Aug 13, 2026 earnings call — FDA feedback on pivotal trial and combo progress
Management said LOTIS-5 raised FDA concerns while ending the quarter with $219.1 million cash.
Revenue $0.0B (est $0.0B) · EPS $-0.11 (est $-0.22)
Key quotes
"During this meeting, the FDA noted substantial concerns regarding the benefit risk or verification of clinical benefit observed in the LOTIS-5 trial. As such, the company is now assessing the regulatory path forward."
"Here, we continue to be encouraged by the promising LOTIS-7 data shared to date, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be the best-in-class combination."
"As part of this, we implemented a reduction in our workforce of approximately 17% as well as additional operational efficiencies, resulting in cost savings of approximately $10 million on an annualized basis."
Analyst Q&A 5
ZYNLONTA approval status and Phase III plans
Q (Eric Schmidt · Cantor): Analyst asked if the FDA discussed keeping ZYNLONTA's accelerated approval. He also asked whether the LOTIS-7 ASH data is final and if Phase III plans are being pursued with Roche or alone.
A: Management said FDA comments were only about the combination on the trial, not the single-agent. They said the monotherapy will keep accelerated approval and they will work with the FDA to secure full approval, possibly via LOTIS-5 or another study. They also said they are preparing Phase III design options and plan to file for breakthrough designation this year.
"So we remain confident that the monotherapy will stay on the market." — Ameet Mallik (CEO)
Phase III timing and LOTIS-5 safety window
Q (Guggenheim): Analyst asked for a timeline for a Phase III plan and for timing detail on deaths in LOTIS-5 and the 105-day safety monitoring window.
A: Management said LOTIS-5 is a positive study and they are assessing regulatory options, including data, risk management, or label changes. They said they will file for breakthrough designation for LOTIS-7 and explore Phase III design, but timing and costs are premature while they gather input and talk with FDA. They also said the 105-day safety window is the same in LOTIS-7 and that LOTIS-7 protocols include prophylaxis and vaccinations that LOTIS-5 did not.
"One thing I want to emphasize is that as Mohamed mentioned on the call, there was a big difference between LOTIS-5 and LOTIS-7, particularly with regards to the prophylactic measures taken." — Ameet Mallik (CEO)
Grade 5 infections and compendia impact
Q (Jefferies): Analyst asked what types of Grade 5 infections occurred in LOTIS-5 and whether prophylaxis would have prevented them. He also asked if LOTIS-5 could affect NCCN compendia inclusion or safety requirements for LOTIS-7.
A: Management said the primary infections were bacterial and that prophylaxis could play a role in mitigation. They said LOTIS-7 is a different study with a different regimen and protocol, so they do not expect read-through to LOTIS-7 or to NCCN inclusion. They noted prior disclosure showed a low percent of Grade 5 events, approximately 4% in the reported 49 patients.
"Yes. So the primary type of infections were bacterial, which is why we think that prophylaxis could play a role." — Ameet Mallik (CEO)
FDA feedback and next steps for LOTIS-5
Q (RBC): Analyst asked whether FDA gave any indication of an effective path forward in their feedback and what strategies the company is considering.
A: Management said the pre-sBLA meeting followed usual format where FDA shared concerns about the data and the sBLA package. They said they are reviewing that feedback to see if additional data, risk management options, or label modifications can address the FDA concerns. That review is the basis for deciding the path forward for LOTIS-5.
"And so right now, we're basically going through the feedback and assessing whether additional data risk management options or modification to the potential label can help to address those FDA concerns." — Ameet Mallik (CEO)
sales impact and elderly safety concerns
Q (H.C. Wainwright): Analyst asked if Q2 product revenue rose versus Q2 '25 and whether patient starts, dosing, or prescribing changed after LOTIS-5 disclosure. He also asked if FDA focused on PFS in patients 75+ and whether that would affect eligibility or label.
A: Management said they have not seen any impact on sales and Q2 volume was consistent with prior quarters, as monotherapy use in third-line plus is established. They said they do not expect impact on monotherapy sales and do not think LOTIS-5 will affect other studies or labels; they noted prophylaxis can help older patients and that LOTIS-7 has a different protocol.
"Yes. So with regard to sales, we haven't seen any impact." — Ameet Mallik (CEO)