UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40431 DAY ONE BIOPHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2415215 (State or othe ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Details unaudited interim financial statements and management's discussion and analysis for the period [Item 1. Interim Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Interim%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Presents Day One Biopharmaceuticals' unaudited condensed consolidated financial statements and notes for Q1 2023 and 2022 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details the company's financial position, including assets, liabilities, and equity, at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Assets (in thousands) | March 31, 2023 | December 31, 2022 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $49,268 | $85,262 | | Short-term investments | $268,911 | $257,007 | | Total current assets | $322,388 | $347,874 | | Total assets | $323,563 | $349,062 | | Total current liabilities | $22,848 | $16,615 | | Total liabilities | $23,148 | $17,023 | | Total stockholders' equity | $300,415 | $332,039 | - The company's total assets decreased from **$349.1 million** at December 31, 2022, to **$323.6 million** at March 31, 2023, primarily due to a decrease in cash and cash equivalents[15](index=15&type=chunk) - Total liabilities increased from **$17.0 million** at December 31, 2022, to **$23.1 million** at March 31, 2023, driven by an increase in accounts payable and accrued expenses[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Presents the company's revenues, expenses, and net loss for the three-month periods Condensed Consolidated Statements of Operations (in thousands) | Operating Expenses (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $27,828 | $15,003 | | General and administrative | $18,027 | $12,745 | | Total operating expenses | $45,855 | $27,748 | | Loss from operations | $(45,855) | $(27,748) | | Investment income, net | $3,466 | $2 | | Net loss attributable to common stockholders | $(42,393) | $(27,747) | | Net loss per share, basic and diluted | $(0.59) | $(0.48) | - Net loss attributable to common stockholders increased by **52.8%** to **$42.4 million** for the three months ended March 31, 2023, compared to **$27.7 million** for the same period in 2022[18](index=18&type=chunk) - Research and development expenses significantly increased by **85.5%** to **$27.8 million** in Q1 2023 from **$15.0 million** in Q1 2022, reflecting increased clinical trial and product development activities[18](index=18&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Outlines the net loss and other comprehensive income/loss components for the reporting periods Condensed Consolidated Statements of Comprehensive Loss (in thousands) | (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(42,393) | $(27,747) | | Other comprehensive loss: | | | | Unrealized gain on available-for-sale securities | $138 | — | | Total comprehensive loss | $(42,255) | $(27,747) | - Total comprehensive loss increased to **$42.3 million** for the three months ended March 31, 2023, from **$27.7 million** in the prior year, primarily driven by the higher net loss[21](index=21&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Details changes in stockholders' equity, including net loss, share-based compensation, and stock issuances Condensed Consolidated Statements of Stockholders' Equity (in thousands, except share amounts) | (in thousands, except share amounts) | Balance at Dec 31, 2022 | Issuance of common stock upon exercise of stock options | Share-based compensation expenses | Unrealized gain on available-for-sale securities | Net loss attributable to common stockholders | Balance at Mar 31, 2023 | | :----------------------------------- | :---------------------- | :-------------------------------------- | :-------------------------------- | :--------------------------------------------- | :------------------------------------------- | :---------------------- | | Common Shares | 73,458,176 | 75,184 | — | — | — | 73,572,633 | | Common Stock, $0.0001 par value | $7 | — | — | — | — | $7 | | Additional Paid-In Capital | $601,771 | $1,184 | $9,447 | — | — | $612,402 | | Accumulated Other Comprehensive Income (Loss) | $(71) | — | — | $138 | — | $67 | | Accumulated Deficit | $(269,668) | — | — | — | $(42,393) | $(312,061) | | Total Stockholders' Equity | $332,039 | $1,184 | $9,447 | $138 | $(42,393) | $300,415 | - Total stockholders' equity decreased from **$332.0 million** at December 31, 2022, to **$300.4 million** at March 31, 2023, primarily due to a net loss of **$42.4 million**, partially offset by share-based compensation expenses and stock option exercises[24](index=24&type=chunk) - Accumulated deficit increased to **$312.1 million** as of March 31, 2023, from **$269.7 million** at December 31, 2022, reflecting ongoing operating losses[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flows (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(25,985) | $(21,563) | | Net cash used in investing activities | $(11,193) | $(15) | | Net cash provided by financing activities | $1,184 | — | | Net decrease in cash and cash equivalents | $(35,994) | $(21,578) | | Cash and cash equivalents, end of period | $49,268 | $262,731 | - Net cash used in operating activities increased to **$26.0 million** in Q1 2023 from **$21.6 million** in Q1 2022, driven by a higher net loss and changes in operating assets and liabilities[28](index=28&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - Net cash used in investing activities significantly increased to **$11.2 million** in Q1 2023, primarily due to net purchases of short-term investments[28](index=28&type=chunk)[160](index=160&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Description of Business and Organization](index=9&type=section&id=1.%20Description%20of%20Business%20and%20Organization) Describes Day One Biopharmaceuticals' core business as a clinical-stage biopharmaceutical company - Day One Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for life-threatening diseases, particularly in pediatric oncology[31](index=31&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the key accounting principles and policies applied in preparing the financial statements - The company's significant accounting policies remain consistent with those disclosed in its 2022 Annual Report on Form 10-K, with interim financial statements prepared in accordance with U.S. GAAP for interim reporting[33](index=33&type=chunk)[34](index=34&type=chunk) - The company operates as a single reporting segment focused on identifying and advancing targeted therapies for genomically defined cancers[38](index=38&type=chunk) - As an emerging growth company (EGC), Day One Biopharmaceuticals has elected to use the extended transition period for complying with new or revised accounting standards[42](index=42&type=chunk) [3. Recurring Fair Value Measurements](index=10&type=section&id=3.%20Recurring%20Fair%20Value%20Measurements) Details the fair value hierarchy and measurements for financial assets, primarily investments Financial Assets Measured at Fair Value (in thousands) | Financial Assets (in thousands) | March 31, 2023 (Total Fair Value) | December 31, 2022 (Total Fair Value) | | :------------------------------ | :-------------------------------- | :----------------------------------- | | Money market funds | $33,059 | $18,765 | | U.S. treasury securities | $37,817 | $145,785 | | U.S. government agency securities | $234,087 | $136,022 | | Total assets measured at fair value | $304,963 | $300,572 | - The company's financial instruments measured at fair value primarily consist of money market funds (Level 1) and U.S. treasury and government agency securities (Level 2)[46](index=46&type=chunk)[47](index=47&type=chunk) - As of March 31, 2023, there were no securities in an unrealized loss position for more than 12 months, and unrealized losses were primarily due to interest rate increases[50](index=50&type=chunk) [4. Balance Sheet Items](index=12&type=section&id=4.%20Balance%20Sheet%20Items) Provides detailed breakdowns of specific balance sheet accounts, such as prepaid and accrued expenses Prepaid Expenses and Other Current Assets (in thousands) | Prepaid Expenses and Other Current Assets (in thousands) | March 31, 2023 | December 31, 2022 | | :--------------------------------------- | :------------- | :---------------- | | Prepaid research and development expenses | $2,753 | $3,007 | | Prepaid insurance | $674 | $1,592 | | Other prepaid expenses and other assets | $782 | $1,006 | | Total | $4,209 | $5,605 | Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expenses and Other Current Liabilities (in thousands) | March 31, 2023 | December 31, 2022 | | :-------------------------------------------- | :------------- | :---------------- | | Accrued research and development expenses | $11,283 | $7,554 | | Accrued payroll related expenses | $2,814 | $6,129 | | Accrued professional service expenses | $3,162 | $2,088 | | Other | $515 | $179 | | Total | $17,774 | $15,950 | - Accrued research and development expenses increased significantly from **$7.6 million** at December 31, 2022, to **$11.3 million** at March 31, 2023, reflecting increased R&D activities[54](index=54&type=chunk) [5. Significant Agreements](index=13&type=section&id=5.%20Significant%20Agreements) Summarizes key licensing and asset acquisition agreements for product candidates - The company holds an exclusive worldwide license for pimasertib and MSC2015103B compounds from Merck KGaA, with potential milestone payments up to **$364.5 million** and high single-digit royalties on net sales[55](index=55&type=chunk)[57](index=57&type=chunk) - Day One acquired technology rights for tovorafenib (DAY101) from Takeda, involving an upfront cash payment and issuance of Series A preferred stock, which was later exchanged for common stock[62](index=62&type=chunk)[63](index=63&type=chunk) - The company has an exclusive worldwide license from Viracta Therapeutics for compounds binding the RAF protein family, with potential milestone payments up to **$54.0 million** and mid-single-digit tiered royalties on net sales[66](index=66&type=chunk)[67](index=67&type=chunk) [6. Commitments and Contingencies](index=15&type=section&id=6.%20Commitments%20and%20Contingencies) Discloses future lease obligations and potential contingent payments from various agreements Future Lease Obligations (in thousands) | Future Lease Obligations (in thousands) | March 31, 2023 | | :------------------------------------ | :------------- | | Remaining in 2023 | $345 | | 2024 | $424 | | Total future minimum lease payments | $769 | | Present value of operating lease liabilities | $717 | - The company has an operating lease for office space in Brisbane, California, with total base rent payments of approximately **$1.1 million** over a 31-month term commencing May 2022[71](index=71&type=chunk) - The company is party to various research and development agreements and license agreements that include contingent milestone and royalty payments, with no royalties due as of March 31, 2023, as all products are in development[76](index=76&type=chunk)[78](index=78&type=chunk) [7. Common Stock](index=16&type=section&id=7.%20Common%20Stock) Details information regarding authorized, issued, and outstanding common stock and share reserves - As of March 31, 2023, Day One Biopharmaceuticals had **73,572,633** shares of common stock issued and outstanding, out of **500 million** authorized shares[81](index=81&type=chunk) - The company has reserved **15,710,481** shares of common stock for future issuances, including options, future grants, ESPP, and restricted stock units[84](index=84&type=chunk) - No sales were made under the **$150.0 million** at-the-market offering program during the three months ended March 31, 2023[82](index=82&type=chunk) [8. Share-based Compensation](index=17&type=section&id=8.%20Share-based%20Compensation) Reports on share-based compensation expenses and unrecognized compensation costs for equity awards Share-based Compensation Expense (in thousands) | Share-based Compensation Expense (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expense | $3,380 | $2,147 | | General and administrative expense | $6,067 | $4,055 | | Total share-based compensation expense | $9,447 | $6,202 | - Total share-based compensation expense increased by **52.3%** to **$9.4 million** for the three months ended March 31, 2023, compared to **$6.2 million** for the same period in 2022[105](index=105&type=chunk) - As of March 31, 2023, there was **$96.6 million** of unrecognized compensation cost related to unvested awards, expected to be recognized over approximately **3.0 years**[105](index=105&type=chunk) [9. Net Loss Per Share](index=21&type=section&id=9.%20Net%20Loss%20Per%20Share) Presents basic and diluted net loss per share calculations and related weighted-average shares Net Loss Per Share (in thousands except share and per share amounts) | (in thousands except share and per share amounts) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss attributable to common stockholders | $(42,393) | $(27,747) | | Net loss per share, basic and diluted | $(0.59) | $(0.48) | | Weighted-average number of common shares | 71,972,888 | 58,382,444 | - Basic and diluted net loss per share increased to **$(0.59)** for the three months ended March 31, 2023, from **$(0.48)** in the prior year, reflecting the higher net loss and increased weighted-average shares outstanding[108](index=108&type=chunk) - Potentially dilutive securities, including stock options, unvested common shares, restricted stock units, and ESPP shares, totaling **11.8 million** in Q1 2023, were excluded from diluted EPS calculation as their effect was anti-dilutive[108](index=108&type=chunk) [10. Defined Contribution Plan](index=22&type=section&id=10.%20Defined%20Contribution%20Plan) Details the company's matching contributions to its 401(k) defined contribution plan Defined Contribution Plan (in thousands) | (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------- | :-------------------------------- | :-------------------------------- | | Matching contributions | $800 | $200 | - The company's matching contributions to its 401(k) plan increased significantly to **$0.8 million** for the three months ended March 31, 2023, compared to **$0.2 million** for the same period in 2022[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes Day One Biopharmaceuticals' financial condition, results of operations, liquidity, and capital resources [Overview](index=22&type=section&id=Overview) Provides a business overview, lead product candidates, and strategic focus on pediatric oncology - Day One Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, with a mission to re-envision cancer drug development[111](index=111&type=chunk)[112](index=112&type=chunk) - Tovorafenib (DAY101), the lead product candidate, is an oral, brain-penetrant, highly-selective pan-RAF kinase inhibitor, which has received Breakthrough Therapy, Orphan Drug, and Rare Pediatric Disease designations for pediatric low-grade glioma (pLGG)[113](index=113&type=chunk)[114](index=114&type=chunk) - The company reported initial data from the pivotal Phase 2 FIREFLY-1 trial in January 2023, showing an overall response rate (ORR) of **64%** and a clinical benefit rate of **91%** in pLGG patients, with an NDA submission anticipated as early as Q2 2023[115](index=115&type=chunk) - Pimasertib, the second product candidate, is an oral MEK inhibitor being evaluated in combination with tovorafenib in the FIRELIGHT-1 trial for MAPK-altered solid tumors[117](index=117&type=chunk)[118](index=118&type=chunk) [Inflation Reduction Act](index=25&type=section&id=Inflation%20Reduction%20Act) Assesses the anticipated impact of the Inflation Reduction Act of 2022 on the company's financials - The company does not anticipate a material impact on its income tax provision and cash taxes from the Inflation Reduction Act of 2022, based on initial evaluation[126](index=126&type=chunk) [Significant Agreements](index=25&type=section&id=Significant%20Agreements) Summarizes key licensing and asset acquisition agreements for product candidates - The MRKDG License Agreement grants Day One exclusive worldwide rights to pimasertib and MSC2015103B, with potential milestone payments up to **$364.5 million** and high single-digit royalties[127](index=127&type=chunk)[129](index=129&type=chunk) - The Takeda Asset Agreement involved the purchase of technology rights for tovorafenib (DAY101) and an exclusive license, with an upfront payment and equity issuance[132](index=132&type=chunk)[133](index=133&type=chunk) - The Viracta License Agreement provides an exclusive worldwide license for RAF protein family compounds, requiring potential milestone payments up to **$54.0 million** and tiered mid-single-digit royalties on net sales[136](index=136&type=chunk)[137](index=137&type=chunk) [Components of Results of Operations](index=27&type=section&id=Components%20of%20Results%20of%20Operations) Explains primary drivers and expected trends for R&D and general and administrative expenses - Research and development expenses include external costs for CROs, CMOs, and intellectual property licenses, as well as internal employee-related costs[140](index=140&type=chunk)[141](index=141&type=chunk) - General and administrative expenses primarily consist of employee-related costs, professional services (legal, accounting, consulting), and other operational costs (rent, travel, IT)[144](index=144&type=chunk) - Both R&D and G&A expenses are expected to increase substantially as the company advances product candidates, expands research, and builds commercial capabilities[142](index=142&type=chunk)[145](index=145&type=chunk) [Results of operations](index=28&type=section&id=Results%20of%20operations) Compares operating expenses and net loss for the three months ended March 31, 2023 and 2022 Operating Expenses (in thousands) | Operating Expenses (in thousands) | March 31, 2023 | March 31, 2022 | $ Change | % Change | | :-------------------------------- | :------------- | :------------- | :------- | :------- | | Research and development | $27,828 | $15,003 | $12,825 | 85.5% | | General and administrative | $18,027 | $12,745 | $5,282 | 41.4% | | Total operating expenses | $45,855 | $27,748 | $18,107 | 65.3% | | Net Loss attributable to common stockholders | $(42,393) | $(27,747) | $(14,646) | 52.8% | - Research and development expenses increased by **$12.8 million** (**85.5%**) due to higher third-party clinical trial, manufacturing, and product development costs, and increased employee-related expenses[147](index=147&type=chunk)[148](index=148&type=chunk) - General and administrative expenses rose by **$5.3 million** (**41.4%**), primarily driven by headcount growth and increased professional services for commercial capabilities and business expansion[149](index=149&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's cash position, funding sources, and future capital requirements - As of March 31, 2023, the company had **$318.2 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations into **2025**[124](index=124&type=chunk)[152](index=152&type=chunk) - The company has funded operations through IPO, follow-on offerings, and sales of redeemable convertible preferred shares and convertible notes, but expects to require substantial additional financing for future operations[123](index=123&type=chunk)[152](index=152&type=chunk)[164](index=164&type=chunk) Cash Flows (in thousands) | Cash Flows (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(25,985) | $(21,563) | | Net cash used in investing activities | $(11,193) | $(15) | | Net cash provided by financing activities | $1,184 | — | [Off-balance sheet arrangements](index=31&type=section&id=Off-balance%20sheet%20arrangements) Confirms the absence of material off-balance sheet arrangements, excluding indemnification agreements - The company does not have any off-balance sheet arrangements, as defined by SEC rules, other than indemnification agreements[168](index=168&type=chunk) [Critical accounting policies and use of estimates](index=31&type=section&id=Critical%20accounting%20policies%20and%20use%20of%20estimates) States that critical accounting policies remain consistent with the prior annual report - The company's critical accounting policies are consistent with those disclosed in its 2022 Annual Report on Form 10-K[169](index=169&type=chunk) [New Accounting Pronouncements](index=31&type=section&id=New%20Accounting%20Pronouncements) Refers to Note 2 for details on recently issued and adopted accounting pronouncements - Information regarding recently issued and adopted accounting pronouncements is summarized in Note 2 of the Notes to Consolidated Financial Statements[170](index=170&type=chunk) [Emerging Growth Company Status](index=31&type=section&id=Emerging%20Growth%20Company%20Status) Explains the benefits and upcoming loss of Emerging Growth Company status for the company - As an emerging growth company (EGC), Day One Biopharmaceuticals benefits from an extended transition period for adopting new or revised accounting standards[171](index=171&type=chunk) - The company will lose its EGC status as of December 31, 2023, and will no longer be able to use these exemptions starting with its 2023 annual report[171](index=171&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Day One Biopharmaceuticals is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[172](index=172&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of disclosure controls and procedures and changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=32&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Reports on the effectiveness of the company's disclosure controls and procedures as of March 31, 2023 - As of March 31, 2023, management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[173](index=173&type=chunk) [Changes in Internal Control over Financial Reporting](index=32&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Confirms no material changes in internal control over financial reporting during Q1 2023 - There were no changes in internal control over financial reporting during Q1 2023 that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[174](index=174&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents other required information, including legal proceedings, risk factors, and equity sales [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) States that Day One Biopharmaceuticals is not currently a party to any material legal proceedings - The company is not subject to any material legal proceedings, nor are any currently pending or threatened[177](index=177&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) Outlines significant risks impacting the business, including financial, operational, and regulatory challenges [Summary of Risk Factors](index=33&type=section&id=Summary%20of%20Risk%20Factors) Highlights key risks such as limited operating history, capital needs, and clinical trial uncertainties - Key risks include a limited operating history, significant net losses, dependence on lead product candidate tovorafenib (DAY101), need for substantial additional capital, and uncertainties in clinical trials and regulatory approvals[180](index=180&type=chunk) - Other risks involve manufacturing complexities, ability to retain key personnel, intellectual property protection, and competition in the biopharmaceutical industry[180](index=180&type=chunk)[181](index=181&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=34&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Addresses risks associated with limited operating history, ongoing losses, and the need for future financing - The company has a limited operating history, no approved products, and has incurred significant net losses, making it difficult for investors to evaluate its viability and increasing the risk of never achieving profitability[182](index=182&type=chunk)[186](index=186&type=chunk) - Substantial additional capital will be required to fund operations and achieve goals, with existing cash projected to last into **2025**, but there's no assurance of obtaining adequate financing on acceptable terms[198](index=198&type=chunk)[200](index=200&type=chunk) - Failure to raise capital could force delays, reductions, or elimination of research, product development, or commercialization efforts, and may result in dilution for stockholders[199](index=199&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk) [Risks Related to Development and Commercialization of Our Product Candidates](index=40&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization%20of%20Our%20Product%20Candidates) Covers risks in clinical trials, regulatory approvals, market competition, and product safety - Clinical trials are expensive, time-consuming, and have uncertain outcomes; earlier results may not predict later success, and product candidates may fail to demonstrate safety and efficacy, delaying or preventing regulatory approval[205](index=205&type=chunk)[206](index=206&type=chunk)[212](index=212&type=chunk) - The company relies on investigator-initiated Phase 1 trial data for tovorafenib (DAY101) but does not control its operations or reporting, and additional data may not show similar results[208](index=208&type=chunk)[209](index=209&type=chunk) - Adverse side effects or safety risks could delay or preclude approval, limit commercial potential, or lead to significant negative consequences post-approval, including withdrawal from the market[233](index=233&type=chunk)[235](index=235&type=chunk)[239](index=239&type=chunk) - The market opportunities for product candidates may be smaller than estimated, limited to specific patient subsets, and subject to intense competition from existing and developing therapies, including other BRAF and MEK inhibitors[222](index=222&type=chunk)[225](index=225&type=chunk)[244](index=244&type=chunk) [Risks related to Government Regulation](index=50&type=section&id=Risks%20related%20to%20Government%20Regulation) Details regulatory approval uncertainties, post-marketing requirements, and compliance with healthcare laws - The development and commercialization of pharmaceutical products are subject to extensive regulation, and there is no guarantee of timely regulatory approvals for tovorafenib (DAY101), pimasertib, or future product candidates[256](index=256&type=chunk)[257](index=257&type=chunk) - Accelerated approval pathways may not lead to faster development or approval and do not increase the likelihood of marketing approval, with post-marketing confirmatory trials required and potential for withdrawal of approval[263](index=263&type=chunk)[264](index=264&type=chunk) - Breakthrough Therapy designation for tovorafenib (DAY101) does not guarantee faster development or approval, nor does it change approval standards, and the designation can be withdrawn[266](index=266&type=chunk)[267](index=267&type=chunk) - Failure to comply with ongoing post-marketing requirements, including promotion restrictions and cGMPs, could lead to substantial penalties, withdrawal of products, or limitations on marketing[283](index=283&type=chunk)[284](index=284&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk) - The company's relationships with healthcare providers and payors are subject to anti-kickback, fraud and abuse, transparency, and health privacy laws, with potential for significant penalties for non-compliance[293](index=293&type=chunk)[295](index=295&type=chunk) - Recently enacted and future legislation, such as the Inflation Reduction Act, may increase the difficulty and cost of obtaining marketing approval and commercializing products, and could decrease prices[296](index=296&type=chunk)[301](index=301&type=chunk)[303](index=303&type=chunk) [Risks Related to Our Reliance on Third Parties](index=62&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Examines risks from dependence on third-party CROs, CMOs, and suppliers for development and manufacturing - The company relies heavily on third parties (CROs, CMOs, investigators) to conduct clinical trials and manufacturing, which introduces risks of delays, increased costs, non-compliance, or substandard performance[323](index=323&type=chunk)[324](index=324&type=chunk)[327](index=327&type=chunk) - Manufacturing product candidates is complex and relies on third-party manufacturers, primarily in China, exposing the company to supply disruptions, increased costs, and geopolitical risks[328](index=328&type=chunk) - Reliance on a limited number of sole suppliers for raw materials creates risks of capacity constraints, price increases, and supply chain disruptions due to various factors including natural disasters or economic conditions[337](index=337&type=chunk) - Future collaborations for product development and commercialization may not be successful, leading to limited control over resources, potential competition from collaborators, and disputes over intellectual property[338](index=338&type=chunk)[339](index=339&type=chunk) [Risks Related to Employee Matters and Our Operations](index=66&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Our%20Operations) Discusses risks related to personnel retention, operational growth, misconduct, and cybersecurity - Future success depends on retaining executive officers and key employees and attracting qualified personnel in a highly competitive industry, particularly in the San Francisco Bay Area[342](index=342&type=chunk)[344](index=344&type=chunk) - The company expects significant growth in employees and operations, which may be difficult to manage effectively due to limited financial resources and management experience in scaling a commercial enterprise[345](index=345&type=chunk)[347](index=347&type=chunk) - The company is exposed to risks of misconduct by employees, clinical trial investigators, and third-party partners, which could lead to regulatory sanctions, reputational harm, and significant penalties[348](index=348&type=chunk)[349](index=349&type=chunk) - Security breaches, cyber-attacks, or failures in information technology systems could disrupt development programs, compromise sensitive information, and expose the company to liability and reputational damage[350](index=350&type=chunk)[351](index=351&type=chunk)[355](index=355&type=chunk) - Compliance with stringent and changing privacy, data protection, and data security laws (e.g., GDPR, CCPA) is costly and complex, with potential for government enforcement actions, fines, and litigation[360](index=360&type=chunk)[362](index=362&type=chunk)[364](index=364&type=chunk) - Natural disasters, power outages, or other unforeseen events could disrupt operations, damage critical infrastructure, and adversely affect the business, with existing disaster recovery plans potentially inadequate[371](index=371&type=chunk) [Risks Related to Our Intellectual Property](index=73&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Highlights challenges in obtaining and maintaining patent protection and avoiding infringement claims - The company's commercial success depends on obtaining and maintaining patent protection, but the patent position in biopharmaceuticals is highly uncertain, with no assurance that patent applications will issue or provide sufficient competitive advantage[377](index=377&type=chunk)[379](index=379&type=chunk)[381](index=381&type=chunk) - Operating without infringing third-party patents is crucial, but claims of infringement may arise, leading to costly litigation, development delays, or the need for expensive licensing agreements[392](index=392&type=chunk)[394](index=394&type=chunk)[395](index=395&type=chunk) - Reliance on licensed intellectual property from third parties (e.g., Viracta, Takeda, Merck KGaA) means that termination or narrow interpretation of these agreements could materially adversely affect the ability to develop and commercialize product candidates[398](index=398&type=chunk)[400](index=400&type=chunk)[404](index=404&type=chunk) - Patent terms may be inadequate to protect competitive position, and failure to obtain patent term extensions could allow competitors to launch products earlier[427](index=427&type=chunk)[428](index=428&type=chunk) - Protecting intellectual property rights globally is challenging and expensive, with varying levels of protection in different countries, potentially allowing competitors to use technologies where patent protection is weak[429](index=429&type=chunk)[430](index=430&type=chunk) [Risks Related to Our Common Stock](index=85&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Addresses stock price volatility, lack of dividends, potential dilution, and anti-takeover provisions - An active and liquid trading market for common stock may not be sustained, potentially making it difficult for investors to resell shares at or above the purchase price[445](index=445&type=chunk) - Quarterly operating results are expected to fluctuate significantly, and falling below investor or analyst expectations could cause the stock price to decline substantially[447](index=447&type=chunk) - The market price of common stock is highly volatile due to various factors, including clinical trial results, regulatory developments, competition, and general economic conditions, which could lead to substantial losses for investors[448](index=448&type=chunk)[451](index=451&type=chunk)[453](index=453&type=chunk) - The company does not intend to pay dividends, so investment return depends solely on stock price appreciation[454](index=454&type=chunk) - Sales of a substantial number of shares by existing stockholders or future capital raises could dilute ownership interests and cause the stock price to decline[455](index=455&type=chunk)[458](index=458&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could prevent or delay an acquisition, even if beneficial to stockholders, and may hinder attempts to replace management[465](index=465&type=chunk)[466](index=466&type=chunk) [General Risk Factors](index=91&type=section&id=General%20Risk%20Factors) Covers increased costs of public company operations, internal control effectiveness, and economic conditions - Operating as a public company incurs increased costs and requires substantial management time for compliance with regulations like Sarbanes-Oxley, especially after losing emerging growth company status[474](index=474&type=chunk) - Failure to maintain effective internal controls over financial reporting could impair the ability to produce accurate financial statements, leading to loss of investor confidence and potential sanctions[475](index=475&type=chunk)[476](index=476&type=chunk) - Unfavorable global economic conditions, including inflation, rising interest rates, and instability in the global banking system, could adversely affect the business, financial condition, and stock price[480](index=480&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=92&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Confirms no unregistered equity sales and details the use of proceeds from the initial public offering [Unregistered Sales of Equity Securities](index=92&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) States that there were no unregistered sales of equity securities during the reported period - There were no unregistered sales of equity securities during the reported period[481](index=481&type=chunk) [Use of Proceeds](index=92&type=section&id=Use%20of%20Proceeds) Details the net proceeds from the IPO and confirms no material change in their planned use - The company completed its IPO on June 1, 2021, selling **11,500,000** shares at **$16.00** per share, generating net proceeds of approximately **$167.0 million**[482](index=482&type=chunk)[483](index=483&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as described in the prospectus[484](index=484&type=chunk) [Item 3. Defaults Upon Senior Securities](index=92&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) States that there were no defaults upon senior securities - There were no defaults upon senior securities[485](index=485&type=chunk) [Item 4. Mine Safety Disclosures](index=93&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Day One Biopharmaceuticals - This item is not applicable to the company[486](index=486&type=chunk) [Item 5. Other Information](index=93&type=section&id=Item%205.%20Other%20Information) This section indicates that there is no other information to report - There is no other information to report under this item[487](index=487&type=chunk) [Item 6. Exhibits](index=94&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed as part of this Quarterly Report on Form 10-Q, including certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents[488](index=488&type=chunk)[489](index=489&type=chunk) [SIGNATURES](index=95&type=section&id=SIGNATURES) Confirms the official signing of the report by the company's principal executive and financial officers - The report is signed by Jeremy Bender, Ph.D., M.B.A., Chief Executive Officer and President, and Charles N. York II, M.B.A., Chief Operating Officer and Chief Financial Officer, on May 1, 2023[492](index=492&type=chunk)[493](index=493&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 (Exact name of Registrant as specified in its Charter) | Delaware | | 83-2415215 | | --- | --- | --- | | (State or other jurisdiction of | | (I.R.S. Employer | | incorporation or organization) | | Identification No.) | | 2000 Sierra Point Parkway, Suite 501 | | | | Brisbane, CA | | 94005 ...

Tovorafenib (DAY101) Clinical Trials and Designations - Tovorafenib (DAY101) received FDA Breakthrough Therapy Designation for relapsed pLGG and FDA Rare Pediatric Disease Designation (PRV Eligible) for pLGG[10] - FIREFLY-1, a pivotal Phase 2 trial of Tovorafenib in relapsed or progressive pLGG, showed a 64% ORR (Overall Response Rate) in RANO-evaluable patients (n=22)[21] - The clinical benefit rate (CBR) in the FIREFLY-1 trial was 91%[25] - The median time to response in the FIREFLY-1 trial was 2.8 months[25] - FIREFLY-2/LOGGIC is a pivotal Phase 3 trial of Tovorafenib in newly diagnosed pLGG, with first patient dosing expected in Q4 2022[5, 33] Safety and Tolerability of Tovorafenib - In the FIREFLY-1 trial, 28% of patients required dose modifications due to treatment-related AEs[25] - The majority (96%) of treatment-emergent AEs were grade 1 or 2[25] - The most common treatment-related AEs (Any Grade) were Blood creatine phosphokinase increased (72%), Hair color changes (68%), and Rash (52%)[24] Market and Financial Information - Day One Biopharmaceuticals projected cash runway into 2025[5, 49] - As of September 30, 2022, Day One Biopharmaceuticals had $374.3 million in cash, cash equivalents, and short-term investments[50] - For the nine months ended September 30, 2022, R&D expense was $59.6 million, G&A expense was $44.6 million, and the net loss was $102.1 million[50] Tovorafenib and Pimasertib Combination - FIRELIGHT-1 is evaluating the combination of Tovorafenib (DAY101) and Pimasertib, with the first patient dosed in May 2022[10, 49]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40431 DAY ONE BIOPHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2415215 (State or ...

Targeted Therapies for People of All Ages August 2022 June 2022 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management's beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "shoul ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the company's unaudited interim condensed consolidated financial statements and management's discussion and analysis for the period [Item 1. Interim Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Interim%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the company's unaudited condensed consolidated financial statements for the quarterly period ended June 30, 2022, including balance sheets, statements of operations, comprehensive loss, changes in stockholders' equity, and cash flows, along with detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2022, shows a significant increase in total assets, primarily driven by a rise in cash and cash equivalents from financing activities, with total stockholders' equity also increasing Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $388,877 | $284,309 | | Total current assets | $402,503 | $289,368 | | Total assets | $404,047 | $289,821 | | **Liabilities & Stockholders' Equity** | | | | Total liabilities | $13,416 | $8,673 | | Total stockholders' equity | $390,631 | $281,148 | | Total liabilities and stockholders' equity | $404,047 | $289,821 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a significantly higher net loss for the three and six months ended June 30, 2022, compared to 2021, primarily due to substantial growth in R&D and G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,560 | $9,914 | $37,563 | $22,547 | | General and administrative | $14,159 | $5,525 | $26,904 | $8,990 | | Loss from operations | ($36,719) | ($15,439) | ($64,467) | ($31,537) | | Net loss | ($36,530) | ($15,473) | ($64,277) | ($31,575) | | Net loss per share | ($0.60) | ($5.04) | ($1.08) | ($10.81) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2022, the company experienced a net cash outflow from operating activities, offset by significant cash inflow from financing activities, resulting in a substantial net increase in cash Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($51,350) | ($23,149) | | Net cash used in investing activities | ($6,012) | ($8,000) | | Net cash provided by financing activities | $161,930 | $297,417 | | **Net increase in cash and cash equivalents** | **$104,568** | **$266,268** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide crucial details on the company's formation, IPO, significant accounting policies, and financial instruments, including license agreements, equity-based compensation, and financing activities - In June 2022, the company completed a follow-on offering, selling **11,500,000 shares** of common stock for net proceeds of approximately **$161.6 million**[86](index=86&type=chunk) - A milestone payment of **$2.5 million** was made to Merck KGaA in the second quarter of 2022 related to the first dosing of a patient in a clinical trial for a product containing pimasertib[66](index=66&type=chunk) - In July 2022, the company entered into an agreement to develop a companion diagnostic for tovorafenib (DAY101), which includes potential milestone payments of up to **$15.0 million**[110](index=110&type=chunk) - As of June 30, 2022, there was **$70.0 million** of unrecognized compensation cost related to unvested equity awards, expected to be recognized over a weighted-average period of approximately **2.9 years**[104](index=104&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management provides an overview of the company's business, focusing on its clinical-stage pipeline led by tovorafenib (DAY101), analyzing the significant increase in operating expenses and net loss, and detailing its strong liquidity position [Overview](index=24&type=section&id=Overview) Day One is a clinical-stage biopharmaceutical company focused on developing targeted therapies, with its lead candidate, tovorafenib (DAY101), in a pivotal Phase 2 trial for pediatric low-grade glioma (pLGG), with promising initial data - The company's lead product candidate, tovorafenib (DAY101), is an oral, brain-penetrant, highly-selective pan-RAF kinase inhibitor[112](index=112&type=chunk) - The pivotal Phase 2 trial (FIREFLY-1) for pediatric patients with relapsed or progressive low-grade glioma (pLGG) completed enrollment in its registrational arm in **May 2022**[112](index=112&type=chunk) - Initial data from FIREFLY-1 in **June 2022** demonstrated an overall response rate (ORR) of **64%** and a clinical benefit rate (CBR) of **91%** in the first **22 evaluable patients**[113](index=113&type=chunk) - The company anticipates reporting topline data from the FIREFLY-1 trial in **Q1 2023** and submitting an NDA to the FDA in the **first half of 2023**[113](index=113&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) The company's operating expenses and net loss increased significantly in the three and six months ended June 30, 2022, primarily due to higher R&D costs from clinical trial and manufacturing activities, and increased G&A expenses from headcount growth and public company operations Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,560 | $9,914 | $12,646 | 127.6% | | General and administrative | $14,159 | $5,525 | $8,634 | 156.3% | | **Total operating expenses** | **$36,719** | **$15,439** | **$21,280** | **137.8%** | - The increase in **Q2 2022 R&D expenses** was driven by a **$7.9 million** rise in third-party clinical trial and manufacturing costs and a **$5.3 million** increase in personnel-related expenses[140](index=140&type=chunk) - The increase in **Q2 2022 G&A expenses** was primarily due to **$4.0 million** in employee compensation from headcount growth and **$4.4 million** in legal, insurance, and professional services[141](index=141&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company significantly strengthened its financial position through a June 2022 follow-on offering, raising net proceeds of $161.6 million, and expects its current cash to fund operations into 2025 - As of **June 30, 2022**, the company had **$388.9 million** in cash and cash equivalents and an accumulated deficit of **$191.8 million**[149](index=149&type=chunk) - Management believes existing cash will be sufficient to fund operating expenses and capital expenditure requirements into **2025**[149](index=149&type=chunk)[160](index=160&type=chunk) - In **June 2022**, the company completed a follow-on offering with net proceeds of approximately **$161.6 million** and also established a **$150.0 million** at-the-market (ATM) offering program[147](index=147&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that as a smaller reporting company, it is not required to provide the information requested under this item - As a smaller reporting company, Day One is not required to provide quantitative and qualitative disclosures about market risk[169](index=169&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of **June 30, 2022**[170](index=170&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended **June 30, 2022**, that have materially affected, or are reasonably likely to materially affect, internal controls[171](index=171&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other important disclosures including legal proceedings, risk factors, equity sales, and exhibits [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any legal proceedings that, in management's opinion, would have a material adverse effect on its business - The company is not presently a party to any legal proceedings that would have a material adverse effect on its business[174](index=174&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of the risks facing the company, including substantial dependence on its lead product candidate, limited operating history, need for additional capital, clinical and regulatory uncertainties, reliance on third parties, and intense competition - **Financial Risks:** The company has a limited operating history, has incurred significant net losses since inception, and expects to incur continued losses, requiring substantial additional capital to finance operations[177](index=177&type=chunk)[181](index=181&type=chunk)[192](index=192&type=chunk) - **Clinical and Commercial Risks:** The company is substantially dependent on the success of its lead product candidate, tovorafenib (DAY101), with clinical trials being expensive, time-consuming, and having uncertain outcomes, potentially impacted by the COVID-19 pandemic[183](index=183&type=chunk)[199](index=199&type=chunk)[227](index=227&type=chunk) - **Third-Party Reliance:** The company relies on third parties for complex manufacturing, which could be subject to delays or disruptions, and for conducting clinical trials[315](index=315&type=chunk)[319](index=319&type=chunk) - **Intellectual Property Risks:** The company's success depends on its ability to obtain and maintain patent protection for its products and technology, which is uncertain and may be challenged by competitors[364](index=364&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=97&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities for the period and confirms no material change in the planned use of proceeds from its June 2021 Initial Public Offering (IPO) - There were no unregistered sales of equity securities during the period[463](index=463&type=chunk) - The company received net proceeds of approximately **$167.0 million** from its IPO on **June 1, 2021**[465](index=465&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as described in the prospectus[466](index=466&type=chunk) [Defaults Upon Senior Securities](index=98&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that there were no defaults upon senior securities during the period - None[467](index=467&type=chunk) [Mine Safety Disclosures](index=98&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[467](index=467&type=chunk) [Other Information](index=98&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[467](index=467&type=chunk) [Exhibits](index=99&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including an office lease agreement and certifications from the Principal Executive Officer and Principal Financial Officer - The report includes an exhibit for an office lease dated **April 1, 2022**[468](index=468&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections **302** and **906** of the Sarbanes-Oxley Act of **2002** are filed as exhibits[468](index=468&type=chunk)

s 11/2 Day One ₹ BIOPHARMACEUTICALS Targeted Therapies for People of All Ages May 2022 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management's beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such a ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Interim Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Interim%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited interim consolidated financial statements show a net loss of $27.7 million for Q1 2022 and a cash position of $262.7 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2022, total assets were $267.8 million, a decrease driven by a reduction in cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $262,731 | $284,309 | | Total current assets | $267,368 | $289,368 | | **Total assets** | **$267,779** | **$289,821** | | **Liabilities & Equity** | | | | Total current liabilities | $8,176 | $8,657 | | **Total liabilities** | **$8,176** | **$8,673** | | **Total stockholders' equity** | **$259,603** | **$281,148** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $27.7 million for Q1 2022, driven by a significant rise in R&D and G&A expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $15,003 | $12,632 | | General and administrative | $12,745 | $3,454 | | **Total operating expenses** | **$27,748** | **$16,086** | | Loss from operations | $(27,748) | $(16,086) | | **Net loss** | **$(27,747)** | **$(16,101)** | | Net loss per share, basic and diluted | $(0.48) | $(2.58) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $21.6 million for Q1 2022, a significant increase from the prior-year period Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,563) | $(9,743) | | Net cash used in investing activities | $(15) | $(8,000) | | Net cash provided by financing activities | $0 | $128,885 | | **Net (decrease) increase in cash** | **$(21,578)** | **$111,142** | | Cash and cash equivalents, end of period | $262,731 | $154,870 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage focus, key licensing agreements, and significant events like its 2021 IPO - The company is a clinical-stage biopharmaceutical company focused on developing targeted therapies for genomically-defined cancers, with its lead product candidate being **tovorafenib (DAY101)**[25](index=25&type=chunk) - In June 2021, the company closed its IPO, receiving **net proceeds of $167.0 million** after deducting underwriting discounts and offering costs[26](index=26&type=chunk) - The company entered into a license agreement with Merck KGaA for pimasertib, making an **$8.0 million upfront payment** with potential future milestone payments up to **$367.0 million**[44](index=44&type=chunk) Share-based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $2,147 | $119 | | General and administrative | $4,055 | $419 | | **Total** | **$6,202** | **$538** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its clinical development focus, Q1 2022 financial results, and its capital sufficiency into 2024 - The lead product candidate, **tovorafenib (DAY101)**, is in a pivotal Phase 2 trial (FIREFLY-1) for pediatric low-grade glioma (pLGG), with initial data expected in June 2022 and a potential NDA filing in 2023[81](index=81&type=chunk) - The second product candidate, **pimasertib**, is being studied in combination with tovorafenib in the FIRELIGHT-1 Phase 1b/2 trial, which was initiated in March 2022[81](index=81&type=chunk) - As of March 31, 2022, the company had **$262.7 million in cash and cash equivalents**, which is believed to be sufficient to fund operations into 2024[85](index=85&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Total operating expenses increased 72.5% to $27.7 million in Q1 2022, driven by higher clinical trial and personnel costs Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2022 | Q1 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $15,003 | $12,632 | $2,371 | 18.8% | | General and administrative | $12,745 | $3,454 | $9,291 | 269.0% | | **Total operating expenses** | **$27,748** | **$16,086** | **$11,662** | **72.5%** | Breakdown of R&D Expenses (in thousands) | Expense Type | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Third-party CRO, CMO costs | $8,245 | $3,434 | | Acquired technology license costs | $0 | $8,000 | | Employee related expenses | $6,168 | $1,156 | | Other R&D costs | $590 | $42 | | **Total R&D expenses** | **$15,003** | **$12,632** | [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $262.7 million in cash, primarily from its 2021 IPO, which is expected to fund operations into 2024 - The company completed its IPO on June 1, 2021, raising **net proceeds of $167.0 million**[107](index=107&type=chunk) - Cash and cash equivalents totaled **$262.7 million** as of March 31, 2022, which management believes is sufficient to fund operations into 2024[107](index=107&type=chunk)[118](index=118&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,563) | $(9,743) | | Net cash used in investing activities | $(15) | $(8,000) | | Net cash provided by financing activities | $0 | $128,885 | [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this disclosure is not required - As a smaller reporting company, Day One Biopharmaceuticals is **not required to provide** quantitative and qualitative disclosures about market risk[127](index=127&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the quarter's end - Management concluded that as of March 31, 2022, the company's disclosure controls and procedures were **effective** at a reasonable assurance level[128](index=128&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the quarter ended March 31, 2022[129](index=129&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not presently a party** to any material legal proceedings[132](index=132&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its limited operating history, dependence on its lead product, and clinical trial uncertainties - The company has a **limited operating history**, has incurred significant net losses since inception, and may never achieve profitability[135](index=135&type=chunk)[139](index=139&type=chunk) - The business is **substantially dependent on the success** of its lead product candidate, tovorafenib (DAY101), which has not yet completed a pivotal trial[141](index=141&type=chunk) - The company will require **substantial additional capital** to finance operations and is exposed to risks if it is unable to raise capital when needed[150](index=150&type=chunk) - The **COVID-19 pandemic** could adversely impact business operations, including clinical trials, due to delays in enrollment, site initiation, and potential supply chain disruptions[185](index=185&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity and no material change in the planned use of its IPO proceeds - The company received **net proceeds of approximately $167.0 million** from its IPO on June 1, 2021[424](index=424&type=chunk) - There has been **no material change** in the planned use of proceeds from the IPO[425](index=425&type=chunk) [Defaults Upon Senior Securities](index=91&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - The company reports **no defaults** upon senior securities[426](index=426&type=chunk) [Mine Safety Disclosures](index=91&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is **not applicable** to the company[426](index=426&type=chunk) [Other Information](index=91&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - The company reports **no other information** for this item[426](index=426&type=chunk) [Exhibits](index=92&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including required officer certifications

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40431 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of Registrant as specified in its Charter) Delaware 83-2415215 (State or other jur ...