Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Form 10-Q and our Annual Report on Form 10-K (Form 10-K) for the year ended December 31, 2020 on file with the SEC. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business, includes forward looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of this Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis. Overview We are a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. We have one approved drug, QINLOCK, which was developed through our proprietary platform. Beyond QINLOCK, we are developing three clinical-stage drug candidates and advancing our research-stage programs. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. We are preparing for a potential launch of QINLOCK in Europe and we have entered, and intend in the future to enter, into select distributor arrangements to offer QINLOCK in geographies where we do not intend to distribute QINLOCK on our own, such as Australia and Canada. Recent Developments QINLOCK In March 2021, the China National Medical Products Administration (NMPA) approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the Hong Kong Department of Health approved QINLOCK in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. We expect to announce top-line results from our pivotal Phase 3 trial in second-line GIST, INTRIGUE, in the fourth quarter of 2021. Additionally, we announced that we are planning to initiate a Phase 1b/2 trial of QINLOCK in combination with binimetinib, a commercially available MEK inhibitor, in patients with post-imatinib GIST, in the fourth quarter of 2021. Rebastinib Rebastinib is currently in clinical development for the treatment of multiple solid tumors in combination with chemotherapy in two Phase 1b/2 trials, one with paclitaxel and one with carboplatin. The Phase 1b/2 trial of rebastinib in combination with paclitaxel is a two-part, open-label, multicenter study assessing the safety, tolerability, anti-tumor activity, and pharmacokinetics of rebastinib in patients with advanced or metastatic solid tumors. As previously announced, in Part 2 of the trial of rebastinib in combination with paclitaxel, designed as a Simon 2-stage design, we observed the required number of responses in Part 2, Stage 1 in both the endometrial and platinum-resistant ovarian cancer (PROC) cohorts, triggering the expansion of enrollment in these cohorts. We expect to present updated data from the ongoing Phase 1b/2 trial of rebastinib in combination with paclitaxel in the PROC cohort in the third quarter of 2021 and finalize the pivotal development plan for rebastinib in combination with paclitaxel in the second half of 2021, subject to favorable data and discussions with regulators. In August 2021, we announced that the inflammatory breast cancer and gynecological carcinosarcoma cohorts in Part 2, Stage 1 of the trial of rebastinib in combination with paclitaxel, did not advance to Part 2, Stage 2. Enrollment in these cohorts has been closed. In August 2021, we announced that the platinum-sensitive ovarian cancer cohort in Part 2, Stage 1 of the trial of rebastinib in combination with carboplatin, designed as a Simon 2-stage design, did not advance to Part 2, Stage 2. Enrollment in the trial has been closed. DCC-3116 In June 2021, we announced dosing of the first patient in the Phase 1, multicenter, open-label, first-in-human study of DCC-3116. DCC-3116 is an investigational ULK kinase inhibitor designed to inhibit autophagy and is being studied as a single agent and in combination with trametinib, a commercially available MEK inhibitor, in patients with advanced or metastatic
Results of Operations Comparison of the Three and Six Months Ended June 30, 2021 and 2020 The following table summarizes our results of operations for the three and six months ended June 30, 2021 and 2020: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2021 2020 2021 2020 Revenues: Product revenues, net $ 22,048 $ 4,825 $ 42,010 $ 4,825 Collaboration revenues 1,525 2,265 6,719 2,327 Total revenues 23,573 7,090 48,729 7,152 Cost and operating expenses: Cost of sales 1,275 8 1,497 8 Research and development 59,984 46,081 115,665 97,469 Selling, general, and administrative 32,828 29,933 63,575 53,869 Total cost and operating expenses 94,087 76,022 180,737 151,346 Loss from operations (70,514) (68,932) (132,008) (144,194) Other income (expense): Interest and other income, net 81 1,691 277 4,146 . . .
Aug 03, 2021
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