On March 14, 2017 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year-ended December 31, 2016 (Press release, Celldex Therapeutics, MAR 14, 2017, View Source [SID1234518126]). 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 2017. Schedule your 30 min Free 1stOncology Demo! "Celldex made important progress across our pipeline in the fourth quarter, including successfully completing the integration of Kolltan Pharmaceuticals and its novel RTK antibody programs into our organization and driving a considerable uptick in enrollment in our ongoing study of glembatumumab vedotin in triple negative breast cancer," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "As we look to 2017, we have prioritized completing the glemba studies in breast cancer and checkpoint-refractory metastatic melanoma, the Phase 2 collaborative study of varlilumab with BMS’s Opdivo and our Phase 1 studies of both CDX-0158 and CDX-014. Data from a number of these programs are expected to be available over the next 6 to 12 months."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In addition, we will have a change on our leadership team this summer as Chip Catlin, Senior Vice President and Chief Financial Officer, has shared with us his intention to retire in June of this year," continued Marucci. "Chip’s contribution to Celldex has been significant, and we wish him all the best in his retirement. Sam Martin, our current Vice President of Finance will be promoted to the CFO role concurrent with Chip’s departure. Chip and Sam have worked closely together over the last eight years, and we expect the transition to be seamless."
Recent Highlights
Kolltan Pharmaceuticals acquisition completed: In late November, Celldex completed the acquisition of Kolltan Pharmaceuticals, Inc., adding a unique platform of antibodies targeting receptor tyrosine kinases (RTKs) to the Company’s pipeline. Clinical and preclinical data suggest these candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies.
Considerable progress in METRIC enrollment: Enrollment in the Phase 2b randomized study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB has accelerated consistently over the last several months across the United States, Canada, Australia and the European Union. Assuming the current rate of enrollment continues, Celldex expects enrollment will be completed by the end of September 2017.
Third arm added to glembatumumab vedotin Phase 2 study in metastatic melanoma: Enrollment has initiated in a glembatumumab vedotin plus checkpoint inhibitor (Opdivo or Keytruda) arm in patients who failed prior checkpoint therapy. Enrollment also continues in the glembatumumab vedotin and varlilumab arm, with data from this portion of the study expected in the fall of 2017. Positive data from the single-agent arm of this study in patients who had previously progressed on checkpoint therapy were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2016.
Continued progress in Phase 2 varlilumab/Opdivo study: The Phase 2 study of varlilumab and Opdivo continues to enroll patients across multiple indications [colorectal cancer (n=18), ovarian cancer (n=54), head and neck squamous cell carcinoma (n=54), renal cell carcinoma (n=25), glioblastoma (n=20)]. The Company anticipates that data from the Phase 1 study of varlilumab and Opdivo will be presented mid-year 2017. The Company plans to complete enrollment across all cohorts in the Phase 2 portion of the study in the first quarter of 2018 and will work with BMS to present data from the study at a future medical meeting. Given the advancement of varlilumab into a broad Phase 2 study with BMS, including in renal cell carcinoma, and efforts to identify areas for cost-containment, Celldex has decided not to advance the varlilumab/Tecentriq and the varlilumab/Sutent combination studies in renal cell carcinoma to Phase 2.
Phase 1 study of CDX-0158 (formerly KTN0158) continues to enroll patients: This dose-escalation study in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors is designed to determine the maximum tolerated dose, recommend a dose for further study and characterize the safety profile of CDX-0158. Data from the study are expected by year-end 2017.
CDX-3379 (formerly KTN3379) advancing to Phase 2: The Company is currently exploring plans for advancement into Phase 2 study.
Enrollment ongoing in Phase 1 study of CDX-014: The study in advanced renal cell carcinoma (clear cell and papillary) is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex expects the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
Fourth Quarter and Twelve Months 2016 Financial Highlights and 2017 Guidance
Cash position: Cash, cash equivalents and marketable securities as of December 31, 2016 were $189.8 million compared to $203.2 million as of September 30, 2016. The decrease was primarily driven by our fourth quarter cash used in operating activities of approximately $20.3 million. This decrease was partially offset by the receipt of $4.6 million of cash received, net of transaction expenses paid related to our acquisition of Kolltan and $3.3 million from sales of our common stock under our Cantor agreement. At December 31, 2016, Celldex had 120.5 million shares outstanding.
Revenues: Total revenue was $1.9 million in the fourth quarter of 2016 and $6.8 million for the twelve months ended December 31, 2016, compared to $1.8 million and $5.5 million for the comparable periods in 2015. The increase in revenue was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and an increase in grant revenue, partially offset by a decrease in revenue from our research and development agreement with Rockefeller University.
R&D Expenses: Research and development (R&D) expenses were $24.6 million in the fourth quarter of 2016 and $102.7 million for the twelve months ended December 31, 2016, compared to $23.9 million and $100.2 million for the comparable periods in 2015. The increase in R&D expenses for the twelve months ended December 31, 2016 as compared to 2015 was primarily due to higher personnel costs of $6.3 million, including higher stock-based compensation and Kolltan-related severance expense of $1.6 million and $0.7 million, respectively, offset by lower product development expense of $5.9 million. This decrease in product development expenses was primarily due to a $19.9 million decrease in Rintega program costs, partially offset by increases in glembatumumab vedotin and varlilumab program costs of $4.6 million and $9.6 million, respectively.
G&A Expenses: General and administrative (G&A) expenses were $11.9 million in the fourth quarter of 2016 and $36.0 million for the twelve months ended December 31, 2016, compared to $11.1 million and $33.8 million for the comparable periods in 2015. The increase in G&A expenses for the twelve months ended December 31, 2016 as compared to 2015 was primarily due to Kolltan-related severance expense, restructuring expense related to our decision to not occupy our Needham, MA expansion space and higher stock based compensation of $2.4 million, $1.2 million and $0.9 million, respectively, partially offset by lower commercial planning costs of $2.8 million.
Net loss: Net loss was $32.3 million, or ($0.30) per share, for the fourth quarter of 2016 and $128.5 million, or ($1.27) per share, for the twelve months ended December 31, 2016, compared to a net loss of $32.7 million, or ($0.33) per share, and $127.2 million, or ($1.31) per share, for the comparable periods in 2015.
Financial guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2016 combined with the anticipated proceeds from future sales of our common stock under our Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2018; however, this guidance assumes we elect to pay future Kolltan contingent milestones, if any, in stock rather than 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 2017 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 69462587.
A replay of the call will be available approximately two hours after the live call concludes through March 21, 2017. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 69462587. The webcast will also be archived on the Company’s website.
Opdivo is a registered trademark of Bristol-Myers Squibb. Keytruda is a registered trademark of Merck Sharp & Dohme Corp. Sutent is a registered trademark of Pfizer. Tecentriq is a registered trademark of Genentech.