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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
June 24, 2026
ADC Therapeutics SA
(Exact Name of Registrant as Specified in Its Charter)
|
Switzerland
(State or Other Jurisdiction of Incorporation) |
001-39071
(Commission File Number) |
N/A
(IRS Employer Identification Number) |
|
Biopôle
Route de la Corniche 3B
1066 Epalinges
Switzerland
(Address of Principal Executive Offices) (Zip
Code) |
+41 21 653 02 00
(Registrant’s Telephone Number) |
N/A
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
| ☐ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
| Common Shares, par value CHF 0.08 per share |
ADCT |
New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17 C.F.R. §230.405) or Rule 12b-2 of the Securities Exchange Act of
1934 (17 C.F.R. §240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
In connection with the events described under Item 8.01 below, ADC
Therapeutics SA (the “Company”) issued a press release, a copy of which is attached as Exhibit 99.1 to this Current Report
on Form 8-K and incorporated by reference herein.
The information contained in this Item 7.01 and the associated exhibits
shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On June 24, 2026, the Company announced a plan to reduce the Company’s
workforce globally by approximately 17 percent. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this
year, as well as operational efficiencies. The Company expects the reduction to generate annualized estimated cost savings of approximately
$10 million. The Company estimates that it will incur one-time pre-tax charges of approximately $3 million for employee severance, benefits
and related termination costs, the majority of which will be recognized in the second quarter of 2026.
The estimated charges that the Company expects to incur, and the timing
thereof, as well as the estimated annual cost savings, are subject to a number of assumptions, and actual results may differ materially
from these estimates. The Company may also incur additional costs not currently contemplated due to events that may occur as a result
of, or that are associated with, the reduction.
This Current Report on Form 8-K 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: the cost and effects of the strategic restructuring and workforce reduction including our
ability to achieve the estimated cost savings; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and
our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome
of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and
acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA
as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for
safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for
ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and
impact of such options; our expected cash runway into at least 2028 assumes use of minimum liquidity amount required to be maintained
under its loan agreement covenants; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial
strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the
ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments
to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the
timing, results and publication of the Company's clinical trials including LOTIS-7; the timing, publication and results of investigator-initiated
trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing
and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities;
projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities,
and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements
and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial
and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies,
including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business,
financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results
to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of
the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities
and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results,
performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed
in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements
contained in this document.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description |
| 99.1 |
Press release dated June 24, 2026 |
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
ADC Therapeutics SA |
| |
|
| Date: June 24, 2026 |
|
| |
By: |
/s/ Peter J. Graham |
| |
Name: |
Peter J. Graham |
| |
Title: |
Chief Legal Officer |
Exhibit 99.1
ADC
Therapeutics Announces Strategic Reorganization to Support ZYNLONTA® Growth Opportunities and Regulatory Priorities
Planned 17% workforce
reduction expected to generate annualized estimated savings of approximately $10m, enhancing financial flexibility
Company focused on delivering
upcoming regulatory and clinical milestones, including planned LOTIS-5 sBLA submission and full LOTIS-7 data by end of 2026
LAUSANNE, Switzerland, June 24, 2026 –
ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today
announced a strategic reorganization to focus resources behind key value-driving initiatives in support of the ZYNLONTA®
(loncastuximab tesirine-lpyl) franchise.
As part of the reorganization, ADC Therapeutics
plans to reduce its workforce globally by approximately 17 percent. The reduction is driven by the expected completion of the LOTIS-5
and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key
clinical, regulatory and manufacturing activities while maintaining the full externally facing medical affairs and commercial footprint
to support ZYNLONTA.
"As we further assess the Phase 3 LOTIS-5
trial outcomes, including feedback from key medical experts, we continue to believe in the favorable
overall benefit-risk profile and look forward to our pre-sBLA meeting with the U.S. Food and Drug Administration in August,"
said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This strategic reorganization will enable us to increase our financial
flexibility as we prepare for upcoming LOTIS-5 regulatory milestones and continue building on the broader opportunity for ZYNLONTA through
LOTIS-7 and support for the indolent lymphoma investigator-Initiated trials. We are grateful to all of our employees for their efforts
to help make a meaningful impact for patients and thank them for their important contributions to our company."
The Company is preparing for a scheduled pre-sBLA
meeting with the FDA in August 2026 to discuss the potential regulatory path forward for ZYNLONTA in combination with rituximab to treat
relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) following the recent topline data results from the Phase 3 LOTIS-5 trial.
ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026.
In addition, the Company continues to advance
the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL, with
data anticipated by the end of 2026, as well as through support for Phase 2 IITs exploring ZYNLONTA across indolent lymphomas.
ADC Therapeutics expects the reorganization
to generate annualized estimated cost savings of approximately $10 million. ADC Therapeutics estimates that it will incur one-time pre-tax
charges of approximately $3 million for employee severance, benefits and related termination costs, the majority of which will be recognized
in the 2nd quarter of 2026. The Company has an expected cash runway at least into 2028.
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 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.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio
with ZYNLONTA® (loncastuximab tesirine-lpyl).
ADC Therapeutics' CD19-directed ADC ZYNLONTA
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.
Headquartered in Lausanne (Biopôle),
Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities
from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn.
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: the cost and effects of the strategic restructuring and workforce reduction including
our ability to achieve the estimated cost savings; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval
and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and
outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission
and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA
as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for
safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for
ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and
impact of such options; our expected cash runway into at least 2028 assumes use of minimum liquidity amount required to be maintained
under its loan agreement covenants; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial
strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the
ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments
to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the
timing, results and publication of the Company's clinical trials including LOTIS-7; the timing, publication and results of
investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future
opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or
foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and
Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply
with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and
the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and
the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and
the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning
these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is
contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and
current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results,
performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not
to place undue reliance on the forward-looking statements contained in this document.
CONTACTS:
Investors and Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040