LENZ Therapeutics Reports $49.77 Million Net Loss for 2024, Prepares for LNZ100 Launch

LENZ Therapeutics, Inc. (LENZ), formerly Graphite Bio, Inc., reported a net loss of $49.77 million for the year ended December 31, 2024, compared to a net loss of $69.97 million in 2023. Research and development expenses decreased by 50% to $29.8 million, primarily due to the completion of Phase 3 CLARITY trials in March 2024. Conversely, selling, general, and administrative expenses increased by 123% to $28.8 million, reflecting investments in building a commercial team and infrastructure in preparation for the potential launch of LNZ100. Other income increased to $8.8 million, largely driven by higher interest income on increased cash reserves.

The company's lead product candidate, LNZ100, a once-daily eye drop for presbyopia, achieved primary and key secondary endpoints in Phase 3 CLARITY trials. In October 2024, the FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100's New Drug Application (NDA). A commercial launch in the U.S. is planned immediately following potential approval, with product availability anticipated in the fourth quarter of 2025. LNZ101, another product candidate, did not demonstrate superiority to LNZ100. Positive topline data from a Phase 3 trial of LNZ100 in China was also announced in October 2024.

As of December 31, 2024, LENZ held $209.1 million in cash, cash equivalents, restricted cash, and marketable securities. The company believes these funds will be sufficient to reach positive operating cash flow after the potential commercial launch of LNZ100. The company's accumulated deficit as of December 31, 2024, was $145.0 million. LENZ anticipates continued operating losses as it pursues FDA approval and commercialization, including expenses related to regulatory processes, commercial launch preparation, sales, marketing, manufacturing, distribution, and public company compliance. The company secured additional funding through a March 2024 PIPE financing ($53.5 million) and a July 2024 PIPE financing ($30.0 million).

LENZ's commercial strategy focuses on the U.S. market, targeting approximately 15,000 eye care professionals who prescribed the majority of pharmaceutical presbyopia treatments in 2022. The company plans to utilize a direct-to-consumer strategy, leveraging digital marketing and a consumer sampling program. LENZ intends to commercialize LNZ100 through the self-pay market, avoiding third-party reimbursement. The company has secured commercial supply agreements with contract manufacturing organizations (CMOs) and is actively building its sales organization, aiming for 100-150 employees. LENZ also has a license and collaboration agreement with CORXEL Pharmaceuticals for the development and commercialization of LNZ100 in Greater China.

The company's 10-K filing details numerous risk factors, including those related to its pre-commercial stage, reliance on LNZ100's success, the inherent uncertainties of clinical trials and regulatory approvals, competition, intellectual property protection, manufacturing and supply chain dependencies, international expansion challenges, and financial risks. The filing also includes extensive disclosures regarding accounting policies, financial statements, and compliance with various U.S. and international regulations. As of December 31, 2024, LENZ employed 42 individuals, with 21 engaged in research and development.