UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On October 30, 2023, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2023. The full text of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Biomea Fusion, Inc. |
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Date: |
October 30, 2023 |
By: |
/s/ Thomas Butler |
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Thomas Butler |
Exhibit 99.1
Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights
REDWOOD CITY, Calif., Oct 30, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported third quarter 2023 financial results and business highlights.
“With the disease modifying potential demonstrated by BMF-219, we are excited to begin the expansion portion of COVALENT-111 in type 2 diabetes, and to initiate the evaluation of BMF-219’s impact in type 1 diabetes with our COVALENT-112 study. Both studies are now open for enrollment more than a quarter ahead of schedule. With the potential to enable patients to retain and regenerate their own insulin-producing beta cells, BMF-219 may represent a promising new approach, if ultimately approved. We believe BMF-219 has the potential to halt and reverse disease progression for people with both type 1 and type 2 diabetes, enabling them to improve glycemic control while being off therapy and avoid insulin dependency,” said Thomas Butler, CEO and Chairman of Biomea. “In the third quarter, we also announced the first clinical data of BMF-219 in relapsed/refractory AML patients with menin-dependent mutations, which we believe yield encouraging efficacy and safety data. Finally in this quarter, we also initiated the clinical study of our second, Biomea-discovered investigational covalent inhibitor, BMF-500, a novel FLT3 inhibitor. We look forward to reporting on our pipeline progress in both diabetes and oncology in the upcoming quarters.”
THIRD QUARTER 2023 CLINICAL AND REGULATORY HIGHLIGHTS
DIABETES
ONCOLOGY
FUSIONTM SYSTEM PLATFORM / ONGOING EFFORTS
THIRD QUARTER 2023 FINANCIAL RESULTS
About Biomea Fusion
Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. 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 with various cancers and metabolic diseases, including diabetes. 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, Twitter 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 our cash runway, the clinical and therapeutic potential of our product candidates and development programs, including BMF-219 and BMF-500, the potential of BMF-500 as an FLT3 inhibitor and as a treatment for various types of cancers, the potential of BMF-219 as a treatment for various types of cancer and type 1 and type 2 diabetes, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including COVALENT-101, COVALENT-102, COVALENT-103, our Phase I/II COVALENT-111 study of BMF-219 in type 2 diabetes and our Phase II COVALENT-112 study of BMF-219 in type 1 diabetes, our plans to provide clinical updates on additional data from the initial dosing cohorts in COVALENT-111, our plans to provide future data from the Phase II portion of COVALENT-111, complete dose escalation, identify optimal dose levels, initiate dose expansion, our plans to explore longer duration of treatment and additional dosage forms and our plans to explore the potential utility of BMF-219 in type 1 diabetes, and our plans to initiate and dose the first patient in COVALENT-112, our plans to advance and announce additional development candidates from the FUSION platform, and the timing of such events, 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, the preparation, filing and clearance of INDs, 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 Relations
Chunyi Zhao, PhD
Sr. Manager of Investor Relations & Corporate Development
czhao@biomeafusion.com
Media Relations
Neera Chaudhary, PhD
Chief Commercial Officer – Diabetes
nchaudhary@biomeafusion.com
- See attached for financial tables -
BIOMEA FUSION, INC.
Condensed Statement of Operations
(Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development (1) |
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$ |
25,347 |
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$ |
18,242 |
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$ |
71,680 |
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$ |
42,174 |
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General and administrative (1) |
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5,772 |
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5,242 |
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17,127 |
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15,184 |
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Total operating expenses |
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31,119 |
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23,484 |
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88,807 |
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57,358 |
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Loss from operations |
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(31,119 |
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(23,484 |
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(88,807 |
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(57,358 |
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Interest and other income, net |
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2,690 |
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594 |
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6,436 |
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844 |
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Net loss |
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$ |
(28,429 |
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$ |
(22,890 |
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$ |
(82,371 |
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$ |
(56,514 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net |
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— |
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4 |
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— |
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(3 |
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Comprehensive loss |
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$ |
(28,429 |
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$ |
(22,886 |
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$ |
(82,371 |
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$ |
(56,517 |
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Net loss per common share, basic and diluted |
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$ |
(0.80 |
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$ |
(0.78 |
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$ |
(2.46 |
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$ |
(1.93 |
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Weighted-average number of shares used to |
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35,653,988 |
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29,319,042 |
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33,551,808 |
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29,214,549 |
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(1) Includes stock-based compensation as follows (non-cash operating expenses):
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Research and development |
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$ |
1,778 |
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$ |
1,186 |
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$ |
4,902 |
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$ |
3,451 |
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General and administrative |
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1,820 |
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1,545 |
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5,365 |
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4,169 |
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Total stock-based compensation expense |
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$ |
3,598 |
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$ |
2,731 |
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$ |
10,267 |
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$ |
7,620 |
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BIOMEA FUSION, INC.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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September 30, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents, investments, and restricted cash |
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$ |
199,459 |
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$ |
113,400 |
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Working capital |
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186,294 |
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98,718 |
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Total assets |
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225,087 |
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129,307 |
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Stockholders' equity |
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199,612 |
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108,539 |
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