Curis(CRIS)

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Curis to Present at Upcoming Healthcare Conference in April
Prnewswire· 2025-04-02 20:05
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]
Curis(CRIS) - 2024 Q4 - Annual Report
2025-03-31 20:04
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].
Curis(CRIS) - 2024 Q4 - Earnings Call Transcript
2025-03-31 13:59
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]
Curis(CRIS) - 2024 Q4 - Annual Results
2025-03-31 12:06
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]
Curis Provides Fourth Quarter 2024 Business Update
Prnewswire· 2025-03-31 12:00
Operational Highlights FDA and EMA discussions completed to support a potential accelerated approval path in both US and EU Orphan Drug Designation for PCNSL granted in both US and EU Management to host conference call today at 8:30 a.m. ET LEXINGTON, Mass., March 31, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today reported its business update and financial results for the ...
Curis to Report Fourth Quarter 2024 Financial and Operating Results and Host Conference Call and Webcast on March 31, 2025
Prnewswire· 2025-03-28 20:07
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].
Curis(CRIS) - 2024 Q3 - Earnings Call Transcript
2024-11-14 16:02
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]
Curis (CRIS) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-14 15:10
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]
Curis(CRIS) - 2024 Q3 - Quarterly Report
2024-11-14 13:05
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].
Curis(CRIS) - 2024 Q3 - Quarterly Results
2024-11-14 13:03
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].