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

Biomea Fusion, Inc. Reports Inducement Grants 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 May 1, 2024, the compensation committee of Biomea's board of directors granted 8 new employees non-qualified stock options to purchase an aggregate of 80,250 shares of the Company's common stock. The shares underlying each employee's stock options will vest 116 on a quarterly basis over four years, in each case subject to each such employee's continued employment with the Company on such vesting dates. All of the above-described awards were made under Biomea's 2023 Inducement Equity Plan (the "Plan").

 

The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. 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
 

  Primary Logo 

 

News Provided by GlobeNewswire via QuoteMedia

BMEA:US
The Conversation (0)
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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
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."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Vertex Minerals Limited  Reward Gold Mine Project Update

Vertex Minerals Limited Reward Gold Mine Project Update

Perth, Australia (ABN Newswire) - Vertex Minerals Limited (ASX:VTX,VTXXF) (OTCMKTS:VTXXF) is pleased to announce that the underground mining operation is on track to be producing high grade gold feed to the recently commissioned gravity gold plant in the coming weeks.

HIGHLIGHTS:

- Operational Milestones

o VTX remains firmly on track to commence production of high-grade ore from the underground mine in the forthcoming weeks.

o Transformer and cabling for the installation of 11kV high voltage underground power system on site with installation commenced.

o Preparations for the underground mine startup up progressing as planned and stripping of the main access is completed.

o New Aramine L350D has departed France for the journey to Hill End. Arrival in Orange NSW expected in by 26th August where it will be fitted with an RCT remote control system for open stoping operations.

o Mining the Reward Gold Mine - Resource 225kozs at 16.7g/t (VTX ASX Announcement 21 June 2023).

o Weekly Gold production Oz's from Stockpiles improving with depth in the stockpiles, with coarser particle size and better process throughput experienced.

- Mine start up

o Fan chambers have been excavated to provide secondary ventilation for production activities, exploration drilling and the future southern access toward the Fosters' exploration target.

o Primary ventilation fan has been installed and bulkhead completed.

o High voltage surface substation has been installed.

o High voltage cabling installation commences next week, with power up of the system scheduled for 28 July 2025.

o Stripping of the main accessis completed with the final elements of ground support (approx. 30m) to be completed before power cable installation starts next week.

o Cable bolts installed for the intersection of Lady Belmore exploration drive with first cut drilled out and ready to charge.

o Development Jumbo #1 (Epiroc T1D) is exceeding performance expectations.

o Dewatered of declines well underway.

o Mine schedule for FY26 finalised.

o First airleg stope secondary vent installed and specialty equipment on site to start first air leg stope.

o First long hole stope planned for August. High grade from airleg and longhole stopes to complement larger tonnage from development ore headings.

- People that have been onboarded

o 2x Drill Fitters and Heavy diesel fitter.

o Process superintendent commences next week.

o Full Tech team started including mine surveyor this week.

o Have back-to-back airleg miners for stoping.

o Full underground and mill crews.

- Improvements to plant

o DSM screen installed to improve product delivery to Wilfley Table.

o Gemini table improvements with new tabletop and gearbox improving final concentrate grade to over 20% gold (suitable for direct smelting to Dore on site).

o Process water pump upgrade improving ore washing and Tomra performance.

- Revised mine plan and schedule completed and ready to implement

- Updated Reward Gold mine mining plan and mine schedule completed.

- Adding a high-grade long hole stope upfront to be mined concurrently with the high grade airleg stope.

Vertex Director Declan Franzmann commented: "It is great to see all the elements of re-developing the underground mine and processing facility coming together so rapidly. The most pleasing aspect is our success in employing an incredible team of people to run the operation and all credit to management for developing great "esprit de corps" and a single sense of purpose as we push to full production."

As previously announced, the startup mine schedule includes mining 2,075 tonnes at 17.8 g/t Au from a developed airleg stope block. The planned stope width is the same as the interpretation of the mineralisation. (Refer to Table 1 in Appendices 1) (VTX ASX announcement 26/06/23).

Given this stope will take some time to extract, the Vertex geology and Mining Team have additionally brought forward a very high-grade long hole stope to commence mining in August as well. Further optimisations to the mining schedule will continue to be made.

This stope can be exploited as soon as services have been established. The mining crews have done a great job in the access drive to make room for the services (11kV cable, water and air lines) while improving accessibility for the mobile mining equipment selected for the Project.

*To view tables and figures, please visit:
https://abnnewswire.net/lnk/OUQP5Z21

 

About Vertex Minerals Limited:  

Vertex Minerals Limited (ASX:VTX,VTXXF) is an Australian based gold exploration company developing its advanced Hargraves and Hill End gold projects located in the highly prospective Eastern Lachlan Fold Belt of Central West NSW. Other Company assets include the Pride of Elvire gold project and Taylors Rock gold/nickel/lithium project both located in the Eastern Goldfields of WA. The focus of Vertex Minerals is to advance the commercial production of gold from its NSW projects embracing an ethical and environmentally sustainable approach.

 

 

Source:
Vertex Minerals Limited

News Provided by ABN Newswire via QuoteMedia

Keep reading...Show less
Juggernaut Closes $1,100,000 from Institutions and Accredited Investors

Juggernaut Closes $1,100,000 from Institutions and Accredited Investors

 

(TheNewswire)

 
        
  Juggernaut Exploration Ltd. 
                   
 

Vancouver, British Columbia July 8, 2025 TheNewswire - Juggernaut Exploration Ltd. (TSX-V: JUGR) (OTCQB: JUGRF) (FSE: 4JE) (the "Company" or "Juggernaut"), further to its June 4, June 12, and June 16, 2025, news releases, the Company is pleased to announce that it has closed its private placement financing (the "Financing") for aggregate gross proceeds of $1,100,000.

News Provided by TheNewsWire via QuoteMedia

Keep reading...Show less
Noble Reports on Canada Nickel's Continued Exploration Success at MacDiarmid, Provides Exploration Update

Noble Reports on Canada Nickel's Continued Exploration Success at MacDiarmid, Provides Exploration Update

 

(TheNewswire)

 
       
  Noble Mineral Exploration Inc. 
                
 

  Highlights  

News Provided by TheNewsWire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×