8-K
ADC Therapeutics SA (ADCT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORTPursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): March 13, 2024
ADC Therapeutics SA
(Exact Name of Registrant as Specified in Its Charter)
| Switzerland<br><br>(State or Other Jurisdiction of Incorporation) | 001-39071<br><br>(Commission File Number) | N/A<br><br>(IRS Employer Identification Number) | |
|---|---|---|---|
| Biopôle<br><br>Route de la Corniche 3B<br><br>1066 Epalinges<br><br>Switzerland<br><br>(Address of Principal Executive Offices) (Zip Code) | +41 21 653 02 00<br><br>(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):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ 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 2.02. Results of Operations and Financial Condition.
On March 13, 2024, ADC Therapeutics SA (the “Company”) issued a press release and made available a corporate presentation announcing the Company’s financial results for the full year and fourth quarter ended December 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein. A copy of the corporate presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein.
The information contained in this Item 2.02 and Exhibits 99.1 and 99.2 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 | Press release dated March 13, 2024 |
| 99.2 | Corporate presentation dated March 13, 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: March 13, 2024 | ||
| By: | /s/ Jose Carmona | |
| Name: | Jose Carmona | |
| Title: | Chief Financial Officer |
Document
Exhibit 99.1
ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates
ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of $16.6 million in 4Q 2023 and $69.1 million for full year (FY) 2023; 4Q sales grew sequentially in both academic and community settings
Focused pipeline progressing with continued LOTIS-7 dose escalation, screening patients for ADCT-601 targeting AXL in pancreatic cancer, and advancing differentiated solid tumor research platform
FY 2023 operating expenses decreased 21%1 year-over-year due to portfolio prioritization and operational efficiencies; $278.6M of cash with expected runway extended into 4Q 2025
Company to host conference call today at 8:30 a.m. EDT
Lausanne, Switzerland, March 13, 2024 – ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates.
“During 2023, we reset our business and capital allocation strategy, strengthened our team and established a clear roadmap to drive value creation for all our stakeholders,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “In the fourth quarter we saw results of our strategy in action across a number of key areas. The impact of our new commercial model resulted in a resumption of growth for ZYNLONTA® sales volume compared to the third quarter, in both community and academic settings. Meanwhile, our prioritized pipeline delivered encouraging data, which we were pleased to share in a business update in January. We also disclosed for the first time our new, differentiated solid tumor platform, which can bring substantial opportunities for the Company through internal and external development. With an expected cash runway into the fourth quarter of 2025 and multiple potential value-generating catalysts ahead, I am excited about our prospects and look forward to updating you on our progress in 2024.”
Recent Highlights and Developments
ZYNLONTA® (loncastuximab tesirine-lpyl)
•ZYNLONTA generated product net sales of $16.6 million in the fourth quarter of 2023, representing a 17% increase over the third quarter of 2023 and a 16% decrease over the fourth quarter of 2022. A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings. The year-over-year net sales decline reflected disruption during the year from the restructuring of the go-to-market model together with the impact of increased competition and higher gross-to-net sales deductions, partially offset by a slight price increase.
Hematology Pipeline
•LOTIS-5: The Phase 3 confirmatory trial for ZYNLONTA in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) continues to see accelerated enrollment. As noted by the clinical team and confirmed with the Independent Data Monitoring Committee (IDMC), we have observed higher-than-expected censoring in this trial. As a result, we may need to enroll additional patients, beyond the originally planned 350 patients, to achieve the required number of pre-specified progression-free survival events. The Company continues to expect to complete enrollment of this trial in 2024. The
(1) on a non-GAAP basis or 29% on a GAAP basis including stock-based compensation expense. See reconciliation of GAAP measures to non-GAAP measures in accompanying financial tables
IDMC noted no safety concerns and recommended the trial to proceed at its most recent meeting held on January 16, 2024.
•LOTIS-7: The Phase 1b trial of ZYNLONTA in combination with bispecific antibodies glofitamab or mosunetuzumab for the treatment of heavily pre-treated patients with DLBCL, follicular lymphoma (FL) and marginal zone lymphoma (MZL) is actively enrolling patients. The dose-limiting toxicity (DLT) period has been cleared for the first two dosing levels of ZYNLONTA (90 µg/kg, 120 µg/kg) in both arms and we are currently enrolling patients at 150 µg/kg. After the first Investigator assessment, we have seen evidence of anti-tumor activity among the majority of patients dosed at the first two levels, with mixed histologies including DLBCL, FL and MZL. The Company expects to share additional data once a larger and more mature dataset is available.
•Investigator-Initiated Trial: As announced by the Company on January 4, 2024, an oral presentation at the American Society of Hematology (ASH) 2023 Annual Meeting from the University of Miami investigator-initiated trial exploring ZYNLONTA in combination with rituximab in high-risk relapsed or refractory FL patients indicated a best overall response rate of 96.3% and a complete response rate of 85.2%. After a median follow-up of 9.7 months, the median progression-free survival (PFS) was not reached, and the 12-month PFS was 92.3%. The majority of AEs were grade 1. Grade 3 AEs included neutropenia (n=2; 6.2%), and one case each (3.1%) of hyperglycemia, increased ALT, fatigue, dyspnea and skin infection. Neutropenia was the only grade 4 AE (n=1; 3.1%).
•ADCT-602 (targeting CD22): Dose escalation and expansion in the Phase 1 study with relapsed or refractory acute lymphoblastic leukemia in collaboration with MD Anderson Cancer Center is progressing and additional clinical trial sites are being added to accelerate enrollment.
Solid Tumor Pipeline
•ADCT-601 (targeting AXL): In the Phase 1b trial, the maximum tolerated dose has been reached, and the study is currently in dose optimization. On January 4, 2024, the Company announced that early signs of anti-tumor activity had been seen in both monotherapy and in combination and that the safety profile indicated that ADCT-601 was well tolerated at the doses tested. Additional data from the trial are expected to be shared in a presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 (April 5–10, 2024). The abstract details are available online. The ongoing dose-optimization/expansion phase is comprised of a monotherapy arm including patients with sarcoma, pancreatic cancer and AXL-expressing non-small cell lung cancer (NSCLC) and a combination arm with gemcitabine in patients with sarcoma and pancreatic cancer. Screening was recently initiated for pancreatic cancer in the monotherapy arm.
•Early-stage pipeline: The Company is advancing a portfolio of investigational ADCs including those targeting Claudin-6, NaPi2b and PSMA. These candidates are based on an innovative proprietary approach which utilizes exatecan with a novel hydrophilic linker as a highly potent and differentiated payload. Data on the Claudin-6 and NaPi2b programs are expected to be shared in presentations at the AACR Annual Meeting 2024. Abstracts details are currently available online. A research investor event is being planned for 2Q 2024 to share additional information.
Upcoming Expected Milestones
ZYNLONTA
•Achieve commercial brand profitability in 2024
•LOTIS-5: Complete enrollment in 2024
•LOTIS-7: Additional data from the Phase 1b dose-escalation in 3L+ in mixed histologies (Part 1) in 2Q 2024 and from the dose-expansion in 2L+ DLBCL (Part 2) in 2H 2024
•Investigator-initiated trial in FL: The study is being expanded to 100 patients in a multicenter clinical trial. Updates are expected at medical meetings.
•Investigator-initiated trial in MZL: The study is designed to enroll 50 patients in a multicenter clinical trial. A futility analysis is expected to be conducted in 2Q 2024. Updates are expected at medical meetings.
Pipeline
ADCT-601 (targeting AXL)
•Additional data updates from the Phase 1 study in patients with sarcoma, pancreatic cancer and NSCLC in 2024
ADCT-602 (targeting CD22)
•Additional data from the Phase 1 study in 2024
Preclinical
•Advancing a broad portfolio of investigational ADCs for solid tumor indications
Fourth Quarter and FY 2023 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were $278.6 million as of December 31, 2023, compared to $326.4 million as of December 31, 2022. The Company currently expects its cash runway to extend into the fourth quarter of 2025.
Product Revenues
Net product revenues were $16.6 million for the fourth quarter and $69.1 million for full year 2023, compared to $19.8 million and $74.9 million, respectively, for the fourth quarter and full year 2022. Net product revenues are for U.S. sales of ZYNLONTA. The fourth quarter and full year decrease was primarily due to higher gross-to-net deductions and lower sales volume which was impacted by disruption following restructuring of the commercial organization and increased competition, partially offset by a slightly higher price.
License Revenues and Royalties
License revenues and royalties were $0.1 million for the fourth quarter and $0.5 million for full year 2023, compared to $50.0 million and $135.0 million, respectively, for the fourth quarter and full year 2022. The fourth quarter and full year decrease was primarily due to upfront and milestone payments under our exclusive license agreements with Sobi and MTPC that were recognized in 2022.
Research and Development (R&D) Expenses
R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022. R&D expenses decreased due to less investment in camidanlumab tesirine (Cami), as well as productivity initiatives and focused investment toward prioritized development programs. The decrease in R&D expenses related to Cami was primarily due to completion of the Phase 2 study in 2022 and the Company’s decision to pause the program while it evaluated FDA feedback.
R&D expenses in the fourth quarter and full year 2023 also decreased due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations.
Selling and Marketing (S&M) Expenses
S&M expenses were $13.9 million for the fourth quarter and $57.5 million for full year 2023, as compared to $16.2 million and $69.1 million, respectively, for the fourth quarter and full year 2022. The decrease in S&M expenses for the fourth quarter and full year was primarily due to lower spend on marketing and analytics, lower wages and benefits, as well as lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations.
General & Administrative (G&A) Expenses
G&A expenses were $11.3 million for the fourth quarter and $48.4 million for full year 2023, compared to $15.7 million and $74.4 million, respectively, for the fourth quarter and full year 2022. G&A expenses decreased for the fourth quarter and full year primarily due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations, as well as lower wages and benefits and insurance costs.
Net Loss and Adjusted Net Loss
Net loss was $85.0 million, or a net loss of $1.03 per basic and diluted share, for the fourth quarter of 2023 and $240.1 million, or a net loss of $2.94 per basic and diluted share for full year 2023. This compares to a net loss of $23.3 million, or a net loss of $0.29 per basic and diluted share, for the fourth quarter of 2022 and $157.1 million, or a net loss of $2.01 per basic and diluted share, for full year 2022. The increase in net loss in both periods primarily reflects the reduction in license revenues and royalties, together with higher income tax expense and lower product revenues, partially offset by lower operating expense.
Adjusted net loss, which is a non-GAAP financial measure, was $79.5 million, or an adjusted net loss of $0.97 per basic and diluted share for the fourth quarter of 2023 and $185.7 million, or an adjusted net loss of $2.27 per basic and diluted share for the full year 2023. This compares to an adjusted net loss of $6.7 million, or an adjusted net loss of $0.08 per basic and diluted share, for the fourth quarter of 2022 and $80.3 million, or an adjusted net loss of $1.03 per basic and diluted share, for full year 2022. The increase in adjusted net loss for the fourth quarter and full year 2023 primarily reflects the reduction in License revenues and royalties, together with higher income tax expense and lower product revenues, partially offset by lower operating expense.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under “Events & Presentations” in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
Use of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this document also contains certain non-GAAP financial measures based on management’s view of performance including:
•Adjusted total operating expenses
•Adjusted net loss
•Adjusted net loss per share
Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-GAAP measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with GAAP. When preparing these supplemental non-GAAP measures, management typically excludes certain GAAP items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these GAAP items to be normal, recurring cash operating expenses; however, these items may not meet the GAAP definition of unusual or non-recurring items. Since non-GAAP financial measures do not have standardized definitions and meanings, they may differ from the non-GAAP financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other GAAP financial measures.
The following items are excluded from adjusted net loss and adjusted net loss per share:
Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy.
Certain Other Items: We exclude certain other significant items that we believe do not represent the performance of our business, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of derivatives and warrant obligations and the effective interest expense associated with the Facility Agreement with Deerfield and the senior secured term loan facility and the effective interest expense and cumulative catch-up adjustments associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners.
See the attached Reconciliation of GAAP Measures to Non-GAAP Measures for explanations of the amounts excluded and included to arrive at the non-GAAP financial measures.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “would”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “future”, “continue”, or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the success of the Company’s updated corporate strategy; the expected cash runway into the beginning of Q4 2025, the effectiveness of the new commercial go-to-market strategy, competition from new technologies, the Company’s ability to grow ZYNLONTA® revenue in the United States; Swedish Orphan Biovitrum AB
(Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; approval by the NMPA of the BLA for ZYNLONTA® in China submitted by Overland ADCT BioPharma and future revenue from the same, our strategic partners’, including Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the timing and results of the Company’s or its partners’ research and development projects or clinical trials including LOTIS 5 and 7, ADCT 601 and 602 as well as IITs in FL and MZL and early research in certain solid tumors with different targets, linkers and payloads; the timing and outcome of regulatory submissions for the Company’s products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company’s indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company’s activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document.
ADC Therapeutics SA
Consolidated Statements of Operation (Unaudited)
(in thousands, except for per share data)
| For the three months ended December 31, | For the years ended December 31, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||
| Revenue | ||||||||
| Product revenues, net | $ | 16,643 | $ | 19,798 | $ | 69,060 | $ | 74,908 |
| License revenues and royalties | 147 | 50,000 | 498 | 135,000 | ||||
| Total revenue, net | 16,790 | 69,798 | 69,558 | 209,908 | ||||
| Operating expense | ||||||||
| Cost of product sales | (1,215) | (320) | (2,529) | (3,301) | ||||
| Research and development | (30,331) | (48,081) | (127,127) | (186,457) | ||||
| Selling and marketing | (13,927) | (16,176) | (57,464) | (69,052) | ||||
| General and administrative | (11,295) | (15,689) | (48,424) | (74,442) | ||||
| Total operating expense | (56,768) | (80,266) | (235,544) | (333,252) | ||||
| Loss from operations | (39,978) | (10,468) | (165,986) | (123,344) | ||||
| Other income (expense) | ||||||||
| Interest income | 3,291 | 2,259 | 10,540 | 2,568 | ||||
| Interest expense | (12,909) | (9,756) | (46,325) | (36,731) | ||||
| Loss on debt extinguishment | — | — | — | (42,114) | ||||
| Other, net | 9,724 | 1,211 | 6,352 | 52,804 | ||||
| Total other income (expense) | 106 | (6,286) | (29,433) | (23,473) | ||||
| Loss before income taxes | (39,872) | (16,754) | (195,419) | (146,817) | ||||
| Income tax expense | (43,171) | (3,055) | (39,106) | (227) | ||||
| Loss before equity in net losses of joint venture | (83,043) | (19,809) | (234,525) | (147,044) | ||||
| Equity in net losses of joint venture | (1,988) | (3,535) | (5,528) | (10,084) | ||||
| Net loss | $ | (85,031) | $ | (23,344) | $ | (240,053) | $ | (157,128) |
| Net loss per share | ||||||||
| Net loss per share, basic and diluted | $ | (1.03) | $ | (0.29) | $ | (2.94) | $ | (2.01) |
| Weighted average shares outstanding, basic and diluted | 82,292,594 | 80,463,306 | 81,712,166 | 78,152,964 |
ADC Therapeutics SA
Consolidated Balance Sheet (Unaudited)
(in thousands)
| December 31<br>2023 | December 31<br>2022 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current assets | ||||
| Cash and cash equivalents | $ | 278,598 | $ | 326,441 |
| Accounts receivable, net | 25,182 | 72,971 | ||
| Inventory | 16,177 | 12,073 | ||
| Prepaid expenses and other current assets | 16,334 | 23,495 | ||
| Total current assets | 336,291 | 434,980 | ||
| Non-current assets | ||||
| Property and equipment, net | 5,622 | 3,355 | ||
| Operating lease right-of-use assets | 10,511 | 6,905 | ||
| Interest in joint venture | 1,647 | 7,613 | ||
| Deferred taxes, net | — | 37,104 | ||
| Other long-term assets | 711 | 902 | ||
| Total assets | $ | 354,782 | $ | 490,859 |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||
| Current liabilities | ||||
| Accounts payable | $ | 15,569 | $ | 12,351 |
| Accrued expenses and other current liabilities | 50,634 | 68,491 | ||
| Operating lease liabilities, short-term | 1,467 | 1,097 | ||
| Total current liabilities | 67,670 | 81,939 | ||
| Deferred royalty obligation | 303,572 | 212,353 | ||
| Senior secured term loans | 112,730 | 109,714 | ||
| Operating lease liabilities, long-term | 10,180 | 6,564 | ||
| Other long-term liabilities | 8,879 | 838 | ||
| Total liabilities | 503,031 | 411,408 | ||
| Total shareholders’ (deficit) equity | (148,249) | 79,451 | ||
| Total liabilities and shareholders’ equity | $ | 354,782 | $ | 490,859 |
ADC Therapeutics SA
Reconciliation of GAAP Measures to Non-GAAP Measures (Unaudited)
(in thousands, except for share and per share data)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| (in thousands) | 2023 | 2022 | Change | % Change | 2023 | 2022 | Change | % Change | ||
| Total operating expense | (56,768) | (80,266) | 23,498 | (29) | % | (235,544) | (333,252) | 97,708 | (29) | % |
| Adjustments: | ||||||||||
| Share-based compensation expense (i) | 2,220 | 8,344 | (6,124) | (73) | % | 13,495 | 50,637 | (37,142) | (73) | % |
| Adjusted total operating expenses | (54,548) | (71,922) | 17,374 | (24) | % | (222,049) | (282,615) | 60,566 | (21) | % |
| Three months ended December 31, | Twelve months ended December 31, | |||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | ||
| in thousands (except for share and per share data) | 2023 | 2022 | 2023 | 2022 | ||||||
| Net loss | $ | (85,031) | $ | (23,344) | $ | (240,053) | $ | (157,128) | ||
| Adjustments: | ||||||||||
| Share-based compensation expense (i) | 2,220 | 8,344 | 13,495 | 50,637 | ||||||
| Convertible loans, derivatives, change in fair value income (ii) | — | — | — | (25,650) | ||||||
| Loss on debt extinguishment (iii) | — | — | — | 42,114 | ||||||
| Deerfield warrants obligation, change in fair value expense (income) (ii) | 279 | (2,086) | (497) | (11,504) | ||||||
| Effective interest expense on convertible loans (iv) | — | — | — | 7,684 | ||||||
| Effective interest expense on senior secured term loan facility (iv) | 4,650 | 3,912 | 18,398 | 5,845 | ||||||
| Deferred royalty obligation interest expense (v) | 8,253 | 5,844 | 27,915 | 23,200 | ||||||
| Deferred royalty obligation cumulative catch-up adjustment (income) expense (v) | (9,823) | 631 | (4,972) | (15,482) | ||||||
| Adjusted net loss | $ | (79,452) | $ | (6,699) | $ | (185,714) | $ | (80,284) | ||
| Net loss per share, basic and diluted | (1.03) | (0.29) | (2.94) | (2.01) | ||||||
| Adjustment to net loss per share, basic and diluted | 0.06 | 0.21 | 0.67 | 0.98 | ||||||
| Adjusted net loss per share, basic and diluted | (0.97) | (0.08) | (2.27) | (1.03) | ||||||
| Weighted average shares outstanding, basic and diluted | 82,292,594 | 80,463,306 | 81,712,166 | 78,152,964 |
(i)Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted, and is recognized over the requisite service period less actual forfeitures by a charge to the statement of operations and a corresponding increase in additional paid-in capital within equity. These accounting entries have no cash impact.
(ii)Change in the fair value of the convertible loan derivatives and Deerfield warrant obligation results from the valuation at the end of each accounting period. There are several inputs to these valuations, but those most likely to result in significant changes to the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. These accounting entries have no cash impact.
(iii)As a result of the exchange agreement entered into on August 15, 2022, the Company recognized a loss on debt extinguishment which primarily consists of the difference between the aggregate principal amount and carrying amount of the convertible loans and exit fee as well as the unpaid interest payments through the maturity date.
(iv)Effective interest expense on convertible loans and senior secured term loans relates to the increase in the value of our loans in accordance with the amortized cost method.
(v)Deferred royalty obligation interest expense relates to the accretion expense on our deferred royalty obligation pursuant to the royalty purchase agreement with HCR and cumulative catch-up adjustment (income) expense relates to changes in the expected payments to HCR based on a periodic assessment of our underlying revenue projections.
CONTACTS:
Investors and Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040
corporatepresentationdat
4Q 2023 Earnings Call March 13, 2024 Exhibit 99.2
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 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 success of the Company’s updated corporate strategy; the expected cash runway into the beginning of Q4 2025, the effectiveness of the new commercial go‐to‐market strategy, competition from new technologies, the Company’s ability to grow ZYNLONTA® revenue in the United States; Swedish Orphan Biovitrum AB (Sobi®) ability to successfully commercialize ZYNLONTA® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; approval by the NMPA of the BLA for ZYNLONTA® in China submitted by Overland ADCT BioPharma and future revenue from the same, our strategic partners’, including Mitsubishi Tanabe Pharma Corporation, ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the timing and results of the Company’s or its partners’ research and development projects or clinical trials including LOTIS 5 and 7, ADCT 601 and 602 as well as IITs in FL and MZL and early research in certain solid tumors with different targets, linkers and payloads; the timing and outcome of regulatory submissions for the Company’s products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company’s ability to enter into business 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 by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward‐looking statements is contained in the “Risk Factors” section of the Company's Annual Report on Form 10‐K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward‐looking statements. The Company cautions investors not to place undue reliance on the forward‐looking statements contained in this document. 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.
3 Agenda 02 Commercial Highlights Kristen Harrington‐Smith Chief Commercial Officer 03 Clinical HighlightsMohamed Zaki Chief Medical Officer 05 Financial UpdatePepe Carmona Chief Financial Officer 01 Introduction Ameet Mallik Chief Executive Officer 04 Research HighlightsPatrick van Berkel Chief Scientific Officer
4 2023: Positioning the Company for Success Management team with extensive commercial, development, and corporate expertise Board members with biotech and large pharma leadership experience; larger number of independents Established new go‐to‐market model with upgraded talent Refined brand positioning and enhanced data generation Hematology: ZYNLONTA Life Cycle Management, ADCT‐602 (CD‐22) Solid tumors: ADCT‐601 (AXL), portfolio of early‐stage ADCs based on novel platform Advancing a range of payloads, linkers, and conjugation technologies against multiple targets Expanded internal capabilities to enable partnerships for early‐stage assets Right‐sized organizational structure; trimmed consulting and contractors Reduced 3rd party spending, optimized operating structure, and improved return on investments Upgraded Organization Enhanced ZYNLONTA Commercialization Prioritized Portfolio Validated Research Platform Realized Cost Efficiencies
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 Mid-long TermHematology Portfolio Solid Tumor 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 additional indications (FL, MZL) OTHER ASSETS ADCT‐602 (CD22) in Phase 1 in ALL KEY ASSETS ADCT‐601 (AXL) in Phase 1 in sarcoma, pancreatic cancer and NSCLC Portfolio of investigational ADCs focused on high‐value targets, utilizing novel exatecan‐based platform 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 Proportion of patients by line‐of‐therapy* DLBCL, FL & MZL account for ~60% of mature B‐cell lymphomas1* 1L (~70%) 1L (~65%) 1L (~61%) MZLFLDLBCL Key: Current Approval Current Development Areas Advancing ZYNLONTA Development in B‐Cell Lymphomas 2L (~24%) 2L (~27%) 3L+ (~11%) 3L+ (~12%) 2023 U.S. Market Value2, 5‐year prevalence3 LOTIS‐5 and LOTIS‐7 potential to move ZYNLONTA into 2L+ DLBCL ‒ LOTIS‐5: 20 patient safety run‐in data showed ORR of 80%, CR of 50% with no new safety signals; may need to enroll additional patients to achieve required number of pre‐specified PFS events; accelerating patient enrollment/completion expected in 2024 ‒ LOTIS‐7: Dose‐limiting toxicity period cleared for first two dosing levels of ZYNLONTA (90 µg/kg, 120 µg/kg) in both arms; currently enrolling patients at 150 µg/kg Current Development Areas IIT suggests ZYNLONTA regimen could provide benefit in 2L+ high‐ risk FL (96% ORR, 85% CR, N=27); IIT studying ZYNLONTA in 2L+ MZL ‒ Unmet need is significant in these populations ‒ Plan to assess regulatory path and compendial strategy ZYNLONTA combination with bispecifics (LOTIS‐7) is also being studied in r/r FL and r/r MZL $3.1b2, ~109 K patients $2.6b2, ~61 K patients $1.4b2, ~38 K patients 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.
7 Key Business Updates DLT: Dose‐Limiting Toxicity; (1) on a non‐GAAP basis or 29% on a GAAP measure including stock‐based compensation Balance sheet with $278.6M cash at end of FY 2023 Operating expenses decreased 21% year‐over‐year¹ reflecting pipeline prioritization and organizational efficiencies Cash runway expected to extend into 4Q 2025 LOTIS‐7 (Ph1b ZYNLONTA with bispecifics): Cleared DLT period for first two dosing cohorts in both arms and currently enrolling patients at 150 µg/kg LOTIS‐5 (Ph3 ZYNLONTA with rituximab): Accelerating patient enrollment with completion expected in 2024 ADCT‐601 (Ph1 targeting AXL): Early signs of anti‐tumor activity in sarcoma; initiated screening in pancreatic cancer Advancing early‐stage portfolio of solid tumor ADCs (targeting Claudin‐6, NaPi2b, PSMA and undisclosed target) 4Q 2023 net product revenues of $16.6M, a 17% increase compared to 3Q 2023 Deployment of new commercial model resulted in return to growth in community and academic settings FY 2023 net product revenue of $69.1M, declined 8% versus prior year primarily due to higher gross‐to‐net Pipeline Corporate ZYNLONTA (loncastuximab tesirine‐lpyl)
8 ZYNLONTA has an important role in academic setting Well‐positioned for patients not suited for bispecifics/ CAR‐T or who have progressed on these therapies Strategy to leverage positive experience of thought leaders to help community physicians understand where to use ZYNLONTA ZYNLONTA Net Sales: $16.6M in 4Q 2023 Majority of the opportunity for ZYNLONTA Well‐suited clinical profile: highly effective monotherapy with manageable safety that can be administered in outpatient setting Prescribing behavior slow to change due to entrenchment of older and/ or less effective agents AcademicCommunity • Sequential volume growth in both community and academic settings in 4Q 2023, despite intensified competition • Average vials/day rebounded in Nov/Dec to 1H 2023 levels, partially offset by high single digit % increase in GtN from 1H to 2H • Confident we have right team and strategy to grow ZYNLONTA in 3L/3L+ DLBCL GtN: gross to net; 3L/3L+: third‐line and third‐line plus; DLBCL: Diffuse Large B‐Cell Lymphoma Improved commercial execution
9 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 ✓ 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% ✓ Polivy + R‐CHP R‐CHOP✓ Polivy + R‐ CHP CAR‐T Clinical Trials ZYNLONTA ✓ BsAbs1 Monjuvi + Len Polivy + BR ZYNLONTA Monjuvi + Len Polivy + BRR‐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 and 3L+ in community centers and 3L+ in academic settings with better efficacy and tolerability ZYNLONTA OPPORTUNITY LOTIS‐5 (Ph3) LOTIS‐7 (Ph1b) ZYNLONTA + bispecifics 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 + rituximab 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
10 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 • Following observation of higher‐than‐expected censoring by the clinical team and confirmed with the IDMC, may need to enroll additional patients, beyond the originally planned 350 patients, to achieve the required number of pre‐specified progression free survival events • 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
11 Ar m E Ar m 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 En d of T re at m en t Pa rt 1 3+ 3 Do se e sc al at io n (Z YN LO N TA 9 0, 1 20 , an d 15 0 μg /k g) Pa rt 2 Do se ex pa ns io n Screening Period (≤28 d) Mosunetuzumab + escalating doses of ZYNLONTA Q3W2 Enrollment began July 2023 Glofitamab + escalating doses of ZYNLONTA Q3W1 Enrollment began July 2023 1. Obinutuzumab pretreatment 1000mg on C1D1; ZYNLONTA administered on C1D2; administration of 1st and 2nd 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) ENDPOINTS Primary: Safety and tolerability; MTD and/or RD Secondary: Efficacy: ORR, DOR, CRR, PFS, RFS, OS; Pharmacokinetics and Immunogenicity 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 RATIONALE 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 Successful completion of first two dose cohorts with no DLTs in either arm in heavily pre‐treated patients All patients dosed to date have no or low grades of CRS Encouraging early signs of anti‐tumor activity in mixed histologies Initial Data
12 ZYNLONTA IITs (Univ. of Miami) in FL and MZL IIT: investigator‐initiated trial; FL: follicular lymphoma; MZL: marginal zone lymphoma; ORR: overall response rate; CR: complete response; PFS: progression‐free survival High‐risk relapsed/refractory Follicular Lymphoma Study: Phase 2 study of ZYNLONTA + rituximab Ambition: Potentially addresses unmet need of high‐risk patient population Status: Data presented at ASH 2023: n=33 patients enrolled of target 39 (27 evaluable for efficacy, 32 for safety) Best ORR 96% and CR rate of 85%; 12‐month PFS 93% Majority of adverse events Grade 1 Grade 3 AEs included neutropenia (n=2), and one case each of hyperglycemia, increased ALT, fatigue, dyspnea and skin infection. Neutropenia was only grade 4 AE (n=1) Next steps: University of Miami plans to expand number of trial participants to 100 and add other cancer research centers Data to be published at medical meetings Path forward to be discussed with regulatory authorities and compendia Relapsed/refractory Marginal Zone Lymphoma Study: Phase 2 open‐label study of ZYNLONTA Ambition: Potentially addresses significant unmet need due to low CR rates with approved therapies Status: Futility analysis to be conducted at n=19 patients Next steps: Futility analysis expected to be conducted in 2Q 2024 Data to be shared at upcoming medical meetings University of Miami plans to add other cancer research centers to accelerate enrollment to 50 trial participants
13 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 ,1and Hydraspace ,1 technology enhance the TI of ADCT‐601 three‐fold in preclinical models compared to ADCs manufactured by random stochastic conjugation PBDSpGal Nac Fuc HydraSpace 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
14 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 NSCLC 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 In pancreatic cancer, screening was recently initiated in the monotherapy arm 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 expression2 ~90% ~30%Sarcoma (STS) 60 – 70%~35%Pancreatic adenocarcinoma 50 – 60%20 – 25%Non‐small cell lung3 TARGET RELEVANCE AXL EXPRESSION1 1. Data as of 02/09/2024; 2. Based on scoring algorithm and cut‐off used in trial 601‐102 to determine high expressing/positive patients: STS = AXL+ tumor cells 2+/ 3+ intensity ≥ 75%, PAAD = AXL+ tumor cells 2+/ 3+ intensity ≥ 10%. NSCLC = Membrane AXL+ Tumor cells (any intensity) ≥ 1%; 3. Membrane expression in general correlates with 2+/3+ tumor cells expression
15 Novel Exatecan‐based ADC Platform with 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, all arms dosed intravenously qdx1 Source: Weng et al., Cancer Discov (2023) EXATECAN V. DXD Better potency No PgP1 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‐DXd (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 MODEL2 EXATECAN ADVANTAGE ADC THERAPEUTICS PLATFORM ADVANTAGE
16 Amino acid transporterEnzymatic glycoproteinAdhesion proteinPhosphate transporterTarget description NSCLC Colorectal cancer Prostate cancer Ovarian cancer Endometrial cancer NSCLC Ovarian cancer Tumor types of interest ExatecanExatecanExatecanExatecanPayload in vitro characterization in vivo efficacy NHP toxicology2 Ongoing in vitro characterization in vivo efficacy NHP toxicology in vitro characterization in vivo efficacy NHP toxicology Validation data 202420242024CompleteCandidate selection1 Growing Portfolio of ADC Assets against High‐Value Solid Tumor Targets Note: 1 IND enabling studies can be completed within 18 months after selection of the candidate ; 2 NHP study done with chimeric candidate NaPi2b Claudin‐6 PSMA Undisclosed target Data on the Claudin‐6 and NaPi2b programs will be shared in poster presentations at the American Association for Cancer Research (AACR) 2024 Annual Meeting (April 5–10, 2024 ). Abstract details are currently available online.
17 Corporate Business Development Strategy for ADCT Portfolio 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 Development3 Non‐dilutive Financing2 Maximize Deal Value & Value Split1 Direct Partnership *Flexible for alternative construct depending on economics. OVERLAND JOINT VENTURE
18 4Q 2023 Selected Financial Data (in $ millions) Non‐GAAP (Adjusted)*GAAP % vs. 4Q 20224Q 2023% vs. 4Q 20224Q 2023Statement of Operations ‐15.916.6‐15.916.6Product Revenues, Net ‐33.929.6‐36.930.3Research & Development Expenses ‐9.214.5‐13.913.9Selling & Marketing Expenses ‐15.19.3‐28.011.3General & Administrative Expenses ‐24.254.5‐29.356.8Total Operating Expenses NM43.2NM43.2Income Tax Expense ** NM79.5NM85.0Net Loss NM$0.97NM$1.03Net loss per share December 31, 2023Balance Sheet $278.6Cash and cash equivalents Cash runway expected to extend into 4Q 2025 based on current business plan * See reconciliation of GAAP to non‐GAAP adjustments for details ** Income Tax Expense attributable to valuation allowance on deferred tax assets
19 Cash Runway to Support Multiple Potential Near‐Term Value‐ Driving Catalysts ZYNLONTA: Achieve commercial brand profitability in 2024 LOTIS‐5: Complete enrollment in 2024 LOTIS‐7: Dose escalation and expansion updates throughout 2024 FL and MZL IITs: Updates at medical meetings in 2024 / 2025 ADCT‐602 (CD22): Additional data updates from Phase 1 study in 2024 Exploring potential partnerships and licensing agreements Cash runway to 4Q 2025 to support company through value‐generating milestones* H em at ol og y ADCT‐601 (AXL): Additional data updates from Phase 1 study in sarcoma, pancreatic cancer and NSCLC throughout 2024 Preclinical: Advancing a portfolio of investigational ADCs; Research investor event in 2Q 2024 So lid T um or s *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
4Q 2023 Earnings Call
21 Reconciliation of GAAP to Non‐GAAP Adjustments (i) Included in operating expenses (ii) Included in other income (expense) 4Q 20224Q 2023in $’000 (23,344)(85,031)Net loss (GAAP) Adjustments: 3,344 753Share‐based compensation expense ‐ R&D (i) 209 (571)Share‐based compensation expense ‐ S&M (i) 4,791 2,038 Share‐based compensation expense ‐ G&A (i) (2,086) 279Deerfield warrants obligation, change in fair value expense (income) (ii) 3,912 4,650 Effective interest expense on senior secured term loan facility (ii) 5,844 8,253 Deferred royalty obligation interest expense (ii) 631 (9,823) Deferred royalty obligation cumulative catch‐up adjustment (income) expense (ii) (6,699)(79,452)Adjusted net loss (Non‐GAAP)