ADC Therapeutics SA
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 13, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-04.
0001628280-26-029819
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001628280-26-056711
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 2 previous paragraphs and 4 current paragraphs.
1 unchanged; 0 reworded; 3 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
Below we are providing, in supplemental form, an addition to our risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Current report
The FDA expressed substantial concerns that the results from the LOTIS-5 trial are not supportive of a favorable benefit-risk assessment or verification of clinical benefit.
Current report
Following the publication of topline results from the LOTIS-5, we discussed the results with the FDA. The FDA noted that the increased Grade 5 adverse events in the treatment arm, compared to the control arm, when assessed in the context of a marginal treatment benefit, processes, substantial concerns that the trial results are not supportive of a favorable benefit-risk assessment or verification of clinical benefit. In the event we decide not to submit an sBLA for LOTIS 5 (or a similar supplemental application in foreign jurisdictions) or in the event we submit an sBLA to the FDA for LOTIS-5 (or a similar supplemental application in foreign jurisdictions), the FDA and other regulatory authorities may determine that the data is insufficient for approval in earlier lines of therapy or for full approval in third-line or later setting. As a result, an additional confirmatory trial may be required, which will require significant time and resources and be subject to the same risks as other clinical trials and the timing and results of which are uncertain. While we are currently able to continue to commercialize ZYNLONTA in the third line or later setting under its existing accelerated approval in the United States (and our partners in other jurisdiction are able to commercialize under similar conditional approvals), continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. The LOTIS-5 trial results could lead regulatory authorities to seek withdrawal of current approvals for ZYNLONTA as a monotherapy in 3L+DLBCL. Further, the results of the LOTIS-5 trial and the perception of the benefit-risk profile of the drug could adversely affect sales of the product and affect enrollment and participation in and perception of our other clinical trials involving ZYNLONTA for other indications and likelihood of approval or compendia inclusion for other indications.
Removed paragraphs (1)
Previous report
There have been no material changes to the risk factors previously disclosed in our Annual Report.