Curis Inc. is a biotechnology company at the forefront of developing innovative cancer therapies, with a primary focus on its lead candidate, emavusertib (CA-4948), an orally available small molecule inhibitor of the Interleukin-1 Receptor Associated Kinase 4 (IRAK4). The company's journey has been marked by significant progress and challenges, as it navigates the complex landscape of oncology drug development.
Company Background
Founded in 1997, Curis has established itself as a prominent player in the field of targeted cancer therapies. The company's early focus was on innovative drug candidates for the treatment of human cancer. In 2003, Curis made a significant move by licensing its proprietary Hedgehog pathway antagonist technologies to Genentech for human therapeutic use. This collaboration led to the development and commercialization of Erivedge, a first-in-class orally administered small molecule Hedgehog signaling pathway antagonist, for the treatment of advanced basal cell carcinoma. As a result of this successful partnership, Curis continues to receive royalties on the sales of Erivedge.
A pivotal moment in Curis' history came in 2015 when the company entered into an exclusive collaboration agreement with Aurigene Discovery Technologies Limited. This partnership focused on the discovery, development, and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology. Through this collaboration, Curis licensed several programs, including its current lead clinical candidate, emavusertib (CA-4948).
Throughout its history, Curis has relied on various funding sources to support its operations. These include private and public placements of equity securities, license fees, contingent cash payments, royalties, and research and development funding from corporate collaborators. The company has also monetized certain royalty rights to generate additional capital. Despite these efforts, Curis has never achieved profitability on an annual basis and has accumulated significant losses since its inception, reflecting the challenging nature of biotechnology research and development.
Financials
Curis' financial performance has been characterized by recurring net losses, a common trend in the biotechnology industry as companies prioritize research and development over immediate profitability. In the fiscal year 2023, the company reported annual revenue of $10.02 million, with a net loss of $47.41 million. The annual operating cash flow and free cash flow for 2023 were both -$38.43 million.
For the third quarter of 2024, Curis reported revenue of $2.93 million, a 3% increase year-over-year, and a net loss of $10.09 million, representing a 17% decrease in net loss compared to the same period in 2023. This improvement was primarily attributed to lower research and development expenses and general and administrative expenses.
The company's accumulated deficit reached $1.20 billion as of December 31, 2023. However, Curis' focus on advancing its lead candidate has led to significant progress in its clinical trials.
It's worth noting that Curis only sells its products in the United States, which represents its sole geographic market.
Clinical Progress
The TakeAim Leukemia study, evaluating emavusertib in relapsed/refractory (R/R) AML and high-risk MDS, has yielded encouraging data. In the study, emavusertib demonstrated objective response rates of over 50% in patients with FLT3 mutations, including complete remissions. These results have garnered the attention of the medical community and regulatory authorities, as Curis continues to engage in discussions with the U.S. Food and Drug Administration (FDA) to explore potential accelerated approval pathways for emavusertib in this patient population.
Curis' commitment to expanding the therapeutic potential of emavusertib is further exemplified by the TakeAim Lymphoma study, which is investigating the drug's efficacy in combination with the Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib in patients with R/R PCNSL. Preliminary data from this study have demonstrated encouraging response rates, including complete responses, in this challenging-to-treat patient population.
Additionally, Curis has initiated a Phase 1 clinical study, referred to as the AML Triplet study, to assess the safety of emavusertib in combination with azacitidine and venetoclax in AML patients.
Liquidity
The company's financial position has been supported by a variety of financing activities, including a $65 million royalty interest purchase agreement with Oberland Capital in 2019, as well as an at-the-market equity offering program that raised an additional $1 million in the third quarter of 2024. In October 2024, Curis further strengthened its balance sheet by securing $10.8 million in net proceeds from a registered direct offering and concurrent private placement of warrants.
As of September 30, 2024, Curis had cash and cash equivalents of $20.85 million, which, combined with the $10.8 million raised in the October 2024 offering, brought the total to $31.6 million. The company expects this funding to support its planned operations into mid-2025. Curis also reported having approximately 8.5 million shares of common stock outstanding following the October 2024 offerings.
The company's liquidity metrics as of the latest reported period include a debt-to-equity ratio of -0.37, a current ratio of 1.22, and a quick ratio of 1.22. These figures reflect the company's financial position and its ability to meet short-term obligations.
Despite the company's progress, it continues to face financial challenges. The company's reliance on external financing and the need for substantial additional capital to support the continued development of emavusertib and its other programs underscore the ongoing financial risks facing Curis.
Regulatory Challenges
Curis has also encountered regulatory hurdles, as evidenced by the letter it received in March 2023 from counsel to Oberland Capital Management, LLC, the Purchasers, and the Agent, alleging certain defaults of the Oberland Purchase Agreement. While Curis and its subsidiary, Curis Royalty, have disputed these allegations, the potential financial and operational impact of this matter remains a significant risk factor for the company.
Strategic Initiatives
In response to these challenges, Curis has implemented strategic cost-cutting measures, including a 30% reduction in its workforce in May 2024, to streamline its operations and focus on the most promising aspects of its pipeline. This is reflected in the company's financial performance, with research and development expenses for the third quarter of 2024 decreasing to $9.7 million from $10.4 million in the same period of 2023. Similarly, general and administrative expenses decreased to $3.8 million in Q3 2024 from $4.8 million in Q3 2023.
For the nine months ended September 30, 2024, Curis reported a net loss of $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. This reduction in net loss, despite relatively stable research and development expenses ($29.6 million for the first nine months of 2024 compared to $29.5 million for the same period in 2023), demonstrates the company's efforts to manage costs while continuing to advance its clinical programs.
The company's management team has also been actively engaged in discussions with the FDA to explore accelerated approval pathways for emavusertib, capitalizing on the drug's demonstrated efficacy and the unmet medical needs in its target indications.
As Curis continues to navigate the complex and dynamic oncology landscape, its success will hinge on its ability to secure additional financing, effectively manage its operations, and continue to demonstrate the clinical and commercial potential of emavusertib. With a strong focus on innovation and a commitment to advancing treatments for patients with hematological malignancies, Curis remains a company to watch in the biotech sector.