On November 7, 2023 ADC Therapeutics SA (NYSE: ADCT) reported financial results for the third quarter 2023 and provided business updates (Press release, ADC Therapeutics, NOV 7, 2023, View Source [SID1234639201]).
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"During the third quarter, we fully rolled out the new commercial strategy, advanced our prioritized pipeline programs and continued to drive operating efficiencies," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We are confident that restructuring the commercial model and the resulting disruptions that continued into the third quarter were necessary to fully capture the potential longer-term value of ZYNLONTA and we expect to see growth in the coming quarters in an increasingly competitive environment. We have a clear roadmap in place as we approach several potential value-generating catalysts in 2024, including data readouts for the LOTIS-7 trial of ZYNLONTA in combination with bispecifics, ADCT-601 targeting AXL, ADCT-901 targeting KAAG1 and ADCT-602 targeting CD22."
Recent Highlights and Developments
ZYNLONTA (loncastuximab tesirine-lpyl)
ZYNLONTA generated net sales of $14.3 million in the third quarter of 2023, representing a 33.1% decrease over the third quarter of 2022. The decline was attributable to an extended period of disruption following the restructuring of the commercial model, increased competition and higher gross-to-net sales deductions. This was partially offset by a slight increase in price.
At the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023) in September, updated safety run-in results from the confirmatory LOTIS-5 Phase 3 trial in combination with rituximab were presented and demonstrated an 80% overall response rate, a 50% complete response rate and median duration of response of 8.0 months with no new safety signals.
The LOTIS-7 trial of ZYNLONTA in combination with bispecifics glofitamab or mosunetuzumab for the treatment of patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL) is actively enrolling patients.
The Company’s partner Mitsubishi Tanabe Pharma Corporation (MTPC) joined the confirmatory Phase 3 LOTIS-5 study of ZYNLONTA in combination with rituximab in second-line or later, transplant ineligible DLBCL patients in Japan.
An American Society of Hematology (ASH) (Free ASH Whitepaper) abstract from the University of Miami investigator-initiated trial exploring ZYNLONTA in combination with rituximab in high-risk relapsed or refractory follicular lymphoma indicated that the combination was well tolerated with a 95% overall response rate at week 12 and at week 21, an 86% metabolic complete response rate.
Pipeline
ADCT-601 (targeting AXL): Dose escalation in patients with non-small cell lung cancer (NSCLC) and sarcoma is proceeding. The maximum tolerated dose has not yet been reached, and the immunohistochemistry (IHC) assay is under final validation. Based on preclinical data, a pancreatic cancer cohort is being added with an enriched patient population.
ADCT-901 (targeting KAAG1): Dose escalation is proceeding, and the IHC assay is under final validation.
ADCT-602 (targeting CD22): Dose escalation and expansion in the Phase 1 trial in collaboration with MD Anderson Cancer is progressing and additional clinical trial sites are being added to accelerate enrollment.
Guidance
The Company maintains the following guidance based on its current business plan:
Continued decrease in total operating expenses expected in full year 2023 and 2024 as compared to 2022
Expected cash runway into the middle of 2025
Upcoming Expected Milestones
ZYNLONTA
Complete enrollment of the Phase 3 LOTIS-5 study in 2024
Initial safety and efficacy data from the LOTIS-7 study in 1H 2024
Pipeline
ADCT-601 (targeting AXL)
Initial data from Phase 1 study in 1H 2024
ADCT-901 (targeting KAAG1)
Initial data from Phase 1 study in 1H 2024
ADCT-602 (targeting CD22)
Additional data from Phase 1 study in 1H 2024
Third Quarter 2023 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were $310.4 million as of September 30, 2023, compared to $326.4 million as of December 31, 2022. The Company continues to expect its cash runway to extend into the middle of 2025.
Product Revenues
Net product revenues were $14.3 million for the quarter ended September 30, 2023, compared to $21.3 million for the same quarter in 2022. Net product revenues are for U.S. sales of ZYNLONTA. The decrease of $7.1 million for the quarter was primarily due to lower sales volume, which was impacted by the extended period of disruption following restructuring of the commercial organization, increased competition, as well as higher gross-to-net deductions, partially offset by a slightly higher price.
License Revenues and Royalties
License revenues and royalties were $0.2 million for the quarter ended September 30, 2023, compared to $55.0 million for the same quarter in 2022. During July 2022, the Company entered into an exclusive license agreement with Sobi for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the U.S., greater China, Singapore and Japan. Under the terms of the agreement, the Company received an upfront payment of $55.0 million during the quarter ended September 30, 2022.
Research and Development (R&D) Expenses
R&D expenses were $28.4 million for the quarter ended September 30, 2023, compared to $41.7 million for the same quarter in 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, while continuing to assess a potential regulatory pathway and seeking a partner to continue developing this program.
R&D expenses in the third quarter of 2023 also decreased due to lower share-based compensation expense as a result of fluctuations in the share price and award forfeitures in connection with voluntary terminations.
Selling and Marketing (S&M) Expenses
S&M expenses were $13.7 million for the quarter ended September 30, 2023, compared to $16.8 million for the same quarter in 2022. The decrease in S&M expenses for the quarter was primarily due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with voluntary terminations as well as lower wages and benefits.
General & Administrative Expenses
G&A expenses were $9.4 million for the quarter ended September 30, 2023, compared to $19.6 million for the same quarter in 2022. G&A expenses decreased during the third quarter of 2023 primarily due to lower share-based compensation expense due to fluctuations in the share price and award forfeitures in connection with voluntary terminations, as well as lower wages and benefits.
Net Loss and Adjusted Net Loss
Net loss was $47.8 million, or a net loss of $0.58 per basic and diluted share, for the quarter ended September 30, 2023. This compares to a net loss of $50.6 million, or a net loss of $0.65 per basic and diluted share, for the same quarter in 2022. The decrease in net loss for the quarter ended September 30, 2023, as compared to the same quarter in 2022, was attributable to a non-cash loss related to the extinguishment of our convertible loans and derivatives during the third quarter of 2022 in connection with restructuring of existing loans, as well as lower operating expenses during the third quarter of 2023 which included lower non-cash charges related to share-based compensation. The decrease in net loss was partially offset by lower revenues during the third quarter of 2023.
Adjusted net loss was $33.8 million, or an adjusted net loss of $0.41 per basic and diluted share, for the quarter ended September 30, 2023. This compares to adjusted net income of $10.3 million, or adjusted net income of $0.13 per basic and diluted share, for the same quarter in 2022. The increase in adjusted net loss is primarily driven by lower revenues during the third quarter of 2023, partially offset by lower operating expenses.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 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.