LENZ Therapeutics Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
Rhea-AI Summary
LENZ Therapeutics (NASDAQ:LENZ) reported Q2 2025 financial results and significant milestones in their presbyopia treatment program. The company's lead drug candidate LNZ100 has a PDUFA date of August 8, 2025, with FDA review progressing smoothly. LENZ has secured multiple international licensing deals worth over $195 million in potential payments plus double-digit royalties.
The company has completed hiring an 88-member sales force ready for immediate post-approval launch. Financial position remains strong with $209.6 million in cash as of June 30, 2025. Q2 net loss was $14.9 million ($0.53 per share), compared to $10.3 million ($0.40 per share) in Q2 2024.
Positive
- FDA review of LNZ100 remains on track with no significant issues reported
- Secured international licensing deals worth over $195 million plus double-digit royalties
- Strong cash position of $209.6 million expected to fund operations to post-launch positive cash flow
- 88-member sales force fully hired and trained for immediate post-approval launch
- NDA submission completed in China, triggering milestone payment from CORXEL partnership
Negative
- Net loss increased to $14.9 million in Q2 2025 from $10.3 million in Q2 2024
- SG&A expenses increased significantly to $12.8 million from $7.4 million year-over-year
- R&D expenses increased to $9.1 million from $6.9 million in Q2 2024
News Market Reaction
On the day this news was published, LENZ declined 2.87%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $25M from the company's valuation, bringing the market cap to $838M at that time.
Data tracked by StockTitan Argus on the day of publication.
New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025
88-member sales force hired and prepared to initiate sales and marketing activities immediately upon approval
Executed multiple international license and commercialization agreements for LNZ100 including over
Cash, cash equivalents and marketable securities of
SAN DIEGO, July 30, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today reported financial results for the second quarter ended June 30, 2025, and recent corporate highlights.
“As our PDUFA target action date is rapidly approaching, we are encouraged by our ongoing engagement with the FDA and are confident that the review of our NDA for LNZ100 is on track,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “Additionally, with the recent execution of multiple licensing agreements in key geographies, we look forward to continuing the momentum to position LNZ100 with a global commercial footprint.”
Second Quarter 2025 and Recent Corporate Highlights
NDA review by U.S. Food and Drug Administration (FDA) for LNZ100 as a treatment for presbyopia remains on track. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100 and noted it is not planning to hold an Advisory Committee Meeting to discuss this application. In May 2025, the late-cycle review meeting and communications were completed, noting no significant review issues and the FDA reiterated it had no plans to request an Advisory Committee Meeting. The Company has not noted any delays or interruptions in the review of its NDA for LNZ100 or changes to the review team. The NDA submission for the treatment of presbyopia is supported by positive data from the pivotal Phase 3 CLARITY study. Aceclidine is a new chemical entity in the United States and, if approved, would mark a global first aceclidine-based eye drop for the treatment of presbyopia.
Commercial team prepared for launch in United States and sales force is in place. The Company has completed the hiring and pre-approval training of the 88-member sales force and is prepared to initiate sales and marketing activities immediately upon approval in the United States. On April 15, 2025, LENZ hosted a Commercial Day at the NASDAQ MarketSite in New York City, where management shared key updates on commercialization strategy, supply chain readiness, product distribution, and insights from Key Opinion Leaders and eye care professionals (ECPs). A replay of the Commercial Day presentations is available in the Events section of the Investor Relations page on the LENZ Therapeutics website at www.LENZ-tx.com.
Executed multiple international license and commercialization agreements for LNZ100 including over
In July 2025, the Company announced an exclusive license and commercialization agreement granting Laboratoires Théa rights to register and commercialize LNZ100 for the treatment of presbyopia in Canada. Under the terms of the licensing and commercialization agreement, LENZ will be eligible to receive over
Submission of NDA for LNZ100 in China results in achievement of milestone under Development and Commercialization Agreement with CORXEL. In July 2025, the Company announced that CORXEL Pharmaceuticals (“CORXEL”) has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC). LENZ licensed the Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022. The submission of the NDA for LNZ100 results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL (the “License”). Under the terms of the License, LENZ is eligible to receive up to
Financial Results for Three and Six Months Ended June 30, 2025
Cash Position: Cash, cash equivalents and marketable securities were
Research and Development (R&D) Expenses: R&D expenses increased to
Selling, General and Administrative (SG&A) Expenses: SG&A expenses increased to
Net Loss: Net loss for the three and six months ended June 30, 2025 was
About LENZ Therapeutics
LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the review and potential approval of our NDA by FDA for the potential regulatory approval; approval and commercialization of LNZ100 as a global therapy; our plans relating to commercialization, including engagement with key opinion leaders and eye care professionals and the development of commercial capabilities; the size of the market opportunity for LNZ100; our expectation that our current cash, cash equivalents and marketable securities will be sufficient to fund operations to post-launch positive operating cash flow and our expected cash balance as of the PDUFA target action date; the beneficial characteristics of LNZ100 and its expected impact on presbyopes and expectations regarding shareholder value creation. These statements are based on numerous assumptions concerning the development of LENZ’s product candidates and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in our Quarterly Report on Form 10-Q to be filed for the quarter ended June 30, 2025 and our subsequent filings with the SEC. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Contact:
Dan Chevallard
LENZ Therapeutics
IR@LENZ-Tx.com
| LENZ Therapeutics, Inc. Selected Balance Sheet Highlights (in thousands) | |||||||
| June 30, 2025 | December 31, 2024 | ||||||
| (unaudited) | |||||||
| 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 | |||||
| LENZ Therapeutics, Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue: | |||||||||||||||
| License revenue | $ | 5,000 | $ | — | $ | 5,000 | $ | — | |||||||
| Total revenue | 5,000 | — | 5,000 | — | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 9,061 | 6,945 | 14,879 | 17,482 | |||||||||||
| Selling, general and administrative | 12,796 | 7,407 | 23,909 | 12,958 | |||||||||||
| Total operating expenses | 21,857 | 14,352 | 38,788 | 30,440 | |||||||||||
| Loss from operations | (16,857 | ) | (14,352 | ) | (33,788 | ) | (30,440 | ) | |||||||
| Other income: | |||||||||||||||
| Other income | 199 | 1,635 | 188 | 287 | |||||||||||
| Interest income | 2,246 | 2,463 | 4,569 | 3,251 | |||||||||||
| Total other income, net | 2,445 | 4,098 | 4,757 | 3,538 | |||||||||||
| Net loss before income taxes | (14,412 | ) | (10,254 | ) | (29,031 | ) | (26,902 | ) | |||||||
| Income tax expense | 500 | — | 500 | — | |||||||||||
| Net loss | $ | (14,912 | ) | $ | (10,254 | ) | $ | (29,531 | ) | $ | (26,902 | ) | |||
| Other comprehensive loss: | |||||||||||||||
| Unrealized loss on marketable securities | (85 | ) | (61 | ) | (158 | ) | (68 | ) | |||||||
| Comprehensive loss | $ | (14,997 | ) | $ | (10,315 | ) | $ | (29,689 | ) | $ | (26,970 | ) | |||
| Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (0.40 | ) | $ | (1.06 | ) | $ | (1.77 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 28,079,071 | 25,608,594 | 27,804,112 | 15,163,103 | |||||||||||
FAQ
When is the PDUFA date for LENZ Therapeutics' LNZ100 presbyopia treatment?
How much cash does LENZ Therapeutics (NASDAQ:LENZ) have as of Q2 2025?
What are the terms of LENZ Therapeutics' international licensing agreements?
How large is LENZ Therapeutics' sales force for LNZ100 launch?
What was LENZ Therapeutics' net loss in Q2 2025?
What is LNZ100 being developed for?
