展示99.1
バイオミア・フュージョンは2024年第3四半期の財務結果と会社のハイライトを報告しました
カリフォルニア州レッドウッドシティ、2024年10月29日(グローブニュースワイヤ) - バイオメアフュージョン社(「バイオメア」または「会社」)(ナスダック:BMEA)は、糖尿病、肥満、遺伝的に定義された癌の患者の生活を改善するために、経口共有結合小分子の発見と開発に専念している臨床段階のバイオ医薬品会社であり、本日、2024年第3四半期の財務結果と企業のハイライトを発表しました。
当社の第3四半期は、会社にとって転換期となる四半期でした。FDAとの協力により、糖尿病の臨床試験に関する中立を効率的に解決し、タイプ2糖尿病の拡大研究の実施状況を維持し、第3開発プログラムであるBMF-650の基礎的な進展を続けています。次世代の経口小分子GLP-1受容体アゴニストとしての第3の臨床開発候補の進展を嬉しく思います。インクレチンは肥満治療の基盤となりつつあり、私たちはインクレチンとともにicovamenibを組み合わせることで、糖尿病と肥満の両治療の基盤になり得ると考えています。icovamenibをGLP-1 RAベースの治療と組み合わせるための包括的な前臨床研究を行っており、10月30日に当社の会議通話でこのデータとBMF-650の最新情報を共有する予定です。日Biomea Fusionの最高経営責任者兼取締役会長であるトーマス・バトラーは、"当社は今年の残りのリードアウトに非常に興奮しており、特に約200例のタイプ2糖尿病患者を対象とした第20相COVALENt-111のトップラインWeek 26データについて、icovamenibに反応を示す患者を明確にし、第3相患者集団のターゲットとすべき患者を定義するでしょう"と述べました。
糖尿病&肥満
COVALENt-111 (2型糖尿病のためのイコバメニブ) & COVALENt-112 (1型糖尿病のためのイコバメニブ)
予想されるマイルストーン:
BMF-650(経口、小分子GLP-1 RA)
予想されるマイルストーン:
オンコロジー
COVALENt-101(液体腫瘍用アイコバメニブ)
予想されるマイルストーン:
COVALENt-102(固形腫瘍向けのイコバメニブ)
予想されるマイルストーン:
COVALENt-103(急性白血病用BMF-500)
予想されるマイルストーン:
融合TM システム発見プラットフォーム
予想されるマイルストーン:
2024年第3四半期の財務結果
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 |
|