第99.1展示文本
Day One报告2024年第三季度财务业绩和公司进展
OJEMDA营业收入达到2010万美元此款超便携式投影仪使用了最新的 Android TV 界面，而且遥控器还内置了 Google AssistantTM 功能，用户可以非常方便地使用它。 （托伐替尼）净产品营业收入
第三季度末现金、现金等价物和短期投资总额达到55840万美元
公司将于今天东部时间下午4:30举行电话会议和网络直播
2024年10月30日，加利福尼亚州布里斯班市， 生物制药公司Day One Biopharmaceuticals, Inc.（纳斯达克股票代码: DAWN）（以下简称“Day One”或“公司”）致力于为所有年龄段患有危及生命疾病的患者开发和销售靶向疗法，今日宣布了其2024年第三季度财务业绩并重点介绍了最近的公司成就。
“我们第三季度的业绩表现显示，OJEMDA仍然受到患儿需求的推动，这得益于为患有儿童低级别胶质瘤的儿童提供新疗法的需求。”Day One首席执行官杰里米·本德尔博士表示。“展望2025年，我们计划通过推进我们的项目和管线，包括DAY301，一个针对PTK7的潜在首创ADC，我们预计该项目将在未来几个月内进入临床阶段，继续推动增长。”
项目亮点
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公司亮点和即将到来的里程碑
2024年第三季度财务亮点
即将举行的活动
电话会议
Day One将于今天10月30日下午4:30举行电话会议和网络直播。要通过电话接入实时电话会议，请拨打877-704-4453（国内）或201-389-0920（国际），并
第99.1展示文本
提供访问码13745150。直播音频网络播放将能从此处访问 Day One投资者和媒体 页面。为确保及时连接到网络播放，建议参与者在计划开始时间前至少注册15分钟。网络播放的存档版本将在Day One投资者和媒体页面的活动与演示部分提供30天的重播。
关于OJEMDA™
OJEMDA（托伐拉非尼）是一种II型RAF激酶抑制剂，可抑制突变型BRAF V600、野生型BRAF和野生型CRAF激酶。
OJEMDA适用于6个月及以上的患有复发或难治的携带BRAF融合或重排，或BRAF V600突变的小儿低级别胶质瘤（LGG）患者。此适应症已获得加速批准，基于应答率和应答持续时间。该适应症的继续批准可能取决于在确证试验中的临床益处验证和描述。
Tovorafenib获得了FDA颁发的突破性疗法和罕见儿童疾病指定，用于治疗携带活化RAF改变的pLGG患者，并且该药物在FDA的优先审查下得到评估。Tovorafenib还获得了FDA颁发的孤儿药物指定，用于治疗恶性胶质瘤，以及从欧洲委员会获得的用于治疗胶质瘤的指定。
更多信息，请访问www.ojemda.com。
关于第一生物制药
Day One生物制药公司相信在儿童癌症领域，我们可以做得更好。该公司成立的初衷是解决儿童癌症治疗领域严重缺乏的问题。Day One受到医生与患者及其家人进行关于初次癌症诊断和治疗计划的“Day One对话”的启发，旨在重新构想癌症药物研发，并重新定义对所有患癌症的人（不论年龄）来说从第一天开始可能的事情。
Day One与领先的临床肿瘤学家、家庭和科学家合作，以确定、收购和研发重要的靶向癌症治疗。该公司的产品管线包括托伐非尼（OJEMDA™）、DAY301和VRK1抑制剂计划。
Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.
Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop and commercialize cancer therapies, expectations from current and planned
Exhibit 99.1
clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, expectations with respect to the timing of Day One’s Phase 1a/b clinical trial of DAY301, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications.
Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
Exhibit 99.1
Day One Biopharmaceuticals, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
|
|
Three Months Ended |
|
Nine Months Ended |
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Revenue: |
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ 20,070 |
|
$ — |
|
$ 28,262 |
|
$ — |
License revenue |
|
73,691 |
|
— |
|
73,691 |
|
— |
Total revenues |
|
93,761 |
|
— |
|
101,953 |
|
— |
Cost and operating expenses: |
|
|
|
|
|
|
|
|
Cost of product revenue |
|
1,590 |
|
— |
|
2,297 |
|
— |
Research and development |
|
33,563 |
|
33,163 |
|
165,879 |
|
93,173 |
Selling, general and administrative |
|
28,972 |
|
18,275 |
|
85,715 |
|
53,374 |
Total cost and operating expenses |
|
64,125 |
|
51,438 |
|
253,891 |
|
146,547 |
Income (loss) from operations |
|
29,636 |
|
(51,438) |
|
(151,938) |
|
(146,547) |
Non-operating income: |
|
|
|
|
|
|
|
|
Gain from sale of priority review voucher |
|
— |
|
— |
|
108,000 |
|
— |
Investment income, net |
|
5,322 |
|
5,291 |
|
13,649 |
|
12,163 |
Other income (expense), net |
|
1,197 |
|
(3) |
|
1,177 |
|
(22) |
Total non-operating income, net |
|
6,519 |
|
5,288 |
|
122,826 |
|
12,141 |
Income (loss) before income taxes |
|
36,155 |
|
(46,150) |
|
(29,112) |
|
(134,406) |
Income tax benefit (expense) |
|
882 |
|
— |
|
(670) |
|
— |
Net income (loss) |
|
37,037 |
|
(46,150) |
|
(29,782) |
|
(134,406) |
Net income (loss) per share - basic |
|
$ 0.38 |
|
$ (0.54) |
|
$ (0.33) |
|
$ (1.73) |
Net income (loss) per share - diluted |
|
$ 0.38 |
|
$ (0.54) |
|
$ (0.33) |
|
$ (1.73) |
Weighted-average number of common shares used in net income (loss) per share - basic |
|
96,623,123 |
|
85,952,501 |
|
90,164,895 |
|
77,682,237 |
Weighted-average number of common shares used in net income (loss) per share - diluted |
|
96,937,759 |
|
85,952,501 |
|
90,164,895 |
|
77,682,237 |
Day One Biopharmaceuticals, Inc.
Selected Condensed Balance Sheet Data
(in thousands)
(unaudited)
|
|
September 30, |
|
December 31, |
Cash, cash equivalents and short-term investments |
|
$ 558,383 |
|
$ 366,347 |
Total assets |
|
600,807 |
|
376,048 |
Total liabilities |
|
45,344 |
|
29,508 |
Accumulated deficit |
|
(488,367) |
|
(458,585) |
Total stockholders’ equity |
|
555,463 |
|
346,540 |
Exhibit 99.1
DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
#####