AI Analysis | Feedback

Here are 1-2 brief analogies for Day One Biopharmaceuticals (DAWN):

• A Moderna or BioNTech for cancer, developing targeted therapies, particularly for children.
• An early-stage Amgen or Gilead, but dedicated to novel cancer drugs for children.

AI Analysis | Feedback

• Tovorafenib: An investigational oral drug candidate being developed for the treatment of pediatric and adult cancers, primarily low-grade glioma, by targeting specific RAF kinase mutations.

AI Analysis | Feedback

• Drug Distributors: These companies purchase pharmaceuticals directly from manufacturers and distribute them to pharmacies, hospitals, and other healthcare providers. The largest drug distributors in the U.S. are generally the initial and primary customers for pharmaceutical companies launching new products.
  • McKesson Corporation (Symbol: MCK)
  • Cencora (formerly AmerisourceBergen Corporation) (Symbol: COR)
  • Cardinal Health, Inc. (Symbol: CAH)
• Specialty Pharmacies: These pharmacies handle complex or high-cost medications that require special handling, administration, or patient monitoring. They often manage prescriptions for specific conditions like cancer. Many specialty pharmacies are part of larger public healthcare organizations or Pharmacy Benefit Managers (PBMs). Day One would likely establish contracts with these specialty pharmacy networks. Examples of parent companies operating significant specialty pharmacy services include:
  • CVS Health (Symbol: CVS) (operates CVS Specialty)
  • Cigna (Symbol: CI) (operates Evernorth, which includes Accredo Specialty Pharmacy)
  • UnitedHealth Group (Symbol: UNH) (operates OptumRx Specialty)
• Hospitals (Pediatric Oncology Centers): While sales to hospitals typically flow through distributors and specialty pharmacies, pediatric oncology centers within hospitals are the ultimate points of care where OJEMDA will be administered to patients. Individual hospital systems are generally not named as direct major customers by pharmaceutical manufacturers in the same way distributors are, due to the indirect nature of the sales channel.

AI Analysis | Feedback

• Lonza Group AG (Symbol: LONN.SW)
• Almac Pharma Services Ltd.

AI Analysis | Feedback

Jeremy Bender, Ph.D., MBA
Chief Executive Officer, President and Director

Dr. Bender has served as Chief Executive Officer, President, and a board member of Day One Biopharmaceuticals since September 2020. Prior to joining Day One, he was Vice President of Corporate Development at Gilead Sciences from March 2018 to September 2020, where he oversaw over 40 transactions totaling more than $10 billion in upfront value. He previously served as Chief Operating Officer of Tizona Therapeutics from July 2015 to March 2018 and Chief Business Officer of Sutro Biopharma from October 2012 to July 2015. Earlier in his career, he was Vice President of Corporate Development at Allos Therapeutics from January 2006 to September 2012. He began his career in the life sciences practice at Boston Consulting Group.

Charles N. York II, MBA
Chief Operating Officer and Chief Financial Officer

Mr. York serves as the Chief Operating Officer and Chief Financial Officer of Day One Biopharmaceuticals. He is also the Principal Accounting Officer.

Elly Barry, MD
Chief Medical Officer

Dr. Barry joined Day One in 2021 and is a board-certified pediatrician and pediatric hematologist/oncologist with over 15 years of drug development experience. Previously, she was the Global Clinical Lead for Pediatric Oncology at Pfizer and Head of Pfizer's Pediatric Oncology Leadership Team. She has also held roles at Genzyme and Millennium/Takeda, focusing on oncology therapeutics development.

Lauren Merendino, MBA
Chief Commercial Officer

Ms. Merendino is a seasoned commercial leader with over 25 years of pharmaceutical and biotech experience. She has expertise in building and leading commercial teams and has a record of successful product launches, including the inaugural product OJEMDA at Day One. Before Day One, she served as Chief Commercial Officer at Myovant Sciences, where she led successful launches of two products across three indications. She spent the majority of her career at Genentech/Roche, holding various commercial leadership roles on multiple launches.

Davy Chiodin, PharmD
Chief Development Officer

Dr. Chiodin serves as the Chief Development Officer for Day One Biopharmaceuticals.

AI Analysis | Feedback

The key risks to Day One Biopharmaceuticals (symbol: DAWN) primarily stem from its stage as a commercial-stage biopharmaceutical company with a limited operating history and a focused product portfolio.

1. Heavy Reliance on OJEMDA and Pipeline Success: Day One Biopharmaceuticals' near-term revenues are highly dependent on the successful commercialization of OJEMDA (tovorafenib). The company's future growth is significantly tied to the performance and expansion of OJEMDA and the successful outcomes of ongoing clinical trials, such as the pivotal Phase 3 FIREFLY-2 trial. Any failure in the commercialization of OJEMDA or adverse results, delays, or failures in securing regulatory approvals for its product candidates could materially and adversely affect the company's business and financial condition. The cancellation of a monotherapy substudy in a previous trial highlights the inherent risks in drug development.
2. History of Net Losses and Need for Capital: Day One Biopharmaceuticals has incurred significant net losses since its inception and expects this trend to continue for the foreseeable future, making it challenging for investors to evaluate its likelihood of achieving profitability. While the company has reported a strong cash position, clinical trials are expensive and time-consuming. The company may require additional capital to finance its operations and achieve its goals, and an inability to raise capital on acceptable terms could force it to delay, reduce, or eliminate its research or product development programs.
3. Customer Concentration for Revenue: A significant business risk for Day One Biopharmaceuticals is its heavy reliance on a small number of large customers for revenue. During the nine months ending September 30, 2024, just three customers accounted for all of the company's net product revenue, with one customer alone representing 66.6%. This concentration risk means that the loss or reduction in demand from any of these customers could severely diminish net sales and negatively affect the company's operating results and accounts receivable balance.

AI Analysis | Feedback

AI Analysis | Feedback

Day One Biopharmaceuticals' primary product, tovorafenib (DAY101), targets pediatric low-grade glioma (pLGG).

• For tovorafenib in the global pediatric gliomas drugs market, the market was estimated at approximately USD 5 billion in 2024 and is projected to surpass USD 11 billion by 2034, with a compound annual growth rate (CAGR) of approximately 8% from 2025 to 2034. Another estimate for the global pediatric gliomas drugs market places it in the range of USD 1.5 billion to USD 2 billion for 2025, with a projected CAGR between 6% and 8% from 2025 to 2033.
• For the broader global low-grade glioma (LGG) treatment market, which includes pLGG, the market size was valued at USD 1.5 billion in 2023 and is projected to reach USD 2.7 billion by 2032, growing at a CAGR of 6.8%.
• In the United States, the low-grade glioma market reached USD 1.24 billion in 2024 and is projected to reach USD 1.87 billion by 2033, growing at a CAGR of 4.7% during the forecast period of 2025-2033. North America holds the largest share in the low-grade glioma treatment market.

For Day One Biopharmaceuticals' other pipeline products:

• Pimasertib: null
• DAY301: null
• VRK1 Inhibitor: null

AI Analysis | Feedback

Expected Drivers of Future Revenue Growth for Day One Biopharmaceuticals (DAWN)

• Commercialization and Increased Adoption of OJEMDA (Tovorafenib) in Relapsed/Refractory Pediatric Low-Grade Glioma (pLGG): Day One Biopharmaceuticals' primary revenue driver is the continued successful commercialization and increasing adoption of OJEMDA (tovorafenib). OJEMDA received accelerated approval from the U.S. Food and Drug Administration (FDA) in April 2024 as the first and only approved systemic therapy for patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The company reported strong performance in Q3 2025, with net product revenue increasing by 15% quarter-over-quarter, an 18% growth in total prescriptions, and nearly a 20% rise in new patient starts quarter-over-quarter. Day One has also raised its full-year 2025 revenue guidance, reflecting confidence in OJEMDA's continued market penetration and increasing physician confidence, particularly in the second-line treatment setting.
• Potential Expansion of OJEMDA to First-Line pLGG Treatment: A significant future growth driver is the ongoing pivotal Phase 3 FIREFLY-2 trial, which is evaluating tovorafenib as a front-line therapy in patients with RAF-altered pLGG. Full enrollment for the FIREFLY-2 trial is anticipated in the first half of 2026. A successful outcome from this trial and subsequent regulatory approval would substantially expand OJEMDA's addressable patient population to include newly diagnosed patients, representing a considerable increase in potential revenue.
• International Expansion of OJEMDA: Day One Biopharmaceuticals is pursuing global market expansion for OJEMDA. In July 2024, the company entered into an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S. Ipsen expects a regulatory decision from the European Medicines Agency (EMA) for OJEMDA in Europe by mid-2026, which would unlock new international markets and contribute to revenue growth.
• Advancement of Pipeline Candidates, Specifically DAY301: Beyond OJEMDA, Day One's pipeline includes DAY301, a potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7. This candidate is expected to enter clinical trials in the coming months (as of July 2024). Successful progression through clinical development and potential commercialization of DAY301 would provide a new source of revenue and diversify the company's product portfolio in the long term.
• Strategic Price Management for OJEMDA: The company has demonstrated the ability to implement price adjustments for OJEMDA, as indicated by a price increase in July 2025, which contributed to the gross-to-net adjustment being at the higher end of the guided range. While not the sole driver, strategic pricing alongside increasing market penetration and volume will contribute to overall revenue growth.

AI Analysis | Feedback

Share Issuance

• Day One Biopharmaceuticals completed its initial public offering (IPO) in May 2021, offering 10,000,000 shares at $16.00 per share, which generated expected gross proceeds of $160.0 million.
• In June 2023, the company conducted an underwritten public offering of $150.0 million of its common stock, with an option for underwriters to purchase an additional $22.5 million in shares.
• The number of shares outstanding increased by 17.10% in one year.

Inbound Investments

• Day One Biopharmaceuticals has attracted significant institutional investment, with 373 institutional owners holding a total of 96,119,623 shares.
• Cash and equivalents increased substantially from $49.3 million in Q1 2023 to $422.8 million by Q3 2024, indicating increased liquidity and financial stability.
• The company ended the third quarter of 2025 with $451.6 million in cash and investments.

Capital Expenditures

• Day One Biopharmaceuticals reported capital expenditures of -$2.46 million over the last 12 months.
• For June 2025, quarterly capital expenditures were -$1.7 million.
• As of December 30, 2024, the company's property, plant, and equipment were valued at $4.7 million.