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]

Financial Condition and Funding - As of December 31, 2024, the company had $20.0 million in cash and cash equivalents and incurred a net loss of $43.4 million for the year[266][269]. - The accumulated deficit of the company reached $1.2 billion as of December 31, 2024, indicating ongoing financial challenges[270]. - The company expects to require substantial additional funding to support the development of emavusertib and its ongoing operations, with a need to raise capital through various avenues[267][273]. - The company has faced significant difficulties in raising capital and may need to delay or reduce its research and development programs if sufficient funds are not available[267][278]. - The company completed a registered direct offering in March 2025, generating net proceeds of approximately $9.0 million, which is expected to fund operations into the fourth quarter of 2025[276]. - The company has entered into a sales agreement to sell up to $100.0 million of its common stock, but the ability to utilize this agreement depends on market conditions[279]. - The company has incurred substantial annual net operating losses since inception and expects to continue incurring significant losses for the foreseeable future[269][271]. - The company has significant financial obligations under its collaboration agreements, which could impact its financial condition and operational capabilities[275][281]. Drug Development and Commercialization - Emavusertib is still in early clinical development, and its commercialization is uncertain, which could materially harm the company's business[293]. - The success of emavusertib is critical for future drug revenues, which are not expected for many years[293]. - Clinical trials for emavusertib may face delays or failures, impacting the drug's development and potential market approval[295]. - The therapeutic efficacy of emavusertib is unproven, and unforeseen side effects could hinder its development and commercialization[297]. - The company has never obtained marketing approval for a drug candidate and may face significant delays or increased costs in obtaining approval for emavusertib[307]. - The company is currently focused on the clinical development program for emavusertib, believing it has the best potential in specific indications, which may lead to the delay or forgoing of other opportunities[313]. - If emavusertib receives marketing approval, it may still fail to achieve sufficient market acceptance, impacting revenue generation and profitability[310]. - The company must build infrastructure for sales, marketing, and distribution or rely on third parties, which may not successfully market or sell the drugs developed[314]. - The company may need to conduct additional clinical trials or studies as required by the FDA, which could delay marketing approval by several years[307]. - The company may face challenges in educating the medical community and third-party payors on the benefits of emavusertib, which could affect market acceptance[313]. Competition and Market Dynamics - The company faces substantial competition from other biotechnology and pharmaceutical companies, which may have greater capital resources and more extensive experience in drug development[322]. - The company is aware of several competitors developing drug candidates targeting the same molecular targets and cancer indications as emavusertib[316]. - The commercial success of drug candidates is heavily dependent on third-party payor coverage and reimbursement practices, which can vary significantly across different payors and regions[325]. - There is significant uncertainty regarding the pricing and reimbursement of newly approved drugs, which may delay commercial launches and negatively impact revenue generation[326]. - The healthcare industry is focused on cost containment, and government authorities may limit coverage and reimbursement for medications, affecting profitability[327]. - Delays in obtaining coverage and reimbursement may occur, and reimbursement rates may not cover the costs associated with research, development, and manufacturing[328]. - Third-party payors are increasingly requiring higher levels of evidence for the benefits of new technologies, which may challenge pricing and reimbursement rates[329]. Regulatory and Compliance Risks - The marketing approval process for emavusertib is expensive, time-consuming, and uncertain, with no current approvals in the U.S. or other jurisdictions[372]. - Regulatory authorities have substantial discretion in the approval process, which could delay or prevent marketing approval of drug candidates[377]. - The FDA may require additional evidence and data before approving a New Drug Application (NDA), potentially necessitating further clinical trials[378]. - The company faces risks related to obtaining marketing authorization in the UK post-Brexit, with new procedures and potential delays[385]. - Changes in foreign regulatory policies, such as the EU pharmaceutical legislation review, could significantly impact the pharmaceutical industry and the company's business[386]. - The company may experience challenges in commercializing emavusertib outside the U.S. due to tariffs, trade barriers, and economic instability in foreign markets[387]. - Non-compliance with regulatory requirements could lead to significant penalties, including withdrawal of marketing approvals and damage to the company's reputation[400]. - The FDA's recent guidance emphasizes the importance of randomized controlled trials for accelerated approval, particularly for oncology drugs[406]. Intellectual Property and Legal Risks - The company faces uncertainties in obtaining and maintaining patent protection for its technologies and drugs, impacting competitive positioning[357]. - Patent litigation risks may arise, potentially leading to significant costs and distractions from core operations[363][365]. - Enforcement of intellectual property rights in China and India may be less effective than in the U.S., posing additional risks to business operations[366][367]. - The company may need to license additional intellectual property to commercialize future drugs, with risks associated with current and future licenses[370]. - The company may seek orphan drug designations for emavusertib but faces uncertainty in obtaining such designations and exclusivity, which may not effectively protect against competition[391]. Privacy and Compliance Regulations - The California Consumer Privacy Act (CCPA) took effect on January 1, 2020, imposing significant requirements on businesses processing personal information of California residents[458]. - The California Privacy Rights Act (CPRA), effective January 1, 2023, expands CCPA provisions and introduces a new enforcement agency, increasing compliance risks[459]. - At least 18 other states have enacted comprehensive privacy laws similar to CCPA and CPRA, impacting business operations and data processing obligations[460]. - GDPR imposes strict obligations on companies regarding the processing of personal data, with potential fines of up to €20 million or 4% of total worldwide annual turnover for non-compliance[462]. - Companies face rising litigation risks related to privacy statutes, particularly concerning the use of web trackers and potential violations of state privacy laws[461]. - Failure to comply with privacy laws could result in significant fines, reputational harm, and operational disruptions[454]. - Companies must implement safeguards to protect the privacy of protected health information as mandated by HIPAA regulations[455].