Workflow
ADC Therapeutics(ADCT)
icon
Search documents
ADC Therapeutics Reports Second Quarter 2025 Financial Results and Provides Operational Update
Prnewswire· 2025-08-12 11:30
Core Insights - ADC Therapeutics reported a strong overall response rate (ORR) of 93.3% and a complete response (CR) rate of 86.7% for ZYNLONTA® in combination with glofitamab in the LOTIS-7 trial [1][3] - The company has completed a $100 million private placement to extend its cash runway into 2028, with net proceeds of $93.1 million allocated for ZYNLONTA's clinical development and commercialization [3][7] - ADC Therapeutics is focusing on expanding ZYNLONTA into earlier lines of therapy for diffuse large B-cell lymphoma (DLBCL) and indolent lymphomas, with key clinical milestones expected through 2026 [2][3] Operational Updates - The LOTIS-7 Phase 1b trial is expanding to include 100 patients with relapsed/refractory DLBCL, with additional data expected in the second half of 2025 [1][3] - The LOTIS-5 Phase 3 trial is on track to reach the prespecified progression-free survival (PFS) events by the end of 2025, with topline data anticipated thereafter [1][3] - The company is also advancing IND-enabling activities for a PSMA-targeting ADC, with completion expected by the end of 2025 [4] Financial Performance - For Q2 2025, net product revenues were $18.1 million, up from $17.0 million in Q2 2024, while total revenues for the first half of 2025 reached $41.9 million compared to $35.5 million in the same period last year [7][20] - Research and development expenses increased to $30.1 million for Q2 2025, compared to $24.3 million in Q2 2024, driven by clinical trial activities [7][20] - The net loss for Q2 2025 was $56.6 million, or $0.50 per share, compared to a net loss of $36.5 million, or $0.38 per share, in Q2 2024 [7][20] Strategic Focus - The company announced a strategic restructuring plan, discontinuing early development efforts for preclinical programs in solid tumors and focusing resources on ZYNLONTA [4] - A workforce reduction of approximately 30% is planned as part of the restructuring, expected to be completed by September 30, 2025 [4] - ADC Therapeutics aims to pursue a supplemental Biologics License Application (sBLA) for ZYNLONTA in 2026, with potential confirmatory approval in DLBCL [2][3]
ADC Therapeutics to Host Second Quarter 2025 Financial Results Conference Call on August 12, 2025
Prnewswire· 2025-08-05 20:05
Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [5] Upcoming Events - ADC Therapeutics will host a conference call and live webcast on August 12, 2025, at 8:30 a.m. EDT to report financial results for Q2 2025 and provide operational updates [1] Product Development - The company's CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - ADC Therapeutics is advancing IND-enabling activities for a next-generation PSMA-targeting ADC utilizing a differentiated exatecan-based payload with a novel hydrophilic linker [4]
Are Medical Stocks Lagging ADC Therapeutics (ADCT) This Year?
ZACKS· 2025-08-04 14:41
Company Performance - ADC Therapeutics SA (ADCT) has gained approximately 35.2% year-to-date, significantly outperforming the average return of -7.2% for Medical companies [4] - The Zacks Consensus Estimate for ADCT's full-year earnings has increased by 4.2% over the past three months, indicating improved analyst sentiment [4] - ADC Therapeutics SA currently holds a Zacks Rank of 2 (Buy), suggesting a positive outlook for the stock [3] Industry Context - ADC Therapeutics SA is part of the Medical - Biomedical and Genetics industry, which consists of 490 companies and currently ranks 143 in the Zacks Industry Rank [6] - The average performance of stocks in the Medical - Biomedical and Genetics industry has been a gain of 0.5% this year, indicating that ADCT is performing better than its industry peers [6] - Another notable performer in the Medical sector is Alnylam Pharmaceuticals (ALNY), which has seen a year-to-date increase of 70.8% and also holds a Zacks Rank of 2 (Buy) [5]
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]