Day One Biopharmaceuticals, Inc. (DAWN): History, Ownership, Mission, How It Works & Makes Money

Day One Biopharmaceuticals, Inc. (DAWN): History, Ownership, Mission, How It Works & Makes Money

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Day One Biopharmaceuticals, Inc. (DAWN) is a commercial-stage biotech, but how does a company founded to address the dire lack of therapies for pediatric cancer project a full-year $140 million to $150 million revenue for the 2025 fiscal year?

The core of that growth is their flagship drug, OJEMDA™ (tovorafenib), which alone delivered $30.5 million in net product revenue in Q1 2025, plus a sharp focus on first-in-class targeted therapies for life-threatening diseases.

Considering their November 2025 move to acquire Mersana Therapeutics, expanding their oncology pipeline, you have to ask: is this a shrewd strategic play to diversify or a defintely costly overreach in a volatile biotech market?

Day One Biopharmaceuticals, Inc. (DAWN) History

You want to understand the foundation of Day One Biopharmaceuticals, Inc. (DAWN), and honestly, it's a remarkably fast-moving story of targeted oncology. The company was purpose-built to address the innovation gap in pediatric cancer, and its trajectory from a concept in 2018 to a commercial-stage company by 2024 is a masterclass in focused execution. They cut straight to a solution for a critical unmet need.

Given Company's Founding Timeline

Year established

Day One Biopharmaceuticals, Inc. was incorporated in 2018 on October 31.

Original location

The company was originally based in San Francisco, California, specifically in South San Francisco, before establishing its headquarters in Brisbane, California.

Founding team members

The company was founded by Julie Grant and Samuel Blackman, leveraging expertise in venture capital and oncology development.

Initial capital/funding

While the initial seed capital is not public, the company's first major funding event was a $60 million Series A round announced in May 2020. This capital was immediately put to work acquiring their lead asset.

Given Company's Evolution Milestones

Year Key Event Significance
2020 Announced $60 million Series A funding and acquired DAY101 (tovorafenib) from Takeda. Secured the foundational lead asset and capital, transitioning from incubation to a clinical-stage company.
2021 Priced Initial Public Offering (IPO) on Nasdaq, raising $160.0 million in gross proceeds. Moved from private to public company (NASDAQ: DAWN) on May 27, 2021, providing significant capital for pivotal trials.
2024 U.S. FDA granted Accelerated Approval for OJEMDA (tovorafenib) for relapsed/refractory pLGG. Transformed into a commercial-stage biopharmaceutical company, launching its first approved product.
2025 Raised full-year net product revenue guidance for OJEMDA to $145 million to $150 million. Demonstrated strong commercial execution and market adoption in the first full year post-approval.

Given Company's Transformative Moments

The company's history is defined by a few high-impact, deliberate decisions that accelerated its path to market, skipping the typical decade-long slog for a de novo biotech.

  • Acquiring Tovorafenib: The decision to acquire tovorafenib (DAY101) from Takeda in 2020 was the single biggest move. It meant starting with a clinical-stage asset, dramatically shortening the timeline to FDA approval and commercialization.
  • The IPO Fuel: The $160.0 million raised in the May 2021 IPO was crucial. That capital funded the pivotal Phase 2 FIREFLY-1 trial, which ultimately led to the accelerated approval of OJEMDA.
  • Commercial Transition: The April 2024 FDA accelerated approval of OJEMDA for pediatric low-grade glioma (pLGG) was the pivot point. It immediately changed the company from a research expense center to a revenue-generating commercial entity. This shift is reflected in the 2025 year-to-date U.S. OJEMDA net product revenue of $102.6 million through the third quarter.
  • 2025 Pipeline Expansion: In November 2025, Day One signed a definitive merger agreement to acquire Mersana Therapeutics. This strategic move, valued up to ~$285 million (with an approximate equity value at closing of $129 million), adds another clinical-stage asset, emiltatug ledadotin, to the pipeline, showing a clear intent to broaden their oncology focus beyond pLGG.

The company ended the third quarter of 2025 with a strong balance sheet, holding $451.6 million in cash, cash equivalents, and short-term investments, which gives them plenty of dry powder to execute on this expanded pipeline, defintely a realist approach to growth.

To understand the core principles driving these decisions, you can read their Mission Statement, Vision, & Core Values of Day One Biopharmaceuticals, Inc. (DAWN).

Day One Biopharmaceuticals, Inc. (DAWN) Ownership Structure

Day One Biopharmaceuticals, Inc. (DAWN) is overwhelmingly controlled by institutional money, a common structure for a commercial-stage biopharmaceutical company focused on oncology. This means large investment firms, not individual investors, drive the majority of shareholder decisions and strategic oversight.

The company's governance is primarily steered by its Board of Directors and executive team, but the significant institutional ownership-which includes firms like BlackRock, Inc., FMR LLC, and The Vanguard Group, Inc.-ensures their interests are paramount in corporate strategy and capital allocation decisions. Honestly, in this sector, institutional backing is your defintely strongest signal of market confidence.

Day One Biopharmaceuticals' Current Status

Day One Biopharmaceuticals is a publicly traded, commercial-stage biopharmaceutical company. Its shares are listed on the Nasdaq Global Select Market under the ticker symbol DAWN. This public status subjects the company to rigorous reporting requirements by the U.S. Securities and Exchange Commission (SEC), providing high transparency for investors.

The company is currently focused on the commercialization of its lead product, OJEMDA™ (tovorafenib), and expanding its pipeline, notably through the November 2025 announced acquisition of Mersana Therapeutics for up to $285 million. For the 2025 fiscal year, the company has raised its net product revenue guidance to a range of $145 million to $150 million, reflecting strong market adoption of OJEMDA. You can read more about their strategic direction here: Mission Statement, Vision, & Core Values of Day One Biopharmaceuticals, Inc. (DAWN).

Day One Biopharmaceuticals' Ownership Breakdown

As of November 2025, the ownership structure shows a clear concentration of shares among institutional investors, which is typical for a biotech firm with a recent product launch. Here's the quick math on who owns the company:

Shareholder Type Ownership, % Notes
Institutional Investors 87.95% Includes mutual funds, hedge funds, and pension funds like BlackRock, Inc. and The Vanguard Group, Inc..
Retail/Individual Investors 4.32% Shares held directly by the general public.
Insiders (Executives & Directors) 1.72% Includes shares held by the management team and board members, signaling some, but limited, direct alignment.
Other (Strategic/Private) 6.01% The remaining float, including early-stage venture capital and other strategic holders.

Day One Biopharmaceuticals' Leadership

The company is steered by an experienced leadership team with deep roots in oncology and biopharmaceutical development. The average tenure for the management team is 2.8 years, demonstrating a relatively stable and focused executive core since its commercial transition.

The key leaders driving Day One Biopharmaceuticals' strategy and execution as of November 2025 are:

  • Jeremy Bender, Ph.D., M.B.A.: Chief Executive Officer, President, and Director. He has led the company since September 2020 and received 2025 total yearly compensation of $6.56 million.
  • Charles York: Chief Operating Officer and Chief Financial Officer. He manages the company's financial discipline, which is crucial given the Q3 2025 net loss of $19.7 million.
  • Lauren Merendino: Chief Commercial Officer. She is responsible for the successful market launch and growth of OJEMDA, which achieved 2025 year-to-date net product revenue of $102.6 million through Q3.
  • Michael Vasconcelles: Head of Research & Development. He oversees the pipeline, including the integration of new assets like the one from the Mersana acquisition.
  • Elly Barry, M.D.: Chief Medical Officer, bringing over 15 years of drug development experience, particularly in pediatric oncology.

The board is chaired by Garry Nicholson, a Lead Independent Director, and the board as a whole has an average tenure of 4.5 years. This blend of commercial expertise and clinical depth is essential for navigating the complex biopharma landscape.

Day One Biopharmaceuticals, Inc. (DAWN) Mission and Values

Day One Biopharmaceuticals, Inc. (DAWN) is fundamentally driven by a mission to address the critical lack of new therapeutic options for children with cancer, extending that focus to people of all ages with life-threatening diseases. This purpose, rooted in urgency and a patient-first approach, dictates its investment strategy and corporate culture.

The company's commitment to its mission is tangible, evidenced by its investment in research and development (R&D). For the first three quarters of the 2025 fiscal year, Day One's R&D expenses totaled approximately $107.1 million, demonstrating a significant allocation of capital toward pipeline advancement and clinical trials.

You're looking for a company that puts its money where its mouth is; Day One's spending on R&D shows that commitment. Breaking Down Day One Biopharmaceuticals, Inc. (DAWN) Financial Health: Key Insights for Investors

Day One Biopharmaceuticals' Core Purpose

The company's cultural DNA is built around disrupting the traditional drug development model, which often leaves pediatric cancer patients waiting too long for new treatments. This core purpose is what guides every major decision, from pipeline selection to commercial strategy, and is supported by a strong financial position, with $451.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025.

Official mission statement

The formal mission is a clear call to action, inspired by the urgent needs of the most vulnerable patients.

  • Creatively and intentionally develop new medicines for people of all ages with life-threatening diseases.
  • Expand the breadth and pace of drug development to fundamentally change how novel medicines reach children and adults.
  • Accelerate better, targeted treatments so patients of any age can look forward from 'day one' to the future they've envisioned.

Vision statement

Day One's vision extends beyond a single product, aiming for a systemic change in oncology care. This is a trend-aware realist view, acknowledging that traditional models have failed certain patient populations.

  • Redefine what's possible for all people living with cancer-regardless of age-starting from day one.
  • Identify and develop breakthrough medicines to improve the outcomes and life trajectories of patients facing serious diseases.
  • Be a company that delivers life-changing medicines faster, bolder, and with greater impact.

The acquisition of Mersana Therapeutics in late 2025, adding the novel antibody-drug conjugate (ADC) Emi-Le for cancers like adenoid cystic carcinoma, is a defintely concrete action that maps to this vision of expanding impact across ages and cancer types.

Day One Biopharmaceuticals' slogan/tagline

The company's most resonant tagline encapsulates its emotional connection to the patient journey and its aspirational goal.

  • Redefining hope from Day One.

Day One Biopharmaceuticals, Inc. (DAWN) How It Works

Day One Biopharmaceuticals, Inc. operates as a commercial-stage biopharmaceutical company by identifying, acquiring, and developing targeted therapies for genetically defined cancers, primarily focusing on pediatric oncology. It generates revenue through the commercial sales of its flagship approved therapy while simultaneously advancing a focused pipeline of novel oncology candidates to address high unmet medical needs in both children and adults.

Day One Biopharmaceuticals' Product/Service Portfolio

The company's commercial success in 2025 is anchored by its first approved product, while its near-term growth is tied to integrating and advancing newly acquired, promising assets like emiltatug ledadotin (Emi-Le).

Product/Service Target Market Key Features
OJEMDA™ (tovorafenib) Relapsed/Refractory Pediatric Low-Grade Glioma (pLGG) with BRAF alterations (ages 6 months+) First-ever FDA-approved Type II RAF inhibitor; once-weekly oral monotherapy; Q3 2025 net product revenue of $38.5 million.
Emiltatug Ledadotin (Emi-Le) Adult and Pediatric Solid Tumors, initially Adenoid Cystic Carcinoma (ACC-1) B7-H4-targeted Antibody-Drug Conjugate (ADC); potential first-in-class monotherapy; acquired via Mersana Therapeutics merger in November 2025.

Day One Biopharmaceuticals' Operational Framework

The operational process is a dual-track model: efficient commercialization of an approved asset and fiscally disciplined pipeline development, which is critical for a biotech focused on rare, high-need cancers. The full-year 2025 net product revenue guidance was raised to between $145 million and $150 million, demonstrating strong commercial execution.

Here's the quick math: Q3 2025 net product revenue grew 15% over the prior quarter, driven by a 19% rise in new patient starts, so the commercial engine is running well.

  • Search & Development Strategy: Actively identifies, in-licenses, and acquires potential best- or first-in-class targeted cancer treatments, exemplified by the acquisition of Mersana Therapeutics for up to $285 million.
  • Targeted Drug Development: Focuses on genetically defined cancers, which allows for smaller, more efficient clinical trials (like the registrational FIREFLY-1 study) and a clearer path to regulatory approval in high-unmet-need populations.
  • Specialty Commercialization: Engages a specialized commercial team to manage the unique distribution and patient support needs for an orphan drug like OJEMDA in the pediatric oncology community.
  • Disciplined Capital Allocation: Maintains a balanced approach to investment, evidenced by reduced R&D expenses to $31.4 million in Q3 2025, while still funding key clinical trials like the Phase 3 FIREFLY-2 trial.

Day One Biopharmaceuticals' Strategic Advantages

The company's market position rests on its first-mover advantage in a niche market, a strong balance sheet, and a clear, focused strategy that resonates with the patient community. You can read more about their core philosophy here: Mission Statement, Vision, & Core Values of Day One Biopharmaceuticals, Inc. (DAWN).

  • First-in-Class Market Position: OJEMDA is the first approved Type II RAF inhibitor for pLGG, establishing Day One Biopharmaceuticals as a leader in treating this specific, devastating pediatric brain tumor.
  • Financial Runway: Ended Q3 2025 with a strong cash position of $451.6 million in cash, cash equivalents, and short-term investments, providing a defintely solid buffer for continued R&D and commercial expansion without immediate reliance on volatile capital markets.
  • Focused Expertise: Deep specialization in pediatric and rare adult cancers allows them to efficiently navigate complex regulatory pathways and build credibility with a highly specialized physician base.
  • Pipeline Diversification via M&A: The strategic acquisition of Emi-Le diversifies the pipeline beyond kinase inhibitors into the high-growth Antibody-Drug Conjugate (ADC) space, targeting a new, aggressive cancer (ACC-1) with no approved therapies.

Day One Biopharmaceuticals, Inc. (DAWN) How It Makes Money

Day One Biopharmaceuticals, Inc. generates nearly all its revenue by selling its flagship product, OJEMDA (tovorafenib), a targeted therapy for pediatric low-grade glioma (pLGG), a type of brain tumor. The company also earns a small, but volatile, amount from licensing agreements related to its pipeline assets.

Day One Biopharmaceuticals, Inc.'s Revenue Breakdown

The financial engine is overwhelmingly focused on product sales, which is a sign of a successful commercial launch. Here's the quick math on the revenue streams based on the Q3 2025 results, which brought in a total of $39.8 million.

Revenue Stream % of Total (Q3 2025) Growth Trend
Net Product Revenue (OJEMDA) 96.7% Increasing
License Revenue 3.3% Decreasing/Volatile

Product revenue is the real story here, growing 15% quarter-over-quarter in Q3 2025, which is a strong signal of market adoption. License revenue, however, is not a sustainable growth driver; it plummeted from $73.7 million in Q3 2024 to just $1.3 million in Q3 2025, reflecting the lumpy nature of one-time deals.

Business Economics

The economics of Day One Biopharmaceuticals, Inc. are now shifting from a pre-commercial, research-heavy model to a commercial one, which is a major inflection point. You need to watch three things: adoption, pricing, and cost control.

  • Pricing Power: The company operates in the ultra-specialized oncology market, treating a rare, life-threatening disease (pLGG). This niche focus allows for premium pricing, which is standard for novel biopharma therapies.
  • Gross-to-Net (GTN) Adjustment: This is the discount between the list price and the net price the company actually receives. Day One Biopharmaceuticals, Inc. guided for a 2025 GTN in the 12% to 15% range, at the high end, partly due to a price increase in July. A lower GTN means more revenue per sale, which is defintely a positive.
  • Operating Leverage: In Q3 2025, the net product revenue from OJEMDA exceeded the combined cost of sales and selling, general, and administrative (SG&A) expenses for the first time. This is the moment the commercial model starts to scale and cover its own operating costs.
  • Commercial Momentum: New patient starts for OJEMDA accelerated by almost 20% in Q3 2025 compared to Q2 2025, showing deepening prescriber confidence and a clear path to becoming the standard of care for relapsed/refractory pLGG.

The company is strategically expanding its portfolio, too, recently announcing the acquisition of Mersana Therapeutics for up to $285 million to bring in a new oncology asset, emiltatug ledadotin (Emi-Le). This shows a realist approach to pipeline growth, not just relying on one drug.

Day One Biopharmaceuticals, Inc.'s Financial Performance

While the commercial performance is strong, the company is still in a net loss position as it invests heavily in R&D for future indications and pipeline expansion. You must balance the top-line growth against the bottom-line burn.

  • 2025 Revenue Guidance: Management raised its full-year 2025 net product revenue guidance for OJEMDA to a range of $145 million to $150 million, reflecting continued strong demand.
  • Cash Runway: Day One Biopharmaceuticals, Inc. ended Q3 2025 with a robust cash position of $451.6 million in cash, cash equivalents, and short-term investments, with no debt. This cash balance provides a long runway to fund operations and the ongoing clinical trials, like the Phase 3 FIREFLY-2 trial.
  • Net Loss: The net loss for Q3 2025 was $19.7 million, a significant shift from the net income in the prior year, primarily due to the non-recurrence of large license revenue payments. This loss is expected as R&D and SG&A expenses totaled $59.5 million for the quarter.

The key takeaway is that the core business-OJEMDA sales-is performing and scaling, but the overall enterprise remains in investment mode. For a deeper dive into the company's long-term vision, you can read the Mission Statement, Vision, & Core Values of Day One Biopharmaceuticals, Inc. (DAWN).

Day One Biopharmaceuticals, Inc. (DAWN) Market Position & Future Outlook

Day One Biopharmaceuticals is a commercial-stage biotech company with a dominant position in the niche market of pediatric low-grade glioma (pLGG) treatment, driven by its flagship drug OJEMDA (tovorafenib). Its future trajectory hinges on expanding OJEMDA into the frontline setting and successfully integrating a new pipeline asset from the recent Mersana Therapeutics acquisition.

The company is on track for significant top-line growth, with raised full-year 2025 net product revenue guidance for OJEMDA at $145 million to $150 million. This momentum is defintely a strong signal, but the company must convert its clinical pipeline into new approvals to sustain long-term value.

Competitive Landscape

In the targeted pediatric oncology space, competition is fierce but highly segmented by specific genetic mutations. Day One's core advantage is OJEMDA's broad label in the relapsed/refractory setting, which captures a much larger portion of the BRAF-altered pLGG market than its primary competitor.

Company Market Share, % (BRAF-altered pLGG Segment) Key Advantage
Day One Biopharmaceuticals >80% First-in-class, broad-label oral pan-RAF inhibitor (OJEMDA) covering both BRAF fusions and V600 mutations.
Novartis <20% Established BRAF/MEK inhibitor combo (Tafinlar-Mekinist) approved only for the smaller BRAF V600E-mutant pLGG population.
AstraZeneca ~5% (Broader Targeted Pediatric Oncology) Marketed MEK inhibitor (Koselugo) for NF1-related tumors, providing an alternative MAPK pathway therapy and established presence.

Opportunities & Challenges

The near-term focus is clear: expand the use of OJEMDA and diversify the pipeline. The acquisition of Mersana Therapeutics is a bold move to enter the solid tumor space, but it introduces new execution risks.

Opportunities Risks
OJEMDA label expansion via Phase 3 FIREFLY-2 trial into the larger, first-line pLGG market. Single-product dependency on OJEMDA for nearly all 2025 revenue.
Pipeline diversification with Mersana acquisition, adding Emi-Le (ADC) for adenoid cystic carcinoma (ACC-1) and other solid tumors. Execution risk of the Mersana acquisition, which is expected to close in January 2026, and its subsequent CVR-based milestones.
Strong balance sheet with $451.6 million in cash and investments (Q3 2025) to fund Emi-Le development through potential approval. Consistent net losses; Q3 2025 net loss was $19.7 million, requiring sustained revenue growth to reach profitability.

Industry Position

Day One Biopharmaceuticals holds a unique position as a high-growth, commercial-stage biotech focused on a critical unmet need in pediatric oncology. They are not a major pharmaceutical powerhouse yet, but they dominate their specific niche.

  • Niche Dominance: OJEMDA's approval for relapsed/refractory BRAF-altered pLGG provides a near-monopoly in the most common childhood brain tumor's molecularly defined sub-segment. They're the first to market for the majority of these patients.
  • Financial Strength: The company's Q3 2025 cash balance of $451.6 million is robust, giving them a significant runway to fund operations and the up to $285 million Mersana deal without immediate dilution risk. That's a strong position for a biotech.
  • Pipeline Catalyst: The Mersana acquisition, adding Emi-Le, shifts the narrative from a single-asset pediatric-focused company to a broader targeted oncology player, targeting a new adult solid tumor (ACC-1) with a high unmet need and no approved therapies.
  • Market Valuation: The stock trades at a price-to-sales ratio that is favorable compared to the broader biotech industry average, suggesting the market is valuing its future growth potential, especially with the Phase 3 FIREFLY-2 data expected soon.

To understand the core principles driving this strategy, you should review the company's foundational goals: Mission Statement, Vision, & Core Values of Day One Biopharmaceuticals, Inc. (DAWN).

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