Biomea Fusion Reports Third Quarter 2026 Financial Results and Corporate Highlights

Projected cash runway extends into the second quarter of 2027, while OPAL topline data are anticipated at the end of 2027.

Rhea-AI Summary

Biomea Fusion (Nasdaq: BMEA) reported a narrower third-quarter net loss while advancing its clinical programs for diabetes and obesity. Net loss was $6.183 million, or $0.09 per share, versus $16.407 million, or $0.27 per share, a year earlier. Cash, cash equivalents and restricted cash totaled $26.772 million at September 30, 2026; the company projects runway into the second quarter of 2027.

COVALENT-211 enrollment is complete, while COVALENT-212 enrollment continues. Biomea expects Week 26 blood-sugar endpoint data in the first and second quarters of 2027, respectively. The OPAL combination study dosed its first patient, with topline data anticipated at the end of 2027. BMF-650 Phase I results showed Day 29 mean weight reductions of 1.5%–3.2% in outpatient cohorts versus 0.1% for pooled placebo. The confined cohort lost 6.1%, but confinement appeared to affect eating behavior, limiting comparison.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointQuarterly net loss narrowed to $6.183 million from $16.407 million; loss per share improved to $0.09 from $0.27.
• Moderate point. Forward-looking: it has not happened yet and may not happen.COVALENT-211 enrollment completed; Biomea expects Week 26 blood-sugar endpoint data in the first quarter of 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.COVALENT-212 enrollment continues; Biomea expects Week 26 blood-sugar endpoint data in the second quarter of 2027.
• Minor pointNine-month net loss narrowed to $26.926 million from $66.409 million; loss per share improved to $0.37 from $1.45.
• Minor pointQuarterly R&D expense fell to $8.531 million from $14.401 million a year earlier.

8 minor points

• Minor pointNine-month R&D expense fell to $26.793 million from $53.864 million a year earlier.
• Minor pointNine-month administrative expense fell to $11.710 million from $15.724 million a year earlier.
• Minor point. Forward-looking: it has not happened yet and may not happen.OPAL dosed its first patient with icovamenib plus semaglutide; topline data are anticipated at the end of 2027.
• Minor pointBMF-650 outpatient cohorts showed 1.5%–3.2% mean weight reduction at Day 29 versus 0.1% for pooled placebo.
• Minor pointBMF-650 doses of 200 mg or higher once daily produced approximately 0.97 kg mean weekly weight reduction.
• Minor pointBMF-650 confined Cohort 5 showed 6.1% (6.2 kg) mean weight reduction at Day 29.
• Minor pointBMF-650 safety results included no severe or serious treatment-emergent adverse events, related dose modifications or related discontinuations.
• Minor point. Forward-looking: it has not happened yet and may not happen.Biomea plans continued BMF-650 work while positioning the program for a potential partnership, including licensing.

Negative

• Moderate pointCash, cash equivalents and restricted cash fell to $26.772 million from $56.181 million at December 31, 2025.
• Minor pointWorking capital fell to $14.522 million at September 30, 2026, from $46.949 million at December 31, 2025.
• Minor pointStockholders' equity fell to $7.586 million at September 30, 2026, from $29.552 million at December 31, 2025.
• Minor pointTotal assets fell to $28.097 million at September 30, 2026, from $58.572 million at December 31, 2025.
• Minor pointQuarterly administrative expense rose to $4.432 million from $4.199 million a year earlier.

3 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.BMF-650 further clinical development requires longer-term toxicology studies following completion of Phase I data collection.
• Minor pointCohort 5 confinement appeared to affect eating behavior; its weight results require separate interpretation from outpatient cohorts.
• Minor pointCohort 5 nausea and vomiting each occurred in 12.5% of participants; all reported adverse events were mild.

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Key Figures

COVALENT-211 primary endpoint data: Q1 2027 COVALENT-212 primary endpoint data: Q2 2027 Mean weight reduction: 1.5% to 3.2% vs. 0.1% pooled placebo +5 more

COVALENT-211 primary endpoint data

Q1 2027

HbA1c reduction at Week 26

COVALENT-212 primary endpoint data

Q2 2027

HbA1c reduction at Week 26

Mean weight reduction

1.5% to 3.2% vs. 0.1% pooled placebo

BMF-650 outpatient Cohorts 1–4, Day 29

Mean weight reduction

6.1% (6.2 kg)

BMF-650 Cohort 5, Day 29; conducted under confinement and reported separately

Active-dose participants

40

BMF-650 five multiple ascending dose cohorts; reported adverse events were mild or moderate

Cash, cash equivalents, and restricted cash

$26.8 million

As of September 30, 2026

Net loss attributable to common stockholders

$6.2 million vs. $16.4 million

Three months ended September 30, 2026 vs. the same period in 2025

Cash runway

Into the second quarter of 2027

Projected

Previous Earnings Reports

1 past event · Latest: Aug 05

Same Type 1 event

1. Aug 05

   Q2 earnings

   24h Move

   -0.8%

   Reported $35.2 million cash, Q2 2027 runway, and both Phase II trials still enrolling.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

hba1c, glp-1 receptor agonist, multiple ascending dose, treatment-emergent adverse events

4 terms

hba1c medical

"Primary endpoint data evaluating HbA1c reduction at Week 26"

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

glp-1 receptor agonist medical

"patients with T2D not achieving glycemic targets on GLP-1 receptor agonist"

A GLP-1 receptor agonist is a medicine that mimics a natural gut hormone to trigger insulin release, slow stomach emptying, and curb appetite — like using a key to turn on a lock that controls blood sugar and hunger signals. For investors, these drugs matter because they treat common conditions such as diabetes and obesity, can drive large prescription and sales growth, reshape healthcare costs, and heavily affect drug pipelines, competition and company valuations.

multiple ascending dose medical

"across five multiple ascending dose (“MAD”) cohorts"

A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.

treatment-emergent adverse events medical

"all reported treatment-emergent adverse events (“TEAEs”) being mild or moderate"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

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

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• Completed enrollment in the Phase II COVALENT-211 clinical trial evaluating icovamenib in patients with insulin-deficient type 2 diabetes (“T2D”); topline data expected in the first quarter of 2027
• Enrollment ongoing in the Phase II COVALENT-212 clinical trial evaluating icovamenib in patients with T2D not achieving glycemic targets on GLP-1 receptor agonist (“GLP-1 RA”)-based therapy; topline data expected in the second quarter of 2027
• Announced Phase I results for BMF-650, an investigational next-generation oral GLP-1 RA, that, demonstrated weight reduction over 28 days and a generally favorable tolerability profile
• First patient dosed in the Open Label Adaptive Platform (“OPAL”) trial evaluating icovamenib in combination with semaglutide, in collaboration with the University of Leicester
  • Cash runway projected into the second quarter of 2027
    
    

SAN CARLOS, Calif., Nov. 10, 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 third quarter ended September 30, 2026, and provided a business update.

“The third quarter was marked by meaningful execution across both of our clinical programs. We completed enrollment in our first diabetes Phase II clinical trial, COVALENT-211, and continue to advance enrollment in our Phase II COVALENT-212 clinical trial, bringing us closer to important Phase II data readouts for icovamenib in two distinct diabetes populations that we estimate represent over 30% of treated patients with diabetes in the U.S.," - said Mick Hitchcock, Ph.D., Interim Chief Executive Officer of Biomea Fusion. "We also reported first-in-human results for BMF-650, providing initial clinical support for our design hypothesis, in that BMF-650 achieved meaningful weight reduction while limited GI side effects were observed, all of which were Grade 1 AEs at the highest dose level. Encouragingly, BMF-650 demonstrated weight reduction and a generally favorable tolerability profile with only one-step titration. We also made important progress with the OPAL trial, overseen by the Leicester Diabetes Centre, dosing the first patient evaluating icovamenib in combination with semaglutide. Together, we believe these accomplishments reinforce our confidence in our pipeline and position us for several important Phase II readouts in 2027.”

Recent Corporate Highlights:

Icovamenib

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

• Three Phase II clinical trials evaluating icovamenib in T2D and obesity are ongoing:
  • COVALENT-211: Completed enrollment in the Phase II, randomized, double-blind, placebo-controlled clinical trial evaluating icovamenib in patients with insulin-deficient T2D not achieving glycemic targets despite standard-of-care therapy. Primary endpoint data evaluating HbA1c reduction at Week 26 are expected in the first quarter of 2027.
  • COVALENT-212: Enrollment is ongoing in the Phase II, randomized, double-blind, placebo-controlled clinical trial evaluating icovamenib in patients with T2D not achieving glycemic targets on GLP-1 receptor agonist (“GLP-1 RA”) based therapy. Primary endpoint data evaluating HbA1c reduction at Week 26 are expected in the second quarter of 2027.
  • First patient has been dosed in the ongoing OPAL study in 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. Topline data is anticipated at the end of 2027.
    
    

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

• Announced Phase I GLP-131 clinical trial results for BMF-650, its investigational oral small molecule GLP-1 RA, that demonstrated consistent weight reduction across five multiple ascending dose (“MAD”) cohorts over four weeks and an encouraging tolerability profile, including rapid one-step titration to the 400 mg once-daily target dose.
• Across Cohorts 1-4, mean weight reduction ranged from 1.5% to 3.2% at Day 29, compared with 0.1% for pooled placebo. At doses of 200 mg or higher once daily, mean weekly weight reduction was approximately 0.97 kg.
• In Cohort 5, conducted under confinement to ensure dosing compliance and better characterize safety and tolerability, mean weight reduction was 6.1% (6.2 kg) at Day 29, averaging approximately 1.55 kg per week without observed attenuation during treatment. As confinement appeared to affect eating behavior, these results should be interpreted separately from outpatient Cohorts 1-4.
• BMF-650 was generally well tolerated across all five active-dose MAD cohorts (n=40) to date, with all reported treatment-emergent adverse events (“TEAEs”) being mild or moderate. There were no severe or serious TEAEs, TEAE-related dose modifications, or TEAE-related study discontinuations.
• In Cohort 5, rapid one-step titration from 200 mg to 400 mg once daily after one week demonstrated similar gastrointestinal tolerability to slower titration regimens. All reported TEAEs were mild, with nausea and vomiting each reported in 12.5% of Cohort 5 participants, supporting further evaluation of a potential “no titration” dosing regimen.
• Following completion of Phase I data collection, additional clinical development of BMF-650 will require longer-term toxicology studies. Biomea intends to continue this work while positioning the program for a potential strategic partnership, including licensing opportunities for late-stage development and commercialization.
  
  

Third Quarter 2026 Financial Results

• Cash, Cash Equivalents, and Restricted Cash: As of September 30, 2026, the Company had cash, cash equivalents and restricted cash of $26.8 million.
• Net Loss: The Company reported a net loss attributable to common stockholders of $6.2 million for the three months ended September 30, 2026, which included $1.6 million of stock-based compensation, compared to a net loss of $16.4 million for the same period in 2025, which included $1.9 million of stock-based compensation. The Company reported a net loss attributable to common stockholders of $26.9 million for the nine months ended September 30, 2026, which included $4.8 million of stock-based compensation, compared to a net loss of $66.4 million for the same period in 2025, which included $7.7 million of stock-based compensation.
• Research and Development (“R&D”) Expenses: R&D expenses were $8.5 million for the three months ended September 30, 2026, compared to $14.4 million for the same period in 2025. The decrease of $5.9 million was primarily driven by a decrease of $1.2 million related to nonclinical and exploratory programs, a decrease of $1.0 million of manufacturing costs, a decrease of $1.0 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $0.9 million related to clinical activities. Personnel-related expenses decreased by $1.0 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $0.9 million due to a decrease in rent and facilities-related costs. R&D expenses were $26.8 million for the nine months ended September 30, 2026, compared to $53.9 million for the same period in 2025. The decrease of $14.8 million in external costs was primarily driven by a decrease of $4.6 million related to nonclinical and exploratory programs, a decrease of $4.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, a decrease of $4.0 million related to clinical activities and a decrease of $2.0 million of manufacturing costs. Personnel-related expenses decreased by $8.0 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $4.3 million due to a decrease in rent and facilities-related costs.
• General and Administrative (“G&A”) Expenses: G&A expenses were $4.4 million for the three months ended September 30, 2026, compared to $4.2 million for the same period in 2025. The increase of $0.2 million was primarily driven by an increase of $0.6 million of corporate-related expenses, offset by a decrease of $0.4 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by less than $0.1 million. G&A expenses were $11.7 million for the nine months ended September 30, 2026, compared to $15.7 million for the same period in 2025. The decrease of $4.0 million was primarily driven by a decrease of $3.1 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.7 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 therapeutic candidates, 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, our Phase I GLP-131 clinical trial and additional toxicology studies for BMF-650; the anticipated availability of data from our clinical trials; our planned interactions with regulators, our plans to pursue a strategic partnership for BMF-650, 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 nonclinical 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 nonclinical 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								Nine Months Ended
		September 30,								September 30,
		2026				2025				2026				2025
Operating expenses:
Research and development (1)		$	8,531			$	14,401			$	26,793			$	53,864
General and administrative (1)			4,432				4,199				11,710				15,724
Impairment of long-lived assets			—				2,205				—				2,205
Total operating expenses			12,963				20,805				38,503				71,793
Loss from operations			(12,963	)			(20,805	)			(38,503	)			(71,793	)
Change in fair value of common warrant liability			6,513				3,872				10,051				4,099
Gain on sale of property and equipment			—				—				510				—
Interest and other income, net			267				526				1,016				1,285
Net and comprehensive loss		$	(6,183	)		$	(16,407	)		$	(26,926	)		$	(66,409	)
Net loss per common share, basic and diluted		$	(0.09	)		$	(0.27	)		$	(0.37	)		$	(1.45	)
Weighted-average number of common shares used to compute basic and diluted net loss per common share			72,591,786				59,848,325				72,418,224				45,787,018

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

		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2026				2025				2026				2025
Research and development		$	775			$	1,075			$	2,338			$	4,563
General and administrative			845				865				2,451				3,119
Total stock-based compensation expense		$	1,620			$	1,940			$	4,789			$	7,682

BIOMEA FUSION, INC. Condensed Balance Sheet Data (Unaudited) (in thousands)
		September 30,				December 31,
		2026				2025
Cash, cash equivalents, and restricted cash		$	26,772			$	56,181
Working capital		$	14,522			$	46,949
Total assets		$	28,097			$	58,572
Stockholders' equity		$	7,586			$	29,552

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Biomea Fusion expect icovamenib Phase II trial results?

Biomea expects COVALENT-211 data in the first quarter of 2027, COVALENT-212 data in the second quarter of 2027 and OPAL topline data at the end of 2027. COVALENT-211 and COVALENT-212 evaluate blood-sugar reduction at Week 26; OPAL assesses its primary endpoint at Week 24.

What were Biomea Fusion's third-quarter 2026 financial results?

Biomea reported a $6.183 million net loss, or $0.09 per share, compared with $16.407 million, or $0.27 per share, a year earlier. Research and development expense was $8.531 million, while general and administrative expense was $4.432 million.

What does Biomea Fusion need before further BMF-650 clinical development?

Further BMF-650 clinical development requires longer-term toxicology studies after Phase I data collection is complete. Biomea intends to continue this work while positioning the program for a potential strategic partnership, including licensing opportunities for late-stage development and commercialization.