On March 7, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year ended December 31, 2017 (Press release, Celldex Therapeutics, MAR 7, 2018, View Source [SID1234524499]). The Company will host a conference call at 4:30 p.m. ET today to provide an in-depth update on its pipeline and upcoming milestones for 2018.
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"2017 was a significant year for Celldex. Notably we completed enrollment in the METRIC study of glembatumumab vedotin for patients with triple negative breast cancer whose tumors overexpress gpNMB. We are hopeful that glemba will offer patients, families and caregivers a potential new option, where there are few approved therapies and none that target gpNMB, which is associated with a more aggressive form of the disease," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We anticipate topline primary endpoint data from the study will be available in the second quarter of 2018."
"We also made considerable progress across our pipeline in the fourth quarter, including initiating the Phase 2 study of CDX-3379 in combination with Erbitux for patients with advanced head and neck squamous cell carcinoma and the Phase 1 study of CDX-1140, a CD40 agonist antibody that we believe holds great potential as an immune activating agent. Both of these antibodies are engineered to be best-in-class molecules. Recently, we completed enrollment in the glemba plus checkpoint inhibitor cohort in our Phase 2 metastatic melanoma study and also in all cohorts in the varlilumab plus Opdivo collaborative Phase 2 study with BMS. In 2018, we expect to present data across multiple programs and execute across our clinical pipeline of novel biologics to improve outcomes and change the standard of care for patients who suffer from life-threatening diseases."
Recent Highlights
Topline primary endpoint data from the METRIC study of glembatumumab vedotin in triple negative breast cancer anticipated in the second quarter of 2018: Enrollment was closed in August 2017 with 327 patients whose tumors overexpressed gpNMB. Patients were randomized 2 to 1 to either glembatumumab vedotin or to Xeloda (capecitabine). The primary endpoint of the study is progression-free survival (PFS), which is defined as the time from randomization to the earlier of disease progression or death due to any cause. The study calls for 203 progression events for evaluation of the primary endpoint, which will be assessed based on an independent, central reading of patient scans. The sum of the data, including the secondary endpoints of response rate, overall survival (OS), duration of response and safety, will be important in assessing clinical benefit. Efforts to ensure delivery of manufactured drug that is ready for commercialization and a companion diagnostic are underway. As previously disclosed, Celldex made the decision to stage some of the more costly work in these areas to begin after the Company has received results from the study. Assuming positive data, Celldex plans to work with the FDA on a regulatory strategy that would support submitting a Biologics License Application (BLA) in the second half of 2019.
Fourth arm added to glembatumumab vedotin Phase 2 study in metastatic melanoma: Enrollment has opened in a glembatumumab vedotin plus CDX-301 cohort for patients who failed checkpoint therapy. Enrollment recently completed in the glembatumumab vedotin plus checkpoint inhibitor cohort.
Enrollment complete in Phase 2 varlilumab/Opdivo collaborative study: Enrollment was completed in January 2018. Cohorts include colorectal cancer (n=21), ovarian cancer (n=58), head and neck squamous cell carcinoma (n=24), renal cell carcinoma (n=14) and glioblastoma (n=22). The primary objective of the Phase 2 cohorts is objective response rate (ORR), except glioblastoma, where the primary objective is the rate of 12-month OS. Secondary objectives include pharmacokinetic assessments, determining the immunogenicity of varlilumab when given in combination with Opdivo, evaluating alternate dosing schedules of varlilumab and further assessing the anti-tumor activity of combination treatment. Working with Bristol-Myers Squibb, data from the study will be presented at appropriate medical meetings in 2018.
Initiated Phase 2 study of CDX-3379/Erbitux in head and neck squamous cell carcinoma: In November 2017, Celldex opened enrollment to an open-label Phase 2 study in combination with Erbitux in approximately 30 patients with HPV negative, Erbitux-resistant, advanced head and neck squamous cell carcinoma. Patients must have been treated previously with an anti-PD1 checkpoint inhibitor, a population with limited options and a particularly poor prognosis. The primary objective of the study is ORR. Secondary objectives include assessments of clinical benefit rate, duration of response, PFS and OS, and safety and pharmacokinetics associated with the combination.
Ongoing Phase 1 study of CDX-014 expanded to include patients with ovarian cancer: Enrollment is ongoing in a Phase 1 study of CDX-014, an antibody-drug conjugate that targets TIM-1. The study initially enrolled patients with both clear cell and papillary renal cell carcinoma. In January 2018, we amended the protocol, expanding enrollment to include patients with ovarian clear cell carcinoma, an indication where TIM-1 expression is also upregulated, and enabling the evaluation of alternate dosing regimens. The study includes a dose-escalation portion across three separate cohorts to determine the maximum tolerated dose (MTD) followed by expansion cohorts of up to 15 patients each to assess the preliminary anti-tumor activity of CDX-014, as measured by ORR. Secondary objectives include safety and tolerability, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity.
Initiated Phase 1 study of CDX-1140: A Phase 1 study of CDX-1140 was initiated in November 2017. The study is expected to enroll up to approximately 105 patients with recurrent, locally advanced or metastatic solid tumors and is designed to determine the MTD during a dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion is designed to further evaluate the tolerability and biologic effects of selected dose(s) of CDX-1140 in specific tumor types. Secondary objectives include assessments of safety and tolerability, pharmacodynamics, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity, including clinical benefit rate. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.
Fourth Quarter and Twelve Months 2017 Financial Highlights and 2018 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2017 were $139.4 million compared to $140.5 million as of September 30, 2017. The decrease was primarily driven by fourth quarter cash used in operating activities of $19.5 million and partially offset by $18.4 million in net proceeds from sales of common stock under the Cantor agreement. At December 31, 2017, Celldex had 138.5 million shares outstanding.
Revenues: Total revenue was $3.5 million in the fourth quarter of 2017 and $12.7 million for the year ended December 31, 2017, compared to $1.9 million and $6.8 million for the comparable periods in 2016. The increase in revenue was primarily due to the manufacturing service agreements with the International AIDS Vaccine Initiative and Frontier Biotechnologies, Inc.
R&D Expenses: Research and development (R&D) expenses were $23.5 million in the fourth quarter of 2017 and $96.2 million for the year ended December 31, 2017, compared to $24.6 million and $102.7 million for the comparable periods in 2016. The decrease in R&D expenses for the year ended December 31, 2017, as compared to 2016, was primarily due to lower contract manufacturing and clinical trial costs of $9.9 million and $7.6 million, respectively, related to varlilumab and Rintega. These decreases were partially offset by increases in (i) glembatumumab vedotin contract manufacturing expenses of $2.7 million, (ii) glembatumumab vedotin, anti-KIT and CDX-3379 clinical trial costs of $3.6 million and (iii) personnel and facility costs related to the Kolltan acquisition.
G&A Expenses: General and administrative (G&A) expenses were $5.9 million in the fourth quarter of 2017 and $25.0 million for the year ended December 31, 2017, compared to $11.9 million and $36.0 million for the comparable periods in 2016. The decrease in G&A expenses for the year ended December 31, 2017, as compared to 2016, was primarily due to lower commercial planning costs of $4.5 million, lower stock-based compensation of $1.9 million and lower severance expense related to the Kolltan acquisition of $2.6 million.
In-Process Research and Development Impairment: The Company recorded a non-cash partial impairment charge of $13.0 million on the anti-KIT program IPR&D asset acquired from Kolltan during the year ended December 31, 2017 due to changes in the anti-KIT program projected development and regulatory timelines.
Income Tax Benefit: The Company recorded a non-cash income tax benefit of $24.3 million during the year ended December 31, 2017 relating to the partial impairment of the anti-KIT program IPR&D asset and the impact of the Tax Cuts and Jobs Act of 2017.
Gain on Fair Value Remeasurement of Contingent Consideration: The Company recorded a gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition of $0.8 million for the year ended December 31, 2017.
Net Loss: Net loss was $3.8 million, or ($0.03) per share, for the fourth quarter of 2017 and $93.0 million, or ($0.72) per share, for the year ended December 31, 2017, compared to a net loss of $32.3 million, or ($0.30) per share, and $128.5 million, or ($1.27) per share, for the comparable periods in 2016.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2017 combined with the (i) $6.1 million in net proceeds from sales of common stock under the Cantor agreement from January 1, 2018 through February 28, 2018 and (ii) anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2019. This could be impacted by clinical data results from the METRIC study and their impact on the pace of commercial manufacturing and the rate of expansion of commercial operations. This could also be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.
Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2018 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 8296067.
A replay of the call will be available approximately two hours after the live call concludes through March 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 8296067. The webcast will also be archived on the Company’s website.
Xeloda is a registered trademark of Genentech, Inc. Opdivo is a registered trademark of Bristol-Myers Squibb. Erbitux is a registered trademark of Eli Lilly & Co.