** charts after earnings **
BRISBANE,
Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals,
Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical
company dedicated to developing and commercializing targeted therapies
for people of all ages with life-threatening diseases, today announced
its third quarter 2024 financial results and highlighted recent
corporate achievements.
Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue.
Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments.
Program Highlights
- Strong
growth in OJEMDA net revenue with $20.1M in the third quarter of 2024,
representing a 145% increase over the second quarter of 2024.
- Quarterly
prescriptions (TRx) grew to 619 in the third quarter of 2024,
representing a 159% increase over the second quarter of 2024.
- Day
One expects to dose the first patient in the Phase 1a portion of the
Phase 1a/b clinical trial of DAY301 by the end of 2024 or in the first
quarter of 2025.
- Day One provided updated duration of response
data from the registrational Phase 2 FIREFLY-1 trial investigating
tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG.
For the 77 patients enrolled on Arm 1, which was the dataset used to
assess OJEMDA’s efficacy, the median duration of response is 18 months.
- The
pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib
as a front-line therapy in patients aged 6 months to 25 years with pLGG
continues to enroll patients in the United States, Canada, Europe,
Australia and Asia, with more than 100 sites activated.
Corporate Highlights and Upcoming Milestones
- Day
One and Ipsen entered into an exclusive licensing agreement to
commercialize tovorafenib outside of the U.S. in July 2024. Under the
agreement, Day One received approximately $111 million upfront in cash
and equity investment at a premium with up to approximately $350 million
in additional launch and sales milestone payments as well as tiered
double-digit royalties starting at mid-teens percentage on net sales.
- Day
One entered into a definitive agreement for an oversubscribed private
placement of its securities for total gross proceeds of approximately
$175 million in July 2024.