Business Update January 4, 2024
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 and any 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", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the actual Zynlonta revenue for 4Q 2023, the success of the Company's updated corporate strategy including operating efficiencies, capital deployment and portfolio prioritization; the expected cash runway into the beginning of Q4 2025, the effectiveness of the new commercial go-to-market strategy, competition from new technologies, the Company's ability to grow ZYNLONTA® revenue in the United States; Swedish Orphan Biovitrum AB (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; approval by the NMPA of the BLA for ZYNLONTA® in China submitted by Overland ADCT BioPharma and future revenue from the same, our strategic partners', including Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the timing and results of the Company's or its partners' research projects or clinical trials including early research in certain solid tumors with different targets, linkers and payloads, LOTIS 5 and 7, ADCT 601 and 602 as well as IITs in FL and MZL, the timing and results of research the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities, the ability to complete clinical trials on expected timelines, if at all, and the results of the same; 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 repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document.
Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. 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 disclaim 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 statements 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 derived 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 representation 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 limitations, 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.
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ADC Therapeutics at a Glance
Platform
Pioneering ADC field with robust technology toolbox and specialized end-to-end capabilities
Hematology
Maximizing ZYNLONTA® in 3L+ DLBCL and expanding into earlier lines of
DLBCL and indolent lymphomas; advancing ADCT-602 targeting CD22
Solid Tumors
Advancing ADCT-601 targeting AXL in the clinic and multiple investigational ADCs
Corporate
Cash runway into 4Q 2025 with multiple catalysts in 2024
3 ADC: Antibody Drug Conjugate; DLBCL: Diffuse Large B-Cell Lymphoma
Platform and Capabilities for Developing Optimized ADCs
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
4 CMC: Chemistry, Manufacturing and Controls; PBD: Pyrrolobenzodiazepines
Clinical
Strong track record including an approved product with robust lifecycle management and multiple clinical assets
Regulatory
Proven capabilities securing FDA and EMA approvals for ZYNLONTA and multiple INDs
Platform
Validated and differentiated ADC platform with multiple payloads and targets
2023: Positioning the Company for Success
Upgraded
Organization
- Management team with extensive commercial, development, and corporate expertise
- Board members with biotech and large pharma leadership experience; larger number of independents
Enhanced ZYNLONTA
Commercialization
- Established new go-to-market model with upgraded talent
- Refined brand positioning and enhanced data generation
Prioritized
Portfolio
- Hematology: ZYNLONTA Life Cycle Management, ADCT-602
- Solid tumors: ADCT-601, multiple novel ADCs
Validated
Research Platform
- Advancing a range of payloads, linkers, and conjugation technologies against multiple targets
- Expanded internal capabilities to enable partnerships for early-stage assets
Realized Cost
Efficiencies
- Right-sizedorganizational structure; trimmed consulting and contractors
- Reduced 3rd party spending, optimized tax, and improved return on investments
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Key Business Updates
ZYNLONTA
(loncastuximab
tesirine-lpyl)
Pipeline
Corporate
- 4Q 2023 revenues expected to be ~$16.5M, a double-digit percentage increase compared to 3Q 2023
-
- LOTIS-7(ZYNLONTA with bispecifics): Cleared first dosing cohort with no DLT and early signs of efficacy
- LOTIS-5(ZYNLONTA with rituximab): Accelerated enrollment in 2023, over 2/3rd enrollment completed
- ADCT-601(Targeting AXL): Reached MTD and currently in dose optimization; early signs of anti-tumor activity in both monotherapy and in combination
- ADCT-901(Targeting KAAG1): Discontinuing due to limited signs of efficacy in dose escalation, reallocating capital to prioritized programs
- Balance sheet with ~$278.5M cash at end of FY 2023
- Cash runway expected to extend into 4Q 2025; double-digit Opex reduction in 2023 compared to 2022
6 DLT: Dose-Limiting Toxicity; MTD: Maximum Tolerated Dose. Note: Financials are unaudited.
Unlocking Value of Robust ADC Portfolio in Hematology and Solid Tumors
Hematology Portfolio
Short-Mid Term
ZYNLONTA
- Maximize ZYNLONTA in 3L+ DLBCL
- Seek to expand ZYNLONTA to earlier lines of DLBCL and other indolent lymphomas (e.g., FL, MZL) as single agent and combination agent of choice
-
- ZYNLONTA
- ZYNLONTA + rituximab (LOTIS-5)
- ZYNLONTA + bispecifics (LOTIS-7)
ADCT-602 (CD22)
- Escalating and expanding Phase 1 dose in r/r ALL
Solid Tumor Portfolio
Term
ADCT-601 (AXL)
- Optimizing dose for expansion as single agent and / or in combination in sarcoma, pancreatic, and NSCLC
Next-generation ADCs
- Advancing a portfolio of investigational ADCs
-
- Differentiated exatecan-based payload with novel hydrophilic linker
- Targeting Claudin-6, NaPi2b, PSMA
- Continuing research with a range of payloads, linkers, and conjugation technologies against undisclosed targets
7 DLBCL: Diffuse Large B-Cell Lymphoma; FL: Follicular Lymphoma; MZL: Marginal Zone Lymphoma; NSCLC: Non Small-Cell Lung Cancer; ALL: Acute Lymphoblastic Leukemia.
Focused Pipeline in Hematology and Solid Tumors
|
ZYNLONTA |
| Targeting CD19 |
|
|
Hematology |
LOTIS-2 in 3L+ DLBCL |
|
|
LOTIS-5 with rituximab in 2L+ NTE DLBCL |
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LOTIS-7 in combination with glofitamab in r/r NHL1 |
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LOTIS-7 in combination with mosunetuzumab in r/r NHL1 |
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|
ADCT-602 |
| Targeting CD22 |
|
|
Acute Lymphoblastic Leukemia |
||
|
Mipasetamab uzoptirine (ADCT-601) | Targeting AXL |
||
|
Single agent and with gemcitabine in adv. / met. Sarcoma |
||
|
Tumors |
Single agent and with gemcitabine and others in adv. / met. Pancreatic |
|
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Single agent and other combinations in adv. / met. NSCLC2 |
||
|
Solid |
Next-GenADCs | Exatecan Payload with Novel Linker |
|
|
NaPi2b |
||
Claudin-6
PSMA
Undisclosed target
|
Preclinical |
Phase 1a |
Phase 1b |
Phase 2 |
Phase 3 / |
Expected Milestones |
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Confirmatory |
|||||||
|
FDA approved (AA) |
|||||||
|
Confirmatory |
LOTIS-5: Complete enrollment |
||||||
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in 2024 |
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LOTIS-7: Additional dose |
|||||||
|
escalation/ expansion data in 2024 |
|||||||
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Additional data from Phase 1 |
|||||||
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study in 2024 |
Additional data from Phase 1 study in 2024
Candidate selected
Candidate selection in 2024
Candidate selection in 2024
Candidate selection in 2024
Anticipated milestones set forth in this chart are subject to further future adjustment. NTE: Non-TransplantEligible. 1. DLBCL, FL, MZL 2. Non-selected advanced / metastatic NSCLC completed. Moving forward with AXL expressing NSCLC contingent on in-house IHC assay.
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AA: Accelerated Approval.
Advancing ZYNLONTA Development in B-Cell Lymphomas
2023 U.S. Market Value2, 5-year prevalence3
DLBCL
$3.1b2, ~109 K patients
1L (~70%)
|
FL |
MZL |
||
|
$2.6b2, ~61 K patients |
$1.4b2, ~38 K patients |
||
|
2L (~24%) |
2L (~27%) |
Proportion ofpatientsbyline- |
|
|
1L (~65%) |
1L (~61%) |
||
|
of- |
|||
|
3L+ (~11%) |
(~12%) |
therapy* |
|
|
3L+ |
|||
Current Development Areas
-
LOTIS-5and LOTIS-7 potential to move ZYNLONTA into 2L+
DLBCL - IIT suggests ZYNLONTA regimen could provide benefit in 2L+ high-riskFL (96% ORR, 85% CR, N=27); IIT studying ZYNLONTA in 2L+ MZL
-
- Unmet need is significant in these populations
- Assessing regulatory path and compendial strategy
- ZYNLONTA combination with bispecifics (LOTIS-7) is currently being studied in r/r FL and r/r MZL
DLBCL, FL & MZL account for ~60% of mature B-cell lymphomas1*
Key:
Current Approval
Current Development Areas
9 1. As per Leukemia & Lymphoma Society data; 2. Clarivate & Global Data used to size US market value; 3. Cerner Enviza CancerMPact database, 2023. Note: Distribution by line of therapy is based on the incident, drug-treated population.
ZYNLONTA: Well-positioned to Lead in 3L/3L+ DLBCL with Product Profile Ideally Suited Across Treatment Settings
PRODUCT PROFILE
- Off-the-shelfoption for R/R patients with rapid, deep and durable single-agent efficacy
-
- Fast time to response (median 41 days) with no step-up dose required
- Median DoR not yet reached for patients in CR at 2- year follow-up
- Manageable safety profile with no CRS, ideal for community care
- Simple dosing, with no REMS or inpatient stay requirements
OPPORTUNITY
Community
HospitalsCenters/ ▪ For patients who will remain in community care and will not get to CAR-T or bispecifics
|
Academic |
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|
Centers |
▪ |
For patients post CAR-T or bispecifics |
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Attachments
Disclaimer
ADC Therapeutics SA published this content on 04 January 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 January 2024 12:18:07 UTC.