On May 6, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported financial results for the first quarter ended March 31, 2021 and provided business updates (Press release, ADC Therapeutics, MAY 6, 2021, View Source [SID1234579403]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are off to an exciting start to the year with the recent accelerated FDA approval of ZYNLONTA, bringing a new and differentiated treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "ZYNLONTA is approved for a broad population of r/r DLBCL patients, including DLBCL NOS, DLBCL arising from low grade lymphoma and also high-grade B-cell lymphoma. This reflects the real world population of patients enrolled in our LOTIS-2 pivotal trial including transplant eligible and ineligible patients, heavily pre-treated patients and patients with difficult-to-treat disease. In addition, we continue to advance our pipeline of next-generation ADCs for patients with difficult-to-treat hematologic and solid tumor cancers."
"On the occasion of the commercial launch of ZYNLONTA, it has been impressive to see the high quality of talented and experienced commercial and medical affairs professionals at ADC Therapeutics fully prepared for an early FDA approval," said Ron Squarer, Chairman of the Board and an advisor to the Company. "This team is executing on its launch plan and is well equipped to support the treating community in adopting an important new option with a broad label which included tough to treat patients in third-line plus DLBCL."
Recent Highlights
ZYNLONTA (loncastuximab tesirine-lpyl)
FDA accelerated approval and launch: ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on April 23, 2021, as a single-agent for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, a key point of differentiation on the label. ZYNLONTA became commercially available last week and the commercial launch is fully underway.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: As of May 5, 2021, ZYNLONTA was added to the NCCN guidelines with a category 2A recommendation for third-line plus DLBCL, including DLBCL arising from low-grade lymphoma such as follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Ongoing trials progressing:
The Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. This trial will fulfill the post-marketing approval requirement with the FDA for a confirmatory study.
The pivotal Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients is intended to support the submission of a supplemental Biologics License Application (BLA) for ZYNLONTA in combination with ibrutinib.
Additional planned trials in 2021 to potentially expand the ZYNLONTA opportunity:
Pivotal Phase 2 clinical trial in follicular lymphoma (FL).
Clinical trial to evaluate ZYNLONTA in combination with multiple other drugs in B-cell non-Hodgkin lymphoma (NHL).
Dose-finding study of ZYNLONTA in combination with R-CHOP in frontline DLBCL.
Camidanlumab Tesirine (Cami)
Ongoing trials progressing:
The pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL) has completed enrollment and is continuing to follow patients. The Company will present data from this study at an upcoming congress.
The Phase 1b clinical trial of Cami in combination with pembrolizumab in selected advanced solid tumors is an open-label, dose-escalation and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor.
2021 Expected Milestones
ZYNLONTA
Initiate a pivotal Phase 2 clinical trial of ZYNLONTA in FL in the second quarter of 2021.
Report updated data from the Phase 1 clinical trial of ZYNLONTA in combination with ibrutinib in relapsed or refractory DLBCL in the second quarter of 2021.
Initiate the dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
Initiate the clinical trial to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
Complete enrollment in the pivotal Phase 2 trial of ZYNLONTA in combination with ibrutinib in the second half of 2021.
Complete safety lead-in of the Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.
Cami
Report interim results from the pivotal Phase 2 clinical trial of Cami in HL in the second quarter of 2021.
Earlier-Stage Pipeline
File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1 in the second quarter of 2021.
Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the first half of 2022.
First Quarter 2021 Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were $383.1 million as of March 31, 2021, compared to $439.2 million as of December 31, 2020. In the coming days, the Company will be drawing down $50 million associated with its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.
Research and Development (R&D) Expenses
R&D expenses were $39.2 million for the quarter ended March 31, 2021, compared to $35.4 million for the same quarter in 2020. R&D expenses increased due to investments to explore the potential of ZYNLONTA in earlier lines of treatment and histologies and advance the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.
Selling and Marketing (S&M) Expenses
During the first quarter of 2021, S&M expenses were $13.9 million as compared to $2.6 million for the same quarter in 2020. The increase in S&M expenses related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of ZYNLONTA in 2021. Prior to December 31, 2020, S&M expenses were reported within General and Administrative ("G&A") expenses within the condensed consolidated interim statement of operations. The period ended March 31, 2020 has been recast to conform to the current year presentation.
G&A Expenses
G&A expenses were $17.6 million for the quarter ended March 31, 2021, compared to $5.9 million for the same quarter in 2020. G&A expenses increased due to higher headcount to support the commercial launch, increased share‐based compensation expense and higher costs of being a public company.
Net Loss and Adjusted Net Loss
Net loss was $51.5 million, or a net loss of $0.67 per basic and diluted share, for the quarter ended March 31, 2021, compared to $43.5 million, or a net loss of $0.85 per basic and diluted share, for the same quarter in 2020. The net loss for the quarter ended March 31, 2021 includes a $21.2 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from December 31, 2020. In addition, net loss included share-based compensation expense of $14.0 million for the quarter ended March 31, 2021, compared to $3.8 million for the same quarter in 2020.
Adjusted net loss was $56.8 million, or an adjusted net loss of $0.74 per basic and diluted share, for the quarter ended March 31, 2021, compared to $39.7 million, or an adjusted net loss of $0.78 per basic and diluted share, for the same quarter in 2020. The increase in adjusted net loss was primarily driven by the expansion of the organization, investment in the expanding clinical portfolio and the preparation for the anticipated launch of ZYNLONTA.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 888-771-4371 (domestic) or +1 847-585-4405 (international) and provide confirmation number 50158735. A live webcast of the presentation will be available under "Events and 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.