On August 10, 2021 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genomically defined cancers, reported financial results for the second quarter of 2021 and highlighted recent corporate achievements (Press release, Day One, AUG 10, 2021, View Source [SID1234586230]).
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"Day One made significant progress across multiple clinical and corporate initiatives during the second quarter of 2021, including dosing the first patients in our ongoing FIREFLY-1 pivotal study of DAY101 in pediatric low-grade glioma," said Jeremy Bender, Ph.D., chief executive officer of Day One. "The success of our recent IPO reflects a strong commitment from our investors who, like all of us at Day One, recognize the therapeutic potential of DAY101. Entering the second half of 2021, we remain well positioned to advance our pipeline through key data readouts with the goal of fulfilling our mission of developing novel medicines to improve the lives of patients of all ages living with cancer." Program Highlights The Company announced first patients dosed in the FIREFLY-1 pivotal clinical trial of DAY101 in pediatric low-grade glioma (pLGG). FIREFLY-1 is being conducted in collaboration with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and is designed to support the regulatory approval of DAY101. Initial data from FIREFLY-1 is expected in the first half of 2022. Day One has initiated a Phase 2 monotherapy trial of DAY101 in adult patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations. The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. If a New Drug Application in the United States for DAY101 is approved, Day One may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold or transferred. The European Commission granted DAY101 Orphan Designation for the treatment of glioma based upon a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products. Corporate Highlights The Company announced the successful closing of its upsized initial public offering, raising gross proceeds of $184.0 million, bringing total cash, cash equivalents and marketable securities to $310.0 million at the end of June 30, 2021. The company expects its current cash position to fund operations into the second half of 2023 and through key clinical milestones. Day One appointed Saira Ramasastry to its Board of Directors. Ms. Ramasastry currently serves as the Managing Partner of Life Sciences Advisory, LLC, and brings more than 20 years of experience to the Board as a life sciences-focused strategic consultant and investment banker. Second Quarter 2021 Financial Highlights Cash Position: Cash and cash equivalents and short-term investments totaled $310.0 million at June 30, 2021. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into the second half of 2023. R&D Expenses: Research and development expenses were $9.9 million for the second quarter 2021 and $1.4 million for the second quarter 2020. The increase was primarily due to additional employee compensation costs, clinical trial expenses, CMC activity and a milestone payment for DAY101. G&A Expenses: General and administrative expenses were $5.5 million for the second quarter 2021 and $0.9 million for the second quarter 2020. The increase was primarily due to additional employee compensation costs, legal, and professional expenses associated with being a public company. Net Loss: Net loss totaled $15.5 million and $2.4 million for the second quarter 2021 and 2020, respectively, with non-cash stock compensation expense of $2.5 million and $0.1 million for the second quarter of 2021 and 2020, respectively. Upcoming Events 12th Annual Wedbush PacGrow Healthcare Conference: Day One’s chief executive officer Jeremy Bender will be a participant on the Panel, "Bullseye – Targeted Oncology Part 2". The panel discussion will take place on Wednesday, August 11th at 10:20 am ET. Day One will also be available for one-on-one investor meetings during the conference. About DAY101 DAY101 is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway. Studies have shown DAY101 has high brain distribution and exposure in comparison to other MAPK pathway inhibitors, thus potentially benefiting patients with primary brain tumors or brain metastases of solid tumors. DAY101 is a type II RAF inhibitor found to selectively inhibit both monomeric and dimeric RAF kinase, which may broaden its potential clinical application to treat an array of RAF-altered tumors. DAY101 has been studied in over 250 patients, and as a monotherapy demonstrated good tolerability and encouraging anti-tumor activity in pediatric and adult populations with specific MAPK pathway-alterations. In November 2020, Day One announced preliminary results from PNOC014, an ongoing Phase 1 Pacific Pediatric Neuro-Oncology Consortium (PNOC) network study with DAY101 sponsored by the Dana-Farber Cancer Institute. Preliminary results demonstrated that of the eight relapsed pLGG patients in the study with RAF fusions, two patients achieved a complete response by Response Assessment for Neuro-Oncology (RANO), three had a partial response, two achieved prolonged stable disease, and one experienced progressive disease. DAY101 also demonstrated a tolerable safety profile with the most common side effects being skin rash and hair color changes. DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma. Day One is conducting a pivotal Phase 2 trial (FIREFLY-1) of DAY101 in pediatric, adolescent and young adult patients with pLGG. Day One also plans to study DAY101 alone or in combination with other agents that target key signaling nodes in the MAPK pathway, such as the Company’s MEK inhibitor pimasertib, in patient populations where various RAS and RAF alterations are believed to play an important role in driving disease.