Do your comments about compelling efficacy and safety for LOTIS-7 reflect the final ASH presentation data?

Yes, the abstract for ASH has already been submitted, containing the vast majority of the 100 enrolled patients. The CEO's belief in compelling efficacy and safety is reflective of that ASH abstract. “So the belief that I'm sharing with you about the fact that we think we have very compelling efficacy and safety data is reflective of that ASH abstract.”

Is the exploration of a Phase III pathway for LOTIS-7 being done with Roche or independently?

The CEO declined to comment on specific collaboration with Roche but stated the company has been preparing different design options for a potential Phase III trial for a long time, given the compelling data. They plan to file for breakthrough designation this year and discuss designs with the FDA. “I don't want to comment on that. Obviously, we have a great partnership with Roche, and they've given us great feedback throughout. But what I would say is we've had lots of discussions, but also lots of thought, as you can imagine, even independent of the feedback from the FDA about a potential Phase III design because we know that this data is so compelling that there could be significant upside for the asset by potentially pursuing a Phase III trial.”

Can you provide more detail on the type of Grade 5 infections in LOTIS-5 and whether they would be mitigated by LOTIS-7's prophylaxis strategy?

The primary type of infections observed in LOTIS-5 were bacterial, which the company believes prophylaxis could help mitigate. The LOTIS-7 protocol includes prophylaxis for viral, fungal, and bacterial infections, which was not part of LOTIS-5. “So the primary type of infections were bacterial, which is why we think that prophylaxis could play a role.”

ADCT

ADC Therapeutics (ADCT) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 13, 2026

Source: earnings call transcript

Executive summary

ADC Therapeutics Q2 FY26 — ZYNLONTA Performance and Pipeline Updates

ADC Therapeutics reported consistent commercial performance for ZYNLONTA monotherapy in Q2 FY26, while navigating regulatory uncertainty for its LOTIS-5 trial due to FDA concerns. The company is actively pursuing a breakthrough designation and assessing a Phase III trial for its LOTIS-7 combination, which showed compelling data. A strategic reorganization is expected to yield significant cost savings, supporting a healthy cash runway into 2028.

Highlights

ZYNLONTA net product revenues were $18.6 million in Q2 FY26, broadly in line with recent quarters.
LOTIS-7 completed enrollment of 100 patients at the selected dose level of ZYNLONTA plus glofitamab.
LOTIS-7 data submitted to ASH demonstrates compelling combination data with a safety profile generally consistent with prior disclosures.
Strategic reorganization implemented in June resulted in annualized cost savings of approximately $10 million.
Ended Q2 FY26 with a healthy cash balance of $219.1 million, maintaining cash runway at least into 2028.

Concerns

FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in the LOTIS-5 trial, leading to an assessment of the regulatory path forward.
The second quarter of 2026 included a one-time expense related to the strategic reorganization.

Guidance & targets

Category	Target	Timeline	Confidence
Cash runway	At least into 2028 high materiality	FY28	High
LOTIS-7 Breakthrough Designation submission	Submit for breakthrough designation high materiality	This year · FY26	High
MZL Breakthrough Designation submission	Submit for breakthrough designation medium materiality	Future	High
LOTIS-5 Compendia inclusion	Potential compendia inclusion medium materiality	Starting in 2027 · FY27	Medium
LOTIS-7 Compendia inclusion	Potential compendia inclusion medium materiality	Starting in 2027 · FY27	Medium
Follicular Lymphoma (FL) data presentation	Anticipated in the second quarter of 2027 medium materiality	Q2 · FY27	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
ZYNLONTA Monotherapy (Third-line plus DLBCL) Commercial performance continued to be broadly in line with recent quarters, demonstrating a well-established profile of rapid, deep, and durable efficacy with manageable safety. No impact on sales observed from LOTIS-5 disclosure. Net product revenues: $18.6 millionNet product revenues (Q2 2025): $18.1 millionPatients treated in U.S. since 2021: ~5,000	$18.6M	—	—	—

Risks & headwinds

FDA concerns regarding LOTIS-5 benefit-risk Ongoing

Substantial concerns noted by FDA

Mitigation:Assessing regulatory path forward, including additional data, risk management options, or modifications to potential label.

One-time expense related to strategic reorganization Q2 FY26

Included in Q2 FY26 GAAP net loss

Mitigation:Strategic reorganization implemented to achieve annualized cost savings of approximately $10 million.

What to watch in Q3 FY26

LOTIS-5 regulatory path update

Future update

Current Assessing path forward after FDA concerns

Target Clear regulatory strategy and timing

Why it matters

Determines the future of ZYNLONTA's full approval in second-line DLBCL.

We plan to provide an update on regulatory strategy and timing in the future.

Find out whether ADCT delivers this. Inve re-checks your case every morning.

Q&A highlights

Given the FDA's concerns on LOTIS-5, was there any discussion about maintaining the accelerated approval status for ZYNLONTA monotherapy?

The FDA's discussions and concerns were solely related to the LOTIS-5 trial (ZYNLONTA in combination), not the single-agent ZYNLONTA. The company remains confident in the monotherapy's accelerated approval status and is committed to working with the FDA for full approval.

“So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market. We'll continue to have accelerated approval.”

asked by Eric Schmidt · answered by Ameet Mallik

2 min read 5 chapters

Detailed narrative

ZYNLONTA Commercial Performance

ZYNLONTA's commercial performance in Q2 FY26 remained broadly in line with recent quarters, with net product revenues of $18.6 million. The company remains confident in ZYNLONTA's role as a differentiated single-agent treatment option for third-line plus DLBCL patients. Since its FDA accelerated approval in 2021, ZYNLONTA monotherapy has been used to treat approximately 5,000 patients in the U.S., establishing its profile of rapid, deep, and durable efficacy with manageable safety.

LOTIS-5 Regulatory Path Forward

The Phase III confirmatory study, LOTIS-5, met its primary endpoint of progression-free survival. However, following a pre-sBLA meeting in early August, the FDA expressed substantial concerns regarding the benefit-risk or verification of clinical benefit observed in the trial. ADC Therapeutics is now assessing the regulatory path forward, considering additional data, risk management options, or modifications to the potential label to address FDA concerns.

The full LOTIS-5 data has been submitted for presentation at ASH and is being prepared for publication and compendia submission.

LOTIS-7 Data and Future Potential

Enrollment for the Phase Ib LOTIS-7 trial, combining ZYNLONTA with glofitamab in second-line plus DLBCL patients, was completed with 100 patients at the 150 micrograms per kg dose. The company believes the data demonstrates compelling combination efficacy with a safety profile consistent with prior disclosures, noting the protocol included prophylaxis measures not present in LOTIS-5.

The data has been submitted to ASH, and the company plans to submit for breakthrough designation this year and is assessing a Phase III trial to position ZYNLONTA plus glofitamab as a leading second-line therapy.

Indolent Lymphoma Pipeline Progress

For multicenter investigator-initiated trials of ZYNLONTA in indolent lymphomas, updated marginal zone lymphoma (MZL) data was submitted to ASH, with publication and compendia submission to follow. The company expects to submit for breakthrough designation for MZL. Updated follicular lymphoma (FL) data is anticipated in Q2 2027, also with plans for publication and compendia submission.

Strategic Reorganization and Financial Position

In June, ADC Therapeutics announced a strategic reorganization, including a workforce reduction of approximately 17% and other operational efficiencies. These changes are expected to result in annualized cost savings of approximately $10 million, while maintaining the necessary resources for clinical, regulatory, manufacturing, and commercial activities.

The company ended Q2 FY26 with a cash and cash equivalents balance of $219.1 million, providing an expected cash runway at least into 2028.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.