On May 9, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported financial results for the first quarter ended March 31, 2022 and provided business updates (Press release, ADC Therapeutics, MAY 9, 2022, View Source [SID1234613963]).
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"ZYNLONTA continues to extend its reach in the DLBCL market with its differentiated product profile and broad applicability across the 3L+ patient population. We are pleased by the team’s progress since launch in bringing ZYNLONTA to patients. Sales in the first quarter were unfavorably impacted by the customer inventory build at the end of last year and fewer new patient starts in the DLBCL market in the first quarter, which was exacerbated by the Omicron surge," said Chris Martin, DPhil, former Chief Executive Officer of ADC Therapeutics. "We have a strong clinical development program to potentially expand ZYNLONTA’s use into earlier lines of therapy, and we are also excited about our promising portfolio of solid tumor programs. We look forward to providing updates as they become available."
Recent Highlights and Developments
Corporate Update
Today, Chris Martin has transitioned the role of Chief Executive Officer to Ameet Mallik. Dr. Martin will serve as a non-executive member of the Board of Directors and Chair of the Science and Technology Committee. He will also serve as an advisor to the Company for the next three months to ensure a smooth transition.
Hematology Franchise
ZYNLONTA (loncastuximab tesirine-lpyl)
ZYNLONTA generated net sales of $16.5 million in the first quarter of 2022, reflecting a modest fourth quarter customer inventory build and fewer new patient starts in the diffuse large B-cell lymphoma (DLBCL) market in 1Q 2022, which was exacerbated by the Omicron surge.
ZYNLONTA awareness and familiarity continues to increase and ZYNLONTA share of voice is performing well in the relapsed/refractory DLBCL market. Market share in the 3L+ setting is also increasing.
In terms of account penetration, 96% of priority accounts have ordered ZYNLONTA since launch and 94% of National Comprehensive Cancer Network centers have ordered ZYNLONTA since launch.
The permanent J-code for ZYNLONTA (J9359) was issued by the U.S. Centers for Medicare & Medicaid Services and took effect April 1, 2022.
The Phase 3 LOTIS-5 trial in combination with rituximab in second-line transplant-ineligible DLBCL patients continues to enroll the randomized portion of the trial.
The Overland ADCT BioPharma joint venture continues to make progress in China and enrollment continues in the local pivotal Phase 2 trial of ZYNLONTA in relapsed or refractory (r/r) DLBCL.
The Company is actively engaged with its partner Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan to develop ZYNLONTA in DLBCL.
Cami (camidanlumab tesirine) in Hodgkin lymphoma (HL)
The 12-month patient follow-up in this pivotal Phase 2 trial has been completed. The Company has submitted the data to an upcoming oncology conference.
Solid Tumor Franchise
Cami (targeting CD25)
The Company is concurrently advancing the dose escalation and a dose expansion cohort of the Phase 1b trial of Cami in combination with pembrolizumab. The Company has initiated a limited expansion at 60 µg/kg based on investigator observation of stable disease or tumor response, and the dose escalation continues at 100 µg/kg.
Upcoming Expected Milestones
Hematology Franchise
ZYNLONTA
Continue to enroll the randomized portion of the LOTIS-5 confirmatory trial in combination with rituximab in second-line transplant-ineligible DLBCL patients
Initiate the LOTIS-7 trial in multiple combinations in non-Hodgkin lymphoma in 1H 2022
Initiate the LOTIS-9 trial in combination with rituximab in first-line unfit/frail DLBCL patients in 2H 2022
Cami
Report topline results for the pivotal Phase 2 trial in HL in 1H 2022
Meet with FDA for pre-BLA meeting in 2H 2022
ADCT-602 (targeting CD22)
Continue to enroll the Phase 1 trial in acute lymphoblastic leukemia (ALL)
Solid Tumor Franchise
Cami (targeting CD25)
Continue to advance the Phase 1b solid tumor trial of Cami in combination with pembrolizumab, with safety and efficacy data anticipated in 2023
ADCT-901 (targeting KAAG1)
Continue to enroll the Phase 1 trial in multiple solid tumors, with safety and efficacy data anticipated in 2023
ADCT-601 (targeting AXL)
Initiate the Phase 1b combination trial in multiple solid tumors in 1H 2022
ADCT-701 (targeting DLK1)
Continue to work with the National Cancer Institute to complete preclinical studies to support an IND filing
ADCT-212 (targeting PSMA)
Continue completion of preclinical studies to support an IND filing
First Quarter Financial Results
Product Revenue
Product revenue (net) was $16.5 million for the quarter, compared to zero for the same quarter in 2021. Net revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.
Cash and Cash Equivalents
Cash and cash equivalents were $430.9 million as of March 31, 2022, compared to $466.5 million as of December 31, 2021.
Research and Development (R&D) Expenses
R&D expenses were $49.0 million for the quarter ended March 31, 2022, compared to $39.2 million for the same quarter in 2021. R&D expense increased for the quarter ended March 31, 2022, as compared to the same quarter in 2021 as a result of increased investment in programs to evaluate ZYNLONTA in earlier lines of therapy and our broad portfolio.
Selling and Marketing (S&M) Expenses
S&M expenses were $18.4 million for the first quarter ended March 31, 2022, as compared to $13.9 million for the same quarter in 2021. The increase in S&M expenses are related to the ongoing launch of ZYNLONTA.
G&A Expenses
G&A expenses were $19.0 million for the quarter ended March 31, 2022, compared to $17.6 million for the same quarter in 2021. G&A expenses increased primarily due to professional fees associated with the MTPC license agreement in Japan.
Net Loss and Adjusted Net Loss
Net loss was $16.7 million, or a net loss of $0.22 per basic and diluted share, for the quarter ended March 31, 2022. This compares to a net loss of $51.5 million, or a net loss of $0.67 per basic and diluted share, for the same quarter in 2021.
Adjusted net loss was $27.7 million, or an adjusted net loss of $0.36 per basic and diluted share, for the quarter ended March 31, 2022. This compares to $56.8 million, or an adjusted net loss of $0.74 per basic and diluted share, for the same quarter in 2021.
The decrease in net loss and adjusted net loss for the quarter ended March 31, 2022, as compared to the same period in 2021, was primarily due to license revenue of $30 million arising from the MTPC agreement, partially offset by the increase in R&D and S&M expenses. In addition, net loss decreased for the first quarter of 2022 as a result of income arising from a cumulative catch-up adjustment associated with the valuation of the deferred obligation with Healthcare Royalty Partners, partially offset by higher interest expense associated with the Deerfield credit facility and deferred obligation, both of which are excluded from adjusted net loss.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2022 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 833-303-1198 (domestic) or +1 914-987-7415 (international) and provide conference ID 6928367. A live webcast of the presentation 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) has 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 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.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.