On August 4, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the second quarter ended June 30, 2022 and provided business updates (Press release, Curis, AUG 4, 2022, View Source [SID1234617526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter, we issued the noteworthy first release of data from the TakeAim Lymphoma trial’s combination arm that examined emavusertib combined with ibrutinib in B cell malignancies. This data showed tumor reduction in 8 of 9 evaluable patients, and the potential to help patients experiencing ibrutinib resistance. We look forward to continuing the advancement of our first-in-class, small molecule IRAK4 inhibitor in nine distinct patient populations across acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) and B cell cancers. On the administrative front, I am also pleased to announce the appointment of Diantha Duvall as our new Chief Financial Officer. Diantha brings a wealth of experience from senior roles at Merck, Biogen, Bioverativ, Genocea and PricewaterhouseCoopers. We look forward to her contributions to the Curis mission," said James Dentzer, President and Chief Executive Officer of Curis.

"I am excited to join Curis at this critical time for the company," said Ms. Duvall. "I found Curis to be particularly compelling due to its novel, targeted approach and pipeline of first-in-class cancer therapeutics with significant potential in areas of unmet need. I look forward to supporting the Curis team’s mission to develop innovative and differentiated therapeutics that improve the lives of cancer patients."

Second Quarter 2022 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

The company presented the first preliminary dataset from the combination arm in the TakeAim Lymphoma study at ASCO (Free ASCO Whitepaper) and at the European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress which examined the use of emavusertib plus ibrutinib in patients with relapsed or refractory (R/R) hematologic malignancies, such as non-Hodgkin’s lymphoma and other B cell malignancies. The presentation included clinical data on 13 patients who received the combination, 9 of whom had post-baseline response assessments and were evaluable for response.
Key findings in patients treated with the combination included:
The combination appeared to be well tolerated
No dose-limiting toxicities (DLTs) at 200mg of emavusertib; 2 DLTs observed at 300mg (stomatitis and syncope)
8 of 9 evaluable patients experienced reduction in tumor burden, including:
2 complete responses (CR) (primary CNS lymphoma and mantle cell lymphoma)
2 partial responses (PR) (chronic lymphocytic leukemia and mantle cell lymphoma)
One of the CRs was in a patient who had received prior treatment with ibrutinib, suggesting the combination may be able to overcome ibrutinib resistance
The company presented data from the TakeAim Leukemia study at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) during the second quarter. The data showed encouraging rates of response in three separate targeted patient populations, namely those with: spliceosome-mutated R/R AML, spliceosome-mutated R/R MDS, and FLT3-mutated R/R AML. In addition, emavusertib was well-tolerated across multiple dose levels.
The company also presented novel findings from its work involving potential biomarker development for use with emavusertib studies which described the previously unrecognized localization of IRAK4 in the nucleus of cancer cells. The localization of IRAK4 in the nucleus is being explored as a potential biomarker.
Curis’s collaborators also presented data on their work with emavusertib. Two of these were in solid tumor indications: one in gastric cancer by Dr. Kian-Huat Lim’s team at Washington University School of Medicine, and the second by Dr. Duane Mitchell’s team at the University of Florida, which investigated emavusertib in melanoma brain metastasis. The third presentation by the Company’s collaborators was also from Dr. Duane Mitchell’s team, and this work was in the treatment of patients with primary CNS lymphoma.
The company is working closely with the FDA to resolve the partial clinical holds on enrollment for the emavusertib studies.
Appointed new CFO:

Curis appointed Diantha Duvall Chief Financial Officer effective August 5, 2022. Ms. Duvall joins the company from Genocea, where she served as the CFO since 2019. Prior to that, she held senior finance roles at Bioverativ, Biogen and Merck, where her roles spanned commercial finance, venture investment, business development, joint ventures, alliances, technical accounting and controls. She received a bachelor’s degree in Economics and Public Policy from Colby College and masters’ degrees in both Accounting and Business Administration from Northeastern University. She is also a Certified Public Accountant licensed in the state of Massachusetts. Ms. Duvall succeeds Bill Steinkrauss, who as previously announced is resigning from the company on August 5, 2022, to pursue an entrepreneurial opportunity in consulting. Mr. Steinkrauss will continue to work with the company as a consultant as needed through the end of 2022 to ensure a smooth transition.
Upcoming Planned Milestones for the remainder of 2022

Report data from the TakeAim Leukemia study
We plan to present an update with additional monotherapy data
We plan to present initial data for the study of emavusertib in combination with azacitadine or venetoclax
Report data from the CI-8993 (VISTA checkpoint inhibitor) study
We plan to present an update with additional monotherapy data
Annual VISTA symposium planned for September 23, 2022
Annual IRAK4 symposium planned for October 7, 2022
Second Quarter 2022 Financial Results

For the second quarter of 2022, Curis reported a net loss of $15.9 million or $0.17 per share on both a basic and diluted basis, as compared to a net loss of $10.8 million, or $0.12 per share on both a basic and diluted basis for the same period in 2021. Curis reported a net loss of $32.0 million or $0.35 per share on both a basic and diluted basis, for the six months ended June 30, 2022 as compared to a net loss of $20.8 million, or $0.23 per share on both a basic and diluted basis for the same period in 2021.

Revenues for the second quarter of 2022 and 2021 were $2.4 million and $2.3 million, respectively. Revenues for the six months ended June 30, 2022 and June 30, 2021 were $4.5 million. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the second quarter of 2022 were $17.5 million, as compared to $12.9 million for the same period in 2021. Operating expenses for the six months ended June 30, 2022 were $34.6 million, as compared to $23.9 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, which represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were less than $0.1 million for the second quarter of 2022 and $0.1 million for the same period in 2021. Cost of royalty revenues for the six months ended June 30, 2022 were $0.1 million, as compared to $0.2 million for the same period in 2021.

Research and Development Expenses. Research and development expenses were $12.3 million for the second quarter of 2022 as compared to $8.8 million for the same period in 2021. The increase in direct research and development expenses for the quarter is primarily attributable to increased consulting services. Additionally, personnel related costs increased by $2.5 million and stock compensation increased $0.4 million, primarily as a result of additional headcount. Research and development expenses were $23.8 million for the six months ended June 30, 2022 as compared to $15.5 million for the same period in 2021.

General and Administrative Expenses. General and administrative expenses were $5.1 million for the second quarter of 2022, as compared to $4.1 million for the same period in 2021. The increase in general and administrative expenses was driven primarily by higher costs for personnel, stock-based compensation, and insurance costs. General and administrative expenses were $10.8 million for the six months ended June 30, 2022, as compared to $8.2 million for the same period in 2021.

Other Expense, Net. For the second quarter of 2022 and 2021, total other expense was $0.9 million and $0.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments, partially offset in the second quarter of 2021 by a gain of $0.9 million related to extinguishment of debt. Net other expense was $1.9 million for the six months ended June 30, 2022, as compared to $1.3 million for the same period in 2021.

As of June 30, 2022, Curis’s cash, cash equivalents and investments totaled $107.2 million, and there were approximately 91.8 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, August 4, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.