ADC Therapeutics(ADCT)

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ADC Therapeutics Makes Grant to New Employee Under Inducement Plan
Prnewswire· 2025-07-01 20:05
Core Points - ADC Therapeutics SA has granted options to purchase 17,000 common shares to a new employee as an inducement for employment [1][2] - The grants were approved by the Compensation Committee under the Company's Inducement Plan to motivate and reward employees [2] - The options will vest 25% on the first anniversary of the grant date and 1/48th monthly thereafter, fully vesting by the fourth anniversary [3] Company Overview - ADC Therapeutics is a global leader in antibody drug conjugates (ADCs) and is focused on transforming treatment for hematologic malignancies and solid tumors [4] - The company's ADC ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [5] - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [6]
ADC Therapeutics Announces Updated ZYNLONTA® Investigator-Initiated Trial Data in R/R Marginal Zone Lymphoma Presented at 18th International Conference on Malignant Lymphoma (ICML)
Prnewswire· 2025-06-16 11:15
Core Insights - ADC Therapeutics announced updated Phase 2 data for ZYNLONTA® showing an overall response rate (ORR) of 85% and a complete response (CR) rate of 69% in patients with relapsed/refractory marginal zone lymphoma (r/r MZL) [1][2] - The treatment was well tolerated, with safety profiles consistent with previous data [2][6] - The study is ongoing, with plans to expand enrollment to 50 patients across multiple sites [3][4] Study Details - The Phase 2 trial is a single-arm, open-label study led by Dr. Izidore S. Lossos at Sylvester Comprehensive Cancer Center [1][3] - As of February 10, 2025, 27 adult patients were enrolled, with 26 evaluable for response [2] - Among patients assessed for response, a CR rate of 61.5% was observed in high-risk POD24 patients [6] Efficacy and Safety - The longest duration of CR was 27 months from the start of treatment, with a progression-free survival (PFS) rate of 92.9% at 12 months [6] - Adverse events were consistent with the known safety profile of ZYNLONTA, with most being grade 1 or 2 [6] - Serious adverse events included neutropenia and RSV lung infection, with some patients requiring dose reductions [6] Regulatory and Future Plans - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Medicines Agency for treating r/r large B-cell lymphoma [7][10] - The company plans to pursue regulatory pathways based on the ongoing trial results [4] - ZYNLONTA is also being evaluated in combination studies for other B-cell malignancies [8][10] Company Overview - ADC Therapeutics is a biotechnology company focused on developing targeted antibody drug conjugates (ADCs) for cancer treatment [9][10] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [11]
ADC Therapeutics (ADCT) Earnings Call Presentation
2025-06-12 22:02
ZYNLONTA Development and Market Opportunity - ZYNLONTA has the potential to move into 2L+ DLBCL treatment [11] - In the r/r DLBCL U S market, complex therapies account for approximately 25% of the market, while broadly accessible therapies account for approximately 75% [15] - ZYNLONTA combinations could double the addressable patient population in 2L [19] - ZYNLONTA U S peak revenue potential is estimated between $600 million and $1 billion in DLBCL and indolent lymphomas [64] LOTIS-7 Clinical Trial Update - LOTIS-7 combines ZYNLONTA with glofitamab, targeting CD19 and CD20/CD3 respectively, with the expectation of additive or synergistic efficacy [26, 27] - Initial LOTIS-7 trial data shows an overall response rate (ORR) of 93 3% (28/30 patients) and a complete response (CR) rate of 86 7% (26/30 patients) in efficacy-evaluable patients with 2L+ LBCL [38] - The LOTIS-7 trial observed grade 3 or higher treatment-emergent adverse events (TEAEs) in >5% of patients, including neutropenia (24 4%), anemia (9 8%), AST increased (7 3%), GGT increased (7 3%), and thrombocytopenia (7 3%) [40] - In the LOTIS-7 trial, any grade Cytokine Release Syndrome (CRS) occurred in 39 0% of patients (16/41), with Grade 3 CRS in 2 4% (1/41) and no Grade 4/5 CRS [52] Upcoming Milestones - The company anticipates sharing fuller/more mature LOTIS-7 data and reaching a prespecified number of PFS events for LOTIS-5 by the end of 2025 [68]
ADC Therapeutics (ADCT) Update / Briefing Transcript
2025-06-12 13:00
Summary of ADC Therapeutics Conference Call - June 12, 2025 Company Overview - **Company**: ADC Therapeutics (ADCT) - **Focus**: Development of therapies for hematological malignancies, particularly diffuse large B-cell lymphoma (DLBCL) Key Industry Insights - **LOTUS-seven Trial**: A Phase 1b study focusing on relapsed or refractory B-cell non-Hodgkin lymphoma, with updated results presented at the European Hematology Association Congress (EHA) [3][7] - **ZULANTA Franchise**: The company is expanding its ZULANTA therapy into earlier lines of treatment for DLBCL and indolent lymphomas, aiming to increase patient reach and commercial opportunity [6][10] Core Points and Arguments - **Efficacy of ZENLANTA**: - ZENLANTA shows rapid, deep, and durable efficacy with a 50% complete response rate in the LOTUS-five trial, which is double that of monotherapy data in line plus DLBCL [9] - The LOTUS-seven trial reported an overall response rate of approximately 93% and a complete response rate of about 87% [16][25] - The combination of ZENLANTA and glufetamab is expected to provide additive or synergistic efficacy due to their complementary mechanisms of action targeting different B-cell surface antigens [11][44] - **Safety Profile**: - The combination therapy has a manageable safety profile, with neutropenia being the most common treatment-emergent adverse event at 24%, consistent with individual drug profiles [21][14] - Lower rates of cytokine release syndrome (CRS) were observed with the 150 microgram per kg dose compared to the 120 microgram per kg dose, indicating a favorable safety profile [84][85] - **Market Potential**: - The company estimates peak sales for ZENLANTA in the range of $600 million to $1 billion across various indications, including DLBCL and indolent lymphomas [30] - The potential to double the addressable patient population and extend the duration of therapy is expected to significantly enhance market share [10][29] Additional Important Insights - **Regulatory Strategy**: - ADC Therapeutics plans to engage with regulatory authorities later in the year, with the aim of submitting for approval based on the expanded cohort data [31][60] - The company is also considering a potential compendia strategy to support the therapy's adoption in clinical practice [32] - **Patient Demographics**: - The median age of patients in the LOTUS-seven trial was 71, with a significant proportion having received prior CAR T therapy [19][20] - The study included patients with complex disease characteristics, such as double or triple hit lymphomas, indicating a challenging patient population [20] - **Future Data Catalysts**: - Multiple data catalysts are expected in 2025 and 2026, with potential approval or compendia listing anticipated in the first half of 2027 [31] - **Community Adoption**: - The combination therapy is expected to be adopted in community centers due to its manageable safety profile and the increasing comfort of physicians with bispecific therapies [41] This summary encapsulates the key points discussed during the ADC Therapeutics conference call, highlighting the company's strategic direction, clinical trial updates, market potential, and regulatory plans.
ADC Therapeutics Announces $100 Million Private Placement Extending Expected Cash Runway into 2028
Prnewswire· 2025-06-12 10:45
Core Viewpoint - ADC Therapeutics has announced a $100 million PIPE financing to support the development and commercialization of its ADC product ZYNLONTA and other strategic initiatives [1][2]. Financing Details - The PIPE involves the sale of 13 million common shares at $3.53 each and pre-funded warrants for 15.7 million common shares at $3.43 each, with gross proceeds expected to be approximately $100 million before fees [1][2]. - The financing is set to close on June 16, 2025, pending customary conditions [2]. Use of Proceeds - The net proceeds from the PIPE will be utilized for ZYNLONTA's clinical development, commercialization activities, working capital, and general corporate purposes [2]. Strategic Developments - The company will advance its preclinical exatecan-based ADC targeting prostate-specific membrane antigen (PSMA) while discontinuing other preclinical solid tumor programs [3]. - A workforce reduction of approximately 30% is planned, with the majority of this restructuring expected to be completed by September 30, 2025, incurring one-time cash charges of $6 to $7 million [3]. Long-term Growth Positioning - These strategic moves are anticipated to reduce operating expenses significantly and extend the company's cash runway into 2028 [4]. - Key anticipated catalysts include ongoing clinical trials such as LOTIS-7 and LOTIS-5, with significant data expected in the coming years [4][8]. Clinical Development Updates - LOTIS-7 Phase 1b trial data for ZYNLONTA plus glofitamab is expected in the second half of 2025, with full enrollment of 100 patients anticipated by the first half of 2026 [8]. - Topline results from the LOTIS-5 Phase 3 trial are expected in late 2025 or early 2026, with potential regulatory submissions following [8]. 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 [14][15].
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]