DAWNMEDIUM SIGNALOPERATIONAL10-K

DAWN evolved from a development-stage to commercial-stage biopharmaceutical company with FDA approval of OJEMDA and sale of a priority review voucher, driving significant revenue growth and improved operating performance.

The company successfully transitioned from pure R&D to commercialization with OJEMDA's accelerated approval for pediatric brain tumors, evidenced by inventory buildup and PRV monetization. The language shifts reflect a maturing business model moving beyond its original pediatric-focused mission to broader therapeutic applications, including the Mersana acquisition for expanded pipeline capabilities.

Comparing 2026-02-24 vs 2025-02-25View on EDGAR →
FINANCIAL ANALYSIS

DAWN's financials reflect successful commercialization with revenue growing 20.6% to $158.2M and operating losses improving 41.2% despite a 32.8% increase in cash burn. The company strengthened its balance sheet with cash increasing 57.7% to $197.1M while reducing total liabilities 16.7%, though current assets declined 13.7% likely due to PRV sale and operational investments. The 90.5% inventory increase and 85.2% reduction in capex suggest focus shifted from infrastructure building to product manufacturing and market preparation.

FINANCIAL STATEMENT CHANGES
Inventory
Balance Sheet
+90.5%
$3.3M→$6.3M

Inventory surged 90.5% — growing significantly faster than typical sales pace; potential demand softening or supply chain overcorrection.

Capital Expenditure
Cash Flow
-85.2%
$2.2M→$320K

Capex reduced 85.2% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

Cash & Equivalents
Balance Sheet
+57.7%
$125.0M→$197.1M

Cash position surged 57.7% — strong cash generation or capital raise providing significant financial cushion.

Operating Income
P&L
+41.2%
-$217.3M→-$127.8M

Operating leverage kicking in — revenue growth outpacing cost growth, a hallmark of scaling businesses.

R&D Expense
P&L
-34.9%
$227.7M→$148.1M

R&D spending cut 34.9% — could signal cost discipline or concerning reduction in innovation investment.

Operating Cash Flow
Cash Flow
-32.8%
-$78.1M→-$103.8M

Operating cash flow fell 32.8% — earnings quality concerns; investigate working capital changes and non-cash items.

Revenue
P&L
+20.6%
$131.2M→$158.2M

Revenue growing 20.6% — solid top-line momentum, watch margins for quality of growth.

Current Liabilities
Balance Sheet
-17.6%
$73.5M→$60.5M

Current liabilities reduced — improved short-term financial position and working capital health.

Total Liabilities
Balance Sheet
-16.7%
$80.0M→$66.7M

Liabilities reduced 16.7% — deleveraging improves balance sheet strength and financial flexibility.

Current Assets
Balance Sheet
-13.7%
$562.3M→$485.1M

Current assets declined 13.7% — monitor working capital adequacy and short-term liquidity.

LANGUAGE CHANGES
NEW — 2026-02-24
PRIOR — 2025-02-25
ADDED
All statements contained in this Annual Report other than statements of historical fact, including statements regarding our future results of operations and financial position, business strategy, market size, potential growth opportunities, the potential benefits and therapeutic scope of our acquisitions and collaborations, including our acquisition of Mersana Therapeutics, Inc.
Food and Drug Administration and reduced funding to federal healthcare programs, significant political, trade or regulatory developments and global regional conflicts on our operations and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, are forward-looking statements.
Overview Day One Biopharmaceuticals, Inc., or the Company or Day One, is a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases.
The indication was approved under accelerated approval based on a regulatory endpoint of overall response rate and the totality of the Company s pivotal open-label Phase 2 trial, or FIREFLY-1, data, including duration of response.
With the approval, we received, and subsequently sold, a rare pediatric disease priority review voucher, or PRV, from the FDA.
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REMOVED
is a commercial-stage company focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity.
We were founded to address the lack of new therapies resulting from the traditional drug development model, which has left children with cancer and their families waiting too long for new treatments.
With the approval, we received a rare pediatric disease priority review voucher, or PRV, from the FDA.
The accelerated approval of OJEMDA is based on data from the Company s pivotal open-label Phase 2 trial, or FIREFLY-1, which enrolled a total of 137 relapsed or refractory BRAF-altered pLGG patients across two study arms.
In Arm 1, data from the 76 RAPNO LGG evaluable patients include: A best ORR of 51% (95% CI: 40 - 63), which included 28% PRs and 11% MRs.
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