Curis, Inc. (NASDAQ:CRIS) Q4 2023 Earnings Call Transcript
Curis, Inc. (NASDAQ:CRIS) Q4 2023 Earnings Call Transcript February 8, 2024
Curis, Inc. misses on earnings expectations. Reported EPS is $-2.03 EPS, expectations were $-1.91. Curis, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good morning, and welcome to Curis' Fourth Quarter 2023 Business Update Call. All participants will be in a listen-only mode. [Operator Instructions] After the company's prepared remarks, all participants will have an opportunity to ask questions. [Operator Instructions] Please note that this event is being recorded. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.
Diantha Duvall: Thank you, and welcome to Curis' fourth quarter 2023 business update call. Before we begin, I would like to encourage everyone to go to our Investors section of our website at www.curis.com to find our fourth quarter 2023 business update release and related financial tables. 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. 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; and Jonathan Zung, Chief Development Officer. We will also be available for a question-and-answer period at the end of our call. I'd like to -- I'd now like to turn the call over to Jim. Jim?
Jim Dentzer: Thank you. Thank you, Diantha. Good morning, everyone, and welcome to Curis' fourth quarter business update call. I'd like to start today's call with a look back over the past 12 months. Entering 2023, the whole biotech industry was struggling in the headwinds of a green financial market. Curis faced all of that and the daunting challenge of seeing our leukemia study stalled on partial clinical hold with the FDA. In the face of that adversity, the Curis team rose to the challenge. We worked tirelessly in answering questions posed by the FDA. This included enrolling additional patients at 200 milligrams BID and performing additional analyses. As a result, we were able to confirm the safety profile of emavusertib, gain alignment on the optimal dosing regimen for monotherapy and secure the removal of the partial clinical hold, a full quarter earlier than expected.
We then redirected our energy to reopening clinical sites and enrolling new patients. In our monotherapy study, we are targeting a genetically-defined population of relapsed/refractory AML patients with a FLT3 or spliceosome mutation. Enrollment is going quite well and we expect to have a data update by midyear. While that study advances, we have initiated a frontline study of emavusertib in combination with azacitidine and venetoclax for all AML patients regardless of their mutation status. This study is being conducted at sites in Spain, Germany and Italy, and we expect preliminary data from this study in the second half of this year. All in all, a terrific year of progress in leukemia. Now let's turn into our lymphoma program, which is generating an equally high level of interest.
After reviewing initial data collected across multiple NHL subtypes, we focused our efforts on the ultra-orphan indication of primary CNS lymphoma, or PCNSL, where we are evaluating emavusertib in combination with ibrutinib. We identified key sites, initiated enrollment. And in December, we released new clinical data in relapsed refractory PCNSL at the ASH conference in San Diego. The meetings we had with physicians at ASH were terrific, and we were especially pleased to have Dr. Greg Nowakowski, and Dr. Han Tun from the Mayo Clinic present the data. As a reminder, frontline treatment in PCNSL is high-dose methotrexate and chemo. When that no longer works, there is no approved second-line treatment. In our study, three of five patients were able to achieve complete remission of their disease.
It is admittedly a small number of patients. However, the response and interest from the clinical community was very encouraging. In the eight weeks since ASH, our team has been fielding calls from clinical sites across the US and Europe wanting to participate in our trials. In fact, by the end of Q1, we expect to have doubled the number of clinical sites versus where we were a year ago. Obviously, this is a reflection of the excitement about emavusertib, but it is also a reflection of the indefatigable efforts of the Curis team. I couldn't be more proud of them. Finally, in December, we announced that we entered into an agreement for an investigator-initiated trial to study the combination of emavusertib and pembrolizumab in patients with metastatic melanoma.
We're excited that this study presents an opportunity to expand upon the research done at academic centers and the NCI to explore the potential of emavusertib in solid tumors. In short, we had an incredibly productive 2023, and we look forward to continuing that momentum in 2024. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?
Diantha Duvall: Thank you, Jim. For the fourth quarter of 2023, Curis reported a net loss of $11.7 million or $2.03 per share as compared to a net loss of $11.3 million or $2.35 per share for the same period in 2022. Curis reported a net loss of $47.4 million or $8.96 per share for the 12 months ended December 31, 2023 as compared to a net loss of $56.7 million or $12.14 per share for the same period in 2022. Revenues net for the fourth quarter of 2023 were $2.7 million compared to $2.9 million for the same period in 2022. Revenues net for the 12 months ended December 31, 2023, were $10 million compared to $10.2 million in 2022. Research and development expenses were $10 million for the fourth quarter of 2023 compared to $8.7 million in 2022.
The increase in R&D was driven by higher clinical development costs. R&D was $39.5 million for the 12 months ended December 31, 2023, compared to $43 million in 2022. General and administrative expenses were $4.9 million for the fourth quarter of 2023 compared to $4.3 million in 2022. The increase in G&A was driven primarily by higher professional, legal and consulting services. G&A was $18.6 million for the 12 months ended December 31, 2023 compared to $19.6 million in 2022. Other income net was $0.5 million for the fourth quarter of 2023 compared to other expense net of $1.1 million in 2022. Other income net was $0.9 million for the 12 months ended December 31, 2023 compared to other expense net of $3.7 million in 2022. Other income expense net consists of interest income and non-cash expense related to the sale of future royalties.
As of December 31, 2023, Curis' cash, cash equivalents and investments totaled $56.3 million, and there were approximately 5.9 million shares of common stock outstanding. We continue to be in a solid cash position and expect that our existing cash, cash equivalents and investments will enable our planned operations into 2025. With that, I'd like to open the call for questions. Operator?
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