On August 4, 2020 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, 2020 (Press release, Curis, AUG 4, 2020, View Source [SID1234562783]).

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"Our recent accomplishments represent meaningful progress for Curis, as we advanced our clinical pipeline and achieved key financial objectives. These recent developments set us up for near-term data readouts, which we expect will provide durable momentum into 2021," said James Dentzer, President and Chief Executive Officer of Curis. "In addition to advancing the ongoing Phase 1 study of our first-in-class IRAK4 inhibitor, CA-4948, in patients with non-Hodgkin’s lymphoma (NHL), we initiated a new Phase 1 study of CA-4948 in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). We are particularly excited about this study, as AML and high-risk MDS are driven, in over half of patients, by the long isoform of IRAK4, which CA-4948 directly targets. Today, I am pleased to announce our plans to initiate a study of CA-4948 before the end of the year, which will evaluate CA-4948 in combination with ibrutinib, a BTK inhibitor, in patients with NHL, including those with MYD88 altered disease."

Mr. Dentzer continued, "For our VISTA program, we received clearance from the U.S. Food and Drug Administration (FDA) on our Investigational New Drug (IND) application for CI-8993 to initiate a Phase 1a/1b dose-escalation study in patients with solid tumors. We look forward to building on our pipeline-wide progress and expect to report data on all three clinical studies, CA-4948 in NHL, CA-4948 in AML/MDS, and CI-8993 in solid tumors, by year-end."

Second Quarter 2020 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Curis is evaluating CA-4948 in an ongoing Phase 1 dose-escalation study for the treatment of patients with R/R NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. As a result of COVID-19 pandemic, enrollment in this trial has been slower than expected and the timeline of this clinical trial has been delayed. The Company expects to report updated efficacy data and the recommended Phase 2 dose for CA-4948 by the end of 2020.
In July 2020, Curis announced the dosing of the first patient in its open-label, Phase 1 dose-escalation study of CA-4948 in patients with R/R AML and high-risk MDS, including patients with spliceosome mutations that drive expression of the long isoform of IRAK4 (IRAK4-L). The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of CA-4948 based on safety and tolerability, dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic findings. A minimum of three patients will be enrolled at each dose level, starting with 200 mg BID, which was determined to be safe, capable of achieving relevant levels of drug exposure, and demonstrated signs of biologic activity and clinical efficacy in a separate, ongoing Phase 1 study. Curis expects to provide initial data from this study by the end of 2020.
Today, Curis announced that it will initiate a Phase 1 study evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor, in the second half of 2020. In preclinical models, CA-4948 has demonstrated anti-cancer activity that is highly synergistic with BTK inhibition.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In June 2020, Curis announced that the FDA cleared its IND application for CI-8993, a first-in-class monoclonal anti-VISTA antibody. Curis expects to initiate a Phase 1a/1b study of CI-8993 in patients with relapsed / refractory solid tumors in the second half of 2020.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Fimepinostat has previously been shown to induce durable single-agent responses in difficult-to-treat lymphomas, including MYC-driven and double-hit disease. Curis is collaborating with DarwinHealth on ongoing analytical research to characterize biomarkers and tumor subtype alignments, which may help guide future clinical development opportunities with fimepinostat.
Corporate:

In June 2020, Curis completed a $17.5 million registered direct offering with fundamental healthcare investors extending its cash runway into the first half of 2021.
Upcoming 2020 Planned Milestones

Declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study and report updated efficacy data from the study by year-end 2020.
Report initial data from the Phase 1 study of CA-4948 in patients with AML/MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L, by year-end 2020.
Initiate Phase 1 study of CA-4948 in combination with ibrutinib in the second half of 2020.
Initiate Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors in the second half of 2020.
Report initial safety data from Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors by year-end 2020.
Second Quarter 2020 Financial Results

For the second quarter of 2020, Curis reported a net loss of $6.7 million, or $0.17 per share on both a basic and diluted basis, as compared to a net loss of $7.2 million, or $0.22 per share on both a basic and diluted basis, for the same period in 2019. Curis reported a net loss of $16.4 million, or $0.44 per share on both a basic and diluted basis, for the six months ended June 30, 2020, as compared to a net loss of $17.1 million, or $0.52 per share on both a basic and diluted basis, for the same period in 2019.

Revenues for the second quarter of 2020 were $2.4 million, as compared to $2.1 million for the same period in 2019. Revenues for the six months ended June 30, 2020 were $5.1 million, as compared to $3.9 million for the same period in 2019. 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 2020 were $7.8 million, as compared to $8.2 million for the same period in 2019. Operating expenses for the six months ended June 30, 2020 were $19.0 million, as compared to $15.6 million for the same period in 2019, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were stable at $0.1 million for the second quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of royalty revenues for the six months ended June 30, 2020 were also stable at $0.2 million, as compared to $0.2 million for the same period in 2019.

Research and Development Expenses. Research and development expenses were $5.3 million for the second quarter of 2020, as compared to $5.6 million for the same period in 2019. The decrease in research and development expenses for the quarter is primarily attributable to reduced clinical trial costs related to CA-170 and fimepinostat. Research and development expenses were $12.8 million for the six months ended June 30, 2020 as compared to $9.7 million for the same period in 2019.

General and Administrative Expenses. General and administrative expenses were $2.4 million for the second quarter of 2020, as compared to $2.5 million for the same period in 2019. The decrease was driven primarily by lower stock-based compensation costs as well as lower legal and professional services fees, partially offset by higher occupancy costs. General and administrative expenses were $6.0 million for the six months ended June 30, 2020, as compared to $5.7 million for the same period in 2019.

Other expense, net. Net other expense was $1.3 million for the second quarter of 2020, as compared to $1.1 million for the same period in 2019. Net other expense for the second quarter 2020 primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $2.5 million for the six months ended June 30, 2020, as compared to $5.4 million for the same period in 2019.

As of June 30, 2020, Curis’ cash, cash equivalents, marketable securities and investments totaled $23.6 million and there were approximately 50.6 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 the first half of 2021.This forecast does not include potential proceeds from the Company’s stock purchase agreement with Aspire Capital or the Company’s at-the-market facility with JonesTrading.

Conference Call Information

Curis management will host a conference call today, August 4, 2020, 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.