BIOMEA FUSION, INC.


Associated tags: Patient, Fusion, Cancer, DSM-IV codes, Pharmaceutical industry, Diabetes, Osteopathic medicine in Canada, Safety, IND, Research

Locations: PK, RA, ONTARIO, VANCOUVER, REDWOOD CITY, CA, US

Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Retrieved on: 
Thursday, May 2, 2024
Patient, Glycated hemoglobin, Research and development, Insulin, Blood, Research, Diabetes, C-peptide, Trial of the century, Osteopathic medicine in Canada, A1C, Administration, Type 2 diabetes, DSM-IV codes, Diagnosis, Glucose, Quantity, Cancer, Hypoglycemia, Pharmaceutical industry

Cash position of $145.3 million at the end of the first quarter of 2024

Key Points: 
  • Cash position of $145.3 million at the end of the first quarter of 2024
    REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- 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.
  • There is currently a waitlist for the fourth cohort which we expect will open for enrollment in the second half of this year.
  • This is truly an exciting and validating update on our progress in type 1 diabetes.
  • On track to announce a third development candidate from the Biomea FUSION™ Platform technology.

Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

Retrieved on: 
Monday, April 1, 2024
Diagnosis, Health, Regeneration, Learning, Glycated hemoglobin, Menin, C-peptide, Insulin, Diabetes, AUC, Patient, Fasting, MD, Metformin, Person, Cancer, Safety, A1C, DSM-IV codes, Pharmaceutical industry

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- 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 initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, April 1, 2024
Diagnosis, Research, Week, CD135, Administration, FMS, Growth, Menin, CLL, NSCLC, C-peptide, AML, BID, Diabetes, Insulin, Patient, Hypoglycemia, FLT3, G&A, Acute myeloid leukemia, Food, PDAC, Health Canada, Trial of the century, IND, Cancer, CRC, Safety, Research and development, Investment, FDA, DLBCL, DSM-IV codes, Pharmaceutical industry

In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.

Key Points: 
  • In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.
  • Cash position of $177.2 million at the end of the fourth quarter of 2023.
  • REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year 2023 financial results and corporate highlights.
  • “2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes.

Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, April 1, 2024
Patient, Employment, Plan, Cancer, DSM-IV codes

The shares underlying each employee’s stock options will vest 1/16 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.

Key Points: 
  • The shares underlying each employee’s stock options will vest 1/16 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.

Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function

Retrieved on: 
Wednesday, March 6, 2024
Type 2 diabetes, Week, PD, Treatment, Cancer, Food, GLP1, Conference, ATTD, Biomarker, Hypoglycemia, DSM-IV codes, Area studies, Poster, C-peptide, Osteopathic medicine in Canada, Pharmaceutical industry

REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- 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 three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study (COVALENT-111), at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy from March 6-9, 2024. This clinical data from all dosing cohorts initiated to date as of February 12, 2024 from the Escalation Phase of COVALENT-111 will be featured during a Poster Discussion Presentation and two Poster Viewing Presentations at ATTD. Biomea will showcase the following three e-poster presentations:

Key Points: 
  • Please find a link here to our website where the poster presentations and discussion will be available.
  • A higher proportion of patients treated with 200mg QD achieved a clinically significant reduction in HbA1c compared to 100mg QD dosing.
  • A durable glycemic response (≥1.0% HbA1C reduction) was seen in 20% and 36% of patients in once daily 100 mg and 200 mg cohorts, respectively.
  • A PK study further assessing the optimal use of BMF-219 to ensure minimal variability of exposure is currently under way.

Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, March 1, 2024
Cancer, Plan, DSM-IV codes, Patient, Employment

The shares underlying each employee’s stock options will vest 1/16 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.

Key Points: 
  • The shares underlying each employee’s stock options will vest 1/16 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.

Biomea Fusion Highlights Recent Updates and Anticipated 2024 Corporate Milestones at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Tuesday, January 9, 2024
Diabetes, DSM-IV codes, Patient, Leukemia, CTA, PST, Research, CLL, Osteopathic medicine in Canada, Diagnosis, FLT3, NSCLC, Insulin, Cancer, IND, Conference, Safety, DLBCL, FDA, Glycated hemoglobin, PDAC, AML, CRC, Phase, Health Canada, Week, Pharmaceutical industry

Open label portion of Phase II COVALENT-112 study readout in 40 patients with type 1 diabetes expected in 2024.

Key Points: 
  • Open label portion of Phase II COVALENT-112 study readout in 40 patients with type 1 diabetes expected in 2024.
  • A live webcast of the presentation will be available on the Investors & Media page of Biomea’s website at: https://investors.biomeafusion.com/news-events/events .
  • “2023 was a truly remarkable year for Biomea as we had several positive data readouts in both type 2 diabetes and AML.
  • “We believe BMF-219 has the potential to address the root cause of diabetes and modify its progression in patients.

Biomea Fusion Announces Dosing of First Type 1 Diabetes Patient in Phase II Study (COVALENT-112) with BMF-219

Retrieved on: 
Monday, January 8, 2024
Phase, Disease, Health, Diabetes, Insulin, Trial of the century, MD, Clinical trial, DSM-IV codes, Person, Cancer, Patient, Diagnosis, Safety, Hypoglycemia, Pharmaceutical industry

The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada.

Key Points: 
  • The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada.
  • Eligible patients include those who have been diagnosed with type 1 diabetes for up to 15 years.
  • Beta cell loss is thought to be a root cause of type 1 and type 2 diabetes.
  • Preclinical studies have shown the potential of BMF-219 to specifically proliferate insulin-producing beta cells in animal models of type 1 and type 2 diabetes.

Biomea Fusion to Present at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Tuesday, January 2, 2024
PST, Conference, Patient, DSM-IV codes, Cancer

REDWOOD CITY, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (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, today announced that Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024 from 8:15 am – 8:55 am PST, and that Biomea management will hold 1x1 meetings during the conference January 8 – 11.

Key Points: 
  • REDWOOD CITY, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (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, today announced that Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024 from 8:15 am – 8:55 am PST, and that Biomea management will hold 1x1 meetings during the conference January 8 – 11.
  • A live webcast of the presentation will be available on the Investors & Media page of Biomea’s website at: https://investors.biomeafusion.com/news-events/events .

Biomea Fusion Presents Achievement of Minimal Residual Disease Negativity (MRD-neg) in First Complete Responder from Ongoing Phase I Study (COVALENT-101) of BMF-219 in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at the 2023 ASH

Retrieved on: 
Monday, December 11, 2023
CRS, CYP, NPM1, Hematopoietic stem cell transplantation, Level 4, Arm, MEN1, ITGAM, Plasma, MEIS1, Society, DS, Hydroxycarbamide, ASH, Postcholecystectomy syndrome, Mutation, Steroid, DSM-IV codes, ANPEP, Gene expression, CD14, Cancer, Poster, Toxicity, HSCT, Patient, AUC, AML, Osteopathic medicine in Canada, Pharmaceutical industry

Pharmacodynamic data from a case study of an AML patient containing NUP98-NSD1 mutation showed suppression of key leukemogenic genes (e.g.

Key Points: 
  • Pharmacodynamic data from a case study of an AML patient containing NUP98-NSD1 mutation showed suppression of key leukemogenic genes (e.g.
  • Initially, patients were enrolled agnostic to mutational status; subsequently, the study protocol was amended to enrich for patients with AML harboring menin-dependent mutations.
  • Biomea is planning to amend the dosing protocol to explore higher dosing levels in Arm B.
  • Dose escalation is to be followed by a dose optimization/expansion to determine the recommended phase 2 dose.