On May 7, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the first quarter ended March 31, 2019 (Press release, Celldex Therapeutics, MAY 7, 2019, View Source [SID1234535819]).
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"Celldex presented positive data across multiple programs at AACR (Free AACR Whitepaper) in April, including from our promising CDX-1140 program," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We have successfully cleared a critical hurdle for CD40 agonists, reaching dose levels with good systemic exposure that are biologically active and well tolerated. Importantly, these dose levels exceed the maximum tolerated dose levels reported with other CD40 agonists, which we believe may support enhanced tissue and tumor penetration. We are also pleased with the results to date in our unique combination of CDX-1140 with CDX-301, where CDX-301 amplifies the numbers of dendritic cells in patients prior to their activation with CDX-1140. To this end, we continue to believe that CDX-1140 can play a very important role in cancer immunotherapy, especially in combination with drugs that target other key immune pathways and are actively planning additional combination cohorts to begin later this year."
"We also recently completed the first stage of the Phase 2 study of CDX-3379 and are pleased that this portion of the study met the clinical criteria that are required to progress the study to the next stage. We look forward to presenting more detailed data from this study at ASCO (Free ASCO Whitepaper) in early June. We are currently conducting a thorough analysis of the overall CDX-3379 program in collaboration with our clinical advisors to determine the optimal path for this candidate. In conclusion, we continue to make considerable progress across our entire pipeline and look forward to updating shareholders over the course of the year," said Marucci.
Recent Highlights:
CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.
Enrollment is nearing completion in the monotherapy arm and progressing on track in the CDX-301 combination arm of the Phase 1 dose-escalation study of CDX-1140 with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. Seven monotherapy dosing cohorts ranging from 0.01 to 1.5 mg/kg have been completed and the dose limiting toxicity (DLT) window successfully cleared; patients are currently being enrolled in the final monotherapy cohort at 3.0 mg/kg. Two combination cohorts in solid tumors (0.09 and 0.18 mg/kg) with CDX-301 have been completed and the DLT window successfully cleared. Patients enrolled in the third cohort at 0.36 mg/kg have been dosed and are currently completing the DLT observation period. Assuming successful clearance, the 0.72 mg/kg combination cohort with CDX-301 should open shortly.
Additional patient enrollment (backfill) has been initiated to characterize the effects of CDX-1140 in the tumor microenvironment and expansion cohorts are being actively planned. Future combination opportunities include PD-1 or PD-L1 inhibitors, chemotherapy, radiation therapy and Celldex’s potent CD27 agonist monoclonal antibody varlilumab.
Data from the ongoing study were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in April and support that CDX-1140 is a potent activator of CD40 and can be safely administered at doses that Celldex believes will support good tissue and tumor penetration.
CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including head and neck squamous cell cancer (HNSCC) and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.
As previously reported, enrollment is complete in the first stage of the Phase 2 study (n=13) of CDX-3379 in advanced HNSCC in combination with Erbitux in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy. According to the study’s Simon two-stage design, if at least one patient achieves an objective response in the first stage, enrollment may progress to the second stage. While a confirmed complete response has been documented, Celldex is currently conducting a comprehensive review to inform decisions on potential future development. Celldex plans to present updated data from the study in a poster session at the 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, June 1, 2019.
Celldex continues to advance a robust preclinical portfolio with data from multiple programs presented at AACR (Free AACR Whitepaper).
Data from the Company’s CDX-527 bispecific candidate and its TAM program were presented at the AACR (Free AACR Whitepaper) Annual Meeting 2019 in April. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. TAM receptors (Tyro3, Axl, MerTK) are receptor tyrosine kinases (RTKs) expressed in innate immune cells. These receptors have been gaining importance in the immunotherapy field due to their role as checkpoint molecules on macrophages, dendritic cells, and other immune cells, where they can negatively regulate anti-tumor immunity.
First Quarter 2019 Financial Highlights and 2019 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2019 were $85.1 million compared to $94.0 million as of December 31, 2018. The decrease was primarily driven by first quarter cash used in operating activities of $13.2 million, partially offset by $4.2 million in net proceeds from sales of common stock under the Cantor agreement. At March 31, 2019, Celldex had 12.8 million shares outstanding.
Revenues: Total revenue was $1.4 million in the first quarter of 2019 compared to $4.1 million for the comparable period in 2018. The decrease in revenue was primarily due to lower revenue from the contract manufacturing and research and development agreement with the International AIDS Vaccine Initiative and the collaboration agreement with Bristol-Myers Squibb Company.
R&D Expenses: Research and development (R&D) expenses were $11.2 million in the first quarter of 2019 compared to $21.9 million for the comparable period in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.
G&A Expenses: General and administrative (G&A) expenses were $4.9 million in the first quarter of 2019 compared to $5.6 million for the comparable period in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs.
Intangible Asset and Goodwill Impairments: During the quarter ended March 31, 2018, the Company recorded $18.7 million in non-cash impairment charges related to fully impaired glembatumumab vedotin-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset.
Changes in Fair Value Remeasurement of Contingent Consideration: During the quarter ended March 31, 2019, the Company recorded a $1.5 million loss on fair value remeasurement of contingent consideration primarily due to changes in discount rates and the passage of time. During the quarter ended March 31, 2018, the Company recorded a $13.6 million gain on the fair value remeasurement of contingent consideration primarily due to updated assumptions for glembatumumab vedotin-related milestones as a result of the METRIC study failure and discontinuation of the glembatumumab vedotin program.
Net Loss: Net loss was $17.2 million, or ($1.40) per share, for the first quarter of 2019 compared to a net loss of $118.1 million, or ($12.61) per share, for the comparable period in 2018.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2019, combined with the 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 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.
Erbitux is a registered trademark of Eli Lilly & Co.