On May 12, 2021 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 first quarter ended March 31, 2021 (Press release, Curis, MAY 12, 2021, View Source [SID1234579778]).
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"The first quarter of 2021 saw continued momentum for our pipeline of next generation targeted cancer therapies designed to meaningfully improve and extend patients’ lives. We continued to make important progress with CA-4948, our first-in-class, small molecule inhibitor of IRAK4, now in three clinical trials after expanding into one new study earlier this year with the Phase 2 LUCAS IST for patients with lower-risk MDS, as well as expanding our previous Phase 1/2 study in patients with relapsed/refractory (R/R) NHL to include the combination of CA-4948 plus ibrutinib. We were also very pleased to announce that CA-4948 was granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of AML and MDS, highlighting the unique potential of our IRAK4 program," said James Dentzer, President and Chief Executive Officer of Curis. "We are especially excited about the AML/MDS data published today in the EHA (Free EHA Whitepaper) abstract, and we look forward to providing additional data from this study in the oral presentation at EHA (Free EHA Whitepaper) next month."
Mr. Dentzer added, "We are also pleased with the continuing dose escalation in our ongoing Phase 1 study of CI-8993, our first-in-class monoclonal anti-VISTA antibody for the treatment of patients with R/R solid tumors and look forward to providing initial data from this study later this year."
First Quarter 2021 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):
Today, EHA (Free EHA Whitepaper) released the Curis abstract reporting interim data from the ongoing Phase 1/2 study of CA-4948 in patients with R/R AML and MDS. The data are from 15 patients as of February 8, 2021 (the cut-off date) and are consistent with previously announced findings, including marrow blast reductions observed at all tested doses in 8 of 9 (89%) evaluable patients with elevated blast counts at baseline, with 1 patient experiencing a full hematologic recovery complete response, 1 complete remission with incomplete hematologic recovery (CRi) with negative minimal residual disease, and 2 bone marrow complete responses (CRs).
All 3 patients presenting with SF3B1 or U2AF1 spliceosome mutations achieved marrow CR or better
All patients with objective responses also saw signs of hematologic recovery
Updated safety, pharmacodynamic, and efficacy data, as well as data from additional trial participants, will be featured in an oral presentation at EHA (Free EHA Whitepaper) on Friday, June 11 at 9:00 am CEST (3:00 am EDT).
Curis updated that the 500mg BID dosing regimen in the AML/MDS study has exceeded the maximum tolerated dose according to protocol guidelines. Two patients in the cohort were observed to have dose-limiting toxicities, one of whom had Grade 3 rhabdomyolysis and the other experienced Grade 3 syncope. Both AEs resolved after discontinuation of dosing. Current enrollment is exploring lower dose levels to determine the appropriate recommended phase 2 dose (RP2D).
Also today, Curis reported non-clinical data to be presented in a poster at EHA (Free EHA Whitepaper) demonstrating synergistic antitumor activity of CA-4948 in combination with azacitidine and venetoclax in leukemia cells, providing supportive rationale for evaluation of the combinations in a clinical setting for AML and MDS patients.
The Phase 1/2 study of CA-4948 in AML and MDS was expanded to include both a combination dose escalation and a monotherapy dose expansion:
Combination dose escalation, which will start at 200mg BID, will include two cohorts:
1) CA-4948 + azacitidine, for patients with AML or MDS who are naïve to hypomethylating agents (HMA)
2) CA-4948 + venetoclax, for patients with AML or MDS after first line therapy who are naïve to venetoclax
Monotherapy dose expansion, which will begin after the RP2D is determined, will include four cohorts:
1) MDS patients, R/R to HMA, with spliceosome mutations
2) MDS patients, R/R to HMA, without spliceosome mutations
3) R/R AML patients with FLT3-ITD mutation
4) R/R AML patients with FLT3 WT
In April 2021, Curis announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug designation for CA-4948 for the treatment of AML and for treatment of MDS.
Also in April, Curis presented updated data on a potentially predictive biomarker demonstrating target engagement in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021.
In February, Curis announced the dosing of the first patient in its Phase 1/2 combination study of CA-4948 plus ibrutinib, for the treatment of patients with R/R NHL or other hematologic malignancies. In preclinical models, CA-4948 demonstrated synergistic anti-cancer activity when combined with a potent BTK inhibitor such as ibrutinib. Curis expects to report initial data from this study in the second half of 2021.
Earlier in February, Curis announced the initiation of the investigator-sponsored Phase 2 LUCAS study of CA-4948 for the treatment of anemia in patients with very low, low, or intermediate-risk MDS. The study is expected to start recruitment in the second quarter of 2021.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):
Curis continues to enroll patients in the ongoing Phase 1 dose escalation study of its first-in-class monoclonal anti-VISTA antibody for the treatment of R/R solid tumors and expects to report initial clinical data in the second half of 2021.
Upcoming 2021 Planned Milestones
Report additional clinical data at the EHA (Free EHA Whitepaper) 2021 Virtual Congress from the Phase 1/2 monotherapy study of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that result in aberrant splicing of oncogenic IRAK4-L.
Initiate dosing in the Phase 1/2 combination study of CA-4948 plus azacitidine and CA-4948 plus venetoclax in patients with R/R AML and MDS.
In the second half of 2021, report initial data from the ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in patients with R/R NHL.
In the second half of 2021, report initial data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors.
First Quarter 2021 Financial Results
For the first quarter of 2021, Curis reported a net loss of $9.9 million or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $9.7 million, or $0.28 per share on both a basic and diluted basis for the same period in 2020.
Revenues for the first quarter of 2021 and 2020 were $2.2 million and $2.7 million, respectively.
Operating expenses for the first quarter of 2021 were $11.0 million, as compared to $11.2 million for the same period in 2020, 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 $0.1 million for the first quarter of 2021 and 2020.
Research and Development Expenses. Research and development expenses were $6.8 million for the first quarter of 2021 as compared to $7.5 million for the same period in 2020. The decrease in direct research and development expenses for the quarter is primarily attributable to the upfront license fee expense from our option and license agreement with ImmuNext that occurred during the first quarter of 2020. These costs were partially offset by a $0.3 million increase in employee related costs.
General and Administrative Expenses. General and administrative expenses were $4.1 million for the first quarter of 2021, as compared to $3.6 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation and professional and consulting services, partially offset by lower legal services costs during the three months ended March 31, 2021.
Other Expense, Net. For the first quarter of 2021 and 2020, net other expense was $1.1 million and $1.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.
As of March 31, 2021, Curis’s cash, cash equivalents and investments totaled $168.4 million, and there were approximately 91.5 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, May 12, 2021, 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.