Day One Biopharmaceuticals pany(DAWN)
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Wall Street Analysts Think Day One Biopharmaceuticals (DAWN) Could Surge 241.59%: Read This Before Placing a Bet
ZACKS· 2025-10-14 14:56
Core Viewpoint - Day One Biopharmaceuticals, Inc. (DAWN) shows significant upside potential with a mean price target of $24.56, indicating a 241.6% increase from its current price of $7.19 [1] Price Targets and Analyst Consensus - The average price target consists of nine estimates ranging from a low of $16.00 to a high of $34.00, with a standard deviation of $5.36, suggesting a high degree of variability among analysts [2] - The lowest estimate indicates a potential increase of 122.5%, while the most optimistic estimate suggests a 372.9% upside [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [9] Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about DAWN's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 0.4%, with one estimate moving higher and no negative revisions [12] - DAWN holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are often sought after, they can mislead investors, as empirical research indicates that they rarely predict actual stock price movements accurately [7] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8] - Investors should approach price targets with skepticism and not rely solely on them for investment decisions [10]
Day One Biopharmaceuticals (DAWN) Moves 7.0% Higher: Will This Strength Last?
ZACKS· 2025-10-06 14:41
Core Viewpoint - Day One Biopharmaceuticals, Inc. (DAWN) experienced a 7% increase in share price, closing at $7.95, driven by notable trading volume and growing investor optimism regarding its lead drug, Ojemda [1][2]. Company Performance - The upcoming quarterly report is expected to show a loss of $0.28 per share, reflecting a year-over-year decline of 173.7%. Revenue is projected to be $37.63 million, down 59.9% from the same quarter last year [3]. - The consensus EPS estimate for the quarter has been revised 2.2% higher in the last 30 days, indicating a positive trend that may lead to price appreciation [4]. Industry Context - Day One Biopharmaceuticals is part of the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Adherex Technologies Inc. (FENC) [5]. - Adherex Technologies has a consensus EPS estimate of $0.16, unchanged over the past month, representing a year-over-year increase of 176.2%. It currently holds a Zacks Rank of 4 (Sell) [6].
Day One Biopharmaceuticals: Bear Case Priced In, But Bull Case Is Not (Rating Upgrade)
Seeking Alpha· 2025-08-08 02:26
Core Viewpoint - The article aims to provide informational content regarding investment opportunities and risks, emphasizing the importance of independent research and verification by readers [2][3]. Group 1: Company Analysis - The article does not provide specific details about any particular company or its financial performance, focusing instead on general investment advice [2][3]. Group 2: Industry Insights - The content does not delve into specific industry trends or analyses, maintaining a broad perspective on investment practices rather than focusing on particular sectors [2][3].
Day One Biopharmaceuticals pany(DAWN) - 2025 Q2 - Earnings Call Transcript
2025-08-05 21:30
Financial Data and Key Metrics Changes - For Q2 2025, the company reported net product revenue of $33.6 million, representing a 10% increase over Q1 2025 [7][21] - The cumulative net revenue for the last twelve months reached $113.1 million, exceeding initial expectations [6][14] - The company provided full-year 2025 net product revenue guidance of $140 million to $150 million, indicating approximately 150% year-over-year growth [22] Business Line Data and Key Metrics Changes - The company achieved over 1,000 prescriptions in Q2 for the first time, with a 15% quarter-over-quarter growth in prescriptions [7][13] - The growth in prescriptions was driven by both the number of prescribing accounts and the number of patients per account [13][19] - The company noted that over 60% of prescribing accounts have initiated multiple patients on Ogenda, indicating strong physician confidence [19] Market Data and Key Metrics Changes - The company reported that over 95% of patients on Ogenda are covered by payers, with less than 5% receiving free drug [14] - Approximately 90% of patients received approval upon initial submission, which helps reduce administrative burdens [14] Company Strategy and Development Direction - The company aims to establish Ogenda as the standard of care in second-line plus PLGG and is focused on expanding its commercial presence [8][11] - The company is advancing its PTK7 targeted ADC Day 301 through the dose escalation portion of its Phase 1a trial [11][57] - The company has discontinued investment in the VRK1 program to focus on more promising opportunities [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued adoption of Ogenda, citing predictable trends in new patient starts and persistence on therapy [30] - The company remains well-capitalized with $453 million in cash and no debt, allowing it to execute its plans without reliance on capital markets [24] Other Important Information - The company welcomed a new Head of Research and Development, Mike Baskinsells, who brings extensive experience in oncology [10] - The company is actively generating additional data and publications to enhance the Ogenda value proposition [20] Q&A Session Summary Question: What levers will you focus on to increase growth rate given the 2025 guidance? - Management highlighted continued adoption through new patient starts and persistence on therapy as critical variables for achieving revenue guidance [30] Question: What proportion of Q2 scripts are new versus continuing patients? - Management noted that the two-year data has positively impacted growth, leading to an uptick in new patient starts [34][35] Question: What are you seeing regarding durability or persistence now that you are one year into launch? - Management indicated that physician intent is to keep patients on treatment for two years, and the three-year data will provide more insights [40][42] Question: Is the distribution of total scripts attributed to repeat versus new prescriptions holding constant? - Management stated that while they haven't calculated the exact ratio, they continue to focus on driving new patient starts [44][46] Question: Can you provide additional color on your guidance in terms of new additions versus discontinuations? - Management emphasized the importance of continued persistence and new patient starts in meeting their guidance range [53]
Day One Biopharmaceuticals pany(DAWN) - 2025 Q2 - Earnings Call Presentation
2025-08-05 20:30
Day One Biopharmaceuticals Targeted therapies for people of all ages August 2025 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 ...
Day One Biopharmaceuticals pany(DAWN) - 2025 Q2 - Quarterly Report
2025-08-05 20:06
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Interim Condensed Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Interim%20Condensed%20Financial%20Statements%20(Unaudited)) Presents unaudited financial statements showing a Q2 2025 net loss of $30.3 million and significant OJEMDA revenue growth Condensed Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $494,428 | $562,330 | | **Total Assets** | $519,037 | $582,788 | | **Total Current Liabilities** | $51,221 | $73,451 | | **Total Liabilities** | $58,203 | $80,037 | | **Total Stockholders' Equity** | $460,834 | $502,751 | Condensed Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Product revenue, net** | $33,562 | $8,192 | $64,065 | $8,192 | | **Total revenues** | $33,908 | $8,192 | $64,669 | $8,192 | | **Loss from operations** | $(34,974) | $(114,807) | $(76,041) | $(181,574) | | **Gain from sale of PRV** | — | $108,000 | — | $108,000 | | **Net loss** | $(30,322) | $(4,407) | $(66,318) | $(66,819) | | **Net loss per share** | $(0.29) | $(0.05) | $(0.64) | $(0.77) | Condensed Statement of Cash Flows Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(83,803) | $(98,858) | | **Net cash (used in) provided by investing activities** | $(6,291) | $106,345 | | **Cash provided by financing activities** | $748 | $1,345 | | **Net (decrease) increase in cash** | $(89,346) | $8,832 | | **Cash and cash equivalents, end of period** | $35,622 | $239,616 | [Item 2. 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 discusses the commercial launch of OJEMDA™, clinical pipeline progress, and financial results [Overview](index=30&type=section&id=Overview) The company is a commercial-stage entity focused on its newly FDA-approved product, OJEMDA™, for pediatric glioma - The FDA granted **accelerated approval for OJEMDA™** (tovorafenib) on April 23, 2024, for patients with relapsed or refractory pLGG, and the company has commenced its commercial launch in the U.S[130](index=130&type=chunk) - The pivotal Phase 3 trial, FIREFLY-2, is evaluating tovorafenib as a front-line therapy in pLGG, with **enrollment expected to be completed in the first half of 2026**[134](index=134&type=chunk) - In June 2024, the company licensed DAY301, a novel Antibody Drug Conjugate (ADC) targeting PTK7, and a Phase 1a/b clinical trial is ongoing[142](index=142&type=chunk) - An agreement with Ipsen grants exclusive rights to commercialize tovorafenib outside the United States in exchange for an upfront payment, milestones, and royalties[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20operations) Total revenues increased to $33.9 million in Q2 2025, driven by OJEMDA sales, while R&D expenses decreased Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Account | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | **Product revenue, net** | $33,562 | $8,192 | $25,370 | | **Total revenues** | $33,908 | $8,192 | $25,716 | | **Research and development** | $36,149 | $92,106 | $(55,957) | | **Selling, general and administrative** | $28,968 | $30,186 | $(1,218) | | **Net loss** | $(30,322) | $(4,407) | $(25,915) | Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Account | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | **Product revenue, net** | $64,065 | $8,192 | $55,873 | | **Total revenues** | $64,669 | $8,192 | $56,477 | | **Research and development** | $75,768 | $132,316 | $(56,548) | | **Selling, general and administrative** | $58,293 | $56,743 | $1,550 | | **Net Loss** | $(66,318) | $(66,819) | $501 | - The decrease in R&D expenses for Q2 2025 was primarily due to a **$55.0 million upfront payment** related to the MabCare License Agreement in Q2 2024, which was not repeated[190](index=190&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $453.1 million in cash and equivalents, sufficient to fund operations for at least twelve months - As of June 30, 2025, the company had **$453.1 million in cash, cash equivalents, and short-term investments**[206](index=206&type=chunk) - Management believes current cash reserves are **sufficient to fund capital requirements for at least twelve months** from the filing date of this report[206](index=206&type=chunk)[217](index=217&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(83,803) | $(98,858) | | **Net cash (used in) provided by investing activities** | $(6,291) | $106,345 | | **Cash provided by financing activities** | $748 | $1,345 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes to its market risks from the prior year's annual report - There were **no material changes** to the company's market risks from those described in the 2024 Form 10-K[228](index=228&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the end of the quarter - Based on an evaluation as of June 30, 2025, the Principal Executive Officer and Principal Financial Officer concluded that the company's **disclosure controls and procedures were effective**[229](index=229&type=chunk) - There were **no changes in internal control over financial reporting** during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[230](index=230&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any material legal proceedings - The company is **not presently a party to any legal proceedings** that would have a material adverse effect on its business[232](index=232&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its commercial operations, financial position, and regulatory environment [Risks Related to Our Financial Position](index=49&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) Financial risks include a limited operating history, a history of net losses, and reliance on a single product - As a commercial-stage company with a **limited operating history** and only one approved product, it is difficult for investors to evaluate the company's likelihood of success[235](index=235&type=chunk) - The company has incurred significant net losses since inception, with an **accumulated deficit of $620.4 million** as of June 30, 2025, and expects to incur continued losses[238](index=238&type=chunk) - The company **may require additional capital** to finance its operations and may be forced to delay, reduce, or eliminate its R&D programs if unable to raise it[250](index=250&type=chunk) [Risks Related to Development and Commercialization of OJEMDA and our Product Candidates](index=56&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization%20of%20OJEMDA%20and%20our%20Product%20Candidates) The company's development and commercialization efforts face significant risks from clinical trials and competition - **Clinical trials are expensive, time-consuming, and involve uncertain outcomes**, with failure possible at any stage[257](index=257&type=chunk)[258](index=258&type=chunk) - The company faces **substantial competition from major pharmaceutical companies** with greater financial resources and established products[287](index=287&type=chunk)[290](index=290&type=chunk) - The commercial success of OJEMDA depends on achieving **market acceptance among physicians and securing adequate reimbursement** from third-party payors, which is uncertain[313](index=313&type=chunk)[315](index=315&type=chunk) [Risks Related to Government Regulation](index=75&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company operates in a highly regulated industry, facing extensive oversight and risks from healthcare reform - The development and commercialization of pharmaceutical products are subject to **extensive, lengthy, and uncertain regulation** by the FDA and other global authorities[325](index=325&type=chunk) - OJEMDA's accelerated approval is **subject to post-marketing requirements**, and failure to confirm clinical benefit could lead to the FDA withdrawing approval[341](index=341&type=chunk)[368](index=368&type=chunk) - The company is subject to **healthcare fraud and abuse laws**, such as the federal Anti-Kickback Statute, which could expose it to significant penalties[378](index=378&type=chunk) - Recent legislation, such as the **Inflation Reduction Act (IRA)**, could increase costs and put downward pressure on drug prices, affecting profitability[380](index=380&type=chunk)[384](index=384&type=chunk) [Risks Related to Our Reliance on Third Parties](index=103&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The business model relies heavily on third-party CROs, CMOs, and licensing partners like Ipsen - The company **relies on third-party CROs** to conduct clinical trials and is responsible for ensuring their compliance with GCP requirements[412](index=412&type=chunk)[413](index=413&type=chunk) - The company **depends on third-party manufacturers**, including some in China, exposing it to production difficulties, quality control issues, and geopolitical risks[418](index=418&type=chunk)[419](index=419&type=chunk) - The **license agreement with Ipsen is crucial** for the ex-U.S. commercialization of tovorafenib, and non-performance by Ipsen could harm the business[432](index=432&type=chunk)[435](index=435&type=chunk) [Risks Related to Our Intellectual Property](index=124&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining, maintaining, and enforcing intellectual property protection for its products - The company's commercial success depends on its ability to **obtain and maintain patent protection**, but the patent position of biopharmaceutical companies is highly uncertain[490](index=490&type=chunk)[491](index=491&type=chunk)[492](index=492&type=chunk) - The company may face claims that it **infringes on third-party patents**, which could lead to costly litigation or prevent commercialization of its products[507](index=507&type=chunk) - The company **relies on license agreements** with third parties like Viracta, Takeda, and MabCare, and a termination could result in the loss of rights to its products[516](index=516&type=chunk)[518](index=518&type=chunk)[519](index=519&type=chunk) [Risks Related to Our Common Stock](index=145&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock faces risks including high price volatility and significant stockholder control - The market price of the company's common stock is likely to be **highly volatile** and subject to wide fluctuations[574](index=574&type=chunk) - The company **does not intend to pay dividends**, so any return on investment will depend on the appreciation of the stock's value[579](index=579&type=chunk) - As of June 30, 2025, executive officers, directors, and 5% stockholders beneficially owned **45.0% of the voting stock**, giving them significant influence[586](index=586&type=chunk) - **Anti-takeover provisions** in the company's charter documents and Delaware law could prevent or delay an acquisition[587](index=587&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=96&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reports no unregistered sales, use of proceeds, or repurchases of its equity securities - There were **no unregistered sales of equity securities**, use of proceeds, or issuer purchases of equity securities during the period[604](index=604&type=chunk)[605](index=605&type=chunk)[606](index=606&type=chunk) [Item 3. Defaults Upon Senior Securities](index=96&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that there have been no defaults upon its senior securities - None[607](index=607&type=chunk) [Item 4. Mine Safety Disclosures](index=96&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[608](index=608&type=chunk) [Item 5. Other Information](index=96&type=section&id=Item%205.%20Other%20Information) No directors or Section 16 officers adopted or terminated a Rule 10b5-1 trading plan during the quarter - During the three months ended June 30, 2025, **none of the Company's Section 16 officers or directors adopted or terminated any Rule 10b5-1 trading plan**[609](index=609&type=chunk) [Item 6. Exhibits](index=97&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with the Form 10-Q - The report includes **certifications from the Principal Executive Officer and Principal Financial Officer** pursuant to the Sarbanes-Oxley Act of 2002[611](index=611&type=chunk) - **Inline XBRL Instance Document** and Taxonomy Extension Schema are filed with the report[611](index=611&type=chunk)
Day One Biopharmaceuticals pany(DAWN) - 2025 Q2 - Quarterly Results
2025-08-05 20:00
[Day One Second Quarter 2025 Financial Results and Corporate Progress](index=1&type=section&id=Day%20One%20Second%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Progress) [Financial & Commercial Highlights](index=1&type=section&id=Financial%20%26%20Commercial%20Highlights) The company reports strong OJEMDA revenue growth, raises full-year guidance, and maintains a robust cash position Q2 2025 Performance Metrics | Metric | Q2 2025 | Change vs. Q1 2025 | Change vs. Q2 2024 | | :--- | :--- | :--- | :--- | | OJEMDA Net Product Revenue | $33.6 million | +10% | +310% | | OJEMDA Prescriptions | >1,000 | +15% | +346% | - The company provides full-year 2025 net product revenue guidance of **$140 to $150 million**[1](index=1&type=chunk)[3](index=3&type=chunk) - The company ended the second quarter with **$453.1 million in cash**, cash equivalents, and short-term investments[1](index=1&type=chunk)[15](index=15&type=chunk) - Achieved **$113.1 million in OJEMDA net product revenue** for the trailing twelve-month period ending June 30, 2025[3](index=3&type=chunk) [Pipeline and Corporate Updates](index=2&type=section&id=Pipeline%20and%20Corporate%20Updates) The company advances its clinical pipeline, provides trial updates, and announces key leadership and collaboration changes - Key pipeline progress includes the DAY301 trial actively enrolling patients, with 3-year FIREFLY-1 data expected in Q4 2025[7](index=7&type=chunk) - The research collaboration and license agreement with Sprint Bioscience AB for the VRK1 program was **terminated** based on strategic objectives[7](index=7&type=chunk) - Dr. Michael Vasconcelles, an industry leader with over 25 years of oncology R&D experience, was appointed as **Head of Research and Development** in June 2025[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reports total revenues of $33.9 million and a net loss of $30.3 million, with a notable decrease in R&D expenses year-over-year [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Net product revenue grew significantly while R&D expenses decreased due to a one-time license payment in the prior year Key Financial Metrics | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Product Revenue | $33.6 million | $8.2 million | | R&D Expenses | $36.1 million | $92.1 million | | SG&A Expenses | $29.0 million | $30.2 million | - The decrease in R&D expenses was primarily due to the upfront payment of **$55.0 million** for the MabCare Therapeutics license agreement in the second quarter of 2024[8](index=8&type=chunk) Net Loss and Cash Position | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $30.3 million | $4.4 million | | Cash Position (end of period) | $453.1 million | N/A | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The unaudited income statement details revenues, expenses, and net loss for the three and six months ended June 30, 2025 Unaudited Condensed Consolidated Statements of Operations | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Total revenues** | **$33,908** | **$8,192** | | Total cost and operating expenses | $68,882 | $122,999 | | Loss from operations | $(34,974) | $(114,807) | | Total non-operating income, net | $4,652 | $111,952 | | **Net loss** | **$(30,322)** | **$(4,407)** | | **Net loss per share - basic & diluted** | **$(0.29)** | **$(0.05)** | [Selected Condensed Balance Sheets](index=5&type=section&id=Selected%20Condensed%20Balance%20Sheets) The balance sheet shows the company's financial position, comparing key assets and liabilities at June 30, 2025, and December 31, 2024 Unaudited Selected Condensed Consolidated Balance Sheets | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $453,103 | $531,720 | | Total assets | $519,037 | $582,788 | | Total liabilities | $58,203 | $80,037 | | Total stockholders' equity | $460,834 | $502,751 | [Company and Product Overview](index=3&type=section&id=Company%20and%20Product%20Overview) Day One Biopharmaceuticals focuses on targeted cancer therapies, with its lead product OJEMDA™ approved for pediatric low-grade glioma - OJEMDA (tovorafenib) is indicated for patients 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a **BRAF fusion, rearrangement, or V600 mutation**[11](index=11&type=chunk) - The indication for OJEMDA was granted under **accelerated approval** by the FDA, with continued approval contingent on confirmatory trials[11](index=11&type=chunk)[12](index=12&type=chunk) - Day One's mission is to address the critical unmet need for therapeutic development in **pediatric cancer**[13](index=13&type=chunk) [Legal Disclaimers](index=4&type=section&id=Legal%20Disclaimers) This section contains forward-looking statements and cautions that actual results may differ due to various risks and uncertainties - The press release includes forward-looking statements concerning plans to develop and commercialize cancer therapies and expectations from clinical trials[18](index=18&type=chunk) - These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially[20](index=20&type=chunk)
Day One Reports Second Quarter 2025 Financial Results and Corporate Progress
Globenewswire· 2025-08-05 20:00
Core Insights - Day One Biopharmaceuticals reported a net product revenue of $33.6 million for OJEMDA in Q2 2025, marking a 10% increase from Q1 2025 and a 310% increase from Q2 2024 [1][5][12] - The company expects full-year 2025 net product revenue to be between $140 million and $150 million [1][5] - Day One ended Q2 2025 with $453.1 million in cash, cash equivalents, and short-term investments [1][12] OJEMDA Commercial Performance - OJEMDA prescriptions exceeded 1,000 in Q2 2025, representing a 15% increase from Q1 2025 and a 346% increase from Q2 2024 [5] - The total net product revenue for OJEMDA for the 12-month period ending June 30, 2025, was $113.1 million [5] Financial Highlights - Research and development expenses for Q2 2025 were $36.1 million, down from $92.1 million in Q2 2024, primarily due to a one-time upfront payment in the previous year [12] - Selling, general, and administrative expenses decreased to $29.0 million in Q2 2025 from $30.2 million in Q2 2024 [12] - The net loss for Q2 2025 was $30.3 million, compared to a net loss of $4.4 million in Q2 2024 [12] Corporate Developments - Michael Vasconcelles, M.D., joined Day One as Head of Research and Development in June 2025, bringing over 25 years of oncology research experience [6] - The company terminated its research collaboration and license agreement with Sprint Bioscience AB to align with its strategic objectives [5] Clinical Trials and Pipeline - DAY301, a PTK7-targeted ADC, is currently enrolling patients in the Phase 1a portion of its clinical trial [5] - Day One plans to present 3-year follow-up data from the FIREFLY-1 clinical trial in Q4 2025 [5] - Patient enrollment for the pivotal Phase 3 FIREFLY-2 clinical trial is on track for completion in the first half of 2026 [5]
Wall Street Analysts Believe Day One Biopharmaceuticals (DAWN) Could Rally 303.46%: Here's is How to Trade
ZACKS· 2025-07-24 14:56
Core Viewpoint - Day One Biopharmaceuticals, Inc. (DAWN) shows significant upside potential with a mean price target of $28, indicating a 303.5% increase from its current trading price of $6.94 [1] Price Targets and Analyst Consensus - The average price target consists of eight estimates ranging from $20.00 to $36.00, with a standard deviation of $5.07, suggesting a high variability in analyst predictions [2] - The lowest estimate indicates a potential increase of 188.2%, while the highest suggests an upside of 418.7% [2] - A low standard deviation among price targets indicates a strong agreement among analysts regarding the stock's price direction [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about DAWN's earnings prospects, with a positive trend in earnings estimate revisions correlating with potential stock price increases [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 2.1%, with one estimate moving higher and no negative revisions [12] - DAWN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are a common tool for investors, they can often mislead, and reliance solely on them may not yield favorable returns [7][10] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]
Day One to Report Second Quarter 2025 Financial Results Tuesday, August 5, 2025
Globenewswire· 2025-07-22 12:30
Company Overview - Day One Biopharmaceuticals is focused on developing and commercializing targeted therapies for life-threatening diseases, particularly in pediatric cancer [3][4] - The company aims to address the critical unmet need in pediatric cancer therapeutic development, inspired by the initial conversations between physicians and families regarding cancer diagnosis and treatment [3] Upcoming Events - Day One will host a live conference call and webcast on August 5, 2025, at 4:30 p.m. ET to report its financial results and discuss corporate progress for the second quarter of 2025 [1] - The live audio of the webcast will be accessible on the company's Media & Investors page, with an archived version available for replay for 30 days following the event [2] Pipeline and Partnerships - The company's pipeline includes targeted cancer treatments such as tovorafenib (OJEMDA™) and DAY301 [4] - Day One collaborates with leading clinical oncologists, families, and scientists to identify, acquire, and develop important cancer treatments [4] Communication Channels - Day One utilizes its Investor Relations website, social media platforms, and other channels to disseminate news, announcements, and financial performance updates [5]