Zinger Key Points
- Firmonertinib targets NSCLC with EGFR mutations, a ~$700 million market opportunity.
- B. Riley expects 50%-100% upside on Phase 3 success.
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B. Riley Securities initiated coverage on Wednesday on ArriVent Biopharma, Inc. AVBP, a clinical-stage biopharmaceutical focused on developing cancer treatment.
The company’s lead drug candidate, firmonertinib is currently being studied in a global FURVENT Phase 3 trial for first-line non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations and in a global Phase 1b study, which includes a cohort evaluating firmonertinib in patients with epidermal growth factor receptor (EGFR) P-loop and alpha-c helix compressing (PACC) mutations.
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In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations.
In September 2024, ArriVent presented interim Phase 1b data for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations. The data demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile.
The B. Riley analyst writes firmonertinib is designed to tackle NSCLC with EGFR exon 20 insertion (ex20ins) and PACC mutation — a market that accounts for ~4% of all NSCLC cases.
Analyst Kalpit Patel estimates firmonertinib could serve as a superior treatment in the potential ~$700 million/year market for ex20ins NSCLC with three key advantages, namely oral administration, brain penetration and better tolerability.
With a Phase 3 clinical catalyst expected this year for ex20ins NSCLC, B. Riley sees the potential for 50%–100% upside ahead if the pivotal study replicates prior data.
The analyst initiated with a Buy rating and a price target of $37.
“While investors are likely focused on ex20ins NSCLC near term, we believe expansion into PACC mutations represents a significantly undervalued opportunity, as these account for ~12% of all EGFR mutations,” the analyst writes.
Analyst Patel adds that although ~40% of mutations are adequately treated with Boehringer Ingelheim’s Gilotrif (afatinib), the other 60% use chemotherapy, which offers limited clinical benefit.
B. Riley writes that firmonertinib is currently the only EGFR TKI with demonstrated activity across a broad spectrum of PACC mutations, including frequent and rare subtypes.
“We believe firmonertinib is well positioned against competing EGFR inhibitors in both ex20ins and PACC NSCLC,” B. Riley notes.
The company ended 2024 with cash and cash equivalents of $266.5 million.
AVBP Price Action: ArriVent Biopharma stock is up 0.56% at $19.71 at publication Thursday.
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