ADCT ADC Therapeutics SA

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): May 14, 2024

 

ADC Therapeutics SA

(Exact Name of Registrant as Specified in Its Charter)

 

Switzerland (State or Other Jurisdiction of Incorporation)

001-39071 (Commission File Number)

N/A (IRS Employer Identification Number)

 

Biopôle Route de la Corniche 3B 1066 Epalinges Switzerland (Address of Principal Executive Offices) (Zip Code)

+41 21 653 02 00 (Registrant’s Telephone Number)

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Shares, par value CHF 0.08 per share	ADCT	New York Stock Exchange

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 C.F.R. §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 C.F.R. §240.12b-2). Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

Item 7.01. Regulation FD Disclosure.

 

On May 14, 2024, ADC Therapeutics SA (the “Company”) made available a presentation expected to be used in connection with certain industry conferences and investor meetings. A copy of the presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.

 

The information contained in this Item 7.01 and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit Number	Description
99.1	Presentation dated May 14, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	ADC Therapeutics SA
Date: May 14, 2024
	By:	/s/ Peter J. Graham
	Name:	Peter J. Graham
	Title:	Chief Legal Officer

 

Exhibit 99.1

 

Corporate Presentation 2Q 2024

2 Forward - Looking Statements This presentation and any accompanying oral presentation have been prepared by ADC Therapeutics SA ("ADC Therapeutics“, “we” or “us”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or ADC Therapeutics or any officer, director, employee, agent or advisor of ADC Therapeutics. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. Information provided in this presentation an d a ny accompanying oral presentation speak only as of the date hereof. This presentation 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”, “assumes”, “will”, “should”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estima te” , “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 state ments 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 u pda ted corporate strategy; the expected cash runway into mid - 2026, the effectiveness of the new commercial go - to - market strategy, competition from new technologies, the Company’s ability to grow ZYNLONTA® revenue in the Unit ed 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 s ame ; 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 a nd 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 re gul atory submissions or NCCN compendia inclusion for the Company’s products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company’s ability to enter into bus ine ss development or research collaboration transactions; the Company’s indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company’s activities b y s uch 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 an d o ther 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 - look ing 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 s tat ements 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. Forward - looking statements are based on our management’s beliefs and assumptions and on information currently available to our m anagement. No assurance can be given that such future results will be achieved. Such forward - looking statements contained in this presentation speak only as of the date of this presentation. The Company expressly discl aim any obligation or undertaking to update these forward - looking statements contained in this presentation to reflect any change in our expectations or any change in events, conditions, or circumstances on which such st ate ments are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward - looking statements. Certain information contained in this presentation relates to or is based on studies, publications, surveys, and other data d eri ved from third - party sources and our own internal estimates and research. While we believe these third - party sources to be reliable as of the date of this presentation, we have not independently verified, and we make no represen tat ion as to the adequacy, fairness, accuracy or completeness of, any information obtained from third - party sources. In addition, all of the market data included in this presentation involve a number of assumptions and limitati ons , and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, although we believe our own internal research is reliable, such research has not been verified by any independent source.

3 ADC Therapeutics at a Glance Solid Tumors Advancing ADCT - 601 targeting AXL in the clinic and multiple investigational ADCs Hematology Maximizing ZYNLONTA® in 3L+ DLBCL and expanding into earlier lines of DLBCL and indolent lymphomas; advancing ADCT - 602 targeting CD22 Corporate Cash runway into mid 2026* with multiple catalysts through 1H 2025 Platform Pioneering ADC field with robust technology toolbox and specialized end - to - end capabilities * Cash runway assumes receipt of anticipated regulatory milestone payments under the Company’s collaboration agreements and use of the amount it is required to maintain under its loan agreement . ADC: Antibody Drug Conjugate; DLBCL: Diffuse Large B - Cell Lymphoma

4 Clinical Strong track record including an approved product with robust lifecycle management and multiple clinical assets Platform Validated and differentiated ADC platform with multiple payloads and targets Regulatory Proven capabilities securing FDA and EMA approvals for ZYNLONTA and multiple INDs Platform and Capabilities for Developing Optimized ADCs CMC: Chemistry, Manufacturing and Controls; PBD: Pyrrolobenzodiazepines Discovery Cutting - edge research to select the optimal targeting moiety, linker, and payload Development Swiftly moving from research to clinical trials with an optimized development strategy Manufacturing Robust in - house CMC capabilities enhanced by a top - tier external manufacturing network Commercialization Integrated go - to - market model with experienced team

5 Corporate and Capital Allocation Strategy Based on Twin Pillars of Hematology and Solid Tumors DLBCL: Diffuse Large B - Cell Lymphoma; FL: Follicular Lymphoma; MZL: Marginal Zone Lymphoma; NSCLC: Non - Small Cell Lung Cancer; ALL: Acute Lymphoblastic Leukemia. Short - Mid Term Hematology Portfolio ZYNLONTA ▪ Primary focus for capital allocation ▪ De - risked asset with $500M+ peak sales potential ▪ Investing to optimize commercial execution in 3L+ DLBCL and potential expansion into earlier lines (LOTIS - 5: rituximab combination, LOTIS - 7: bispecific combinations) and indolent lymphomas (FL and MZL) OTHER ASSETS ▪ ADCT - 602 (CD22) in Phase 1 in ALL Solid Tumor Portfolio ADCT - 601 (AXL) ▪ Optimizing dose for expansion as single agent and / or in combination in sarcoma, pancreatic, and NSCLC Next - generation ADCs ▪ Differentiated exatecan - based payload with novel hydrophilic linker, targeting Claudin - 6, NaPi2b, PSMA, ASCT2 ▪ Advancing one candidate to IND COLLABORATION STRATEGY ▪ Partnership/collaboration approach to support progression of broad early - stage portfolio ▪ Non - dilutive capital from partners to help fund internal development of select solid tumor programs

6 Focused Pipeline in Hematology and Solid Tumors Anticipated milestones set forth in this chart are subject to further future adjustment. NTE: Non - Transplant Eligible. 1. DLBCL, FL, MZL 2. Non - selected advanced / metastatic NSCLC completed. Moving forward with AXL expressing NSCLC contingent on in - house IHC assay. AA: Accelerated Approval. Preclinical Phase 1a Phase 1b Phase 2 ZYNLONTA | Targeting CD19 ADCT - 602 | Targeting CD22 Expected Milestones LOTIS - 5: Complete enrollment in 2024 Phase 3 / Confirmatory Hematology Confirmatory LOTIS - 5 with rituximab in 2L+ NTE DLBCL LOTIS - 2 in 3L+ DLBCL NaPi2b Candidate selected FDA approved (AA) LOTIS - 7 with glofitamab in r/r NHL 1 Solid Tumors Single agent and with gemcitabine in adv. / met. Sarcoma Mipasetamab uzoptirine (ADCT - 601) | Targeting AXL Additional data from Phase 1 study in 2024 Acute Lymphoblastic Leukemia Additional data from Phase 1 study in 2024 Claudin - 6 PSMA ASCT2 Candidate selected Candidate selection in 2024 Candidate selection in 2024 Single agent and with gemcitabine and others in adv. / met. Pancreatic Single agent and other combinations in adv. / met. NSCLC 2 LOTIS - 7 with mosunetuzumab in r/r NHL 1 Next - Gen ADCs | Exatecan Payload with Novel Linker U of Miami IIT with rituximab in r/r FL U of Miami IIT single agent in r/r MZL IITs: Updates at medical meetings in 2024 / 2025 LOTIS - 7: Initial dose expansion data with glofitamab in 2H 2024

7 Proportion of patients by line - of - therapy* DLBCL, FL & MZL account for ~60% of mature B - cell lymphomas 1 1L (~70%) 1L (~65%) 1L (~61%) MZL^ FL DLBCL Key: Current Approval Current Development Areas Advancing ZYNLONTA Development in B - Cell Lymphomas *Distribution by line of therapy is based on the incident, drug - treated population; ^Internal analysis of Global Data (2017) and Clarivate DRG (2022). Source: 1. Leukemia & Lymphoma Society w ebsite ; 2. Clarivate DRG (2022) and Global Data (2017); 3. Cerner Enviza CancerMPact (2023). 2L (~24%) 2L (~27%) 3L+ (~11%) 3L+ (~12%) Projected U.S. Market Value 2 , 2023 5 - year prevalence 3 ▪ LOTIS - 5 and LOTIS - 7 potential to move ZYNLONTA into 2L+ DLBCL ‒ LOTIS - 5 (ZYNLONTA + R): 20 patient safety run - in data showed ORR of 80%, CR of 50% with no new safety signals; accelerating patient enrollment/completion expected in 2024 ‒ LOTIS - 7 (ZYNLONTA + BsAbs ): Dose escalation in Phase 1b trial completed with no dose - limiting toxicities and early signs of anti - tumor activity; Part 2 dose expansion initiated with ZYNLONTA in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels in 2L+ DLBCL Current Development Areas ▪ Initial IIT data suggests ZYNLONTA regimen could provide benefit in indolent lymphomas: ‒ FL 2L+ high - risk (ZYNLONTA + R): 96% ORR, 85% CR, N=27 ‒ MZL 2L+ (ZYNLONTA): 13 achieved a complete response and 1 achieved a partial response, N = 15 $3.1b 2 , ~109 K patients $2.6b 2 , ~61 K patients $1.4b 2 , ~38 K patients

8 Significant opportunity for ZYNLONTA combinations in 2L+, despite a highly evolving market 1. Epcoritamab or Glofitamab . Source: Putnam Associates Primary Research. SoC: standard of care, BsAbs : bispecific antibodies, CRS: cytokine release syndrome Key ض Recently approved Shifting to 1L use No standard of care Academic Community 1L (~30 K patients) 2L (~11 K patients) 3L+ (~6 K patients) R - CHOP ~35% ض Polivy + R - CHP R - CHOP ض Polivy + R - CHP CAR - T Clinical Trials ZYNLONTA ض BsAbs 1 Monjuvi + Len Polivy + BR ZYNLONTA Monjuvi + Len Polivy + BR R - Based Chemo ~30% ~70% R - Based Chemo Monjuvi + Len Pola - BR ~65% ~60% ~40% CAR - T Clinical Trials Salvage +/ - ASCT ILLUSTRATIVE MARKET EVOLUTION ▪ Despite recent advancements, a true SoC only exists in 1L and in the academic setting in 2L with CAR - T ▪ Aside from CAR - T, the market is evolving towards combinations with off - the - shelf agents as a cornerstone ▪ With polatuzumab moving into 1L, retreatment with pola - based combos in 2L+ may be less likely ▪ Need for novel combinations in the 2L+ in community centers and 3L+ in academic settings with better efficacy and tolerability ZYNLONTA + b ispecifics (LOTIS - 7, Ph1b) combinations may: ▪ Improve efficacy over BsAbs and other combinations in 2L+ academic settings ▪ Improve CRS rates and enable broader accessibility to community centers in 2L+ ZYNLONTA + r ituximab (LOTIS - 5, Ph3) has the potential to: ▪ Provide competitive efficacy with a familiar safety profile ▪ Be a SoC in the 2L+ setting in community centers and 3L+ in academic settings ZYNLONTA POTENTIAL

9 LOTIS - 5 Overview IDMC: Independent Data Monitoring Committee, OS: Overall Survival, ORR: Overall Response Rate, CRR: Complete Response Rate, DoR : Duration of Response ▪ Patient Population: 2L+ DLBCL, ASCT ineligible ▪ Summary: Ph3 confirmatory trial in combination with rituximab ▪ Study Design: Randomized, open - label, two - part, two - arm, multi - center clinical trial of ZYNLONTA combined with rituximab compared to immunochemotherapy in patients with relapsed or refractory DLBCL ▪ Primary and Secondary Endpoints: ‒ Primary endpoint - to evaluate the efficacy of ZYNLONTA combined with rituximab compared to standard immunochemotherapy, as measured by PFS ‒ Secondary endpoints include OS; ORR; CRR; DoR ; frequency and severity of adverse events; changes from baseline in safety laboratory and clinical variables; concentration and pharmacokinetic parameters of ZYNLONTA; immunogenicity; and changes in patient - reported outcomes ▪ Initial Data: Updated safety lead - in results at SOHO 2023: ORR of 80%, CR of 50% with no new safety signals Status and Next Steps LOTIS - 5: Developing ZYNLONTA to be the Combination Agent of Choice in Earlier Lines of Therapy Target Positioning Competitive 2L+ efficacy with favorable safety and convenient dosing schedule, well - suited for use in both academic and community settings *As of March 13, 2024 ▪ Enrollment ongoing in randomized portion; > 2/3rd patients enrolled ▪ Required number of pre - specified progression free survival events unchanged from original study design; total number of patients enrolled dependent on patient censoring rate ▪ In January 2024, IDMC noted no safety concerns, recommended study to proceed ▪ Expect full enrollment in 2024 ▪ Depending on events, potential data by end of 2025

10 Arm E Arm F Treatment Period (cycles of 21 days) r/r DLBCL, FL, MZL for both arms May include r/r DLBCL, FL, and MZL ZYNLONTA will be given at RD for the specific combinations and subpopulations determined in part 1 End of Treatment Part 1 3+3 Dose escalation (ZYNLONTA 90, 120, and 150 μg /kg) Part 2 Dose expansion Screening Period (≤28 d) Mosunetuzumab + escalating doses of ZYNLONTA Q3W 2 Enrollment began July 2023 Glofitamab + escalating doses of ZYNLONTA Q3W 1 Enrollment began July 2023 1. Obinutuzumab pretreatment 1000mg on C1D1; ZYNLONTA administered on C1D2; administration of 1 st and 2 nd step - up dose(s) of IV glofitamab (2.5mg on C1D8 & 10mg on C1D15); ZYNLONTA plus glofitamab 30mg on C2D1 and beyond (reduce ZYNLONTA to 75 ug/kg at C3 if starting dose is 120 ug/kg or higher) 2. ZYNLONTA plus subcutaneous mosunetuzumab 1st step - up dose of 5 mg on C1D1, followed by mosunetuzumab 2nd step - up & target dose of 45 mg for C1D8 & C1D15; ZYNLONTA plus 45mg of subcutaneous mosunetuzumab on C2D1 and beyond (reduce ZYNLONTA to 75 μg /kg at C3 if starting dose is 120 ug/kg or higher) LOTIS - 7: Combining ZYNLONTA with Bispecific Antibodies ( Glofitamab or Mosunetuzumab ) ▪ Primary: Safety and tolerability; MTD and/or RD ▪ Secondary: Efficacy: ORR, DOR, CRR, PFS, RFS, OS; Pharmacokinetics and Immunogenicity ENDPOINTS STUDY POPULATION ▪ Relapsed or Refractory B - NHL patients and have received: Part 1: >2 systemic treatment regimens; Part 2: >1 systemic treatment regimens ▪ Prior autologous SCT (>100 days) or CAR - T (>30 days) is allowed ▪ Distinct MOAs and non - overlapping toxicities, except neutropenia ▪ Most potent off - the - shelf, single agent drugs approved in DLBCL ▪ ZYNLONTA use prior to glofitamab may debulk the tumors and reduce peripheral B cells, leading to lower CRS rates RATIONALE ▪ Dose escalation in Phase 1b trial completed with no dose - limiting toxicities, no or low - grade cytokine release syndrome and no immune effector cell - associated neurotoxicity syndrome across all patients and early signs of anti - tumor activity ▪ Part 2 dose expansion initiated with ZYNLONTA in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels in 2L+ DLBCL Part 1 Dose Escalation Completed

11 Arm F* (ZYNLONTA + Mosun) n = 9 Arm E* (ZYNLONTA + Glofit ) n = 9 n (%) Grade 4 (44.4%) 2 (22%) Grade 1 1 (11%) 1 (11%) Grade 2 0 (0%) 0 (0%) Grade > 3 5 (55.6%) 3 (33.3%) Total CRS Profile ▪ After the first investigator assessment, e vidence of anti - tumor activity (complete response or partial response) was observed among the majority of patients ▪ Majority of CRS events were grade 1 and no CRS > grade 2 was observed ▪ All CRS grade 2 events responded to Tocilizumab / corticosteroids; no requirement for pressors or ICU management Initial Safety Findings Initial Efficacy Findings LOTIS - 7 Part 1 Dose Escalation Data as of April 19, 2024 * Arm E: Loncastuximab + Glofitamab - obi is dosed C1D1, lonca dosed C1D2, and glofit dosed C1D8, Arm F: Loncastuximab + Mosunetuzumab - both dosed on C1D1.

12 CR ZYNLONTA + Rituximab IIT Showed Strong Initial Signals in High - risk r/r FL, including POD24, with 96% ORR and 85% CR rates Patient Population – 2L+ FL U of Miami IIT in 2L+ FL Overview 1L ▪ Highlights of Phase 2 study of ZYNLONTA with rituximab in patients with high - risk relapsed/refractory follicular lymphoma presented at ASH include: ‒ N = 33 patients enrolled, 27 patients evaluable for efficacy and 32 patients evaluable for toxicity ‒ Best overall response rate of 96% and CR rate of 85% ‒ 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% ‒ Majority of adverse events (AEs) were grade 1. Grade 3 AEs included neutropenia (n=2; 6%), and one case each (3%) of hyperglycemia, increased ALT, fatigue, dyspnea and skin infection. Neutropenia was the only grade 4 AE (n=1; 3%) ^Data does not include R - / Obin - CHOP or R - / Obin - CVP which are included in 2L+ NCCN preferred guidelines based on 1L systemic therapy data only. * Bendamustine mono - therapy has broad FDA approval in indolent B - cell non - Hodgkin lymphoma after R - containing regimens, however, is not specific to FL. 1. GALEN study ( single arm, multicenter ph 2; n = 88); 2. GADOLIN study (randomized ph3 of B + O vs. B; total n = 396, total FL n= 321, B+O FL n = 155; AUGMENT study (r an domized ph 3 of R2 vs. R; total n = 358, total FL n = 295, R2 FL n = 147, R mono FL n = 148); 4. Cerner Enviza CancerMPact (2023), d istribution by line of therapy is based on the incident, drug - treated population; 5. Casulo et al., J Clin Oncol (2015), Casulo et al., Blood (2022). Benda* + Obin (2L+) 2 17% ~21 K 2L+ FL patients U.S. 5 - year Prevalence 4 3L+ Key: 2L 1L ▪ University of Miami plans to expand the number of trial participants up to 100 and add other cancer research centers ▪ Data is expected to be published at a medical conference ▪ Path forward will be discussed with regulatory authorities and compendia Next Steps ▪ Estimated 6 K 2L+ FL patients are drug - treated in the US annually 4 , of which ~20% are POD24 patients , characterized by an unfavorable prognosis 5 NCCN Preferred Regimens with 2L+ Data Len + Obin (2L+) 1 38% 0 - 80 - ORR % 60 - 40 - 20 - Len + Rituximab (R2) (2L+) 3 78% Benda* + Obin (2L+) 2 79% Len + Obin (2L+) 1 79% Len + Rituximab (R2) (2L+) 3 34% FDA Approved / NCCN Preferred^ NCCN Preferred^ Only 0 - 80 - % 60 - 40 - 20 -

13 ZYNLONTA IIT Showed Strong Initial Signals in 15 r/r MZL patients with 13 achieving a CR and 1 achieving a PR ▪ 2 sites currently enrolling, expanding to 5 sites to accelerate trial enrollment ▪ ADCT plans to potentially pursue regulatory pathway and compendia in parallel as soon as sufficient data is available ▪ Highlights of Phase 2 study of ZYNLONTA in patients with relapsed/refractory marginal zone lymphoma presented at LRF’s 2024 MZL Scientific Workshop include: ‒ Initial data as of April 19, 2024 in 15 patients (n total = 50) showed 13 achieved a complete response and 1 achieved a partial response ‒ ZYNLONTA was generally well - tolerated , and safety was consistent with the known profile ▪ Total addressable 2L+ MZL patient population has a potential peak market value of approximately $500 M 9 ; Potential expansion in MZL contributes to the overall ZYNLONTA growth strategy in NHL Next Steps NCCN Preferred Regimens with 2L+ Data Patient Population – 2L+ MZL ~15 K 2L+ MZL patients U.S. 5 - year Prevalence 8 1L 1L 0 - 80 - ORR Benda* + Obin 1 Zanubritinib 2 68% % 79% 60 - Len + Rituximab (R2) 4 65% CR 40 - 20 - Zanubritinib 2 26% Acalabrutinib 3 53% Acalabrutinib 3 13% Pirtobrutinib 5 50% Pirtobrutinib 5 2.8% FDA Approved / NCCN Preferred^ N = 63 – 68 NCCN Preferred^ Only N = 36 – 46 ^ Data does not include R - CHOP, R - CVP, or B - R data which are included in 2L+ NCCN preferred guidelines based on 1L systemic ther apy data only; * Bendamustine mono - therapy has broad FDA approval in indolent B - cell non - Hodgkin lymphoma after R - containing regimens, however, is not specific to MZL; bendamustine combinations are not FDA approved for MZL and are guidelines only. Source: 1. GADOLIN study (randomized ph3 of B + O vs. B; total n = 396, total MZL n= 46, B+O MZL n = 27); 2. MAGNOLIA Trial (single arm, multicenter ph 2; n = 68); 3. ACE - LY - 003 study (part 2 of multicenter, ph 1/2b; n = 43); 4. AUGMENT study (randomized ph3 of R2 vs. R; total n = 358, total MZL n = 63, R2 MZL n = 31, R mono MZL n = 32); 5. BRUIN study ( ph 1/2 of pirtobrutinib in CLL/SLL and NHL, total estimated n = 860, total MZL n = 36). 6. Clarivate DRG (2022); 7. Global Data (2017); 8. Cerner Enviza CancerMPact (2023), d istribution by line of therapy is based on the incident, drug - treated population ; 9. Assumes total addressable population and average net price for ZYNLONTA in 2030 with a CAGR of ~2% and ~3% respectively, an d average cycles expected in MZL. ▪ Estimated 3 – 4 K 2L+ MZL patients are drug - treated in the US annually 6 - 8 ; despite patients achieving durable responses, high unmet medical need remains with <30% CR for 2L+ NCCN preferred treatments 1 - 5 U of Miami IIT in 2L+ MZL Overview 3L+ Key: 2L 1L 0 - 80 - % 60 - 40 - 20 - Benda* + Obin 1 17% Len + Rituximab (R2) 4 29%

14 ADCT - 601: A Novel, Potent Approach to Targeting AXL Note: 1. GlycoConnect and HydraSpace are technologies licensed from Synaffix ; TI: therapeutic index; MTD: maximum tolerated dose; GlcNax : N - acetyl - glucosamine; GalNac : N - acetylgalactosamine ; SP: Spacer; PBD: Pyrrolobenzodiazepine . Source: Zammarchi et al., Mol Cancer Ther (2022) ADCT - 601 Structure Anticipated Differentiation ▪ Potential best - in - class ADC against a target expressed across multiple solid tumor types with unmet medical needs ▪ First AXL - targeted ADC conjugated to a PBD dimer cytotoxin ▪ Glycoconnect Ρ ,1 and Hydraspace Ρ ,1 technology enhance the TI of ADCT - 601 three - fold in preclinical models compared to ADCs manufactured by random stochastic conjugation PBD Sp Gal Nac Fuc HydraSpace Ρ cleavable linker and SG3199 (PBD dimer cytotoxin) Anti - human AXL antibody Antibody Linker + payload ADCT - 601 MOA Warhead released after internalization, and binds in minor groove of DNA ▪ PBD dimer creates interstrand cross - links ▪ No DNA distortion ▪ Avoids DNA repair mechanism ADCT - 601

15 ADCT - 601 Phase 1 Trial Design Note: 1 Sarcoma indications can include any from the following categories - soft tissue sarcoma (leiomyosarcoma, liposarcoma, undiffere ntiated pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and synovial sarcoma) or bone sarcoma ( ewing's sarcoma (including extraskeletal ), osteosarcoma, and chondrosarcoma). 2 Only 1 patient enrolled with cervical neuroendocrine carcinoma. MID: Maximum Investigated Dose. PoC: Proof of Concept. ADCT - 601 MONOTHERAPY Advanced/metastatic AXL Expressing NSCLC Advanced/metastatic Pancreatic Cancer Advanced/metastatic Tissue Sarcoma Part 2: Dose Optimization/Expansion Prioritized Indications Indications Tested Advanced/ metastatic NSCLC Any solid tumors with AXL amplification 2 Advanced/metastatic Sarcoma indications 1 ▪ 7.5 mg ​ ▪ 11 mg​ ▪ 13 mg (Dose / schedule optimization ongoing)​ ▪ 15 mg (MID) Doses Tested Part 1: 3+3 Dose Escalation – Ongoing ▪ 3.8 mg 601 +1000 mg/m Gem ▪ 11 mg 601 + 1000mg/m Gem ▪ 7.5 mg 601 +1000 mg/m Gem ▪ 11 mg 601 + 800mg/m Gem ▪ 13 mg 601 +1000 mg/m Gem ▪ 13 mg 601 + 800mg/m Gem Advanced/metastatic Sarcoma indications 1 Advanced/metastatic Sarcoma indications 1 Advanced/metastatic Pancreatic Cancer ADCT - 601 WITH GEMCITABINE Key : High AXL expression within a small indication (PoC) Moderate AXL expression within a large indication Subpopulation with high AXL expression within a large indication

16 ADCT - 601 targeting AXL: Rationale and Differentiation ▪ A Phase 1b study is ongoing including a monotherapy arm enrolling patients with sarcoma, pancreatic cancer and AXL - expressing NS CLC and a combination arm with gemcitabine in patients with sarcoma and pancreatic cancer ▪ Reached recommended dose of 13mg; dose optimization is ongoing ▪ In sarcoma, early signs of anti - tumor activity have been seen in monotherapy and combination with a tolerable safety profile in the dose range tested ▪ Enrolling patients in pancreatic cancer and expect to initiate NSCLC in 2H 2024 CLINICAL STUDY STATUS & NEXT STEPS ▪ AXL is expressed in multiple tumor types - including NSCLC, pancreatic, and sarcoma ▪ High expression of AXL is correlated to worse patient overall survival across these cancer types % of cases with any AXL Expression % of cases with high AXL expression ~90% ~30% Sarcoma (STS) 60 – 70% ~35% Pancreatic adenocarcinoma 50 – 60% 20 – 25% Non - small cell lung TARGET RELEVANCE AXL EXPRESSION 1 1. Based on internal biomarker analysis as of 02/09/2024.

17 ADCT - 601 Early Safety Results in Advanced / Metastatic Sarcoma Safety – ADCT - 601 Monotherapy (STS) N (%) Total (N=18) 9 (50.0) Any TEAE ≥ Gr3 Discontinuation due to Treatment (%) Total Discontinued (%) 3 (16.7) 15 (83.3%) Any TEAE ≥ Gr3 (%) Preferred Term 1 (5.6) Cheilitis 1 (5.6) Abdominal pain 1 (5.6) Drug - induced liver injury 1 (5.6) Dyspnoea 1 (5.6) Eczema 1 (5.6) Generalized oedema 1 (5.6) Oedema peripheral 1 (5.6) Pulmonary embolism 1 (5.6) Thrombocytopenia 1 (5.6) Skin infections 1 (5.6) Photosensitivity reactions 1 (5.6) Lymphoedema 1 (5.6) LFT increased 1 (5.6) Hypotension 1 (5.6) Alanine aminotransferase increased 1 (5.6) Aspartate aminotransferase increased 2 (11.1) Gamma - glutamyltransferase increased 1 (5.6) Pleural effusion 1 (5.6) Uncoded Safety – ADCT - 601 With Gemcitabine (Sarcoma) N (%) Total (N=9) 8 (88.9) Any TEAE ≥ Gr3 Discontinuation due to Treatment (%) Total Discontinued (%) 0 9 (100) Any TEAE ≥ Gr3 (%) Preferred Term 4 (44.4) Anaemia 2 (22.2) Pleural effusion 4 (44.4) Thrombocytopenia 1 (11.1) Alanine aminotransferase increased 3 (33.3) Neutropenia 3 (33.3) Neutrophil count decreased 2 (22.2) Platelet count decreased 2 (22.2) Gamma - glutamyltransferase increased 1 (11.1) Arthralgia 1 (11.1) Aspartate aminotransferase increased 1 (11.1) Fatigue 1 (11.1) Hypertension 1 (11.1) Pleuritic pain 1 (11.1) Pneumonia Note: Data as of 12/04/2023. The data captured includes individual patients who experienced multiple AEs while on study.

18 ADCT - 601 Shows Early Signs of Anti - Tumor Activity as Monotherapy and in Combination in Sarcoma Patients Note: Data as of 12/04/2023. STS: Soft Tissue Sarcoma; NSCLC: Non - small cell lung cancer. ADCT - 601 Monotherapy (STS) -60% -50% -40% -30% -20% -10% 0% 10% 20% 30% 40% Baseline Week 6 Week 12 Week 21 15mg 13mg 11mg 7.5mg ADCT - 601 + Gemcitabine (Sarcoma) -60% -50% -40% -30% -20% -10% 0% 10% 20% 30% 40% 50% 60% Baseline Week 6 Week 12 Week 21 Week 30 Week 39 Week 48 % Change in Tumor Size 11mg 7.5 mg 3.8 mg Dose and schedule optimization at 13 mg initiated in STS and Pancreatic cancer; expect enrollment in NSCLC with FDA approved assay in 2H Dose optimization in combination with gemcitabine planned in Sarcoma and Pancreatic cancer Change in Tumor Size Over Time Change in Tumor Size Over Time PR PR PR PR

19 A Focused Research Strategy Areas of High Unmet Patient Need Targets Amenable to an ADC Approach Tumors with high incidence, high unmet need, and high chemo use Targets that are specific, highly expressed, and effectively internalized Optimized ADC Design Platform designed with validated toxin, linker, and conjugation chemistry

20 A growing toolbox with novel payloads, linkers and chemistries Note: 1 DAR: Drug antibody ratio Antibody ▪ Extensive experience identifying and advancing compelling targets with high unmet need ▪ Focus on masking binding, conditional binding moieties, bispecifics and biparatropics Linker ▪ Proprietary linkers that enable increased plasma stability and controlled payload release with tunable DAR 1 ‒ Cleavable linkers ‒ Reducible linkers ‒ Non - cleavable linkers Payload ▪ Forged next - gen PBDs as novel warheads; first to bring PBD ADC from conception to market ▪ Advancing next - gen payloads to improve selectivity, potency, therapeutic index ‒ Camptothecin derivatives ‒ DNA damaging agents ‒ Immunomodulators ‒ Dual payloads Conjugation Technology ▪ Technologies enabling precise site - specific attachment of diverse payloads ‒ Orthogonal conjugation approaches

21 Executing Our Research Strategy NaPi2b Claudin - 6 PSMA ASCT2 NSCLC OVARIAN PAYLOAD RELEASING EXATECAN PROSTATE ENDOMETRIAL CRC Areas of High Unmet Patient Need Optimized ADC Design Targets Amenable to an ADC Approach

22 Exatecan has the Potential to be Differentiated over Commercial - Stage Toxins such as DXd Note: 1 PgP : P - glycoprotein; 2 Cell line derived xenograft (CDX) model is a renal leiomyoblastoma model, a ll arms dosed intravenously qdx1 Source: Weng et al., Cancer Discov (2023) EXATECAN V. DXD ▪ Better potency ▪ No PgP 1 transport, enabling enhanced intracellular presence ▪ Increased bystander effect , leading to more cell death and enhancing therapeutic impact over DXd Exatecan DXd Vehicle Isotype (10 mg/kg) Antibody - D Xd (15 mg/kg) Antibody - exatecan (6.6 mg/kg) Antibody - exatecan (10 mg/kg) ▪ ADCT has developed a novel hydrophilic linker that enables efficient conjugation of exatecan ▪ Our exatecan - based ADCs enable traceless release of exatecan after internalization ▪ Superior therapeutic index driven by strong in vivo efficacy and excellent tolerability in cynomolgus monkey without any signs of ILD EXATECAN ADC V. DXD ADC in CDX MODEL 2 EXATECAN ADVANTAGE ADC THERAPEUTICS PLATFORM ADVANTAGE

23 Developing Differentiated ADCs with a High Therapeutic Index A novel hydrophilic, highly stable, protease - cleavable linker conjugated to Exatecan Note: 1 IND enabling studies have typically averaged approximately 18 months (13 – 24 months) after selection of the candidate; NHP: No n - human primate. Amino acid transporter Enzymatic glycoprotein Adhesion protein Phosphate transporter Target description NSCLC Colorectal cancer Heme Malignancies Prostate cancer NSCLC Ovarian cancer Endometrial cancer NSCLC Ovarian cancer Endometrial cancer Tumor types of interest Exatecan Exatecan Exatecan Exatecan Toxin Payload Novel, hydrophilic, protease cleavable Novel, hydrophilic, protease cleavable Novel, hydrophilic, protease cleavable Novel, hydrophilic, protease cleavable Linker in vitro characterization in vivo efficacy NHP toxicology – Repeat - dose (Q3Wx2) in vitro characterization in vivo efficacy Ongoing in vitro characterization in vivo efficacy NHP toxicology – Repeat - dose (Q3Wx2) in vitro characterization in vivo efficacy NHP toxicology – Repeat - dose (Q3Wx2) Preclinical data Drug - candidate (2024) Drug - candidate (2024) IND - enabling IND - enabling Stage NaPi2b Claudin - 6 PSMA ASCT2 Company expects to move forward with one drug candidate to IND and seek research collaboration(s) to advance broad portfolio

24 HEMATOLOGY ZYNLONTA, ADCT - 602 SOLID TUMORS ADCT - 601, Research Assets Business Development to Unlock Value Business Development Goals: U.S. EX - U.S. Co - development & Co - promote* Royalty & Milestones to ADCT Accelerate & Expand Asset Development 3 Non - dilutive Financing 2 Maximize Deal Value & Value Split 1 Direct Partnership *Flexible for alternative construct depending on economics. OVERLAND JOINT VENTURE Corporate Business Development Strategy for ADCT Portfolio

25 □ LOTIS - 7: Completed dose escalation with all doses cleared □ r/r FL and r/r MZL IITs: Encouraging i nitial data shared □ ADCT - 601 (AXL): Dose escalation completed in sarcoma □ Research platform : Shared pre - clinical data on exatecan - based platform and four lead candidates at Research Event ▪ Expected cash runway into mid 2026* ▪ Exploring potential partnerships and licensing agreements □ ADCT - 601 (AXL): Additional data updates from Phase 1 study in sarcoma, pancreatic cancer in 2H 2024; mature data in 1H 2025 □ Research platform: Advancing a broad portfolio of investigational ADCs for solid tumor indications Milestones Achieved Upcoming Expected Milestones □ Solid Tumor □ Hematology □ ZYNLONTA □ Achieve commercial brand profitability in 2024 □ LOTIS - 7: Part 2 with glofitamab enrollment complete with initial efficacy/safety update in 2H 2024; mature data in 1H 2025 □ LOTIS - 5: Complete enrollment in 2H 2024 □ r/r FL and r/r MZL IITs: Updates at medical meetings in 2024 / 2025 □ ADCT - 602 (CD22): Additional data updates from Phase 1 study in 2H 2024 Delivering on Our Strategy * Cash runway assumes receipt of anticipated regulatory milestone payments under the Company’s collaboration agreements and use of the amount it is required to maintain under its loan agreement .

Appendix

27 LOTIS 7 Part 1 Dose Escalation Grade 3 and 4 Adverse Events Regardless of relatedness, Data as of April 19, 2024 *A patient may have more than one adverse event Total N=18 Arm F (Lonca + Mosun) N=9 Arm E (Lonca + Glofit) N=9 Patients Treated 18 (100 %) 9 (100 %) 9 (100 %) Patients with any grade AE 8 (88.8%) 5 (55.5%) 3 (33.3%) Patients with Any Grade 3/4 AE 6 (33.3%) 4 (44.4%) 2 (22.2)%) Patients with Grade 3/4 Hematologic AE 1 (5.5%) 0 1 (11.1%) Lymphopenia 4 (22.2%) 3 (33.3%) 1 (11.1%) Neutropenia 1 (5.5%) 0 1 (11.1%) Thrombocytopenia 3 (16.6%) 3 (33.3%) 0 Anemia 4 (22.2%) 3 (33.3%) 1 (11.1%) Patients with Grade 3/4 Non - hematologic events 1 (5.5%) 0 1 (11.1%) Hypertension worsened 1 (5.5%) 1 (11.1%) 0 Bronchiectasis 1 (5.5%) 1 (11.1%) 0 Bronchitis 1 (5.5%) 1 (11.1%) 0 Decompensation cardiac 1 (5.5%) 1 (11.1%) 0 Pneumonia pseudomonal 1 (5.5%) 1 (11.1%) 0 Sepsis

28 LOTIS 7 Part 1 Dose Escalation Summary of Serious Adverse Events Regardless of relatedness, Data as of April 19, 2024 *CRS expressed as number of patients with at least 1 CRS event. 2 patients experienced multiple Grade 1 CRS events. 5 of 8 pat ients experiencing CRS coded SAE based on whether hospitalization required and/or prolonged. Total N=18 Arm F (Lonca + Mosun) N=9 Arm E (Lonca + Glofit) N=9 Patients Treated 6 (33.3%) 5 (55.5%) 1 (5.5%) Patients with any SAE 5 (27.7) (grade 1 or 2) 4 (44.4%) (grade 1 or 2) 1 (5.5%) (grade 1) Cytokine release syndrome* Grade per ASTCT Criteria 1 (5.5%) 1 (11.1%) 0 Sepsis 1 (5.5%) 1 (11.1%) 0 Dyspnea 1 (5.5%) 1 (11.1%) 0 Bronchiectasis 1 (5.5%) 1 (11.1%) 0 Bronchitis 1 (5.5%) 1 (11.1%) 0 Decompensation cardiac 1 (5.5%) 1 (11.1%) 0 Pneumonia pseudomonal 1 (5.5%) 1 (11.1%) 0 CRP increased

29 3L+ Current MZL Treatment Landscape LoT : Line of Therapy. Source: 1. Clarivate DRG (2022), Global Data (2017), Cerner Enviza CancerMPact (2023); 2. NCCN Guidelines. LoT / Epidemiology 1 Treatment Paradigm 2 Anti - CD20 - based regimens BTKis Anti - CD20 - based regimens T - cell - mediated therapy ( Axi - cel ) Anti - CD20 - based regimens BTKis # of treated patients per year 0.8 – 1.3 K 2L # of treated patients per year 2.2 – 3.2 K 1L # of treated patients per year 5.5 – 6.5 K Areas of Focus

30 A Phase 2, Open - label, IIT Evaluating Safety and Efficacy of Loncastuximab in R/R MZL Source: 1. UTX - TGR - 205 Study (two single - arm cohorts; total n = 710, total MZL n = 69). Clinical Design R/R MZL Previously Treated with ≥ 1 Line of Systemic Therapy Loncastuximab 150 μ g / kg (Day 1, +/ - 3) CT / MRI or FDG - PET / CT based on PET Avidity at screening Loncastuximab 75 μ g / kg (Day 1 +/ - 3 q 21 days) CT / MRI or FDG - PET / CT Bone Marrow CT / MRI or FDG - PET / CT based on PET Avidity at screening Cycles 1 – 2 Cycles 3 – 6 30 Days End of Study / Follow - up Confirmation by bone marrow CR by Imaging No CR by Imaging Study Overview ▪ The null hypothesis is H 0 : P≤P 0 , and the alternative hypothesis is H a : P≥P1 ▪ The best reported CR rate for relapsed MZL using single agent at study initiation was reported with umbralisib - 16% in 69 patients treated 1 ▪ Based on this estimate, under the null hypothesis, we assumed the CR rate (P) to be 16% (P 0 ) ▪ Expected a 15% increase in the CR rate, resulting in CR rate of 31% or greater. Thus, under the alternative hypothesis, the CR rate for the proposed treatment is 31% (P 1 ) ▪ A multi - institutional study of 50 patients with r/r MZL after previous systemic treatment (clinicaltrials.gov ID: NCT05296070) ▪ 2 sites currently enrolling, expanding to 5 sites ▪ Futility analysis after 20 patients Study Rationale

31 Patient Baseline Characteristics from Initial Data 15 evaluable patients out of 20 enrolled patients as of 04/18/2024 *Prior lines of treatment included current standard of care including R - based regimens, systemic chemo, BTKis, and CAR - T. N Baseline Characteristics 15 Number of patients 64 (48 – 80) Age, average (range), years 3:12 Gender (M:F) Ethnicity 6 8 1 White non - Hispanic White Hispanic Black MZL type 11 (73%) 3 (20%) 1 (7%) EMZL, n (%) NMZL, n (%) SMZL, n (%) 15 ECOG 0 – 1 Stage 2 0 3 10 I II III IV 2 (1 – 4)* N of previous line of treatment 12/3 Relapsed/Refractory 8 POD24 N Previous Treatments 3 1 XRT Splenectomy Non - systemic 6 5 3 1 1 1 1 1 1 1 1 Rituximab R - CHOP BR R2 Ibrutinib Zanubrutinib Zevalin R - MVP RICE R - GemOx CAR - T Systemic

32 PR CR PD SD Patients on ZYNLONTA treatment Patient stopped treatment Patient stopped due to a toxicity ▪ 13 out of 15 patients with a CR, 1 out of 15 with a PR ▪ 9 out of 13 CRs were achieved after 2 cycles ▪ All patients achieving responses are maintaining them as of the data cutoff Initial Efficacy Findings ▪ ZYNLONTA was generally well - tolerated within the population and consistent with the known safety profile ▪ One patient discontinued after cycle 4 due to a toxicity which fully resolved upon discontinuation of treatment Initial Safety Findings Initial study results from University of Miami presentation at Lymphoma Research Foundation’s 2024 MZL Scientific Workshop Data as of March 30, 2024 Patients Time from Start (months) 5 10 15 20 25

 

v3.24.1.1.u2

Cover	May 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 14, 2024
Entity File Number	001-39071
Entity Registrant Name	ADC Therapeutics SA
Entity Central Index Key	0001771910
Entity Tax Identification Number	00-0000000
Entity Incorporation, State or Country Code	V8
Entity Address, Address Line One	Biopôle
Entity Address, Address Line Two	Route de la Corniche 3B
Entity Address, City or Town	Epalinges
Entity Address, Country	CH
Entity Address, Postal Zip Code	1066
Country Region	41
City Area Code	21
Local Phone Number	653 02 00
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Shares, par value CHF 0.08 per share
Trading Symbol	ADCT
Security Exchange Name	NYSE
Entity Emerging Growth Company	false

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