ADC Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Updates
ADC Therapeutics (NYSE: ADCT) reported Q1 2021 results, highlighted by the accelerated FDA approval of ZYNLONTA for treating relapsed or refractory DLBCL. This approval broadens treatment options for patients with difficult-to-treat cancers. Cash equivalents stood at $383.1 million, down from $439.2 million at year-end 2020. R&D expenses increased to $39.2 million, reflecting investments for ZYNLONTA's potential. Net loss was $51.5 million or $0.67 per share, up from $43.5 million in Q1 2020, driven by organizational expansion and preparation for ZYNLONTA's launch.
- Accelerated FDA approval of ZYNLONTA, enhancing treatment options.
- ZYNLONTA's broad label includes hard-to-treat patient populations.
- Cash and cash equivalents of $383.1 million as of March 31, 2021.
- Net loss increased to $51.5 million in Q1 2021 compared to $43.5 million in Q1 2020.
- R&D expenses rose to $39.2 million attributed to expansion and clinical investments.
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, today reported financial results for the first quarter ended March 31, 2021 and provided business updates.
“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).
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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.
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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)
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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
Research and Development (R&D) Expenses
R&D expenses were
Selling and Marketing (S&M) Expenses
During the first quarter of 2021, S&M expenses were
G&A Expenses
G&A expenses were
Net Loss and Adjusted Net Loss
Net loss was
Adjusted net loss was
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.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in late-stage clinical trials in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple PBD-based 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 Twitter and LinkedIn.
The Company’s annual report on Form 20-F filed with the Securities and Exchange Commission and its Swiss statutory annual report for the fiscal year ended December 31, 2020 are available at ir.adctherapeutics.com under “Events and Presentations”. Shareholders may receive a hard copy of the Company’s audited financial statements, or its complete annual report including audited financial statements, free of charge, by requesting a copy from Investor Relations at Amanda.Hamilton@adctherapeutics.com. Any requests for hard copies may be subject to a delay in mailing due to the COVID-19 pandemic.
ZYNLONTA™ is a trademark of ADC Therapeutics SA.
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. 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.
The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following two or more prior lines of systemic therapy. Results from the trial demonstrated an overall response rate (ORR) of
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
Use of Non-IFRS Financial Measures
In addition to financial information prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management’s view of performance including:
- 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-IFRS 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 IFRS. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these IFRS items to be normal, recurring cash operating expenses; however, these items may not meet the IFRS definition of unusual or non-recurring items. Since non-IFRS financial measures do not have standardized definitions and meanings, they may differ from the non-IFRS 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 IFRS 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 may occur occasionally and are not normal, recurring operating expenses, cash or non-cash, 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 and generally represent items that, either as a result of their nature or significance, management would not anticipate occurring as part of our normal business on a regular basis. 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 the effective interest expense, associated with the Facility Agreement with Deerfield, transaction costs associated with debt or equity issuances that are expensed pursuant to IFRS, as well as the non-cash gain related to the contribution of our intellectual property for our equity interest in Overland ADCT BioPharma.
See the attached Reconciliation of IFRS Measures to Non-IFRS Measures for explanations of the amounts excluded and included to arrive at the non-IFRS financial measures for the three-month periods ended March 31, 2021 and 2020.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, planned commercialization activities, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release 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.
ADC Therapeutics SA
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| For the Three Months Ended March 31, | |||
2021 |
2020 (1) |
||
| Operating expense | |||
| Research and development expenses | (39,172) |
(35,375) |
|
| Selling and marketing expenses | (13,911) |
(2,628) |
|
| General and administrative expenses | (17,582) |
(5,882) |
|
| Total operating expense | (70,665) |
(43,885) |
|
| Loss from operations | (70,665) |
(43,885) |
|
| Other income (expense) | |||
| Other income | 194 |
148 |
|
| Convertible loans, derivatives, change in fair value income | 21,169 |
- |
|
| Share of results with joint venture | (527) |
- |
|
| Financial income | 15 |
374 |
|
| Financial expense | (2,000) |
(42) |
|
| Exchange differences | 394 |
29 |
|
| Total other income | 19,245 |
509 |
|
| Loss before taxes | (51,420) |
(43,376) |
|
| Income tax expense | (107) |
(100) |
|
| Net loss | (51,527) |
(43,476) |
|
| Net loss attributable to: | |||
| Owners of the parent | (51,527) |
(43,476) |
|
| Net loss per share, basic and diluted | (0.67) |
(0.85) |
|
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FAQ
What are the financial results for ADC Therapeutics in Q1 2021?
ADC Therapeutics reported a net loss of $51.5 million in Q1 2021, with cash equivalents at $383.1 million.
What significant regulatory milestone did ADC Therapeutics achieve recently?
ADC Therapeutics received accelerated FDA approval for ZYNLONTA on April 23, 2021.
What is the future outlook for ZYNLONTA after its FDA approval?
ADC Therapeutics plans ongoing trials and aims to expand ZYNLONTA's applications in difficult-to-treat cancers.
ADC Therapeutics SA
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