ADC Therapeutics Reports First Quarter 2025 Financial Results and Provides Operational Update
- Strong LOTIS-7 trial results with 95.5% ORR and 90.9% CR rate for ZYNLONTA plus glofitamab combination
- Successful enrollment of 40 patients in LOTIS-7 dose expansion arm
- Reduced net loss to $38.6M from $46.6M year-over-year
- $5M milestone payment received for ZYNLONTA's Health Canada approval
- Cash runway extended into second half of 2026
- ZYNLONTA product revenues slightly declined to $17.4M from $17.8M year-over-year
- R&D expenses increased to $28.9M from $25.7M year-over-year
- Cash position decreased to $194.7M from $250.9M in December 2024
- Discontinuation of ADCT-602 clinical trial
Insights
ADCT's ZYNLONTA plus glofitamab shows exceptional 95.5% response rate in DLBCL, with strong cash position through 2026 despite quarterly loss.
The LOTIS-7 trial data for ZYNLONTA
What's particularly noteworthy is the durability signal - 20 of 21 responders maintaining their response with median duration not yet reached. This suggests the combination may offer not just initial response but lasting disease control, addressing a critical unmet need in DLBCL treatment.
The reported safety profile appears manageable across all 31 evaluated patients, which is crucial for combination therapies where toxicity concerns can often limit clinical utility. The data is sufficiently compelling to warrant upcoming presentations at two major lymphoma conferences (EHA2025 and ICML).
The completion of 40-patient enrollment in the dose expansion cohort represents important operational progress, enabling more robust efficacy and safety assessment in the second half of 2025.
The LOTIS-5 confirmatory trial remains on track, with progression-free survival events expected by year-end 2025. This trial is strategically critical as it could potentially move ZYNLONTA into earlier treatment lines, significantly expanding its market opportunity.
Importantly, the company has discontinued the ADCT-602 program in B-cell acute lymphoblastic leukemia based on available clinical data, demonstrating appropriate pipeline prioritization and resource allocation. Their
ADCT shows strong clinical progress but continues to post losses despite stable revenue; cash runway into H2 2026 provides operational flexibility.
ADCT's Q1 2025 financial performance presents a mixed picture. ZYNLONTA's product revenues remained relatively flat at
On the expense side, R&D costs increased
The net loss narrowed to
Cash position declined to
The financial structure demonstrates the classic biotech paradigm of balancing cash burn against clinical progress. With promising LOTIS-7 data potentially positioning ZYNLONTA plus glofitamab as a best-in-class combination therapy, and LOTIS-5 potentially expanding market opportunity in earlier treatment lines, the company appears strategically positioned despite ongoing losses.
Forty patient enrollment reached in
Cash runway expected to fund multiple catalysts into the second half of 2026
Company to host conference call today at 8:30 a.m. EDT
LAUSANNE,
"We are encouraged by the promising
First Quarter 2025 Operational Updates & Recent Highlights
- Abstract accepted for
LOTIS-7 data presentations at EHA2025 and ICML. As of the abstract cutoff date of January 17, 2025, 31 patients received ≥1 ZYNLONTA dose and were safety evaluable, with 22 patients evaluable for efficacy. ZYNLONTA plus glofitamab (COLUMVI®) demonstrated an overall response rate (ORR) of95.5% and complete response (CR) rate of90.9% . Four of the efficacy evaluable patients (2 each at 120µg/kg and 150 µg/kg) converted to CR within 3 weeks after the data cutoff and are included as CRs. Twenty of 21 responders have remained in response and the median duration of response has not been reached. Manageable safety and tolerability were observed across all 31 safety evaluable patients. Updated data will be presented during a poster session on Saturday, June 14 at 12:30 p.m. ET at EHA2025 taking place inMilan, Italy from June 12–15, 2025 and an oral presentation at ICML taking place in Lugano,Switzerland from June 17-21, 2025. - Enrollment of 40 patients reached in
LOTIS-7 dose expansion arm. Forty patients have been enrolled in the dose expansion arm of the Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab in patients with r/r DLBCL. The Company expects to provide an update on theLOTIS-7 trial in the second half of 2025. - Abstract accepted for
LOTIS-5 trial safety run-in data presentation at EHA2025. As of the abstract cutoff date of October 4, 2024, the safety run-in data included 20 patients, fromLOTIS-5 , a Phase 3, randomized trial of ZYNLONTA plus rituximab in patients with r/r DLBCL. Fixed treatment duration of this combination showed no new safety signals and demonstrated encouraging antitumor activity, with signs of durable responses in r/r DLBCL/HGBL patients >28 months after end of treatment. The data will be presented during a poster session on Saturday, June 14 at 12:30 p.m. ET at EHA2025. LOTIS-5 remains on track to reach prespecified progression-free survival (PFS) events by end of 2025. After the prespecified number of PFS events is reached and data are available, the Company expects to provide topline data on the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL.- Abstract accepted for presentation of marginal zone lymphoma (MZL) data at ICML. A poster entitled, "Updated analysis of a phase 2 multicenter study of the loncastuximab in relapsed/refractory marginal zone lymphoma demonstrates high rate of complete responses" will be presented at ICML. This single-arm, open-label investigator-initiated study is being conducted at the Sylvester Comprehensive Cancer Center at University of
Miami and City of Hope, and led by Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University ofMiami . - Discontinuation of ADCT-602 trial. Based on the available clinical data, the Phase 1/2 ADCT-602 clinical trial, sponsored by The University of Texas MD Anderson Cancer Center, evaluating ADCT-602 in patients with r/r B-cell acute lymphoblastic leukemia will be discontinued.
- Preclinical programs highlighted at the American Association for Cancer Research (AACR) Annual Meeting 2025. Data from preclinical studies of our exatecan-based ADCs targeting Claudin-6 (CLDN6), prostate-specific membrane antigen (PSMA), and Alanine, Serine, Cysteine Transporter 2 (ASCT2) were featured.
First Quarter 2025 Financial Results
- Product Revenues: ZYNLONTA generated net product revenues of
$17.4 million $17.8 million - License Revenues and Royalties: License revenue and royalties were
$5.6 million $0.2 million $5.0 million - Research and Development (R&D) Expense: R&D expense was
$28.9 million $25.7 million - Selling and Marketing (S&M) Expense: S&M expense was
$10.6 million $11.4 million - General & Administrative (G&A) Expense: G&A expense was
$10.0 million $12.0 million - Net Loss: Net loss for the quarter ended March 31, 2025 was
$38.6 million $0.36 $46.6 million $0.56 - Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was
$24.0 million $0.22 $31.1 million $0.38 - Cash and cash equivalents: As of March 31, 2025, cash and cash equivalents were
$194.7 million $250.9 million
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2025 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for
About ZYNLONTA®
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
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),
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
Use of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with
- 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 total operating expenses:
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.
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 warrant obligations and the effective interest expense associated with 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: whether future
ADC Therapeutics SA Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except for share and per share data)
| ||||
For the Three Months Ended March 31, | ||||
2025 | 2024 | |||
Revenue | ||||
Product revenues, net | $ 17,404 | $ 17,848 | ||
License revenues and royalties | 5,629 | 205 | ||
Total revenue, net | 23,033 | 18,053 | ||
Operating expense | ||||
Cost of product sales | (2,061) | (2,510) | ||
Research and development | (28,928) | (25,735) | ||
Selling and marketing | (10,553) | (11,390) | ||
General and administrative | (9,955) | (12,031) | ||
Total operating expense | (51,497) | (51,666) | ||
Loss from operations | (28,464) | (33,613) | ||
Other income (expense) | ||||
Interest income | 2,054 | 2,948 | ||
Interest expense | (12,230) | (12,496) | ||
Other, net | 203 | (2,595) | ||
Total other expense, net | (9,973) | (12,143) | ||
Loss before income taxes | (38,437) | (45,756) | ||
Income tax expense | (165) | (163) | ||
Loss before equity in net losses of joint venture | (38,602) | (45,919) | ||
Equity in net losses of joint venture | — | (687) | ||
Net loss | $ (38,602) | $ (46,606) | ||
Net loss per share | ||||
Net loss per share, basic and diluted | $ (0.36) | $ (0.56) | ||
Weighted average shares outstanding, basic and diluted | 107,202,374 | 82,552,322 | ||
ADC Therapeutics SA Condensed Consolidated Balance Sheets (Unaudited) (in thousands)
| ||||
March 31, 2025 | December 31, 2024 | |||
ASSETS | ||||
Current assets | ||||
Cash and cash equivalents | $ 194,701 | $ 250,867 | ||
Accounts receivable, net | 31,762 | 20,316 | ||
Inventory | 17,447 | 18,387 | ||
Prepaid expenses | 6,899 | 8,370 | ||
Other current assets | 7,180 | 9,450 | ||
Total current assets | 257,989 | 307,390 | ||
Non-current assets | ||||
Property and equipment, net | 5,156 | 5,075 | ||
Operating lease right-of-use assets | 8,231 | 8,354 | ||
Other long-term assets | 1,163 | 1,161 | ||
Total assets | $ 272,539 | $ 321,980 | ||
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY | ||||
Current liabilities | ||||
Accounts payable | $ 15,592 | $ 18,029 | ||
Accrued expenses and other current liabilities | 42,202 | 62,440 | ||
Total current liabilities | 57,794 | 80,469 | ||
Deferred royalty obligation, long-term | 326,792 | 320,093 | ||
Senior secured term loans | 113,823 | 113,632 | ||
Operating lease liabilities, long-term | 7,907 | 7,995 | ||
Other long-term liabilities | 4,446 | 2,433 | ||
Total liabilities | 510,762 | 524,622 | ||
Total shareholders' (deficit) equity | (238,223) | (202,642) | ||
Total liabilities and shareholders' (deficit) equity | $ 272,539 | $ 321,980 | ||
ADC Therapeutics SA Reconciliation of GAAP Measures to Non-GAAP Measures (Unaudited) (in thousands, except for share and per share data)
| ||||||||
Three Months Ended March 31, | ||||||||
(in thousands) | 2025 | 2024 | Change | % Change | ||||
Total operating expense | $ (51,497) | $ (51,666) | $ 169 | — % | ||||
Adjustments: | ||||||||
Share-based compensation expense (i) | 2,421 | 158 | 2,263 | 1432 % | ||||
Adjusted total operating expenses | $ (49,076) | $ (51,508) | $ 2,432 | (5) % | ||||
Three Months Ended March 31, | ||||
in thousands (except for share and per share data) | 2025 | 2024 | ||
Net loss | $ (38,602) | $ (46,606) | ||
Adjustments: | ||||
Share-based compensation expense (i) | 2,421 | 158 | ||
— | 3,068 | |||
Effective interest expense on senior secured term loan facility (iii) | 3,785 | 4,403 | ||
Deferred royalty obligation interest expense (iv) | 8,445 | 8,093 | ||
Deferred royalty obligation cumulative catch-up adjustment income (iv) | (12) | (263) | ||
Adjusted net loss | $ (23,963) | $ (31,147) | ||
Net loss per share, basic and diluted | $ (0.36) | $ (0.56) | ||
Adjustment to net loss per share, basic and diluted | 0.14 | 0.18 | ||
Adjusted net loss per share, basic and diluted | $ (0.22) | $ (0.38) | ||
Weighted average shares outstanding, basic and diluted | 107,202,374 | 82,552,322 | ||
(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
|
(iii) | Effective interest expense on senior secured term loans relates to the increase in the value of our loans in accordance with the amortized cost method.
|
(iv) | 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 adjustments related to changes in the expected payments to HCR based on a periodic assessment of our underlying revenue projections. |
CONTACTS:
Investors | Media |
Marcy Graham | Nicole Riley |
ADC Therapeutics | ADC Therapeutics |
+1 650-667-6450 | +1 862-926-9040 |
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SOURCE ADC Therapeutics SA
FAQ
What were ADCT's ZYNLONTA sales in Q1 2025?
What were the results of ADCT's LOTIS-7 trial for ZYNLONTA plus glofitamab?
How much cash does ADCT have and how long will it last?
What was ADCT's net loss in Q1 2025?
Why did ADCT discontinue the ADCT-602 trial?
