0000950170-22-009945.txt : 20220516 0000950170-22-009945.hdr.sgml : 20220516 20220516073835 ACCESSION NUMBER: 0000950170-22-009945 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220516 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220516 DATE AS OF CHANGE: 20220516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Biomea Fusion, Inc. CENTRAL INDEX KEY: 0001840439 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40335 FILM NUMBER: 22925517 BUSINESS ADDRESS: STREET 1: 900 MIDDLEFIELD ROAD STREET 2: 4TH FLOOR CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: (650) 980-9099 MAIL ADDRESS: STREET 1: 900 MIDDLEFIELD ROAD STREET 2: 4TH FLOOR CITY: REDWOOD CITY STATE: CA ZIP: 94063 8-K 1 bmea-20220516.htm 8-K 8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 16, 2022

 

 

Biomea Fusion, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-40335

82-2520134

(State or other jurisdiction
of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

900 Middlefield Road, 4th Floor

 

Redwood City, California

 

94063

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: 650 980-9099

 

Not Applicable

(Former name or former address, if changed since last report)

 

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value

 

BMEA

 

The NASDAQ Global Select Market

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 16, 2022, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended March 31, 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

Press release dated May 16, 2022, furnished herewith.

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.

 

 

 

Biomea Fusion, Inc.

 

 

 

 

Date:

May 16, 2022

By:

/s/ Thomas Butler

 

 

 

Thomas Butler
Principal Executive Officer

 

 EX-99.1 2 bmea-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

Biomea Fusion Reports First Quarter 2022 Financial Results and Business Highlights

•
COVALENT-101 study continues to enroll relapsed/refractory (R/R) acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) patients and has included R/R diffuse large B-cell lymphoma (DLBCL) and R/R multiple myeloma (MM) patients to the study. Company continues to explore indication expansion with the announced upcoming presentation of preclinical ex vivo data of BMF-219 in Chronic Lymphocytic Leukemia (CLL) at the American Society of Clinical Oncology (ASCO)
•
Presented preclinical validation data for BMF-219 in multiple solid and liquid tumor types at AACR 2022, with BMF-219 showing strong cytotoxic activity as a single agent at similar concentrations across multiple preclinical patient-derived (PDX) models ex vivo including DLBCL, MM, colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and pancreatic cancer
•
Announced upcoming presentation of preclinical in vivo data of BMF-219 in diabetes at the American Diabetes Association (ADA) Scientific Sessions 2022 and plans to initiate a Phase I/II trial in the second half of 2022 using BMF-219 as a first-in-class covalent menin inhibitor in type 2 diabetes patients
•
Cash position of $165.6 million at the end of the first quarter of 2022

 

REDWOOD CITY, Calif., May 16, 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 first quarter 2022 financial results and business highlights.

 

“We had a very exciting start to the year as we initiated our first Phase I study of BMF-219, COVALENT-101, in AML and ALL patients. We have now expanded enrollment to include also DLBCL and MM patients. Targeting menin with our covalent inhibitor is an innovative approach with potential safety, tolerability, efficacy, and durability advantages. Our COVALENT-101 investigators are enthusiastic to use BMF-219 for many of their patients who currently have relapsed from or not responded to traditional approaches,” said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board.

 

Mr. Butler continued, “We believe covalent inhibitors afford the optimal profile for a therapeutic. The aim is to maximize depth and durability of response, to support improved survival, while minimizing exposure, which is the source for unwanted toxicity. We have now provided preclinical evidence highlighting BMF-219’s profound anti-tumor effects in MYC-driven cancers and pan-KRAS mutant solid tumors. By indirectly targeting MYC and KRAS via the scaffold protein menin, our preclinical data demonstrates that BMF-219 can affect these oncoproteins in a very meaningful way. We are managing our expenses and will continue to execute on the clinical development of this first-in-human and first-in-class covalent menin inhibitor not only in the various tumor types, but also in type 2 diabetic patients.”

 

Clinical and Regulatory Highlights

•
Enrolled first patient in first-in-human Phase I clinical trial evaluating BMF-219 in patients with relapsed or refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.
•
Presented preclinical data at AACR 2022 highlighting impact of BMF-219 on MYC- and KRAS-driven solid tumors. Building on prior data, BMF-219 exhibited robust anti-tumor effect in cell lines and PDX models in DLBCL and MM cell lines.
•
Announced upcoming presentation of preclinical BMF-219 data from multiple in vivo models of diabetes at ADA Scientific Sessions 2022.
•
Announced upcoming presentation of preclinical BMF-219 data from multiple ex vivo models of CLL at ASCO 2022.

 

Corporate Highlights

•
Appointed Steve Morris, M.D. as Chief Medical Officer. Dr. Morris led a basic and translational research laboratory at St. Jude Children’s Research Hospital, where he served for 25 years. Among his lab’s pioneering work at St. Jude was the discovery and characterization of anaplastic lymphoma kinase, or ALK.

 

First Quarter 2022 Financial Results

•
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $16.4 million for quarter ended March 31, 2022, compared to a net loss of $5.9 million for the same period in 2021.
•
R&D Expenses: Research and development expenses were $11.4 million for the quarter ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase of $7.6 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s lead product candidate, BMF-219.
•
G&A Expenses: General and administrative expenses were $5.1 million for the quarter ended March 31, 2022, compared to $2.1 million for the same period in 2021. The increase of $3.0 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
•
Cash, Cash Equivalents, Restricted Cash, and Investments: As of March 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $165.6 million, compared to $175.7 million as of December 31, 2021.

 

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, 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, its expansion to include patients with DLBCL and MM, 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:

 

Van Sandwick
Director, Investor Relations & Corporate Development
vsandwick@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)

 

 

 

Three Months Ended

 

 

 

 

March 31,

 

 

 

 

2022

 

 

2021

 

 

Operating expenses:

 

 

 

 

 

 

 

Research and development (1)

 

$

11,350

 

 

$

3,798

 

 

General and administrative (1)

 

 

5,050

 

 

 

2,059

 

 

Total operating expenses

 

 

16,400

 

 

 

5,857

 

 

Loss from operations

 

 

(16,400

)

 

 

(5,857

)

 

Interest and other income, net

 

 

34

 

 

 

5

 

 

Net loss

 

$

(16,366

)

 

$

(5,852

)

 

Other comprehensive loss:

 

 

 

 

 

 

 

Unrealized gain (loss) on investments, net

 

 

(13

)

 

 

(15

)

 

Comprehensive loss

 

$

(16,379

)

 

$

(5,867

)

 

Net loss per common share, basic and diluted

 

 

(0.56

)

 

 

(0.49

)

 

Weighted-average number of shares used to
   compute basic and diluted net loss per common share

 

 

29,126,088

 

 

 

11,964,205

 

 

 

(1) Includes stock-based compensation as follows:

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2022

 

 

2021

 

Research and development

 

$

1,012

 

 

$

313

 

General and administrative

 

 

1,318

 

 

 

606

 

Total stock-based compensation expense

 

$

2,330

 

 

$

919

 

 

 

BIOMEA FUSION, INC.

Condensed Balance Sheet Data

(Unaudited)

(in thousands)

 

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

Cash, cash equivalents, investments, and restricted cash

 

$

165,572

 

 

$

175,743

 

Working capital

 

 

159,061

 

 

 

171,924

 

Total assets

 

 

174,864

 

 

 

185,705

 

Stockholders' equity

 

 

164,765

 

 

 

178,783

 

 

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