On February 23, 2022 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended December 31, 2021, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook (Press release, Clovis Oncology, FEB 23, 2022, View Source [SID1234608875]).

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!

"We have been looking forward to 2022 for a long time, which we anticipate will be the most significant year for clinical data read-outs in the Company’s history," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Despite the ongoing impact of COVID-19 on ovarian cancer diagnoses and treatments, and consequently on Rubraca revenues in 2021, our commitment to Phase 3 trials has potentially set the stage for significant label expansion, and therefore sales growth, in both the US and Europe. For Rubraca, we anticipate three Phase 3 read-outs during the year: ATHENA-MONO as monotherapy in the first-line ovarian cancer maintenance treatment setting now anticipated during Q2 based on a slower than expected event count, TRITON3 in the second-line prostate cancer treatment setting for selected patients during Q2, and ATHENA-COMBO in combination with Opdivo in the first-line ovarian cancer maintenance treatment setting in the fourth quarter of 2022. In addition, for FAP-2286, we continue to enroll the Phase 1 portion of LuMIERE and believe we are maintaining our lead in the clinical development of an FAP-targeted radionuclide therapeutic candidate. We and our investigators are extremely enthusiastic about this program and look forward to both presenting data at nuclear medicine meetings during 2022 and initiating the Phase 2 portion of the LuMIERE study later this year."

Fourth Quarter and Year-End 2021 Financial Results

Clovis reported global net product revenues for Rubraca of $36.0 million for Q4 2021, which included US product revenues of $27.6 million and ex-US product revenues of $8.4 million, respectively. This represents a sequential 5% decrease from Q3 2021 and a 17% decrease year-over-year, compared to Q4 2020 net product revenues of $43.3 million, which included US net product revenues of $36.4 million and ex-US net product revenues of $6.9 million. The decrease in revenues for the quarter and year was primarily due to fewer ovarian cancer diagnoses and fewer patients treated in the US related to the ongoing impact of COVID-19.

Rubraca global net product revenues for 2021 were $148.8 million, which included $115.7 million in the US and $33.1 million in ex-US product revenues, respectively. This represents a 10% percent decrease compared to 2020 net product revenues of $164.5 million, which included $146.3 million in the US and ex-US net product revenues of $18.2 million.

Research and development expenses totaled $41.8 million for Q4 2021 and $186.6 million for FY 2021, down 26% and 28%, respectively, compared to $56.7 million and $257.7 million for the comparable periods in 2020. Research and development expenses decreased for the quarter and year compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials.

Selling, general and administrative expenses totaled $33.3 million for Q4 2021 and $128.4 million for FY 2021, down 18% and 22%, respectively, compared to $40.8 million and $163.9 million for the comparable periods in 2020. Selling, general and administrative expenses decreased during the quarter and year compared to the same periods in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

Clovis reported a net loss for Q4 2021 of $64.4 million, or ($0.50) per share, and a net loss of $264.5 million, or ($2.29) per share, for FY 2021. Net loss for Q4 2020 was $99.0 million, or ($1.02) per share, and $369.2 million, or a net loss of ($4.38) per share, for FY 2020. Net loss for Q4 and FY 2021 included share-based compensation expense of $7.1 million and $25.5 million, compared to $12.0 million and $50.8 million for the comparable periods of 2020.

Clovis had $143.4 million in cash and cash equivalents as of December 31, 2021. During Q4 2021, the Company raised $3.0 million in net proceeds, and in Q1 2022 so far has raised $27.2 million in net proceeds through its previously established "at-the-market" equity offering program (the "ATM Program"). The Company currently has capacity to issue additional shares of common stock under this ATM program. Clovis remains focused on its liquidity position and is committed to raising additional capital in the near term in order to fund its operating plan for the next 12 months and beyond.

Clovis also paid off in full at maturity 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 December 31, 2021, the Company had drawn $147.2 million under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial financing and had up to $27.8 million available to draw under the agreement to fund the expenses of the ATHENA trial.

Net cash used in operating activities was $41.3 million for 4Q 2021, down from $56.1 million reported in 4Q 2020. Similarly, net cash used in operating activities for FY 2021 was $196.1 million, compared with $252.7 million for FY 2020. Cash burn in Q4 2021 was $31.6 million, down 23% from the Q4 2020 quarter cash burn of $40.9 million. Cash burn for the twelve months ended December 31, 2021 was $148.6 million, down 24% from the twelve months ended 2020 cash burn of $195.6 million.

Clovis Oncology Pipeline Highlights

Three Anticipated Rubraca Phase 3 Studies on Track for 2022 Read-Outs

Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) are expected in the second quarter of 2022 based on a slower than expected event count. Data from the combination arm of Rubraca plus Opdivo (nivolumab) versus Rubraca monotherapy (ATHENA-COMBO) are expected in the fourth quarter of 2022.

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 read-outs, ATHENA-MONO, ATHENA-COMBO and TRITON3, provide the potential to reach larger patient populations in earlier lines of therapy for ovarian and prostate cancers. Beyond the opportunity for monotherapy Rubraca in first-line ovarian cancer, the ATHENA-COMBO study represents the potential to introduce an anti-PD-1-containing regimen for the first time into a broad population of ovarian cancer patients.

The timing for each Phase 3 data read-out is contingent upon the occurrence of the protocol-specified progression-free survival (PFS) events, and timing estimates are based on event-based projections.

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 Phase 1 portion of the LuMIERE study, for which enrollment in the second dose cohort is currently ongoing, 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) is being 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 nuclear medicine-focused 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.

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, February 23, at 8:30am ET, to discuss Q4 and Full Year 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.