On November 9, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Celldex Therapeutics, NOV 9, 2022, View Source [SID1234623545]).
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"Celldex continued to execute towards our clinical and corporate milestones, making strong progress across multiple programs; importantly, this includes the initiation of our Phase 2 studies in chronic spontaneous and chronic inducible urticaria this past summer. As we near the close of 2022 and look to 2023, we anticipate a consistent stream of data readouts from the barzolvolimab program, starting in December with additional data from our Phase 1 study in chronic inducible urticaria," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We are also enthusiastic about the potential of our bispecific platform and believe our strategic updates including the development of CDX-585, our ILT4 and PD-(L)1 bispecific antibody, which is expected to enter the clinic in 2023, will drive value for this platform."
"In summary, our recent advances of the barzolvolimab program, development of our bispecific platform, and strong balance sheet continue to position us very well to execute across our upcoming key clinical milestones. We look forward to continued momentum across the company for the rest of the year and providing updates in the coming months," concluded Mr. Marucci.
Recent Program Highlights
Barzolvolimab – KIT Inhibitor Program
Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.
In June and July 2022, Celldex announced that the first patients have been dosed in the Phase 2 clinical studies of barzolvolimab for the treatment of Chronic Spontaneous Urticaria (CSU) and the two most common forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD). These randomized, double-blind, placebo-controlled, parallel group Phase 2 studies are evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategies.
On June 30, Celldex reported interim data from the barzolvolimab multiple dose Phase 1b study in CSU which were presented as a late-breaking electronic poster presentation as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2022. The Company has since completed enrollment to the 3 and 4.5 mg/kg dose groups and plans to present 12-week treatment data from these dose groups in February 2023.
EAACI 2022 Data Summary:
Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Barzolvolimab resulted in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.
Mean reduction from baseline in urticaria activity (UAS7) of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the 3 mg/kg dose group (n=9) at week 8 (reflects only one dose), demonstrating clinically meaningful symptom improvements for patients.
Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and 44.4% at week 8 (reflects only one dose) in the 3 mg/kg dose group which is a key therapeutic goal.
75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects only one dose).
Tryptase suppression paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.
Celldex has completed enrollment in the barzolvolimab Phase 1b open label study in chronic inducible urticaria. The Company plans to present data from the 1.5 mg/kg cold urticaria cohort and long-term follow up from the 3 mg/kg symptomatic dermographism and cold urticaria cohorts in December. Patient follow up continues in the cholinergic cohort and is planned for presentation in mid-2023.
Celldex continues to enroll patients in the barzolvolimab Phase 1b multi-center, randomized, double-blind, placebo-controlled study in patients with prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin.
Celldex plans to initiate a Phase 2 international trial of barzolvolimab in eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease, in the first half of 2023. The Company is finalizing clinical study design and completing the chronic toxicology study which will support study initiation in the United States.
Bispecific Antibody Platform
CDX-585 – Bispecific ILT4 & PD-(L)1
CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells.
CDX-585 is currently completing CMC and IND-enabling activities and is expected to enter the clinic in 2023.
CDX-527 – Bispecific PD-L1 & CD27
CDX-527 utilizes the Company’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.
The standard of care in ovarian cancer continues to evolve, making drug development in this indication more challenging. With multiple clinical trials actively recruiting in ovarian cancer, enrollment to the expansion cohort in patients with checkpoint naïve ovarian cancer (n=8) did not meet the Company’s internal timelines and a review of the results to date also did not meet internal hurdles for proceeding. Given the evolving environment and Celldex’s pipeline and resource priorities, the Company has decided to discontinue the program.
Third Quarter 2022 Financial Highlights and 2022 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2022 were $323.5 million compared to $356.8 million as of June 30, 2022. The decrease was primarily driven by third quarter cash used in operating activities of $35.2 million, which includes the $15.0 million payment to Shareholder Representative Services (SRS), the representative of the former stockholders of Kolltan Pharmaceuticals, Inc., pursuant to our settlement agreement. At September 30, 2022, Celldex had 47.1 million shares outstanding.
Revenues: Total revenue was $0.4 million in the third quarter of 2022 and $0.7 million for the nine months ended September 30, 2022, compared to $0.2 million and $4.3 million for the comparable periods in 2021. The decrease in revenue for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021 was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.
R&D Expenses: Research and development (R&D) expenses were $21.6 million in the third quarter of 2022 and $59.4 million for the nine months ended September 30, 2022, compared to $13.6 million and $38.6 million for the comparable periods in 2021. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, barzolvolimab contract manufacturing and personnel expenses.
G&A Expenses: General and administrative (G&A) expenses were $6.5 million in the third quarter of 2022 and $20.6 million for the nine months ended September 30, 2022, compared to $5.8 million and $14.2 million for the comparable periods in 2021. The increase in G&A expenses was primarily due to higher legal costs related to our settlement agreement with SRS, barzolvolimab commercial planning and stock-based compensation expenses.
Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $6.9 million gain on fair value remeasurement of contingent consideration for the nine months ended September 30, 2022, primarily due to the Company’s decision to deprioritize the CDX-1140 program in the second quarter of 2022.
Litigation Settlement Related Loss: The Company recorded a one-time loss of $15.0 million in the second quarter of 2022 related to the $15.0 million paid to SRS pursuant to our settlement agreement.
Net Loss: Net loss was $26.8 million, or ($0.57) per share, for the third quarter of 2022, and $85.8 million, or ($1.83) per share, for the nine months ended September 30, 2022, compared to a net loss of $20.5 million, or ($0.45) per share, for the third quarter of 2021 and $50.4 million, or ($1.21) per share, for the nine months ended September 30, 2021. The litigation settlement related loss had a ($0.32) impact on net loss per share for the nine months ended September 30, 2022. The gain on fair value remeasurement of contingent consideration had a $0.15 impact on net loss per share for the nine months ended September 30, 2022.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025.