Cullinan Therapeutics Updates and Q2 2024 Financial Results

Cullinan Therapeutics, Inc., a biopharmaceutical firm specializing in targeted therapies, has announced its strategic focus and financial results for the second quarter ending June 30, 2024. The company is advancing its therapeutic pipeline in both autoimmune diseases and oncology, bolstered by recent successful financing. CEO Nadim Ahmed highlighted the company's commitment to executing strategic plans set in the first half of the year, emphasizing progress in both autoimmune and oncology sectors.

The company remains on schedule to file an Investigational New Drug (IND) application for CLN-978 by the third quarter of 2024, aimed at treating systemic lupus erythematosus (SLE). Additionally, Cullinan will explore the potential of CLN-978 for treating rheumatoid arthritis (RA), partnering with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome, to conduct clinical trials in RA. These institutions are leaders in T cell redirecting therapies and have shown the promise of CD19 T cell engagers in RA. CLN-978's development will be discontinued based on initial clinical observations.

In the oncology domain, Cullinan presented data on CLN-619, an anti-MICA/MICB monoclonal antibody, at the ASCO Annual Meeting in June 2024. The data revealed objective responses in non-small cell lung cancer (NSCLC) patients with oncogenic mutations, typically resistant to checkpoint inhibitors. This has led to additional disease expansion cohorts for both monotherapy and combination therapies in NSCLC and platinum-resistant ovarian cancer. Initial data from these cohorts are expected in the first half of 2025.

Further, Cullinan's collaboration with Taiho Oncology on zipalertinib for EGFR ex20ins NSCLC showed positive initial results in the Phase 2b REZILIENT1 study. This study targets patients who progressed after chemotherapy and exon 20 targeted therapy amivantamab. Updated results will be presented at the European Society for Medical Oncology (ESMO) meeting in September 2024, with enrollment expected to be completed by the end of the year.

For CLN-049, a bispecific antibody for AML and MDS, dose escalation continues with IV administration due to dose-limiting reactions observed with subcutaneous delivery. CLN-617, a cytokine fusion protein for solid tumors, also continues enrollment in its Phase 1 study. However, development of CLN-418, a bispecific immune activator for solid tumors, will be discontinued following a review of Phase 1 data, with rights returned to Harbour BioMed.

On the corporate front, Cullinan completed an oversubscribed private placement in April 2024, raising $280 million. The company also appointed biotech executive Mary Thistle to its Board of Directors in August, bringing significant expertise in autoimmune diseases to support Cullinan’s growth strategy.

Financially, Cullinan reported cash, cash equivalents, investments, and interest receivable totaling $664.9 million as of June 30, 2024. The company expects these resources to sustain operations into 2028. Research and development (R&D) expenses for the second quarter were $36.3 million, a rise from $27.4 million in the same period last year, mainly due to increased clinical and preclinical costs and added personnel. For the first six months of 2024, R&D expenses were $66.9 million, down from $79.5 million in 2023, attributed partly to a one-time upfront licensing fee for CLN-418.

General and administrative (G&A) expenses increased to $13.8 million in the second quarter, up from $10.2 million last year, driven by higher personnel costs. For the first six months, G&A expenses were $26.1 million, compared to $20.9 million in 2023, with equity-based compensation expenses contributing to the rise.

Net loss for the second quarter of 2024 was $42.0 million, compared to $32.2 million in the same period last year. For the first six months, the net loss was $79.4 million, down from $90.4 million in 2023, partly offset by interest income.

As of July 31, 2024, Cullinan had 57,976,641 shares of common stock outstanding, with additional convertible shares from pre-funded warrants and non-voting preferred stock.

Cullinan Therapeutics continues to pursue advancements in targeted therapies, focusing on its promising programs to bring new treatment options to patients in need.