LENZ Therapeutics Reports Third Quarter 2024 Financial Results
LENZ Therapeutics reported Q3 2024 financial results with key highlights including FDA acceptance of their New Drug Application for LNZ100 for presbyopia treatment, with a PDUFA date of August 8, 2025. The company announced positive Phase 3 study results in China, with 74% of patients achieving significant vision improvement. Cash position stands at $217.2 million as of September 30, 2024. Q3 financial results showed R&D expenses decreased to $6.5 million from $17.0 million year-over-year, while SG&A expenses increased to $6.5 million from $2.9 million. Net loss was $10.2 million or $0.38 per share.
LENZ Therapeutics ha riportato i risultati finanziari del terzo trimestre 2024, con punti salienti tra cui l'accettazione da parte dell'FDA della loro Domanda di Nuovo Farmaco per LNZ100 per il trattamento della presbiopia, con una data PDUFA fissata per l'8 agosto 2025. L'azienda ha annunciato risultati positivi dello studio di Fase 3 in Cina, con il 74% dei pazienti che ha ottenuto un significativo miglioramento visivo. La posizione di liquidità è di 217,2 milioni di dollari al 30 settembre 2024. I risultati finanziari del terzo trimestre hanno mostrato che le spese per R&S sono diminuite a 6,5 milioni di dollari rispetto ai 17,0 milioni dell'anno precedente, mentre le spese SG&A sono aumentate a 6,5 milioni di dollari rispetto ai 2,9 milioni. La perdita netta è stata di 10,2 milioni di dollari, ovvero 0,38 dollari per azione.
LENZ Therapeutics informó los resultados financieros del tercer trimestre de 2024, con puntos clave que incluyen la aceptación por parte de la FDA de su Solicitud de Nuevo Medicamento para LNZ100 para el tratamiento de la presbicia, con una fecha PDUFA del 8 de agosto de 2025. La compañía anunció resultados positivos de un estudio de Fase 3 en China, con un 74% de los pacientes logrando una mejora significativa en la visión. La posición de efectivo es de 217.2 millones de dólares al 30 de septiembre de 2024. Los resultados financieros del tercer trimestre mostraron que los gastos en I+D disminuyeron a 6.5 millones de dólares desde 17.0 millones en el año anterior, mientras que los gastos SG&A aumentaron a 6.5 millones de dólares desde 2.9 millones. La pérdida neta fue de 10.2 millones de dólares, o 0.38 dólares por acción.
LENZ Therapeutics는 2024년 3분기 재무 결과를 보고했으며, 주요 사항으로는 LNZ100의 노안 치료를 위한 신규 의약품 승인 신청서가 FDA에 의해 수락되었으며, PDUFA 날짜는 2025년 8월 8일로 설정되었습니다. 회사는 중국에서 실시한 3상 연구의 긍정적인 결과를 발표했으며, 환자의 74%가 시력 개선의 유의미한 향상을 보였습니다. 2024년 9월 30일 기준으로 현금 잔고는 2억 1,720만 달러입니다. 3분기 재무 결과는 R&D 비용이 전년 대비 1,700만 달러에서 650만 달러로 감소한 반면, SG&A 비용은 290만 달러에서 650만 달러로 증가했음을 보여주었습니다. 순손실은 1,020만 달러, 즉 주당 0.38 달러였습니다.
LENZ Therapeutics a annoncé ses résultats financiers pour le troisième trimestre 2024, avec des faits marquants comprenant l'acceptation par la FDA de leur Demande de Nouveau Médicament pour LNZ100 pour le traitement de la presbytie, avec une date PDUFA fixée au 8 août 2025. L'entreprise a annoncé des résultats positifs d'une étude de Phase 3 en Chine, avec 74 % des patients ayant obtenu une amélioration significative de la vision. La position de trésorerie s'élève à 217,2 millions de dollars au 30 septembre 2024. Les résultats financiers du troisième trimestre ont montré que les dépenses en R&D ont diminué à 6,5 millions de dollars contre 17,0 millions l'année précédente, tandis que les dépenses SG&A ont augmenté à 6,5 millions de dollars contre 2,9 millions. La perte nette était de 10,2 millions de dollars ou 0,38 dollar par action.
LENZ Therapeutics hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit wichtigen Highlights, einschließlich der Annahme ihres Antrags auf Zulassung eines neuen Arzneimittels durch die FDA für LNZ100 zur Behandlung von Presbyopie, mit einem PDUFA-Datum vom 8. August 2025. Das Unternehmen gab positive Ergebnisse aus einer Phase-3-Studie in China bekannt, bei der 74 % der Patienten eine signifikante Sehverbesserung erzielten. Die Liquiditätsposition beläuft sich zum 30. September 2024 auf 217,2 Millionen US-Dollar. Die finanziellen Ergebnisse für das dritte Quartal zeigten, dass die F&E-Ausgaben von 17,0 Millionen US-Dollar im Vorjahr auf 6,5 Millionen US-Dollar gesenkt wurden, während die SG&A-Ausgaben von 2,9 Millionen US-Dollar auf 6,5 Millionen US-Dollar erhöht wurden. Der Nettoverlust betrug 10,2 Millionen US-Dollar oder 0,38 US-Dollar pro Aktie.
- FDA accepted NDA for LNZ100 with PDUFA date set for August 8, 2025
- Strong Phase 3 results in China with 74% efficacy rate
- Solid cash position of $217.2 million, expected to fund operations through launch
- R&D expenses decreased by 61.8% year-over-year to $6.5 million
- Completed $30 million private placement financing
- Net loss of $10.2 million in Q3 2024
- SG&A expenses increased 124% year-over-year to $6.5 million
Insights
The Q3 2024 results reveal a strong financial position with
SG&A expenses increased to
The FDA acceptance of LNZ100's NDA with a PDUFA date of August 8, 2025, marks a significant milestone. The Phase 3 data from China is particularly impressive, with
As the first aceclidine-based eye drop for presbyopia, LNZ100 addresses an unmet need in a massive market of 1.8 billion people globally. The lack of planned FDA advisory committee meeting suggests confidence in the safety profile.
New Drug Application (NDA) for LNZ100 for treatment of presbyopia accepted for review by the U.S. Food and Drug Administration (FDA); PDUFA target action date of August 8, 2025
CORXEL and LENZ Therapeutics announced positive topline data from Phase 3 study in China for the treatment of presbyopia
Cash, cash equivalents and marketable securities of
Company to host a conference call today at 8:00 a.m. ET
SAN DIEGO, Nov. 06, 2024 (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 and operational highlights for the third quarter ended September 30, 2024 and recent period.
“The third quarter and recent period has continued to be a time of tremendous execution and focus on our primary objective, which is to advance LNZ100 towards approval in the United States and a commercial launch as early as the fourth quarter of 2025,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “In addition, we believe the recently announced data from the Phase 3 clinical study in China is extremely important, further enhancing the potential for LNZ100 to become a global therapy for the treatment of presbyopia. With an estimated 128 million people in the United States and 400 million people in China with presbyopia, we look forward to the prospect of unlocking significant access to LNZ100 worldwide and further generating shareholder value through that effort.”
Third Quarter 2024 and Recent Highlights
Announced New Drug Application (NDA) acceptance by the U.S. Food and Drug Administration (FDA) for LNZ100 as a treatment for presbyopia. In October 2024, the Company announced that the FDA accepted the NDA for LNZ100 for the treatment of presbyopia, a condition that impacts an estimated 1.8 billion people globally and 128 million people in the United States. The Company previously announced the submission of its NDA in August 2024. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. 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 is not approved for the treatment of presbyopia in any country.
CORXEL and LENZ Therapeutics announced positive topline data from Phase 3 study in China for the treatment of presbyopia. In October 2024, CORXEL and the Company announced topline data from the Phase 3 safety and efficacy study in China. In the Phase 3 study, LNZ100 (
US Commercial launch preparations underway and on track for mid-2025 approval. Building upon the acceptance of the Company’s NDA application by the FDA with an August 8, 2025 target action date, LENZ continues to progress its launch readiness for an anticipated approval of LNZ100 for the treatment of presbyopia in the United States. The Company has hired and established its full commercial leadership team across sales, marketing and commercial operations. In addition, the Company has also hired both Regional Sales Directors adding key sales force leadership, with significant eye care and pharmaceutical sales experience.
Market research of surveyed Eye Care Professionals (“ECPs”) confirmed enthusiasm for LNZ100 clinical data and likelihood to prescribe. The Company commissioned a survey of 426 Optometrists and Ophthalmologists, to further define the presbyopia market and evaluate the interest for LNZ100. Key results of the surveyed ECPs included:
- ECPs see an average of approximately 300-400 patients per month, of which
61% are presbyopic 87% of ECPs’ eye exams include a retinal eye exam, confirming that the retinal exam is already a common practice in these evaluations78% of ECPs agree with the statement that LNZ100 was a “well tolerated and safe” option for the treatment of presbyopia, if approved78% of ECPs agree with the statement that LNZ100 was “attractive as a presbyopia treatment”, if approved83% of ECPs would be likely to sample, based on its clinical data profile82% of ECPs would be likely to prescribe, based on its clinical data profile
Completed
Financial Results for Third Quarter 2024
Cash Position: Cash, cash equivalents and marketable securities were
Research and Development (R&D) Expenses: R&D expenses decreased to
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were
Net Loss: Net loss for the three months ended September 30, 2024, was
Conference Call Information
The Company will host a conference call and webcast today, Wednesday, November 6, 2024, at 8:00 a.m. ET. To participate in the conference call via telephone, dial (800) 715-9871 (Domestic) or (646) 307-1963 (International) and enter code 7959303. The live webcast from today’s conference call can be accessed here and on the LENZ Therapeutics website at www.LENZ-Tx.com in the Investors & Media section. A replay of the webcast will be available on the Company’s website for 30 days following the event.
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; 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 September 30, 2024 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) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| (unaudited) | |||||||
| Cash and cash equivalents | $ | 41,046 | $ | 35,140 | |||
| Marketable securities | $ | 176,061 | $ | 30,654 | |||
| Total assets | $ | 224,007 | $ | 70,376 | |||
| Total liabilities | $ | 8,727 | $ | 19,698 | |||
| Total stockholders’ equity (deficit) | $ | 215,280 | $ | (92,712 | ) | ||
| LENZ Therapeutics, Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 6,451 | $ | 17,004 | $ | 23,933 | $ | 39,968 | |||||||
| Selling, general and administrative | 6,494 | 2,861 | 19,452 | 7,472 | |||||||||||
| Total operating expenses | 12,945 | 19,865 | 43,385 | 47,440 | |||||||||||
| Loss from operations | (12,945 | ) | (19,865 | ) | (43,385 | ) | (47,440 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Other income (expense) | (6 | ) | (101 | ) | 281 | (174 | ) | ||||||||
| Interest income | 2,736 | 1,086 | 5,987 | 1,338 | |||||||||||
| Total other income (expense), net | 2,730 | 985 | 6,268 | 1,164 | |||||||||||
| Net loss | $ | (10,215 | ) | $ | (18,880 | ) | $ | (37,117 | ) | $ | (46,276 | ) | |||
| Other comprehensive loss: | |||||||||||||||
| Unrealized loss on marketable securities | 585 | 9 | 517 | (5 | ) | ||||||||||
| Comprehensive loss | $ | (9,630 | ) | $ | (18,871 | ) | $ | (36,600 | ) | $ | (46,281 | ) | |||
| Net loss per share, basic and diluted | $ | (0.38 | ) | $ | (9.62 | ) | $ | (1.93 | ) | $ | (23.66 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 27,172,330 | 1,961,822 | 19,195,399 | 1,956,282 | |||||||||||
FAQ
When is the PDUFA date for LENZ Therapeutics' LNZ100?
What were the Phase 3 trial results for LENZ (LENZ) in China?
What was LENZ Therapeutics' (LENZ) cash position in Q3 2024?
What was LENZ Therapeutics' (LENZ) net loss per share in Q3 2024?
