Core Insights - Curis, Inc. has received Orphan Drug Designation for emavusertib in the treatment of primary central nervous system lymphoma (PCNSL) from both the FDA and EMA, supporting a potential accelerated approval path [6][8] - The company reported a net loss of $43.4 million for the year ended December 31, 2024, an improvement from a net loss of $47.4 million in 2023 [10] - Curis has initiated a Phase 1 clinical study of emavusertib in combination with venetoclax and azacitidine for frontline acute myeloid leukemia (AML), with positive early results [4][8] Operational Highlights - Emavusertib is being evaluated in multiple studies, including the TakeAim Lymphoma study for relapsed/refractory PCNSL and the TakeAim Leukemia study for relapsed/refractory AML [19] - In the TakeAim Lymphoma study, 9 out of 13 BTKi-experienced patients showed a reduction in tumor burden, with 6 objective responses [6] - The TakeAim Leukemia study reported that 10 out of 19 response-evaluable patients achieved an objective response, including 6 complete responses [6] Financial Performance - For the fourth quarter of 2024, Curis reported a net loss of $9.6 million, compared to a net loss of $11.7 million in the same period of 2023 [10] - Revenues for the year ended December 31, 2024, were $10.9 million, up from $10.0 million in 2023, primarily from royalty revenues related to Erivedge® [11] - Research and development expenses decreased to $38.6 million in 2024 from $39.5 million in 2023, attributed to lower clinical and consulting costs [12] Corporate Developments - Curis has successfully concluded discussions with the FDA and EMA regarding the potential for accelerated approval for emavusertib [6][8] - The company priced a registered direct offering of common stock and concurrent private placement with gross proceeds of approximately $10.0 million, expected to close on March 31, 2025 [7] - As of December 31, 2024, Curis had cash and cash equivalents totaling $20.0 million, which, along with expected proceeds from the March 2025 offerings, is anticipated to fund operations into the fourth quarter of 2025 [15][16]

Core Viewpoint - Curis, Inc. is set to report its fourth quarter 2024 financial and operational results on March 31, 2025, with a conference call scheduled for the same day [1]. Company Overview - Curis, Inc. is a biotechnology company focused on developing emavusertib (CA-4948), an orally available small molecule IRAK4 inhibitor [3]. - Emavusertib is currently being evaluated in multiple clinical studies, including the Phase 1/2 TakeAim Lymphoma study for relapsed/refractory primary central nervous system lymphoma (PCNSL) and the Phase 1/2 TakeAim Leukemia study for relapsed/refractory acute myeloid leukemia (AML) [3]. - The drug has received Orphan Drug Designation from the U.S. FDA for PCNSL, AML, and myelodysplastic syndrome (MDS), as well as from the European Commission for PCNSL [3]. - Curis has an exclusive license to emavusertib through a collaboration with Aurigene established in 2015 [3]. - The company also licensed its rights to Erivedge® to Genentech, which is commercializing the drug for advanced basal cell carcinoma [3].

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.1 million or $1.70 per share for Q3 2024, an improvement from a net loss of $12.2 million or $2.13 per share in Q3 2023 [11] - For the nine months ended September 30, 2024, the net loss was $33.8 million or $5.77 per share, compared to a net loss of $35.7 million or $6.96 per share for the same period in 2023 [11] - Research and development expenses decreased to $9.7 million in Q3 2024 from $10.4 million in Q3 2023, primarily due to lower consulting and employee-related costs [12] - General and administrative expenses were $3.8 million in Q3 2024, down from $4.8 million in Q3 2023, attributed to lower legal and employee-related costs [13] - Cash and cash equivalents totaled $31.6 million post-offering, expected to fund operations into mid-2025 [14] Business Line Data and Key Metrics Changes - The TakeAim Leukemia Study is evaluating emavusertib in combination with ibrutinib for relapsed/refractory PCNSL patients, showing early promising results with 3 complete responses and 1 unconfirmed complete response among 10 evaluable patients [7][8] - In the TakeAim Leukemia Study for relapsed/refractory AML, 6 of 11 evaluable patients achieved an objective response, including 3 complete responses [9] Market Data and Key Metrics Changes - The company is actively engaging with regulatory authorities in the U.S., Europe, and Israel to define the registrational path for emavusertib [8] - The market for primary CNS lymphoma is highlighted as having a critical unmet need, with no approved drugs currently available [18] Company Strategy and Development Direction - The company is prioritizing the development of emavusertib for primary CNS lymphoma due to the promising data and the significant unmet need in this area [34] - There is an ongoing exploration of combining emavusertib with other agents for MDS, with upcoming data expected to inform future strategies [25][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the data from ongoing studies and the potential for accelerated approval pathways with the FDA [18] - The company anticipates maintaining a burn rate of around $10 million in 2025, with variations based on manufacturing timing [20] Other Important Information - Curis completed a registered direct offering and private placement in October 2024, raising approximately $10.8 million [14] - The company is preparing for data presentations at upcoming ASH meetings, which are expected to provide further insights into their studies [10] Q&A Session Summary Question: Alignment with FDA on PCNSL - Management clarified that discussions with the FDA are ongoing and not out of alignment, aiming for an accelerated approval path due to promising early data [16][18] Question: Future Expense Projections - Management indicated that the historical burn rate is expected to stabilize around $10 million for 2025, with some variability [20] Question: MDS Potential and Gene Signatures - Management acknowledged the exciting potential in MDS and the need for further data to understand the broader implications of their findings [25] Question: PCNSL Trial and FDA Concerns - Management confirmed that discussions with the FDA are evolving, and the study design is intended to address potential questions regarding treatment efficacy [28][30] Question: Prioritization of Programs - Management stated that primary CNS lymphoma is currently the highest priority due to the clear unmet need and promising data, while also considering other therapeutic areas [34][35] Question: Data Package for Primary CNS Lymphoma - Management discussed the need for a sufficient safety database and the potential for a smaller study size if accelerated approval is granted [43] Question: Enrollment Challenges in Triplet Study - Management noted that challenges in enrollment are related to identifying suitable patients rather than safety concerns, and they plan to expand sites once safety is established [46]

Core Insights - Curis (CRIS) reported a quarterly loss of $1.70 per share, better than the Zacks Consensus Estimate of a loss of $1.88, and an improvement from a loss of $2.13 per share a year ago, resulting in an earnings surprise of 9.57% [1] - The company generated revenues of $2.93 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 3.20%, and showing an increase from $2.83 million in the same quarter last year [2] - Curis shares have declined approximately 69.2% year-to-date, contrasting with the S&P 500's gain of 25.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$1.28 on revenues of $2.69 million, and for the current fiscal year, it is -$6.79 on revenues of $8.44 million [7] - The estimate revisions trend for Curis is mixed, leading to a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Curis belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Performance - As of September 30, 2024, the company had an accumulated deficit of $1.2 billion and incurred a net loss of $33.8 million for the nine months ended September 30, 2024[90]. - Revenues, net increased by $0.1 million, or 3%, for the three months ended September 30, 2024, compared to the same period in 2023, primarily from royalties on net sales of Erivedge[113]. - Cash used in operating activities increased to $30.3 million for the nine months ended September 30, 2024, compared to $28.2 million for the same period in 2023, reflecting a $2.1 million increase due to timing of payments[127]. - Cash used in financing activities was $5.4 million for the nine months ended September 30, 2024, compared to cash provided of $9.7 million in 2023, mainly due to payments related to the Oberland Purchase Agreement[129]. - As of September 30, 2024, the company had an accumulated deficit of approximately $1.2 billion, indicating significant losses since inception[130]. Cash and Funding - The company has $20.9 million in cash and cash equivalents as of September 30, 2024, and expects to fund operations into mid-2025 with additional proceeds of approximately $10.8 million from recent offerings[90]. - Existing cash and cash equivalents of $20.9 million, along with net proceeds of approximately $10.8 million from the October 2024 offerings, are expected to fund operations into mid-2025[131]. - The company plans to seek additional funding through various avenues, including private or public equity financings and collaborations, to support the development of emavusertib[92]. - The company sold 120,356 and 140,032 shares of common stock under the 2024 Sales Agreement, generating gross proceeds of $0.8 million and $1.0 million during the three and nine months ended September 30, 2024, respectively[121]. - In October 2024, the company entered into a securities purchase agreement to sell 2,398,414 shares of common stock, with net proceeds of approximately $10.8 million expected from the offerings[122]. Research and Development - The company expects to provide additional clinical data from the TakeAim studies in December 2024 and the first quarter of 2025[87]. - Research and development expenses are expected to increase substantially over the next several years due to larger clinical trials and regulatory preparations for emavusertib[104]. - The successful development and commercialization of emavusertib remains highly uncertain due to various risks, including regulatory approval and clinical trial outcomes[105]. - The company may need to delay or reduce its research and development program for emavusertib if sufficient funding is not obtained, which could adversely affect business prospects[132]. - Significant capital will be required to develop and commercialize emavusertib, with expectations of incurring substantial operating losses in the foreseeable future[132]. Operational Changes - The company expects to complete enrollment in the TakeAim Leukemia Phase 1/2 study and has streamlined operations resulting in an approximate 30% reduction in workforce[85]. - The company has entered into a collaboration agreement with Genentech for the commercialization of Erivedge, which is approved for advanced basal cell carcinoma[89]. - The Oberland Purchase Agreement allows for milestone payments of $53.5 million if certain conditions are met, with an estimated Put/Call Price of $41.0 million as of September 30, 2024[96]. - The company faces potential financial obligations due to agreements with collaborators, which could impact future capital requirements[132]. - The company is currently focused on emavusertib, which is in early clinical testing, and must successfully navigate various challenges to achieve profitability[132]. Expenses - Total research and development expenses decreased by $0.7 million, or 6%, for the three months ended September 30, 2024, primarily due to lower consulting and employee-related costs[115]. - General and administrative expenses decreased by $1.0 million, or 21%, for the three months ended September 30, 2024, primarily due to lower legal and employee-related costs[117]. - Other income increased significantly for the three and nine months ended September 30, 2024, primarily due to a decrease in non-cash expenses related to the sale of future royalties[118].

Financial Performance - Curis reported a net loss of $10.1 million or $1.70 per share for Q3 2024, compared to a net loss of $12.2 million or $2.13 per share in Q3 2023, reflecting a 17.9% improvement in loss per share [5]. - Revenues for Q3 2024 were $2.9 million, slightly up from $2.8 million in Q3 2023, with total revenues for the nine months ended September 30, 2024, at $7.6 million compared to $7.3 million in the same period of 2023 [6]. Expenses - Research and development expenses decreased to $9.7 million in Q3 2024 from $10.4 million in Q3 2023, primarily due to lower consulting and employee-related costs [7]. - General and administrative expenses were $3.8 million in Q3 2024, down from $4.8 million in Q3 2023, attributed to reduced legal and employee-related costs [8]. Capital and Funding - Curis completed a registered direct offering and private placement in October 2024, generating net proceeds of approximately $10.8 million [4]. - Curis expects its cash and cash equivalents of $31.6 million will support its operations into mid-2025 [10]. Clinical Development - The company is engaged in discussions with regulatory authorities regarding the registrational path for emavusertib in primary central nervous system lymphoma (PCNSL) [2]. - Preliminary efficacy data for emavusertib showed 3 complete responses and 1 unconfirmed complete response in 10 patients who had progressed on BTK inhibitor treatment, with a duration of response exceeding 6 months for 3 patients [2]. - The company will present additional clinical data at the upcoming ASH annual meeting in December 2024, highlighting its ongoing research efforts [3]. Assets and Liabilities - Total assets decreased to $42.5 million as of September 30, 2024, from $77.3 million at the end of the previous year [17]. - Total liabilities decreased from $57,612 million to $51,208 million, a reduction of approximately 11.5% [18]. - Total stockholders' equity shifted from $19,670 million to a deficit of $8,735 million, indicating a significant decline [18]. - Total liabilities and stockholders' equity combined decreased from $77,282 million to $42,473 million, reflecting a drop of about 45% [18]. - Accounts payable and accrued liabilities slightly decreased from $12,212 million to $11,959 million, a reduction of about 2.1% [18]. - Operating lease liability increased from $2,794 million to $3,260 million, an increase of approximately 16.6% [18]. - Liability related to the sale of future royalties decreased from $42,606 million to $35,989 million, a decline of about 15.7% [18].

Core Viewpoint - Curis, Inc. is making significant progress in its clinical programs, particularly with emavusertib, an IRAK4 inhibitor, showing promising results in combination therapies for various cancers, setting a positive outlook for 2025 [2][3]. Clinical Developments - Emavusertib demonstrated efficacy in a study involving patients with relapsed/refractory primary central nervous system lymphoma (PCNSL), with 3 complete responses and 1 unconfirmed complete response among 10 evaluable patients [3]. - The company plans to present additional clinical data from the TakeAim Leukemia study at the upcoming ASH annual meeting [4][5]. Financial Performance - For Q3 2024, Curis reported a net loss of $10.1 million, or $1.70 per share, an improvement from a net loss of $12.2 million, or $2.13 per share, in Q3 2023 [6]. - Revenues for Q3 2024 were $2.9 million, slightly up from $2.8 million in the same period last year, primarily from royalty revenues [7]. - Research and development expenses decreased to $9.7 million in Q3 2024 from $10.4 million in Q3 2023, attributed to lower consulting and employee-related costs [8]. Cash Position - Following a recent offering, Curis's cash and cash equivalents totaled $31.6 million, which is expected to support operations into mid-2025 [11].

Company Overview - Curis, Inc. is a biotechnology company focused on developing emavusertib (CA-4948), an orally available small molecule IRAK4 inhibitor [3] - Emavusertib is currently in clinical trials, including the Phase 1/2 TakeAim Lymphoma study for relapsed/refractory primary central nervous system lymphoma (PCNSL) and the Phase 1/2 TakeAim Leukemia study for relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (hrMDS) [3] - The drug has received Orphan Drug Designation from the U.S. FDA for treating AML and MDS [3] Upcoming Financial Results - Curis will report its third quarter 2024 financial and operating results on November 14, 2024, at 8:00 a.m. ET [1] - A conference call and webcast will follow at 8:30 a.m. ET on the same day [1][2] Collaboration and Licensing - Curis has an exclusive license to emavusertib through a collaboration with Aurigene established in 2015 [3] - The company has licensed its rights to Erivedge® to Genentech, which is commercializing the drug for advanced basal cell carcinoma [3]

Core Viewpoint - Curis, Inc. has announced a definitive agreement for a registered direct offering and concurrent private placement, aiming to raise approximately $12.1 million to support its research and development efforts [1][2]. Group 1: Offering Details - Curis will sell 2,398,414 shares of common stock at a combined purchase price of $5.045 per share, which includes unregistered warrants for the same number of shares with an exercise price of $4.92 [1][2]. - The offering is expected to close on or about October 30, 2024, pending customary closing conditions [2]. - Truist Securities and Laidlaw & Company (U.K.) Ltd. are acting as placement agents for the offering [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for research, development, working capital, and other general corporate purposes [2]. Group 3: Company Background - Curis is focused on developing emavusertib, an orally available IRAK4 inhibitor, currently in clinical trials for various hematological malignancies [7]. - Emavusertib has received Orphan Drug Designation from the FDA for treating acute myeloid leukemia and myelodysplastic syndromes, as well as from the European Commission for primary central nervous system lymphoma [7].

Symposium hosted by Eric S. Winer, MD, and Grzegorz S. Nowakowski, MD Updated data for 10 evaluable patients in Curis's PCNSL study Experts will present at the virtual meeting, free and open to the public, on September 26, 2024 LEXINGTON, Mass., Sept. 23, 2024 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced the 3rd Annual Symposium on IRAK4 in Cancer taking place virt ...