Celldex Therapeutics, Inc. (NASDAQ: CLDX) reported its financial results for the fourth quarter and year ended December 31, 2023. The firm is a clinical-stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients.The company's cash, cash equivalents, and marketable securities as of December 31, 2023, stood at $423.6 million, a significant increase from $235.3 million as of September 30, 2023. This increase was primarily driven by net proceeds of $216.2 million from a November 2023 underwritten public offering.
Total revenue for the fourth quarter of 2023 was $4.1 million and $6.9 million for the year ended December 31, 2023, compared to $1.6 million and $2.4 million for the comparable periods in 2022. This increase in revenue was primarily due to an increase in services performed under the company's manufacturing and research and development agreements with Rockefeller University.
Research and development (R&D) expenses were $30.4 million in the fourth quarter of 2023 and $118.0 million for the year ended December 31, 2023, compared to $22.9 million and $82.3 million for the comparable periods in 2022. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, contract manufacturing, and personnel expenses.
General and administrative (G&A) expenses were $8.8 million in the fourth quarter of 2023 and $30.9 million for the year ended December 31, 2023, compared to $6.6 million and $27.2 million for the comparable periods in 2022. The increase in G&A expenses was primarily due to higher stock-based compensation, recruiting, and commercial planning expenses, partially offset by a decrease in legal expenses.
The net loss was $43.3 million, or ($0.83) per share, for the fourth quarter of 2023, and $141.4 million, or ($2.92) per share, for the year ended December 31, 2023, compared to a net loss of $26.5 million, or ($0.56) per share, for the fourth quarter of 2022 and $112.3 million, or ($2.40) per share, for the year ended December 31, 2022.
Celldex believes that the cash, cash equivalents, and marketable securities at December 31, 2023, are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.
The company made transformational progress across the barzolvolimab development program, reporting multiple positive data sets across mast cell-mediated diseases, with plans to initiate phase 3 CSU studies in the summer of 2024. Additionally, positive 12-week data from the ongoing phase 2 CSU study directly support the planned initiation of registrational studies in CSU this summer.
Celldex is conducting 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 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.
The company is currently planning two phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer. In November 2023, Celldex reported positive topline data from the phase 2 CSU study, and in February 2024, 12-week treatment results were reported at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in a late breaking oral presentation.
Celldex's enrollment to the phase 2 CIndU study is nearing completion, and 12-week primary endpoint data from this study is expected to be reported in the second half of 2024.
In addition to its work on barzolvolimab, Celldex is currently planning for the initiation of a phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024. This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety profile of barzolvolimab in approximately 120 patients with moderate to severe PN who had an inadequate response to prescription topical medications, or for whom topical medications are medically inadvisable.
Celldex also provided an update on its bispecific antibody platform, with the initiation of a phase 1 study of cdx-585, which combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells.
Following these announcements, the company's shares moved 27.8%, and are now trading at a price of $48.23. Check out the company's full 8-K submission here.
