High grade B-cell lymphoma

Multiple clinical trials across three AI-guided drug candidates are active with first expected data and readouts for LP-184 in the second half of 2024; with additional next-generation drug development programs approaching IND studies. Dosed initial patients in both Phase 1 clinical trials for synthetic lethal drug-candidates, LP-184 and LP-284, each of which are first-in-human molecules with the potential for use across multiple cancer indications. Expanded Phase 2 LP-300 Harmonic™ clinical trial into 12 sites in the US and advanced towards initial regulatory allowance for trial commencement in Japan, Taiwan and South Korea where approximately 30-35+% of all lung cancer cases occur in never-smokers with NSCLC. Advanced Starlight Therapeutics with hiring of Chief Medical Officer (CMO) and preparing for potential Phase 1B/2 clinical trial in adult CNS tumors beginning in second half of 2024. Demonstrated significant advancement of our cryptophycin focused antibody-drug-conjugate program (cpADC) in multiple solid tumor models, with additional preclinical data to be generated during 2024 in advance of IND studies. Exceeded 2023 goal of 60 billion datapoints for oncology drug development AI platform, RADR®, and announced 100 billion datapoint goal for 2024 to include additional advancements in integrating generative AI features into platform functionality. Approximately $41.3 million in cash, cash equivalents, and marketable securities as of December 31, 2023. The conference call and webcast are scheduled for today, Monday March 18, 2024, at 4:30 p.m. ET / 1:30 p.m. PT. DALLAS--(BUSINESS WIRE)-- Lantern Pharma, Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical-stage drug programs, today announced operational highlights and financial results for the fourth quarter and fiscal year ended December 31, 2023. “This past quarter and the entire year of 2023 was a period of meaningful and remarkable progress for our programs and our AI platform at Lantern Pharma. Our team demonstrated how combining emerging AI technologies, cancer biology models and experiments, chemical, molecular, and multiomic biomarker data, along with large-scale patient data holds the promise of transforming timelines and costs in drug development for oncology. We are very enthusiastic about 2024 and will be actively focused on meeting and possibly exceeding the milestones ahead of us, which include potential initial data from our LP-184 Phase 1A trial; advancing the new company born from AI – Starlight Therapeutics, which is focused wholly on CNS cancers; and progressing our ADC oncology program,” said Panna Sharma, President and CEO of Lantern Pharma. Sharma continued, “Computational and AI-driven approaches are increasing their value-driving impact on oncology drug development, and our team continues to increase the capabilities and usefulness of our platform while also helping to de-risk and sharpen the focus of our existing clinical drug candidates. Our leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies has guided three drug development programs in active clinical trials. We believe this pace of development with our focused team and resources should yield significant future benefits for investors and patients as our industry matures, adopts and accepts a data and AI-centric approach to drug development.” Highlights of AI-Powered Pipeline: LP-284 – Launched the first-in-human Phase 1 clinical trial with LP-284 targeting recurrent non-Hodgkin’s lymphomas (NHL) and other cancers. Lantern also announced recently that initial patients had been dosed in the LP-284 clinical trial. LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. Nearly all MCL, DHL, and High Grade B-Cell Lymphoma (HGBL) patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over USD 3+ billion. LP-184 – Several cohorts of patients have been dosed in the ongoing Phase 1 clinical trial – a first-in-human Phase 1 basket trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. The trial is enrolling patients that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), brain metastases (brain mets.), lung cancer, triple-negative breast cancer, and multiple other solid tumor types with DNA damage response deficiencies. Lantern expects to continue Phase 1A enrollment throughout the first half of 2024 across a growing number of US clinical trial sites, including Fox Chase Cancer Center, Johns Hopkins Medicine, and other leading centers, with the potential for an initial readout in Phase 1A during late summer or early fall. The dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications for a future Phase 1b/2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics. Additionally, AI and preclinical studies are ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability of response and/or the overall response rates in combination with FDA approved drugs that are widely used in cancer treatment. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors. LP-300 – Twelve sites for the Phase 2 Harmonic™ trial have been activated in the US, and 3 Asian countries are in various phases of regulatory allowance for clinical trial commencement. This strategy should increase the potential for dosing additional patients in the Phase 2 Harmonic™ trial during 2024, which should help address the patient enrollment challenges Harmonic™ has faced in the US. In these Asian countries, Japan, South Korea and Taiwan, the incidence of never-smokers with NSCLC (non-small cell lung cancer) is double or higher than that of patients in the US. The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC. Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies, leaving them with reduced treatment options. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing an estimated US annual market potential of $1.5 billion and a global estimated annual market potential of over $2.6 billion. Additional information on the Harmonic™ trial can be found at the Harmonic™ website and clinicaltrials.gov. RADR® Platform Growth and Development: RADR® continues to advance in size, scope, and capabilities and is also progressing towards becoming a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. RADR® has now surpassed 60+ billion oncology-focused datapoints and is projected to reach over 100 billion datapoints by the end of 2024. The scope of RADR®’s data has broadened with a strategic focus on additional classes of compounds, detailed data on chemical and biochemical features and drug-interaction data. Additionally, data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR®. Lantern will potentially focus additional data growth efforts of the RADR® platform on: drug sensitivity data, combination treatment outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies for Lantern and its partners. Additionally, the RADR® platform's generative AI capabilities, focusing on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality and scope in the coming quarters. Starlight Therapeutics: In Q1 2023, Lantern formed a wholly-owned subsidiary, Starlight Therapeutics Inc. (“Starlight”), for the clinical development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including GBM, brain mets., and several rare pediatric CNS cancers. Starlight will refer to the molecule LP-184, as it is developed in CNS indications, as “STAR-001”. Lantern recently recruited a Starlight Chief Medical Officer who will focus on Starlight’s clinical trials, development of personnel to execute on the planned clinical strategy and overall support in corporate development activity. Starlight and Lantern plan on initiating Phase 1B/2 clinical trials during the second half of 2024. The market potential for the currently planned indications for Starlight’s synthetically-lethal, cancer-cell DNA damaging agent – STAR-001 – is estimated to be $4.5 billion to $5+ billion USD across both adult and pediatric primary and secondary CNS cancers. ADC Program: Lantern, in collaboration with academic research partners, has advanced the development, synthesis, and preclinical proof-of-concept of a novel, highly potent, cryptophycin-based ADC (cpADC). The cpADC has shown picomolar potency in a wide range of solid tumors tested in preclinical development and is being further evaluated for clinical potential in six solid tumor indications. In preclinical work, the cpADC produced an 80% cancer cell kill rate which is more than other ADC drug payloads, including in a cancer sub-type, medium HER-2 expression cancers, which is an unmet and critical patient need. Lantern leveraged RADR®, a proprietary AI platform for oncology drug development, for target selection and molecular payload characterization in ADCs, and a unique, controlled conjugation approach for maximizing drug-to-antibody ratios while controlling for non-specific conjugation. Lantern expects to move towards IND development of the ADC program during 2024 with a focus on select solid tumors that are unresponsive or refractory to current therapies. Additional Operational Highlights: During the 4th quarter of 2023, Lantern filed 3 new patent applications culminating in 11 new patent applications for the calendar year 2023. Lantern was awarded its fifth orphan drug designation by the FDA during the fourth quarter of 2023 relating to LP-284 in High Grade B-Cell Lymphoma (HGBL) HGBL represents a rare and aggressive form of B-cell non-Hodgkin's lymphoma (NHL) with no established standard of care treatment approach. Typically, frontline intervention involves a combination of chemo-immunotherapies such as R-CHOP or DA-R-EPOCH. However, approximately 20-30% of HGBL patients stop responding to these therapeutic agents and continue cancer progression. For those with relapsed or refractory (R/R) disease, the survival prognosis is 8.6 to 16 months. The other 4 FDA granted orphan designations, include 3 for LP-184 in High Grade Gliomas (including GBM), Pancreatic Cancer, and Atypical Teratoid Rhabdoid Tumors (ATRT), and another for LP-284 in Mantle Cell Lymphoma. New data and scientific findings will be presented for LP-284 at AACR (American Association for Cancer Research) during the 2024 Annual Meeting in San Diego from April 5 to 10. Presentation Title: Phase 1a/1b clinical trial of LP-284, a highly potent TP53 mutation agnostic DNA damaging agent, in patients with refractory or relapsed lymphomas and solid tumors (NCT06132503) Presenter: Jianli Zhou, PhD (Molecular Biologist, Data Scientist & Member of the RADR®, AI team at Lantern Pharma) Fourth Quarter & Fiscal Year 2023 Financial Highlights: Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $41.3 million as of December 31, 2023, compared to approximately $55.2 million as of December 31, 2022. The cash burn rate for the 4th quarter and full year of 2023 continues to reflect our capital-efficient, collaborator-centered business model. R&D Expenses: Research and development expenses were approximately $3.6 million for the quarter ended December 31, 2023, compared to approximately $2.3 million for the quarter ended December 31, 2022. G&A Expenses: General and administrative expenses were approximately $1.3 million for the quarter ended December 31, 2023, compared to approximately $1.6 million for the quarter ended December 31, 2022. Net Loss: Net loss was approximately $4.2 million (or $0.39 per share) for the quarter ended December 31, 2023, compared to a net loss of approximately $3.4 million (or $0.31 per share) for the quarter ended December 31, 2022. Full Year Net Loss: Net loss per share was $1.47 per share for the fiscal year 2023 compared to $1.31 per share for the fiscal year 2022. Share Repurchase: Lantern’s total outstanding shares were reduced in 2023 through a repurchase of 145,348 shares of LTRN common stock at a purchase price of $3.44 per share that the company executed in November of 2023. Earnings Call and Webinar Details: Lantern will host its 4th quarter & full year 2023 earnings call and webinar today, March 18, 2024, at 4:30 p.m. ET. Related presentation materials will be accessible at: A replay of the 4th quarter and year-end 2023 earnings call and webinar will be available at: About Lantern Pharma: Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 60 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0 - 2.5 million per program. Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world. Please find more information at: Website: LinkedIn: X: @lanternpharma Forward-looking Statements: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," “model,” "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that our research and the research of our collaborators may not be successful, (ii) the risk that promising observations in preclinical studies do not ensure that later studies and development will be successful, (iii) the risk that we may not be successful in licensing potential ADC candidates or in completing potential partnerships and collaborations, (iv) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (v) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vi) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 18, 2024. You may access our Annual Report on Form 10-K for the year ended December 31, 2023 under the investor SEC filings tab of our website at or on the SEC's website at . Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this presentation represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Lantern Pharma Disclosure Channels to Disseminate Information: Lantern Pharma’s investors and others should note that we announce material information to the public about our company and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma’s website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time.

Breyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with median duration of CR not reached, along with an established safety pro > Breyanzi is now FDA approved for relapsed or refractory large B-cell lymphoma and CLL or SLL, bringing this differentiated CD19-directed CAR T cell therapy to more patients PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). In R/R CLL or SLL, Breyanzi is delivered through a treatment process which culminates in a one-time infusion* with a single dose containing 90 to 110 x 106 CAR-positive viable T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies. This press release features multimedia. View the full release here: Product image for download (Photo: Bristol Myers Squibb) “CAR T cell therapies represent a transformative treatment option for patients with certain types of blood cancers,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb. “For years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success. With the approval of Breyanzi as the first CAR T for relapsed or refractory CLL or SLL, we are now able to offer these patients a personalized option, while further expanding access across the broadest array of B-cell malignancies, to address this critical unmet need.” CLL and SLL are among the most common types of B-cell lymphoma. Treatments for people living with CLL or SLL primarily consist of targeted therapies including BTK- and BCL-2 inhibitors. However, patients often experience relapse or become refractory following early-line treatment with these therapies and there is no established standard of care for patients with double-class exposed CLL or SLL. After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses. The Phase 1/2 open-label, single-arm TRANSCEND CLL 004 study was the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL. The CR rate associated with Breyanzi treatment was 20% (95% CI: 11.1-31.8). Among patients who achieved a CR, median duration of response was not reached (95% CI: 15 months-NR) at the time of data cutoff. Among all responders (ORR = 45%; 95% CI: 32.3-57.5), median duration of response was 35.3 months (95% CI: 12.4-NR). High rates of minimal residual disease (MRD) negative status were observed across patients treated with Breyanzi who achieved a CR, with an MRD-negativity rate of 100% in the blood (95% CI: 75.3-100) and 92.3% in the bone marrow (95% CI: 64-99.8). “CLL and SLL are currently considered incurable diseases with few treatment options in the relapsed setting that can confer complete responses, something that has historically been associated with improved long-term outcomes,” said Tanya Siddiqi, M.D., lead investigator and Associate Professor, Division of Lymphoma, City of Hope National Medical Center. “The FDA approval of liso-cel in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL2i is a remarkable breakthrough, shifting the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance, to a one-time personalized T-cell based approach that has the potential to offer patients complete and lasting remission.” Among 89 patients in the study treated with Breyanzi, occurrences of cytokine release syndrome (CRS) and neurologic events (NEs) were mostly low grade. Any grade CRS occurred in 83% of patients, with Grade 3 CRS occurring in 9% of patients. No Grade 4/5 CRS events were reported. Any grade NEs were reported in 46% of patients, with Grade 3 NEs reported in 20% of patients and one case of Grade 4 NE reported. No Grade 5 NEs were reported. “For people struggling with relapsed or refractory CLL or SLL, current treatment choices are limited,” said Dr. Brian Koffman, physician, CLL patient and cofounder, executive vice president and chief medical officer of CLL Society. “The approval of Breyanzi as the first CAR T cell therapy available for relapsed or refractory CLL or SLL brings new hope to these patients with the potential for durable responses after a single CAR T infusion. We are grateful to the patients and their families who enter the trials and to all the researchers involved in making possible this important new treatment option in CLL and SLL.” Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provides support that allows for access to therapies, including Breyanzi. Bristol Myers Squibb also supports the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information, manufacturing updates, and patient and caregiver support. About TRANSCEND CLL 004 TRANSCEND CLL 004 (NCT03331198) is a Phase 1/2 open-label, single-arm, multicenter study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The Phase 1 dose escalation portion of the study assessed the safety and recommended dose for the subsequent Phase 2 expansion cohort. The Phase 2 portion of the study is evaluating Breyanzi at the recommended dose from the Phase 1 monotherapy arm. The primary endpoint of the Phase 2 portion of the study is complete response rate, including complete remission with incomplete bone marrow recovery, based on independent review committee according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. About CLL and SLL Chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adults. In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes, and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows, there is less room for healthy white blood cells, red blood cells and platelets. Small lymphocytic lymphoma (SLL) also affects the lymphocytes, with cancer cells found mostly in the lymph nodes. While there are several treatments available for CLL and SLL, there is a need for additional effective therapies as there is no standard of care for relapsed or refractory CLL or SLL after prior therapy with targeted agents, such as Bruton tyrosine kinase (BTK) and B-cell lymphoma 2 (BCL-2) inhibitors. Patients with relapsed or refractory disease have limited treatment options and generally experience shorter periods of response with each subsequent treatment. About Breyanzi Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. Breyanzi is approved in the U.S., Japan and Europe for the second-line treatment of relapsed or refractory LBCL, and in Japan, Europe, Switzerland, and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy. Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov. * Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. Indication BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Among patients receiving BREYANZI for LBCL (N=418), CRS occurred in 46% (190/418), including ≥ Grade 3 CRS in 3.1% of patients. In patients receiving BREYANZI after two or more lines of therapy for LBCL, CRS occurred in 46% (122/268), including ≥ Grade 3 CRS in 4.1% of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 98% with a median duration of 5 days (range: 1 to 17 days). In patients receiving BREYANZI after one line of therapy for LBCL, CRS occurred in 45% (68/150), including Grade 3 CRS in 1.3% of patients. The median time to onset was 4 days (range: 1 to 63 days). CRS resolved in all patients with a median duration of 4 days (range: 1 to 16 days). Among patients receiving BREYANZI for CLL/SLL, CRS occurred in 83% (74/89), including Grade 3 CRS in 9% of patients. The median time to onset was 4 days (range: 1 to 18 days). CRS resolved in 97% with a median duration of 6 days (range: 2 to 37 days). The most common manifestations of CRS (≥ 10% in LBCL or CLL/SLL) included fever (94% LBCL; 97% CLL/SLL), hypotension (42% LBCL; 46% CLL/SLL), tachycardia (28% LBCL), chills (23% LBCL; 43% CLL/SLL), hypoxia (16% LBCL; 35% CLL/SLL), sinus tachycardia (22% CLL/SLL), and headache (12% LBCL; 18% CLL/SLL). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Of the patients who received BREYANZI for LBCL (n=418) and CLL/SLL (n=89), 23% (LBCL) and 64% (CLL/SLL) received tocilizumab and/or a corticosteroid for CRS, including 10% (LBCL) and 33% (CLL/SLL) who received tocilizumab only and 2.2% (LBCL) and 2.2% (CLL/SLL) who received corticosteroids only. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In patients receiving BREYANZI after two or more lines of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in 35% (95/268), including ≥ Grade 3 cases in 12% of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of neurotoxicity was 8 days (range: 1 to 46 days). Neurologic toxicities resolved in 85% of patients with a median duration of 12 days (range: 1 to 87 days). In patients receiving BREYANZI after one line of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in 27% (41/150) of patients, including Grade 3 cases in 7% of patients. The median time to onset of neurologic toxicity was 8 days (range: 1 to 63 days). The median duration of neurologic toxicity was 6 days (range: 1 to 119 days). In all patients combined receiving BREYANZI for LBCL, CAR T cell-associated neurologic toxicities occurred in 33% (136/418), including ≥ Grade 3 cases in 10% of patients. The median time to onset was 8 days (range: 1 to 63), with 87% of cases developing by 16 days. Neurologic toxicities resolved in 85% of patients with a median duration of 11 days (range: 1 to 119 days). Of patients developing neurotoxicity, 77% (105/136) also developed CRS. In patients receiving BREYANZI for CLL/SLL, CAR T cell-associated neurologic toxicities occurred in 46% (41/89), including Grade 3 cases in 20% of patients and a single Grade 4 case. The median time to onset of neurotoxicity was 7 days (range: 1 to 21 days), with 95% of cases developing by 16 days. Neurologic toxicities resolved in 85% with a median duration of 7 days (range: 1 to 83 days). Of patients developing neurotoxicity, 95% (39/41) also developed CRS. The most common neurologic toxicities (≥ 5% in LBCL or CLL) included encephalopathy (20% LBCL; 36% CLL/SLL), tremor (13% LBCL; 14% CLL/SLL), aphasia (8% LBCL; 8% CLL/SLL), headache (6% LBCL; 9% CLL/SLL), dizziness (6% LBCL), and delirium (5% LBCL; 12% CLL/SLL). CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. BREYANZI REMS Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are: Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS. Further information is available at , or contact Bristol-Myers Squibb at 1-866-340-7332. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In patients receiving BREYANZI, infections of any grade occurred in 36% (LBCL) and 35% (CLL/SLL), with Grade 3 or higher infections occurring in 12% (LBCL) and 16% (CLL/SLL) of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7% (LBCL) and 10% (CLL/SLL), bacterial infections in 4.3% (LBCL) and 2.2% (CLL/SLL), viral infections in 1.9% (LBCL) and 1.1% (CLL/SLL), and fungal infections in 0.5% (LBCL) and 2.2% (CLL/SLL). Febrile neutropenia developed after BREYANZI infusion in 8% (LBCL) and 12% (CLL/SLL) of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In patients who received BREYANZI, 15 of 16 LBCL patients, and all 9 CLL/SLL patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 36% (LBCL) and 45% (CLL/SLL) of patients, and included thrombocytopenia in 28% (LBCL) and 23% (CLL/SLL), neutropenia in 21% (LBCL) and 35% (CLL/SLL), and anemia in 6% (LBCL) and 12% (CLL/SLL). Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In patients receiving BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 11% (LBCL) and 14% (CLL/SLL) of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 28% (LBCL) and 37% (CLL/SLL) of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1- 888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Effects on Ability to Drive and Use Machines Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common nonlaboratory adverse reactions (incidence ≥ 30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities (≥ 30%) include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, and diarrhea. The most common Grade 3-4 laboratory abnormalities (≥ 30%) in CLL/SLL include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, whether Breyanzi (lisocabtagene maraleucel) for such additional indication described in this release will be commercially successful, that any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such product candidate for such additional indication described in this release may be contingent upon verification and description of clinical benefit in confirmatory trial(s). No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of $16.6 million in 4Q 2023 and $69.1 million for full year (FY) 2023; 4Q sales grew sequentially in both academic and community settings Focused pipeline progressing with continued LOTIS-7 dose escalation, screening patients for ADCT-601 targeting AXL in pancreatic cancer, and advancing differentiated solid tumor research platform FY 2023 operating expenses decreased 21%1 year-over-year due to portfolio prioritization and operational efficiencies; $278.6M of cash with expected runway extended into 4Q 2025 Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, March 13, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates. “During 2023, we reset our business and capital allocation strategy, strengthened our team and established a clear roadmap to drive value creation for all our stakeholders,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “In the fourth quarter we saw results of our strategy in action across a number of key areas. The impact of our new commercial model resulted in a resumption of growth for ZYNLONTA® sales volume compared to the third quarter, in both community and academic settings. Meanwhile, our prioritized pipeline delivered encouraging data, which we were pleased to share in a business update in January. We also disclosed for the first time our new, differentiated solid tumor platform, which can bring substantial opportunities for the Company through internal and external development. With an expected cash runway into the fourth quarter of 2025 and multiple potential value-generating catalysts ahead, I am excited about our prospects and look forward to updating you on our progress in 2024.” Recent Highlights and Developments ZYNLONTA® (loncastuximab tesirine-lpyl) ZYNLONTA generated product net sales of $16.6 million in the fourth quarter of 2023, representing a 17% increase over the third quarter of 2023 and a 16% decrease over the fourth quarter of 2022. A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings. The year-over-year net sales decline reflected disruption during the year from the restructuring of the go-to-market model together with the impact of increased competition and higher gross-to-net sales deductions, partially offset by a slight price increase. Hematology Pipeline LOTIS-5: The Phase 3 confirmatory trial for ZYNLONTA in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) continues to see accelerated enrollment. As noted by the clinical team and confirmed with the Independent Data Monitoring Committee (IDMC), we have observed higher-than-expected censoring in this trial. As a result, we may need to enroll additional patients, beyond the originally planned 350 patients, to achieve the required number of pre-specified progression-free survival events. The Company continues to expect to complete enrollment of this trial in 2024. The IDMC noted no safety concerns and recommended the trial to proceed at its most recent meeting held on January 16, 2024.LOTIS-7: The Phase 1b trial of ZYNLONTA in combination with bispecific antibodies glofitamab or mosunetuzumab for the treatment of heavily pre-treated patients with DLBCL, follicular lymphoma (FL) and marginal zone lymphoma (MZL) is actively enrolling patients. The dose-limiting toxicity (DLT) period has been cleared for the first two dosing levels of ZYNLONTA (90 µg/kg, 120 µg/kg) in both arms and we are currently enrolling patients at 150 µg/kg. After the first Investigator assessment, we have seen evidence of anti-tumor activity among the majority of patients dosed at the first two levels, with mixed histologies including DLBCL, FL and MZL. The Company expects to share additional data once a larger and more mature dataset is available.Investigator-Initiated Trial: As announced by the Company on January 4, 2024, an oral presentation at the American Society of Hematology (ASH) 2023 Annual Meeting from the University of Miami investigator-initiated trial exploring ZYNLONTA in combination with rituximab in high-risk relapsed or refractory FL patients indicated a best overall response rate of 96.3% and a complete response rate of 85.2%​. After a median follow-up of 9.7 months, the median progression-free survival (PFS) was not reached, and the 12-month PFS was 92.3%​. The majority of AEs were grade 1. Grade 3 AEs included neutropenia (n=2; 6.2%), and one case each (3.1%) of hyperglycemia, increased ALT, fatigue, dyspnea and skin infection. Neutropenia was the only grade 4 AE (n=1; 3.1%).ADCT-602 (targeting CD22): Dose escalation and expansion in the Phase 1 study with relapsed or refractory acute lymphoblastic leukemia in collaboration with MD Anderson Cancer Center is progressing and additional clinical trial sites are being added to accelerate enrollment. Solid Tumor Pipeline ADCT-601 (targeting AXL): In the Phase 1b trial, the maximum tolerated dose has been reached, and the study is currently in dose optimization. On January 4, 2024, the Company announced that early signs of anti-tumor activity had been seen in both monotherapy and in combination and that the safety profile indicated that ADCT-601 was well tolerated at the doses tested. Additional data from the trial are expected to be shared in a presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 (April 5–10, 2024). The abstract details are available online. The ongoing dose-optimization/expansion phase is comprised of a monotherapy arm including patients with sarcoma, pancreatic cancer and AXL-expressing non-small cell lung cancer (NSCLC) and a combination arm with gemcitabine in patients with sarcoma and pancreatic cancer. Screening was recently initiated for pancreatic cancer in the monotherapy arm.Early-stage pipeline: The Company is advancing a portfolio of investigational ADCs including those targeting Claudin-6, NaPi2b and PSMA. These candidates are based on an innovative proprietary approach which utilizes exatecan with a novel hydrophilic linker as a highly potent and differentiated payload. Data on the Claudin-6 and NaPi2b programs are expected to be shared in presentations at the AACR Annual Meeting 2024. Abstracts details are currently available online. A research investor event is being planned for 2Q 2024 to share additional information. Upcoming Expected Milestones ZYNLONTA Achieve commercial brand profitability in 2024LOTIS-5: Complete enrollment in 2024LOTIS-7: Additional data from the Phase 1b dose-escalation in 3L+ in mixed histologies (Part 1) in 2Q 2024 and from the dose-expansion in 2L+ DLBCL (Part 2) in 2H 2024Investigator-initiated trial in FL: The study is being expanded to 100 patients in a multicenter clinical trial. Updates are expected at medical meetings.Investigator-initiated trial in MZL: The study is designed to enroll 50 patients in a multicenter clinical trial. A futility analysis is expected to be conducted in 2Q 2024. Updates are expected at medical meetings. Pipeline ADCT-601 (targeting AXL) Additional data updates from the Phase 1 study in patients with sarcoma, pancreatic cancer and NSCLC in 2024 ADCT-602 (targeting CD22) Additional data from the Phase 1 study in 2024 Preclinical Advancing a broad portfolio of investigational ADCs for solid tumor indications Fourth Quarter and FY 2023 Financial Results Cash and Cash Equivalents Cash and cash equivalents were $278.6 million as of December 31, 2023, compared to $326.4 million as of December 31, 2022. The Company currently expects its cash runway to extend into the fourth quarter of 2025. Product Revenues Net product revenues were $16.6 million for the fourth quarter and $69.1 million for full year 2023, compared to $19.8 million and $74.9 million, respectively, for the fourth quarter and full year 2022. Net product revenues are for U.S. sales of ZYNLONTA. The fourth quarter and full year decrease was primarily due to higher gross-to-net deductions and lower sales volume which was impacted by disruption following restructuring of the commercial organization and increased competition, partially offset by a slightly higher price. License Revenues and Royalties License revenues and royalties were $0.1 million for the fourth quarter and $0.5 million for full year 2023, compared to $50.0 million and $135.0 million, respectively, for the fourth quarter and full year 2022. The fourth quarter and full year decrease was primarily due to upfront and milestone payments under our exclusive license agreements with Sobi and MTPC that were recognized in 2022. Research and Development (R&D) Expenses R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022. R&D expenses decreased due to less investment in camidanlumab tesirine (Cami), as well as productivity initiatives and focused investment toward prioritized development programs. The decrease in R&D expenses related to Cami was primarily due to completion of the Phase 2 study in 2022 and the Company’s decision to pause the program while it evaluated FDA feedback. R&D expenses in the fourth quarter and full year 2023 also decreased due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations. Selling and Marketing (S&M) Expenses S&M expenses were $13.9 million for the fourth quarter and $57.5 million for full year 2023, as compared to $16.2 million and $69.1 million, respectively, for the fourth quarter and full year 2022. The decrease in S&M expenses for the fourth quarter and full year was primarily due to lower spend on marketing and analytics, lower wages and benefits, as well as lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations. General & Administrative (G&A) Expenses G&A expenses were $11.3 million for the fourth quarter and $48.4 million for full year 2023, compared to $15.7 million and $74.4 million, respectively, for the fourth quarter and full year 2022. G&A expenses decreased for the fourth quarter and full year primarily due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations, as well as lower wages and benefits and insurance costs. Net Loss and Adjusted Net Loss Net loss was $85.0 million, or a net loss of $1.03 per basic and diluted share, for the fourth quarter of 2023 and $240.1 million, or a net loss of $2.94 per basic and diluted share for full year 2023. This compares to a net loss of $23.3 million, or a net loss of $0.29 per basic and diluted share, for the fourth quarter of 2022 and $157.1 million, or a net loss of $2.01 per basic and diluted share, for full year 2022. The increase in net loss in both periods primarily reflects the reduction in license revenues and royalties, together with higher income tax expense and lower product revenues, partially offset by lower operating expense. Adjusted net loss, which is a non-GAAP financial measure, was $79.5 million, or an adjusted net loss of $0.97 per basic and diluted share for the fourth quarter of 2023 and $185.7 million, or an adjusted net loss of $2.27 per basic and diluted share for the full year 2023. This compares to an adjusted net loss of $6.7 million, or an adjusted net loss of $0.08 per basic and diluted share, for the fourth quarter of 2022 and $80.3 million, or an adjusted net loss of $1.03 per basic and diluted share, for full year 2022. The increase in adjusted net loss for the fourth quarter and full year 2023 primarily reflects the reduction in License revenues and royalties, together with higher income tax expense and lower product revenues, partially offset by lower operating expense. Conference Call Details ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time. 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 ZYNLONTA® (loncastuximab tesirine-lpyl) ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com. ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) 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. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. 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 expensesAdjusted net lossAdjusted 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 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 derivatives and warrant obligations and the effective interest expense associated with the Facility Agreement with Deerfield and 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. 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 success of the Company’s updated corporate strategy; the expected cash runway into the beginning of Q4 2025, the effectiveness of the new commercial go-to-market strategy, competition from new technologies, the Company’s ability to grow ZYNLONTA® revenue in the United States; Swedish Orphan Biovitrum AB (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; approval by the NMPA of the BLA for ZYNLONTA® in China submitted by Overland ADCT BioPharma and future revenue from the same, our strategic partners’, including Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the timing and results of the Company’s or its partners’ research and development projects or clinical trials including LOTIS 5 and 7, ADCT 601 and 602 as well as IITs in FL and MZL and early research in certain solid tumors with different targets, linkers and payloads; 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 and the significant cash required to service such indebtedness; and the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities. 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. ADC Therapeutics SAConsolidated Statement of Operations (Unaudited)(in thousands, except for per share data) For the three months ended December 31, For the years ended December 31, 2023 2022 2023 2022Revenue Product revenues, net $16,643 $19,798 $69,060 $74,908License revenues and royalties 147 50,000 498 135,000Total revenue, net 16,790 69,798 69,558 209,908Operating expense Cost of product sales (1,215) (320) (2,529) (3,301)Research and development (30,331) (48,081) (127,127) (186,457)Selling and marketing (13,927) (16,176) (57,464) (69,052)General and administrative (11,295) (15,689) (48,424) (74,442)Total operating expense (56,768) (80,266) (235,544) (333,252)Loss from operations (39,978) (10,468) (165,986) (123,344) Other income (expense) Interest income 3,291 2,259 10,540 2,568Interest expense (12,909) (9,756) (46,325) (36,731)Loss on debt extinguishment — — — (42,114)Other, net 9,724 1,211 6,352 52,804Total other income (expense) 106 (6,286) (29,433) (23,473)Loss before income taxes (39,872) (16,754) (195,419) (146,817)Income tax expense (43,171) (3,055) (39,106) (227)Loss before equity in net losses of joint venture (83,043) (19,809) (234,525) (147,044)Equity in net losses of joint venture (1,988) (3,535) (5,528) (10,084)Net loss $(85,031) $(23,344) $(240,053) $(157,128) Net loss per share Net loss per share, basic and diluted $(1.03) $(0.29) $(2.94) $(2.01)Weighted average shares outstanding, basic and diluted 82,292,594 80,463,306 81,712,166 78,152,964 ADC Therapeutics SAConsolidated Balance Sheet (Unaudited)(in thousands) December 31 2023 December 31 2022ASSETS Current assets Cash and cash equivalents $278,598 $326,441Accounts receivable, net 25,182 72,971Inventory 16,177 12,073Prepaid expenses and other current assets 16,334 23,495Total current assets 336,291 434,980 Non-current assets Property and equipment, net 5,622 3,355Operating lease right-of-use assets 10,511 6,905Interest in joint venture 1,647 7,613Deferred taxes, net — 37,104Other long-term assets 711 902Total assets $354,782 $490,859 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities Accounts payable $15,569 $12,351Accrued expenses and other current liabilities 50,634 68,491Operating lease liabilities, short-term 1,467 1,097Total current liabilities 67,670 81,939 Deferred royalty obligation 303,572 212,353Senior secured term loans 112,730 109,714Operating lease liabilities, long-term 10,180 6,564Other long-term liabilities 8,879 838Total liabilities 503,031 411,408 Total shareholders’ (deficit) equity (148,249) 79,451 Total liabilities and shareholders’ equity $354,782 $490,859 ADC Therapeutics SAReconciliation of GAAP Measures to Non-GAAP Measures (Unaudited)(in thousands, except for share and per share data) Three Months Ended December 31, Years Ended December 31,(in thousands)2023 2022 Change % Change 2023 2022 Change % ChangeTotal operating expense (56,768) (80,266) 23,498 (29)% (235,544) (333,252) 97,708 (29)%Adjustments: Share-based compensation expense (i)2,220 8,344 (6,124) (73)% 13,495 50,637 (37,142) (73)%Adjusted total operating expenses (54,548) (71,922) 17,374 (24)% (222,049) (282,615) 60,566 (21)% Three months ended December 31, Twelve months ended December 31,in thousands (except for share and per share data)2023 2022 2023 2022Net loss$(85,031) $(23,344) $(240,053) $(157,128)Adjustments: Share-based compensation expense (i)2,220 8,344 13,495 50,637Convertible loans, derivatives, change in fair value income (ii)— — — (25,650)Loss on debt extinguishment (iii)— — — 42,114Deerfield warrants obligation, change in fair value expense (income) (ii)279 (2,086) (497) (11,504)Effective interest expense on convertible loans (iv)— — — 7,684Effective interest expense on senior secured term loan facility (iv)4,650 3,912 18,398 5,845Deferred royalty obligation interest expense (v)8,253 5,844 27,915 23,200Deferred royalty obligation cumulative catch-up adjustment (income) expense (v)(9,823) 631 (4,972) (15,482)Adjusted net loss$(79,452) $(6,699) $(185,714) $(80,284) Net loss per share, basic and diluted(1.03) (0.29) (2.94) (2.01)Adjustment to net loss per share, basic and diluted0.06 0.21 0.67 0.98Adjusted net loss per share, basic and diluted(0.97) (0.08) (2.27) (1.03)Weighted average shares outstanding, basic and diluted82,292,594 80,463,306 81,712,166 78,152,964 (i)Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted, and is recognized over the requisite service period less actual forfeitures by a charge to the statement of operations and a corresponding increase in additional paid-in capital within equity. These accounting entries have no cash impact. (ii)Change in the fair value of the convertible loan derivatives and Deerfield warrant obligation results from the valuation at the end of each accounting period. There are several inputs to these valuations, but those most likely to result in significant changes to the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. These accounting entries have no cash impact. (iii)As a result of the exchange agreement entered into on August 15, 2022, the Company recognized a loss on debt extinguishment which primarily consists of the difference between the aggregate principal amount and carrying amount of the convertible loans and exit fee as well as the unpaid interest payments through the maturity date. (iv)Effective interest expense on convertible loans and senior secured term loans relates to the increase in the value of our loans in accordance with the amortized cost method. (v)Deferred royalty obligation interest expense relates to the accretion expense on our deferred royalty obligation pursuant to the royalty purchase agreement with HCR and cumulative catch-up adjustment (income) expense relates to changes in the expected payments to HCR based on a periodic assessment of our underlying revenue projections. CONTACTS: Investors and MediaNicole RileyADC TherapeuticsNicole.Riley@adctherapeutics.com+1 862-926-9040 ________________ (1) on a non-GAAP basis or 29% on a GAAP basis including stock-based compensation expense. See reconciliation of GAAP measures to non-GAAP measures in accompanying financial tables