LAUSANNE, Switzerland, May 30, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE:ADCT) today announced that Ameet Mallik, Chief Executive Officer, will present a company overview at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 a.m. ET. A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics' website at ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days. Abo ...

Company Overview - ADC Therapeutics is a commercial-stage global leader in antibody drug conjugates (ADCs) [2] - The company is focused on transforming treatment for patients with hematologic malignancies and solid tumors [2] - ADC Therapeutics is based in Lausanne, Switzerland, with operations in London and New Jersey [3] Product Development - ADC Therapeutics' 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 [2] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [2] - The company has multiple ADCs in ongoing clinical and preclinical development [2] Upcoming Events - Ameet Mallik, CEO of ADC Therapeutics, will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024 [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [1]

Company Overview - ADC Therapeutics is a commercial-stage global leader in antibody drug conjugates (ADCs) [2] - The company is focused on transforming treatment for patients with hematologic malignancies and solid tumors [2] - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [3] Product Development - ADC Therapeutics' 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 [2] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [2] - The company has multiple ADCs in ongoing clinical and preclinical development [2] Upcoming Events - Ameet Mallik, CEO of ADC Therapeutics, will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024 [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [1]

Company Overview - ADC Therapeutics is a commercial-stage global leader in antibody drug conjugates (ADCs) [2] - The company is focused on transforming treatment for patients with hematologic malignancies and solid tumors [2] - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [3] Product Development - ADC Therapeutics' 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 [2] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [2] - The company has multiple ADCs in ongoing clinical and preclinical development [2] Upcoming Events - Ameet Mallik, CEO of ADC Therapeutics, will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024, at 1:35 p.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [1]

Company Overview - ADC Therapeutics is a commercial-stage global leader in antibody drug conjugates (ADCs) [2] - The company is focused on transforming treatment for patients with hematologic malignancies and solid tumors [2] Product Development - ADC Therapeutics' 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 [2] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [2] - The company has multiple ADCs in ongoing clinical and preclinical development [2] Upcoming Events - Ameet Mallik, CEO of ADC Therapeutics, will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024, at 1:35 p.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [1]

Financial Data and Key Metrics Changes - ZYNLONTA revenues were $17.8 million in Q1 2024, representing a 7% increase over Q4 2023 but a 6% decrease compared to the prior year [9][26] - Total operating expenses decreased by 16% year-over-year on a non-GAAP basis, reflecting a focus on operational efficiencies [11][27] - The company reported a net loss of $46.6 million for the quarter, or $0.56 per basic undiluted share, with an adjusted net loss of $31.1 million, or $0.38 per basic and diluted share [28] Business Line Data and Key Metrics Changes - The ZYNLONTA franchise remains the primary focus, with efforts to expand its use in earlier lines of DLBCL therapy and indolent lymphomas [13][29] - Initial data from the Phase 2 trial of ZYNLONTA in relapsed/refractory marginal zone lymphoma showed 13 out of 15 patients achieved a complete response [17][21] Market Data and Key Metrics Changes - The total addressable market for second-line plus marginal zone lymphoma patients is estimated to have a peak market opportunity of approximately $500 million [18] - The competitive landscape includes CD20 bispecifics, which are gaining traction primarily in academic centers, but ZYNLONTA has seen modest growth in both academic and community settings [50] Company Strategy and Development Direction - The company aims to maintain a disciplined capital allocation strategy, focusing on hematology and expanding the ZYNLONTA franchise [12][29] - The second pillar of the strategy involves advancing a solid tumor pipeline, with ADCT-601 being the most advanced asset [13][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to drive value creation, supported by a strengthened balance sheet and enhanced financial flexibility [32] - The company plans to pursue regulatory pathways for both the follicular lymphoma and marginal zone lymphoma studies in parallel based on positive data outcomes [34][36] Other Important Information - The company announced a registered direct offering expected to raise approximately $105 million in gross proceeds, extending the cash runway into mid-2026 [12][29] - The company is in the process of optimizing the dose and schedule for ADCT-601 in pancreatic cancer and sarcoma patients [11] Q&A Session Summary Question: Plans for follicular lymphoma compared to marginal zone lymphoma - Management highlighted positive data from both studies and plans to pursue regulatory strategies in parallel, with a focus on high-risk patient populations in follicular lymphoma [34][35][36] Question: Duration of clinical benefit for other drugs in marginal zone lymphoma - Management noted that initial results showed promising durability, with one patient reaching 20 months and others over 10 months [40][41] Question: Competitive dynamics from CD20 bispecifics - Management acknowledged the competitive impact but noted that ZYNLONTA has maintained growth in academic centers and community settings [50][51] Question: Strategy for LOTIS-7 and potential Phase 3 study - Management indicated that they are evaluating the efficacy and safety data from LOTIS-7 and will consider a Phase 3 study based on the results [57] Question: Definition of commercial brand profitability - Management clarified that commercial brand profitability includes direct commercialization costs but excludes pipeline and corporate G&A expenses [59]

1Q 2024 Earnings Call May 6, 2024 Agenda Ameet Mallik 01 ...

Company Performance - ADC Therapeutics reported a quarterly loss of $0.56 per share, which aligns with the Zacks Consensus Estimate, an improvement from a loss of $0.74 per share a year ago [1] - The company's revenues for the quarter ended March 2024 were $18.05 million, missing the Zacks Consensus Estimate by 0.75% and down from $18.99 million year-over-year [1] - Over the last four quarters, ADC Therapeutics has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [1] Stock Movement and Outlook - ADC Therapeutics shares have increased approximately 195.2% since the beginning of the year, significantly outperforming the S&P 500's gain of 7.5% [2] - The sustainability of the stock's price movement will largely depend on management's commentary during the earnings call [2] Earnings Estimates and Industry Context - The current consensus EPS estimate for the upcoming quarter is -$0.58 on revenues of $20.01 million, and for the current fiscal year, it is -$2.20 on revenues of $83.22 million [4] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 32% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [5] - ThermoGenesis Holdings, Inc., another company in the same industry, is expected to report quarterly earnings of $0.01 per share, reflecting a year-over-year change of +100.3% [5]

LAUSANNE, Switzerland, May 06, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE:ADCT) today announced that it has agreed to sell, by way of an underwritten offering, 13,411,912 of its common shares at a price of $4.900 per share and, to certain investors who so choose in lieu of common shares, pre-funded warrants to purchase 8,163,265 common shares at a price of $4.812 per pre-funded warrant (being the offering price per common share in the offering minus the exercise price). The gross proceeds from the o ...

PART I: FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) ADC Therapeutics reported Q1 2024 revenues of $18.1 million, a net loss of $46.6 million, and $234.3 million in cash, reflecting reduced operating expenses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $308.0 million by Q1 2024, primarily due to lower cash, while the shareholders' deficit grew to $194.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $234,285 | $278,598 | | Total current assets | $290,206 | $336,291 | | Total assets | $307,966 | $354,782 | | **Liabilities & Equity** | | | | Total liabilities | $502,415 | $503,031 | | Total shareholders' (deficit) | ($194,449) | ($148,249) | [Condensed Consolidated Statements of Operation](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operation) Q1 2024 total revenue decreased to $18.1 million, but reduced operating expenses led to a smaller net loss of $46.6 million Q1 2024 vs. Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Product revenues, net | $17,848 | $18,953 | | Total revenue, net | $18,053 | $18,992 | | Total operating expense | ($51,666) | ($69,202) | | Research and development | ($25,735) | ($38,375) | | Net loss | ($46,606) | ($59,374) | | Net loss per share, basic and diluted | ($0.56) | ($0.73) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $44.1 million in Q1 2024, resulting in a $44.3 million net decrease in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($44,095) | ($15,392) | | Net cash used in investing activities | ($531) | ($1,016) | | Net cash provided by financing activities | $356 | $425 | | **Net decrease in cash and cash equivalents** | **($44,270)** | **($15,983)** | [Notes to the Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Notes detail accounting policies, going concern assessment, revenue disaggregation, debt facilities, and share-based compensation - The company concluded there is no substantial doubt about its ability to continue as a going concern for at least one year from the financial statement issuance date, based on its cash and cash equivalents of **$234.3 million** as of March 31, 2024[34](index=34&type=chunk) - Product revenue is primarily generated in the U.S., totaling **$17.8 million** for Q1 2024. Three major customers, McKesson, AmerisourceBergen, and Cardinal Health, accounted for **43.0%**, **38.0%**, and **19.0%** of product revenues, respectively[69](index=69&type=chunk)[73](index=73&type=chunk) - The fair value of the Deerfield warrant obligation increased significantly from **$0.3 million** at year-end 2023 to **$3.4 million** as of March 31, 2024, primarily due to an increase in the company's share price. This resulted in a **$3.1 million** expense recorded in 'Other, net'[57](index=57&type=chunk) Key Liabilities (in millions) | Liability | March 31, 2024 | | :--- | :--- | | Deferred royalty obligation | $310.0 | | Senior secured term loans | $113.2 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses ZYNLONTA's performance, pipeline progress, Q1 2024 revenue decrease to $17.8 million, and significant operating expense reductions, affirming sufficient liquidity [Recent Developments](index=22&type=section&id=Recent%20Developments) Recent developments include positive LOTIS-7 trial data for ZYNLONTA, high response rates in MZL, and advancement of solid tumor ADC candidates - In the LOTIS-7 trial (Part 1), combining ZYNLONTA with glofitamab or mosunetuzumab, no dose-limiting toxicities were observed, and cytokine release syndrome (CRS) was low-grade, suggesting good combinability[102](index=102&type=chunk) - Initial data from a Phase 2 investigator-initiated trial in relapsed/refractory Marginal Zone Lymphoma (MZL) showed a **13/15** complete response rate among evaluable patients, indicating high efficacy[108](index=108&type=chunk) - The company is advancing its solid tumor pipeline with a novel exatecan-based ADC platform. Lead candidates targeting Claudin-6 and NaPi2b are in IND-enabling studies for potential use in ovarian and non-small cell lung cancer[112](index=112&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Q1 2024 net product revenues decreased by **5.8%** to **$17.8 million**, while total operating expenses significantly reduced by **25.3%** to **$51.7 million** Operating Results Comparison (in thousands) | Line Item | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $17,848 | $18,953 | (5.8)% | | Research and development | ($25,735) | ($38,375) | (32.9)% | | Selling and marketing | ($11,390) | ($15,351) | (25.8)% | | General and administrative | ($12,031) | ($15,503) | (22.4)% | | **Net loss** | **($46,606)** | **($59,374)** | **(21.5)%** | - The decrease in R&D expenses was primarily driven by a **$5.1 million** reduction in spending on the Cami program, which was stopped, and a **$4.2 million** decrease in ZYNLONTA clinical trial costs[124](index=124&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q1 2024 with **$234.3 million** in cash, deemed sufficient for the next twelve months, despite increased cash usage in operations - As of March 31, 2024, the company had cash and cash equivalents of **$234.3 million**, which is deemed sufficient to fund operations for the next twelve months[144](index=144&type=chunk) - The increase in net cash used in operations in Q1 2024 compared to Q1 2023 was primarily due to the non-recurring receipt of a **$50.0 million** license milestone payment from Sobi in the prior-year period[149](index=149&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, ADC Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[153](index=153&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2024 - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[154](index=154&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, these controls[155](index=155&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently party to any legal proceedings that would be reasonably expected to have a material adverse effect on its business - As of the report date, the company is not involved in any material legal proceedings[156](index=156&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) A supplemental risk factor was added concerning investigator-initiated clinical trials, highlighting the company's lack of control over their design, administration, or data quality - A new risk factor was disclosed regarding the company's lack of control over investigator-initiated clinical trials, such as the ongoing Phase 2 trial of ZYNLONTA in MZL. This includes no control over trial design, conduct, or data quality control[157](index=157&type=chunk)[158](index=158&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no sales of unregistered equity securities or purchases of its own equity securities during the period covered by this report - There were no sales of unregistered equity securities or issuer purchases of equity securities during the quarter[159](index=159&type=chunk)[160](index=160&type=chunk) [Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No directors or officers of the company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the reporting period[161](index=161&type=chunk)