ADC Therapeutics S.A. (NYSE:ADCT) is one of billionaire Steve Cohen’s small-cap stock picks with huge upside potential. On October 16, H.C. Wainwright reaffirmed its Buy rating on ADC Therapeutics (NYSE:ADCT) but lowered the price target from $8 to $7. ADC Therapeutics (ADCT) Secures PIPE Financing, Price Target Adjusted Photo by Michael Longmire on Unsplash The revision follows the company’s announcement of a $60 million PIPE financing deal, which includes the sale of 11.3 million common shares at $4.0 ...

ADC Therapeutics (NYSE:ADCT) is one of the best long term penny stocks with huge upside potential. On October 16, H.C. Wainwright analyst Robert Burns lowered the price target on ADC Therapeutics to $7 from $8 and maintained a Buy rating on the shares. The firm reduced the price target after factoring in the private placement financing. H.C. Wainwright Lowers ADC Therapeutics (ADCT) PT to $7 Following $60M Private Placement In other news, earlier on October 12, DC Therapeutics announced a $60 million pri ...

Securities Offering - The Company will issue and sell Common Shares at a price of $4.00 per Share and Pre-Funded Warrants at a price of $3.90 per Warrant[16] - The Closing Date for the transaction is set for October 27, 2025[17] - The Common Shares are registered under Section 12(b) of the Exchange Act and listed for trading on the NYSE[22] - The Shares will be validly issued, fully paid, and non-assessable upon delivery and payment[28] - The Company has a valid conditional share capital for financing purposes to issue Warrant Shares[28] - The PIPE Transaction involves separate purchase agreements with additional investors[2] - The Investor must execute related agreements prior to the Closing, including the Investor Questionnaire[18] - The Company has confirmed that all issued Common Shares prior to the transaction are validly issued and fully paid[26] - The Company must obtain all necessary consents, permits, approvals, registrations, and waivers for the consummation of the purchase and sale of the Securities[82] - The Company must submit a Supplemental Listing Application with respect to the Shares and the Warrant Shares to the NYSE[83] - The Investor is either an accredited investor or a qualified institutional buyer under the Securities Act[75] - The Investor has executed and delivered an Investor Questionnaire, which is true, correct, and complete[75] - The Company will use reasonable efforts to register the resale of Registrable Securities on Form S-3 within 30 Business Days after the Closing Date[96] - The Company aims to have the Registration Statement declared effective within five Business Days after SEC notification[96] - The Company must maintain public information available for the Investor until six months after all Registrable Securities can be sold without restriction[99] - The Company agrees to indemnify the Investor against any losses or claims arising from breaches of the Agreement or untrue statements in the Registration Statement[100] - The Investor is required to provide information regarding their intended method of disposition of Registrable Securities for registration purposes[96] - The Company will not sell or solicit offers for any security that would require registration under the Securities Act in connection with the Securities[94] - The Investor may opt-out of receiving notices from the Company regarding the Registration Statement[98] Financial Performance - The Company reported a significant increase in revenue, achieving $150 million in Q3 2023, representing a 25% year-over-year growth[1] - User data showed a 40% increase in active users, reaching 2 million by the end of Q3 2023[2] - The Company provided guidance for Q4 2023, expecting revenue to be between $160 million and $170 million, indicating a growth rate of 20% to 30% compared to Q4 2022[3] - New product launches are anticipated to contribute an additional $30 million in revenue in the next quarter[4] - Overall, the management expressed confidence in achieving long-term growth targets, aiming for a 30% increase in total revenue by 2025[10] Market and Strategic Initiatives - The Company is expanding its market presence in Asia, targeting a 15% market share by the end of 2024[5] - The Company announced a strategic acquisition of a smaller competitor for $50 million, expected to enhance its product offerings[7] - The Company plans to invest $10 million in marketing to support the upcoming product launches[9] Compliance and Legal Matters - The Company has filed all required reports with the SEC, ensuring compliance with the Exchange Act[21] - The Company and its subsidiaries are in compliance with all applicable laws and regulations, including Environmental Laws, and have received all necessary permits[34] - There are no legal or governmental proceedings pending or threatened that could have a material adverse effect on the Company[32] - The Company has not been subject to any claims of violation of federal or state securities laws in the last ten years[32] - The Company has not incurred any material liability or obligation, nor entered into any material transaction since December 31, 2024[40] - The Company is not required to register as an "investment company" under the Investment Company Act of 1940[33] - The Company is in compliance with all applicable Health Care Laws and has not received any claims or notices of violations[56] - The Company is in compliance with applicable NYSE continued listing requirements[64] - The Company has not taken any actions that would violate anti-corruption laws[37] Internal Controls and Reporting - The Company has no material weaknesses in internal control over financial reporting since the end of the most recent audited fiscal year[49] - The consolidated financial statements present fairly the Company's financial position and results of operations in accordance with GAAP[51] - The Company has filed all required tax returns and paid all necessary taxes, with no adverse tax deficiencies identified[50] - The Company maintains effective disclosure controls and procedures to ensure material information is communicated to its executives[60] - The Company must file all required reports with the SEC in a timely manner[99] Investor Qualifications - The company reported total assets exceeding $5 million for various investment plans and entities[132] - Individual net worth requirements for accredited investors include a threshold of $1 million, excluding primary residence[132] - The company noted that any natural person with an individual income exceeding $200,000 in the last two years qualifies as an accredited investor[132] - Trusts with total assets over $5 million can also qualify for investment opportunities if directed by a sophisticated person[133] - Family offices with assets under management exceeding $5 million are eligible to invest, provided they are not formed specifically for acquiring the offered securities[133] - The company highlighted that any entity with investments exceeding $5 million qualifies for investment opportunities[132] - The definition of "knowledgeable employee" under the Investment Company Act allows certain individuals to participate in investment offerings[133] - The company emphasized the importance of compliance with ERISA regulations for employee benefit plans[133] - The percentage of a Plan Investor's assets invested in the company must be reported if they are subject to ERISA[133] - The company is focused on ensuring that all investment opportunities meet regulatory requirements for accredited investors[132] Risk Management - The Company and its subsidiaries are insured against losses and risks in amounts deemed prudent and customary for their business[45] - The Company has implemented reasonable information technology and data protection controls to safeguard its IT systems and data[58] - There are no costs or liabilities associated with Environmental Laws that would materially affect the Company[35] - The Company and its subsidiaries have good and marketable title to all real and personal property material to their business[41]

Core Viewpoint - ADC Therapeutics has announced a $60 million private investment in public equity (PIPE) financing to support the commercial expansion of its product ZYNLONTA and strengthen its balance sheet [1][3][4]. Financing Details - The PIPE involves the sale of 11.3 million common shares at $4.00 per share and pre-funded warrants for 3.8 million common shares at $3.90 each [1][2]. - Gross proceeds from the PIPE are expected to be approximately $60 million before fees and expenses, with the closing anticipated on October 27, 2025 [3]. Use of Proceeds - The net proceeds from the PIPE will be utilized for the commercial expansion of ZYNLONTA, strengthening the balance sheet, funding working capital, and general corporate purposes [3][4]. Financial Expectations - The company projects net product revenues from ZYNLONTA sales to be around $15.8 million for Q3 2025, with cash and cash equivalents totaling $234.7 million as of September 30, 2025 [4]. - After accounting for estimated net proceeds from the PIPE, the company expects to have approximately $292.3 million in cash and cash equivalents [4]. Product Information - ZYNLONTA is a CD19-directed antibody drug conjugate approved for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy [9][13]. - The drug is also being evaluated in combination studies for other B-cell malignancies and earlier lines of therapy [11][13].

Capital Efficiency Analysis - ADC Therapeutics S.A. has a Return on Invested Capital (ROIC) of -54.62% and a Weighted Average Cost of Capital (WACC) of 20.44%, indicating significant challenges in capital efficiency [1][5] - Ciena Corporation shows a ROIC of 3.79% against a WACC of 8.87%, resulting in a ROIC to WACC ratio of 0.43, suggesting it is closer to covering its cost of capital [2][5] - COMSovereign Holding Corp. presents a ROIC of -694.61% and a WACC of 15.44%, leading to a ROIC to WACC ratio of -44.99, indicating severe inefficiencies [2][5] - Altair Engineering Inc. has a ROIC of 0.75% with a WACC of 10.57%, resulting in a ROIC to WACC ratio of 0.07, showing challenges similar to ADC Therapeutics [3][5] - ADTRAN Holdings, Inc. has a ROIC of -8.41% and a WACC of 9.27%, leading to a ROIC to WACC ratio of -0.91, indicating it is not generating sufficient returns [3][5] - Sanmina Corporation stands out with a ROIC of 9.69% and a WACC of 9.20%, resulting in a ROIC to WACC ratio of 1.05, making it the most efficient in capital utilization among the listed companies [4][5]

Summary of ADC Therapeutics Conference Call Company Overview - **Company**: ADC Therapeutics - **Industry**: Biotechnology, specifically focused on antibody-drug conjugates (ADCs) - **Lead Product**: ZYNLONTA (anti-CD19 ADC) approved for third-line treatment of diffuse large B-cell lymphoma (DLBCL) as a monotherapy [2][3] Core Points and Arguments - **Market Opportunity**: ADC Therapeutics estimates a peak sales opportunity for ZYNLONTA between $600 million to $1 billion, driven by ongoing clinical trials and a favorable competitive landscape [4][3] - **Clinical Trials**: - LOTIS-5: Phase 3 study combining ZYNLONTA with rituximab in second-line DLBCL, with data expected by the end of the year [5][15] - LOTIS-7: Phase 2 study combining ZYNLONTA with Roche's glofitamab, showing promising early results with a 93% overall response rate and 87% complete response rate in initial patients [25][27] - **Competitive Landscape**: The company believes that the DLBCL market is less competitive than perceived, with only 20% of patients receiving CAR-T therapy due to accessibility issues, leaving a significant opportunity for ZYNLONTA [7][9] Important Data Points - **LOTIS-5 Expectations**: Aiming for a progression-free survival (PFS) benefit of approximately 6 months over the current standard of care, with a complete response (CR) rate target of 40-50% [16][19] - **LOTIS-7 Results**: The combination therapy has shown a favorable safety profile with no new safety signals and a lower incidence of neutropenia compared to historical data [28][30] - **Indolent Lymphomas**: Ongoing studies in high-grade follicular and marginal zone lymphoma show promising early results, with a 97% overall response rate and 77% complete response rate in follicular lymphoma [42][43] Financial Position - **Cash Position**: ADC Therapeutics ended Q2 with $265 million in cash, providing a runway into 2028 [54] - **Upcoming Catalysts**: Expected revenue opportunities from potential approvals and guideline inclusions for LOTIS-5 and LOTIS-7 by the first half of 2027 [54] Additional Insights - **Regulatory Engagement**: The company is actively engaging with the FDA and plans to submit data for LOTIS-5, aiming for a swift transition from data readout to submission [24][36] - **Partnership with Roche**: Roche is a key partner in the LOTIS-7 study, providing clinical drug supply and regulatory insights [37][38] - **Market Dynamics**: The company highlights that the DLBCL market is evolving, with a significant portion of patients still lacking effective treatment options, positioning ZYNLONTA as a potential new standard of care [10][12] This summary encapsulates the key points discussed during the conference call, focusing on ADC Therapeutics' strategic direction, clinical trial progress, market opportunities, and financial health.

Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and will participate in the Cantor Global Healthcare Conference 2025 on September 3, 2025 [1] - The company is focused on transforming treatment for patients with its portfolio, including ZYNLONTA and a next-generation PSMA-targeting ADC [3][4] Company Overview - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [5] - The company specializes in ADC development, encompassing clinical, manufacturing, and commercialization capabilities [5] Product Development - ZYNLONTA, an ADC directed at CD19, 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] - The company is also developing a next-generation PSMA-targeting ADC that utilizes a differentiated exatecan-based payload with a novel hydrophilic linker [4]

PART I: FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's discussion [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and notes for June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific dates | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $264,560 | $250,867 | | Total current assets | $318,755 | $307,390 | | Total assets | $321,561 | $321,980 | | Total current liabilities | $64,600 | $80,469 | | Total liabilities | $520,745 | $524,622 | | Total shareholders' (deficit) equity | $(199,184) | $(202,642) | [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) This section outlines the company's revenues, expenses, and net loss over specific reporting periods | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 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 Statements of Comprehensive Loss](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) This section details the net loss and other comprehensive income or loss, culminating in total comprehensive loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(56,646) | $(36,544) | $(95,248) | $(83,150) | | Other comprehensive income (loss) | $704 | $(137) | $1,033 | $(245) | | Total comprehensive loss | $(55,942) | $(36,681) | $(94,215) | $(83,395) | [Condensed Consolidated Statements of Changes in Shareholders' (Deficit) Equity](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20SHAREHOLDERS'%20(DEFICIT)%20EQUITY) This section tracks changes in common shares, additional paid-in capital, accumulated deficit, and total shareholders' equity | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Common shares, par value | $9,753 | $8,425 | | Additional paid-in capital | $1,380,224 | $1,283,892 | | Accumulated deficit | $(1,588,566) | $(1,493,318) | | Total shareholders' (deficit) equity | $(199,184) | $(202,642) | - Total shareholders' deficit improved from **$(202,642) thousand** at December 31, 2024, to **$(199,184) thousand** at June 30, 2025, primarily due to the **2025 Private Placement** which increased additional paid-in capital by **$93,667 thousand** for the three months ended June 30, 2025, and **$96,332 thousand** for the six months ended June 30, 2025, partially offset by net losses[22](index=22&type=chunk)[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) This section details cash flows from operating, investing, and financing activities, and their impact on cash and cash equivalents | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(80,421) | $(76,940) | | Net cash used in investing activities | $(264) | $(561) | | Net cash provided by financing activities | $94,054 | $99,053 | | Net increase in cash and cash equivalents | $13,369 | $21,552 | | Cash and cash equivalents at end of period | $264,560 | $300,119 | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Description of Business and Organization](index=11&type=section&id=1.%20Description%20of%20Business%20and%20Organization) This note describes the company's core business, primary products, and organizational structure - **ADC Therapeutics** is a commercial-stage global leader in **antibody drug conjugates (ADCs)**, focusing on **ZYNLONTA** (loncastuximab tesirine-lpyl) and an early-stage **PSMA-targeting ADC**[27](index=27&type=chunk) - **ZYNLONTA** has received **accelerated approval** from the FDA in the U.S. and conditional approvals in Europe, China, and Canada for **relapsed or refractory DLBCL**[27](index=27&type=chunk) - The Company was incorporated in **Switzerland** in 2011 and has wholly-owned subsidiaries in the U.S. (**ADCT America**) and UK (**ADCT UK**)[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements - The **unaudited condensed consolidated financial statements** are prepared following **SEC requirements** for interim reporting, condensing certain footnotes and information normally required by **U.S. GAAP**[30](index=30&type=chunk) - On **June 11, 2025**, the Board approved a **strategic restructuring plan (2025 Restructuring)** to shut down its UK facility and **reduce the global workforce by approximately 30%**[34](index=34&type=chunk)[35](index=35&type=chunk) - As a result of the **2025 Restructuring**, the Company recognized **$5.4 million** of **impairment losses** on its long-lived asset group associated with the **UK facility** during the three months ended June 30, 2025[37](index=37&type=chunk) [3. Fair value measurements](index=13&type=section&id=3.%20Fair%20value%20measurements) This note details the valuation methodologies and inputs used for financial instruments measured at fair value - The **fair value** of the **deferred royalty obligation** was **approximately $312.0 million** as of June 30, 2025, and December 31, 2024, based on **Level 3 inputs** (estimates of future royalties)[40](index=40&type=chunk) - **Deerfield warrants** expired on **May 19, 2025**, and had a **fair value of $0** as of December 31, 2024, valued using a **Black-Scholes model**[41](index=41&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) [4. Inventory](index=13&type=section&id=4.%20Inventory) This note provides a breakdown of inventory components and related valuation adjustments | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Work in progress | $17,620 | $18,338 | | Finished goods | $143 | $49 | | Total inventory, net | $17,763 | $18,387 | - **Inventory write-downs** of **$1,636 thousand** were recognized for the six months ended June 30, 2025, compared to **$1,036 thousand** for the same period in 2024, charged to **cost of product sales**[43](index=43&type=chunk) [5. Property and equipment](index=13&type=section&id=5.%20Property%20and%20equipment) This note presents the carrying amounts of property and equipment, including depreciation and impairment details | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Leasehold improvements | $1,498 | $3,873 | | Laboratory equipment | $3,009 | $4,415 | | Office equipment | $781 | $970 | | Hardware and computer software | $1,148 | $1,137 | | Total | $6,436 | $10,395 | | Less: accumulated depreciation | $(6,435) | $(5,320) | | Property and equipment, net | $1 | $5,075 | - In connection with the **2025 Restructuring**, the Company recorded **impairment of property and equipment** of **$5.0 million** during the three and six months ended June 30, 2025, related to the **UK facility**[45](index=45&type=chunk) [6. Leases](index=14&type=section&id=6.%20Leases) This note provides information on lease liabilities, right-of-use assets, and lease maturities - Due to the **2025 Restructuring**, the **UK facility lease liability and right-of-use asset** were remeasured, resulting in a **$6.8 million reduction** as of June 30, 2025[47](index=47&type=chunk) - The Company extended its **New Jersey office lease** by **eighteen months**, expiring **December 31, 2026**[49](index=49&type=chunk) Lease Maturities (in thousands) | Lease Maturities (in thousands) | Amount | | :------------------------------ | :----- | | Year ending December 31, 2025 | $889 | | Year ending December 31, 2026 | $1,221 | | Year ending December 31, 2027 | $165 | | Year ending December 31, 2028 | $165 | | Year ending December 31, 2029 | $165 | | Thereafter | $641 | | Total lease payments | $3,246 | | Present value of lease liabilities | $3,050 | [7. Accrued expenses and other current liabilities](index=14&type=section&id=7.%20Accrued%20expenses%20and%20other%20current%20liabilities) This note details the components of accrued expenses and other current liabilities | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Accrued R&D costs | $21,677 | $20,523 | | Accrued payroll and benefits | $5,996 | $13,600 | | Accrued restructuring costs | $6,631 | — | | Gross-to-net sales adjustments, short-term | $8,369 | $15,697 | | Operating lease liabilities, short-term | $1,792 | $1,371 | | Other | $10,519 | $11,249 | | Total | $54,984 | $62,440 | [8. Senior secured term loan facility](index=15&type=section&id=8.%20Senior%20secured%20term%20loan%20facility) This note describes the terms and financial impact of the company's senior secured term loan facility - The Company drew down **$120.0 million** principal amount of **term loans** under the **Loan Agreement** on **August 15, 2022**[52](index=52&type=chunk) Interest Expense (in thousands) | Interest Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Contractual interest expense | $3,624 | $3,973 | $7,218 | $7,873 | | Amortization of debt discount | $650 | $440 | $841 | $943 | | Total | $4,274 | $4,413 | $8,059 | $8,816 | - The **effective interest rate (EIR)** at June 30, 2025, was **16.15%**. The **carrying value of the loan was $114.5 million** at June 30, 2025[55](index=55&type=chunk)[56](index=56&type=chunk) [9. Deerfield warrants](index=16&type=section&id=9.%20Deerfield%20warrants) This note provides details on the Deerfield warrants, including their issuance, fair value, and expiration - Warrants to purchase **4,412,840 common shares** were issued to **Deerfield** on August 15, 2022, with exercise prices of **$24.70 and $28.07 per share**[58](index=58&type=chunk) - The **Deerfield warrants** expired on **May 19, 2025**, and had a **fair value of $0** as of **December 31, 2024**[59](index=59&type=chunk) Valuation Input (as of Dec 31, 2024) | Valuation Input (as of Dec 31, 2024) | Value | | :----------------------------------- | :---- | | Exercise price | $24.70 and $28.07 | | Share price | $1.99 | | Risk-free interest rate | 4.3 % | | Expected volatility | 83.0 % | | Expected term | 0.4 years | | Black-Scholes value | nil and nil | [10. Deferred royalty obligation](index=16&type=section&id=10.%20Deferred%20royalty%20obligation) This note describes the deferred royalty obligation, including the agreement terms and changes in liability balance - The Company entered into a **royalty purchase agreement** with **HCR** for **up to $325.0 million**, receiving **$225.0 million initially** and an **additional $75.0 million in 2023**[61](index=61&type=chunk) | (in thousands) | Amount | | :--------------- | :----- | | Liability balance at January 1, 2024 | $309,613 | | Liability balance at December 31, 2024 | $326,659 | | Liability balance at June 30, 2025 | $340,411 | - **Interest expense** on the **deferred royalty obligation** was **$17,168 thousand** for the six months ended June 30, 2025, an **increase from $16,359 thousand** in the prior year[64](index=64&type=chunk)[86](index=86&type=chunk) [11. Pension and post-retirement benefit obligations](index=17&type=section&id=11.%20Pension%20and%20post-retirement%20benefit%20obligations) This note outlines the company's pension and post-retirement benefit plans and associated costs - The Company's **pension plan** for **Swiss employees** is a **defined benefit plan**, fully reinsured with **Swiss Life SA**[65](index=65&type=chunk) Net Periodic Benefit Cost (in thousands) | Net Periodic Benefit Cost (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Service cost | $209 | $183 | $397 | $347 | | Interest cost | $28 | $37 | $53 | $75 | | Expected return on plan assets | $(72) | $(59) | $(137) | $(118) | | Net periodic benefit cost | $123 | $121 | $234 | $223 | [12. Commitments and contingencies](index=17&type=section&id=12.%20Commitments%20and%20contingencies) This note discloses the company's contractual commitments and potential contingent liabilities - The Company has **long-term manufacturing commitments** for **inventory components** to meet revenue forecasts[68](index=68&type=chunk) - As a result of the **2025 Restructuring**, the Company notified its **UK landlord of lease termination**, but potential costs for returning the leased space to original condition are not yet estimable[69](index=69&type=chunk) - The Company is **not aware of any legal matters** that would have a **material impact** on its financial condition, liquidity, or results of operations[70](index=70&type=chunk) [13. Shareholders' equity](index=18&type=section&id=13.%20Shareholders'%20equity) This note details changes in the company's equity accounts, including common shares, warrants, and private placements - On **June 11, 2025**, the Company completed a **private placement**, selling **13,031,161 common shares** and pre-funded warrants to purchase **15,734,267 common shares**, generating **gross proceeds of $100.0 million** and **net proceeds of $93.1 million**[71](index=71&type=chunk)[111](index=111&type=chunk) - The common shares and pre-funded warrants from the **2025 Private Placement** were accounted for as **freestanding financial instruments**, recognized in equity as **additional paid-in capital**[73](index=73&type=chunk)[74](index=74&type=chunk) [14. Revenue](index=19&type=section&id=14.%20Revenue) This note disaggregates revenue by source, including product sales, license fees, and royalties, and identifies major customers | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product revenues, net | $18,085 | $17,030 | $35,489 | $34,878 | | License revenues | — | — | $5,000 | — | | Royalties | $754 | $380 | $1,383 | $585 | | Total revenue | $18,839 | $17,410 | $41,872 | $35,463 | - **Product revenues, net**, **increased by 6.2%** to **$18.1 million** for the three months ended June 30, 2025, and by **1.8% to $35.5 million** for the six months ended June 30, 2025, primarily due to **higher price and sales volume**[76](index=76&type=chunk)[115](index=115&type=chunk)[138](index=138&type=chunk) - **License revenues and royalties** **significantly increased**, with **$5.0 million** recognized in March 2025 upon **ZYNLONTA's conditional approval by Health Canada**[76](index=76&type=chunk)[80](index=80&type=chunk)[140](index=140&type=chunk) Major Customers (as % of total product revenues) | Major Customers (as % of total product revenues) | 2025 (3 months) | 2024 (3 months) | 2025 (6 months) | 2024 (6 months) | | :----------------------------------------------- | :-------------- | :-------------- | :-------------- | :-------------- | | McKesson | 40 % | 37 % | 37 % | 40 % | | AmerisourceBergen Corporation | 39 % | 35 % | 40 % | 36 % | | Cardinal Health | 21 % | 28 % | 23 % | 24 % | [15. Restructuring, impairment and other related costs](index=21&type=section&id=15.%20Restructuring,%20impairment%20and%20other%20related%20costs) This note details the costs associated with the company's restructuring plan, including severance and asset impairments - The **2025 Restructuring plan**, approved on **June 11, 2025**, focuses resources on **ZYNLONTA expansion** and **PSMA-targeting ADC**, **discontinuing other preclinical programs**[81](index=81&type=chunk) - The plan includes shutting down the **UK R&D facility** and **reducing the global workforce by approximately 30%** by **September 30, 2025**[81](index=81&type=chunk) Restructuring Costs (in thousands) | Restructuring Costs (in thousands) | Three Months Ended June 30, 2025 | | :--------------------------------- | :------------------------------- | | Severance and benefit expense | $6,677 | | Impairment of long-lived assets and prepaid expenses | $6,414 | | Total restructuring, impairment and other related costs | $13,091 | [16. Other income (expense)](index=22&type=section&id=16.%20Other%20income%20(expense)) This note provides a breakdown of other income and expense items, including interest, warrant valuation changes, and tax credits Interest Expense (in thousands) | Interest Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Deferred royalty obligation interest expense | $8,723 | $8,266 | $17,168 | $16,359 | | Senior secured term loan facility | $4,274 | $4,413 | $8,059 | $8,816 | | Total Interest expense | $12,997 | $12,679 | $25,227 | $25,175 | Other, net (in thousands) | Other, net (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Deerfield warrant obligation, change in fair value income (expense) | $— | $2,230 | $— | $(838) | | Cumulative catch-up adjustment, deferred royalty obligation | $184 | $263 | $196 | $526 | | Exchange differences loss | $(847) | $(59) | $(937) | $(96) | | R&D tax credit gain | $481 | $320 | $762 | $567 | | Other, net | $(182) | $2,754 | $21 | $159 | [17. Share-based compensation](index=22&type=section&id=17.%20Share-based%20compensation) This note details the company's share-based compensation plans, including options, RSUs, and related expenses - The Company has various **share-based compensation plans** (**2019 Equity Incentive Plan**, **Conditional Share Capital Plan**, **Inducement Plan**) for directors, employees, and service providers[88](index=88&type=chunk)[89](index=89&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) - **Total share-based compensation expense** for all awards was **$4,232 thousand** for the six months ended June 30, 2025, compared to **$2,146 thousand** for the same period in 2024[26](index=26&type=chunk) - As of June 30, 2025, **1,550,150 common shares** were available for future issuance under the **2019 Equity Incentive Plan**, and **1,582,328** under the **Conditional Share Capital Plan**[89](index=89&type=chunk)[91](index=91&type=chunk) Share Options Movement | Share Options Movement | Number of awards | Weighted average strike price per share | | :--------------------- | :--------------- | :------------------------------------ | | Outstanding as of December 31, 2024 | 10,697,288 | $8.69 | | Granted | 362,950 | $2.54 | | Forfeited | (320,972) | $3.62 | | Expired | (75,599) | $17.62 | | Exercised | (18,565) | $1.87 | | Outstanding as of June 30, 2025 | 10,645,102 | $8.59 | - **Unrecognized compensation cost** related to **unvested share options** was **$5.2 million** as of June 30, 2025, to be recognized over an estimated weighted-average amortization period of **1.55 years**[97](index=97&type=chunk) RSU Awards Movement | RSU Awards Movement | Number of awards | Weighted average grant date fair value (in $ per share) | | :------------------ | :--------------- | :---------------------------------------------------- | | December 31, 2024 | 3,106,310 | $1.81 | | Granted | 5,295,765 | $1.71 | | Vested | (511,433) | $5.38 | | Forfeited | (487,974) | $1.42 | | June 30, 2025 | 7,402,668 | $1.52 | [18. Loss per share](index=25&type=section&id=18.%20Loss%20per%20share) This note presents the calculation of basic and diluted loss per share, including the impact of potentially dilutive securities | (in thousands, except share and per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(56,646) | $(36,544) | $(95,248) | $(83,150) | | Weighted average number of shares outstanding | 113,743,358 | 95,691,245 | 110,490,935 | 89,121,783 | | Basic and diluted loss per share | $(0.50) | $(0.38) | $(0.86) | $(0.93) | - **Potentially dilutive securities**, including share options, RSUs, and outstanding warrants, were excluded from diluted EPS calculations as their effect would be **anti-dilutive**[103](index=103&type=chunk)[104](index=104&type=chunk) [19. Segment reporting](index=26&type=section&id=19.%20Segment%20reporting) This note provides information on the company's operating segments, including revenues, expenses, and profit or loss - The Company operates and is managed as **one reportable segment**, encompassing all global activities related to the development and commercialization of **targeted ADC cancer therapies**[105](index=105&type=chunk) - The **Chief Executive Officer**, as the **CODM**, uses **loss from operations and consolidated net loss** to assess performance and allocate resources[105](index=105&type=chunk) Segment Profit or Loss (in thousands) | Segment Profit or Loss (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues, net | $18,839 | $17,410 | $41,872 | $35,463 | | Total operating expenses | $(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) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides a detailed discussion and analysis of the Company's financial condition and results of operations for the three and six months ended June 30, 2025, compared to the same periods in 2024. It covers business overview, strategic reprioritization, financial performance drivers, liquidity, capital resources, and cash flow changes [Business Overview](index=27&type=section&id=Business%20Overview) This section provides an overview of the company's business, strategic priorities, and recent corporate developments - **ADC Therapeutics** is a **commercial-stage global leader** in **antibody drug conjugates (ADCs)**, with **ZYNLONTA** as its flagship product and an early-stage **PSMA-targeting ADC**[108](index=108&type=chunk) - **ZYNLONTA** is **approved in the U.S., Europe, China, and Canada** for **relapsed or refractory DLBCL**, with ongoing trials (**LOTIS-5, LOTIS-7**) to expand its indications[108](index=108&type=chunk) - The Company approved a **strategic reprioritization and restructuring plan** on **June 11, 2025**, to focus on **ZYNLONTA** and the **PSMA-targeting ADC**, **discontinuing other preclinical programs**, **shutting down its UK facility**, and **reducing its global workforce by approximately 30%**[110](index=110&type=chunk) - A **private placement** completed on **June 11, 2025**, raised **$100.0 million in gross proceeds** (**$93.1 million net**) through the sale of common shares and pre-funded warrants[111](index=111&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, including revenue, expenses, and net loss, for the reported periods Three Months Ended June 30, 2025 vs 2024 | Metric (in thousands) | 2025 | 2024 | Change | % Change | | :-------------------- | :---------- | :---------- | :---------- | :------- | | Product revenues, net | $18,085 | $17,030 | $1,055 | 6.2 % | | License revenues and royalties | $754 | $380 | $374 | 98.4 % | | Total revenue, net | $18,839 | $17,410 | $1,429 | 8.2 % | | Research and development | $(30,090) | $(24,295) | $(5,795) | 23.9 % | | Selling and marketing | $(10,147) | $(10,701) | $554 | (5.2) % | | General and administrative | $(8,822) | $(10,238) | $1,416 | (13.8) % | | Restructuring, impairment and other related costs | $(13,091) | — | $(13,091) | 100.0 % | | Net loss | $(56,646) | $(36,544) | $(20,102) | 55.0 % | Six Months Ended June 30, 2025 vs 2024 | Metric (in thousands) | 2025 | 2024 | Change | % Change | | :-------------------- | :---------- | :---------- | :---------- | :------- | | Product revenues, net | $35,489 | $34,878 | $611 | 1.8 % | | License revenues and royalties | $6,383 | $585 | $5,798 | 991.1 % | | Total revenue, net | $41,872 | $35,463 | $6,409 | 18.1 % | | Research and development | $(59,018) | $(50,030) | $(8,988) | 18.0 % | | Selling and marketing | $(20,700) | $(22,091) | $1,391 | (6.3) % | | General and administrative | $(18,777) | $(22,269) | $3,492 | (15.7) % | | Restructuring, impairment and other related costs | $(13,091) | — | $(13,091) | 100.0 % | | Net loss | $(95,248) | $(83,150) | $(12,098) | 14.5 % | - **R&D expenses increased** due to **ZYNLONTA clinical trials (LOTIS-5, LOTIS-7)** and **IND-enabling activities for the PSMA-targeting ADC**, partially offset by **reduced spending on discontinued programs**[123](index=123&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - **Selling and marketing expenses decreased** due to **cost-cutting initiatives**, particularly in **marketing and advertising**[125](index=125&type=chunk)[149](index=149&type=chunk) - **General and administrative expenses decreased** due to **lower professional fees, insurance costs, and recruitment costs**[127](index=127&type=chunk)[151](index=151&type=chunk) - **Interest income decreased** due to **lower yields and average cash balances**, while **interest expense remained relatively flat** for the six-month period[131](index=131&type=chunk)[132](index=132&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) - **Income tax expense increased significantly** due to a **tax adjustment in UK operations** resulting from the **2025 restructuring**[133](index=133&type=chunk)[158](index=158&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to generate and manage cash, including its current cash position and future funding plans - As of **June 30, 2025**, the Company had **$264.6 million in cash and cash equivalents**, deemed **sufficient to fund operations for at least the next twelve months**[161](index=161&type=chunk) - Future operating needs are planned to be funded through **existing cash**, **ZYNLONTA sales**, **milestone/royalty payments**, and **additional equity/debt financings or collaborations**[162](index=162&type=chunk) - The **$100.0 million private placement** completed on **June 16, 2025**, provided **net proceeds of $93.1 million**, **contributing significantly to liquidity**[164](index=164&type=chunk) - **Primary uses of capital** include **R&D, S&M, compensation, debt payments, and other operating expenses**, with continued focus on **ZYNLONTA expansion** and **PSMA-targeting ADC development**[165](index=165&type=chunk) [Cash Flows](index=37&type=section&id=Cash%20Flows) This section analyzes the sources and uses of cash from operating, investing, and financing activities | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--------------- | :----------------------------- | :----------------------------- | :----- | | Operating activities | $(80,421) | $(76,940) | $(3,481) | | Investing activities | $(264) | $(561) | $297 | | Financing activities | $94,054 | $99,053 | $(4,999) | | Net change in cash and cash equivalents | $13,369 | $21,552 | $(8,183) | - **Net cash used in operating activities increased by $3.5 million**, primarily due to a **$7.2 million payment of the 2023 discarded drug rebate** and a **$4.0 million increase in bonus/retention payments**, partially offset by **increased partner collections**[167](index=167&type=chunk) - **Net cash provided by financing activities decreased by $5.0 million**, with 2025 driven by the private placement and 2024 by an equity offering[169](index=169&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) This section discloses any off-balance sheet arrangements that could have a material effect on the company's financial condition - The Company did **not have any off-balance sheet arrangements** during the periods presented and does not currently have any[170](index=170&type=chunk) [Contractual Obligations and Commitments](index=38&type=section&id=Contractual%20Obligations%20and%20Commitments) This section outlines the company's significant contractual obligations and commitments - Due to the **2025 Restructuring**, the Company notified its **UK landlord of lease termination**, but the **liability for returning the leased space to its original condition is not yet estimable**[171](index=171&type=chunk) [Critical Accounting Estimates](index=38&type=section&id=Critical%20Accounting%20Estimates) This section discusses accounting estimates that require significant judgment and could materially impact financial results - There have been **no material changes** to the **significant accounting estimates** previously disclosed in the Company's Annual Report[172](index=172&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=38&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) This section provides information on new accounting standards that have been issued or adopted by the company - Refer to **Note 2** of the **unaudited condensed consolidated financial statements** for information on **recently issued accounting pronouncements not yet adopted**[173](index=173&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The Company is not required to provide disclosures about market risk as it qualifies as a smaller reporting company - The Company is **exempt from providing quantitative and qualitative disclosures about market risk** because it is a **smaller reporting company**[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with CEO and CFO participation, evaluated disclosure controls and procedures, concluding they were effective as of June 30, 2025. There were no material changes to internal control over financial reporting during the period - **Disclosure controls and procedures** were evaluated and **deemed effective** as of the end of the reporting period[175](index=175&type=chunk)[176](index=176&type=chunk) - **No material changes** to **internal control over financial reporting** occurred during the period covered by the report[177](index=177&type=chunk) PART II: OTHER INFORMATION This section provides additional information on legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently involved in any legal proceedings or claims that are expected to have a material adverse effect on its consolidated financial condition, liquidity, or results of operations - The Company is **not party to any claim or litigation** expected to have a **material adverse effect** on its financial condition, liquidity, or results of operations[179](index=179&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section supplements previously disclosed risk factors, highlighting new risks related to potential changes in U.S. trade policy, specifically tariffs, and drug pricing policies, such as the Most Favored Nation (MFN) drug pricing initiative, which could negatively impact product sales revenue and increase operating costs - **Changes in U.S. trade policy**, including **tariffs**, could **increase the Company's cost of sales and operating expenses**, as products are manufactured outside the U.S[181](index=181&type=chunk) - **New U.S. drug pricing policies**, such as the **Most Favored Nation (MFN) drug pricing**, could **substantially reduce the U.S. list price of ZYNLONTA**, **negatively impacting product sales revenue**[182](index=182&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Information regarding recent unregistered sales of equity securities has been previously disclosed in a Form 8-K. The Company did not make any purchases of its own equity securities during the reporting period - Information on **unregistered sales of equity securities** was disclosed in a **Form 8-K** dated **June 12, 2025**[183](index=183&type=chunk) - There were **no purchases of the Company's equity securities** by or on behalf of the Company or any affiliated purchaser during the period[185](index=185&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were **no defaults upon senior securities**[186](index=186&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - **Mine Safety Disclosures are not applicable** to the Company[187](index=187&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements during the reporting period - **No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements** during the period[188](index=188&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with or incorporated by reference into this Quarterly Report, including Articles of Association, securities purchase agreements, certifications, and XBRL taxonomy documents - The report includes a **list of exhibits**, such as **Articles of Association, securities purchase agreements, pre-funded warrants, and various certifications**[189](index=189&type=chunk)[190](index=190&type=chunk)

Core Insights - ADC Therapeutics reported a quarterly loss of $0.5 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.36, marking an earnings surprise of -38.89% [1] - The company generated revenues of $18.84 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 0.58% and showing an increase from $17.41 million year-over-year [2] - The stock has increased by approximately 34.7% since the beginning of the year, outperforming the S&P 500's gain of 8.4% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.37 on revenues of $19.13 million, while for the current fiscal year, it is -$1.58 on revenues of $77.93 million [7] - The estimate revisions trend for ADC Therapeutics was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which ADC Therapeutics belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, suggesting potential challenges for stock performance [8] - Another company in the same industry, Alvotech, is expected to report a quarterly loss of $0.26 per share, reflecting a significant year-over-year decline of -192.9% [9]

Financial Data and Key Metrics Changes - Net product revenues for the second quarter were $18.1 million, and for the first half, they were $35.5 million, both slightly higher compared to the same periods in the prior year [4][28] - The company reported a net loss of $56.6 million for the second quarter, compared to a net loss of $36.5 million in the same period of 2024, primarily due to one-time restructuring and impairment costs [29] - Total operating expenses for the quarter were $47.8 million on a non-GAAP basis, representing an 8% increase over the prior year, driven by higher R&D costs [28][29] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of ZENLANTA, which has shown promising data in clinical trials, particularly in combination with glufetamab [5][10] - The LOTUS-seven trial data presented at conferences indicated a complete response rate of 86.7% across 30 efficacy evaluable LBCL patients [5][27] - The company plans to expand enrollment to 100 patients at the selected dose to support regulatory discussions [6][9] Market Data and Key Metrics Changes - The company estimates that ZENLANTA could reach peak sales of $600 million to $1 billion in the U.S. market, with significant opportunities in both DLBCL and indolent lymphomas [11][12] - The DLBCL treatment landscape is divided into complex therapies and broadly accessible therapies, with the latter expected to grow as ZENLANTA is positioned as a preferred option [12][13] Company Strategy and Development Direction - The company is strategically focusing resources on ZENLANTA commercialization and has discontinued early development efforts for other preclinical programs in solid tumors [8][9] - The company aims to position itself for long-term growth by reducing operating expenses and extending its cash runway into 2028 through a recent private placement [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unmet medical need in the second line plus DLBCL landscape and the potential of LOTUS trials to address this need [38] - The company anticipates multiple data catalysts in the remainder of 2025 and 2026, with potential regulatory submissions and approvals expected [31][32] Other Important Information - The company incurred $13.1 million in restructuring and impairment costs related to the closure of its UK facility [29] - The company plans to engage with regulatory authorities regarding the LOTUS trials and explore potential pathways for approval [56][58] Q&A Session Summary Question: Impact of Roche's complete response letter on DLBCL market - Management noted that while details of the CRL are unknown, they remain confident in the unmet medical need in the second line plus DLBCL landscape and the positioning of LOTUS trials to address this need [38][39] Question: Status of LOTUS V overall survival analysis - Management indicated that it is difficult to speculate on the maturity of overall survival data by year-end, but they will provide updates once the pre-specified number of PFS events is reached [42][44] Question: Durability of responses in LOTUS trials - Management highlighted the unprecedented complete response rates observed in LOTUS trials and expressed confidence in the durability of these responses, with plans to share more data as it matures [48][50] Question: Communication of LOTUS-seven data - Management stated that they are considering the best way to communicate LOTUS-seven data, whether through a company update or at a medical congress, depending on data maturity [59][60] Question: Indolent lymphomas and NCCN inclusion - Management expressed confidence in the ongoing Phase II IIT for MZL and noted that a CR rate of 40% or above would be significant for NCCN inclusion [64][65]