Nature of Business	6 Months Ended
Jun. 30, 2022
Nature of Business
Nature of Business	1. Nature of Business Clovis Oncology, Inc. (together with its consolidated subsidiaries, the “Company”, “Clovis”, “we”, “our”, “us”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets. We target our development programs for the treatment of specific subsets of cancer populations, and simultaneously develop, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. We have and intend to continue to license or acquire rights to oncology compounds in all stages of development. In exchange for the right to develop and commercialize these compounds, we generally expect to provide the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, we generally expect to assume the responsibility for future drug development and commercialization costs. We currently operate in two segments. Since inception, our operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities and since 2016 we have also marketed and sold products. Our marketed product Rubraca® (rucaparib), an oral small molecule inhibitor of poly ADP-ribose polymerase (“PARP”), is marketed in the United States for an indication specific to recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and also an indication specific to metastatic castration-resistant prostate cancer (“mCRPC”). Rubraca received an approval from the United States Food and Drug Administration (“FDA”) in April 2018 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. Diagnostic testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. We have voluntarily withdrawn the initial indication for Rubraca covering the treatment of adult patients with deleterious BRCA (human genes associated with the repair of damaged DNA) mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, for which approval was received from the FDA in December 2016. In May 2020, the FDA approved Rubraca for the treatment of adult patients with mCRPC associated with a deleterious BRCA mutation (germline and/or somatic) who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the TRITON2 clinical trial. As an accelerated approval, 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 Rubraca’s approval in mCRPC as well as the basis for us to seek a potential second-line label expansion. We anticipate the initial data readout from TRITON3 early in the fourth quarter of 2022. In Europe, the European Commission granted a conditional marketing authorization in May 2018 for Rubraca as monotherapy 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. We have voluntarily requested this treatment indication be withdrawn in Europe. In January 2019, the European Commission granted a variation to the marketing authorization to include 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. The approval for this indication is not affected by the voluntarily withdrawal of the later-line treatment indication, and Rubraca is authorized in Europe for certain patients in the recurrent ovarian cancer maintenance setting regardless of their BRCA mutation status. Following successful reimbursement negotiations, Rubraca is marketed in each of Germany, United Kingdom, Italy, France, Spain, the Netherlands and Switzerland. Beyond our labeled indications, we have a clinical development program underway to further evaluate Rubraca in a variety of solid tumor types, either as monotherapy or in combination with other agents, including the ATHENA Phase 3 study as part of our ongoing clinical collaboration with Bristol Myers Squibb Company (“Bristol Myers Squibb”) to evaluate its immunotherapy OPDIVO® (nivolumab) in combination with Rubraca. On March 31, 2022, we announced positive top-line data from the monotherapy portion of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (“PFS”) compared with placebo. Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombination deficiency (HRD-positive), including deleterious BRCA mutations, as well as all patients randomized in the trial (overall intent-to-treat population (“ITT”)). Benefit in PFS was also seen in the exploratory subgroups of patients with BRCA mutant (BRCAm) tumors, BRCA wild type HRD-negative and BRCA wild type HRD-positive and in patients with unknown biomarker status. The safety of Rubraca observed in the ATHENA-MONO study was consistent with both the US and European labels. The portion of the ATHENA trial evaluating the combination of OPDIVO and Rubraca (ATHENA-COMBO) is ongoing. Based on the results of ATHENA-MONO, we are currently preparing an sNDA for submission to the FDA and a Type II variation for submission to the European Medicines Agency (“EMA”) for a first-line maintenance treatment indication for women with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy. In early May 2022, the FDA recommended that we should not submit the first line maintenance sNDA until overall survival (“OS”) data from the ATHENA-MONO trial are as much as 50% mature, and if we do choose to submit prior to that, we should expect the FDA to require a discussion at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in connection with its review of such sNDA submission. In addition, the FDA will consider overall survival data from other rucaparib clinical trials when it reviews the ATHENA-MONO dataset. We currently intend to submit the sNDA during the third quarter of 2022. There can be no assurances regarding the timing or outcome of the FDA review of the sNDA submission. Additionally, we continue to prepare a Type II variation for submission to the EMA for the same indication and plan to submit that filing in the third quarter of 2022 as well. There can be no assurances regarding the timing or outcome of the EMA review of the Type II variation submission. The timing for the Phase 3 data readouts from the ATHENA-COMBO trial is contingent upon the occurrence of the protocol-specified PFS events. We hold worldwide rights to Rubraca. FAP-2286 is our initial product candidate to emerge from our targeted radionuclide collaboration with 3B Pharmaceuticals GmbH (“3BP”). FAP-2286 is a peptide-targeted radionuclide therapy (“PTRT”) and imaging agent targeting fibroblast activation protein (“FAP”). PTRT uses cancer cell-targeting peptides to deliver radiation-emitting radionuclides specifically to tumors. Following the clearance by the FDA of two INDs submitted in December 2020 to support the use of FAP-2286 as an imaging and treatment agent, we initiated the Phase 1 portion of the LuMIERE clinical study in June 2021. LuMIERE is a Phase 1/2 study of FAP-2286 labeled with lutetium-177 (¹⁷⁷Lu-FAP-2286) evaluating the compound in patients with advanced solid tumors to determine the dose, schedule, and tolerability of FAP-2286 as a therapeutic agent with expansion cohorts planned in multiple tumor types as part of a global development program. We are currently enrolling patients in the third dose cohort, and we plan to initiate Phase 2 expansion cohorts during the fourth quarter of 2022. FAP-2286 labeled with gallium-68 (⁶⁸Ga-FAP-2286) is being utilized to identify tumors that contain FAP for treatment in this study. We presented Phase 1 clinical data from LuMIERE in an oral presentation at the Society of Nuclear Medicine & Molecular Imaging (“SNMMI”) 2022 Annual Meeting in June. During 2022, we also anticipate additional presentations of non-clinical data for FAP-2286. In addition to investigating for therapeutic use FAP-2286 labeled with the beta particle-emitting lutetium-177, we are also exploring FAP-2286 labeled with the alpha particle-emitting actinium-225 (Ac-225). We hold US and global rights to FAP-2286, excluding Europe (defined to include Russia, Turkey, and Israel), where 3BP retains rights. We are also collaborating with 3BP on a discovery program directed to up to three additional, undisclosed targets for targeted radionuclide therapy, to which we would have global rights for any resulting product candidates. Lucitanib, another of our small molecule product candidates, is an investigational, oral, potent angiogenesis inhibitor which inhibits vascular endothelial growth factor receptors 1 through 3 (“VEGFR1-3”), platelet-derived growth factor receptors alpha and beta (“PDGFR α/β”) and fibroblast growth factor receptors 1 through 3 (“FGFR1-3”). Lucitanib inhibits the same three pathways as Lenvima® (lenvatinib), which has received an FDA approval for use in certain populations of patients with endometrial cancer in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This, together with preclinical data for lucitanib in combination with a PD-1 inhibitor that demonstrated enhanced anti-tumor activity compared to that of single agents, represent a scientific rationale for development of lucitanib in combination with a PD-1 inhibitor, and in February 2019, lucitanib was added to our clinical collaboration with Bristol Myers Squibb. The Phase 1b/2 LIO-1 study evaluated the combination of lucitanib and Opdivo in gynecologic cancers. Interim data from the non-clear cell ovarian cancer expansion cohort were presented at the American Society of Clinical Oncology (“ASCO”) 2021 and the initial efficacy data do not support further development in non-clear cell ovarian cancer. The remaining three cohorts, which include non-clear cell endometrial, cervical and clear-cell ovarian and endometrial cancers, showed sufficient responses in stage one of each of the cohorts to advance to stage 2. The data from the cervical cohort were presented at the Society of Gynecologic Oncology (“SGO”) 2022 Annual Meeting on Women’s Cancer in March 2022 and represent encouraging data in this subset of gynecological cancers. Phase 2 LIO-1 efficacy and safety data results across the different types of gynecologic cancers were presented at the ASCO 2022 Annual Meeting in June. However, given the competing priorities, including development of FAP-2286, we have determined that we will not pursue further development of lucitanib in gynecological cancers at this time. We hold the global (excluding China) development and commercialization rights for lucitanib. Going Concern and Management Plans We have incurred significant net losses since inception and have relied on our ability to fund our operations through debt and equity financings. We expect operating losses and negative cash flows to continue for the foreseeable future even with Rubraca generating revenues. Rubraca revenues have not been consistent in prior quarters, mainly as a result of the impact of COVID-19 and competition from other products on the market, including the impact on second-line maintenance that may result from an increase in first-line maintenance treatment of ovarian cancer, which has made forecasting revenues difficult. In addition to factors described, future Rubraca revenues will depend, in part, on the timing and extent of any increase in the number of patient visits and diagnoses and their impact on second-line maintenance new patient starts but to a larger extent on our ability to expand the label for Rubraca in the first-line maintenance setting based the results of the ATHENA-MONO trial, which forms the basis of our planned sNDA submission to the FDA in the third quarter of 2022 and the Type II variation submission to the EMA in the third quarter of 2022, and ultimately our ability to compete against two competitors with existing and established labels in the first-line maintenance indication. Until we obtain these approvals (which are uncertain given our interactions with the FDA and EMA described elsewhere in this report), it is unlikely that Rubraca revenues will return to pre-COVID levels and may continue to erode, and any such recovery of revenues is expected to take several quarters from that point forward to have a meaningful impact on our financial results. We do not expect to generate a sufficient amount of Rubraca revenues to finance our cash requirements in the foreseeable future, and which we may never be able to do in sufficient amounts. We require significant cash resources to execute our business plans and we will need to raise additional cash to continue to fund our operating plan. We cannot be certain that additional funding will be available on acceptable terms, or at all, especially given that we will need our stockholders to approve an amendment to our certificate of incorporation to increase the number of shares of common stock that we are authorized to issue. The aforementioned factors, which are largely outside of our control, raise substantial doubt about our ability to continue as a going concern within one year from the date of filing of this quarterly report. Based on our current cash, cash equivalents and liquidity available under our ATHENA clinical financing agreement, together with current estimates for revenues generated by sales of Rubraca, we will need to raise additional capital in the near term in order to fund our operating plan and to continue as a going concern beyond February 2023. Our ability to obtain additional financing (including through collaborating and licensing arrangements) will depend on a number of factors, including, among others, our ability to generate positive data from our clinical studies and to obtain label expansions through regulatory approvals, the condition of the capital markets and the other risks described under Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021 (“2021 Form 10-K”). We expect to finance our operating plan through a combination of public or private equity or debt offerings, collaborations, strategic alliances and other similar licensing arrangements in both the short term and the long term. Our stockholders did not approve a proposed reverse stock split of our common stock at our 2022 Annual Meeting of Stockholders, which would have had the effect of increasing the number of authorized but unissued and unreserved shares of our common stock that are available to be issued. Although approximately 58% of shares voted supported the proposal, the affirmative vote of holders of a majority of our issued and outstanding shares of common stock was necessary for this proposal to be approved. We are currently exploring alternatives and strategies to increase the number of shares of that are voted at our stockholders meetings, including more outreach and engagement with our stockholders and also the offer and sale of super-voting mirrored preferred stock that have been utilized by some of our peers in similar situations. However, until we are able to successfully gain the approval of our stockholders for an increase in our authorized shares of common stock through an amendment to our certificate of incorporation, we will not be able to raise sufficient additional capital through public or private equity offerings (or offerings of securities convertible into our equity securities). We cannot be certain that we will be able to successfully increase the number of authorized but unissued and unreserved shares of our common stock that are available to be issued. We currently only have capacity to issue approximately $14.2 million of additional shares of common stock under our previously established “at-the-market” offering program (“ATM Program”), assuming the remaining authorized but unissued shares of our common stock are sold at an offering price of $1.65 per share, the closing price of our common stock on the Nasdaq Global Select Market on August 3, 2022. There can be no assurance that we will be able to sell any shares of our common stock under the ATM Program or regarding the price at which we will be able to sell any such shares, and any sales of shares of our common stock under the ATM Program may be at prices that result in additional dilution to existing stockholders of the Company. Even in the event we are able to sell the remaining shares of common stock under our ATM Program, the proceeds resulting from such sales would only be sufficient to fund our operating plan for approximately one additional month beyond the current forecast. The purchase of shares in the ATM Program at this point, without us having secured other sources of financing that alone or in combination will provide us with longer term liquidity, is very risky and highly speculative and may result in a complete loss of investment in the near future if we are unable to continue as a going concern. In light of our inability to raise sufficient capital through potential equity offerings (or offerings of securities convertible into equity securities), we are considering other sources of funding, potentially through incurring further indebtedness or entering into strategic partnerships or licensing arrangements for one or more of our products or product candidates in which we may have to give up certain of our future commercialization or other rights to obtain interim funding. We are exploring various partnership and licensing arrangements for our products and product candidates outside the US, some of which depend on our ability to generate positive data from our clinical studies and resolving the current uncertainty around the timing of and our ability to obtain label expansions through regulatory approvals. Additionally, we are currently in preliminary discussions related to partnering certain development and commercialization rights to FAP-2286, for which we seek consideration such as an upfront payment and additional payments in the form of milestones, research and development support and royalties. However, we expect that a significant portion of the consideration would be contingent on future events. No assurances can be made that we will be successful in reaching agreement or entering into such potential arrangement, or that if we do enter into a definitive agreement, that the timing and amounts of such payments, including contingent payments, would be sufficient to meet our liquidity needs in the absence of other sources of funding. In the event that we are unable to raise sufficient additional capital, which is dependent on factors outside of our control, we will need to cut expenses further, including potentially delaying, scaling back, or eliminating certain of our pipeline development programs, and undertake a more significant restructuring of our operations, in order to continue as a going concern and fund our committed obligations and working capital requirements. We have not committed to executing these actions at this time and we estimate that doing so would only save cash sufficient to fund our operating plan for approximately two additional months, at most, beyond the current forecast of February 2023. There can be no assurances that we will be able to achieve such a restructuring or that such a restructuring will be successful over the long term to allow us to fund our requirements and our plan to invest sufficient amounts to fund the development of FAP-2286 to its potential. Certain covenants in our financing agreements and indentures also limit our ability to undertake certain restructuring or cost cutting initiatives without triggering a default or a “fundamental change” (right of the holders of our convertible senior notes to require us to repurchase up to $443.0 million in principal amount). For us to raise sufficient capital to fund our operating plan and to continue as a going concern beyond February 2023, we will most likely need to successfully complete some combination of the partnership opportunities described above and additional equity financings beyond the current ATM Program. We are continuing to evaluate, together with our partners and advisors, our strategic options to provide us the liquidity runway we need to successfully implement our business plans. Basis of Presentation All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments that, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented herein. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”) have been condensed or omitted pursuant to the rules and regulations of the US Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our 2021 Form 10-K for a broader discussion of our business and the opportunities and risks inherent in such business. Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates, including estimates related to revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.

Nature of Business

6 Months Ended

Jun. 30, 2022

1. Nature of Business

Clovis Oncology, Inc. (together with its consolidated subsidiaries, the “Company”, “Clovis”, “we”, “our”, “us”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets. We target our development programs for the treatment of specific subsets of cancer populations, and simultaneously develop, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. We have and intend to continue to license or acquire rights to oncology compounds in all stages of development. In exchange for the right to develop and commercialize these compounds, we generally expect to provide the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, we generally expect to assume the responsibility for future drug development and commercialization costs. We currently operate in two segments. Since inception, our operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities and since 2016 we have also marketed and sold products.

Our marketed product Rubraca® (rucaparib), an oral small molecule inhibitor of poly ADP-ribose polymerase (“PARP”), is marketed in the United States for an indication specific to recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and also an indication specific to metastatic castration-resistant prostate cancer (“mCRPC”). Rubraca received an approval from the United States Food and Drug Administration (“FDA”) in April 2018 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. Diagnostic testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. We have voluntarily withdrawn the initial indication for Rubraca covering the treatment of adult patients with deleterious BRCA (human genes associated with the repair of damaged DNA) mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, for which approval was received from the FDA in December 2016.

In May 2020, the FDA approved Rubraca for the treatment of adult patients with mCRPC associated with a deleterious BRCA mutation (germline and/or somatic) who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the TRITON2 clinical trial. As an accelerated approval, 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 Rubraca’s approval in mCRPC as well as the basis for us to seek a potential second-line label expansion. We anticipate the initial data readout from TRITON3 early in the fourth quarter of 2022.

In Europe, the European Commission granted a conditional marketing authorization in May 2018 for Rubraca as monotherapy 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. We have voluntarily requested this treatment indication be withdrawn in Europe. In January 2019, the European Commission granted a variation to the marketing authorization to include 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. The approval for this indication is not affected by the voluntarily withdrawal of the later-line treatment indication, and Rubraca is authorized in Europe for certain patients in the recurrent ovarian cancer maintenance setting regardless of their BRCA mutation status. Following successful reimbursement negotiations, Rubraca is marketed in each of Germany, United Kingdom, Italy, France, Spain, the Netherlands and Switzerland.

Beyond our labeled indications, we have a clinical development program underway to further evaluate Rubraca in a variety of solid tumor types, either as monotherapy or in combination with other agents, including the ATHENA Phase 3 study as part of our ongoing clinical collaboration with Bristol Myers Squibb Company (“Bristol Myers Squibb”) to evaluate its immunotherapy OPDIVO® (nivolumab) in combination with Rubraca.

On March 31, 2022, we announced positive top-line data from the monotherapy portion of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (“PFS”) compared with placebo. Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombination deficiency (HRD-positive), including deleterious BRCA mutations, as well as all patients randomized in the trial (overall intent-to-treat population (“ITT”)). Benefit in PFS was also seen in the exploratory subgroups of patients with BRCA mutant (BRCAm) tumors, BRCA wild type HRD-negative and BRCA wild type HRD-positive and in patients with unknown biomarker status. The safety of Rubraca observed in the ATHENA-MONO study was consistent with both the US and European labels. The portion of the ATHENA trial evaluating the combination of OPDIVO and Rubraca (ATHENA-COMBO) is ongoing.

Based on the results of ATHENA-MONO, we are currently preparing an sNDA for submission to the FDA and a Type II variation for submission to the European Medicines Agency (“EMA”) for a first-line maintenance treatment indication for women with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy. In early May 2022, the FDA recommended that we should not submit the first line maintenance sNDA until overall survival (“OS”) data from the ATHENA-MONO trial are as much as 50% mature, and if we do choose to submit prior to that, we should expect the FDA to require a discussion at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in connection with its review of such sNDA submission. In addition, the FDA will consider overall survival data from other rucaparib clinical trials when it reviews the ATHENA-MONO dataset. We currently intend to submit the sNDA during the third quarter of 2022. There can be no assurances regarding the timing or outcome of the FDA review of the sNDA submission. Additionally, we continue to prepare a Type II variation for submission to the EMA for the same indication and plan to submit that filing in the third quarter of 2022 as well. There can be no assurances regarding the timing or outcome of the EMA review of the Type II variation submission.

The timing for the Phase 3 data readouts from the ATHENA-COMBO trial is contingent upon the occurrence of the protocol-specified PFS events.

We hold worldwide rights to Rubraca.

FAP-2286 is our initial product candidate to emerge from our targeted radionuclide collaboration with 3B Pharmaceuticals GmbH (“3BP”). FAP-2286 is a peptide-targeted radionuclide therapy (“PTRT”) and imaging agent targeting fibroblast activation protein (“FAP”). PTRT uses cancer cell-targeting peptides to deliver radiation-emitting radionuclides specifically to tumors. Following the clearance by the FDA of two INDs submitted in December 2020 to support the use of FAP-2286 as an imaging and treatment agent, we initiated the Phase 1 portion of the LuMIERE clinical study in June 2021. LuMIERE is a Phase 1/2 study of FAP-2286 labeled with lutetium-177 (¹⁷⁷Lu-FAP-2286) evaluating the compound in patients with advanced solid tumors to determine the dose, schedule, and tolerability of FAP-2286 as a therapeutic agent with expansion cohorts planned in multiple tumor types as part of a global development program. We are currently enrolling patients in the third dose cohort, and we plan to initiate Phase 2 expansion cohorts during the fourth quarter of 2022. FAP-2286 labeled with gallium-68 (⁶⁸Ga-FAP-2286) is being utilized to identify tumors that contain FAP for treatment in this study.

We presented Phase 1 clinical data from LuMIERE in an oral presentation at the Society of Nuclear Medicine & Molecular Imaging (“SNMMI”) 2022 Annual Meeting in June. During 2022, we also anticipate additional presentations of non-clinical data for FAP-2286. In addition to investigating for therapeutic use FAP-2286 labeled with the beta particle-emitting lutetium-177, we are also exploring FAP-2286 labeled with the alpha particle-emitting actinium-225 (Ac-225).

We hold US and global rights to FAP-2286, excluding Europe (defined to include Russia, Turkey, and Israel), where 3BP retains rights. We are also collaborating with 3BP on a discovery program directed to up to three additional, undisclosed targets for targeted radionuclide therapy, to which we would have global rights for any resulting product candidates.

Lucitanib, another of our small molecule product candidates, is an investigational, oral, potent angiogenesis inhibitor which inhibits vascular endothelial growth factor receptors 1 through 3 (“VEGFR1-3”), platelet-derived growth factor receptors alpha and beta (“PDGFR α/β”) and fibroblast growth factor receptors 1 through 3 (“FGFR1-3”).

Lucitanib inhibits the same three pathways as Lenvima® (lenvatinib), which has received an FDA approval for use in certain populations of patients with endometrial cancer in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This, together with preclinical data for lucitanib in combination with a PD-1 inhibitor that demonstrated enhanced anti-tumor activity compared to that of single agents, represent a scientific rationale for development of lucitanib in combination with a PD-1 inhibitor, and in February 2019, lucitanib was added to our clinical collaboration with Bristol Myers Squibb. The Phase 1b/2 LIO-1 study evaluated the combination of lucitanib and Opdivo in gynecologic cancers. Interim data from the non-clear cell ovarian cancer expansion cohort were presented at the American Society of Clinical Oncology (“ASCO”) 2021 and the initial efficacy data do not support further development in non-clear cell ovarian cancer. The remaining three cohorts, which include non-clear cell endometrial, cervical and clear-cell ovarian and endometrial cancers, showed sufficient responses in stage one of each of the cohorts to advance to stage 2. The data from the cervical cohort were presented at the Society of Gynecologic Oncology (“SGO”) 2022 Annual Meeting on Women’s Cancer in March 2022 and represent encouraging data in this subset of gynecological cancers. Phase 2 LIO-1 efficacy and safety data results across the different types of gynecologic cancers were presented at the ASCO 2022 Annual Meeting in June. However, given the competing priorities, including development of FAP-2286, we have determined that we will not pursue further development of lucitanib in gynecological cancers at this time.

We hold the global (excluding China) development and commercialization rights for lucitanib.

Going Concern and Management Plans

We have incurred significant net losses since inception and have relied on our ability to fund our operations through debt and equity financings. We expect operating losses and negative cash flows to continue for the foreseeable future even with Rubraca generating revenues. Rubraca revenues have not been consistent in prior quarters, mainly as a result of the impact of COVID-19 and competition from other products on the market, including the impact on second-line maintenance that may result from an increase in first-line maintenance treatment of ovarian cancer, which has made forecasting revenues difficult. In addition to factors described, future Rubraca revenues will depend, in part, on the timing and extent of any increase in the number of patient visits and diagnoses and their impact on second-line maintenance new patient starts but to a larger extent on our ability to expand the label for Rubraca in the first-line maintenance setting based the results of the ATHENA-MONO trial, which forms the basis of our planned sNDA submission to the FDA in the third quarter of 2022 and the Type II variation submission to the EMA in the third quarter of 2022, and ultimately our ability to compete against two competitors with existing and established labels in the first-line maintenance indication. Until we obtain these approvals (which are uncertain given our interactions with the FDA and EMA described elsewhere in this report), it is unlikely that Rubraca revenues will return to pre-COVID levels and may continue to erode, and any such recovery of revenues is expected to take several quarters from that point forward to have a meaningful impact on our financial results. We do not expect to generate a sufficient amount of Rubraca revenues to finance our cash requirements in the foreseeable future, and which we may never be able to do in sufficient amounts. We require significant cash resources to execute our business plans and we will need to raise additional cash to continue to fund our operating plan. We cannot be certain that additional funding will be available on acceptable terms, or at all, especially given that we will need our stockholders to approve an amendment to our certificate of incorporation to increase the number of shares of common stock that we are authorized to issue. The aforementioned factors, which are largely outside of our control, raise substantial doubt about our ability to continue as a going concern within one year from the date of filing of this quarterly report.

Based on our current cash, cash equivalents and liquidity available under our ATHENA clinical financing agreement, together with current estimates for revenues generated by sales of Rubraca, we will need to raise additional capital in the near term in order to fund our operating plan and to continue as a going concern beyond February 2023.

Our ability to obtain additional financing (including through collaborating and licensing arrangements) will depend on a number of factors, including, among others, our ability to generate positive data from our clinical studies and to obtain label expansions through regulatory approvals, the condition of the capital markets and the other risks described under Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021 (“2021 Form 10-K”). We expect to finance our operating plan through a combination of public or private equity or debt offerings, collaborations, strategic alliances and other similar licensing arrangements in both the short term and the long term.

Our stockholders did not approve a proposed reverse stock split of our common stock at our 2022 Annual Meeting of Stockholders, which would have had the effect of increasing the number of authorized but unissued and unreserved shares of our common stock that are available to be issued. Although approximately 58% of shares voted supported the

proposal, the affirmative vote of holders of a majority of our issued and outstanding shares of common stock was necessary for this proposal to be approved. We are currently exploring alternatives and strategies to increase the number of shares of that are voted at our stockholders meetings, including more outreach and engagement with our stockholders and also the offer and sale of super-voting mirrored preferred stock that have been utilized by some of our peers in similar situations. However, until we are able to successfully gain the approval of our stockholders for an increase in our authorized shares of common stock through an amendment to our certificate of incorporation, we will not be able to raise sufficient additional capital through public or private equity offerings (or offerings of securities convertible into our equity securities). We cannot be certain that we will be able to successfully increase the number of authorized but unissued and unreserved shares of our common stock that are available to be issued.

We currently only have capacity to issue approximately $14.2 million of additional shares of common stock under our previously established “at-the-market” offering program (“ATM Program”), assuming the remaining authorized but unissued shares of our common stock are sold at an offering price of $1.65 per share, the closing price of our common stock on the Nasdaq Global Select Market on August 3, 2022. There can be no assurance that we will be able to sell any shares of our common stock under the ATM Program or regarding the price at which we will be able to sell any such shares, and any sales of shares of our common stock under the ATM Program may be at prices that result in additional dilution to existing stockholders of the Company. Even in the event we are able to sell the remaining shares of common stock under our ATM Program, the proceeds resulting from such sales would only be sufficient to fund our operating plan for approximately one additional month beyond the current forecast. The purchase of shares in the ATM Program at this point, without us having secured other sources of financing that alone or in combination will provide us with longer term liquidity, is very risky and highly speculative and may result in a complete loss of investment in the near future if we are unable to continue as a going concern.

In light of our inability to raise sufficient capital through potential equity offerings (or offerings of securities convertible into equity securities), we are considering other sources of funding, potentially through incurring further indebtedness or entering into strategic partnerships or licensing arrangements for one or more of our products or product candidates in which we may have to give up certain of our future commercialization or other rights to obtain interim funding. We are exploring various partnership and licensing arrangements for our products and product candidates outside the US, some of which depend on our ability to generate positive data from our clinical studies and resolving the current uncertainty around the timing of and our ability to obtain label expansions through regulatory approvals. Additionally, we are currently in preliminary discussions related to partnering certain development and commercialization rights to FAP-2286, for which we seek consideration such as an upfront payment and additional payments in the form of milestones, research and development support and royalties. However, we expect that a significant portion of the consideration would be contingent on future events. No assurances can be made that we will be successful in reaching agreement or entering into such potential arrangement, or that if we do enter into a definitive agreement, that the timing and amounts of such payments, including contingent payments, would be sufficient to meet our liquidity needs in the absence of other sources of funding.

In the event that we are unable to raise sufficient additional capital, which is dependent on factors outside of our control, we will need to cut expenses further, including potentially delaying, scaling back, or eliminating certain of our pipeline development programs, and undertake a more significant restructuring of our operations, in order to continue as a going concern and fund our committed obligations and working capital requirements. We have not committed to executing these actions at this time and we estimate that doing so would only save cash sufficient to fund our operating plan for approximately two additional months, at most, beyond the current forecast of February 2023. There can be no assurances that we will be able to achieve such a restructuring or that such a restructuring will be successful over the long term to allow us to fund our requirements and our plan to invest sufficient amounts to fund the development of FAP-2286 to its potential. Certain covenants in our financing agreements and indentures also limit our ability to undertake certain restructuring or cost cutting initiatives without triggering a default or a “fundamental change” (right of the holders of our convertible senior notes to require us to repurchase up to $443.0 million in principal amount).

For us to raise sufficient capital to fund our operating plan and to continue as a going concern beyond February 2023, we will most likely need to successfully complete some combination of the partnership opportunities described above and additional equity financings beyond the current ATM Program. We are continuing to evaluate, together with our partners and advisors, our strategic options to provide us the liquidity runway we need to successfully implement our business plans.

Basis of Presentation

All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.

The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments that, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented herein. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”) have been condensed or omitted pursuant to the rules and regulations of the US Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our 2021 Form 10-K for a broader discussion of our business and the opportunities and risks inherent in such business.

Use of Estimates

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates, including estimates related to revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.