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ADC Therapeutics(ADCT) - 2025 Q2 - Earnings Call Presentation
2025-08-12 12:30
Commercial Performance - 2Q 2025 net product revenues reached $18.1 million, a 6.2% increase compared to $17.0 million in the same quarter of 2024 [16, 58] - Total 1H 2025 net product revenue was $35.5 million, up from $34.9 million during the 1H of 2024 [16] Pipeline Progress - LOTIS-7 data showed a 93.3% ORR (Overall Response Rate) and an 86.7% CR (Complete Response) rate across 30 efficacy evaluable patients when ZYNLONTA was combined with glofitamab [16, 53] - Updated MZL IIT data presented at ICML demonstrate an 85% ORR and a 69% CR rate [16] - LOTIS-5 is on track to reach pre-specified PFS (Progression-Free Survival) events by the end of 2025 [16] Corporate Update - The company secured $100 million in private placement, extending the expected cash runway into 2028 [16] - A strategic prioritization was implemented, resulting in a 30% reduction in force and one-time charges of $13.1 million, including $6.7 million in employee severance and $6.4 million in non-cash impairment of assets related to the UK facility closure [16] - The company's cash balance was $264.6 million as of June 30, 2025 [16, 58] LOTIS-7 Trial Safety - In the LOTIS-7 Phase 1b trial, 56.1% of patients experienced Grade 3/4 TEAEs (Treatment-Emergent Adverse Events) [47] - Cytokine Release Syndrome (CRS) of any grade was observed in 39% of patients [49] - ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome) of any grade was observed in 7.3% of patients [49] ZYNLONTA Market Potential - ZYNLONTA has a U S peak revenue potential of $600 million to $1 billion in DLBCL (Diffuse Large B-Cell Lymphoma) and indolent lymphomas [21, 22]
ADC Therapeutics(ADCT) - 2025 Q2 - Quarterly Results
2025-08-12 11:41
[Key Highlights and Strategic Overview](index=1&type=section&id=Key%20Highlights%20and%20Strategic%20Overview) ADC Therapeutics reported strong Q2 2025 results, with ZYNLONTA® showing **93.3% ORR** and a **$100 million** private placement extending cash runway - ZYNLONTA® in combination with glofitamab (LOTIS-7 trial) demonstrated a **93.3% overall response rate (ORR)** and an **86.7% complete response (CR) rate** in 30 efficacy evaluable patients with relapsed/refractory DLBCL[1](index=1&type=chunk)[3](index=3&type=chunk) - Completed a **$100 million private placement (PIPE financing)**, securing net proceeds of **$93.1 million** and extending the company's expected cash runway into 2028[1](index=1&type=chunk)[3](index=3&type=chunk) - The company has streamlined its strategic focus to pursue the expansion of ZYNLONTA® into earlier lines of therapy, leveraging its strengthened financial foundation[2](index=2&type=chunk) [Operational and Clinical Development Updates](index=1&type=section&id=Operational%20and%20Clinical%20Development%20Updates) The company advances ZYNLONTA® clinical programs and a new PSMA-targeting ADC, while restructuring to focus resources and reduce its workforce by **30%** [ZYNLONTA® Clinical Programs](index=1&type=section&id=ZYNLONTA%C2%AE%20Clinical%20Programs) ZYNLONTA® showed high efficacy in LOTIS-7 for r/r DLBCL, with FDA engagement planned, while LOTIS-5 is on track for 2025 completion, and an investigator-initiated trial showed **84.6% ORR** in marginal zone lymphoma - LOTIS-7 (ZYNLONTA® + glofitamab): The Phase 1b trial is being expanded to **100 patients** with r/r DLBCL following strong efficacy data (**93.3% ORR, 86.7% CR**), with plans to engage with the FDA in H2 2025[1](index=1&type=chunk)[3](index=3&type=chunk) - LOTIS-5 (ZYNLONTA® + rituximab): The Phase 3 confirmatory trial is expected to reach its prespecified progression-free survival (PFS) events by the end of 2025, with a potential sBLA submission anticipated in H1 2026[1](index=1&type=chunk)[5](index=5&type=chunk) - Marginal Zone Lymphoma: An investigator-initiated trial of ZYNLONTA® monotherapy demonstrated an **ORR of 84.6%** and a **CR of 69.2%** in 26 patients, with plans to assess a potential regulatory pathway[5](index=5&type=chunk) [Pipeline and Corporate Strategy](index=2&type=section&id=Pipeline%20and%20Corporate%20Strategy) The company advances a new PSMA-targeting ADC, with IND-enabling activities concluding by year-end 2025, while strategically restructuring to focus on ZYNLONTA® and reduce its global workforce by **30%** - A new exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC is advancing, with IND-enabling activities expected to be completed by the end of 2025[5](index=5&type=chunk) - Announced a strategic restructuring to focus on ZYNLONTA®, which includes discontinuing early solid tumor programs, shutting down the UK facility, and reducing the global workforce by approximately **30%**[5](index=5&type=chunk) [Second Quarter and First Half 2025 Financial Results](index=2&type=section&id=Second%20Quarter%20and%20First%20Half%202025%20Financial%20Results) ADC Therapeutics reported Q2 2025 net product revenues of **$18.1 million**, with net loss widening to **$56.6 million** due to increased R&D and **$13.1 million** restructuring costs, ending with **$264.6 million** cash Q2 & H1 2025 Key Financial Metrics (in millions USD, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | **Product Revenues, Net** | $18.1 | $17.0 | $35.5 | $34.9 | | **Total Operating Expense** | $63.0 | $46.5 | $114.5 | $98.1 | | **R&D Expense** | $30.1 | $24.3 | $59.0 | $50.0 | | **Restructuring Costs** | $13.1 | $0.0 | $13.1 | $0.0 | | **Net Loss** | ($56.6) | ($36.5) | ($95.2) | ($83.2) | | **Net Loss Per Share** | ($0.50) | ($0.38) | ($0.86) | ($0.93) | | **Adjusted Net Loss** | ($28.7) | ($24.4) | ($52.6) | ($55.5) | | **Adjusted Net Loss Per Share**| ($0.25) | ($0.25) | ($0.48) | ($0.62) | - The increase in R&D expenses was driven by the timing and enrollment of the ZYNLONTA® clinical trials LOTIS-5 and LOTIS-7, and IND-enabling activities for the PSMA-targeting ADC[5](index=5&type=chunk) - The company incurred **$13.1 million** in restructuring and impairment costs in Q2 2025, consisting of **$6.7 million** in employee severance and **$6.4 million** in non-cash asset impairments related to the UK facility closure[5](index=5&type=chunk)[6](index=6&type=chunk) - Cash and cash equivalents stood at **$264.6 million** as of June 30, 2025, compared to **$250.9 million** at the end of 2024, with the increase primarily due to the **$100 million PIPE financing**[10](index=10&type=chunk) [Appendix: Financial Statements](index=7&type=section&id=Appendix%3A%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements for Q2 and H1 2025, including Statements of Operations, Balance Sheets, and a detailed reconciliation of GAAP to Non-GAAP financial measures [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This statement details the company's revenues, operating expenses, and other income/expenses, culminating in a net loss of **$56.6 million** for Q2 2025 and **$95.2 million** for H1 2025 Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Total revenue, net** | $18,839 | $17,410 | $41,872 | $35,463 | | **Total operating expense** | $(62,986) | $(46,451) | $(114,483) | $(98,117) | | **Loss from operations** | $(44,147) | $(29,041) | $(72,611) | $(62,654) | | **Net loss** | $(56,646) | $(36,544) | $(95,248) | $(83,150) | | **Net loss per share, basic and diluted** | $(0.50) | $(0.38) | $(0.86) | $(0.93) | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of **$321.6 million**, total liabilities of **$520.7 million**, and a total shareholders' deficit of **$199.2 million**, with cash at **$264.6 million** Condensed Consolidated Balance Sheets (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $264,560 | $250,867 | | Total current assets | $318,755 | $307,390 | | **Total assets** | **$321,561** | **$321,980** | | **LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY** | | | | Total current liabilities | $64,600 | $80,469 | | **Total liabilities** | **$520,745** | **$524,622** | | **Total shareholders' (deficit) equity** | **$(199,184)** | **$(202,642)** | [Reconciliation of GAAP to Non-GAAP Measures](index=10&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) This table reconciles GAAP net loss to non-GAAP adjusted net loss, showing Q2 2025 GAAP net loss of **$56.6 million** adjusted to **$28.7 million** after specific non-cash and restructuring items Reconciliation of Net Loss to Adjusted Net Loss (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Net loss (GAAP)** | **$(56,646)** | **$(36,544)** | **$(95,248)** | **$(83,150)** | | Share-based compensation expense | $2,062 | $1,988 | $4,483 | $2,146 | | Restructuring charges | $6,677 | $— | $6,677 | $— | | Impairment charges | $6,414 | $— | $6,414 | $— | | Other non-cash/non-recurring items | $12,813 | $10,216 | $25,031 | $24,853 | | **Adjusted net loss (Non-GAAP)** | **$(28,680)** | **$(24,370)** | **$(52,643)** | **$(55,517)** |
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].