Core Viewpoint - Curis, Inc. is set to report its second quarter 2025 financial and operational results on August 5, 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 TakeAim Lymphoma Phase 1/2 study for patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and the TakeAim Leukemia Phase 1/2 study for patients with relapsed/refractory acute myeloid leukemia (AML) [3]. - The drug has received Orphan Drug Designation from the U.S. FDA for the treatment of PCNSL, AML, and myelodysplastic syndrome (MDS) [3]. - Curis holds exclusive licensing rights 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 $7.0 million to support its research and development efforts [1][2]. Group 1: Offering Details - Curis will issue 1,538,460 shares of common stock at a market price, along with unregistered pre-funded warrants and common warrants [1]. - The pre-funded warrants will allow investors to purchase an additional 1,538,461 shares at an exercise price of $0.01, while common warrants will allow for the purchase of 3,076,921 shares at an exercise price of $2.15 [1]. - The combined purchase price for one share and the associated common warrant is $2.275, and for one pre-funded warrant and the associated common warrant is $2.265 [1]. 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: Closing and Agents - The registered direct offering and concurrent private placement are expected to close on or about July 3, 2025, pending customary closing conditions [2]. - Laidlaw & Company (U.K.) Ltd. and Jones are acting as placement agents for the offerings [3]. Group 4: Regulatory Information - The shares are being offered under a shelf registration statement filed with the SEC, and a prospectus supplement will be available on the SEC's website [4]. - The unregistered warrants are being offered under an exemption from registration requirements, and Curis will file a resale registration statement with the SEC for the underlying shares [5]. Group 5: Company Overview - Curis is focused on developing emavusertib, an orally available IRAK4 inhibitor, currently in various clinical studies for treating relapsed/refractory cancers [7][8]. - Emavusertib has received Orphan Drug Designation from the FDA for multiple cancer treatments [8].

Company Performance - Curis reported a quarterly loss of $1.25 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.14, but an improvement from a loss of $2.05 per share a year ago, indicating a surprise of -9.65% [1] - The company posted revenues of $2.38 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 11.74% and showing an increase from $2.09 million in the same quarter last year [2] - Curis has surpassed consensus EPS estimates two times over the last four quarters and has topped consensus revenue estimates four times during the same period [2] Stock Outlook - Curis shares have declined approximately 19.9% since the beginning of the year, contrasting with the S&P 500's decline of -3.9% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the upcoming quarter is -$0.76 on revenues of $2.6 million, and for the current fiscal year, it is -$2.72 on revenues of $11.13 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Curis belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook for stocks in this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with expectations to fund operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma (PCNSL), with 27 patients treated as of the latest data cutoff [8] - Among 20 BTKi experienced patients, 9 showed a reduction in tumor burden, including 6 objective responses, while 5 out of 7 BTKi naive patients also demonstrated a reduction [8] - In the AML segment, a 38% composite complete response (CR) rate was reported in a study involving patients with FLT3 mutations, showcasing the potential of emavucertib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across major centers in the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while simultaneously advancing its AML studies, with a focus on safety and tolerability in frontline AML [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting 6 to 8 responses in that dataset [9] - The addition of Dr. Ahmed Hamdy to the executive team is expected to enhance the company's strategic direction in both lymphoma and AML [4][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement despite industry turmoil [28] - The company is optimistic about the potential of emavucertib, particularly in combination therapies, and is focused on maximizing its utility across various indications [37] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the upcoming ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management confirmed that resources are primarily dedicated to the PCNSL study while also advancing AML studies, with a focus on safety and initial patient enrollment [18][22] Question: Enrollment and FDA discussions - Management stated that they are on track with enrollment and have no concerns regarding their agreement with the FDA, appreciating the timing of their collaboration [28] Question: Mutations affecting responses and EMA development steps - Management indicated it is too early to discuss specific mutations impacting responses, emphasizing the mechanism of action instead [34] - Future plans for AML development will be discussed after completing the ongoing triplet study [36]

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with the company expecting this to support operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is progressing, evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma [7] - As of January 2, 2025, 27 patients have been treated with the emavucertib and ibrutinib combination, showing promising results in tumor burden reduction [8] - In AML, a 38% composite complete response rate was observed in a study of 21 patients with FLT3 mutations treated with emavucertib, which is significantly higher than the 21% rate for gilteritinib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while also advancing its AML studies, with a focus on safety and tolerability in the frontline setting [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting six to eight responses in that dataset [9] - The addition of Dr. Ahmad Hamdi to the executive team is expected to enhance the company's strategic direction in expanding treatment options [4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement [28] - The company is optimistic about the potential of emavucertib in combination therapies and is focused on maximizing its utility across various indications [36] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management is advancing both lymphoma and AML studies simultaneously, with more resources allocated to the PCNSL study due to its advanced stage [18] Question: Enrollment in lymphoma study and FDA conversations - Enrollment is on track with 37 sites open, and management is confident in their collaboration with the FDA [25][28] Question: Mutations affecting responses and AML development steps - It is too early to discuss specific mutations affecting responses; the focus is on the mechanism of action [33] - Future plans for AML development will be discussed after completing the ongoing triplet study [35]

Financial Position - Curis, Inc. reported an accumulated deficit of $1.3 billion as of March 31, 2025, with a net loss of $10.6 million for the three months ended March 31, 2025[109]. - The company has $20.3 million in cash and cash equivalents as of March 31, 2025, which is expected to fund operations into the fourth quarter of 2025[110]. - Cash used in operating activities decreased by $6.0 million to $7.3 million for the three months ended March 31, 2025, compared to $13.2 million in the same period in 2024[142]. - Cash provided by financing activities was $7.5 million for the three months ended March 31, 2025, primarily due to proceeds from the March 2025 Offerings[144]. - Cash and cash equivalents as of March 31, 2025, were $20.3 million, excluding restricted cash[133]. - The company has an accumulated deficit of approximately $1.3 billion as of March 31, 2025[145]. - The Put/Call Price related to the Oberland Purchase Agreement was approximately $108.2 million as of March 31, 2025[141]. - The company may face substantial difficulty in raising capital, which could adversely affect its business prospects and financial condition[147]. - The ability to raise additional funds will depend on financial, economic, and market conditions, many of which are outside the company's control[147]. - The company’s failure to achieve profitability could depress the market price of its common stock and impair its ability to raise capital[149]. Research and Development - Emavusertib (CA-4948) is being evaluated in multiple Phase 1/2 studies, including the TakeAim Lymphoma and TakeAim Leukemia studies, with preliminary clinical data provided in December 2023[103][104]. - Emavusertib has received Orphan Drug Designation from the FDA for the treatment of PCNSL, AML, and MDS, and from the European Commission for PCNSL[101]. - Research and development expenses primarily consist of costs incurred to develop emavusertib, including clinical trial costs and personnel expenses[115][117]. - The ongoing clinical trials for emavusertib are critical for the company's future operating results and depend on favorable data generation[112]. - The company expects substantial increases in research and development expenses as it advances emavusertib and other drug candidates[129]. - The company anticipates incurring substantial operating losses while developing and commercializing emavusertib[149]. - Future capital requirements may be affected by unanticipated costs in research and development, regulatory approvals, and commercialization activities[150]. - If sufficient funding is not obtained, the company may need to delay or eliminate its research and development programs[147]. Revenue and Expenses - Revenues increased by $0.3 million, or 14%, to $2.38 million for the three months ended March 31, 2025, compared to $2.08 million in the same period in 2024[125]. - Research and development expenses decreased by $1.1 million, or 11%, to $8.54 million for the three months ended March 31, 2025, primarily due to lower employee-related costs[128]. - General and administrative expenses decreased by $0.9 million, or 19%, to $3.98 million for the three months ended March 31, 2025, mainly due to reductions in employee-related and professional costs[130]. - Net loss for the three months ended March 31, 2025, was $10.62 million, a decrease of 11% from a net loss of $11.88 million in the same period in 2024[125]. - The company does not expect to generate revenues from direct product sales for several years, relying instead on royalty payments from Genentech's sales of Erivedge[114]. Strategic Partnerships and Collaborations - The company has entered into a collaboration agreement with Genentech for the commercialization of Erivedge, which is approved for advanced basal cell carcinoma[107]. - Curis Royalty received proceeds of $65.0 million from the Oberland Purchase Agreement, which involves the sale of future royalty rights[113]. - The company may explore strategic alternatives, including partnerships or asset divestitures, but there is no assurance of success[147].

Financial Performance - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share in Q1 2024[8]. - Revenues for Q1 2025 were $2.4 million, an increase from $2.1 million in Q1 2024, primarily from royalty revenues from Genentech/Roche's sales of Erivedge®[8]. - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, mainly due to lower employee-related costs[9]. - General and administrative expenses also decreased to $4.0 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related and consulting costs[9]. - Curis has approximately $20.3 million in cash and cash equivalents as of March 31, 2025, which is expected to support operations into Q4 2025[11]. - Curis completed a registered direct offering and private placement with net proceeds of approximately $8.8 million[7]. Clinical Development - The company is currently enrolling patients in the TakeAim Lymphoma study to enable accelerated approval filings for emavusertib in both the EU and US[3]. - Emavusertib has received Orphan Drug Designation for PCNSL in both the U.S. and Europe[5]. - The TakeAim Lymphoma study has provided data updates for 27 patients, including 20 BTK-experienced and 7 BTK-naïve patients[5]. - Curis aims to expand emavusertib's application beyond PCNSL into additional indications in NHL, AML, and solid tumors[4].

Core Insights - Curis, Inc. has appointed Dr. Ahmed Hamdy as Chief Medical Officer, enhancing its executive team with his extensive industry experience [2][3] - The company is making significant progress towards accelerated approval of its drug emavusertib for relapsed/refractory primary central nervous system lymphoma (PCNSL) in both the U.S. and Europe [2][8] - Curis reported a net loss of $10.6 million for Q1 2025, a slight improvement from a net loss of $11.9 million in Q1 2024, with revenues increasing to $2.4 million from $2.1 million year-over-year [7][18] Management and Strategy - Dr. Hamdy's appointment is expected to contribute positively to Curis's strategic direction, particularly in advancing emavusertib through regulatory processes [2][3] - The company is currently enrolling patients in the TakeAim Lymphoma study to support accelerated approval filings [2][8] Operational Highlights - Curis has successfully completed the first dosing cohort in the Ema-Ven-Aza triplet study for frontline acute myeloid leukemia (AML) and is now commencing the second cohort [5] - The ongoing TakeAim Lymphoma study has received Orphan Drug Designation for emavusertib in both the U.S. and Europe [8] Financial Performance - For Q1 2025, Curis reported revenues of $2.4 million, primarily from royalty revenues related to Erivedge® [7][18] - Research and development expenses decreased to $8.5 million from $9.6 million in Q1 2024, while general and administrative expenses also saw a decline [9][18] - As of March 31, 2025, Curis had cash and cash equivalents totaling $20.3 million, which is expected to support operations into Q4 2025 [11]

Company Overview - Curis, Inc. is a biotechnology company focused on the development of 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 patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and the Phase 1/2 TakeAim Leukemia study for patients with relapsed/refractory acute myeloid leukemia (AML) [3] - The drug has received Orphan Drug Designation from the U.S. FDA for the treatment of PCNSL, AML, and MDS, as well as from the European Commission for PCNSL [3] Upcoming Financial Results - Curis will report its first quarter 2025 financial and operating results on May 6, 2025, at 8:00 a.m. ET [1] - Management will host a conference call and simultaneous webcast on the same day at 8:30 a.m. ET [1][2] Collaboration and Licensing - Curis has an exclusive license to emavusertib through a collaboration with Aurigene established in 2015 [3] - The company licensed its rights to Erivedge® to Genentech, a member of the Roche Group, for the treatment of advanced basal cell carcinoma [3]

Core Insights - Curis, Inc. is focused on the development of emavusertib, an orally available small molecule IRAK4 inhibitor [2] - The company will participate in the Jones Healthcare and Technology Innovation Conference on April 9, 2025, featuring a fireside chat and company presentation [1] Company Overview - 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) [2] - The drug has received Orphan Drug Designation from the U.S. FDA for PCNSL, AML, and myelodysplastic syndrome (MDS) [2] - Curis has an exclusive license to emavusertib through a collaboration with Aurigene and has licensed its rights to Erivedge® to Genentech for commercialization [2]