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 ...

Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million BRISBANE, Calif., July 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-threaten ...

Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 About Day One Biopharmaceuticals Day One Biopharmaceuticals believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by "The Day ...

The private placement includes participation from both new and existing investors including Fairmount, Braidwell LP, Deerfield Management, Wellington Management, Frazier Life Sciences and Access Biotechnology, as well as large investment management firms and several healthcare dedicated funds. J.P. Morgan, TD Cowen, Goldman Sachs & Co. LLC and Piper Sandler are acting as joint placement agents for the private placement. About Day One Biopharmaceuticals Day One is based in Brisbane, California. Forward-looki ...

Core Viewpoint - Day One Biopharmaceuticals has announced an oversubscribed private placement of securities, raising approximately $175 million to support its commercial and research initiatives [1][4]. Group 1: Private Placement Details - The private placement consists of 10,551,718 shares of common stock priced at $14.50 per share, along with 1,517,241 pre-funded warrants sold at $14.4999 each [3]. - The transaction is expected to close on August 1, 2024, pending customary closing conditions [4]. - Major investors include Fairmount, Braidwell LP, Deerfield Management, Wellington Management, Frazier Life Sciences, and Access Biotechnology [2]. Group 2: Use of Proceeds - Proceeds from the private placement will be utilized for enhancing commercial capabilities, ongoing research and development, potential strategic acquisitions or licensing, working capital, and general corporate purposes [4]. Group 3: Company Overview - Day One Biopharmaceuticals focuses on developing targeted therapies for pediatric cancer, addressing a significant unmet need in therapeutic development for this demographic [8]. - The company collaborates with clinical oncologists, families, and scientists to develop important cancer treatments, with a pipeline that includes tovorafenib (OJEMDA™), DAY301, and a VRK1 inhibitor program [9].

Day One Biopharmaceuticals (DAWN) signed an exclusive licensing agreement with MabCare Therapeutics for exclusive worldwide rights to develop, manufacture and commercialize the latter's investigational candidate, MTX-13 (now DAY301), for solid tumor indications. Shares of the company gained 11.3% on Jun 18, in response to the encouraging news. It is important to note that the investigational new drug application for DAY301 received FDA clearance in April 2024 based on positive results from its pre-clinical ...

Core Insights - The U.S. FDA has cleared the IND application for MTX-13, now known as DAY301, which has demonstrated antitumor activity in various solid tumors during pre-clinical studies [1][8] - DAY301 targets PTK7, a protein overexpressed in multiple adult and pediatric cancers, making it a promising therapeutic target due to its limited expression in normal tissues [2][8] - Day One Biopharmaceuticals has entered an exclusive licensing agreement with MabCare Therapeutics for the development and commercialization of DAY301, with potential milestone payments totaling $1.207 billion [3][8] Company Overview - Day One Biopharmaceuticals is focused on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, addressing a significant unmet need in therapeutic development [4][8] - The company aims to redefine cancer drug development and improve outcomes for patients of all ages, collaborating with clinical oncologists and families [4][9] - The pipeline includes other treatments such as tovorafenib (OJEMDA™) and pimasertib, with plans to expand through in-licensing clinical-stage assets [9] Financial Aspects - Under the licensing agreement, Day One will receive an upfront payment of $55 million and is eligible for up to $1.152 billion in additional milestone payments, along with royalties on net sales outside Greater China [3][8] - The company expects to begin dosing the first patient in the Phase I study of DAY301 in late 2024 or early 2025 [3][8]

"The sale of the PRV delivers true non-dilutive capital to Day One and further strengthens our balance sheet as we continue executing on the launch of OJEMDA and investing in clinical development opportunities for children and adults living with cancer," said Charles York II, chief operating and financial officer of Day One. Under the Rare Pediatric Disease Priority Review Voucher Program, FDA awards PRVs to sponsors of rare pediatric disease product applications that meet certain criteria. The program is i ...