolent lymphomas, with promising data from ASH showing a 77% CR rate in high-risk follicular lymphoma patients [29][30] - The marginal zone lymphoma (MZL) opportunity is estimated at $500 million in peak sales, with a 70% CR rate observed in early studies [31][32] Future Outlook - The company anticipates significant data releases and derisking events in the coming months, setting the stage for a growth trajectory starting in early 2027 [27][49] - ADC Therapeutics is open to partnerships for advancing solid tumor assets, emphasizing the need for collaboration to unlock value [43][44]
ADC Therapeutics(ADCT) - 2025 Q1 - Quarterly Report
2025-05-14 20:07
Revenue Performance - Product revenues, net, were $17.4 million for the three months ended March 31, 2025, compared to $17.8 million for the same period in 2024, a decrease of $0.4 million, or 2.5%[98] - License revenues and royalties increased to $5.6 million for the three months ended March 31, 2025, from $0.2 million in the same period in 2024, an increase of $5.4 million[100] - Total revenue, net, for the three months ended March 31, 2025, was $23.0 million, up from $18.1 million in 2024, representing a 27.6% increase[96] Expenses - Research and development expenses rose to $28.9 million for the three months ended March 31, 2025, compared to $25.7 million in 2024, an increase of $3.2 million, or 12.4%[106] - Selling and marketing expenses decreased to $10.6 million for the three months ended March 31, 2025, from $11.4 million in 2024, a reduction of $0.8 million, or 7.3%[112] - Cost of product sales decreased to $2.1 million for the three months ended March 31, 2025, from $2.5 million in 2024, a decrease of $0.4 million, or 17.9%[103] - Research and development expenses for preclinical product candidates increased significantly to $7.8 million for the three months ended March 31, 2025, from $3.7 million in 2024, an increase of $4.1 million, or 110.3%[109] - Share-based compensation expense increased to $1.0 million for the three months ended March 31, 2025, compared to a reversal of $0.6 million in 2024, an increase of $1.5 million[111] - General and administrative expenses were $10.0 million for the three months ended March 31, 2025, compared to $12.0 million for the same period in 2024, reflecting a decrease of 17.3%[118] Net Loss and Operational Performance - The net loss for the three months ended March 31, 2025, was $38.6 million, compared to a net loss of $46.6 million for the same period in 2024, a decrease of $8.0 million, or 17.2%[96] - Loss from operations improved to $28.5 million for the three months ended March 31, 2025, from $33.6 million in 2024, a reduction of $5.1 million, or 15.3%[96] Cash Flow and Financial Position - Net cash used in operating activities increased to $56.3 million for the three months ended March 31, 2025, compared to $44.1 million in the same period of 2024, an increase of $12.2 million[132] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, sufficient to fund operations for at least the next twelve months[127] - The total change in cash and cash equivalents for the three months ended March 31, 2025, was a decrease of $56.3 million compared to a decrease of $44.3 million in the same period of 2024[131] Interest Income and Expense - Interest income was $2.1 million for the three months ended March 31, 2025, down from $2.9 million in the same period of 2024, a decrease of 30.3%[120] - Interest expense decreased to $12.2 million for the three months ended March 31, 2025, from $12.5 million in the same period of 2024, a decline of 2.1%[121] Strategic Initiatives - The company plans to continue funding operations through existing cash, revenues from ZYNLONTA sales, and potential collaborations[128] - The company is exploring strategic collaborations and business combinations to support its early-stage research pipeline and commercialization efforts[128] - The company recorded an income tax expense of $0.2 million for both the three months ended March 31, 2025, and March 31, 2024[125]
ADC Therapeutics SA (ADCT) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-14 14:10
Core Insights - ADC Therapeutics SA reported a quarterly loss of $0.36 per share, which is better than the Zacks Consensus Estimate of a loss of $0.38, and an improvement from a loss of $0.56 per share a year ago [1] - The company achieved revenues of $23.03 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 26.94% and up from $18.05 million year-over-year [2] - The stock has underperformed, losing approximately 33.7% since the beginning of the year, while the S&P 500 has gained 0.1% [3] Financial Performance - Over the last four quarters, ADC Therapeutics has surpassed consensus EPS estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.39 on revenues of $18.73 million, and for the current fiscal year, it is -$1.65 on revenues of $75.43 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which ADC Therapeutics belongs, is currently in the top 30% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor sentiment [5] Future Outlook - The company's earnings outlook will be crucial for determining the sustainability of its stock price movement, particularly following management's commentary on the earnings call [3][4] - The current Zacks Rank for ADC Therapeutics is 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6]
ADC Therapeutics(ADCT) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:32
Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, which is consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][16] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, primarily due to higher license revenues and lower expenses [17] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, mainly due to net loss from operations and timing of cash receipts [17] Business Line Data and Key Metrics Changes - Milestone and royalty payments contributed an additional $5.6 million to total revenue for the quarter [6] - The LOTUS-seven study showed a 95.5% overall response rate and a 90.9% complete response rate in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with ongoing trials showing promising data [5][9] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][10] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant patient reach and commercial opportunity [9][10] - Regulatory discussions are planned based on data from 100 patients, aligning with recent examples of bispecific combination therapies [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash runway extending into the second half of 2026, positioning the company to deliver on upcoming catalysts [20] - The management is encouraged by the promising data from ongoing trials and believes in multiple pathways to achieve peak revenue goals [22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [7][19] - The company is engaged in discussions for potential research collaborations to advance its preclinical assets [8][19] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with encouraging complete response rates serving as strong biomarkers for durability [24][27] Question: Competitive strategy and regulatory engagement - Management plans to engage with regulatory authorities after gathering data from approximately 100 patients, assessing the best path forward [29][47] Question: Expected patient numbers at upcoming conferences - Management confirmed that 40 patients have been enrolled, with additional patients expected to be presented at the EHA conference [33][34] Question: LOTUS-five trial data expectations - Management reiterated that the timing for top-line data from the LOTUS-five trial could be late 2025 or early 2026, depending on the number of PFS events [42][43] Question: Discontinuation of the ADCT-602 program - Management clarified that the discontinuation of the ADCT-602 program has minimal financial impact, allowing focus on other research programs [49][50]
ADC Therapeutics(ADCT) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:30
Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][17] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, attributed to higher license revenues and lower expenses [18] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, primarily due to net loss from operations [18] Business Line Data and Key Metrics Changes - The company reported $5.6 million in milestone and royalty payments included in total revenue for the quarter [6] - The LOTUS-seven study showed an overall response rate of 95.5% and a complete response rate of 90.9% in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with promising data from the LOTUS-seven study [5][10] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][11] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant revenue growth [10][22] - The strategy includes pursuing regulatory discussions and compendia strategies based on the data from ongoing trials [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming catalysts and the company's cash runway expected to fund operations into the second half of 2026 [10][21] - The management is optimistic about the promising data from ongoing trials and the potential to change treatment paradigms for patients with aggressive lymphoma [15][22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [8][20] - The company is engaged in discussions for potential research collaborations to advance its programs [9][20] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with high complete response rates being a strong biomarker for durability [27][28] Question: Competitive strategy and regulatory engagement - The company plans to engage with regulatory authorities once sufficient data from approximately 100 patients is available [30] Question: Expected patient numbers at upcoming conferences - Management confirmed that more patients than the 22 already discussed will be presented at the EHA and ICML conferences, but exact numbers cannot be disclosed [34] Question: Timing for LOTUS-five data readout - The company expects to reach the pre-specified number of PFS events this year, with data readout potentially at the end of this year or early next year [42] Question: Discontinuation of the ADCT-602 program - The discontinuation of the ADCT-602 program has minimal capital implications, allowing focus on advancing other research programs [50][51]
ADC Therapeutics(ADCT) - 2025 Q1 - Quarterly Results
2025-05-14 12:14
Financial Performance - ZYNLONTA generated net product revenues of $17.4 million for Q1 2025, compared to $17.8 million in Q1 2024[5] - Total revenue for Q1 2025 was $23.033 million, a 27.5% increase from $18.053 million in Q1 2024[22] - Product revenues decreased slightly to $17.404 million from $17.848 million, a decline of 2.5% year-over-year[22] - License revenue and royalties increased to $5.6 million in Q1 2025 from $0.2 million in Q1 2024, including a $5.0 million milestone payment from Health Canada[5] Expenses - Research and Development (R&D) expenses rose to $28.9 million in Q1 2025, up from $25.7 million in Q1 2024, primarily due to increased spending on next-generation ADCs[5] - Selling and Marketing (S&M) expenses decreased to $10.6 million in Q1 2025 from $11.4 million in Q1 2024, attributed to lower marketing costs[5] - General & Administrative (G&A) expenses fell to $10.0 million in Q1 2025 from $12.0 million in Q1 2024, mainly due to reduced professional fees[5] - Total operating expenses for Q1 2025 were $51.497 million, a marginal decrease of 0.3% from $51.666 million in Q1 2024[25] - Share-based compensation expense rose significantly to $2.421 million from $158, a 1,432% increase[25] Net Loss - Net loss for Q1 2025 was $38.6 million, or $0.36 per share, an improvement from a net loss of $46.6 million, or $0.56 per share, in Q1 2024[5] - Adjusted net loss for Q1 2025 was $24.0 million, or $0.22 per share, compared to an adjusted net loss of $31.1 million, or $0.38 per share, in Q1 2024[5] - Net loss for Q1 2025 was $38.602 million, compared to a net loss of $46.606 million in Q1 2024, reflecting an improvement of 17.3%[22] - Adjusted net loss for Q1 2025 was $23.963 million, down from $31.147 million in Q1 2024, indicating a 23.0% reduction[25] Cash Position - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million as of December 31, 2024, with a cash runway expected to extend into the second half of 2026[6] - Cash and cash equivalents as of March 31, 2025, were $194.701 million, down from $250.867 million at the end of 2024[24] Clinical Trials - LOTIS-7 trial reached 40 patient enrollments, with updates expected in the second half of 2025[3] - ZYNLONTA plus glofitamab demonstrated an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% in the LOTIS-7 trial[3] Shareholder Information - The weighted average shares outstanding increased to 107,202,374 in Q1 2025 from 82,552,322 in Q1 2024[25] - Total liabilities increased slightly to $510.762 million from $524.622 million, with total shareholders' equity showing a deficit of $238.223 million[24]
ADC Therapeutics(ADCT) - 2025 Q1 - Earnings Call Presentation
2025-05-14 12:07
1Q 2025 Earnings Call May 14, 2025 Agenda Financial Update Pepe Carmona Chief Financial Officer 01 Introduction Ameet Mallik Chief Executive Officer 02 Chief Medical Officer Clinical Highlights Mohamed Zaki 03 04 Q&A 2 Forward-Looking Statements This presentation and any accompanying oral presentation have been prepared by ADC Therapeutics SA ("ADC Therapeutics", "we" or "us") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, ...
ADC Therapeutics Reports First Quarter 2025 Financial Results and Provides Operational Update
Prnewswire· 2025-05-14 12:00
Core Insights - ADC Therapeutics reported promising data from the LOTIS-7 trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% for ZYNLONTA® in combination with glofitamab in patients with relapsed/refractory DLBCL [1][3][9] - The company expects its cash runway to extend into the second half of 2026, allowing for multiple catalysts to be funded [1][9] - The CEO expressed confidence in ZYNLONTA's potential as a best-in-class treatment in a dynamic market, particularly as the company progresses with the LOTIS-5 confirmatory trial [2][3] Financial Performance - For Q1 2025, ZYNLONTA generated net product revenues of $17.4 million, slightly down from $17.8 million in Q1 2024 [9][21] - License revenues and royalties increased significantly to $5.6 million from $0.2 million in the same period last year, driven by a milestone payment related to ZYNLONTA's approval in Canada [9][21] - Research and development expenses rose to $28.9 million from $25.7 million year-over-year, reflecting increased spending on next-generation ADCs [9][21] - The net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024 [9][21] Clinical Development Updates - The LOTIS-7 trial has reached 40 patient enrollments in its dose expansion arm, with updates expected in the second half of 2025 [1][3] - The LOTIS-5 trial's safety run-in data will also be presented at EHA2025, showing no new safety signals and encouraging antitumor activity [3] - An abstract for marginal zone lymphoma data will be presented at ICML, highlighting the high rate of complete responses in a phase 2 study [3] Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for hematologic malignancies and solid tumors [11][12] - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory DLBCL after two or more lines of systemic therapy [8][12]
ADC Therapeutics Announces Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML)
Prnewswire· 2025-05-14 11:45
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b clinical trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% among 22 evaluable patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [1][4] - The combination of ZYNLONTA and glofitamab demonstrated a manageable safety profile, with adverse events consistent with known profiles of the individual agents [2][4] - Updated data will be presented at the European Hematology Association 2025 Congress (EHA2025) and the International Conference on Malignant Lymphoma (ICML) [1][5] Efficacy and Safety Data - In the efficacy evaluable population, the ORR was 95.5% (21 out of 22 patients), and the CR rate was 90.9% (20 out of 22 patients) [4] - Among 31 patients treated, the most common Grade ≥3 treatment-emergent adverse event (TEAE) was neutropenia at 32.3% [4] - Other notable Grade 3/4 TEAEs included generalized edema, pericardial effusion, photosensitivity reaction, rash, sepsis, and pneumonia, each at 3.2% [4] Presentation Details - The LOTIS-7 data will be presented in a poster session at EHA2025 on June 14, 2025, with the presenting author being Juan Pablo Alderuccio, MD [3][5] - An oral encore presentation will take place at ICML on June 20, 2025, also featuring Juan Pablo Alderuccio as the presenting author [5] Study Overview - LOTIS-7 is a Phase 1b global multicenter study evaluating ZYNLONTA in combination with various agents, including glofitamab, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma [6] - The study includes a dose escalation phase and a dose expansion phase, with primary endpoints focusing on safety and tolerability [6] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy [9][12] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]