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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Trading |
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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 May 2, 2024, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2024. 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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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: |
May 2, 2024 |
By: |
/s/ Thomas Butler |
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Thomas Butler |
Exhibit 99.1
Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights
REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) - Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported first quarter 2024 financial results and corporate highlights.
“Over the last two months we have seen a significant increase in the rate of enrollment for the expansion phase cohorts of our Phase 1/2 study, COVALENT-111, investigating BMF-219 in patients with type 2 diabetes. There is currently a waitlist for the fourth cohort which we expect will open for enrollment in the second half of this year. We have also seen a significant increase in the rate of enrollment of our Phase 2 study, COVALENT-112, in patients with type 1 diabetes following the press release which provided an early look at the first two patients dosed with BMF-219. Here we highlighted the first two patients dosed with BMF-219 demonstrated an increase in C-peptide Index (Amount of C-peptide secreted per unit of glucose) during the early stages of treatment. This is truly an exciting and validating update on our progress in type 1 diabetes. Patients with type 2 diabetes have lost about 50% of their pool of beta cells while patients with type 1 diabetes have lost at least 90% of their beta-cell pool at diagnosis and are therefore not able to produce sufficient insulin to address the glucose levels in their blood. Currently approved treatments for diabetes are mostly chronic treatments helping patients to reduce the blood glucose while the mass and function of the beta cells continues to decline. We have now demonstrated in multiple preclinical experiments that BMF-219 has the potential to address diabetes at the root cause level by improving the function and mass of beta cells. The data we reported from the escalation portion of our clinical study COVALENT-111 in the first quarter of 2024 demonstrated for the first time how an agent can achieve durable glycemic control while patients are off therapy, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “In 2024, we expect to continue to advance our clinical programs with BMF-219 in diabetes and plan to report multiple data readouts throughout the remainder of the year, including topline Week 26 data of over 200 patients from our Phase 1/2 study, COVALENT-111, in type 2 diabetes and topline Week 26 data from approximately 40 patients enrolled in the open label portion of our Phase 2 study, COVALENT-112, in type 1 diabetes patients. Our goal is to deliver a short-term, non-chronic treatment that will reconstitute insulin-producing beta cells, allowing the patients’ own bodies to normalize blood sugar levels.”
DIABETES
COVALENT-111 (BMF-219 for Type 2 Diabetes)
Anticipated 2024 Milestones:
COVALENT-112 (BMF-219 for Type 1 Diabetes)
Anticipated 2024 Milestones:
ONCOLOGY
COVALENT-101 (BMF-219 for Liquid Tumors)
Anticipated 2024 Milestones:
COVALENT-102 (BMF-219 for Solid Tumors)
Anticipated 2024 Milestones:
COVALENT-103 (BMF-500 for Acute Leukemias)
Anticipated 2024 Milestones:
FUSIONTM SYSTEM DISCOVERY PLATFORM
Anticipated 2024 Milestones:
FIRST QUARTER 2024 FINANCIAL RESULTS
About Biomea Fusion
Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases 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, 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 the clinical and therapeutic potential of our product candidates and development programs, including BMF-219 and BMF-500, the potential of BMF-219 as a treatment for type 1 and type 2 diabetes, various types of liquid tumors and solid tumors, the potential of BMF-500 as a treatment for acute leukemia, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including our Phase 1/2 COVALENT-111 study of BMF-219 in type 2 diabetes, our Phase 2 COVALENT-112 study of BMF-219 in type 1 diabetes, our Phase 1 COVALENT-101 study of BMF-219 in relapsed or refractory acute myeloid leukemia, our Phase 1/1b COVALENT-102 study of BMF-219 in KRAS mutant solid tumors and our Phase 1 COVALENT-103 study of BMF-500 in leukemia, the anticipated enrollment of patients and availability of data from our clinical trials 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 Relations
Chunyi Zhao, PhD
Associate Director of Investor Relations & Corporate Development
czhao@biomeafusion.com
Media Relations
Neera Chaudhary
nchaudhary@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)
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Three Months Ended |
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March 31, |
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2024 |
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2023 |
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Operating expenses: |
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Research and development (1) |
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$ |
33,776 |
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$ |
24,395 |
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General and administrative (1) |
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7,283 |
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5,636 |
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Total operating expenses |
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41,059 |
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30,031 |
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Loss from operations |
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(41,059 |
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(30,031 |
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Interest and other income, net |
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1,998 |
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980 |
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Net loss |
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$ |
(39,061 |
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$ |
(29,051 |
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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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1 |
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Comprehensive loss |
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$ |
(39,061 |
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$ |
(29,050 |
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Net loss per common share, basic and diluted |
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$ |
(1.09 |
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$ |
(0.98 |
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Weighted-average number of common shares used to |
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35,890,370 |
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29,586,468 |
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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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March 31, |
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2024 |
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2023 |
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Research and development |
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$ |
2,546 |
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$ |
1,474 |
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General and administrative |
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2,476 |
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1,759 |
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Total stock-based compensation expense |
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$ |
5,022 |
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$ |
3,233 |
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BIOMEA FUSION, INC.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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March 31, |
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December 31, |
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2024 |
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2023 |
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Cash, cash equivalents, and restricted cash |
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$ |
145,287 |
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$ |
177,236 |
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Working capital |
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122,312 |
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156,321 |
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Total assets |
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168,494 |
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199,927 |
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Stockholders' equity |
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135,314 |
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169,237 |
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