Day One Biopharmaceuticals, Inc. (DAWN): Business Model Canvas [Dec-2025 Updated]

You're looking at Day One Biopharmaceuticals, Inc. (DAWN) right at the pivotal moment they shift from pure development to a commercial player, driven by the FDA-approved oral therapy, OJEMDA. As a former analyst, I see this transition clearly mapped out in their business model: they're backing up significant year-to-date spending-over $107.187 million in R&D alone through Q3 2025-with a solid cash cushion of $451.6 million and a full-year net revenue guidance landing between $145 million and $150 million. To truly grasp how they plan to execute this launch, from their Ipsen partnership for ex-U.S. rights to managing the high-touch sales force for pediatric oncologists, you need to see the full nine blocks of their strategy below.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Key Partnerships

You're looking at the structure of Day One Biopharmaceuticals, Inc. (DAWN) as it stands in late 2025, particularly how they build value through external relationships. Honestly, the partnerships are where the near-term value creation is most visible, especially with the recent M&A activity.

Ipsen for ex-U.S. commercialization of tovorafenib, including EMA filing

The agreement with Ipsen for ex-U.S. rights to tovorafenib (Ojemda) is a cornerstone partnership. Day One Biopharmaceuticals received an upfront payment of approximately $111 million for these rights, which was structured as $71 million in cash and a $40 million equity investment at a premium. This deal also sets up significant future value, with Day One eligible for up to approximately $350 million in additional launch and sales milestone payments, plus tiered double-digit royalties starting at the mid-teens percentage on sales. You can see the recognition of this revenue stream in their quarterly filings; for instance, license revenue from the sale of ex-U.S. commercial rights was $0.3 million in the second quarter of 2025, but the upfront consideration recognized in the third quarter of 2024 was $73.5 million. Ipsen is responsible for regulatory and commercial activities outside the U.S., which includes the European Medicines Agency (EMA) filing efforts.

Acquisition of Mersana Therapeutics to expand the oncology pipeline

Day One Biopharmaceuticals entered into a definitive merger agreement on November 13, 2025, to acquire Mersana Therapeutics. This move immediately expands the pipeline with Emi-Le, an antibody-drug conjugate (ADC) targeting B7-H4. The transaction structure involves an upfront consideration of $25.00 per share in cash, representing an upfront equity value of approximately $129 million. Furthermore, Mersana stockholders can receive up to an aggregate of $30.25 per share in cash contingent upon achieving certain milestones, bringing the total potential deal value up to approximately $285 million. Day One plans to fund this using its current cash reserves, which totaled $453.1 million as of June 30, 2025. The closing is expected by the end of January 2026.

Collaboration with leading clinical oncologists and research institutions

Day One Biopharmaceuticals actively partners with leading clinical oncologists and scientists to drive development. This collaboration is evidenced by the presentation of clinical data at major medical meetings. For example, Day One published data characterizing rash management at the 2025 American Society of Clinical Oncology Annual Meeting. More recently, three-year follow-up data from the FIREFLY-1 trial were presented by Dr. Cassie Kline at the Society of Neuro-Oncology Annual Meeting on November 23, 2025. The company is also progressing the global Phase 3 FIREFLY-2 trial for tovorafenib in front-line pLGG, with enrollment expected to complete in the first half of 2026.

Payer organizations and government agencies for reimbursement access

Securing payer access is critical for the commercial success of OJEMDA. As of the second quarter of 2025, Day One Biopharmaceuticals reported strong payer performance metrics. Over 90% of OJEMDA patients received approval upon initial submission. Critically, more than 95% of patients on OJEMDA are paid patients, meaning less than 5% are receiving free drugs, which signals robust coverage. Looking at year-end 2024 data, coverage across Commercial and Medicaid lives was 76%, with patients receiving approval on their initial request being >80%, and the average time from script to fill being < 7 Days.

Here's a quick look at the payer metrics as of late 2024 and mid-2025:

The company's 2025 net product revenue guidance of $140 to $150 million reflects the success of these access efforts.

Specialty distributors and pharmacies for product logistics and delivery

Day One Biopharmaceuticals is focused on increasing the breadth and depth of prescribers for OJEMDA. The company achieved over 1,000 scripts in the second quarter of 2025. Quarterly total prescriptions (TRx) grew to 1,256 in the third quarter of 2025, an 18% increase from the prior quarter.

Logistics partnerships support these prescription numbers:

• Third quarter new patient starts grew 19% compared to the second quarter of 2025.
• U.S. OJEMDA net product revenue for Q3 2025 was $38.5 million.
• Year-to-date U.S. OJEMDA net product revenue through Q3 2025 reached $102.6 million.

Finance: draft 13-week cash view by Friday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Key Activities

You're looking at the core engine driving Day One Biopharmaceuticals, Inc. (DAWN) right now-the set of actions they must execute flawlessly to turn their science into revenue and new patient options. Honestly, it's a mix of commercial execution and deep pipeline advancement, all while managing significant corporate transactions.

Commercialization and market penetration of OJEMDA in the U.S.

The immediate, critical activity is driving the adoption of OJEMDA (tovorafenib) in the U.S. market for relapsed or refractory pediatric low-grade glioma (pLGG). This is where the rubber meets the road for Day One Biopharmaceuticals as a commercial-stage company. The momentum has been building steadily throughout 2025.

For the third quarter of 2025, Day One Biopharmaceuticals reported OJEMDA net product revenue of $38.5 million. That represented a 15% jump from the second quarter of 2025. To put that in perspective, the total U.S. OJEMDA net product revenue for the year-to-date through the third quarter of 2025 reached $102.6 million, which is an 89% increase over the full fiscal year 2024 revenue. This commercial strength led the company to raise its full-year 2025 net product revenue guidance to a range of $145 to $150 million.

Prescription growth supports this revenue trend. Total prescriptions (TRx) hit 1,256 in the third quarter of 2025, an 18% sequential increase, with new patient starts growing by 19% over the second quarter of 2025. That's real-world demand showing up.

Here's a quick look at the quarterly commercial performance:

Research and development (R&D) for pipeline assets like DAY301.

Beyond the current commercial focus, Day One Biopharmaceuticals is actively executing R&D to build out its future portfolio, which includes DAY301, a PTK7-targeted antibody-drug conjugate (ADC). This is about securing the next wave of potential first- or best-in-class medicines for both pediatric and adult cancers.

The DAY301 program, which was licensed from MabCare Therapeutics, has progressed into the clinic. Day One Biopharmaceuticals cleared the first cohort in the Phase 1a portion of the Phase 1a/b clinical trial for DAY301 in early 2025. This licensing deal itself was a major activity, involving an upfront payment of $55 million to MabCare, with potential milestone payments reaching up to $1.152 billion, plus low-to-mid single-digit royalties on ex-Greater China net sales. In the third quarter of 2025, R&D expenses were $31.4 million, reflecting ongoing investment in these pipeline activities.

Key R&D and Pipeline Activities:

• Advance DAY301 (PTK7 ADC) through Phase 1a dose escalation.
• Continue to invest in the development of DAY301 for solid tumors.
• Manage R&D spend, which was $31.4 million in Q3 2025.

Execution of the pivotal Phase 3 FIREFLY-2 trial for first-line pLGG.

A crucial activity is the execution of the FIREFLY-2 trial, which evaluates tovorafenib as a front-line systemic therapy for RAF-altered pLGG, versus standard of care chemotherapy. This trial is designed to potentially support the next indication expansion for OJEMDA, moving it from second-line to first-line treatment.

The trial is a pivotal Phase 3, 2-arm, randomized, multicenter, open-label study. Day One Biopharmaceuticals has been focused on enrollment, with expectations set to complete enrollment in the first half of 2026. This timeline is key for investors tracking the next major data readout for the drug.

Regulatory filings and life-cycle management for tovorafenib globally.

Life-cycle management involves securing and expanding regulatory approvals globally. OJEMDA already has accelerated approval from the U.S. Food and Drug Administration (FDA) for relapsed/refractory pLGG harboring specific BRAF alterations. Furthermore, tovorafenib has received both Breakthrough Therapy and Rare Pediatric Disease designations from the FDA.

Globally, a major milestone was achieved in April 2025 when the European Medicines Agency (EMA) accepted the regulatory filing for tovorafenib for review in the European Union. On the data front, Day One Biopharmaceuticals presented three-year follow-up data from the pivotal Phase 2 FIREFLY-1 study at the Society for Neuro-Oncology (SNO) Annual Meeting on November 23, 2025. That updated data showed an overall response rate of 53% and a median duration of response of 19.4 months.

Strategic business development, including acquisitions like Mersana.

Day One Biopharmaceuticals is actively pursuing value-driving portfolio expansion, exemplified by the late 2025 acquisition of Mersana Therapeutics. This activity diversifies the pipeline into Antibody-Drug Conjugates (ADCs).

Day One Biopharmaceuticals announced on November 13, 2025, that it entered a definitive merger agreement to acquire Mersana Therapeutics. The deal structure involves an upfront cash payment of $25 per share, representing an equity value of approximately $129 million at closing. This upfront amount is a premium of 181.85% from Mersana's last closing price. Additionally, Mersana stockholders are eligible for up to an aggregate of $30.25 per share in cash via non-tradable Contingent Value Rights (CVRs) upon hitting specific clinical, regulatory, and commercial milestones for Mersana's lead asset, Emi-Le. If all milestones are met, the total deal value reaches up to approximately $285 million (or $55.25 per share total cash consideration). The closing is expected by the end of January 2026. This acquisition adds a pipeline that Mersana spent $16 million on in the second quarter of 2025.

The company's financial footing for these activities is supported by its cash position. As of September 30, 2025, Day One Biopharmaceuticals reported cash, cash equivalents, and short-term investments of $451.6 million. This strong balance sheet is essential for funding both the commercial launch and strategic M&A.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Key Resources

You're looking at the core assets Day One Biopharmaceuticals, Inc. is using to drive its business right now, late in 2025. It's a mix of a singular, approved product, strong financial backing, and critical clinical proof.

The most tangible resource is OJEMDA (tovorafenib), which is an FDA-approved, oral, targeted therapy. This drug is a Type II RAF kinase inhibitor, approved for treating pediatric patients 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement. The fact that it's an oral, once-weekly treatment is a key feature for patient compliance.

Financially, Day One Biopharmaceuticals, Inc. is in a solid position. As of September 30, 2025, the Company ended the third quarter with $451.6 million in cash, cash equivalents, and short-term investments. That's a strong war chest to fund commercial build-out and pipeline progression. Honestly, that cash level gives them a good runway.

The intellectual property (IP) protecting tovorafenib is foundational. Day One Biopharmaceuticals, Inc. retains the exclusive global development rights for OJEMDA. This exclusivity is buttressed by regulatory recognition; tovorafenib has received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA for patients with an activating RAF alteration. Plus, it carries Orphan Drug designation from the FDA for malignant glioma and from the European Commission for glioma. The ex-U.S. rights were licensed to Ipsen for an upfront payment of approximately $111 million, which included $71 million in cash and a $40 million equity investment, with potential for up to $350 million more in milestones plus tiered double-digit royalties.

The commercial and medical affairs teams are clearly executing, given the sales figures. While I don't have the headcount, their output is clear. OJEMDA net product revenue hit $38.5 million in the third quarter of 2025 alone. Year-to-date U.S. net product revenue through Q3 2025 reached $102.6 million, an 89% increase over the full fiscal year 2024. The team is driving adoption, evidenced by quarterly prescriptions (TRx) growing to 1,256 in Q3 2025, an 18% sequential increase. The company raised its full-year 2025 net product revenue guidance to a range of $145 to $150 million. The team also saw a 19% jump in new patient starts in Q3 2025 compared to Q2 2025. The recent addition of Heather Adkins Huet, PhD, as Chief Scientific Officer in September 2025 also points to strengthening scientific leadership within the organization.

The clinical data from the pivotal FIREFLY-1 trial is a massive resource for building prescriber confidence. The data, updated with a median study duration of 40.6 months (cutoff June 6, 2025), provides long-term support for the drug's profile.

Here's a quick look at the efficacy metrics from the 137 relapsed or refractory BRAF-altered pLGG patients evaluated in the study:

These results are helping to build the case for OJEMDA to become the second-line standard of care in pLGG. Also, tovorafenib is now added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma. That's a huge validation point for the medical affairs team to use.

The ongoing pipeline progress, including the pivotal Phase 3 FIREFLY-2 trial in first-line pLGG, with enrollment completion anticipated in the first half of 2026, represents future resource potential. Also, the Phase 1a trial of DAY301, a PTK7-targeted antibody drug conjugate (ADC), is advancing.

Finance: review burn rate against the $451.6 million cash position by next Tuesday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Value Propositions

You're looking at the core value Day One Biopharmaceuticals, Inc. (DAWN) delivers with OJEMDA (tovorafenib), which is a significant shift for a very vulnerable patient group. The value proposition centers on being the first-in-class, targeted option where few existed before.

First and only targeted therapy for relapsed/refractory pediatric low-grade glioma (pLGG). This is the cornerstone. OJEMDA received Accelerated Approval from the U.S. FDA on April 23, 2024, for patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This made it the first and only FDA-approved type II RAF inhibitor for this indication.

The drug offers an oral, brain-penetrant treatment option for a vulnerable patient population. Tovorafenib is specifically designed as an oral, brain-penetrant, highly-selective type II RAF kinase inhibitor. This is crucial because pLGG is the most common pediatric brain cancer, and for the majority of children whose disease recurs after surgery, systemic therapy is needed.

The clinical benefit demonstrated in the pivotal FIREFLY-1 trial provides tangible value, especially regarding durability. The latest three-year follow-up data from Arm 1 of the FIREFLY-1 trial, with a data cutoff of June 6, 2025, showed compelling results for the 76 evaluable patients.

Here are the key clinical metrics that define this value:

• Overall response rate (ORR) was 53% (40/76).
• Median duration of response (DOR) was 19.4 months (95% CI [13.8-27.2]).
• Median time to next treatment (TTNT) exceeded 3.5 years.
• 58% (44/76) of patients completed 26 or more cycles of treatment (approximately 24 months).
• 77% of patients who entered the treatment-free observation period remained off therapy for a minimum of 12 months.

For clinicians, the value proposition includes a reduced administrative burden, supported by high initial assessment rates indicating broad efficacy. While the initial ORR was 51%, an earlier assessment showed a Clinical Benefit Rate (CBR) of 91%, which captures a wider range of positive patient outcomes beyond just tumor shrinkage, helping streamline treatment decisions for patients not achieving a formal response.

The company's mission reinforces this value by showing a commitment to developing medicines for unmet needs in pediatric cancer. This focus is evident in their commercial performance, which supports continued pipeline investment. For instance, the company raised its full-year 2025 net product revenue guidance to $145 to $150 million as of November 2025, following Q3 2025 net product revenue of $38.5 million.

Here's a quick look at the commercial traction supporting this value proposition as of late 2025:

This combination of being the first-in-class, offering durable responses, and showing strong commercial uptake-with Q3 2025 revenue hitting $38.5 million-is what defines the current value proposition for Day One Biopharmaceuticals, Inc. (DAWN).

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Customer Relationships

You're looking at how Day One Biopharmaceuticals, Inc. connects with the specialized community that prescribes and uses OJEMDA. For a targeted therapy like this, the relationship isn't about mass marketing; it's about deep, specialized engagement with a small group of pediatric oncologists.

High-touch, specialized sales force engagement with pediatric oncologists

The sales force strategy focuses on depth within key accounts, which is where the majority of relapsed/refractory BRAF-altered, pLGG patients are managed. Day One Biopharmaceuticals, Inc. has segmented its customer base to focus resources effectively. As of the first quarter of 2025, the company estimated the patient management load across these segments:

This structure supports the goal of accelerating adoption and establishing OJEMDA as the second-line standard of care. The commercial momentum reflects this focus, with quarterly total prescriptions (TRx) reaching 1,256 in the third quarter of 2025, an 18% increase from the second quarter of 2025. New patient starts also accelerated, growing 19% quarter-over-quarter in Q3 2025.

Patient support programs like EveryDay Support From Day One

Day One Biopharmaceuticals, Inc. supports the patient journey through dedicated programs. While specific enrollment numbers for the EveryDay Support From Day One program aren't public, the financial data strongly suggests high patient adherence and successful access, which these programs help facilitate. The reliance on paid prescriptions is very low for free drug support.

Direct communication with the pLGG patient and caregiver community

The company actively engages with the community that lives with pediatric low-grade glioma (pLGG). This is evident in the public sharing of patient and caregiver perspectives, such as hearing from Heather, a mom to a pLGG patient, and featuring stories like Bradon's. This direct connection helps ground the commercial and clinical strategy in real-world patient needs.

• Hear from patients living with pediatric low-grade glioma (pLGG) and their caregivers.
• Featuring stories like Bradon's, who has been living with pLGG since age 11.

Building prescriber confidence through consistent clinical data presentations

Sustained confidence among prescribers is built on robust, long-term data. The introduction of clinical updates has directly supported prescription growth. For instance, the presentation of two-year follow-up data from the FIREFLY-1 trial at the 2025 American Society of Clinical Oncology (ASCO) meeting, and the planned oral presentation of three-year FIREFLY-1 data at the Society for Neuro-Oncology on November 23, 2025, serve as key relationship-building milestones with the medical community.

Managed access programs to ensure patients get the drug defintely

Ensuring patients can actually start and stay on therapy is critical. The managed access framework appears highly effective, translating to strong payer coverage. As of the second quarter of 2025, the results showed:

• Over 90% of OJEMDA patients received approval upon initial submission.
• More than 95% of patients on OJEMDA are paid patients.
• Less than 5% of patients are receiving free drugs.

To be fair, the company has also closed the door on one form of access; Tovorafenib is no longer available for expanded access or compassionate use in the United States (U.S.).

The commercial success, with OJEMDA net product revenue reaching $38.5 million in Q3 2025 and the full-year 2025 guidance raised to $145 to $150 million, is a direct reflection of these customer relationship successes.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Channels

You're looking at how Day One Biopharmaceuticals, Inc. gets its product, OJEMDA (tovorafenib), to the pediatric oncologists and patients who need it, while also managing its pipeline and investor base as of late 2025. The channels are a mix of direct commercial efforts and scientific engagement.

Direct sales force targeting key pediatric cancer centers and oncologists. This is the engine for OJEMDA's commercial success. The company reported that quarterly prescriptions (TRx) grew to 1,256 in the third quarter of 2025, an 18% increase compared to the second quarter of 2025. New patient starts accelerated by almost 20% quarter-over-quarter in Q3 2025. Day One Biopharmaceuticals, Inc. had 181 total employees as of October 2025, which supports the field force and overall operations. The commercial execution delivered the best quarter launch-to-date for OJEMDA, leading to raised full-year 2025 net product revenue guidance to $145 to $150 million.

Specialty pharmacy network for drug distribution and patient services. Distribution relies on a strong payer mix to ensure patient access. Over 95% of patients on OJEMDA are paid patients, with less than 5% receiving free drugs. Furthermore, about 90% of patients receive approval upon initial submission, which helps streamline the process from the specialty pharmacy network to the patient.

Medical Science Liaisons (MSLs) for scientific exchange with key opinion leaders. Scientific exchange is critical for building the case for second-line standard-of-care. This channel is supported by data dissemination, such as the three-year follow-up data from the pivotal FIREFLY-1 trial presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting in November 2025. The company's pipeline progress, including advancing DAY301, also fuels MSL discussions.

Investor and media relations for corporate communication and visibility. Day One Biopharmaceuticals, Inc. actively communicates progress through formal channels. The company hosted a webcast to report third quarter 2025 financial results on November 4, 2025. They also participated in the Piper Sandler 37th Annual Healthcare Conference in November 2025. For ongoing communication, Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and its LinkedIn Home Page (linkedin.com/company/dayonebio) to disseminate news.

Clinical trial sites for pipeline development and data generation. These sites are essential for advancing the pipeline beyond the currently approved indication. The company is progressing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial, with enrollment completion anticipated in the first half of 2026. The DAY301 program is also advancing dose escalation in its Phase 1a clinical trial.

Here's a quick look at the commercial scale driving the distribution channels as of the end of Q3 2025:

The success of the commercial channel is evident in the prescription growth, but the pipeline channel requires continued investment, as reflected by the $451.6 million cash position at the end of Q3 2025, which funds both current sales and future development.

• Payer Coverage: Over 95% paid patients.
• Initial Approval Rate: About 90% on first submission.
• Pipeline Milestone: FIREFLY-2 enrollment completion targeted for first half of 2026.

Finance: review the Q4 2025 cash burn projection against the current $451.6 million reserve by next Tuesday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Customer Segments

You're hiring before product-market fit is fully cemented, so understanding exactly who you are selling to-and who is paying-is the core of the strategy right now. For Day One Biopharmaceuticals, Inc. (DAWN), the customer segments are layered, moving from the end-user patient to the ultimate payer.

Pediatric patients with relapsed/refractory low-grade glioma (pLGG)

This is the core patient population for OJEMDA (tovorafenib), which received FDA accelerated approval in April 2024 for patients 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The market opportunity is defined by the number of patients needing systemic therapy after initial treatments fail.

Here's the quick math on the U.S. patient flow as of late 2025:

What this estimate hides is the dynamic nature of progression; the majority of pLGG patients will progress within 5 years, constantly feeding the relapsed/refractory pool. Day One Biopharmaceuticals is also advancing its pivotal Phase 3 FIREFLY-2 clinical trial for first-line pLGG, which is expected to complete enrollment in the first half of 2026.

Oncologists and hematologists at specialized cancer treatment centers

These are the prescribers who translate clinical data into treatment decisions. Their confidence directly drives prescription volume. The commercial momentum shows they are adopting OJEMDA.

• Total Prescriptions (TRx) in Q3 2025 reached 1,256.
• New patient starts grew 19% in Q3 2025 compared to Q2 2025.
• The drug is now added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.
• The company raised its full-year 2025 net product revenue guidance to $145-$150 million based on this physician confidence.

The introduction of 2-year follow-up data from the FIREFLY-1 trial at the Society for Neuro-Oncology conference in November 2025 was a key event for strengthening prescriber conviction.

Global regulatory bodies (e.g., FDA, EMA) and health technology assessment groups

These bodies control market access and the standard of care evolution. The FDA has already provided a major tailwind with accelerated approval in April 2024 and Breakthrough Therapy designation.

• FDA granted OJEMDA Breakthrough Therapy and Rare Pediatric Disease designations.
• The European Medicines Agency (EMA) accepted the regulatory filing for tovorafenib for review in April 2025.
• An EMA regulatory decision is expected in 2026.

Health technology assessment (HTA) groups, which determine value for reimbursement, are influenced by the growing clinical evidence, including the 3-year follow-up data expected in late 2025.

Payers and third-party reimbursement organizations

Payer acceptance is critical for commercial success, especially in the US where patient out-of-pocket costs can be a barrier. Day One Biopharmaceuticals has achieved strong initial access metrics.

As of Q2 2025 reporting:

This high rate of paid prescriptions suggests favorable coverage terms are largely in place, though the company noted in Q1 2025 that they still manage seasonality related to payer dynamics and deductible resetting.

Caregivers and patient advocacy groups in the pediatric oncology space

While not direct purchasers, these groups influence physician choice and payer dialogue. Day One Biopharmaceuticals was founded, in part, by being inspired by the 'Day One Talk' physicians have with families about diagnosis and treatment plans. The company partners with leading clinical oncologists, families, and scientists. The focus on targeted therapy for a rare pediatric cancer addresses a critical unmet need that resonates strongly with advocacy organizations dedicated to improving outcomes for children with life-threatening diseases.

Finance: draft 13-week cash view by Friday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Cost Structure

You're looking at the cost side of Day One Biopharmaceuticals, Inc. (DAWN) as they scale up OJEMDA and push pipeline assets. The cost structure is heavily weighted toward getting the drug to market and advancing clinical programs. Honestly, for a commercial-stage biotech, this is where the cash burn is most visible.

Research and Development (R&D) remains a major cost driver, funding the future pipeline alongside the current commercial product. For the third quarter of 2025, R&D expenses totaled $31.4 million. This covers the ongoing work for key programs like the pivotal Phase 3 FIREFLY-2 trial for first-line pediatric low-grade glioma (pLGG) and the advancement of the DAY301 antibody drug conjugate (ADC) through dose escalation in its Phase 1a trial.

Selling, General, and Administrative (SG&A) costs reflect the investment in the OJEMDA launch. In Q3 2025, SG&A expenses were $28.1 million. This line item absorbs the commercialization and marketing costs associated with building physician confidence and driving adoption for OJEMDA. To be fair, the company noted that in Q3 2024, the increase in SG&A was primarily due to employee compensation costs and commercial launch activities.

The cost of revenue is relatively small compared to operating expenses, especially since a large portion of revenue comes from a license agreement that has now largely recognized its upfront payment. For instance, in Q3 2025, License Revenue was only $1.3 million. The cost of product revenue is a more direct operational expense. For example, in Q1 2025, the Cost of product revenue was $2.9 million.

Here's a quick look at how the major operating expenses trended across the first three quarters of 2025, showing the scale of investment:

The company's overall financial discipline is evident in its cash position, which stood at $451.6 million as of September 30, 2025, providing a substantial runway to fund these costs without immediate external financing pressure.

You can see the key cost components that Day One Biopharmaceuticals, Inc. (DAWN) is managing:

• R&D spending supporting pipeline progression.
• SG&A covering the OJEMDA commercial infrastructure.
• Clinical trial costs for FIREFLY-2 and DAY301 embedded in R&D.
• Marketing and sales efforts for OJEMDA within SG&A.

Finance: draft 13-week cash view by Friday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Revenue Streams

You're looking at the current revenue generation for Day One Biopharmaceuticals, Inc. as of late 2025. It's a mix of product sales, which are ramping up nicely, and the tail end of a significant upfront payment from a prior licensing deal. Honestly, the focus now is on driving that product revenue higher.

The primary driver for Day One Biopharmaceuticals, Inc. revenue streams is the commercial success of its lead product, OJEMDA. The company has been gaining traction with prescribers, which is reflected in their updated financial outlook.

• U.S. net product revenue from OJEMDA sales is guided to be between $145 million and $150 million for the full-year 2025.
• Year-to-date through the third quarter of 2025, U.S. OJEMDA net product revenue reached $102.6 million.
• The third quarter of 2025 alone saw net product revenue of $38.5 million, a 15% increase from the second quarter of 2025.

License revenue, which was a large component in the prior year due to an upfront payment, is now much smaller as that initial recognition is complete. For instance, license revenue from the sale of ex-U.S. commercial rights for tovorafenib was only $1.3 million in the third quarter of 2025. To be fair, this compares to a much larger $73.7 million recognized in the third quarter of 2024, which included the upfront consideration of $73.5 million received from Ipsen for the pLGG license rights.

The partnership agreements are structured to provide significant future, non-guaranteed revenue through milestones and royalties. These represent potential upside that analysts definitely watch closely.

Looking ahead, future product revenue hinges on the success of pipeline assets like DAY301, the Company's PTK7-targeted Antibody-Drug Conjugate (ADC). The IND application for DAY301 was cleared by the FDA in April 2024, and the Phase 1a trial is actively enrolling patients, with first patient dosing having been expected in late 2024 or early 2025. If approved, DAY301 could open up an entirely new revenue stream targeting multiple adult and pediatric solid tumors.

You should keep an eye on the progression of DAY301, as achieving development or regulatory milestones on that asset could trigger those large, contingent payments outlined in the MabCare agreement. Finance: draft 13-week cash view by Friday.