On November 3, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2021, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook (Press release, Clovis Oncology, NOV 3, 2021, View Source [SID1234594259]).
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"While COVID-19 continues to impact our revenues, as fewer patients have been diagnosed and treated for ovarian cancer during the pandemic, it has not affected our development programs. We remain on track for an eventful 2022, with three data readouts from Phase 3 ATHENA and TRITON3 studies of Rubraca with label expansion potential, as well as initial data from the ongoing Phase 1 LuMIERE study of our first targeted radiotherapy candidate FAP-2286 anticipated during 2022," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "With the additional capital raised in the quarter and recent repayment of the remaining 2021 notes, we have made further progress on improving our balance sheet and remain focused on our three core strategies: expand the Rubraca label to drive revenue growth, emerge as a leader in targeted radionuclide therapy, and achieve long-term financial stability."
Third Quarter 2021 Financial Results
Clovis reported global net product revenues for Rubraca of $37.9 million for Q3 2021, which included US product revenues of $28.7 million and ex-US product revenues of $9.2 million, respectively. This represents a sequential 3% increase over Q2 2021 and a 2% decrease year-over-year, compared to Q3 2020 net product revenues of $38.8 million, which included US net product revenues of $33.9 million and ex-US net product revenues of $4.9 million. The decrease in year-over-year revenues was primarily due to fewer ovarian cancer diagnoses and fewer patients treated in the US related to the ongoing impact of COVID-19.
Clovis reported net product revenue for Rubraca of $112.8 million for the nine months ended September 30, 2021, which included US product revenue of $88.1 million and ex-US product revenue of $24.7 million, compared to net product revenue for same period in 2020 of $121.2 million, which included US net product revenue of $109.8 million and ex-US net product revenue of $11.4 million.
Research and development expenses totaled $46.2 million for Q3 2021, down 27% compared to $62.9 million for the comparable period in 2020, due primarily to lower spending on Rubraca clinical trials. For the nine months ended September 30, 2021, research and development expenses totaled $144.8 million, down 28% compared to $201.0 million for the comparable period in 2020. As previously discussed, the Company expects research and development expenses to be lower in the full year 2021 compared to 2020.
Selling, general and administrative expenses totaled $32.2 million for Q3 2021, down 17% compared to $38.6 million for the comparable period in 2020, due to overall cost reduction efforts. For the nine months ended September 30, 2021, selling, general and administrative expenses totaled $95.1 million, down 23% compared to $123.1 million for the comparable period in 2020. Clovis continues to expect selling, general and administrative expenses to decrease in the full year 2021 compared to 2020.
Clovis reported a net loss for Q3 2021 of $67.4 million, or ($0.56) per share, compared to a net loss for Q3 2020 of $78.7 million, or ($0.89) per share. Net loss for Q3 2021 included share-based compensation expense of $7.0 million, compared to $12.5 million for the comparable period of 2020.
Clovis had $171.9 million in cash and cash equivalents as of September 30, 2021. During Q3 2021, the Company established an "at-the-market" equity offering program (ATM) with the capacity to issue up to $125 million of shares of common stock. During Q3, the Company raised $41.5 million in net proceeds through this ATM. Clovis also paid off in full at maturity, the remaining $64.4 million in principal amount outstanding of its 2.50% convertible senior notes due 2021. The Company’s next convertible debt maturity is August 1, 2024 and has a conversion price of $7.29 for a portion, and a conversion price of $6.24 for the remainder.
As of September 30, 2021, the Company had drawn $137.5 million under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial financing and had up to $37.5 million available to draw under the agreement to fund the expenses of the ATHENA trial.
Net cash used in operating activities was $46.1 million for Q3 2021, down 15% from the $54.3 million reported in Q3 2020. Net cash used in operating activities for the first nine months of 2021 was $154.7 million, down 21% from the same period in 2020.
Cash burn in Q3 2021 was $35.5 million, down 6% from $37.7 million in Q3 2020. Cash burn for the first nine months of 2021 was $117.0 million, down 24% from $154.7 million in the first nine months of 2020.
Clovis Oncology Pipeline Highlights
Three Anticipated Rubraca Phase 3 studies on Track for 2022 Readouts
Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are expected in the first quarter of 2022 based on event-based projections. Data from the combination arm of Rubraca plus Opdivo (nivolumab) versus Rubraca monotherapy are expected in the second half of 2022 based on protocol-defined assumptions.
Top-line data from the TRITON3 trial, which is expected to serve as the confirmatory study for Rubraca’s approval in metastatic castration-resistant prostate cancer (mCRPC) as well as a potential second-line label expansion, are expected in the second quarter of 2022. TRITON3 is a Phase 3 study evaluating Rubraca versus physician’s choice of chemotherapy or second-line androgen deprivation therapy in patients with mCRPC with BRCA and ATM mutations.
The three anticipated data readouts, ATHENA monotherapy, ATHENA combination and TRITON3, provide the potential to reach larger patient populations in earlier lines of therapy for ovarian and prostate cancers, in which Rubraca is currently approved in later-line indications. The timing for each full data release is contingent upon the occurrence of the protocol-specified progression-free survival (PFS) events.
LuMIERE Phase 1/2 Study of FAP-2286 Enrolling Patients with FAP-Positive Solid Tumors into Phase 1; Initial Phase 1 LuMIERE Data Expected in 2022
FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development and is the lead candidate in Clovis Oncology’s TRT development program. The ongoing Phase 1 portion of the LuMIERE study, for which enrollment in the second dose cohort is expected to initiate in Q4 2021, 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 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment in LuMIERE. The first presentations of Phase 1 data from LuMIERE are expected at medical meetings in 2022. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types and are expected to initiate in 2022.
Nonclinical data evaluating FAP expression across a variety of solid tumor types were presented at AACR (Free AACR Whitepaper)-NCI-EORTC in October. High FAP expression was observed in multiple indications, including pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous NSCLC, and head and neck cancers as well as in cancers of unknown primary. In these tumor types, high FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. The analysis also demonstrated that in most tumor types, FAP expression was predominantly localized to cancer-associated fibroblasts (CAFs) surrounding the tumor cells and integrated into the tumor microenvironment. In addition, in cancers of mesenchymal origin including sarcoma and mesothelioma, expression was observed in tumor cells in addition to CAFs. These data support the investigation of FAP-2286 in multiple tumor types in the planned Phase 2 expansion cohorts of LuMIERE. Additional presentations of nonclinical data are anticipated at medical meetings over the next few quarters.
In addition, Clovis and ITM Isotope Technologies Munich SE recently announced the signing of a clinical supply agreement that provides Clovis with ITM’s therapeutic radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu), EndolucinBeta, for use in the clinical development of FAP-2286 for the next five years.
For more information about FAP-2286, targeted radionuclide therapy (TRT), or Clovis’ TRT development program, click here.
Conference Call Details
Clovis will hold a conference call this morning, November 3, at 8:30am ET, to discuss Q3 2021 results and provide an update on the Company’s clinical development programs and regulatory and commercial outlook. The conference call will be simultaneously webcast on the Clovis Oncology website at clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (888) 440-4615, International participants (646) 960-0682, conference ID: 2259685.
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.
In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial, ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the US for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.
In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed, high-grade epithelial, ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.
Rubraca is an unlicensed medical product outside the US and Europe.
About FAP-2286
FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements: a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non-small cell lung, squamous head and neck cancers, and cancers of unknown primary. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.
FAP-2286 is an unlicensed medical product.
About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.