LENZ Therapeutics Q3 2024 Financial Results

LENZ Therapeutics, Inc., a biopharmaceutical company focusing on developing aceclidine-based eye drops for presbyopia, has reported its financial results and operational highlights for the third quarter ending September 30, 2024. The recent announcement includes the acceptance of the New Drug Application (NDA) for LNZ100 by the U.S. Food and Drug Administration (FDA), targeting an action date of August 8, 2025.

Eef Schimmelpennink, President and CEO of LENZ Therapeutics, emphasized the company's dedication to advancing LNZ100 towards approval in the United States and planning for a commercial launch by late 2025. He highlighted the significance of the Phase 3 clinical study data from China, underscoring the potential for LNZ100 to become a global treatment option for presbyopia, which affects around 128 million people in the U.S. and 400 million in China.

The company's NDA submission to the FDA, accepted in October 2024, is backed by promising data from the pivotal Phase 3 CLARITY study. Aceclidine, the active ingredient in LNZ100, is a new chemical entity in the United States and has not been approved for presbyopia treatment elsewhere.

In partnership with CORXEL, LENZ Therapeutics announced positive topline results from a Phase 3 study in China. The study showed that LNZ100 significantly improved near vision without compromising distance vision in a majority of patients. Specifically, 74% of patients treated with LNZ100 achieved a three-line or greater improvement in near vision three hours post-dosing, with statistically significant differences compared to the control group.

LENZ Therapeutics is preparing for the U.S. commercial launch of LNZ100, with efforts underway to ensure readiness for mid-2025 approval. The company has built a comprehensive commercial leadership team, covering sales, marketing, and operations. Additionally, they have recruited regional sales directors with extensive experience in eye care and pharmaceutical sales.

Market research involving 426 eye care professionals (ECPs) revealed strong support for LNZ100. The surveyed ECPs, who see an average of 300-400 patients monthly, showed high enthusiasm for the drug's clinical data and its potential approval. Around 78% of ECPs considered LNZ100 to be a well-tolerated and safe treatment option, and approximately 83% expressed a likelihood to sample the drug based on its clinical profile.

In July 2024, LENZ Therapeutics secured $30 million through a private placement financing with Ridgeback Capital Investments L.P. This funding is part of the company's strategy to support its operations and commercial activities.

Financially, LENZ Therapeutics reported cash, cash equivalents, and marketable securities totaling $217.2 million as of September 30, 2024. This financial position is expected to sustain the company's operations until they achieve positive operating cash flow post-launch. Research and development (R&D) expenses decreased significantly, from $17.0 million in the third quarter of 2023 to $6.5 million in the same period in 2024. This reduction is attributed mainly to the completion of the Phase 3 CLARITY study. Conversely, selling, general, and administrative (SG&A) expenses increased from $2.9 million to $6.5 million over the same periods, reflecting growth in personnel and pre-commercial activities.

The net loss for the third quarter of 2024 was $10.2 million, or $0.38 per share, compared to $18.9 million, or $9.62 per share, in the third quarter of 2023. For the nine months ending September 30, 2024, LENZ Therapeutics reported a net loss of $37.1 million, or $1.93 per share, an improvement from the $46.3 million, or $23.66 per share, loss reported in the same period in 2023.

The company remains focused on its goal of bringing LNZ100 to market, aiming to provide an effective solution for the millions affected by presbyopia globally.