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

Insights

Biotech Regulatory & Commercial Expert

LENZ on track for August FDA decision for presbyopia drug with strong cash position, commercialization ready, and international deals worth $195M+.

LENZ Therapeutics is at a critical inflection point with their lead asset LNZ100 for presbyopia. The regulatory pathway appears exceptionally clean - their PDUFA date of August 8 remains on track, the FDA has completed late-cycle review without raising significant issues, and importantly, no Advisory Committee meeting is planned. This regulatory clarity substantially de-risks the approval process.

The company has executed a textbook pre-commercial strategy. They've fully staffed an 88-member sales force ahead of approval, demonstrating both operational execution and confidence in their regulatory outcome. This advance preparation should enable immediate commercialization upon approval, avoiding the typical lag between approval and market penetration.

Most impressive is their business development execution. LENZ has secured multiple international licensing agreements worth over $195 million in upfront and milestone payments plus double-digit royalties. These deals with Lotus Pharmaceutical (Korea/Southeast Asia), Laboratoires Théa (Canada), and CORXEL (China) validate the commercial potential of LNZ100 while providing non-dilutive capital.

Their $209.6 million cash position is particularly significant as it's projected to fund operations until post-launch positive cash flow. With anticipated expenses through launch, they expect to maintain over $205 million at their PDUFA date. This financial runway eliminates near-term financing risk and gives them leverage to execute their commercial strategy without capital constraints.

If approved, LNZ100 would be the first aceclidine-based eye drop for presbyopia globally, giving LENZ first-mover advantage in a substantial market. With regulatory momentum, commercial readiness, strategic partnerships, and financial strength, LENZ appears exceptionally well-positioned for their transformation to a commercial-stage company.

Financial Analyst

LENZ's strong $209.6M cash position funds operations through profitability, with international deals providing substantial revenue potential.

LENZ's financial position reflects a company executing a well-funded transition to commercialization. Their $209.6 million cash balance represents a formidable war chest that management explicitly states will fund operations until they achieve positive cash flow post-launch. This financial cushion significantly reduces investment risk by eliminating near-term funding concerns.

The execution of multiple international licensing agreements is particularly noteworthy from a financial perspective. These deals unlock over $195 million in potential upfront and milestone payments plus double-digit royalties, providing substantial non-dilutive capital and validation of LNZ100's commercial potential. The geographic diversification across Asia, Canada, and China creates multiple revenue streams.

Quarterly financial metrics show a company appropriately investing toward commercialization. The $9.1 million R&D expense (+32% YoY) reflects increased pre-approval manufacturing activities, while SG&A costs of $12.8 million (+73% YoY) demonstrate significant investment in commercial infrastructure and personnel. While this accelerated spending has increased their quarterly net loss to $14.9 million, this is a calculated investment preceding potential revenue generation.

The company's cash management strategy appears disciplined, projecting to maintain over $205 million at their August 8 PDUFA date despite increased pre-commercial spending. This careful financial stewardship, combined with their explicit statement about funding operations through to positive cash flow, suggests management confidence in both regulatory approval and subsequent commercial success.

With minimal financing risk, multiple revenue-generating agreements already in place, and a clear path to commercialization, LENZ demonstrates financial strength unusual for a pre-revenue biopharma company approaching its first product launch.

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 $195 million in upfront and milestone payments together with double-digit royalties on net sales

Cash, cash equivalents and marketable securities of $209.6 million as of June 30, 2025

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 $195 million in upfront and milestone payments together with double-digit royalties on net sales. In May 2025, the Company announced an exclusive license and commercialization agreement granting Lotus Pharmaceutical rights to commercialize LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore. Under the terms of the agreement, LENZ is eligible to receive up to $125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on net sales.

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 $70 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on net sales.

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 $95.0 million of regulatory and sales milestones, as well as tiered mid single-digit to low double-digit royalties on net sales in Greater China.

Financial Results for Three and Six Months Ended June 30, 2025
Cash Position: Cash, cash equivalents and marketable securities were $209.6 million as of June 30, 2025, which is anticipated to fund operations to post-launch positive cash flow. The Company anticipates a cash balance in excess of $205.0 million as of its August 8, 2025 PDUFA target action date.

Research and Development (R&D) Expenses: R&D expenses increased to $9.1 million for the three months ended June 30, 2025, compared to $6.9 million during the same period in 2024, primarily driven by an increase in pre-approval and contingent product manufacturing activities to support the potential commercial launch of LNZ100, which is recorded in research and development prior to approval. R&D expenses decreased to $14.9 million for the six months ended June 30, 2025, compared to $17.5 million during the same period in 2024, driven by decreases in clinical trial-related expenses, as our Phase 3 CLARITY study was substantially completed in March 2024.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses increased to $12.8 million and $23.9 million for the three and six months ended June 30, 2025, respectively, compared to $7.4 million and $13.0 million during the same periods in 2024, primarily driven by increases in personnel-related expenses due to a growth in headcount, including the hiring of 88 sales specialists, and pre-commercial marketing, advertising and sales infrastructure expenses as we prepare for a potential commercial launch of LNZ100, subject to FDA approval.

Net Loss: Net loss for the three and six months ended June 30, 2025 was $14.9 million and $29.5 million, respectively, or $0.53 and $1.06 per share (basic and diluted), respectively, compared to a net loss of $10.3 million and $26.9 million, or $0.40 and $1.77 per share (basic and diluted) during the same periods in 2024. Net loss per share (basic and diluted) considers only the weighted-average common shares outstanding for the respective periods

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?

The FDA has assigned a PDUFA target action date of August 8, 2025 for LNZ100, with no Advisory Committee Meeting planned.

How much cash does LENZ Therapeutics (NASDAQ:LENZ) have as of Q2 2025?

LENZ reported $209.6 million in cash, cash equivalents and marketable securities as of June 30, 2025, expected to fund operations to post-launch positive cash flow.

What are the terms of LENZ Therapeutics' international licensing agreements?

LENZ secured deals worth over $195 million in potential upfront and milestone payments, plus double-digit royalties on net sales, including agreements with Lotus Pharmaceutical for Southeast Asia and Laboratoires Théa for Canada.

How large is LENZ Therapeutics' sales force for LNZ100 launch?

LENZ has hired and completed pre-approval training for an 88-member sales force ready to initiate sales and marketing activities immediately upon approval.

What was LENZ Therapeutics' net loss in Q2 2025?

LENZ reported a net loss of $14.9 million, or $0.53 per share, compared to $10.3 million, or $0.40 per share, in Q2 2024.

What is LNZ100 being developed for?

LNZ100 is being developed as the first and only aceclidine-based eye drop to improve near vision in people with presbyopia.