Financial Data and Key Metrics Changes - Curis reported a net loss of $9.6 million or $1.25 per share for Q4 2024, compared to a net loss of $117 million or $2.03 per share for the same period in 2023 [19] - For the full year 2024, the net loss was $43.4 million or $6.88 per share, compared to a net loss of $47.4 million or $8.96 per share in 2023 [19] - Research and development expenses were $9 million for Q4 2024, down from $10 million in Q4 2023, primarily due to lower clinical and research costs [19][20] - General and administrative expenses decreased to $3.4 million in Q4 2024 from $4.9 million in Q4 2023, attributed to lower legal and consulting costs [20][21] Business Line Data and Key Metrics Changes - In the NHL segment, the TakeAim Lymphoma study is evaluating emavusertib in combination with ibrutinib, with positive feedback from EMA and FDA regarding potential accelerated approval pathways [6][12] - The study has 30 clinical sites open for enrollment, aiming to complete enrollment in the next 12 to 18 months [8][12] - In the AML segment, emavusertib showed a 38% composite CR rate in a study involving patients with FLT3 mutations, indicating strong efficacy compared to existing treatments [14][15] Market Data and Key Metrics Changes - The company has received Orphan Drug Designation for emavusertib in primary CNS lymphoma in both the U.S. and Europe, enhancing its market position [12] - The discussions with regulatory agencies indicate a favorable environment for potential approvals, as there are currently no approved treatments for primary CNS lymphoma [43] Company Strategy and Development Direction - The company is focused on accelerating the development timeline for emavusertib, with plans to enroll additional patients to support filings for accelerated approval [8][12] - There is an ongoing strategy to explore partnerships with major players in the NHL and AML spaces, indicating a proactive approach to enhance its market presence [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical data and the clarity received from regulatory agencies, which supports the company's development plans [12][42] - The company anticipates maintaining a cash runway into Q4 2025, with a quarterly burn rate of approximately $10 million [26][22] Other Important Information - The company completed a registered direct offering and private placement with net proceeds of approximately $10.8 million, extending its financial runway [21] - The company is currently conducting a Phase 1 study of emavusertib in combination with venetoclax and azacitidine for frontline AML, with ongoing enrollment [16][52] Q&A Session Summary Question: Can you talk about cash runway and expenses going forward? - Management confirmed a quarterly burn rate of about $10 million, extending the cash runway to Q4 2025 due to recent offerings [26] Question: Any potential inbound interest from partners? - Management indicated ongoing discussions with potential partners, given the promising data in NHL and AML [28] Question: How many patients have been dosed with emavusertib? - A total of 13 patients have been dosed at 100 mg BID in the study [35] Question: What does the EMA expect in terms of response rates? - Management noted that both agencies are supportive and expect compelling data, with a response rate above 25% being favorable [43] Question: How should we think about TakeAim Leukemia? - Management emphasized caution regarding data expectations in leukemia but highlighted ongoing studies and interest in monotherapy extensions [50][55]

Financing and Securities - The Company plans to sell an aggregate of $10,000,002.72 of Shares, Pre-Funded Warrants, and Warrants on the Closing Date[35] - Each Purchaser will receive a Warrant to purchase two shares of Common Stock for each Share or Warrant Share underlying a Pre-Funded Warrant purchased[35] - The Per Share Purchase Price is set at $2.41, subject to adjustments for stock splits and similar transactions[18] - The Pre-Funded Warrant Purchase Price is established at $2.40[19] - The Shares and Pre-Funded Warrants will be sold in fixed combinations with the Warrants[35] - The Company will deliver the Shares in book entry form registered in the Purchasers' names[35] - The Closing shall occur at the offices of the Company or another mutually agreed location[35] - The Company will execute and deliver the Registration Rights Agreement to each Purchaser prior to the Closing Date[36] - The exercise of the Warrants is subject to receipt of the Requisite Stockholder Approval[3] - The Company acknowledges the receipt and adequacy of consideration for the mutual covenants contained in the Agreement[4] - The Company has reserved the maximum number of shares of Common Stock issuable pursuant to the Agreement, Pre-Funded Warrants, and Warrants, subject to Requisite Stockholder Approval[52] - The exercise price for the Warrant registered in the name of each Purchaser is set at $2.41 per share[46] - The exercise price for the Pre-Funded Warrant is set at $0.01 per share[46] - The Company must obtain Requisite Stockholder Approval for the issuance of Warrant Shares upon the exercise of the Warrants[49] - The issuance of the Securities does not require registration under the Securities Act, assuming Purchasers' representations are accurate[90] - The Company will not integrate the sale of the Securities with any other security offerings that would require additional registration under the Securities Act[111] - The Purchasers must sell any Warrant Shares in compliance with the registration requirements of the Securities Act or an exemption therefrom[109] - The Company has reserved a sufficient number of shares of Common Stock to issue Shares and Warrant Shares as per the Agreement[121] - The Company is prohibited from issuing any Common Stock or Common Stock Equivalents for 90 days following the date of the Prospectus Supplement[122] - The Company will hold a Stockholder Meeting within 90 days from the Closing to obtain approval for the exercise of all Warrants for shares of Common Stock[129] Financial Performance - The Company reported a significant increase in revenue, achieving $150 million for the quarter, representing a 25% year-over-year growth[1] - User data showed a total of 2 million active users, up from 1.5 million in the previous quarter, indicating a 33% increase[1] - The Company provided guidance for the next quarter, projecting revenue between $160 million and $170 million, which would reflect a growth rate of 7% to 13%[1] - New product launches are expected to contribute an additional $20 million in revenue over the next two quarters[1] - The Company reported a net profit margin of 12%, up from 10% in the previous quarter, reflecting improved operational efficiency[1] - The total assets of the Company increased to $500 million, a 10% rise compared to the previous fiscal year[1] Corporate Governance and Compliance - The Company has prepared and filed the Registration Statement in conformity with the requirements of the Securities Act, and it is effective under the Securities Act[52] - The Company has not issued any capital stock since its most recently filed periodic report under the Exchange Act, except for stock options and restricted stock units[53] - The Company is eligible to use Form S-3 under the Securities Act and met the transaction requirements at the time of filing the Registration Statement[52] - The obligations of the Company in connection with the Closing are subject to the accuracy of representations and warranties of the Purchasers[41] - The obligations of the Purchasers in connection with the Closing are subject to the accuracy of representations and warranties of the Company[42] - The Company has filed all required SEC Reports on a timely basis, complying with the Securities Act and the Exchange Act[55] - The financial statements included in the SEC Reports fairly present the financial position of the Company and its consolidated Subsidiaries, prepared in accordance with GAAP[56] - Since the last unaudited financial statements, there have been no events that would reasonably be expected to result in a Material Adverse Effect[57] - The Company has not incurred any liabilities other than trade payables and accrued expenses incurred in the ordinary course of business[57] - The Company and its Subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance regarding financial reporting[69] - The Company is in compliance with all applicable requirements of the Sarbanes-Oxley Act of 2002[69] - The Company and its Subsidiaries possess all necessary regulatory permits to conduct their businesses[63] - There are no outstanding securities or instruments that would obligate the Company to issue additional shares of Common Stock[54] - The Company has good and marketable title to all real and personal property material to its business[64] - The Company and its Subsidiaries are insured against losses and risks in amounts customary for their business[67] - The Company is not classified as an "investment company" under the Investment Company Act of 1940[72] - The Common Stock is registered under the Exchange Act and is compliant with listing and maintenance requirements[73] - The Company has made all required tax filings and has no material unpaid taxes claimed by any jurisdiction[77][78] - The Company's assets exceed its liabilities, indicating a strong financial position and solvency[79] - The Company's accounting firm is PricewaterhouseCoopers LLP, a registered public accounting firm[81] - The Company has not engaged in any unlawful contributions or payments related to political activities[80] - The Company is in compliance with FDA regulations for its Pharmaceutical Products, with no pending or threatened actions against it[86] Strategic Initiatives - The Company is investing $10 million in research and development for new technologies aimed at enhancing user experience[1] - Market expansion efforts include entering three new international markets, projected to increase user base by 15%[1] - The Company is considering strategic acquisitions to bolster its market position, with a budget of $50 million allocated for potential deals[1] - A new marketing strategy is set to roll out, aiming for a 20% increase in brand awareness over the next year[1] Confidentiality and Disclosure - The Purchasers have had the opportunity to review the Transaction Documents and ask questions regarding the investment, ensuring they are well-informed[98] - The Company agrees that any confidentiality obligations regarding the Purchasers will terminate upon the issuance of the press release[112] - The Purchasers have maintained confidentiality regarding all disclosures made in connection with the transaction[100] - The Company must issue a press release disclosing the material terms of the transactions and file a Current Report on Form 8-K with the Commission within the required time frame[112] - The Purchasers are acquiring the Securities for their own account and not for distribution or resale in violation of applicable laws[94]

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]