Mohamed Zaki: Yes. Thank you for the question. Actually, as you know, I came to the company, was it weeks ago with a fresh perspective. And looking at the CAG-1 a novel agent, actually. So, we also have quite an experience with discussion with the agency about Project Optimus, which technically agencies asking exploring multiple doses and schedules. So, we took a decision to post installations and amend the protocol to explore the redosing schedule to maximize the experience for patients with patient utilization to prepare for possible future meeting with the regulators and also to prepare for the most convenient dose ready for the pivotal study. So, as you know also, Project Optimus guide just got published in January 2023, so many companies around the world right now are preparing and adjusting the protocol to accommodate for the requirements — the new requirements, as I say, for regulators to come to them with multiple doses with a number of patients in each dose in each indication.
So, I hope that explains your question.
Naureen Quibria: Yes, it does.
Ameet Mallik: Yes, I think Naureen, that we expect that dose escalation is going to be probably in general, I like their process because you’re going to have to dose-escalation expansion, you’re going to have to expand at multiple doses.
Operator: Our next question comes from Matthew Harrison with Morgan Stanley. Please go ahead.
Unidentified Analyst: This is Chris on for Matthew. Thank you for taking my question. I know someone earlier asked about the potential impact of kind of new treatment paradigms entering the market, specifically for bispecifics. Can you help us think about kind of the near-term impact of that entering the market as they penetrate the 3L plus DLBCL market? Thank you.
Kristen Harrington-Smith: Sure. So, we expect bispecifics to play a role in the third-line setting upon approval. We do think that uptake in the community will take longer. In general, the community is slower to adopt new therapies. And given the risk of CRS and icam with bispecifics, we think initial uptake will be limited to the academic centers. When it comes to competing in that space in the academic centers, we’ve been competing with bispecifics for years now in that setting, given the multiple bispecifics that are being studied in clinical trials.
Unidentified Analyst: Okay. Thank you.
Ameet Mallik: I would just add that the penetration of any agent in the third-line setting is still relatively low. So, there’s clearly room for bispecifics to penetrate, particularly magnetic sensing, and for, continues to grow in both the academic and the community setting.
Unidentified Analyst: Great. Thanks.
Operator: Our next question comes from Boris Peaker with Cowen. Please go ahead.
Unidentified Analyst: Great. This is Nick on for Boris. Thanks for taking my question. I just have a couple for ZYNLONTA and the LOTIS trials. For the LOTIS-5 trial, I know this is a confirmatory trial from the single arm, but can this be used for an SNDA or regulatory submission for DLBCL in both the U.S. and EU? And then also second, for LOTIS-7, which lines of therapy are you guys looking at? And is that different based on which combination approaches or whatnot? Thank you.
Mohamed Zaki: So, regarding LOTIS – 5 you’re absolutely correct. It is a regulatory study for both U.S. and next U.S. It is a confirmatory study with a potential also to get and SNDA for the second line-plus setting. Remember, ZYNLONTA is in the third line-plus setting at a single agent. we are maximizing that and getting into the second line-plus agent with a substantial number of patients in that setting, and the plan is to go worldwide with that approval. Both what — I’m sorry, you want
Unidentified Analyst : Yes. For LOTIS-7.
