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LENZ Therapeutics, Inc.(LENZ) - 2025 Q2 - Quarterly Results

Corporate Highlights and Business Updates LENZ Therapeutics is advancing LNZ100's FDA review towards an August 8, 2025 PDUFA date, while preparing for U.S. launch and expanding globally through licensing agreements worth over $195 million LNZ100 U.S. Regulatory and Commercial Readiness The LNZ100 NDA is on track for an August 8, 2025 PDUFA date with no significant FDA issues, and an 88-member sales force is ready for immediate U.S. launch upon approval - The FDA has set a PDUFA target action date of August 8, 2025, for LNZ100 and does not plan to hold an Advisory Committee Meeting13 - The late-cycle review meeting in May 2025 concluded with no significant review issues noted3 - A full 88-member sales force has been hired and trained, prepared to initiate sales and marketing activities immediately upon potential U.S. approval14 - If approved, LNZ100 would be the first aceclidine-based eye drop for presbyopia in the United States and globally3 International Expansion and Licensing Agreements LENZ secured international LNZ100 partnerships with Lotus Pharmaceutical, Laboratoires Théa, and CORXEL, totaling over $195 million in potential milestones and royalties, with CORXEL submitting an NDA in China - Executed multiple international license agreements for LNZ100, securing rights to over $195 million in combined upfront and milestone payments, plus double-digit royalties on net sales15 International Licensing Agreements | Partner | Region(s) | Potential Payments (USD) | Royalties (%) | | :--- | :--- | :--- | :--- | | Lotus Pharmaceutical | South Korea & Southeast Asia | Up to $125 million | Tiered, double-digit | | Laboratoires Théa | Canada | Over $70 million | Tiered, double-digit | | CORXEL Pharmaceuticals | Greater China | Up to $95 million | Tiered, mid single-digit to low double-digit | - Partner CORXEL submitted the New Drug Application (NDA) for LNZ100 in China, achieving the first milestone under their licensing agreement8 Q2 2025 Financial Results LENZ Therapeutics reported a Q2 2025 net loss of $14.9 million, primarily due to increased SG&A for LNZ100 pre-commercialization, while maintaining a strong $209.6 million cash position expected to fund post-launch operations Financial Performance Analysis Q2 2025 saw R&D expenses rise to $9.1 million and SG&A to $12.8 million, leading to a net loss of $14.9 million ($0.53/share) compared to $10.3 million ($0.40/share) in Q2 2024 Q2 Financial Performance Summary | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $9.1M | $6.9M | | SG&A Expenses | $12.8M | $7.4M | | Net Loss | $14.9M | $10.3M | | Net Loss per Share | $0.53 | $0.40 | - The increase in Q2 R&D expenses was driven by pre-approval and contingent product manufacturing activities for LNZ10010 - The increase in SG&A expenses was primarily due to personnel costs from a growth in headcount, including 88 sales specialists, and pre-commercial marketing expenses11 Financial Position As of June 30, 2025, the company held $209.6 million in cash, cash equivalents, and marketable securities, expected to fund operations to post-launch positive cash flow - Cash, cash equivalents, and marketable securities totaled $209.6 million as of June 30, 202519 - The company anticipates its cash balance will be sufficient to fund operations to post-launch positive cash flow9 - The company expects to have a cash balance exceeding $205.0 million as of its PDUFA target action date on August 8, 20259 Financial Statements Unaudited financial statements for June 30, 2025, show total assets of $217.3 million, $5.0 million in license revenue, and net losses of $14.9 million (quarter) and $29.5 million (six months) Selected Balance Sheet Highlights As of June 30, 2025, LENZ reported total assets of $217.3 million (vs. $215.3 million at year-end 2024), $206.4 million in stockholders' equity, with $37.6 million cash and $171.9 million marketable securities Selected Balance Sheet Highlights | Account (in thousands) | June 30, 2025 (unaudited, USD thousands) | December 31, 2024 (USD thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $37,608 | $20,158 | | Marketable securities | $171,911 | $188,872 | | Total assets | $217,332 | $215,304 | | Total liabilities | $10,967 | $11,220 | | Total stockholders' equity | $206,365 | $204,084 | Condensed Consolidated Statement of Operations and Comprehensive Loss For Q2 2025, the company reported $5.0 million in license revenue, $21.9 million in operating expenses, a $16.9 million loss from operations, and a $14.9 million net loss, with a six-month net loss of $29.5 million Condensed Consolidated Statement of Operations and Comprehensive Loss | (in thousands, except per share data) | Three Months Ended June 30, 2025 (USD thousands) | Six Months Ended June 30, 2025 (USD thousands) | | :--- | :--- | :--- | | License revenue | $5,000 | $5,000 | | Total operating expenses | $21,857 | $38,788 | | Loss from operations | $(16,857) | $(33,788) | | Net loss | $(14,912) | $(29,531) | | Net loss per share, basic and diluted | $(0.53) | $(1.06) |