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Biomea Fusion (Nasdaq: BMEA) narrows loss as diabetes and obesity trials advance

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Biomea Fusion, a clinical-stage diabetes and obesity medicines company, reported results for the quarter ended June 30, 2026 and highlighted progress across its pipeline. Two Phase II COVALENT-211 and -212 trials of icovamenib in Type 2 diabetes are enrolling, with 26-week data expected in the first and second quarters of 2027, and a Phase I GLP-131 obesity trial of BMF-650 is on track to deliver initial 28-day weight reduction data in the third quarter of 2026. The company is planning a Phase II trial in recently diagnosed Type 1 diabetes and initiated a research collaboration with the University of Leicester to test icovamenib plus semaglutide in obesity. Cash runway is projected into the second quarter of 2027.

For the second quarter of 2026, net loss attributable to common stockholders was $8.3 million versus $20.7 million a year earlier, and first-half net loss was $20.7 million versus $50.0 million. R&D expenses fell to $9.1 million from $16.6 million, and G&A expenses to $3.6 million from $4.7 million, largely reflecting reduced headcount and lower external and facility costs. Cash, cash equivalents and restricted cash totaled $35.2 million as of June 30, 2026.

Positive

  • Net loss decreased, with Q2 2026 net loss at $8.3 million versus $20.7 million a year earlier, driven by lower R&D and G&A expenses.

Negative

  • None.

Filing Explained

This Form 8-K reports Biomea Fusion’s June 30, 2026 results under Item 2.02, but the accompanying release is furnished rather than filed under Section 18 and is not incorporated by reference into another filing unless expressly stated.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and restricted cash $35.2 million As of June 30, 2026
Net loss Q2 2026 $8.3 million Three months ended June 30, 2026; compared with $20.7 million in the same period of 2025
Net loss first half 2026 $20.7 million Six months ended June 30, 2026; compared with $50.0 million in the same period of 2025
R&D expenses Q2 2026 $9.1 million Three months ended June 30, 2026; down from $16.6 million in Q2 2025
G&A expenses Q2 2026 $3.6 million Three months ended June 30, 2026; down from $4.7 million in Q2 2025
Total stock-based compensation Q2 2026 $1.6 million Non-cash stock-based compensation included in operating expenses for the three months ended June 30, 2026
Projected cash runway into the second quarter of 2027 Based on current cash, cash equivalents and restricted cash
C-peptide AUC medical
"A 52% increase from baseline in mean C-peptide AUC at Week 12"
C‑peptide AUC is the total amount of C‑peptide measured in the blood over a specified test period, calculated by taking repeated measurements and summing the area under the concentration‑versus‑time curve. Because C‑peptide is released alongside insulin, the AUC gives a running total of a person’s insulin production; investors use it as a straightforward, quantitative signal of how well a diabetes treatment preserves or restores pancreatic insulin‑making function — like measuring total rainfall to judge a storm’s strength.
glucagon-like peptide-1 receptor agonists medical
"patients with T2D not achieving glycemic targets while on glucagon-like peptide-1 receptor agonists"
randomized, double-blind, placebo-controlled medical
"a Phase II, randomized, double-blind, placebo-controlled trial in patients with insulin-deficient T2D"
A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.
stock-based compensation financial
"which included $1.6 million of stock-based compensation, compared to $2.6 million in 2025"
Stock-based compensation is when a company pays employees, directors or consultants with shares or the right to buy shares instead of or in addition to cash. It matters to investors because issuing stock or options spreads ownership thinner (like cutting a pie into more slices), which can reduce each existing share’s claim on profits and can also change reported earnings; investors watch it to assess true cost of running the business and how management is incentivized.
working capital financial
"Working capital $ 25,576 as part of condensed balance sheet data"
Working capital is the money a business has available to cover its daily expenses, like paying bills and buying supplies. It’s like the cash in your wallet that helps you handle everyday costs; having enough ensures the business can operate smoothly without running into money shortages.
Net loss attributable to common stockholders Q2 2026 $8.3 million compared with $20.7 million for the three months ended June 30, 2025
Net loss attributable to common stockholders first half 2026 $20.7 million compared with $50.0 million for the six months ended June 30, 2025
R&D expenses Q2 2026 $9.1 million decreased from $16.6 million in the same period in 2025, primarily due to lower preclinical, external, personnel and facility costs
G&A expenses Q2 2026 $3.6 million decreased from $4.7 million in the same period in 2025, mainly from reduced personnel and corporate-related expenses
Cash, cash equivalents and restricted cash $35.2 million balance as of June 30, 2026 supporting a projected runway into the second quarter of 2027
Guidance

Projects its cash runway into the second quarter of 2027.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What was Biomea Fusion (BMEA)'s net loss for Q2 2026?
Biomea Fusion reported a Q2 2026 net loss of $8.3 million, compared with $20.7 million in Q2 2025. For the first half of 2026, net loss was $20.7 million versus $50.0 million in the prior-year period.

How much cash and runway does Biomea Fusion (BMEA) have?
As of June 30, 2026, Biomea Fusion held $35.2 million in cash, cash equivalents and restricted cash. The company projects its cash runway extending into the second quarter of 2027, supporting ongoing diabetes and obesity clinical programs.

What key icovamenib clinical trials is Biomea Fusion (BMEA) running?
Biomea Fusion is enrolling two Phase II icovamenib trials in Type 2 diabetes, COVALENT-211 and COVALENT-212, with 26-week data expected in Q1 and Q2 2027. It is also planning a Phase II trial in recently diagnosed Type 1 diabetes patients.

What were Biomea Fusion (BMEA)'s R&D and G&A expenses in Q2 2026?
In Q2 2026, R&D expenses were $9.1 million, down from $16.6 million in Q2 2025, and G&A expenses were $3.6 million, down from $4.7 million. Reductions mainly reflected lower headcount, external costs, and facility-related expenses.

What Type 1 diabetes data did Biomea Fusion (BMEA) report for icovamenib?
In Type 1 diabetes patients diagnosed within 0–3 years receiving icovamenib 200 mg, Biomea Fusion observed a 52% increase in mean C-peptide AUC at Week 12 (n=3), with levels largely preserved through Week 52, showing only about a 7% decline from baseline.

What is the status of Biomea Fusion (BMEA)'s obesity program BMF-650?
Biomea Fusion is conducting GLP-131, a Phase I randomized, double-blind, placebo-controlled trial of oral GLP-1 RA BMF-650 in overweight or obese participants. The company expects initial 28-day clinical weight reduction data in the third quarter of 2026.

What new collaboration did Biomea Fusion (BMEA) announce in obesity?
Biomea Fusion announced a research collaboration with the University of Leicester to evaluate icovamenib plus semaglutide in a Phase II obesity trial. The randomized, double-blind study will assess weight, body composition and metabolic outcomes, with Week 24 as the primary endpoint.
false000184043900018404392026-08-052026-08-05

 

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): August 05, 2026

 

 

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.)

 

 

 

 

 

1599 Industrial Road

 

San Carlos, California

 

94070

(Address of principal executive offices)

 

(Zip Code)

 

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

 

 

 

Not Applicable

(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 August 5, 2026, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. 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 August 5, 2026, 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:

August 5, 2026

By:

/s/ Michael J.M. Hitchcock

 

 

 

Michael J.M. Hitchcock
Interim Chief Executive Officer, Director
(Principal Executive Officer)

 

Exhibit 99.1

 

 

Biomea Fusion Reports Second Quarter 2026 Financial Results and Corporate Highlights

 

•
Enrollment ongoing for the Phase II COVALENT-211 clinical trial in patients with insulin deficiency in Type 2 diabetes ("T2D"); data expected in the first quarter of 2027
•
Enrollment also ongoing for the Phase II COVALENT-212 clinical trial in patients with T2D not achieving glycemic targets while on glucagon-like peptide-1 receptor agonists ("GLP-1 RA")-based therapy; data expected in the second quarter of 2027
•
Phase I GLP-131 (BMF-650) obesity clinical trial on track with initial 28-day weight reduction data expected in the third quarter of 2026
•
Research collaboration initiated with the University of Leicester to evaluate icovamenib in combination with semaglutide in a Phase II clinical trial in obesity
•
Cash runway projected into the second quarter of 2027
 

SAN CARLOS, Calif., August 5, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the second quarter ended June 30, 2026, and provided a business update.

“The second quarter marked continued execution across our diabetes and obesity programs. We are near completion of enrollment in our COVALENT-211 Phase II clinical trial, continue to advance enrollment in COVALENT-212, and remain on track to report initial 28-day clinical weight reduction data from our BMF-650 Phase I clinical trial in the third quarter," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer of Biomea Fusion."The Type 1 diabetes data presented at the American Diabetes Asociation's Scientific Sessions strengthened our confidence in icovamenib's potential to preserve and improve endogenous insulin secretion, providing additional evidence that this program may have potential to address a significant unmet need. We are excited to advance the planned Phase II clinical trial in Type 1 diabetes patients and look forward to providing updates on this important program.”

Recent Corporate Highlights:

Icovamenib

Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes

•
Two Phase II clinical trials evaluating icovamenib in T2D are ongoing:
•
COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled trial in patients with insulin-deficient T2D not achieving glycemic targets despite standard of care therapy. The trial is currently enrolling patients, with 26-week primary endpoint data expected in the first quarter of 2027.
•
COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled trial in patients with T2D not achieving glycemic targets while on a GLP-1 RA-based therapy. The trial is currently enrolling patients, with 26-week primary endpoint data expected in the second quarter of 2027.
•
The Company presented 52-week follow-up data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in Type 1 diabetes ("T1D") patients at the American Diabetes Association’s ("ADA") Scientific Sessions:
•
A 52% increase from baseline in mean C-peptide AUC at Week 12 was observed in T1D patients diagnosed within 0 to 3 years who received icovamenib 200 mg (n=3). The effect

 

 

was durable, with mean C-peptide AUC largely preserved through Week 52 following completion of the 12-week dosing period (~7% decline from baseline).
•
Preservation of C-peptide also observed in T1D patients diagnosed between 3-15 years (n=9).
•
Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52.
•
Planning a Phase II clinical trial in recently diagnosed T1D patients (≤ 3 years since diagnosis), in collaboration with four U.S. academic centers, to evaluate extended dosing (6-12 months) of icovamenib 200 mg and assess potential combination with an immunosuppressive agent; trial initiation expected in the second half of the year at leading centers including the Barbara Davis Center for Diabetes, Joslin Diabetes Center, University of Texas Health Science Center at San Antonio Diabetes Division, and the University of Miami Diabetes Research Institute.
•
Announced a research collaboration with the University of Leicester to evaluate icovamenib in a Phase II clinical trial in combination with semaglutide in obesity through a newly activated experimental arm of the Open Label Adaptive Platform Trial. The randomized, double-blind study will assess physical function, body weight, body composition, muscle health and metabolic outcomes, with the primary endpoint assessed at Week 24. Enrollment is expected to begin in the third quarter of 2026.

BMF-650
Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity

•
GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing.
•
The Company expanded its Phase I BMF-650 trial to evaluate a rapid one-step titration and enhanced weight loss potential with its oral GLP-1 receptor agonist.
•
Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the third quarter of 2026.

Second Quarter 2026 Financial Results

•
Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2026, the Company had cash, cash equivalents and restricted cash of $35.2 million.
•
Net Loss: The Company reported a net loss attributable to common stockholders of $8.3 million for the three months ended June 30, 2026, which included $1.6 million of stock-based compensation, compared to a net loss of $20.7 million for the same period in 2025, which included $2.6 million of stock-based compensation. The Company reported a net loss attributable to common stockholders of $20.7 million for the six months ended June 30, 2026, which included $3.2 million of stock-based compensation, compared to a net loss of $50.0 million for the same period in 2025, which included $5.7 million of stock-based compensation.
•
Research and Development (“R&D”) Expenses: R&D expenses were $9.1 million for the three months ended June 30, 2026, compared to $16.6 million for the same period in 2025. The decrease of $7.4 million was primarily driven by a decrease of $1.5 million related to preclinical and exploratory programs, a decrease of $1.3 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.0 million of manufacturing costs, offset by an increase of $0.6 million related to clinical activities. Personnel-related expenses decreased by $2.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses

 

 

decreased by $1.7 million due to a decrease in rent and facilities-related costs. R&D expenses were $18.3 million for the six months ended June 30, 2026, compared to $39.5 million for the same period in 2025. The decrease of $21.2 million was primarily driven by a decrease of $10.7 million in external costs primarily driven by a decrease of $3.1 million related to clinical activities, a decrease of $3.4 million related to preclinical and exploratory programs, a decrease of $3.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.0 million of manufacturing costs. Personnel-related expenses decreased by $7.0 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $3.5 million due to a decrease in rent and facilities-related costs.
•
General and Administrative (“G&A”) Expenses: G&A expenses were $3.6 million for the three months ended June 30, 2026, compared to $4.7 million for the same period in 2025. The decrease of $1.1 million was primarily driven by a decrease of $0.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.1 million. G&A expenses were $7.3 million for the six months ended June 30, 2026, compared to $11.5 million for the same period in 2025. The decrease of $4.2 million was primarily driven by a decrease of $2.7 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.3 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million.

 

 

About Biomea Fusion

Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.

Visit us at biomeafusion.com and follow us on LinkedIn, X 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 expected benefits resulting from the implementation of the cost saving measures and potential ability to fund key value drivers; clinical and therapeutic potential of our product candidates and development programs, including icovamenib and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our plans to initiate a Phase II clinical trial in T1D, our Phase II COVALENT-211 clinical trial, our Phase II COVALENT-212 clinical trial and our Phase I GLP-131 clinical trial; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events; and our expected cash runway 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 preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and 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 (“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:

Meichiel Jennifer Weiss

Sr. Director of Investor Relations and Corporate Development

ir@biomeafusion.com

 

 

 

BIOMEA FUSION, INC.

Condensed Statement of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

$

9,142

 

 

$

16,566

 

 

$

18,262

 

 

$

39,463

 

General and administrative (1)

 

 

3,624

 

 

 

4,710

 

 

 

7,278

 

 

 

11,525

 

Total operating expenses

 

 

12,766

 

 

 

21,276

 

 

 

25,540

 

 

 

50,988

 

Loss from operations

 

 

(12,766

)

 

 

(21,276

)

 

 

(25,540

)

 

 

(50,988

)

Change in fair value of common warrant liability

 

 

4,119

 

 

 

227

 

 

 

3,538

 

 

 

227

 

Gain on sale of property and equipment

 

 

—

 

 

 

—

 

 

 

510

 

 

 

—

 

Interest and other income, net

 

 

319

 

 

 

309

 

 

 

749

 

 

 

759

 

Net and comprehensive loss

 

$

(8,328

)

 

$

(20,740

)

 

$

(20,743

)

 

$

(50,002

)

Net loss per common share, basic and diluted

 

$

(0.12

)

 

$

(0.51

)

 

$

(0.29

)

 

$

(1.29

)

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

 

 

72,360,235

 

 

 

40,630,403

 

 

 

72,330,005

 

 

 

38,639,834

 

 

(1) Includes stock-based compensation as follows (non-cash operating expenses):

 

Three Months Ended

 

 

Six Months Ended

 

June 30,

 

 

June 30,

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Research and development

$

779

 

 

$

1,568

 

 

$

1,563

 

 

$

3,488

 

General and administrative

 

808

 

 

 

1,005

 

 

 

1,606

 

 

 

2,254

 

Total stock-based compensation expense

$

1,587

 

 

$

2,573

 

 

$

3,169

 

 

$

5,742

 

 

 

 

BIOMEA FUSION, INC.

Condensed Balance Sheet Data

(Unaudited)

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

Cash, cash equivalents, and restricted cash

 

$

35,193

 

 

$

56,181

 

Working capital

 

$

25,576

 

 

$

46,949

 

Total assets

 

$

36,873

 

 

$

58,572

 

Stockholders' equity

 

$

12,137

 

 

$

29,552

 

 

 

Source: View Original Filing on SEC EDGAR

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