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Aug. 3, 2021, 4:17 p.m. EDT

10-Q: DECIPHERA PHARMACEUTICALS, INC.







        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

COMTEX_390872712/2041/2021-08-03T16:16:58

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