Business Overview and History
Curis Inc is a biotechnology company dedicated to the development of novel cancer therapies. With a focus on its lead clinical-stage drug candidate emavusertib, Curis is navigating the challenging landscape of oncology research and positioning itself as a potential disruptor in the field.
Curis was founded in 1998 and is headquartered in Lexington, Massachusetts. The company’s origins trace back to its founding mission of discovering and developing innovative drug candidates to treat various types of cancer. Over the years, Curis has built a diverse pipeline of oncology programs, with emavusertib (CA-4948) as its primary focus.
In June 2003, Curis achieved a significant milestone by licensing its proprietary Hedgehog pathway antagonist technologies to Genentech for human therapeutic use. This collaboration led to the development and commercialization of Erivedge (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway antagonist approved for the treatment of advanced basal cell carcinoma.
A key strategic move came in January 2015 when Curis 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. The collaboration has been fruitful, resulting in several licensed programs, including emavusertib.
In March 2019, Curis and its wholly owned subsidiary, Curis Royalty LLC, entered into a royalty interest purchase agreement with entities managed by Oberland Capital Management, LLC. Through this agreement, Curis sold a portion of its rights to receive royalties from Genentech on potential net sales of Erivedge. This transaction provided Curis with $65 million in upfront proceeds, which has been used to fund its operations and research and development activities.
Emavusertib is an orally available, small molecule inhibitor of Interleukin-1 receptor associated kinase 4 (IRAK4), a crucial signaling node in the Toll-like receptor (TLR) and Interleukin-1 receptor (IL-1R) pathways. These pathways are frequently dysregulated in patients with hematological malignancies, making IRAK4 an attractive therapeutic target. Curis is currently evaluating emavusertib in several clinical trials, including the TakeAim Leukemia Phase 1/2 study and the TakeAim Lymphoma Phase 1/2 study, as well as a Phase 1 study in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML).
Financial Performance and Liquidity
Curis has historically operated at a net loss, reflecting the significant investments required to advance its clinical-stage programs. For the year ended December 31, 2023, the company reported a net loss of $47.4 million, compared to a net loss of $56.7 million in the prior year. Revenue for 2023 was $10.0 million, primarily consisting of royalty payments from Genentech’s sales of Erivedge.
As of September 30, 2024, Curis had $20.9 million in cash and cash equivalents, excluding $0.5 million in restricted cash. The company also received net proceeds of approximately $10.8 million from a registered direct offering and concurrent private placement of warrants in October 2024. Based on its current operating plan, Curis believes its existing cash and cash equivalents should enable it to fund its planned operations into mid-2025.
Curis’ financial position and liquidity have been an ongoing challenge, as the company continues to prioritize the development of its pipeline, particularly emavusertib. The company has relied on equity financings, collaborations, and the monetization of certain royalty rights to fund its operations. Going forward, Curis will need to secure additional capital to support the continued development and potential commercialization of emavusertib and its other programs.
For the third quarter of 2024, Curis reported revenues of $2.93 million, primarily comprised of royalties on net sales of Erivedge. The company reported a net loss of $10.1 million or $1.70 per share for the quarter, compared to a net loss of $12.2 million or $2.13 per share for the same period in 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.
Research and development expenses for the third quarter of 2024 were $9.7 million, compared to $10.4 million for the same period in 2023. General and administrative expenses were $3.8 million for the third quarter of 2024, compared to $4.8 million for the same period in 2023.
As of the end of October 2024, Curis had cash and cash equivalents totaling $31.6 million and approximately 8.5 million shares of common stock outstanding. The company has no debt, but its current ratio and quick ratio stand at 1.22, indicating potential liquidity challenges. Curis has concluded that there are conditions and events that raise substantial doubt about its ability to continue as a going concern within the next 12 months, and the company will need to seek additional funding to support its operations and the development of emavusertib.
Clinical Pipeline and Regulatory Milestones
Emavusertib (CA-4948) is Curis’ lead clinical-stage drug candidate and the primary focus of the company’s research and development efforts. In the TakeAim Leukemia Phase 1/2 study, emavusertib has demonstrated anti-tumor activity in relapsed/refractory AML patients, including those with FLT3 mutations. The company plans to present expanded data from this study at the upcoming American Society of Hematology (ASH) meeting in December 2024.
In the TakeAim Lymphoma Phase 1/2 study, emavusertib is being evaluated in combination with the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL). In September 2024, Curis reported updated data from this study, showing that 4 out of 10 evaluable patients achieved either a complete response (CR) or an unconfirmed complete response (CRu), with 3 of these responses lasting more than 6 months.
Curis is also conducting a Phase 1 study of emavusertib in combination with azacitidine and venetoclax for the treatment of AML, referred to as the AML Triplet study. This study, which is currently being conducted in Spain, Germany, and Italy, is designed to assess the safety of the triplet regimen.
In July 2024, the European Commission granted Orphan Drug Designation (ODD) to emavusertib for the treatment of PCNSL, recognizing the significant unmet need in this rare and aggressive form of non-Hodgkin’s lymphoma.
Competitive Landscape and Risks
Curis operates in a highly competitive oncology landscape, with numerous biopharmaceutical companies vying for advancements in hematological and solid tumor indications. The company faces competition from both established and emerging players in the development of novel cancer therapies targeting similar pathways or mechanisms of action as emavusertib.
One of the key risks facing Curis is its ability to successfully navigate the regulatory approval process for emavusertib. The company is in discussions with the FDA regarding a potential accelerated approval pathway for emavusertib in PCNSL, but the outcome of these discussions remains uncertain. Failure to obtain regulatory approval or delays in the approval process could significantly impact Curis’ future prospects.
Additionally, Curis’ financial position and ability to fund its ongoing operations remain a significant risk. The company’s reliance on external financing sources, such as equity issuances and collaborations, could become increasingly challenging if market conditions deteriorate or if the company is unable to demonstrate consistent progress in its clinical programs.
Conclusion
Curis is a biotechnology company with a focus on developing innovative cancer treatments, with emavusertib as its lead clinical-stage drug candidate. The company has made progress in advancing emavusertib through multiple clinical trials, targeting hematological malignancies and solid tumors. However, Curis faces the ongoing challenges of navigating the competitive oncology landscape, securing regulatory approvals, and maintaining a strong financial position to support its research and development efforts. Investors should closely monitor the company’s progress in its clinical programs, its ability to secure additional financing, and any updates regarding the regulatory pathway for emavusertib. The company’s financial performance, including its consistent net losses and limited cash runway, underscores the risks associated with investing in early-stage biotech companies. Despite these challenges, Curis continues to push forward with its development programs, aiming to bring potentially groundbreaking cancer treatments to market.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.