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 August 1, 2022, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended June 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: |
August 1, 2022 |
By: |
/s/ Thomas Butler |
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Thomas Butler |
Exhibit 99.1
Biomea Fusion Reports Second Quarter 2022 Financial Results and Business Highlights
REDWOOD CITY, Calif., August 1, 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 second quarter 2022 financial results and business highlights.
“The team continues to deliver against critical corporate goals as we look to build tremendous value potential for the company in the near and long-term. During the second quarter, we focused specifically on key clinical operations and clinical science activities to support COVALENT-101. Additionally, we continued to design and execute key experiments to support our diabetes effort as we march towards the clinic,” said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. “The scaffold protein menin has many more functional responsibilities than was previously characterized and, thus, is central to multiple disease settings. Moreover, we believe our approach of covalent menin inhibition with BMF-219 offers potential safety, tolerability, efficacy and durability benefits to patients. We are now well positioned to execute a robust clinical development plan for BMF-219, which includes many liquid and solid tumor indications, as well as type 2 diabetes. Beyond menin inhibition, we are advancing toward the clinic with our second IND candidate, BMF-500, a covalent FLT3 inhibitor with best-in-class potential.”
Second Quarter 2022 Pipeline Highlights
Cancer
Diabetes
219’s strong, prolonged glycemic control, insulin sensitization, and hemoglobin A1C (HbA1c)
reduction in two preclinical rat models of diabetes while on drug and after washout, outperforming
standard-of-care agents
Second 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-500 and BMF-219, 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 COVALENT-101 Phase I clinical trial, including ongoing enrollment in the trial, our pursuit of BMF-219 in metabolic diseases, our plans to submit an IND application for BMF-219 in KRAS mutant NSCLC, CRC and PDAC, our plans to submit an IND application for BMF-219 in type 2 diabetes, our plans to continue IND-enabling studies for BMF-500 and file an IND, 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 patient enrollment and in the initiation, conduct and completion of our 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:
Sasha Blaug
Senior Vice President, Corporate Development
SB@biomeafusion.com
(650) 460-7759
- 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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Six Months Ended |
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June 30, |
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June 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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$ |
12,582 |
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$ |
5,224 |
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$ |
23,932 |
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$ |
9,022 |
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General and administrative (1) |
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4,892 |
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3,211 |
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9,942 |
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5,270 |
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Total operating expenses |
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17,474 |
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8,435 |
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33,874 |
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14,292 |
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Loss from operations |
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(17,474 |
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(8,435 |
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(33,874 |
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(14,292 |
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Interest and other income, net |
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216 |
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36 |
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250 |
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41 |
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Net loss |
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$ |
(17,258 |
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$ |
(8,399 |
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$ |
(33,624 |
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$ |
(14,251 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net |
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6 |
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17 |
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(7 |
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2 |
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Comprehensive loss |
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$ |
(17,252 |
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$ |
(8,382 |
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$ |
(33,631 |
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$ |
(14,249 |
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Net loss per common share, basic and diluted |
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(0.59 |
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(0.33 |
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(1.15 |
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(0.77 |
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Weighted-average number of shares used to |
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29,196,398 |
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25,161,038 |
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29,161,437 |
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18,598,521 |
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(1) Includes stock-based compensation as follows:
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 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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$ |
1,253 |
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$ |
611 |
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$ |
2,265 |
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$ |
924 |
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General and administrative |
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1,306 |
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852 |
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2,624 |
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1,458 |
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Total stock-based compensation expense |
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$ |
2,559 |
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$ |
1,463 |
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$ |
4,889 |
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$ |
2,382 |
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BIOMEA FUSION, INC.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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June 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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$ |
150,170 |
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$ |
175,743 |
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Working capital |
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144,776 |
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171,924 |
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Total assets |
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161,736 |
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185,705 |
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Stockholders' equity |
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150,390 |
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178,783 |
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