On November 5, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2020, 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, NOV 5, 2020, View Source [SID1234570013]).

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"We are pleased that third quarter revenues for Rubraca grew slightly over the same period in 2019, despite a very challenging sales environment caused by COVID-19, which has severely limited oncology patient visits and cancer diagnoses. In addition, oncology practices have substantially limited traditional in-person sales calls – a trend that we see accelerating – and physicians increasingly prefer digital communications and virtual peer-to-peer interactions. In response to this evolving U.S. oncology market, we are shifting to a hybrid commercial strategy to support these preferences. This new strategy incorporates more targeted in-person promotion, online resources for prescribers customized to their practices and new approaches to peer-to-peer interactions. We believe this hybrid strategy will increase awareness and interest in Rubraca. We have undertaken this change with the goal of returning to growth as rapidly as we can, despite cancer diagnoses and cancer patient visits currently remaining lower than pre-COVID-19," said Patrick J. Mahaffy, President and CEO of Clovis Oncology.

"We also remain focused on our growing pipeline activities and in 2021, we anticipate multiple meaningful clinical, development and regulatory milestones. For Rubraca, we anticipate data from the ATHENA monotherapy arm, and pending data, a potential sNDA filing for the LODESTAR pan-tumor study in the second half of 2021. Interim updates from the LIO-1 study of lucitanib and Opdivo in combination are anticipated in 2021. Following allowance of the IND filings for our peptide-targeted radiotherapeutic candidate, FAP-2286, planned for submission this quarter, we plan to initiate a robust clinical development program in early 2021," Mr. Mahaffy continued.

Third Quarter 2020 Financial Results

Clovis reported net product revenue for Rubraca of $38.8 million for the third quarter of 2020, which included U.S. product revenue of $33.9 million and ex-U.S. product revenue of $4.9 million, compared to net product revenue for Q3 2019 of $37.6 million, which included U.S. net product revenue of $36.5 million and ex-U.S. net product revenue of $1.1 million.

Clovis reported net product revenue for Rubraca of $121.2 million for the nine months ended September 30, 2020, which included U.S. product revenue of $109.8 million and ex-U.S. product revenue of $11.4 million, compared to net product revenue for same period in 2019 of $103.7 million, which included U.S. net product revenue of $101.1 million and ex-U.S. net product revenue of $2.6 million.

Clovis Oncology expects global net product revenue for the fourth quarter 2020 to be in a range of $38 million to $40 million. The effects of COVID-19 on future sales are difficult to predict, especially with the increase in COVID-19 cases in the U.S. and Europe.

Research and development expenses totaled $62.9 million for Q3 2020 and $201.0 million for the first nine months of 2020, compared to $77.9 million and $210.7 million for the comparable periods in 2019. Research and development expenses decreased for the third quarter and the first nine months of 2020 compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

Selling, general and administrative expenses totaled $38.6 million for Q3 2020 and $123.1 million for the first nine months of 2020, compared to $41.8 million and $137.6 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the third quarter and first nine months of 2020 compared to the same period in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

Clovis reported a net loss for the third quarter of 2020 of $78.7 million, or ($0.89) per share, and a net loss of $270.3 million, or ($3.37) per share, for the first nine months of 2020. Net loss for Q3 2019 was $94.1 million, or ($1.72) per share, and $300.9 million, or a net loss of ($5.62) per share, for the first nine months of 2019. Net loss for Q3 and the first nine months of 2020 included share-based compensation expense of $12.5 million and $38.8 million, compared to $14.0 million and $41.7 million for the comparable periods of 2019.

Clovis had $224.7 million in cash and cash equivalents as of September 30, 2020.

As of September 30, 2020, the Company had drawn approximately $85 million under the TPG ATHENA clinical trial financing and had up to $90 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the Company’s anticipated revenues, spending, available financing sources and existing cash and cash equivalents, the Company believes it has sufficient cash and cash equivalents to fund its operating plan into early 2022, after taking into account any cash repayment (unless refinanced earlier) of the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021. Assuming the completion of the offering of $50 million of convertible notes announced today, the additional cash proceeds are anticipated to fund the Company’s operating plan into early 2023.

Net cash used in operating activities was $54.3 million for the third quarter of 2020, down from $57.0 million reported in the third quarter of 2019. Similarly, net cash used in operating activities for the first nine months of 2020 was $196.7 million, compared with $253.5 million for the first nine months of 2019.

Cash burn in Q3 2020 was $37.7 million, which represents a 25 percent sequential decrease from the Q2 2020 cash burn of $50.1 million. Borrowings under the TPG ATHENA financing provided $16.6 million in cash in Q3 2020. Cash burn in the first nine months of 2020 was $154.7 million.

Restructured U.S. Commercial Organization

The COVID-19 pandemic has accelerated a preference by oncology practices for more digital programming, including digital peer-to-peer interactions and reduced in-person promotion. In order to meet these changing preferences, the Company is adopting a hybrid commercial strategy combining increased digital promotional activities, greater online resources and more peer-to-peer interactions with reduced and more targeted in-person promotion. Accordingly, new tools and performance indicators based on this hybrid approach are being rolled out during the fourth quarter, and the U.S. commercial organization has been reduced in size by approximately 45 employees. Despite increased investment in digital promotion, we anticipate an effect of adopting this hybrid model will result in annual cost-savings of approximately $10 million. The Company is adopting this strategy in order to better reach customers in the way they want to be reached with the goal of returning to growth, especially as the ongoing impact of COVID-19 is reduced.

FDA-approved Companion Diagnostic to Identify Eligible mCRPC Patients Added to Rubraca U.S. Label

In late August, the U.S. FDA approved the FoundationOne Liquid CDx, Foundation Medicine’s comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca. It is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including Rubraca. In early October, the companion diagnostic for Rubraca in mCRPC was added to the Rubraca U.S. label.

These events follow the U.S. FDA’s May 2020 approval of Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated mCRPC who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial.

Data from the TRITON2 study of Rubraca for the treatment of mCRPC harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology during the quarter. These results supported the May approval and provide additional detail for physicians about the study and about Rubraca as a treatment option for eligible men with mCRPC and a deleterious BRCA1/2 mutation.

Initial Presentations for Lucitanib and Rucaparib Combinations and Preclinical Data for FAP-2286 at Medical Meetings

Six e-posters for Clovis’ three portfolio compounds were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September. These included the following:

Initial data from the Phase 1b part of the LIO-1 trial of lucitanib combined with Opdivo (nivolumab) in advanced metastatic solid tumors which identified a recommended Phase 2 dose and showed promising signs of antitumor activity; also, a Trials In Progress e-poster describing the Phase 2 study currently enrolling patients.
The first presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT), showed the compound potently and selectively binds fibroblast activation protein (FAP); in addition, compelling anti-tumor activity was observed in FAP-expressing tumor models.
New data analyses from pivotal Rubraca studies ARIEL3 and TRITON2 further characterized its safety profile in recurrent ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC), respectively.
Encouraging initial data from the SEASTAR study evaluating Rubraca in combination with Trodelvy (sacituzumab govitecan-hziy).
In addition, in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting in September, data from an exploratory analysis of the ARIEL3 clinical study evaluating Rubraca as maintenance treatment in recurrent ovarian cancer were presented. The findings demonstrate that rucaparib maintenance treatment can lead to a clinically meaningful delay in starting subsequent therapy and lasting clinical benefits in patients with BRCA1- or BRCA2-mutant ovarian cancer.

The data described here are available online at www.clovisoncology.com/pipeline/scientificpresentations.

Lucitanib Combination Studies Underway

The Phase 2 portion of LIO-1 trial evaluating lucitanib and Opdivo in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2) is open for enrollment and the first patient was treated in August. Clovis intends to submit updated interim data from the LIO-1 study for presentation at a 2021 medical meeting.

FAP-2286 and Radionuclide Therapy Development Program

Clovis intends to submit two Investigational New Drug (IND) applications for FAP-2286 for use as imaging and treatment agents respectively. Following allowance of the INDs by the U.S. FDA, Clovis will initiate a Phase 1 study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with expansion cohorts planned in multiple tumor types. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 study.

Conference Call Details

Clovis will hold a conference call to discuss Q3 2020 results this morning, November 5, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.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: 2999168.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed 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 U.S. 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 a 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 of the U.S. and Europe.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe.

FAP-2286 is an unlicensed medical product.