On September 20, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has paid off in full at maturity the remaining $64.4 million in principal amount outstanding of its 2.50% convertible senior notes due 2021 (Press release, Clovis Oncology, SEP 20, 2021, View Source [SID1234587959]). In addition, the Company provided an update on the progress of its renewed "at-the-market" (ATM) equity offering program announced in mid-August, pursuant to which it has sold during the third quarter of 2021 to date an aggregate of approximately 9.4 million shares of its common stock for gross proceeds of approximately $43.0 million and resulting in net proceeds to Clovis Oncology of approximately $41.7 million after commissions and offering related expenses. This is in addition to the previously announced approximately $72.5 million in net proceeds raised by Clovis Oncology pursuant to its ATM equity offering program during the second quarter of 2021.
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"These activities improve our balance sheet and complement our ongoing focus on cost control as we look forward to the potentially transformative events of 2022," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In 2022, we anticipate three Phase 3 data read-outs for Rubraca, which offer the potential to significantly expand the number of ovarian and prostate cancer patients eligible for Rubraca treatment in the US and Europe. In addition, we are enthusiastic about our ongoing Phase 1 LuMIERE study of FAP-2286 in advanced solid tumors, and expect the presentation of initial Phase 1 data at a medical meeting in 2022. Each of these supports our three key strategies: expand the Rubraca label to drive revenue growth, emerge as a leader in targeted radionuclide therapy, and achieve long-term financial stability."
Three anticipated data readouts from Rubraca studies are anticipated in 2022: ATHENA monotherapy in first-line maintenance treatment ovarian cancer in Q1 2022, TRITON3 monotherapy in second-line metastatic castration-resistant prostate cancer in Q2 2022, and ATHENA combination with Opdivo infirst-line maintenance treatment ovarian cancer in 2H 2022. These data read-outs provide the potential to reach larger patient populations in earlier lines of therapy for ovarian and prostate cancers. The timing of each of these read-outs is contingent upon the occurrence of the protocol-specified progression-free survival events.
FAP-2286 is Clovis Oncology’s peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) and is the lead candidate in the Company’s TRT development program. The Phase 1 portion of the LuMIERE study is evaluating the safety of the FAP-targeting investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286. FAP-2286 labeled with gallium-68 will be used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment in LuMIERE. The first presentation of Phase 1 data from LuMIERE is expected at a medical meeting in 2022. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types and expected to initiate in 2022.
Sales of its common stock under the ATM equity offering program were made by Clovis Oncology pursuant to a prospectus supplement filed with the U.S. Securities and Exchange Commission. This press release is for informational purposes only and is not an offer to sell or the solicitation of an offer to buy any securities of Clovis Oncology.