第99.1展示文本
Biomea Fusion報告2024年第三季度財務業績和企業亮點
加州紅木城,2024年10月29日(環球新聞社)-- Biomea Fusion,Inc.(「Biomea」或「該公司」)(納斯達克:BMEA),一家致力於發現和開發口服共價小分子,以改善患有糖尿病、肥胖症和基因定義癌症患者生活質量的臨床階段生物製藥公司,今天發佈了2024年第三季度財務業績和企業要聞。
我們的第三季度是公司的一個關鍵時刻。通過與FDA的合作努力,我們成功解決了糖尿病研究的臨床暫停,同時保持了2型糖尿病擴展研究數據的進展,並繼續基本進展第三發展項目BMF-650。我們很高興地宣佈我們第三個臨床開發候選藥物的進展-一種下一代口服小分子GLP-1受體激動劑。胰高血糖素已成爲肥胖治療的基石,我們相信icovamenib與一種胰高血糖素一起潛在地成爲糖尿病和肥胖治療的基石。我們已經進行了大量的臨床前工作,將icovamenib與GLP-1 RA藥物療法結合,並在10月30日的電話會議上分享這些數據,同時更新BMF-650。th托馬斯·巴特勒,Biomea Fusion的首席執行官和董事會主席表示:「我們對今年計劃剩餘的數據讀出非常興奮,特別是擬在第20期$20億COVALENt-111期間公佈的頂線第26週數據,涉及約200名2型糖尿病患者,這將幫助我們確定對icovamenib有反應的患者,並制定我們應該針對的第3期患者人群。」
糖尿病和肥胖症
COVALENt-111(icovamenib 用於2型糖尿病)& COVALENt-112(icovamenib 用於1型糖尿病)
預期里程碑:
BMF-650(口服、小分子GLP-1受體激動劑)
預期里程碑:
腫瘤學
COVALENT-101(用於液體腫瘤的icovamenib)
預期里程碑:
COVALENt-102(用於固體腫瘤的icovamenib)
預期里程碑:
COVALENt-103(BMF-500用於急性白血病)
預期里程碑:
融合此款超便攜式投影儀使用了最新的 Android TV 界面,而且遙控器還內置了 Google AssistantTM 功能,用戶可以非常方便地使用它。 系統發現平台
預期里程碑:
2024年第三季度財務結果
About Biomea Fusion
Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.
We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.
Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials, the anticipated enrollment of patients and availability of data from our clinical trials, anticipated milestones, and the timing of such events, and our expectations regarding the Biomea FUSION™ Platform and our plans to announce a third development candidate, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.
Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Investor & Media Relations
Ramses Erdtmann
re@biomeafusion.com
- See attached for financial tables -
BIOMEA FUSION, INC.
Condensed Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development (1) |
|
$ |
27,244 |
|
|
$ |
25,347 |
|
|
$ |
92,845 |
|
|
$ |
71,680 |
|
General and administrative (1) |
|
|
6,795 |
|
|
|
5,772 |
|
|
|
21,151 |
|
|
|
17,127 |
|
Total operating expenses |
|
|
34,039 |
|
|
|
31,119 |
|
|
|
113,996 |
|
|
|
88,807 |
|
Loss from operations |
|
|
(34,039 |
) |
|
|
(31,119 |
) |
|
|
(113,996 |
) |
|
|
(88,807 |
) |
Interest and other income, net |
|
|
1,252 |
|
|
|
2,690 |
|
|
|
4,872 |
|
|
|
6,436 |
|
Net loss |
|
$ |
(32,787 |
) |
|
$ |
(28,429 |
) |
|
$ |
(109,124 |
) |
|
$ |
(82,371 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on investments, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(32,787 |
) |
|
$ |
(28,429 |
) |
|
$ |
(109,124 |
) |
|
$ |
(82,371 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.91 |
) |
|
$ |
(0.80 |
) |
|
$ |
(3.03 |
) |
|
$ |
(2.46 |
) |
Weighted-average number of shares used to |
|
|
36,220,736 |
|
|
|
35,653,988 |
|
|
|
36,052,173 |
|
|
|
33,551,808 |
|
(1) Includes stock-based compensation as follows (non-cash operating expenses):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Research and development |
|
$ |
2,478 |
|
|
$ |
1,778 |
|
|
$ |
7,472 |
|
|
$ |
4,902 |
|
General and administrative |
|
|
2,264 |
|
|
|
1,820 |
|
|
|
7,132 |
|
|
|
5,365 |
|
Total stock-based compensation expense |
|
$ |
4,742 |
|
|
$ |
3,598 |
|
|
$ |
14,604 |
|
|
$ |
10,267 |
|
BIOMEA FUSION, INC.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
|
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash |
|
$ |
88,321 |
|
|
$ |
177,236 |
|
Working capital |
|
|
66,026 |
|
|
|
156,321 |
|
Total assets |
|
|
110,419 |
|
|
|
199,927 |
|
Stockholders' equity |
|
|
75,972 |
|
|
|
169,237 |
|