Q1 2025 Curis Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the Curis provides first quarter 2025 Business Update Conference Call.
At this time, all lines are in listen only mode.
Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, May 6th, 2025.
Speaker Change: I would now like to turn the call of Prince over to Diantha Duvall. Please go ahead.
Speaker Change: to find our first quarter 2025 business update press release and related financial tables.
Speaker Change: I would also like to remind everyone that during the call we will be making forward looking statements which are based on our current expectations and beliefs.
Speaker Change: Joining me today, joining me on today's call, our Jim Dentzer, President and Chief Executive Officer, Jonathan Zung, Chief Development Officer, and Dr. Ahmed Hamdi joining us today as our new Chief Medical Officer.
Speaker Change: You 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. Thanks, Dan Thub. Good morning, everyone, and welcome to Curis' first quarter business update call.
Speaker Change: I'd like to start this quarter's call by welcoming Dr. Oman Hamdi to the Curis executive team.
Speaker Change: Dr. Hamby is a well-known and respected leader in the industry and brings a wealth of experience as the CMO of Pharmacyclics
Founder and CMO of Assurda [inaudible]
and Founder and CEO of ThinsRx, Ockman Welcom.
Achmed: Thank you, Jim. It's a great pleasure to be here. I'm excited to join the Curis team at this very critical time to advance EMAVU to assert it towards regulatory filings in primary CNS lymphoma in both US and Europe .
Achmed: I'll also look forward to expand its use beyond primary CNS into additional indications like NHL, AML, and Solid Tumors.
Achmed: Given my experience in both Ibrutinib, I have a special appreciation for the potential of email assertive in combination with BGK and Abyssin in NHL.
Achmed: I look forward to working with the team here at Curis to bring novel therapies to patients.
Thanks, Robert.
Achmed: In addition to strengthening our leadership team with Dr. Hamdi, we continue to make steady progress in our take aim lymphoma study, which is evaluating MOVOSERTIB in combination with the Brutinib in PCNSL patients.
as a reminder.
Achmed: The take aim lymphoma study is a single arm study, with an OR endpoint.
in patients with PCNSL who have progressed on VTKI treatment.
Achmed: And after collaborative discussions with FDA and EMA over the last year, we expect the study to support accelerated submissions in both the US and Europe .
Achmed: As of January 2, 2025, the most recent data cutoff date.
Achmed: 27 patients with relapsed refractory PCNSL have been treated with the M.O. who served it and the Brutonib combination.
including seven BTKI naive patients.
and 20 BTKI-experienced patients.
Achmed: Among 13 of the 20 BTKI experienced patients for whom change in tumor burden data were available.
Achmed: 9 patients demonstrated a reduction in tumor burden, including 6 subjective responses, 2 partial responses and 4 complete responses.
Achmed: With three of the four CRs lasting more than six months and one patient who has been in complete remission for almost two years and is still on study.
among six of seven BTKI naive patients.
for whom change in tumor burden data were available.
Achmed: 5 patients demonstrated a reduction in tumor burden, including 5 objective responses, 4 partial responses and one complete response.
Achmed: We expect to have additional data from the take aim lymphoma study at ash later this year.
In addition, over the next 12 to 18 months,
Achmed: We'll be focused on enrolling 30 to 40 additional patients we'll need for the NDA's submission.
Achmed: and we'd like to see six to eight responses in that data set.
Now let's turn to AML.
As you recall, at the Ash Conference in December
Achmed: Dr. Eric Weiner from Dana Farber presented data for 21 patients with a flip-3 mutation who had received fewer than three lines of prior therapy and were treated with M of assertive as monotherapy at the RP2D of 300 milligrams BID.
Achmed: These data show a 38% composite CR rate in the salvage line setting.
with 10 objective responses in 19 response valuable patients.
Achmed: and seven of the ten responses reported at the first assessment.
to put these data into context.
was approved with a composite CR rate of 21%.
Achmed: In a patient population where only 13% of patients had been previously treated with a
Achmed: In the M of Usertib study, over 80% of the patients had been previously treated with a flip three inhibitor.
Achmed: We believe the reason the M.O. research of data are so compelling.
Achmed: is its novel mechanism of action. It blocks both Ira Q4 and Slit 3.
Achmed: For several years, it has been suggested in the literature that blocking Ira Q4 can enable patients to overcome adaptive resistance to flip 3 inhibition.
These clinical data clearly support that thesis.
Achmed: Finally, I'd like to provide an update on our progress with the triplet study in front line AML.
Achmed: As a reminder, we initiated a Phase I study last year of M.A.V. assertive as an add-on agent to Vanetta-Clacks and the East Side of Dean in Frontline AML.
Achmed: This study is assessing safety and tolerability, where M. of a is added to a patient's venase of regimen in 7, 14 and 21 day dosing regimens.
Achmed: After they have achieved a CR and Venesa, but are still positive for minimal residual disease.
Achmed: We have successfully completed the 7-day dosing cohort and enrollment of the 14-day cohort is currently ongoing.
Thank you.
Achmed: With that, I'll turn the call back to Diantha for the financial update.
Diantha Duvall: Thank you, Jim. Curis reported a net loss of $10.6 million or $1.25 per share for the first quarter of 2025 compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024.
Diantha Duvall: Research and Development expenses were 8.5 million for the first quarter of 2025, as compared to 9.6 million for the same period in 2024. The decrease was primarily attributable to the lower employee-related costs.
Diantha Duvall: General and administrative expenses were 4.0 million for the first quarter of 2025, as compared to 4.9 million for the same period in 2024. The decrease was primarily attributable to lower employ related costs, professional, legal, and consulting costs.
Diantha Duvall: In March, we've completed a registered direct financing and concurrent private placement with net proceeds of approximately 8.8 million.
Diantha Duvall: Curis's cash and cash equivalence totaled 20.3 million as of March 31st, 2025, and the company had approximately 10.5 million shares of common stock outstanding.
Diantha Duvall: Curis expects its existing cash and cash equivalents will enable its planned operations into the fourth quarter of 2025. With that, I'd like to open the call-up for questions.
Operator.
Diantha Duvall: Should you wish to remove your hand from the question and answer process, please press star followed by two. If you're using a speaker phone, please lift the handset before pressing any keys. One moment for your first question.
Speaker Change: And your first question comes from Lee Watst with Cantor. Please go ahead.
Speaker Change: Good day. Good morning, guys. I wanted to welcome Dr. Henry to the team.
Speaker Change: You might need a large studying phone like M.L. I guess the question is...
Speaker Change: Number one, how much data do you want to generate in a frontline EML to either move forward or maybe pause and focus on the link's format opportunity?
Speaker Change: And the sad can is what are the things you are doing or could be doing to potentially accelerate the enrollment of the lymphoma study.
Speaker Change: Thank you, Leeds. Jim, so let me address this briefly lymphoma versus AML, and now I'll ask Dr. Zung to talk about things we're doing on enrollment.
Speaker Change: In the foam of versus AML, we are moving ahead with both simultaneously.
Speaker Change: On the AML side, the spend is a little lighter because it's earlier stage, but we're focused on our frontline study getting through that safety study.
Speaker Change: So we're trying to evaluate, as you know, M of assertive in combination with Venezuela in the frontline setting.
Speaker Change: And while we think that has a long term, very strong potential, in the short term, our focus is really just enrolling a small number of patients to clear those initial regimens for safety. So it's a relatively small use of our resources.
Speaker Change: But it's absolutely just as strong a focus for us as the primary CNS lymphoma site.
Speaker Change: I would that maybe Jonathan, if you'd like to chime in on the enrollment? Sure. In terms of the enrollment in the lymphoma program, we've got 37 sites that are currently open. We're at the major centers of excellence in the US, Europe , and Israel where the patients are seen and treated. We have regular site engagement outreaches.
Speaker Change: with the investigators and the coordinators. So we're doing everything that's normally done on a clinical trial to sort of drive engagement to result in enrollment.
Speaker Change: Bob Goodmouringly, the SOHMED. Obviously, there's quite a bit of thinking that's going on right now as far as the NHL indications and AML. So, there's more discussions that could be coming down the road on...
Speaker Change: How do we prioritize and when do we prioritize, obviously we'll keep everybody posted.
Speaker Change: Yeah, and as you can imagine, Li, obviously, we're all thrilled to get Dr. Handy here on board as part of the team.
Speaker Change: and as we not just push ahead aggressively towards PCNSL but look to expand across NHL and AML to make the most of this drug wherever it provides utility. Obviously we're very eager to
Speaker Change: for the team and really look forward to our progress. Thank you.
Thank you guys.
Thank you. Thank you. Thank you.
Speaker Change: Thank you. Your next question comes from Crepa Devarakanda with Truist. Please go ahead.
Kripa Devarakonda: Hey guys, thank you so much for taking my question and congratulations on bringing Dr. a handy aboard.
Kripa Devarakonda: So, a couple of questions. One for the lymphoma. You noted you have 37 sites open. I think previously you'd mentioned 30, just wondering if this is the final or you're planning to add more sites and are you still on track to complete enrollment in the time frame that you mentioned, I think last time you said 12 to 18 months.
Kripa Devarakonda: And have you had any additional conversations with the FDA? Just given all the changes of the FDA, just was wondering if there's any concern that the agreement that you came to with the FDA will continue to be respected with all the changes that are happening. Thank you.
Kripa Devarakonda: So Jim, this is Jonathan. So on the enrollment side, there are no real changes there. We're constantly looking at the sites that we have opened. We opened, as we had mentioned in previous calls, additional sites last year. So that's where we are.
Speaker Change: on the FDA side, Krippa. I don't think we have any concerns at all that there will be a change. I think we are grateful to be blunt.
Speaker Change: that we were able to get to the FDA to get the collaboration that we needed last quarter before this current turmoil started. I worry about the industry and about companies who have to reach out to gain some more effort from the FDA in this climate.
Speaker Change: but I think for Curis's perspective, we were very fortunate in our timing. We're grateful to have their support and we're pushing ahead. So yeah, we share your concern for the industry as a whole, but I think from Curis's perspective, we're pleased about where we are.
Great. Thank you so much for the call.
Speaker Change: Your next question comes from Soumit Roy with Jones Research, please go ahead.
Speaker Change: Hi. Thank you for taking my question. This is Danya for Soumit Roy. I have a question about your ASCO presentation. Can you give any color and what type of mutations might affect responses?
Speaker Change: And I have another question for the AML. Are there any updates on potential developing in steps for AMA in the relapse or factory AML? Thank you.
Speaker Change: Yeah, so when I take the first one and then actually I'll ask Jonathan to chime in on the second one so on the first one I think it's a little too early to talk about mutations and their impact. I think the primary impact that we see
Jonathan Zung: with M of assertive, is really driven by the mechanism of action more broadly.
Speaker Change: So, as we know, the way to treat NHL is to down-regulate the overactivity of M&F Gapabee.
Jonathan Zung: Historically, at least for the last ten years, paid by pharmaceuticals.
Jonathan Zung: The way to do that is with the BTK inhibitor, it blocks the BCR pathway, which is one of the two pathways that drives that of Kappa V.
We have the only drug that blocks the other pathway.
The TLR Pathway
Jonathan Zung: in our thesis, which panned out in the lab, and we now see in the clinical data it's panning out as well.
Is that when you block both pathways?
that are driving NF Kappa B.
Jonathan Zung: You can maximize the down-regulation of NF-capability activity and that's what's driving the benefit to patients. So it's less about any particular genetic mutation and it's more about blocking the fundamental drivers of that oncologic activity.
Jonathan Zung: Jonathan, maybe if you could chime in on the second run on the end of the AML development side. Obviously, once we complete the ongoing triplet study, the safety study, along with the data that we've presented Eric Winer.
Jonathan Zung: Dana Farber presented, we'll come back and talk about what forward plans are on the AML side whether it's front line, relapse refractory and or both. And I would close also in saying one of the
Jonathan Zung: One of the things that should be very clear to everyone on the call is certainly very clear to us on the team is one of the biggest advantages of having Dr. Handy join the team. Is now that we've got a solid path on primary CNS lymphoma?
We're looking to expand across NHL.
Jonathan Zung: to everywhere where BTK inhibitors provide benefit because the BTK inhibitor provides benefit in an NHL indication.
Whether it's PCNSL.
Speaker Change: CLL, Waldenstroms, any of the indications where a BTK inhibitor gets used?
Speaker Change: That's going to be an opportunity where blocking the second pathway could provide benefit. It's exactly what we see in our first indications. It's exactly what we saw in the lab. And it's precisely why we've asked Dr. Hamdi to come on board. So I look forward to reporting out that progress.
Okay, thank you.
Speaker Change: Thank you so much. As a reminder, if you would like to ask a question, please press star one.
[inaudible]
Speaker Change: And at this time, there are no further questions. I would now like to pass the call over to Jim Dentzer for closing remarks.
Jim Dentzer: Thank you, operator, and thank you everyone for joining today's call. And as always,
Speaker Change: Thank you to the patients and families participating in our clinical trials.
Speaker Change: to our team at Curis for their hard work and commitment and to our partners at Origin, the NCI and the academic community.
for their ongoing collaboration and support.
We look forward to updating you again soon. Operator?
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you so much for your participation. You may now disconnect.