Reported Earnings • May 05
First quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2026 results: US$0.21 loss per share (improved from US$0.36 loss in 1Q 2025). Revenue: US$20.9m (down 9.5% from 1Q 2025). Net loss: US$33.0m (loss narrowed 15% from 1Q 2025). Revenue exceeded analyst estimates by 4.3%. Earnings per share (EPS) missed analyst estimates by 4.1%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has only increased by 20% per year, which means it is significantly lagging earnings growth. 공시 • Apr 13
ADC Therapeutics SA, Annual General Meeting, Jun 01, 2026 ADC Therapeutics SA, Annual General Meeting, Jun 01, 2026, at 15:00 W. Europe Standard Time. Major Estimate Revision • Mar 17
Consensus estimates of losses per share improve by 28% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has improved. 2026 revenue forecast increased from US$78.5m to US$80.8m. EPS estimate increased from -US$1.11 per share to -US$0.806 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target up from US$7.80 to US$8.00. Share price fell 14% to US$4.11 over the past week. New Risk • Mar 11
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 31% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$186m). Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$1.6m net loss in 3 years). Breakeven Date Change • Mar 11
No longer forecast to breakeven The 6 analysts covering ADC Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$13.2m in 2028. New consensus forecast suggests the company will make a loss of US$1.63m in 2028. Reported Earnings • Mar 10
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: US$1.12 loss per share (improved from US$1.63 loss in FY 2024). Revenue: US$81.4m (up 15% from FY 2024). Net loss: US$142.6m (loss narrowed 9.6% from FY 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 20%. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 20% per year whereas the company’s share price has increased by 25% per year. Price Target Changed • Mar 03
Price target decreased by 8.5% to US$7.50 Down from US$8.20, the current price target is an average from 4 analysts. New target price is 85% above last closing price of US$4.05. Stock is up 126% over the past year. The company is forecast to post a net loss per share of US$1.41 next year compared to a net loss per share of US$1.62 last year. Breakeven Date Change • Dec 31
Forecast to breakeven in 2028 The 6 analysts covering ADC Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$8.26m in 2028. Average annual earnings growth of 51% is required to achieve expected profit on schedule. New Risk • Dec 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Negative equity (-US$238m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$23m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). 공시 • Dec 04
ADC Therapeutics SA Announces Updated Data from Lotis-7 Phase 1B Clinical Trial of Zynlonta®? in Combination with Bispecific Antibody Supporting Potential Best-In-Class Regimen in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma ADC Therapeutics SA announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA®? in combination with the bispecific antibody glofitamab (COLUMVI®?) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). Enrollment in the LOTIS-7 clinical trial is ongoing, with complete enrollment of approximately 100 patients at the selected 150 ug/kg dose expected during the first half of 2026. 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 ref refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphomas (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. 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. Factors that may cause such differences include, but are not limited to: whether future LOTIS-7 clinical trial results will be consistent with or different from the LOTIS-7 data presented, the timing and outcome of the full LOTIS-7 trial, potential best-in-class results, future publication, compendia and regulatory strategy and the commercial opportunity; the success of the Company's strategic restructuring plan; changes in estimated costs associated with the restructuring plan including the workforce reduction and planned closure of the UK facility; the strengthened balance sheet and expected cash run into at least 2028 which assumes use of minimum liquidity amount required to be maintained under its loan agreement covenants; the timing of the PFS events and topline data release for LOTIS-5 and the results of the trial and full FDA approval; the Company's ability to grow ZYNLONTA revenue in the United States and potential peak revenue; the ability of partners to commercialize ZYNLONTA in foreign markets, the timing and amount of future revenue and payments to the company from such partnerships and their ability to obtain regulatory approval for ZYNLONTA™? in foreign jurisdictions; the timing and results of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7, as well as early pre-clinical research for their excan-based ADC targeting PSMA; the timing 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 and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for the Company's indebtedness; and the company's indebtedness; and the ability to obtain financial and other assets for the Company's indebtedness. 공시 • Dec 03
ADC Therapeutics SA to Provide Update on LOTIS-7 Clinical Trial ADC Therapeutics SA announced to provide an update on the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). 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. In addition to ZYNLONTA, ADC Therapeutics is leveraging its expertise to advance IND-enabling activities for a next-generation PSMA-targeting ADC which utilizes a differentiated exatecan-based payload with a novel hydrophilic linker. Reported Earnings • Nov 11
Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2025 results: US$0.30 loss per share (improved from US$0.42 loss in 3Q 2024). Revenue: US$16.4m (down 11% from 3Q 2024). Net loss: US$41.0m (loss narrowed 6.8% from 3Q 2024). Revenue missed analyst estimates by 2.2%. Earnings per share (EPS) exceeded analyst estimates by 17%. Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 3% per year, which means it is significantly lagging earnings. 공시 • Oct 14
ADC Therapeutics SA announced that it expects to receive $60.02 million in funding from TCG Crossover Management, LLC, Redmile Group, LLC ADC Therapeutics SA announced a private placement and entered into a purchase agreement to issue 11,300,000 common shares at a price of $4 per share for aggregate proceeds of $45,200,000 and 3,800,000 Pre-funded warrants at a price of $3.9 per warrant for aggregate proceeds of $14,820,000 and total gross proceeds amounting to $60,020,000. The pre-funded warrants will have an exercise price of $0.099. The transaction is expected to close on October 27, 2025, and will include participation from lead investor TCGX and Redmile Group among other Investors. Reported Earnings • Aug 13
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$0.50 loss per share (further deteriorated from US$0.38 loss in 2Q 2024). Revenue: US$18.8m (up 8.2% from 2Q 2024). Net loss: US$56.6m (loss widened 55% from 2Q 2024). Revenue exceeded analyst estimates by 5.5%. Earnings per share (EPS) missed analyst estimates by 4.5%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Major Estimate Revision • Aug 12
Consensus EPS estimates fall by 14% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$1.52 to -US$1.73 per share. Revenue forecast of US$78.9m unchanged since last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$8.20 unchanged from last update. Share price rose 6.5% to US$2.94 over the past week. New Risk • Jul 09
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 17% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-US$238m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$103m net loss in 3 years). Shareholders have been diluted in the past year (17% increase in shares outstanding). 공시 • Jun 18
ADC Therapeutics SA Announces Updated ZYNLONTA®? Investigator-Initiated Trial Data in R/R Marginal Zone Lymphoma ADC Therapeutics SA announced updated data from a Phase 2 multicenter investigator-initiated trial (IIT) of ZYNLONTA® to treat relapsed/refractory marginal zone lymphoma (r/r MZL) will be presented during a poster session at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 20. In addition to the MZL poster presentation at ICML, an oral encore presentation of the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) will also be presented at ICML June 20 at 3:00 p.m. CEST. 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 and refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphom (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. Factors that may cause such differences include, but are not limited to: future safety and efficacy results of the Phase 2 IIT in MZL and any regulatory or compendia pathways; the success of the Company's strategic restructuring plan; changes in estimated costs associated with the restructuring plan including the workforce reduction and planned closure of the UK facility; the expected cash runway into 2028 which assumes use of minimum liquidity amount required to be maintained under its loan agreement covenants; whether future LOTIS-7 clinical trial results will be consistent with or different from the LOTIS-7 data presented at EHA and ICML and future compendia and regulatory strategy and opportunity; the timing of the PFS events for LOTIS-5 and the results of the trial and full FDA approval; the Company's ability to grow ZYNLONTA revenue in the United States and potential peak revenue; the ability of partners to commercialize ZYNLONTA in foreign markets, the timing and amount of future revenue and payments to the company's such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7, as well as early pre-clinical research for exatecan-based ADC targeting PSMA; the timing 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 the Company's activities by the U.S. and the restrictions imposed on the company's activities by the company's activities by the Company's financial and financial requirements. Price Target Changed • Jun 15
Price target increased by 7.3% to US$8.80 Up from US$8.20, the current price target is an average from 5 analysts. New target price is 146% above last closing price of US$3.58. Stock is up 8.5% over the past year. The company is forecast to post a net loss per share of US$1.57 next year compared to a net loss per share of US$1.62 last year. 공시 • Jun 13
ADC Therapeutics SA announced that it expects to receive $100.000002 million in funding from Redmile Group, LLC and other invetsors ADC Therapeutics SA announced that it has entered into a securities purchase agreement to issue 13,031,161 common shares at a price of $3.53 per share for the gross proceeds of $45,999,998.33, 15,734,267 pre-funded warrant at a price of $3.432 per warrant for the gross proceeds of $54,000,004.344 for the total gross proceeds of $100,000,002.674 on June 11, 2025. The warrants will exercisable into 15,734,267 common shares. The pre-funded warrants are exercisable at any time after their original issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the pre-funded warrant for, and the Company will issue, a new pre-funded warrant for the number of common shares then remaining under the pre-funded warrant. The pre-funded warrants will be exercisable, at the option of each holder, in whole or in part (but not for less than a common share) by delivering to the Company a duly executed exercise notice and by payment of the aggregate exercise price; provided that any exercise of the pre-funded warrants must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the pre-funded warrants).The transaction will include participation from lead investor, Redmile Group, LLC and includes participation from other institutional investors. The transaction is expected to close on June 16, 2025, subject to customary closing conditions. 공시 • Jun 12
Adc Therapeutics Announces Updated Data from Lotis-7 Clinical Trial Presented At the European Hematology Association 2025 Congress ADC Therapeutics SA announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) to be presented at the European Hematology Association 2025 Congress (EHA2025) in Milan, Italy. The Company will host a conference call and webcast featuring LOTIS-7 trial principal investigator and EHA presenting author, Juan Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine June 12, 2025 at 8:00 a.m. ET to discuss the results. The presentation highlights updated data as of April 14, 2025, in which r/r LBCL patients received dose levels of 120 µg/kg or 150 µg/kg of ZYNLONTA plus the bispecific antibody glofitamab, with 41 patients evaluable for safety and 30 patients evaluable for efficacy. Key highlights of the LOTIS-7 data presentation are as follows: Best overall response data among the 30 efficacy evaluable patients shows overall response rate (ORR) of 93.3% (28/30 pts) as assessed by Lugano Criteria; Complete response (CR) rate of 86.7% (26/30 pts); Of these, 25/26 patients achieving CR remain in CR as of the data cut-off; Median time to CR in 120 µg/kg = 80 days, Median time to CR in 150 µg/kg = 42 days; 12 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 11 pts respectively); Of the 6 patients previously treated with CAR-T and undergoing response assessment, 5 achieved a CR; Among the 41 safety evaluable patients, the combination was generally well tolerated with a manageable safety profile and no DLTs across dose levels; Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (24.4%), anemia (9.8%), AST increased (7.3%), GGT increased (7.3%), and thrombocytopenia (7.3%); In the 150 µg/kg dose, cytokine release syndrome (CRS) (23.8%), all of which were Grade 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) (4.8%), with one case of Grade 2, were observed; In the 120 µg/kg dose, CRS all grades (55%), all of which were Grade 1/2 except one case of Grade 3, and ICANS (10%), with one case of Grade 1 and one case of Grade 2, were observed; TEAEs leading to discontinuation included 3 each for ZYNLONTA and glofitamab; There were no Grade 5 TEAEs observed. This data will be shared at EHA2025 during a poster presentation on June 14 at 6:30 p.m. CEST and also as an oral encore presentation at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20 at 9:00 a.m. ET. The Company plans to share additional data before the end of 2025. 공시 • Jun 06
ADC Therapeutics SA Elects Timothy Coughlin as Director ADC Therapeutics SA announced that at its AGM held on June 3, 2025, elected Timothy Coughlin as director for a one-year term, beginning as of the Annual Meeting and ending at the closing of the 2026 annual general meeting of shareholders. Timothy Coughlin, 58, became a member of board of directors upon election at the Annual Meeting. From 2002 to 2018, Mr. Coughlin was with Neurocrine Biosciences, becoming the Chief Financial Officer of Neurocrine Biosciences in 2006. Prior to joining Neurocrine, he was with Catholic Health Initiatives, where he served as Vice President of Financial Services. He also served on the board of directors of Peloton Therapeutics prior to its sale to Merck & Co in 2019 and Fate Therapeutics from 2013 to 2025. In addition to board of directors, he currently serves on the board of directors of Travere Therapeutics and is chairman of the board at aTyr Pharma. Mr. Coughlin holds a master’s degree in international business from San Diego State University and a bachelor’s degree in accounting from Temple University. Mr. Coughlin is a certified public accountant (CPA) in both California and Pennsylvania. Reported Earnings • May 15
First quarter 2025 earnings: EPS and revenues exceed analyst expectations First quarter 2025 results: US$0.36 loss per share (improved from US$0.56 loss in 1Q 2024). Revenue: US$23.0m (up 28% from 1Q 2024). Net loss: US$38.6m (loss narrowed 17% from 1Q 2024). Revenue exceeded analyst estimates by 30%. Earnings per share (EPS) also surpassed analyst estimates by 13%. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 7% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings. 공시 • May 15
ADC Therapeutics SA Announces Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML) ADC Therapeutics SA announced data presentations from the LOTIS-7 Phase 1b clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with glofitamab in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). Updated results will be shared at the European Hematology Association 2025 Congress (EHA2025) taking place in Milan, Italy with an oral core presentation at the 18thInternational Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. Updated LOTIS-5 safety run-in data evaluating the combination of ZYNLONTA plus rituximab (Lonca-R) will also be featured at EHA2025. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (lofitamab 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 lymphomas (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. 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. ADC Therapeutics' CD19-directed ADC ZYNLONTA (lancastuximab 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 lymph cancer after two or more lines ofsystem therapy, including diffuse large B -cell lymphoma (DLBC Lonca-R) not otherwise specified (N OS), DLBCL arising from high-grade lymphoma and also low-grade B-cell lymphomas. 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 of this indication may be contingent upon verify and description of clinical benefit in an confirmatory trial. ADC Theraputics' CD19-directed AD19-directed ADC ZY NLONTA (loncastuxIMab tesirine-LPyl) received accelerated approval by The FDA and conditional approval from the Europe Commission for the treatment of rel relapsed or refractory large B-cell lymphoma After two or more lines of systemic treatment. Factors that may cause such differences include, but are not limited to: the expected cash runway into mid-2026 the Company's ability to grow ZYNLONTA revenue in the United States; the ability of partners to commercialize ZYNLONTA in foreign markets, the timing and amount of future revenue and payments to the company from such partnerships and their ability to obtain regulatory approval for ZYNLONTA®? in foreign markets, the timing & amount of future revenue and payments of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7, ADCT 602, as well as early research in certain solid tumors with different targets, linkers and payloads; the timing 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 Health Health and Drug Administration (ADCs) and the Company's indebtedness, and the Company's debt and Drug Administration (ADCs). 공시 • Apr 22
ADC Therapeutics SA, Annual General Meeting, Jun 03, 2025 ADC Therapeutics SA, Annual General Meeting, Jun 03, 2025. Location: at the company headquarters, at biopole, route de la corniche 3b, switzerland., epalinges United States Reported Earnings • Mar 27
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: US$1.63 loss per share (improved from US$2.94 loss in FY 2023). Revenue: US$70.8m (up 1.8% from FY 2023). Net loss: US$157.8m (loss narrowed 34% from FY 2023). Revenue missed analyst estimates by 2.7%. Earnings per share (EPS) exceeded analyst estimates by 4.1%. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings. Buy Or Sell Opportunity • Mar 09
Now 25% overvalued Over the last 90 days, the stock has fallen 43% to US$1.84. The fair value is estimated to be US$1.47, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 5.7% over the last 3 years. Earnings per share has grown by 4.6%. For the next 3 years, revenue is forecast to grow by 32% per annum. Earnings are also forecast to grow by 30% per annum over the same time period. Buy Or Sell Opportunity • Feb 04
Now 24% overvalued Over the last 90 days, the stock has fallen 48% to US$1.65. The fair value is estimated to be US$1.33, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 5.7% over the last 3 years. Earnings per share has grown by 4.6%. For the next 3 years, revenue is forecast to grow by 30% per annum. Earnings are also forecast to grow by 25% per annum over the same time period. 공시 • Dec 31
ADC Therapeutics SA Announces Completion of Enrollment of Phase 3 Confirmatory Clinical Trial of ZYNLONTA® in Combination with Rituximab in 2L+ Diffuse Large B-Cell Lymphoma ADC Therapeutics SA announced the completion of enrollment in LOTIS-5, the Phase 3 confirmatory trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). ZYNLONTA previously received accelerated approval for the treatment of r/r DLBCL after two or more lines of systemic therapy from the FDA in 2021. The randomized, open-label, two-part, two-arm, multicenter study is designed to confirm accelerated approval and may support potential label expansion into 2L+ in combination with rituximab. Twenty patients were enrolled in part 1 of a non-randomized safety run-in. As previously reported, the results showed an overall response rate (ORR) by central review of 80% (16/20) with a complete response (CR) rate of 50% (10/20) and no new safety signals. In part 2, patients with 2L+ DLBCL are randomized 1:1 to receive fixed-dose ZYNLONTA with rituximab or rituximab-gemcitabine-oxaliplatin (R-GemOx). The primary endpoint of LOTIS-5 is progression-free survival with secondary endpoints of overall survival, ORR, CR rate and duration of response as well as frequency and severity of adverse events. Topline results of the primary endpoint analysis are anticipated by the end of 2025 once the required number of pre-specified events is reached followed by regulatory submission to the FDA in First Quarter 2026 and potential approval in late 2026. 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. 공시 • Dec 10
Adc Therapeutics Sa Announces the Lancet Haematology Publication of Data from Investigator-Initiated Trial Evaluating Zynlonta®? in Combination with Rituximab to Treat Relapsed/Refractory Follicular Lymphoma ADC Therapeutics SA announced updated data from the investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) were published in the December issue of The Lancet Haematology, following an oral presentation of the data at the recent 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The primary endpoint of the study is complete response rate (CR) by week 12 PET/CT based on Lugano 2014 criteria. The publication titled, "Loncastuximab Tesirine with rituximab in patients with relapsed or refractory®?: a single centre, single arm Phase 2 trial," is now available online and will be published in the December issue of the Lancet Haematology. Price Target Changed • Nov 10
Price target decreased by 12% to US$8.60 Down from US$9.80, the current price target is an average from 5 analysts. New target price is 194% above last closing price of US$2.93. Stock is up 523% over the past year. The company is forecast to post a net loss per share of US$1.60 next year compared to a net loss per share of US$2.94 last year. Reported Earnings • Nov 08
Third quarter 2024 earnings: EPS misses analyst expectations Third quarter 2024 results: US$0.42 loss per share (improved from US$0.58 loss in 3Q 2023). Revenue: US$18.5m (up 27% from 3Q 2023). Net loss: US$44.0m (loss narrowed 8.0% from 3Q 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 6.5%. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 07
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: US$0.38 loss per share (improved from US$0.58 loss in 2Q 2023). Revenue: US$17.4m (down 9.7% from 2Q 2023). Net loss: US$36.5m (loss narrowed 22% from 2Q 2023). Revenue missed analyst estimates by 7.4%. Earnings per share (EPS) exceeded analyst estimates by 17%. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings. 공시 • Aug 07
ADC Therapeutics SA has filed a Follow-on Equity Offering in the amount of $100 million. ADC Therapeutics SA has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Major Estimate Revision • May 13
Consensus EPS estimates upgraded to US$1.84 loss, revenue downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$80.9m to US$77.7m. 2024 losses expected to reduce from -US$2.15 to -US$1.84 per share. Biotechs industry in the US expected to see average net income decline 9.8% next year. Consensus price target broadly unchanged at US$10.00. Share price fell 3.4% to US$4.30 over the past week. Recent Insider Transactions • May 12
CEO & Director recently sold US$133k worth of stock On the 7th of May, Ameet Mallik sold around 30k shares on-market at roughly US$4.48 per share. This transaction amounted to 2.5% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Ameet's only on-market trade for the last 12 months. 공시 • May 10
ADC Therapeutics SA has completed a Follow-on Equity Offering in the amount of $105 million. ADC Therapeutics SA has completed a Follow-on Equity Offering in the amount of $105 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 13,411,912
Price\Range: $4.9
Discount Per Security: $0.294
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 8,163,265
Price\Range: $4.812
Discount Per Security: $0.2887 공시 • May 08
ADC Therapeutics Announces Initial Data from Investigator-Initiated Phase 2 Clinical Trial of ZYNLONTA® in Patients with Relapsed/Refractory Marginal Zone Lymphoma ADC Therapeutics SA announced that initial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) demonstrated a high response rate in patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL). The 50-patient single-arm, open-label Phase 2 multicenter study is currently being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope, and led by Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami. This study is evaluating the safety and efficacy of six cycles of ZYNLONTA across 18 weeks in patients with r/r MZL previously treated with =1 line of systemic therapy (ClinicalTrials.gov identifier: NCT05296070). As of the data cutoff date of March 30, 2024, 15 patients were evaluable. Of these 15 patients evaluated, 13 achieved a complete response (CR) and one patient achieved a partial response (PR). All patients who achieved responses had maintained them at the time of the data cutoff. In this study, ZYNLONTA was generally well-tolerated and safety was consistent with the known profile, with two patient discontinuations. One patient discontinued after cycle 2 and a second patient discontinued after cycle 4 due to a toxicity, which fully resolved upon discontinuation of treatment. Both of these patients remain in CR at 10 and 6 months, respectively. These initial data were presented at the Lymphoma Research Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop by the trial’s lead investigator, Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami. MZL is a rare, indolent non-Hodgkin lymphoma (NHL) and the third most common NHL subtype. There are few FDA-approved therapies for MZL. Reported Earnings • May 07
First quarter 2024 earnings: Revenues and EPS in line with analyst expectations First quarter 2024 results: US$0.56 loss per share (improved from US$0.73 loss in 1Q 2023). Revenue: US$18.1m (down 4.9% from 1Q 2023). Net loss: US$46.6m (loss narrowed 22% from 1Q 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) were also in line with analyst expectations. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. 공시 • May 06
ADC Therapeutics SA has filed a Follow-on Equity Offering. ADC Therapeutics SA has filed a Follow-on Equity Offering.
Security Name: Common Shares
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant 공시 • Apr 28
ADC Therapeutics SA, Annual General Meeting, Jun 13, 2024 ADC Therapeutics SA, Annual General Meeting, Jun 13, 2024, at 04:00 Eastern Daylight. Location: Company’s headquarters located at Biopôle, Route de la Corniche 3B, 1066 Epalinges Epalinges Switzerland Agenda: To consider approving the company’s management report, annual financial statements and consolidated financial statements for the year ended december 31, 2023 (collectively, the “reports”) and acknowledging the auditors’ reports for the year ended december 31, 2023 (the “auditors’ report”); to consider approving, on an advisory basis under swiss law, the company’s compensation report for the year ended december 31, 2023; and to transact such other business matters. Major Estimate Revision • Mar 20
Consensus EPS estimates fall by 13%, revenue upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$80.7m to US$82.1m. Forecast EPS reduced from -US$1.85 to -US$2.10 per share. Biotechs industry in the US expected to see average net income decline 8.2% next year. Consensus price target up from US$9.25 to US$10.00. Share price rose 4.9% to US$4.67 over the past week. New Risk • Mar 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.2% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-US$148m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$119m net loss in 3 years). Shareholders have been diluted in the past year (2.2% increase in shares outstanding). Reported Earnings • Mar 13
Full year 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2023 results: US$2.94 loss per share (further deteriorated from US$1.99 loss in FY 2022). Revenue: US$69.6m (down 67% from FY 2022). Net loss: US$240.1m (loss widened 54% from FY 2022). Revenue exceeded analyst estimates by 1.9%. Earnings per share (EPS) missed analyst estimates by 23%. Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 49% per year, which means it is significantly lagging earnings. 공시 • Jan 04
ADC Therapeutics Regains Compliance with NYSE Continued Listing Standards ADC Therapeutics SA announced that it received a notice from the New York Stock Exchange (NYSE) on January 2, 2024 that the Company has regained compliance with the continued listing minimum price criteria set in Section 802.01C of the NYSE Listed Company Manual and, as a result, will be removed from the NYSE’s noncompliant issuers list. The Company previously received a notice from the NYSE that it was not in compliance with the continued listing minimum price criteria, as the average closing price of its common shares was below $1.00 over a consecutive 30 trading-day period. As closing price of the common shares on December 29, 2023 and the average closing price of the common shares over the 30 trading-day period ending on December 29, 2023 were both above $1.00, the deficiency was cured. New Risk • Nov 10
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-US$54m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$138m net loss in 3 years). Market cap is less than US$100m (US$48.5m market cap). Reported Earnings • Nov 09
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: US$0.58 loss per share (improved from US$0.65 loss in 3Q 2022). Revenue: US$14.5m (down 81% from 3Q 2022). Net loss: US$47.8m (loss narrowed 5.5% from 3Q 2022). Revenue missed analyst estimates by 4.4%. Earnings per share (EPS) exceeded analyst estimates by 11%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. New Risk • Nov 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$8.6m). Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$141m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$69.7m market cap). Price Target Changed • Nov 02
Price target increased by 19% to US$10.50 Up from US$8.80, the current price target is an average from 4 analysts. New target price is 1,400% above last closing price of US$0.70. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$2.44 next year compared to a net loss per share of US$1.99 last year. Price Target Changed • Oct 08
Price target increased by 12% to US$8.80 Up from US$7.83, the current price target is an average from 5 analysts. New target price is 948% above last closing price of US$0.84. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$2.47 next year compared to a net loss per share of US$1.99 last year. New Risk • Oct 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-US$8.6m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$150m net loss in 3 years). Market cap is less than US$100m (US$66.6m market cap). Major Estimate Revision • Sep 19
Consensus revenue estimates fall by 11% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$82.3m to US$73.0m. Forecast losses increased from -US$2.35 to -US$2.45 per share. Biotechs industry in the US expected to see average net income decline 3.3% next year. Consensus price target down from US$8.17 to US$7.83. Share price fell 16% to US$0.80 over the past week. 공시 • Aug 31
ADC Therapeutics SA Announces Updates on ZYNLONTA® LOTIS Clinical Trial Programs At the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023) ADC Therapeutics SA announced that two ZYNLONTA® (loncastuximab tesirine-lpyl) abstracts have been accepted for presentation at the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023), which will be held in Houston, Texas from September 6-9, 2023. LOTIS-5 Safety Run-In Results: LOTIS-5 is a Phase 3, randomized, open-label, two-part, two-arm, multicenter study of loncastuximab tesirine in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is the confirmatory trial for accelerated approval for 3L+ and would also support potential label expansion into 2L+ in combination with rituximab. Twenty patients were enrolled in part 1 of a non-randomized safety run-in. In part 2, approximately 330 patients will be randomized 1:1 to receive fixed-dose Lonca-R or rituximab-gemcitabine-oxaliplatin (R-GemOx). The 20 patients in the safety run-in were a median age of 74.5 years and had previously received a median of five cycles of Lonca-R and one previous therapy. As of the April 10, 2023, data cutoff: Seven patients completed treatment and five continue in follow-up. The overall response rate by central review was 16/20 (80%). A total of 10/20 (50%) and 6/20 (30%) patients attained complete and partial response, respectively. The median duration of response was 8.0 months and the median progression-free survival was 8.3 months. A total of 11 (55%) patients had grade =3 treatment-emergent adverse events (TEAEs). The most common grade =3 TEAEs were increased gamma-glutamyltransferase (5 patients [25%]) and neutropenia (3 patients [15%]). LOTIS-7 is a multicenter and multi-arm study that will enroll approximately 200 patients with relapsed or refractory B-cell non-Hodgkin lymphoma in part 1 (dose escalation in approximately 60 patients) and part 2 (dose expansion in approximately 120 patients). Dosing arms include ZYNLONTA (loncastuximab tesirine-lpyl) plus polatuzumab vedotin, as well as ZYNLONTA (loncastuximab tesirine-lpyl) plus glofitamab and mosunetuzumab, t-cell-engaging bispecific monoclonal antibodies (BsAbs). The bispecific combination arms of the LOTIS-7 trial are now actively enrolling patients with DLBCL, including transformed follicular lymphoma (FL), high-grade B-cell lymphoma (HGBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL). Combining these agents with different mechanisms of action has the potential to have increased activity compared to either agent alone. New Risk • Aug 11
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$8.6m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risk Negative equity (-US$8.6m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$136m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (5.2% increase in shares outstanding). Major Estimate Revision • Aug 09
Consensus revenue estimates decrease by 20%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$104.2m to US$83.0m. EPS estimate increased from -US$2.73 to -US$2.42 per share. Biotechs industry in the US expected to see average net income decline 20% next year. Consensus price target up from US$8.33 to US$9.40. Share price was steady at US$1.50 over the past week. New Risk • Aug 09
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$8.6m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risk Negative equity (-US$8.6m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$159m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (5.2% increase in shares outstanding). Reported Earnings • Aug 08
Second quarter 2023 earnings: EPS and revenues miss analyst expectations Second quarter 2023 results: US$0.58 loss per share (improved from US$0.84 loss in 2Q 2022). Revenue: US$19.3m (up 12% from 2Q 2022). Net loss: US$47.1m (loss narrowed 27% from 2Q 2022). Revenue missed analyst estimates by 54%. Earnings per share (EPS) also missed analyst estimates by 1.8%. Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. 공시 • Aug 03
ADC Therapeutics SA to Report Q2, 2023 Results on Aug 08, 2023 ADC Therapeutics SA announced that they will report Q2, 2023 results at 8:30 AM, Eastern Standard Time on Aug 08, 2023 공시 • Jul 25
China National Medical Products Administration Accepts Biologics License Application and Grants Priority Review for ZYNLONTA for Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals (CY) Inc. and ADC Therapeutics SA announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA(R) (loncastuximab tesirine-lpyl), which is seeking an indication for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in China. The BLA has been granted priority review by the NMPA. The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA. The study was designed to evaluate the efficacy and safety of ZYNLONTA as a single-agent treatment for Chinese patients with r/r DLBCL. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab Tesirine-lpyl) for the treatment of adult patients With relapsed or refractory®? large B-cell lymphoma after two or more line of systemic therapy, including DLBCL not otherwise specified, 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 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. 공시 • Jul 12
ADC Therapeutics SA Announces Voluntary Pause in the Enrollment of New Patients in the Phase 2 LOTIS-9 Clinical Trial Evaluating ZYNLONTA On July 11, 2023, ADC Therapeutics SA announced a voluntary pause in the enrollment of new patients in the Phase 2 LOTIS-9 clinical trial (ClinicalTrials.gov Identifier: NCT05144009) evaluating ZYNLONTA (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated treat large B-cell lymphoma (DLBCL). The voluntary action was taken by the Company after a recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events. These respiratory-related treatment acute adverse events ("TEAEs") included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs. As per investigator assessment, eleven of the twelve events (including six of the seven Grade 5 fatal events) were individually assessed as unlikely or unrelated to study drug. Four out of the five Grade 3 or Grade 4 events have since resolved and the patients have completed treatment per protocol. The cause of these events remains under further investigation. All patients with fatal events had one or more significant active underlying respiratory and/or cardiac co-morbidities including severe chronic obstructive pulmonary disease (COPD), pulmonary edema, chronic bronchiectasis, idiopathic pulmonary fibrosis and recent COVID-19 infection and all were greater than or equal to 80 years of age. The mean age was 82.7 years and the mean number of days from the last dose to death was 51 days, with a range of 19 to 86 days. It is important to note that all twelve of the patients with Grade 3-5 TEAEs in the LOTIS-9 study would have been excluded from the LOTIS-5 trial. The Company’s decision to pause enrollment enables time to evaluate data around the TEAEs and determine next steps. The Company has notified all study investigators and regulatory authorities including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) of the Company’s decision to pause enrollment. The Company does not expect to report additional data from the trial by the end of the year. Buying Opportunity • Jul 12
Now 31% undervalued after recent price drop Over the last 90 days, the stock is down 22%. The fair value is estimated to be US$2.67, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 119% over the last 3 years. Earnings per share has grown by 19%. For the next 3 years, revenue is forecast to grow by 15% per annum. Earnings is also forecast to grow by 14% per annum over the same time period. Board Change • Jul 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Board Observer Michael Forer was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. 
