On August 4, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2021, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year (Press release, Clovis Oncology, AUG 4, 2021, View Source [SID1234585672]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While these are obviously complicated times, I’m encouraged that, based on the data available to us, we have maintained our US market share for Rubraca and achieved meaningful growth in Europe in the second-line maintenance ovarian cancer setting, and significantly advanced our development and pipeline programs during the quarter," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Importantly, in the next six to 18 months, we expect three Phase 3 data read-outs for Rubraca, potentially expanding the number of ovarian and prostate cancer patients eligible for Rubraca treatment in the US and Europe, which we anticipate will drive growth in sales. In addition, we achieved a significant milestone in the second quarter with the initiation of our Phase 1/2 LuMIERE clinical study of FAP-2286, the first peptide-targeted radionuclide therapeutic targeting FAP in clinical development. This represents the first of multiple anticipated milestones in our strategy to develop innovative precision-targeted radiotherapies for a broad range of tumors."

Second Quarter 2021 Financial Results

Clovis reported global net product revenues for Rubraca of $36.8 million for Q2 2021, which included US product revenues of $27.7 million and ex-US product revenues of $9.1 million, respectively. This represents an 8% decrease year-over-year, compared to Q2 2020 net product revenues of $39.9 million, which included US net product revenues of $36.7 million and ex-US net product revenues of $3.2 million. The decrease was primarily due to fewer diagnoses and fewer patient starts, due to the ongoing COVID-19 pandemic.

Clovis reported net product revenue for Rubraca of $74.9 million for the six months ended June 30, 2021, which included US product revenue of $59.4 million and ex-U.S. product revenue of $15.5 million, compared to net product revenue for same period in 2020 of $82.5 million, which included US net product revenue of $76.0 million and ex-US net product revenue of $6.5 million.

Research and development expenses totaled $45.8 million for Q2 2021, down 35% compared to $69.9 million for the comparable period in 2020, due primarily to lower spending on Rubraca clinical trials. For the six months ended June 30, 2021, research and development expenses totaled $98.6 million, down 29% compared to $138.1 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 $32.9 million for Q2 2021, down 21% compared to $41.9 million for the comparable period in 2020, due to overall cost reduction efforts. For the six months ended June 30, 2021, selling, general and administrative expenses totaled $62.9 million, down 26% compared to $84.5 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 Q2 2021 of $66.4 million, or ($0.61) per share, compared to a net loss for Q2 2020 of $92.2 million, or ($1.15) per share. Net loss for Q2 2021 included share-based compensation expense of $7.4 million, compared to $13.3 million for the comparable period of 2020.

Clovis had $230.2 million in cash and cash equivalents as of June 30, 2021. During Q2 2021, the Company raised $72.5 million in net proceeds through its "at-the-market" equity offering program.

As of June 30, 2021, the Company had drawn $126.9 million under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial financing and had up to $48.1 million available to draw under the agreement to fund the expenses of the ATHENA trial.

Net cash used in operating activities was $46.8 million for Q2 2021, down 22% from the $59.9 million reported in Q2 2020. Net cash used in operating activities for the first six months of 2021 was $108.6 million, down 24% from the same period in 2020.

Cash burn in Q2 2021 was $33.4 million, down 33% from $50.1 million in Q2 2020. Cash burn for the first six months of 2021 was $81.5 million, down 30% from $117.0 million in the first six months of 2020.

Clovis Oncology Pipeline Highlights

Three Anticipated Rubraca Phase 3 Read-outs in Next 6 to 18 Months

Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are now 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 data readout is contingent upon the occurrence of the protocol-specified progression-free survival (PFS) events.

LuMIERE Phase 1/2 Study of FAP-2286 Now Opened for Enrollment

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. Following FDA clearance of each of the treatment and imaging IND applications for FAP-2286, Clovis opened enrollment for the Phase 1/2 LuMIERE clinical study. The Phase 1 portion of the LuMIERE study will evaluate the safety of the FAP-targeting investigational therapeutic agent and 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. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

Conference Call Details

Clovis will hold a conference call this morning, August 4, at 8:30 a.m. ET to discuss Q2 2021 results and provide an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year. 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 (877) 698-7048, International participants (647) 689-5448, conference ID: 3887398.

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. FAP is highly expressed on cancer-associated fibroblasts (CAFs) in many epithelial cancers, including more than 90% of breast, lung, colorectal, and pancreatic carcinomas.i 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.