On November 10, 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 third quarter ended September 30, 2020 (Press release, Curis, NOV 10, 2020, View Source [SID1234570479]).

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"We have continued to advance our clinical programs towards important catalysts at the end of this year and into 2021, which we expect to be another important year of data for Curis," said James Dentzer, President and Chief Executive Officer of Curis. "We have been pleased with the enrollment progress of our first-in-class IRAK4 inhibitor, CA-4948, in a Phase 1 study in patients with non-Hodgkin’s lymphoma (NHL), and we look forward to providing an update at ASH (Free ASH Whitepaper). We began a second Phase 1 study for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) and we are pleased to announce today a CRADA with the NCI for further development of CA-4948 as an anti-cancer agent. We also look forward to initiating our Phase 1 combination study evaluating CA-4948 and the BTK inhibitor, ibrutinib, in patients with NHL, including those with MYD88 altered disease."

Mr. Dentzer continued, "We also initiated patient dosing during the third quarter in our VISTA program, CI-8993, in the Phase 1a/1b study for patients with relapsed / refractory solid tumors. We are excited about our rapid progress from IND approval to patient dosing in this study and look forward to providing more updates over the coming quarters."

Third 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. An update of safety and efficacy data from the trial will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held virtually from December 5-8, 2020.
Curis continues to enroll patients in a second 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. Initial data from the study will be presented in a Trial in Progress poster at ASH (Free ASH Whitepaper).
Today, Curis announced that it entered into a CRADA with the NCI’s Experimental Therapeutics Program for the development of CA-4948. Under the agreement, the NCI and Curis will collaborate on the non-clinical and clinical development of Curis’s proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor as an anti-cancer agent.
Curis expects to initiate a Phase 1 study evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor. In preclinical models, CA-4948 has demonstrated anti-cancer activity that is highly synergistic with BTK inhibition. The Company will present a Trial in Progress poster at ASH (Free ASH Whitepaper).
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Curis initiated patient dosing in Q3 in a Phase 1a/1b study of CI-8993 in patients with relapsed / refractory solid tumors.
Curis will present a Trial in Progress poster on CI-8993 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, which is being held virtually from November 9-14, 2020.
Corporate:

As of November 3, 2020, extended cash runway through the second quarter of 2021, as a result of aggregate proceeds of approximately $10.0M since June 30, 2020 from the Company’s at-the-market sales agreement with JonesTrading and stock purchase agreement with Aspire Capital.
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 later this quarter.
Report initial data later this quarter from the Phase 1 study of CA-4948 in patients with AML/MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L.
Continue enrollment in Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors.
Initiate Phase 1 study of CA-4948 in combination with ibrutinib.
Third Quarter 2020 Financial Results

For the third quarter of 2020, Curis reported a net loss of $6.0 million, or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $6.4 million, or $0.19 per share on both a basic and diluted basis, for the same period in 2019. Curis reported a net loss of $22.4 million, or $0.52 per share on both a basic and diluted basis, for the nine months ended September 30, 2020 as compared to a net loss of $23.5 million, or $0.71 per share on both a basic and diluted basis for the same period in 2019.

Revenues for the third quarter of 2020 were $2.7 million, as compared to $2.9 million for the same period in 2019. Revenues for the nine months ended September 30, 2020 were $7.8 million, as compared to $6.7 million for the same period in 2019. Revenues for all periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the third quarter of 2020 were $7.5 million, as compared to $8.2 million for the same period in 2019. Operating expenses for the nine months ended September 30, 2020 were $26.4 million, as compared to $23.7 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 third quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of royalty revenues for the nine months ended September 30, 2020 were $0.4 million, as compared to $0.3 million for the same period in 2019.

Research and Development Expenses. Research and development expenses were $4.7 million for the third quarter of 2020, as compared to $5.1 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 $17.5 million for the nine months ended September 30, 2020, as compared to $14.8 million for the same period in 2019.

General and Administrative Expenses (G&A). General and administrative expenses were $2.6 million for the third quarter of 2020, as compared to $2.9 million for the same period in 2019. The decrease was driven primarily by lower personnel and stock-based compensation costs partially offset by higher legal, professional and consulting services costs. General and administrative expenses were $8.6 million for the nine months ended September 30, 2020, as compared to $8.6 million for the same period in 2019.

Other expense, net. Net other expense was $1.3 million for the third quarter of 2020, as compared to $1.1 million for the same period in 2019. Net other expense for the third quarter 2020 primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $3.8 million for the nine months ended September 30, 2020, as compared to $6.5 million for the same period in 2019.

As of September 30, 2020, Curis’ cash, cash equivalents, marketable securities and investments totaled $23.6 million and there were approximately 56.7 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations through the second quarter of 2021.

Conference Call Information

Curis management will host a conference call today, November 10, 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.