Avanti Biosciences, Inc.
June 22, 2026
Theater 4
Type: Company Presentation
Focus Area:
Respiratory
Avanti Biosciences is a San Diego-based biotechnology company developing ABI-171, a first-in-class multi-kinase inhibitor for idiopathic pulmonary fibrosis (IPF). Unlike approved therapies that only slow disease progression, ABI-171 is the only treatment to demonstrate complete functional restoration to healthy baseline levels across seven independent endpoints (77-86% recovery vs. 30-65% with standard of care). With FDA Orphan Drug Designation, IND-ready status, and $7M+ in non-dilutive NIH funding, including NHLBI Catalyze Program support, Avanti has completed comprehensive GLP toxicology studies showing exceptional safety (therapeutic index >70, zero drug-related adverse events). Led by CEO Dr. Gian Luca Araldi and supported by world-class advisors, including IPF expert Dr. Ganesh Raghu, Avanti is advancing a novel mechanism (DYRK1A/B and PIM1 inhibition) validated by human proof-of-concept data showing rapid biomarker reversal in just 14 days.
Company HQ City:
San Diego
Company HQ State:
California
Company HQ Country:
United States
Year Founded:
2009
Lead Product in Development:
ABI-171 - First-in-class oral multi-kinase inhibitor (DYRK1A/B and PIM1) for Idiopathic Pulmonary Fibrosis (IPF)
Development Stage: IND-ready; Pre-IND meeting March 5, 2026; Phase 1 start Q4 2026
Indication: Idiopathic Pulmonary Fibrosis (primary); Platform expansion into MASH/liver fibrosis and SSc-ILD
Mechanism: Dual inhibition of DYRK1A/B and PIM1 kinases, converging on TGF-β pathway suppression
Differentiation: Only therapy achieving complete functional restoration to a healthy baseline (77-86% recovery vs. 30-65% for approved drugs) across 7 independent endpoints in head-to-head preclinical studies
Key Milestones Achieved:
-FDA Orphan Drug Designation (7-year exclusivity)
-IND 180251 opened
-GLP toxicology complete: Therapeutic index >70, zero drug-related adverse events
-Human proof-of-concept: Natural analog EGCG demonstrated biomarker reversal in 14 days (NEJM 2020); ABI-171 is 4-16× more potent
IP Position: 2 PCT patents (WO 2023/288020 & WO 2025/264484) with protection through 2046
CEO
Gian Luca Araldi
Development Phase of Lead Product
Pre-Clinical
Number of Unlicensed Products Looking for Licensing
1 primary asset with platform expansion potential
ABI-171 for Idiopathic Pulmonary Fibrosis (IPF) - primary indication, fully unlicensed and available for partnership across all geographies and development stages.
Platform Expansion Opportunities:
MASH-associated liver fibrosis (preclinical validation ongoing)
Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
Other fibrotic indications (renal, cardiac, dermal fibrosis)
The multi-kinase inhibition mechanism (DYRK1A/B + PIM1) targeting TGF-β pathway convergence positions ABI-171 as a platform technology applicable across multiple organ fibrosis indications, offering partners flexibility for indication-specific licensing or comprehensive platform acquisition.
When you expect your next catalyst update?
March 2026 - FDA Pre-IND written responses (confirmed date: March 5, 2026)
Follow-on catalysts:
Q2 2026: Convertible note round closure target
Q3 2026: IND submission
Q4 2026: Phase 1 trial initiation (first patient dosed)
Q4 2027: Phase 1 data readout (safety, PK/PD, biomarkers)
The March 2026 FDA meeting represents the immediate near-term value inflection point that will inform all subsequent development and partnership strategy.
What is your next catalyst (value inflection) update?
Immediate Catalyst - FDA Pre-IND Written Responses (March 5, 2026):
FDA feedback on Phase 1 trial design, biomarker strategy, and regulatory pathway will validate the development approach and potentially unlock partnership discussions.
Near-Term Catalysts (2026):
IND submission (Q3 2026): Formal regulatory filing demonstrating clinical readiness
Phase 1 trial initiation (Q4 2026): First-in-human dosing represents a major de-risking milestone
Convertible note round closure (Q1-Q2 2026): $4-5M raise validates commercial interest and funds clinical operations
Medium-Term Catalyst (2027):
Phase 1 safety and PK/PD data (End 2027): Human proof-of-concept with safety, tolerability, and biomarker engagement data will significantly increase valuation and attract strategic pharma partnerships
Each milestone progressively de-risks the asset and positions Avanti for higher-value partnership terms or Series A financing.
Primary Speaker
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