secwatch.observer — SEC 8-K summary
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Issuer:     Biomea Fusion, Inc. (BMEA)
CIK:        0001840439
Form:       8-K
Filed at:   2022-11-07T23:59:59+00:00
Accession:  0000950170-22-022598
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Biomea Fusion Q3 net loss $22.9M, cash $133.8M; advances BMF-219 into KRAS solid tumors and T2D
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- Net loss $22.9M in Q3 2022 ($12.6M in Q3 2021); cash & investments $133.8M vs $175.7M year-end 2021.
- BMF-219 Phase I COVALENT-101 enrolling four liquid tumor cohorts; Cohort I at Dose Level 3, no DLTs; initial data H1 2023.
- COVALENT-102 (Phase I/Ib) initiated for KRAS-mutated solid tumors (NSCLC, CRC, PDAC) under FDA clearance Oct 2022.
- COVALENT-111 (Phase I/II) dosed first type 2 diabetes patient; healthy volunteer portion completed with no safety signals.
- Expect IND submissions for BMF-500 (FLT3 inhibitor) and BMF-219 in T2D in H1 2023 and year-end 2022, respectively.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1840439/000095017022022598/0000950170-22-022598-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1840439/000095017022022598/bmea-20221107.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-022598

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer