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INOVIO Reports First Quarter 2022 Financial Results and Program Developments

On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported financial results for the quarter ended March 31, 2022 and announced recent program and corporate developments (Press release, Inovio, MAY 10, 2022, View Source [SID1234614074]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

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In a separate press release, the Company announced the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO). Dr. Shea, INOVIO’s former Chief Operating Officer, succeeds Dr. J. Joseph Kim in these roles.

"We believe in the potential of our DNA medicines and vaccines to combat infectious diseases, cancer and HPV-associated diseases," said Dr. Jacqueline Shea, President and CEO of INOVIO. "To achieve these goals, INOVIO must strategically prioritize our resources to capitalize on its demonstrated ability to generate functional T-cell and antibody immune responses, lack of anti-vector response, tolerability for re-administration and favorable temperature stability for transport, storage and distribution."

First Quarter Program Updates

COVID-19: INNOVATE

INOVIO has decided to prioritize its COVID-19 efforts to advance its heterologous booster strategy. In so doing, the company will discontinue its Phase 3 INNOVATE trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases1, which would necessitate an increase in trial size and costs for INNOVATE. In contrast, the heterologous booster market offers greater opportunities as the world prepares to enter the endemic phase of COVID-19.

COVID-19: Heterologous Booster – Preliminary Data

With its partner, Advaccine, INOVIO reported positive T cell immune response data with INO-4800 as a heterologous booster to an inactivated COVID-19 vaccine. This data came from a heterologous booster clinical trial conducted by Advaccine that assessed the immune responses following a primary series of two doses of an inactivated COVID-19 vaccine followed by a booster with INO-4800 after 3 or 6 months. Interim immunogenicity data showed that using INO-4800 as a booster after 6 months resulted in a 6.3-fold increase in T cell immune response. In a separate Advaccine study where a third dose of an inactivated COVID-19 vaccine was assessed, the cellular response increased by 1.7-fold. The highest booster effect of INO-4800 was observed with a 2 mg dose of INO-4800 delivered 6 months after a primary series with an inactivated vaccine.

Following INO-4800 vaccination, the preservation of cross-reactive T cell responses remains a consistent observation against multiple SARS-CoV-2 variants of concern, including Omicron, without a significant loss in response magnitude. T cells that can recognize SARS-CoV-2 may play a role in reducing disease severity. Therefore, INO-4800 has the potential to play an important role in reducing incidence of severe COVID-19 cases, which could reduce hospitalizations as the virus continues to mutate and new variants arise.

INOVIO is continuing discussions with regulators in select countries regarding potential regulatory pathways for licensure. The Company believes the increased global awareness about the importance of T cell immune responses and durability of protection for effective booster vaccines correspond well with INO-4800’s key strength – its ability to generate CD8+ T cell responses against SARS-CoV-2.

INOVIO is planning to expand its partnership with Advaccine beyond INO-4800 to include heterologous boosters and vaccine candidates covering future variants. The expanded partnership will allow both companies to share data, leverage Advaccine’s multiple manufacturing sites in China, and access opportunities globally.

VGX-3100: HPV-associated Cervical High-Grade Squamous Intraepithelial Lesions (HSIL)

Based on feedback from the U.S. Food and Drug Administration (FDA), INOVIO has changed its development plans for VGX-3100 for HPV-16/18-associated cervical HSIL to a biomarker-selected population. In a recent preliminary letter, the FDA advised INOVIO that the REVEAL2 Phase 3 study would not be sufficient to support approval of a potential marketing application for VGX-3100 in that population. The FDA recommended that using REVEAL2 as an exploratory study to evaluate a biomarker-selected population and then conducting one or two additional well-controlled trials in the biomarker-positive population would be more likely to provide sufficient evidence to support approval of a marketing application.

To better assess potential efficacy in a biomarker-selected population, the Company plans to amend the fully enrolled REVEAL2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. Both the biomarker-positive population and the all-comers population will be analyzed.

INOVIO will continue its REVEAL2 trial to completion and assess the path forward for the VGX-3100 program following analysis of the REVEAL2 results. Given the likelihood for at least one additional trial, INOVIO no longer expects to submit a BLA in 2023 for VGX-3100.

INO-3107: Recurrent Respiratory Papillomatosis (RRP)

INOVIO completed enrollment of 32 participants in the open-label, multicenter Phase 1/2 trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in participants with HPV-6/11-associated RRP who have required at least two interventions in the past year for the removal of associated papilloma(s). For this study, adult participants will first undergo removal of their papilloma(s) and will subsequently receive four doses of INO-3107, one every three weeks. The efficacy endpoint will be a reduction in the frequency of therapeutic interventions following the first dose of INO-3107 relative to the frequency prior to study therapy.

INOVIO expects preliminary efficacy, safety and immunogenicity data from a portion of participants from this Phase 1/2 trial in the second half of this year. The Company will share additional clinical development plans after analysis of the data.

INO-5401: Newly Diagnosed Glioblastoma Multiforme (GBM)

INOVIO’s abstract providing follow-up Phase 1/2 overall survival, safety and immunogenicity data from the Company’s novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed GBM has been selected for oral presentation as part of an Oral Abstract Session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting under the title "Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma".

The complete text of the abstract will be posted on the website, meetings.asco.org, on May 26, 2022 at 5:00 PM EDT. The 2022 ASCO (Free ASCO Whitepaper) Annual Meeting will take place on June 3-7, 2022 at the McCormick Place Convention Center in Chicago, Illinois.

First Quarter 2022 Financial Results

INOVIO reported total revenue was $199,000 for the three months ended March 31, 2022, compared to $371,000 for the same period in 2021. Total operating expenses were $71.9 million compared to $52.9 million for the same period in 2021.

INOVIO’s net loss for the quarter ended March 31, 2022, was $79.1 million, or $0.36 per basic and diluted share, compared to net loss of $54.4 million, or $0.27 per basic and diluted share, for the quarter ended March 31, 2021.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2022, were $56.0 million compared to $39.0 million for the same period in 2021. The increase in R&D expenses was primarily related to higher drug manufacturing and clinical trial expenses related to INO-4800 and higher employee compensation. The increase was also due to $6.3 million lower contra-research and development expense recorded from grant agreements. These increases were offset by lower engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project, among other variances.

General and administrative (G&A) expenses were $16.0 million for the three months ended March 31, 2022, versus $13.9 million for the same period in 2021. The increase in G&A expenses was primarily related to an increase in employee compensation and insurance expenses, among other variances.

Capital Resources

As of March 31, 2022, cash and cash equivalents and short-term investments were $360.4 million compared to $401.3 million as of December 31, 2021. As of March 31, 2022, the Company had 226.5 million common shares outstanding and 247.8 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended March 31, 2022, which can be accessed at: View Source

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Daylight Time today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

INOVIO Announces the Appointment of Jacqueline Shea, Ph.D., as Chief Executive Officer

On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO) of INOVIO, effective immediately (Press release, Inovio, MAY 10, 2022, View Source [SID1234614073]). Dr. Shea succeeds Dr. J. Joseph Kim in these roles. Dr. Kim has also resigned as a member of the INOVIO board of directors, and the board intends to appoint Dr. Shea as a director following INOVIO’s annual meeting of the stockholders on May 16, 2022.

Mr. Simon X. Benito, Chairman of the Board of INOVIO, said, "On behalf of the entire Board, I am pleased to announce Dr. Shea’s appointment as President and CEO of INOVIO. Dr. Shea brings more than 25 years of experience in the life sciences and biotech industries. Since joining as Chief Operating Officer in March 2019, Dr. Shea has shown exceptional leadership and technical expertise overseeing INOVIO’s manufacturing, commercial, business development, project and alliance management operations as well as serving as a key member of the executive team. We look forward to Dr. Shea taking the helm during a particularly challenging period in INOVIO’s history. Her tenured leadership, deep knowledge of our business, and broad expertise makes her an excellent choice for the role."

Mr. Benito added, "On behalf of the Board, I would like to thank Dr. Kim for his commitment to INOVIO and his founding vision of a world free from disease through DNA medicines. As a co-founder of the Company, Joseph has been a true entrepreneur and pioneer in the field of vaccines and immunotherapies since its inception. I am pleased that he has agreed to act in an advisory capacity to Dr. Shea during the transition."

Dr. Shea said, "I am honored to take on the role of CEO and grateful for the support of the Board in entrusting me to lead INOVIO for its next chapter. While we have many challenges to face, I believe strongly in the potential of our DNA medicines technology and continue to be inspired by INOVIO’s talented and dedicated team. I look forward to reshaping the future of INOVIO and advancing our efforts across multiple therapeutic areas with the potential to improve the lives of patients globally."

Prior to joining INOVIO in March 2019, Dr. Shea served as the Chief Operating Officer and later the Chief Executive Officer of Aeras, a not-for-profit organization dedicated to developing new vaccines against tuberculosis (TB). During her tenure she oversaw two major clinical trial breakthroughs in the development of TB vaccines. Previously, she held executive roles at Emergent BioSolutions and was also the General Manager and Vice President of The Oxford-Emergent Tuberculosis Consortium. A molecular biologist and cell cycle geneticist, Dr. Shea received a BSc Hons in Applied Biology from the University of Bath and holds a Ph.D. from the National Institute for Medical Research in the United Kingdom. She has been named as an inventor on more than 20 patents, has authored numerous publications, served on multiple advisory boards and currently serves on the board of Trustees for the Sabin Vaccine Institute.

Quarterly Statement First Quarter of 2022

Viracta Therapeutics Reports First Quarter 2022 Financial Results and Recent Updates

On May 10, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported financial results for the first quarter of 2022 and provided an update on recent corporate progress (Press release, Viracta Therapeutics, MAY 10, 2022, View Source [SID1234614072]).

"We have made encouraging progress in both clinical programs with our all-oral drug product candidate, Nana-val, which are advancing towards potential key catalysts in the second half of the year," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Since the first patient was dosed in January, our Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors has proceeded nicely and we anticipate reporting preliminary safety and efficacy data later this year. In addition, we are pleased to have expanded the clinical reach of NAVAL-1 beyond North America into Europe as well as Asia, and anticipate having an update on cohorts advancing into Stage 2 of the trial later this year."

First Quarter 2022 and Recent Highlights

Clinical

Continued global expansion and enrollment into NAVAL-1, the pivotal trial of Nana-val (nanatinostat and valganciclovir) for the treatment of patients with relapsed/refractory EBV+ lymphoma. NAVAL-1 employs a Simon two-stage design where patients are initially enrolled into six cohorts based on lymphoma subtype in Stage 1. If a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. Lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded. If successful, the Company believes NAVAL-1 could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. Clinical sites are open across the globe, including in the U.S., Canada, Europe, and Asia. The Company anticipates providing an update on the initial cohort(s) that may advance into Stage 2 of the trial in the second half of the year.
Dosed first patient in the Phase 1b/2 trial of Nana-val in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other EBV+ solid tumors. Enrollment continues in the Phase 1b dose escalation part of the study, which is designed to evaluate safety and determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2, up to 60 patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. Viracta anticipates reporting preliminary Phase 1b safety and efficacy data from the trial in the second half of 2022.
Corporate

Hosted key opinion leader webinar on Nana-val for the treatment of advanced EBV+ solid tumors. The webinar featured presentations from key opinion leader Ezra Cohen, MD, FRCPSC, FASCO (University of California, San Diego) and members of the Viracta management team. Topics discussed included the current treatment landscape and unmet medical need in NPC, the design of the Phase 1b/2 trial of Nana-val in advanced EBV+ solid tumors, and preclinical data supporting the trial. A replay of the webinar is available here.
Anticipated 2022 Milestones

Provide preliminary Phase 1b safety and efficacy data from the Phase 1b/2 trial in advanced EBV+ solid tumors: 2H 2022
Update on NAVAL-1 cohort(s) that may progress from Stage 1 to Stage 2: 2H 2022
First Quarter 2022 Financial Results

Cash Position – Cash and cash equivalents totaled approximately $92.2 million as of March 31, 2022, which Viracta expects will be sufficient to fund its operations into mid-2024, excluding any borrowing under its previously announced $50.0 million credit facility from Silicon Valley Bank and Oxford Finance.
Research and development expenses – Research and development expenses were approximately $6.1 million for the three months ended March 31, 2022, compared to $4.0 million for the same period in 2021. The increase in research and development expenses for the three months ended March 31, 2022, was primarily due to increases in costs incurred to support the initiation of the NAVAL-1 and solid tumor trials as well as an increase in headcount and non-cash share-based compensation.
Acquired in-process research and development – For the three months ended March 31, 2021, the acquired in-process research and development included non-cash and non-recurring cost of $84.5 million associated with the estimated fair value of the in-process research and development projects acquired in the Sunesis asset acquisition with no alternative future use, which was charged to expense on the Sunesis merger date.
General and administrative expenses – General and administrative expenses were approximately $4.3 million for the three months ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase was largely due to incremental costs associated with being a publicly traded company including directors and officers’ insurance costs, and non-cash share-based compensation.
Gain on Royalty Purchase Agreement – For the three months ended March 31, 2021, the gain was associated with upfront proceeds of $13.5 million recorded in connection with the multi-license milestone and royalty monetization transaction with XOMA (US) LLC.
Adjusted loss from operations – There was not a comparative adjustment to loss from operations for the quarter ended March 31, 2022. Adjusted income from operations for the quarter ended March 31, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $5.6 million, compared to an unadjusted loss from operations of $78.8 million.
Net loss – Net loss was approximately $10.5 million, or $0.28 per share (basic and diluted) for the quarter ended March 31, 2022, compared to a net loss of $79.2 million or $5.22 per share for the same period in 2021.
About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden and is also associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.

Exelixis Announces First Quarter 2022 Financial Results and Provides Corporate Update

On May 10, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2022 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones (Press release, Exelixis, MAY 10, 2022, View Source [SID1234614071]).

"Exelixis had a strong start to 2022 as we continued to gain momentum across all components of our business," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "We are pleased with the growth of the cabozantinib franchise, driven by increased demand for CABOMETYX (cabozantinib) in combination with OPDIVO (nivolumab) in the first-line renal cell carcinoma setting, as well as by the initial impact of the drug’s most recent U.S. label expansion into differentiated thyroid cancer. As we strive to help as many eligible cancer patients as possible benefit from cabozantinib, we look forward to top-line results from the COSMIC-313, CONTACT-01 and CONTACT-03 pivotal phase 3 clinical trials expected over the course of this year."

Dr. Morrissey continued: "Cabozantinib franchise revenues fuel the growth of our expanding pipeline, which now comprises four differentiated clinical-stage programs. We are on track to initiate the pivotal trial series for XL092 beginning in the second quarter of 2022 with the first phase 3 trial, STELLAR-303, which will evaluate the compound in combination with atezolizumab in a form of colorectal cancer, and we expect to advance the ongoing phase 1 studies of XL092, XB002 and XL102, and to present initial data from these trials later this year. Additionally, in April we initiated the first-in-human phase 1 trial of XL114, our small molecule inhibitor of the CARD11-BCL10-MALT1 complex. As our pipeline advances, we are building out our infrastructure, both on our Alameda campus as well as in the Greater Philadelphia area through our Exelixis East expansion. I look forward to providing further updates on our progress throughout the year and want to thank the Exelixis team for their collective hard work and execution as we advance our mission to help cancer patients recover stronger and live longer."

First Quarter 2022 Financial Results

Total revenues for the quarter ended March 31, 2022 were $356.0 million, compared to $270.2 million for the comparable period in 2021.

Total revenues for the quarter ended March 31, 2022 included net product revenues of $310.3 million, compared to $227.2 million for the comparable period in 2021. The increase in net product revenues was due to an increase in sales volume, primarily as a result of the growth in the number of units sold following the FDA’s approval of CABOMETYX in combination with OPDIVO as a first-line treatment of patients with advanced RCC in January 2021 and in part due to the longer duration of therapy for this combination. The increase in net product revenues was partially offset by increases in discounts and allowances, primarily from higher utilization by covered entities in the 340B Drug Pricing Program, an increase in Medicaid utilization and an increase in Exelixis’ co-pay assistance for commercially insured patients.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $45.7 million for the quarter ended March 31, 2022, compared to $43.0 million for the comparable period in 2021. The increase in collaboration revenues was primarily related to higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda), which was partially offset by a decrease in development cost reimbursements.

Research and development expenses for the quarter ended March 31, 2022 were $156.7 million, compared to $159.3 million for the comparable period in 2021. The decrease in research and development expenses was primarily related to decreases in license and other collaboration costs and stock-based compensation expense, which was partially offset by increases in personnel expenses.

Selling, general and administrative expenses for the quarter ended March 31, 2022 were $102.9 million, compared to $102.4 million for the comparable period in 2021. The increase in selling, general and administrative expenses was primarily related to increases in personnel expenses and marketing costs, which was partially offset by a decrease in stock-based compensation expense.

Provision for (benefit from) income taxes for the quarter ended March 31, 2022 was $16.7 million, compared to $(3.6) million for the comparable period in 2021, primarily due to the change in pre-tax income (loss).

GAAP net income for the quarter ended March 31, 2022 was $68.6 million, or $0.21 per share, basic and diluted, compared to GAAP net income of $1.6 million, or $0.01 per share, basic and $0.00 per share, diluted, for the comparable period in 2021.

Non-GAAP net income for the quarter ended March 31, 2022 was $83.9 million, or $0.26 per share, basic and diluted, compared to non-GAAP net income of $28.5 million, or $0.09 per share, basic and diluted, for the comparable period in 2021.

Cash, cash equivalents, restricted cash equivalents and investments were $2.0 billion at March 31, 2022, compared to $1.9 billion at December 31, 2021.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented.

Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

2022 Financial Guidance

Exelixis is maintaining the following previously provided financial guidance for fiscal year 2022:

(1) Includes $45 million of non-cash stock-based compensation expense.

(2) Includes $50 million of non-cash stock-based compensation expense.

Cabozantinib Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $310.3 million during the first quarter of 2022, up 3% over the prior quarter, with net product revenues of $302.8 million from CABOMETYX and $7.5 million from COMETRIQ (cabozantinib). Exelixis earned $27.0 million in royalty revenues during the quarter ended March 31, 2022, pursuant to collaboration agreements with its partners, Ipsen and Takeda.

Completion of Enrollment in CONTACT-03 Pivotal Trial of Cabozantinib in Combination with Atezolizumab in Previously Treated Metastatic Renal Cell Carcinoma (RCC). In January 2022, Exelixis announced that enrollment was complete for CONTACT-03, the global phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab versus cabozantinib alone in patients with locally advanced or metastatic clear cell or non-clear cell RCC who progressed during or following treatment with an immune checkpoint inhibitor (ICI). CONTACT-03 enrolled 523 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of cabozantinib alone. The primary endpoints of the trial are progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors v. 1.1 as assessed by independent radiology review and overall survival (OS). Secondary endpoints include PFS, objective response rate (ORR) and duration of response as assessed by study investigators. CONTACT-03 is sponsored by F. Hoffmann-La Roche Limited and co-funded by Exelixis. Interim data from the trial are anticipated in the second half of 2022.

Cabozantinib Data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2022). In January 2022, investigators presented encouraging data from two trials of cabozantinib in combination with ICIs for the treatment of advanced colorectal cancer (CRC) at ASCO (Free ASCO Whitepaper) GI 2022. The results reinforce Exelixis’ decision to pursue clinical development of XL092, which pairs a target profile similar to cabozantinib with a potentially significantly improved safety profile, in advanced CRC through the STELLAR-303 global phase 3 pivotal trial expected to initiate in the second quarter of 2022.

Cabozantinib Data at the 2022 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU 2022). In February 2022, cabozantinib was the subject of multiple data presentations at ASCO (Free ASCO Whitepaper) GU 2022. Notable presentations include two additional data sets from the phase 3 pivotal CheckMate -9ER study providing final OS analysis and organ-specific target lesion assessments with two-year follow-up, and updated health-related quality of life results.

Announcement of Final OS Results from Phase 3 COSMIC-312 Trial in Patients with Previously Untreated Advanced Hepatocellular Carcinoma (HCC). In March 2022, Exelixis announced results from the final analysis of the second primary endpoint of OS from the phase 3 COSMIC-312 trial, which evaluated cabozantinib in combination with atezolizumab versus sorafenib in patients with previously untreated advanced HCC. The final analysis showed neither improvement nor detriment in OS for cabozantinib in combination with atezolizumab versus sorafenib. Based on this outcome for OS and the rapidly evolving treatment landscape for previously untreated advanced HCC, Exelixis decided not to submit a supplemental New Drug Application to the U.S. FDA.

Exelixis’ Partner Ipsen Receives European Commission (EC) and Health Canada Approvals for CABOMETYX for Patients with Previously Treated Radioactive Iodine (RAI)-Refractory Differentiated Thyroid Cancer (DTC). In May 2022, Exelixis announced its partner Ipsen received approval from the EC for CABOMETYX as a monotherapy for the treatment of adult patients with locally advanced or metastatic DTC, refractory or not eligible to RAI who have progressed during or after prior systemic therapy. This approval allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union, Norway, Liechtenstein and Iceland. Similarly, in late April 2022, Ipsen received approval from Health Canada to market CABOMETYX for a similar DTC indication in Canada. Both approvals were based on the positive results of the phase 3 COSMIC-311 pivotal trial.

Cabozantinib Data Presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. In June 2022, cabozantinib will be the subject of 13 presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, being held from June 3-7 in Chicago. Notable presentations will include results from cohorts 7 and 20 in non-small cell lung cancer and cohorts 3, 4 and 5 in urothelial carcinoma from the ongoing COSMIC-021 study evaluating cabozantinib in combination with atezolizumab across multiple tumor types, and a phase 2 investigator-sponsored trial from the Emory Winship Cancer Institute evaluating the combination of cabozantinib and pembrolizumab in recurrent metastatic head and neck squamous cell carcinoma.

Pipeline Highlights

Amendment of Option and License Agreement for XB002, an Antibody-Drug Conjugate (ADC) Targeting Tissue Factor (TF). In January 2022, Exelixis and Iconic Therapeutics, Inc. (Iconic) announced amended terms to their May 2019 exclusive option and license agreement for XB002, a next-generation TF-targeting ADC. Under the amended agreement, Exelixis acquired broad rights to use the anti-TF antibody incorporated into XB002 for any application, including conjugated to other payloads, as well as rights within oncology to a number of other anti-TF antibodies developed by Iconic, including for use in ADCs and multispecific biotherapeutics. Based on early clinical data supportive of a potentially differentiated and best-in-class profile, Exelixis intends to aggressively expand development of XB002, both as a monotherapy and in combination with ICIs and other targeted therapies, across a wide range of tumor types, including indications other than those currently addressed by commercially available TF-targeted therapies. Exelixis expects to provide clinical updates from the ongoing phase 1 study of XB002 in the second half of 2022.

Initiation of First-In-Human Phase 1 Trial Evaluating XL114 Monotherapy in Patients with Non-Hodgkin’s Lymphoma (NHL). In April 2022, Exelixis announced the initiation of the dose-escalation stage of the first-in-human phase 1 trial of XL114, a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 complex, as a monotherapy in patients with NHL who have received prior standard therapies. The objectives of the study are to determine the recommended dose and/or the maximum tolerated dose of XL114 and to evaluate the safety and preliminary efficacy of XL114 in patients with NHL. The dose-escalation stage will determine the recommended dose of XL114 in patients with advanced B- and T-cell NHL. In the cohort-expansion stage, the safety and preliminary efficacy of XL114 will be further evaluated in various B-cell NHL-specific expansion cohorts. The primary endpoint of the expansion stage will be ORR based on lymphoma-specific response criteria as assessed by the investigator. Exelixis in-licensed XL114 from Aurigene Discovery Technologies Limited under the companies’ July 2019 collaboration, option and license agreement and assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114.

Corporate Updates

Appointment of Vicki L. Goodman, M.D., as Executive Vice President, Product Development & Medical Affairs and Chief Medical Officer (CMO). In January 2022, Exelixis announced the appointment of Vicki L. Goodman, M.D., as Executive Vice President, Product Development & Medical Affairs and CMO. Dr. Goodman has more than 20 years of oncology experience as a drug development leader at global biopharmaceutical organizations, regulator and clinician. She joined from Merck & Co., where she served as Vice President, Clinical Research and Therapeutic Area Head, Late Stage Oncology. Dr. Goodman is based in the Greater Philadelphia area. As part of her role overseeing the company’s product development operations, she is leading the buildout of a new Exelixis team that will expand the company’s development activities on the East Coast. Exelixis’ East Coast presence will complement the company’s growing West Coast development team and enable the company to lay additional groundwork for potential future growth outside the U.S.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended April 1, 2022, and April 2, 2021, are indicated as being as of and for the periods ended March 31, 2022, and March 31, 2021, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the first quarter of 2022 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, May 10, 2022.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6282616 to join by phone.

A telephone replay will be available until 8:00 p.m. ET on Thursday, May 12, 2022. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 6282616. A webcast replay will also be archived on www.exelixis.com for one year.