Day One Announces Q2 2024 Financial Results and Corporate Update

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) has released its second quarter 2024 financial results, showcasing a period marked by significant achievements and growth. The company, based in Brisbane, California, is committed to developing and commercializing targeted therapies for various life-threatening diseases affecting individuals of all ages.

A major highlight for Day One is the impressive performance of OJEMDA™ (tovorafenib), which generated $8.2 million in net product revenues within the first two months of its launch. This medication received accelerated approval from the U.S. Food and Drug Administration (FDA) in April 2024 and stands as the only FDA-approved treatment for patients aged six months and older with relapsed or refractory pediatric low-grade glioma (pLGG) characterized by specific genetic mutations.

Chief Executive Officer Jeremy Bender, Ph.D., expressed his satisfaction with the quarter’s achievements, noting the strong demand for OJEMDA following its approval. He also highlighted the company’s strategic advancements, including the expansion of their pipeline with the introduction of DAY301, a promising first-in-class antibody-drug conjugate (ADC) targeting PTK7, which is anticipated to enter clinical trials soon.

In addition to the successful launch of OJEMDA, Day One entered into a significant licensing agreement with Ipsen to commercialize tovorafenib outside the U.S. This deal brought in approximately $111 million upfront in cash and equity investment, with potential for additional milestone payments and royalties. Moreover, the company secured an exclusive licensing agreement with MabCare Therapeutics for a novel ADC targeting PTK7, with clinical trials expected to commence late 2024 or early 2025.

Day One also made the strategic decision to discontinue its pimasertib program, reallocating resources to focus on the DAY301 program. The company plans to present detailed results at upcoming medical conferences. Furthermore, the pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial continues to enroll patients globally, aiming to evaluate tovorafenib as a front-line therapy for pLGG.

On the corporate front, Day One announced a definitive agreement for an oversubscribed private placement of its securities, totaling approximately $175 million in gross proceeds. The company also sold a rare pediatric disease Priority Review Voucher awarded by the FDA for OJEMDA's approval for $108 million, marking a significant gain.

Financially, Day One reported a robust cash position with cash, cash equivalents, and short-term investments totaling nearly $362 million as of June 30, 2024. Research and development expenses for the quarter reached $92.1 million, a substantial increase from the previous year, primarily due to the upfront payment for the MabCare Therapeutics license agreement, heightened clinical trial activities, and additional employee compensation costs. Selling, general and administrative expenses also rose to $30.2 million, reflecting increased compensation, commercial launch activities, and professional service expenses to support the company’s growth.

The net loss for the second quarter of 2024 was $4.4 million, a significant improvement compared to a net loss of $45.9 million in the same period in 2023. This decrease in net loss is attributed to the gain from the sale of the Priority Review Voucher and other non-operating income.

Day One has strengthened its leadership team by appointing John Stubenrauch as Chief Technology Officer. With over 25 years of experience in developing and commercializing medicines, including ADCs, Dr. Stubenrauch’s expertise is expected to be instrumental in advancing the company’s initiatives.

Lastly, Day One plans to participate in the 2024 Wedbush PacGrow Healthcare Conference from August 12-14, 2024, continuing its engagement with the investor and medical community to discuss its ongoing projects and future milestones.

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