Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. (Nasdaq: BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on June 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 25,000 shares of the Company's common stock. The shares underlying the employee's stock options will vest 116 on a quarterly basis over four years, subject to the employee's continued employment with the Company on such vesting dates.

The above-described award was made pursuant to the terms of Biomea's 2023 Inducement Equity Plan (the "Plan") and was granted as an inducement material to the employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The Plan was adopted by Biomea's board of directors on November 17, 2023.

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 with various cancers and metabolic diseases, including diabetes. 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 .


Contact: Investor Relations Chunyi Zhao, PhD Associate Director of Investor Relations & Corporate Development czhao@biomeafusion.com

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Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

Biomea Fusion, Inc. ("Biomea" or the "Company") (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea's ongoing Phase III clinical trials of the Company's investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. The Company will continue ongoing safety and efficacy data collection during the hold.

"We respect the FDA's decision and agree that patient safety is paramount and our top priority. We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA. The results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control. Based on the totality of the safety and efficacy data for BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile," stated Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board.

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Biomea Fusion Announces Completion of Enrollment of First 3 Arms in Phase 2 Expansion Cohorts of COVALENT-111 Study for BMF-219 in Type 2 Diabetes

Biomea Fusion Announces Completion of Enrollment of First 3 Arms in Phase 2 Expansion Cohorts of COVALENT-111 Study for BMF-219 in Type 2 Diabetes

Biomea Fusion, Inc. ("Biomea") (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, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260 type 2 diabetes patients enrolled.

The COVALENT-111 study is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. Phase II consists of multiple dose escalation and dose expansion cohorts including adult patients with type 2 diabetes uncontrolled by standard of care medicines. The dose escalation phase is evaluating BMF-219 dosed over 4 weeks with 22 weeks follow-up off treatment. The first three arms (A, B, C) of the expansion phase are evaluating BMF-219 dosed over 8 and 12 weeks at 100 mg and 200 mg with up to 40 weeks of follow-up off treatment.

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Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

  • Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells
  • Announced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219
  • We expect a reduction in operating expenses in the second half of the year due to the near completion of enrollment of the first three arms of our type 2 diabetes study and near completion of enrollment of the open label portion of our type 1 diabetes study. Cash position of $145.3 million at the end of the first quarter of 2024

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."

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Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

  • Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells
  • Announced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219
  • We expect a reduction in operating expenses in the second half of the year due to the near completion of enrollment of the first three arms of our type 2 diabetes study and near completion of enrollment of the open label portion of our type 1 diabetes study. Cash position of $145.3 million at the end of the first quarter of 2024

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."

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Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

  • Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells
  • Announced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219
  • We expect a reduction in operating expenses in the second half of the year due to the near completion of enrollment of the first three arms of our type 2 diabetes study and near completion of enrollment of the open label portion of our type 1 diabetes study. Cash position of $145.3 million at the end of the first quarter of 2024

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."

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World Copper Identifies New Opportunity at Zonia Copper Project in Arizona

World Copper Identifies New Opportunity at Zonia Copper Project in Arizona

World Copper Ltd. (TSXV: WCU) (OTCQB: WCUFF) (FSE: 7LY0)  ("World Copper" or the "Company") provides an update on its Zonia copper-oxide project in Arizona, USA ("Zonia" or the Zonia Project").

A review of historical data by World Copper's newly formed Technical Advisory Committee has revealed the potential for re-processing mineralized material that was included in the historical mine plan at the Zonia Project. This material, located on heap leach pads from historical production on private patented land, and last processed in the mid-1970s, was treated with acid to recover soluble copper. Two historical reports, a 1979 mine production summary report by McAlester Fuel Company ("McAlester") and a 1982 resource evaluation report by Mountain States Research & Development ("MSRD"), indicate that the site hosts over 14 million tons of historically mined material available for re-processing:

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Noble Minerals Initiates Temporarily Delayed Drill Program in proximity to the Location of a 140 kg, Mineralized Boulder Found near Hearst, Ontario

Noble Minerals Initiates Temporarily Delayed Drill Program in proximity to the Location of a 140 kg, Mineralized Boulder Found near Hearst, Ontario

(TheNewswire)

Noble Mineral Exploration Inc.

Toronto, Ontario TheNewswire - July 2, 2024 Noble Mineral Exploration Inc. ( "Noble" or the "Company" ) (TSX-V:NOB, FRANKFURT: NB7, OTCQB:NLPXF) is pleased to announce that after a delay due to inclement weather, Noble is now ready to initiate their drill program.  Extreme hot, dry weather in mid June gave way to thunderstorms and in some cases tornadoes.  Noble was concerned with potential forest fire risk and the health and welfare of their workers.  With the coming of more stable weather in July, the company is now ready to start the drill program.

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Noble Minerals Initiates Temporarily Delayed Drill Program in proximity to the Location of a 140 kg, Mineralized Boulder Found near Hearst, Ontario.

Noble Minerals Initiates Temporarily Delayed Drill Program in proximity to the Location of a 140 kg, Mineralized Boulder Found near Hearst, Ontario.

(TheNewswire)

Noble Mineral Exploration Inc.

Toronto, Ontario TheNewswire - July 2, 2024 Noble Mineral Exploration Inc. ( "Noble" or the "Company" ) (TSX-V:NOB, FRANKFURT: NB7, OTCQB:NLPXF) is pleased to announce that after a delay due to inclement weather, Noble is now ready to initiate their drill program.  Extreme hot, dry weather in mid June gave way to thunderstorms and in some cases tornadoes.  Noble was concerned with potential forest fire risk and the health and welfare of their workers.  With the coming of more stable weather in July, the company is now ready to start the drill program.

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Aston Bay and American West Metals Confirm New Zone of Thick, Near-Surface, High-Grade Copper at Storm Copper Project, Canada

Aston Bay and American West Metals Confirm New Zone of Thick, Near-Surface, High-Grade Copper at Storm Copper Project, Canada

Grades of more than 7% copper in recent drilling of The Gap; planned 20,000m summer drilling program underway

  • Drill hole SR24-03 at the underexplored Gap prospect has intersected:

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Falco Announces Resignation of Board Member

Falco Announces Resignation of Board Member

Falco Resources Ltd. (TSX-V: FPC) ( "Falco" or the " Corporation" ) announced today that Mr. Claude Dufresne has resigned as a member of the Board of Directors so that he may focus his efforts on other professional duties.

The Board of Directors would like to thank Mr. Dufresne for his contribution over the past few years and wish him well in his future endeavors.

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Bold Options Claims in Ring of Fire Region

Bold Options Claims in Ring of Fire Region

Bold Ventures Inc. (TSXV:BOL) (the "Company" or "Bold") is pleased to announce that it has signed an option agreement (the "Agreement") to option a 100% interest in two claim groups (the "Optioned Claims") to an arms-length party (the "Optionee"). The claims are located in the Ring of Fire Region. The Optioned Claims were staked during a regional airborne Electromagnetic and Magnetic survey flown in 2013 for Bold Ventures and its co-Venturer, a subsidiary of Dundee Resources. The survey resulted in over 14 claim groups being staked at various times over two campaigns. The Optioned Claims have a combined area of approximately 2,595 acres (1,050 hectares) and comprise approximately 90 claim units. The Optioned Claims have seen very little exploration work in the past

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