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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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 November 7, 2022, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2022. 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: |
November 7, 2022 |
By: |
/s/ Thomas Butler |
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Thomas Butler |
Exhibit 99.1
Biomea Fusion Reports Third Quarter 2022 Financial Results and Business Highlights
REDWOOD CITY, Calif., November 7, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (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 2022 financial results and business highlights.
“We continue to solidify Biomea’s position as the leader in next-generation covalent medicines, and build near- and long-term value, through our rapid progress and strong execution. With BMF-219, we have now brought the first covalent menin inhibitor to the clinic for KRAS-mutated solid tumors, adding to our already robust development strategy of BMF-219 in distinct patient subsets of multiple liquid tumors. In addition, we are very excited to announce the first type 2 diabetes patient dosed with BMF-219, which marks the first non-oncology indication for which an investigational menin inhibitor is being evaluated in the clinic,” said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “Over the coming quarters, we expect to gain valuable feedback and believe we will achieve clinical proof of concept for BMF-219 in multiple indications. We also continue to advance our second IND candidate, BMF-500, an investigational covalent FLT3 inhibitor with best-in-class potential, toward the clinic. BMF-500 further demonstrates the versatility enabled by our proprietary FUSION System to discover and validate novel covalent product candidates.”
Third Quarter 2022 and Recent Pipeline Highlights
Oncology
Diabetes
Outlook
Third Quarter 2022 Financial Results
About Biomea Fusion
Biomea Fusion is a 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. The company is utilizing its proprietary FUSION™ System to advance a pipeline of covalent-binding therapeutic agents against key oncogenic drivers of cancer and metabolic diseases. Biomea Fusion’s goal is to utilize its capabilities and platform to become a leader in developing covalent small molecules in order to maximize the clinical benefit when treating various cancers and metabolic diseases.
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, the potential of BMF-219 as a treatment for various types
of cancer and diabetes, our research, development and regulatory plans, the progress of our ongoing clinical trials, including COVALENT-101, COVALENT-102 and our Phase I/II COVALENT-111 study of BMF-219 in type 2 diabetes, our plans to submit IND applications for BMF-500 in patients with FLT3 mutations and for BMF-219 in type 2 diabetes, our plans to provide clinical updates on the healthy volunteer section of our Phase I/II type 2 diabetes study of BMF-219, BMF-219 in type 2 diabetes patients, and patients in the COVALENT-101 study, 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.
- 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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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development (1) |
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$ |
18,242 |
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$ |
7,886 |
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$ |
42,174 |
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$ |
16,908 |
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General and administrative (1) |
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5,242 |
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4,752 |
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15,184 |
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10,022 |
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Total operating expenses |
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23,484 |
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12,638 |
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57,358 |
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26,930 |
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Loss from operations |
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(23,484 |
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(12,638 |
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(57,358 |
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(26,930 |
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Interest and other income, net |
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594 |
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32 |
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844 |
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73 |
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Net loss |
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$ |
(22,890 |
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$ |
(12,606 |
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$ |
(56,514 |
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$ |
(26,857 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net |
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4 |
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— |
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(3 |
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2 |
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Comprehensive loss |
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$ |
(22,886 |
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$ |
(12,606 |
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$ |
(56,517 |
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$ |
(26,855 |
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Net loss per common share, basic and diluted |
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(0.78 |
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(0.43 |
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(1.93 |
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(1.21 |
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Weighted-average number of shares used to |
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29,319,042 |
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29,001,213 |
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29,214,549 |
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22,105,321 |
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(1) Includes stock-based compensation as follows:
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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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2022 |
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2021 |
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2022 |
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2021 |
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Research and development |
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$ |
1,186 |
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$ |
766 |
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$ |
3,451 |
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$ |
1,690 |
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General and administrative |
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1,545 |
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1,155 |
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4,169 |
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2,613 |
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Total stock-based compensation expense |
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$ |
2,731 |
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$ |
1,921 |
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$ |
7,620 |
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$ |
4,303 |
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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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2022 |
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2021 |
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Cash, cash equivalents, investments, and restricted cash |
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$ |
133,819 |
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$ |
175,743 |
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Working capital |
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126,272 |
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171,924 |
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Total assets |
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145,050 |
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185,705 |
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Stockholders' equity |
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130,635 |
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178,783 |
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Contact:
Sasha Blaug
Senior Vice President, Corporate Development
SB@biomeafusion.com
(650) 460-7759