f 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, 2024 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 ...

Revenue and Sales Performance - OJEMDA net product revenue reached $20.1 million in Q3 2024, a 145% increase from Q2 2024[2] - Quarterly prescriptions (TRx) for OJEMDA grew to 619 in Q3 2024, representing a 159% increase over Q2 2024[3] - License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $73.7 million in Q3 2024[8] Expenses - Research and development expenses were $33.6 million in Q3 2024, compared to $33.2 million in Q3 2023[9] - Selling, general and administrative expenses increased to $29.0 million in Q3 2024 from $18.3 million in Q3 2023[10] Profitability - Net income for Q3 2024 was $37.0 million, compared to a net loss of $46.2 million in Q3 2023[11] Financial Position - Cash, cash equivalents, and short-term investments totaled $558.4 million as of September 30, 2024[11] Pipeline and Development - Day One plans to advance its pipeline, including the DAY301 program, expected to enter the clinic in the coming months[2] - An exclusive licensing agreement with Ipsen for tovorafenib outside the U.S. included approximately $111 million upfront and potential milestone payments of up to $350 million[6] - The pivotal Phase 3 FIREFLY-2/LOGGIC trial for tovorafenib continues to enroll patients across multiple regions with over 100 sites activated[5]

Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threat ...

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Day One Biopharmaceuticals, Inc. (DAWN) closed the last trading session at $15.01, gaining 1.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $36.13 indicates a 140.7% upside potential.The mean estimate comprises eight short-term price targets with a standard deviation of $6.33. While the lowest estimate of $24 indicates a 59.9% increase from the current price level, the most opt ...

BRISBANE, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it will host a live conference call and webcast on Wednesday, October 30, 2024 at 4:30 p.m. ET to report financial results and discuss corporate progress for the third quarter 2024. Live audio of the webcast will be accessible ...

When volatility strikes the stock market as it sets new highs, investors get nervous. Wild swings in price can often signal a market top. After setting a new record high last month, the S&P 500 has peeled back 5% from that level. A string of upcoming economic indicators coming out this week could determine whether the economy is heading into a recession or if the Federal Reserve will cut interest rates. Stocks are flailing to and fro as investors try to gauge the direction. Yet analysts at Bank of America ( ...

PART I. FINANCIAL INFORMATION [Item 1. Interim Condensed Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Interim%20Condensed%20Financial%20Statements%20%28Unaudited%29) First product revenue of **$8.2 million** from OJEMDA and a **$108.0 million** PRV sale significantly reduced Q2 net loss to **$4.4 million**, increasing total assets to **$400.4 million** Condensed Balance Sheet Data (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $239,616 | $230,784 | | Total current assets | $383,158 | $375,274 | | Total assets | $400,437 | $376,048 | | **Liabilities & Equity** | | | | Total current liabilities | $93,706 | $29,508 | | Total liabilities | $93,706 | $29,508 | | Total stockholders' equity | $306,731 | $346,540 | Condensed Statements of Operations (in thousands, except per share data) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $8,192 | $— | $8,192 | $— | | Research and development | $92,106 | $32,182 | $132,316 | $60,010 | | Selling, general and administrative | $30,186 | $17,072 | $56,743 | $35,099 | | Loss from operations | $(114,807) | $(49,254) | $(181,574) | $(95,109) | | Gain from sale of priority review voucher | $108,000 | $— | $108,000 | $— | | Net loss | $(4,407) | $(45,863) | $(66,819) | $(88,256) | | Net loss per share, basic and diluted | $(0.05) | $(0.61) | $(0.77) | $(1.20) | Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(98,858) | $(68,417) | | Net cash provided by investing activities | $106,345 | $9,081 | | Cash provided by financing activities | $1,345 | $163,285 | | Net increase in cash and cash equivalents | $8,832 | $103,949 | [Notes to Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail OJEMDA revenue, key agreements like MabCare's **$55.0 million** upfront, and subsequent Ipsen licensing and **$175.0 million** private placement - The company began recognizing net product revenue from **OJEMDA** in May 2024 following its FDA approval in April 2024, recorded net of deductions[27](index=27&type=chunk)[28](index=28&type=chunk) - Upon FDA approval of OJEMDA, the company capitalized a **$9.0 million** milestone payment to Viracta, and following the **$108.0 million** PRV sale, an additional **$8.1 million** payment was made to Viracta and capitalized[31](index=31&type=chunk)[44](index=44&type=chunk) - In June 2024, the company licensed **DAY301** from MabCare Therapeutics for a **$55.0 million** upfront payment and potential future milestones of up to **$1.152 billion**[47](index=47&type=chunk)[48](index=48&type=chunk) - Subsequent to quarter end, on July 23, 2024, the company licensed tovorafenib to Ipsen for ex-U.S. commercialization for an upfront fee of **~$71.0 million**, a **$40.0 million** equity investment, and up to **~$350.0 million** in milestones plus royalties[72](index=72&type=chunk) - On July 30, 2024, the company raised gross proceeds of approximately **$175.0 million** through a private placement of common stock and pre-funded warrants, which closed on August 1, 2024[73](index=73&type=chunk)[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses OJEMDA's launch and initial revenue, increased R&D from a **$55.0 million** license payment, and a **$108.0 million** PRV sale improving net loss, with cash sufficient into 2026 [Overview](index=31&type=section&id=Overview) Day One, a commercial-stage biopharmaceutical company, launched OJEMDA™ after FDA approval for pLGG, based on FIREFLY-1, and is advancing FIREFLY-2, while also developing DAY301 - On April 23, 2024, the FDA granted accelerated approval to **OJEMDA™** (tovorafenib) for relapsed or refractory pLGG with specific BRAF alterations, leading to its U.S. launch[76](index=76&type=chunk) - The approval was based on the **FIREFLY-1** trial, showing a best overall response rate (ORR) of **51%** in 76 evaluable patients, with a median duration of response of **13.8 months**[76](index=76&type=chunk)[77](index=77&type=chunk) - In June 2024, the company licensed **DAY301**, a novel ADC targeting PTK7, from MabCare Therapeutics for solid tumor development, with its IND cleared by the FDA in April 2024[78](index=78&type=chunk) - In July 2024, the company decided to close the **FIRELIGHT-1** program, evaluating tovorafenib and pimasertib in MAPK-altered solid tumors, due to an unfavorable benefit/risk profile and market opportunity[78](index=78&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20operations) Q2 2024 saw **$8.2 million** in OJEMDA revenue, R&D surged due to a **$55.0 million** MabCare payment, SG&A increased, and a **$108.0 million** PRV gain reduced net loss to **$4.4 million** Comparison of Results for the Three Months Ended June 30 (in thousands) | Metric | 2024 | 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $8,192 | $— | $8,192 | N/A | | Research and development | $92,106 | $32,182 | $59,924 | 186.2% | | Selling, general and administrative | $30,186 | $17,072 | $13,114 | 76.8% | | Gain from sale of PRV | $108,000 | $— | $108,000 | N/A | | Net loss | $(4,407) | $(45,863) | $41,456 | (90.4)% | - The **$59.9 million** increase in Q2 2024 R&D expenses was primarily driven by a **$55.0 million** upfront payment for the MabCare License Agreement[94](index=94&type=chunk)[95](index=95&type=chunk) Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2024 | 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $8,192 | $— | $8,192 | N/A | | Research and development | $132,316 | $60,010 | $72,306 | 120.5% | | Selling, general and administrative | $56,743 | $35,099 | $21,644 | 61.7% | | Gain from sale of PRV | $108,000 | $— | $108,000 | N/A | | Net Loss | $(66,819) | $(88,256) | $21,437 | (24.3)% | - The **$72.3 million** increase in H1 2024 R&D expenses was primarily due to a **$55.0 million** upfront fee for the MabCare agreement and a **$5.0 million** amendment payment for the Viracta agreement[98](index=98&type=chunk)[99](index=99&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company had **$361.9 million** in cash as of June 30, 2024, sufficient to fund operations into 2026, with **$98.9 million** cash used in operations and **$106.3 million** provided by investing activities - As of June 30, 2024, the company had **$361.9 million** in cash, cash equivalents, and short-term investments[101](index=101&type=chunk)[125](index=125&type=chunk) - The company believes its existing cash and investments will be sufficient to fund operating expenses and capital requirements into **2026**[125](index=125&type=chunk) - Net cash used in operating activities was **$98.9 million** for H1 2024, compared to **$68.4 million** in H1 2023, driven by higher operating expenses partially offset by the PRV sale gain[104](index=104&type=chunk) - Net cash provided by investing activities was **$106.3 million** in H1 2024, primarily due to **$108.0 million** in proceeds from the sale of the rare pediatric disease PRV[105](index=105&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes occurred to the company's market risks from those described in its 2023 Form 10-K - There were no material changes to the company's market risks from those described in the **2023 Form 10-K**[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2024, with no material changes in internal control over financial reporting - Management concluded that as of June 30, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[112](index=112&type=chunk) - No changes in internal control over financial reporting occurred during the six months ended June 30, 2024, that materially affected or are reasonably likely to materially affect it[113](index=113&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that would materially adversely affect its business - The company is not presently a party to any legal proceedings that would have a material adverse effect on its business[113](index=113&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including limited operating history, net losses, OJEMDA dependence, capital needs, clinical trial uncertainties, regulatory hurdles, manufacturing reliance, competition, and IP protection - The company has a limited operating history, incurred significant net losses since inception, and its near-term revenues are highly dependent on **OJEMDA's** successful commercialization[115](index=115&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - Substantial additional capital will be required to finance operations, and failure to raise it could force delays or elimination of research, development, or commercialization efforts[115](index=115&type=chunk)[124](index=124&type=chunk) - Clinical trials are expensive, time-consuming, and have uncertain outcomes, with earlier positive results not predictive of future results, and product candidates may not receive marketing authorization[115](index=115&type=chunk)[126](index=126&type=chunk) - The company relies on third-party manufacturers, posing risks of production difficulties, supply disruptions, and compliance issues that could halt clinical trials or commercial sales[115](index=115&type=chunk)[178](index=178&type=chunk) - Failure to obtain and maintain sufficient patent protection for products and technology could allow competitors to develop similar products, adversely affecting commercialization[116](index=116&type=chunk)[198](index=198&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=94&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, use of proceeds, or issuer purchases during the period - There were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities in the reported period[249](index=249&type=chunk) [Item 5. Other Information](index=94&type=section&id=Item%205.%20Other%20Information) No other information was reported under this item for the period - No information was reported under Item 5[250](index=250&type=chunk) [Item 6. Exhibits](index=95&type=section&id=Item%206.%20Exhibits) The report lists several exhibits, including the Asset Purchase Agreement, Exclusive License Agreement with MabCare, and required officer certifications - Key exhibits filed include the Asset Purchase Agreement from May 29, 2024, and the Exclusive License Agreement with MabCare Therapeutics from June 17, 2024[250](index=250&type=chunk) - Certifications by the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906 are included as exhibits[250](index=250&type=chunk)[252](index=252&type=chunk)

Core Insights - Day One Biopharmaceuticals reported a quarterly loss of $0.05 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.67, and an improvement from a loss of $0.61 per share a year ago [1][12] - The company achieved revenues of $8.19 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 810.22%, compared to zero revenues in the same quarter last year [2] Company Performance - Over the last four quarters, Day One Biopharmaceuticals has surpassed consensus EPS estimates two times [7] - The stock has increased by approximately 5.2% since the beginning of the year, while the S&P 500 has gained 14.5% [8] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.55 on revenues of $19.02 million, and for the current fiscal year, it is -$2.67 on revenues of $28.67 million [10] - The upcoming report is expected to show a quarterly loss of $1.37 per share, reflecting a year-over-year change of -39.8% [11] - The estimate revisions trend for Day One Biopharmaceuticals is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [14] Industry Context - Day One Biopharmaceuticals operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 33% of over 250 Zacks industries [5]

Exhibit 99.1 Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million Company to host conference call and webcast today, July 30, 8:00 a.m. Eastern Time BRISBANE, Calif., Jul. 30, 2024 – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today ann ...