Loncastuximab tesirine

Atara Biotherapeutics, Inc. (Nasdaq: ATRA) announced on March 12, 2026, that a Type A meeting with the US FDA has been scheduled to discuss the Complete Response Letter issued for the Biologics License Application for tabelecleucel, also known as tab-cel or EBVALLO, an allogeneic EBV-specific cytotoxic T-cell immunotherapy for the treatment of Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease (PTLD). Pierre Fabre Pharmaceuticals, which holds the BLA, will lead the meeting with support from Atara. The CRL issued in January 2026 indicated that the FDA required additional evidence of effectiveness beyond what was included in the original BLA submission. Pierre Fabre and Atara stated they intend to address the agency’s concerns collaboratively and pursue resubmission with additional efficacy data collected since the initial filing. Cokey Nguyen, Atara’s President and CEO, said the company anticipates providing a regulatory update in Q2 2026. The Type A meeting designation indicates the FDA recognized the urgency of the discussion, as such meetings are typically reserved for stalled programs or serious safety matters. Tabelecleucel is an allogeneic, off-the-shelf T-cell immunotherapy derived from healthy third-party donors. The T cells are selected and expanded to recognize and destroy EBV-infected cells through their native T-cell receptors in an HLA-restricted manner. Unlike CAR T-cell therapies, tabelecleucel does not involve genetic modification. EBV-positive PTLD is a rare and often fatal complication arising after solid organ or hematopoietic cell transplantation, where immunosuppression allows uncontrolled proliferation of EBV-infected B cells. No therapy has received specific FDA approval for this indication. Current treatment relies on reduction of immunosuppression, off-label use of rituximab, and chemotherapy regimens such as R-CHOP for refractory cases. The molecule originated from foundational research at Memorial Sloan Kettering (MSK) Cancer Center. Atara Biotherapeutics licensed the technology from MSK and advanced tabelecleucel through clinical development. In 2024, Pierre Fabre acquired global rights to the program from Atara, assuming responsibility for commercialization, regulatory strategy, and further development. Atara retains a supporting role in the partnership. Tabelecleucel received European Commission approval in December 2022 for the treatment of EBV-positive PTLD, making it the first allogeneic T-cell immunotherapy to receive regulatory approval globally. The US regulatory path has faced delays, with the CRL representing a request for additional efficacy data rather than concerns related to safety or manufacturing. The company’s forward-looking statements reference pursuit of accelerated approval for EBVALLO in the United States. The competitive landscape for EBV-positive PTLD remains sparse. No FDA-approved therapy carries a specific indication for this disease. Agents approved in the adjacent diffuse large B-cell lymphoma space, including polatuzumab vedotin, loncastuximab tesirine, and glofitamab, may have off-label utility given histological overlap with monomorphic PTLD, but none has been studied specifically in the PTLD population. Tabelecleucel, if approved, would be the first therapy with a specific FDA-approved indication for EBV-positive PTLD. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

LOTIS-5 Phase 3 topline data expected in second quarter 2026, with full data for LOTIS-5 and LOTIS-7 anticipated by year-end 2026 Recent amendment to HealthCare Royalty financing agreement increases strategic flexibility Fourth quarter and full year 2025 net product revenue of approximately $22.3M and $73.6M, respectively Cash and cash equivalents of $261.3M as of December 31, 2025, provide expected cash runway at least into 2028 Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, March 10, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent operational updates. "Building off the meaningful progress achieved across our ZYNLONTA clinical program in DLBCL and through investigator-initiated trials in indolent lymphomas this past year, we believe we have laid the foundation for multiple anticipated value-creating catalysts," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We expect topline LOTIS-5 results in the second quarter, followed by full LOTIS-5 and LOTIS-7 results in 2L+ DLBCL by the end of 2026 and, assuming positive data, potential compendia inclusions in first half of 2027 with LOTIS-5 regulatory approval to follow. Supported by an expected cash runway at least into 2028, we are confident we will drive significant potential long-term growth beginning in 2027." Fourth Quarter 2025 Operational Updates and Upcoming Milestones LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) once the pre-specified number of approximately 262 progression-free survival events is reached and data are available. Full results are anticipated to be published by the end of 2026. Assuming positive results, the Company will file a supplemental Biologics License Application (sBLA) submission with the U.S. Food and Drug Administration (FDA), with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL to follow in mid-2027. LOTIS-7 trial ongoing with data anticipated by year-end. In December 2025, the Company reported updated data from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory (r/r) DLBCL. The data demonstrated an 89.8% best overall response rate and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of six months follow-up. The LOTIS-7 trial is ongoing at the selected 150 µg/kg dose and the Company plans to share full data at a medical meeting and through publication by the end of 2026. The Company plans to assess regulatory and compendia strategies. Ongoing investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies. The Company anticipates publication of data from the University of Miami Sylvester Comprehensive Cancer Center-led multi-center trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and as a monotherapy to treat marginal zone lymphoma (MZL) between the end of 2026 and mid-2027. Assuming positive data, the Company intends to assess potential regulatory and compendia pathways. Fourth Quarter and Full Year 2025 Financial Results Product Revenues: Net product revenues were $22.3 million and $73.6 million for the fourth quarter and full year ended December 31, 2025, as compared to $16.4 million and $69.3 million for the same periods in 2024. The quarter-over-quarter increase in revenue primarily reflected variability in customer ordering, with underlying demand broadly stable. The increase for the full year was driven by higher selling price and relatively flat volume year-over-year. Research and Development (R&D) Expense: R&D expense was $18.2 million and $104.0 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to R&D expense of $27.1 million and $109.6 million for the same periods in 2024. The decrease in R&D costs quarter-over quarter was primarily driven by a reduction in spending on discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease in R&D costs for the full year was driven by a reduction in spending on discontinued programs, partially offset by expenditure associated with completion of the IND-enabling activities for our PSMA-targeting ADC and our ongoing ZYNLONTA clinical trials. Selling and Marketing (S&M) Expense: S&M expense was $12.0 million and $43.4 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to S&M expense of $11.3 million and $44.0 million for the same periods in 2024. S&M expense remained relatively flat period-over-period. General & Administrative (G&A) Expense: G&A expense was $9.5 million and $36.6 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to G&A expense of $9.6 million and $41.9 million for the same periods in 2024. G&A expense remained relatively flat quarter-over-quarter. The reduction in G&A expense for the full year was primarily due to lower external professional fees. Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $0.3 million in income for the fourth quarter and $13.1 million in restructuring, impairment and other related costs for the full year ended December 31, 2025, which consisted of $6.0 million in employee severance and related benefit costs, $5.8 million in non-cash impairment of assets and $1.3 million in dilapidations, lease termination, legal fees, and other related costs in connection with the closure of the UK facility. Total operating expenses and adjusted total operating expenses: Total operating expenses were $41.0 million and $202.9 million for the fourth quarter and full year ended December 31, 2025, respectively, as compared to $49.3 million and $201.5 million for the fourth quarter and full year ended December 31, 2025, respectively. On a non-GAAP basis, total adjusted operating expenses were $39.4 million and $181.3 million for the quarter and full year ended December 31, 2025, respectively, as compared to $46.6 million and $193.8 million for the quarter and full year ended December 31, 2024, respectively. The reduction in total adjusted operating expenses for the fourth quarter was primarily driven by lower R&D expenses. The decrease in total adjusted operating expenses for the full year was a result of lower R&D, G&A and S&M expenses. Net Loss: Net loss for the quarter ended December 31, 2025, was $6.4 million, or a net loss of $0.04 per basic and diluted share, as compared to net loss of $30.7 million, or a net loss of $0.29 per basic and diluted share for the same period in 2024. Net loss for the full year ended December 31, 2025, was $142.6 million, or a net loss of $1.12 per basic and diluted share, as compared to net loss of $157.8 million, or a net loss of $1.62 per basic and diluted share for the full year ended December 31, 2024. The lower net loss over both periods was primarily due to a higher cumulative catch-up adjustment gain associated with our deferred royalty obligation and reduced R&D expense, partially offset by the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan. Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $13.5 million, or an adjusted net loss of $0.09 per basic and diluted share for the quarter ended December 31, 2025, as compared to an adjusted net loss of $26.5 million, or $0.25 per basic and diluted share, for the same period in 2024. Adjusted net loss for the full year ended December 31, 2025, was $91.7 million, or an adjusted net loss of $0.72 per basic and diluted share, as compared to net loss of $111.4 million, or an adjusted net loss of $1.15 per basic and diluted share for the full year ended December 31, 2024. The decrease in adjusted net loss over both periods was due to lower operating expenses and a higher number of weighted average shares outstanding. Cash and cash equivalents: As of December 31, 2025, cash and cash equivalents were $261.3 million, compared to $250.9 million as of December 31, 2024, providing expected cash runway at least into 2028. The Company significantly strengthened its cash and cash equivalents position by entering into a $100 million PIPE financing in June 2025 and a $60.0 million PIPE financing in October 2025 with certain institutional investors, which raised $150.8 million in total after deducting placement agent fees and offering expenses. Subsequent event Amended HealthCare Royalty Financing Agreement. In February 2026, ADC Therapeutics entered into an amendment to its royalty purchase agreement with entities managed by HealthCare Royalty, offering greater strategic flexibility to the Company. The new agreement reduces the change of control payment from $750 million to $150 million through the end of 2027, and to $200 million thereafter. In the event of a change of control, HealthCare Royalty will continue to receive royalties on sales by the acquirer until the original royalty cap is reached. In return, HealthCare Royalty has been granted warrants to purchase approximately 9.8 million common shares, with an exercise price of $3.81 per share. These warrants are exercisable until December 31, 2030, and are subject to a lock-up through the end of 2027. Conference Call Details ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2025 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn. Use of Non-GAAP Financial Measures In addition to financial information prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this document also contains certain non-GAAP financial measures based on management's view of performance including: Adjusted total operating expenses Adjusted net loss Adjusted net loss per share Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-GAAP measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with GAAP. When preparing these supplemental non-GAAP measures, management typically excludes certain GAAP items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these GAAP items to be normal, recurring cash operating expenses; however, these items may not meet the GAAP definition of unusual or non-recurring items. Since non-GAAP financial measures do not have standardized definitions and meanings, they may differ from the non-GAAP financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other GAAP financial measures. The following items are excluded from adjusted total operating expenses: Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. The following items are excluded from adjusted net loss and adjusted net loss per share: Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. Certain Other Items: We exclude certain other significant items that we believe do not represent the performance of our business, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of warrant obligations and the effective interest expense associated with the senior secured term loan facility and the effective interest expense and cumulative catch-up adjustments associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners. See the attached Reconciliation of GAAP Measures to Non-GAAP Measures for explanations of the amounts excluded and included to arrive at the non-GAAP financial measures. Revision of Prior Period Financial Information The Company identified and corrected an error in its prior period consolidated financial statement related to the classification of certain inventory balances between current and long-term assets. As a result, the Company revised its consolidated balance sheet for the year ended December 31, 2024, with a decrease to Inventory and Total current assets of $16.1 million, and a corresponding increase to Inventory, long-term. The impact of the reclassification revision has been reflected in the Condensed Consolidated Balance Sheets (unaudited) below. Management evaluated the materiality of the reclassification revision from a quantitative and qualitative perspective and concluded that the reclassification revision is immaterial to the consolidated financial statements. This reclassification revision had no impact on the Company's total assets, as previously reported. The reclassification revision also had no impact on the consolidated statements of operations, comprehensive loss, stockholders' (deficit) equity, or cash flows. Additionally, the reclassification revision does not affect the Company's compliance with any financial covenants. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the timing of the PFS events and topline data release for LOTIS-5 and the results of the trial, the timing for the sBLA submission, acceptance and outcome of review of the sBLA submission, and full FDA approval; the Company's ability to grow ZYNLONTA® revenue in the United States and potential peak revenue; whether future LOTIS-7 clinical trial results will be consistent with or different from the LOTIS-7 data presented by the Company on December 3, 2025, the timing, publication and outcome of the full LOTIS-7 trial, compendia inclusion and regulatory strategy and the commercial opportunity; expected cash runway at least to 2028 which assumes use of minimum liquidity amount required to be maintained under its loan agreement covenants; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness, the impact on our future revenue streams, and the significant cash required to service such indebtedness; the impact, if any, from the amendment to the agreement with HealthCare Royalty Management and our strategic alternatives; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACT: Investors and Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 SOURCE ADC Therapeutics SA 21% more press release views with Request a Demo