Good afternoon, everyone, and welcome to Curis' second quarter 2022 earnings conference call. [Operator instructions] At this time, I'd like to turn the conference over to Curis' vice president of investor relations and corporate communications, Craig West. Sir, please go ahead.

Thank you, Jamie, and welcome to Curis' second quarter 2022 earnings call. Before we begin, I would like to encourage everyone to go to the Curis investors section of our website at www.curis.com to find our second quarter 2022 earnings release and related financial tables. I would also like to remind everyone during -- that during the call, we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. For additional details, please see our SEC filings. Joining me on today's call are Jim Dentzer, president and chief executive officer; Bill Steinkrauss, chief financial officer and chief administrative officer; and Bob Martell, head of R&D. We will also be available for a question-and-answer period at the end of the call. I'd now like to turn the call over to Jim. Jim?

Thank you, Craig. Good afternoon, everyone, and welcome to Curis' second quarter earnings call. Every day at Curis, we strive to develop the next generation of first-in-class cancer therapies that meaningfully improve and extend patients' lives. We have several updates for you this quarter. First, as we've noted previously, the path of drug development is seldom a straight line, and the second quarter began with FDA placing a partial clinical hold on our TakeAim studies in leukemia and lymphoma in April. We're having productive discussions with the agency to bring these discussions to a resolution as quickly as possible. Second, we are delighted to announce that we have appointed a new CFO, which I'll talk about more in a minute. Third, the second quarter also saw several positive presentations on emavusertib at ASCO and EHA, both by our internal team at Curis and by several of our partners in academia with whom we are expanding the frontiers of IRAK4 research. These presentations included the first data from the combination arm of the TakeAim lymphoma study, as well as additional data in solid tumors and novel discoveries that are deepening our understanding of IRAK4 biology. In short, we are encouraged that in emavusertib, we have a drug that works as a single agent in exactly the places our research predicted. To start our update tonight, I'd like to welcome Diantha Duvall, who is joining the Curis team as our new CFO. Diantha began her career with PricewaterhouseCoopers and, over the last 20 years, has built an impressive track record of financial leadership at Merck, Biogen, Bioverativ and Genocea. We're delighted to have such a well-respected industry veteran join the team. I'd also like to take this opportunity to thank Bill Steinkrauss. He has been a key leader on the executive team…

Thank you, Jim. Curis continues to execute on its strategy from a place of financial strength. For the second quarter of 2022, Curis reported a net loss of $15.9 million or $0.17 per share on both a basic and diluted basis, as compared to a net loss of $10.8 million or $0.12 per share on both a basic and diluted basis for the same period in 2021. For the six months ended June 30, 2022, we reported a net loss of $32 million or $0.35 per share, as compared to a net loss of $20.8 million or $0.23 per share for the same period in 2021. Revenues for the second quarter of 2022 and 2021 were $2.4 million and $2.3 million, respectively. Revenues for the six months ended June 30, 2022 and June 30, 2021 were $4.5 million. Operating expenses for the second quarter of 2022 were $17.5 million, as compared to $12.9 million for the same period 2021. Operating expenses for the six months ended June 30, 2022 were $34.6 million, as compared to $23.9 million for the same period 2021 and comprised the following: cost of royalty revenues, which comprised amounts due to third-party university patent licensors in connection with Genentech and Roche's Erivedge net sales were less than $0.1 million for the second quarter of 2022, as compared to $0.1 million for the same period in 2021. Positive royalty revenues for the six months ended June 30, 2022 were $0.1 million, as compared to $0.2 million for the same period 2021. Research and development expenses were $12.3 million for the second quarter of 2022, as compared to $8.8 million for the same period in 2021. The increase was primarily attributable to increased consulting services and higher personnel costs as a result of additional headcount. Research and development…

[Operator Instructions]. Our first question today comes from Soumit Roy from Jones Research. Please go ahead with your question.

Would love to get some, if you have any, color on any recent FDA interaction where we were originally thinking with an average of three months turnaround time from the FDA to hear on the clinical hold, if August is still a reasonable time line. Or you think there is any reason to think it could be further delayed?

Thank you, Soumit. Thanks for calling in and for your question. So no, actually, I think our experience in this as we look at AML and the prior companies they put on hold, I think they've put five trials in AML on hold in the last 18 months. It generally takes a quarter or two for them to finish their process, asking their questions and collecting the data. So I think we're on track for that as far as I know. But I'd say, the discussions are going very well. As you may remember, the FDA had questions about the patient who died. They want more data on that, which makes sense. And of course, they've got some questions about dose and Project Optimus. Our hope would be that they get comfortable as we do, that this drug appears to be safe, that it offers a compelling risk-benefit profile in an area of severe unmet need. Most patients in the relapsed/refractory space, as you know, have a median survival of 2.3 months. So I think the FDA, I hope, is going to come out where we are, which is this is a very compelling alternative for clinicians and will release that whole process, but they need to finish their review. So my hope is that they will in due time, and discussions seem to be going well.

Great. My second question is on the low-risk MDS, the investigator on trial. If you can provide us any status on that. Is that trial also on enrollment hold? Or that's still enrolling?

No. So that's not our study, so that one wouldn't be affected by the FDA hold. That's an IST in Germany, run by the 17 sites with Dr. Platzbecker. But we don't have control or visibility into that study as an IST. As you know, that's going into a population which is primarily treated with best supportive care, which is, of course, by definition, not disease modifying. So my hope is that we're going to have a readout from that, and we continue to hope that there would be one by the end of this year. But of course, we have no control over that of where he is in enrollment or what those data look like at this point in time. We're very excited about the outcome. We think it's the potential to put an oral disease-modifying drug into a clearly unmet need space. But as I say, you will know when we know when we hear from Dr. Platzbecker that the team is ready to give an update on their results so far.

Great. Thank you so much for taking my questions.

Of course. Thank you.

[Operator instructions]. Our next question comes from Li Watsek from Cantor Fitzgerald. Please go ahead with your question.

I guess, I just want to follow up on the clinical hold. I just wonder if you can share some color on, I guess, where you are in terms of the alignment with the FDA on some of the key issues like dose selection and perhaps what additional information may be needed. And also curious if you had any discussion around the potential for accelerated approval pathway.

This is Bob Martell. As Jim said, we're in discussions with the agency about this. And so let me sort of step back and give sort of a high-level overview of the situation, maybe a little bit more detail than what Jim provided so far. Obviously, we take safety extremely seriously and are always saddened when a patient passes. And that's the reason why we have looked very closely at this particular case where this patient on the study eventually did pass. Let me give you a little bit of background on this. So this patient came on to study with this therapy, a patient with AML, was managed quite successfully on the study for over eight months. And in the ninth month of treatment, unfortunately, this patient declined fairly rapidly, was admitted to the emergency department and unfortunately died rather quickly. We know that the patient, again, was managed successfully up to the last point. Unfortunately, when patients pass away as such, many things are going on. They're at high risk for sepsis and other complications. And so part of what we wanted to do and what the FDA requested us to provide information on is all the details around that. And so we are in those discussions and providing that level of detail to the agency. And I think, it's also important to put this into context. This is a patient with AML who had previously been treated with a hypomethylating agent. And we know from the literature that the median survival of that patient population is only about two and a half months. It's extremely short. So unfortunately, the natural history for these patients allows them just a couple of months of survival. We note that this particular patient was in the ninth month of treatment. And…

Yeah, great. Thanks for the color. I guess, another question, I guess, is on the dose for the combination with ibrutinib. I guess, do you think you can move forward with 200 mg? Or do you think you need to explore perhaps a lower dose? And can you just share more details around the safety data at 200 mg?

Sure. So this is Jim again. Hi, Li. Yeah, as Bob said, we are very fortunate we're in this position where we've got multiple doses of emavusertib that appear to be both safe and effective. And our hope would be, as the FDA reviews the data, whether it's -- whether we're looking at monotherapy or combo therapy, we're getting really strong responses in every single place we're testing. Monotherapy and combination therapy, AML with spliceosome, MDS with spliceosome, AML with FLT3 and lymphoma in NHL and CLL. So the performance of the drug is clear. I hope that the FDA is going to agree with us that the risk-benefit profile looks really quite attractive and that emavusertib offers a novel way with a novel mechanism to give clinicians and their patients an extra tool that could be very valuable in addressing cancer. Of course, it is an expectation with Project Optimus, as Bob said. The FDA is very interested in learning more about doses. Our hope would be that, as I said, they're going to complete their review, and they'll come to where we are, which is the drug looks to be a really compelling novel alternative. And that what really should happen is that we should be dosing more patients and learning more about those doses and proceeding with the next step in clinical development. But I don't want to get too far ahead of ourselves. As I said, we're having discussions with FDA now, and I hope that they'll come out in that sort of positive place.

Thanks and gentlemen, this concludes our question-and-answer session. I'd like to turn the conference call over to the company's president and chief executive officer, James Dentzer, for any closing remarks.

Thanks, Jamie, and thank you, everyone, for joining today's call. And as always, thank you to our patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment and to our partners at Aurigene, ImmuNext and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator?

The conference has now concluded. We thank you for attending today's presentation. You may now disconnect your lines.