LEXINGTON, Mass. , Nov. 14, 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 announced that Curis will report emavusertib and BTKi clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations and preclinical data on emavusertib in an oral presentation at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19 ...

Market Overview - Nifty closed at 25,492.30, down 17.40 points or 0.07%, indicating near-term weakness as it trades below the 50EMA [1][19] - The index has been declining since forming a double top around 26,100, with crucial resistance at 25,600 and support at 25,400 [2][19] Earnings Season - More than 2,500 BSE listed companies are set to announce their Q2 earnings this week, including major Nifty companies like Bajaj Finance, Bajaj Finserv, Tata Steel, and Eicher Motors [6][19] - Notable non-Nifty companies reporting include Vodafone Idea, Fortis Healthcare, and Hero MotoCorp [7][19] US Market Influence - The Nasdaq Composite closed at 23,004.50, down 49.46 points or 0.22%, marking its largest weekly percentage drop since early April, which may influence domestic markets [8][19] IPO Activity - Four mainboard IPOs are expected this week: PhysicsWallah, Tenneco Clean Air India, Emmvee Photovoltaic Power, and Fujiyama Power Systems, with bidding for Pine Labs concluding on Tuesday [9][10][19] - In the SME segment, new public issues will launch, and ongoing issues will close this week [10][19] Corporate Actions - Over 60 companies are scheduled for record dates related to interim dividends, bonus issues, buybacks, spin-offs, and stock splits this week [11][19] - Infosys is expected to be active ahead of its buyback record date on November 14 [11][19] FII/DII Activity - Foreign Institutional Investors (FIIs) were net buyers with purchases of Rs 4,581.34 crore, while Domestic Institutional Investors (DIIs) were net buyers at Rs 6,674.77 crore [13][19] Technical Analysis - Nifty is undergoing a retracement with key support at 25,160 and resistance at 25,700, indicating a potential 'buy on dips' strategy as long as it holds above 25,160 [15][19] Currency Movement - The Indian rupee settled at 88.66 against the U.S. dollar, slightly down from the previous session but up 0.1% for the week, supported by RBI interventions [16][19] - Ongoing uncertainty in U.S.-India trade negotiations may keep the rupee under pressure [17][19]

Core Insights - Curis (CRIS) reported a quarterly loss of $0.49 per share, better than the Zacks Consensus Estimate of a loss of $0.62, and an improvement from a loss of $1.7 per share a year ago, resulting in an earnings surprise of +20.97% [1] - The company generated revenues of $3.18 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 8.58% and showing growth from $2.93 million in the same quarter last year [2] - Curis has surpassed consensus EPS estimates three times over the last four quarters and has topped consensus revenue estimates four times during the same period [2] Financial Performance - Curis shares have declined approximately 53.6% year-to-date, contrasting with the S&P 500's gain of 15.6% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.62 on revenues of $3.06 million, while for the current fiscal year, the estimate is -$2.60 on revenues of $11.05 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Curis belongs, is currently ranked in the top 41% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked using tools like the Zacks Rank [5][6]

Financial Data and Key Metrics Changes - Curis reported a net loss of $7.7 million, or $0.49 per share, for Q3 2025, compared to a net loss of $10.1 million, or $1.70 per share, for the same period in 2024, indicating an improvement in financial performance [9] - For the nine months ended September 30, 2025, the net loss was $26.9 million, or $2.19 per share, compared to a net loss of $33.8 million, or $5.77 per share, for the same period in 2024 [9] - Research and development expenses decreased to $6.4 million in Q3 2025 from $9.7 million in Q3 2024, primarily due to lower employee-related costs [9] - General and administrative expenses were $3.7 million in Q3 2025, slightly down from $3.8 million in Q3 2024 [10] - Cash and cash equivalents stood at $9.1 million as of September 30, 2025, with approximately 12.7 million shares of common stock outstanding [10] Business Line Data and Key Metrics Changes - The company is making progress in the take-aim lymphoma study, evaluating emavusertib in combination with ibrutinib for primary CNS lymphoma, with plans for accelerated submissions to the FDA and EMA [3][4] - A proof-of-concept study for CLL patients on BTKI monotherapy is expected to begin enrollment in late Q4 2025 or early Q1 2026, with initial data anticipated at the ASH annual meeting in December 2026 [5] - In the ongoing AML triplet study, MRD conversion to undetectable levels occurred in four of eight evaluable patients, indicating potential effectiveness of the treatment [6][8] Market Data and Key Metrics Changes - The company is focusing on expanding emavusertib studies into additional NHL subtypes, particularly CLL, where there is significant unmet medical need [4][5] - The market opportunity in CLL is viewed as substantial, with expectations of achieving deeper responses and potentially time-limited treatment for patients [20] Company Strategy and Development Direction - Curis aims to improve the current standard of care by adding emavusertib to BTKI regimens, potentially allowing patients to achieve deeper responses and reduce the risk of developing BTKI-resistant mutations [5] - The company is prioritizing the continuation of the PCNSL trial and the launch of the new CLL trial, while also seeking additional capital to support these initiatives [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the potential to change treatment paradigms in CLL and NHL, highlighting the importance of addressing unmet medical needs [4][20] - The company is preparing for upcoming conferences, including SNO and ASH, where they expect to present significant data and updates [26] Other Important Information - The company is actively engaging with key opinion leaders (KOLs) to explore the potential of emavusertib in various NHL subtypes, indicating strong interest and support from the medical community [4] Q&A Session Summary Question: Insights on the CLL program and FDA discussions - Management confirmed alignment with the FDA on primary endpoints and study design for the CLL study, aiming to address unmet medical needs [12][14] Question: Size of the phase two CLL trial and resource prioritization - The CLL study is anticipated to involve 40 patients, with hopes of achieving a significant increase in complete response rates [17][19] - Resource allocation will focus on continuing the PCNSL trial and launching the CLL trial, with plans to secure additional capital [20] Question: Safety considerations for the CLL study - Management expressed confidence in the safety profile of emavusertib in combination with BTK inhibitors, with no expected additive toxicities [22][24] Question: Expectations for the upcoming SNO meeting - The company will present several posters at the SNO conference, providing updates on the PCNSL study and new data on secondary CNS lymphoma [26]

Financial Performance - Curis reported an accumulated deficit of $1.3 billion as of September 30, 2025, with a net loss of $26.9 million for the nine months ended September 30, 2025[115]. - The company expects to generate significant revenues to achieve profitability, but does not anticipate profitability in the foreseeable future[117]. - As of September 30, 2025, the company reported an accumulated deficit of approximately $1.3 billion, indicating significant financial challenges[158]. - Cash used in operating activities decreased to $20.8 million for the nine months ended September 30, 2025, down from $30.3 million in the same period of 2024, reflecting reduced operating expenses[155]. - The company expects to incur substantial operating losses as it continues to develop and commercialize emavusertib, which could impact its financial condition[162]. Cash and Funding - The company has $9.1 million in cash and cash equivalents as of September 30, 2025, which is expected to fund operations into the first quarter of 2026[116]. - The company had cash and cash equivalents of $9.1 million as of September 30, 2025, which is expected to fund operations into the first quarter of 2026[159]. - Cash provided by financing activities was $9.9 million for the nine months ended September 30, 2025, primarily from the March and July 2025 offerings[157]. - The Put/Call Price related to the Oberland Purchase Agreement was approximately $103.8 million as of September 30, 2025, indicating potential future financial obligations[153]. - The company may need to explore strategic alternatives, including partnerships or asset sales, to secure additional funding[160]. Research and Development - Emavusertib is being evaluated in multiple clinical trials, including the TakeAim Lymphoma Phase 1/2 study and the TakeAim Leukemia Phase 1/2 study, with preliminary data provided in December 2023[109][111]. - Research and development expenses are primarily focused on the development of emavusertib, with a need for additional financing to support operations[122]. - The company expects a majority of its research and development expenses for the foreseeable future will be incurred in connection with advancing emavusertib, including clinical and preclinical development costs[139]. - Research and development expenses decreased by $7.2 million, or 24%, in the nine months ended September 30, 2025, primarily due to lower employee-related, clinical, consulting, research, manufacturing, and facility costs[138]. - The successful development and commercialization of emavusertib is highly uncertain, with significant risks and costs associated with regulatory approvals and clinical trials[126]. Clinical Trials and Collaborations - Emavusertib has received Orphan Drug Designation from the FDA for the treatment of PCNSL, AML, and MDS, and from the European Commission for PCNSL[107]. - Curis plans to initiate a new clinical study of emavusertib in combination with a commercially approved BTK inhibitor for frontline CLL, with data expected in Q4 2026[110]. - Curis has entered into a collaboration agreement with Genentech for the commercialization of Erivedge, which is approved for advanced basal cell carcinoma[113]. Revenue and Expenses - Revenues, net increased by $0.2 million, or 8%, in the three months ended September 30, 2025, compared to the same period in 2024, and increased by $0.7 million, or 10%, for the nine months ended September 30, 2025[135]. - Research and development expenses decreased by $3.3 million, or 34%, in the three months ended September 30, 2025, primarily due to lower clinical, employee-related, manufacturing, research, and consulting costs[137]. - General and administrative expenses decreased by $0.1 million, or 3%, in the three months ended September 30, 2025, primarily attributable to lower employee-related costs[140]. - Other income (expense) decreased by $1.3 million, or 269%, in the three months ended September 30, 2025, primarily due to an increase in the expense related to the sale of future royalties[142]. - General and administrative expenses decreased by $2.3 million, or 17%, in the nine months ended September 30, 2025, primarily due to lower employee-related, legal, insurance, and consulting costs[141]. Stock and Share Issuance - The company did not sell any shares of common stock under the 2024 Sales Agreement during the nine months ended September 30, 2025, leaving $98.8 million of shares available for sale[146]. - In March 2025, the company raised approximately $8.8 million from the issuance of 1,974,432 shares of common stock and warrants to purchase up to 10,500,891 additional shares[149]. - In July 2025, the company raised approximately $6.1 million from the issuance of 1,538,460 shares of common stock and warrants to purchase up to 4,615,382 additional shares[150].

Financial Performance - Curis reported a net loss of $7.7 million or $0.49 per share for Q3 2025, an improvement from a net loss of $10.1 million or $1.70 per share in Q3 2024[12]. - Revenues for Q3 2025 were $3.2 million, up from $2.9 million in Q3 2024, with total revenues of $8.3 million for the nine months ended September 30, 2025, compared to $7.6 million for the same period in 2024[13]. - Curis reported net revenues of $3,176,000 for the three months ended September 30, 2025, an increase of 8.4% compared to $2,931,000 for the same period in 2024[26]. - Total operating expenses for the three months ended September 30, 2025, were $10,100,000, down 25.3% from $13,498,000 in the same period of 2024[26]. - The net loss for the three months ended September 30, 2025, was $7,729,000, a decrease of 23.5% compared to a net loss of $10,092,000 for the same period in 2024[26]. Expenses - Research and development expenses decreased to $6.4 million in Q3 2025 from $9.7 million in Q3 2024, totaling $22.4 million for the nine months ended September 30, 2025, down from $29.6 million in the same period in 2024[14]. - General and administrative expenses slightly decreased to $3.7 million in Q3 2025 from $3.8 million in Q3 2024, totaling $11.2 million for the nine months ended September 30, 2025, compared to $13.4 million in the same period in 2024[15]. Cash and Assets - Curis has cash and cash equivalents totaling $9.1 million as of September 30, 2025, which is expected to fund operations into Q1 2026[17]. - Curis's cash and cash equivalents decreased to $9,051,000 as of September 30, 2025, from $19,997,000 as of December 31, 2024[28]. - Total assets decreased to $27,641,000 as of September 30, 2025, from $41,265,000 as of December 31, 2024[28]. - Curis reported a weighted average of 15,680,178 common shares outstanding for the three months ended September 30, 2025[26]. Liabilities and Stockholders' Deficit - Total liabilities were $42,332,000 as of September 30, 2025, down from $47,263,000 as of December 31, 2024[28]. - Curis's total stockholders' deficit increased to $14,691,000 as of September 30, 2025, compared to $5,998,000 as of December 31, 2024[28]. Clinical Development - Curis is advancing clinical studies in PCNSL, CLL, and AML, with initial data from the frontline AML triplet study expected to be presented at the ASH annual meeting in December 2025[3]. - The company is initiating a Phase 2 study of emavusertib in combination with a BTK inhibitor in CLL, with the first patient expected to be dosed in late Q4 2025 or early Q1 2026[8]. - Curis aims to achieve accelerated approval for emavusertib in PCNSL in the US and Europe, having received orphan drug designation from both the FDA and EMA[8]. - Curis will present updated PCNSL and SCNSL data at the Society for Neuro-Oncology annual meeting in November 2026[19]. Competition and Risks - The company faces substantial competition and requires significant additional capital to fund its operations and development of emavusertib[23]. - The company may face risks related to regulatory approvals and potential adverse decisions from authorities, which could impact its business prospects[23]. Funding Activities - The company completed a registered direct offering and concurrent private placement to extend its cash runway into 2026[10].

Company Overview - Curis is at an exciting crossroads with a focus on one primary drug, an IRAK4 and FLT3 inhibitor, which is being developed for Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML) [3] - The company has a promising pipeline and is funding studies for solid tumors, primarily supported by the NIH [3] Drug Development - The drug has shown compelling proof-of-concept data in Primary Central Nervous System Lymphoma (PCNSL) with a study involving 34 patients [3] - The drug is designed to be an add-on therapy to BTK inhibitors, targeting the TLR pathway while BTK inhibitors block the BCR pathway, potentially leading to higher response rates and complete remission in NHL [4]

Core Insights - Curis is at a pivotal moment with a focus on a single drug, an IRAK4 and FLT3 inhibitor, which is central to its resources and strategy [3] - The drug is being developed for Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML), with promising proof-of-concept data in Primary Central Nervous System Lymphoma (PCNSL) involving 34 patients [3] - The approach combines the use of BTK inhibitors to block the BCR pathway and Curis's drug to inhibit the TLR pathway, potentially leading to improved response rates and complete remission in NHL [4] Company Overview - Curis is currently funding one primary drug while maintaining a pipeline of additional studies, particularly in solid tumors [3] - The focus on NHL is driven by the understanding that the disease is influenced by the NF-kappaB pathway, which is activated through BCR and TLR pathways [3][4] - The strategy involves targeting all NHL subtypes similarly to the approach taken with PCNSL, aiming for enhanced therapeutic outcomes [4]

Core Insights - Curis is focusing on emavusertib, a first-in-class IRAK4 inhibitor, which has shown promising proof-of-concept data in treating various cancers, including lymphoma, leukemia, and solid tumors [3][4]. Company Overview - Curis has a broad pipeline of novel cancer therapies, with a particular emphasis on emavusertib, which has demonstrated significant improvements over standard care in clinical studies [3]. - The leadership team at Curis is highly experienced, with each member having over 20 years of experience in drug development at notable biotech companies [5]. Clinical Data - The proof-of-concept studies for emavusertib include data from 34 patients with primary central nervous system lymphoma (PCNSL) and 21 patients with acute myeloid leukemia (AML), both showing significant efficacy [3]. - The results from the PCNSL study suggest potential effectiveness in other non-Hodgkin lymphoma (NHL) subtypes, including chronic lymphocytic leukemia (CLL) [4]. - The findings in relapsed/refractory AML indicate confidence in the drug's potential application in frontline AML treatment [4].

Core Insights - Curis is focusing on emavusertib, a first-in-class IRAK4 inhibitor, which shows promise in treating various cancers including lymphoma, leukemia, and solid tumors [3][4] - The company has reported proof-of-concept data from studies involving 34 patients with primary central nervous system lymphoma (PCNSL) and 21 patients with acute myeloid leukemia (AML), both showing significant improvements over standard care [3][4] - Curis believes that the positive results from these studies indicate potential efficacy in other subtypes of non-Hodgkin lymphoma (NHL) and frontline AML [4] Company Expertise - Curis boasts a highly experienced leadership team, with each member having over 20 years of experience in drug development at notable biotech firms such as Dicerna, Biogen, BMS, and Merck [5] - The addition of Dr. Ahmed Handy, who has experience in developing BTK inhibitors, is expected to enhance the company's efforts in chronic lymphocytic leukemia (CLL) [5]