On November 7, 2022 Biomea Fusion, Inc. (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, reported third quarter 2022 financial results and business highlights (Press release, Biomea Fusion, NOV 7, 2022, View Source [SID1234623337]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We continue to solidify Biomea’s position as the leader in next-generation covalent medicines, and build near- and long-term value, through our rapid progress and strong execution. With BMF-219, we have now brought the first covalent menin inhibitor to the clinic for KRAS-mutated solid tumors, adding to our already robust development strategy of BMF-219 in distinct patient subsets of multiple liquid tumors. In addition, we are very excited to announce the first type 2 diabetes patient dosed with BMF-219, which marks the first non-oncology indication for which an investigational menin inhibitor is being evaluated in the clinic," said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. "Over the coming quarters, we expect to gain valuable feedback and believe we will achieve clinical proof of concept for BMF-219 in multiple indications. We also continue to advance our second IND candidate, BMF-500, an investigational covalent FLT3 inhibitor with best-in-class potential, toward the clinic. BMF-500 further demonstrates the versatility enabled by our proprietary FUSION System to discover and validate novel covalent product candidates."
Third Quarter 2022 and Recent Pipeline Highlights
Oncology
COVALENT-101
Continued site activation and patient enrollment across four liquid tumor cohorts including patients with AML/ALL (including those with MLL rearrangement and NPM1 mutation), DLBCL, MM and CLL
Cohort I (AML/ALL with MLL-r or NPM1) is enrolling patients in the escalation phase currently at Dosing Level #3. No DLTs observed, enrollment is proceeding on track for near term expansion and initial data in the first half of 2023
Cohort IV (CLL) achieved its first patient enrolled in October 2022
COVALENT-102
Received FDA clearance in October 2022 and initiated a Phase I/Ib clinical trial of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with any (pan) KRAS mutation
Preclinical
Presented abstract "Anti-tumor activity of covalent menin inhibitor, BMF-219, in High-Grade B-Cell Lymphoma and Multiple Myeloma Preclinical Models" at the 2022 International Myeloma Society (IMS) Annual Meeting in Los Angeles, CA
Announced abstract "BMF-500: An Orally Bioavailable Covalent Inhibitor of FLT3 with High Selectivity and Potent Antileukemic Activity in FLT3-Mutated AML" to be presented at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, LA
Diabetes
COVALENT-111
Initiated COVALENT-111 a multi-site, double-blind, randomized, placebo-controlled Phase I/II study of BMF-219 following clearance of CTA by Health Canada; alignment has been reached with the FDA on the contents of the IND filing
Completed the healthy volunteer portion in Phase I/II (COVALENT-111) study of BMF-219 currently ongoing in Canada. No safety signals were detected
Dosed first type 2 diabetes patient in Phase I/II (COVALENT-111) study of BMF-219 currently ongoing in Canada
Preclinical
Presented two oral abstracts, "Oral Menin Inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a Type 2 Diabetes Rat Model" and "Oral Long-Acting Menin Inhibitor, BMF-219, Normalizes Type 2 Diabetes Mellitus in Two Rat Models" at the 2022 European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden
New preclinical data from two in-vivo models at EASD demonstrated BMF-219’s ability to improve pancreatic beta cell mass and function, and BMF-219’s robust and prolonged glycemic control, insulin sensitization, and reduction of weight and lipid levels
Outlook
Submit IND for BMF-219 in type 2 diabetes patients before the end of 2022
Present clinical update of AML/ALL patients (including those with MLL rearrangement and NPM1 mutation), dosed in COVALENT-101 study in the first half of 2023
Present clinical update on type 2 diabetes patients in the first half of 2023
Submit IND for BMF-500 in patients with FLT3 mutations in the first half of 2023
Present clinical update of the healthy volunteer section of our Phase I/II type 2 diabetes COVALENT-111 study of BMF-219 at a scientific meeting in 2023
Expect to provide an update leveraging the proprietary FUSIONTM System, a discovery and design platform to expand pipeline of covalent medicines for cancer to a third development candidate in the first half of 2023
Third Quarter 2022 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Investments: As of September 30, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $133.8 million, compared to $175.7 million as of December 31, 2021.
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $22.9 million for the three months ended September 30, 2022, compared to a net loss of $12.6 million for the same period in 2021. Net loss attributable to common stockholders was $56.5 million for the nine months ended September 30, 2022, compared to a net loss of $26.9 million for the same period in 2021.
Research and Development (R&D) Expenses: R&D expenses were $18.2 million for the three months ended September 30, 2022, compared to $7.9 million for the same period in 2021. The increase of $10.4 million was primarily due to an increase in preclinical and clinical development costs as well as an increase in personnel-related expenses. R&D expenses were $42.2 million for the nine months ended September 30, 2022, compared to $16.9 million for the same period in 2021. The increase of $25.3 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
General and Administrative (G&A) Expenses: G&A expenses were $5.2 million for the three months ended September 30, 2022, compared to $4.8 million for the same period in 2021. The increase of $0.5 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company. G&A expenses were $15.2 million for the nine months ended September 30, 2022, compared to $10.0 million for the same period in 2021. The increase of $5.2 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.