Aligos Therapeutics, Inc.

Who we are and what we do

• Clinical-stage biotechnology company developing therapeutics for liver diseases and viral infections.
• Target indications:
  • Chronic hepatitis B virus (HBV) infection
  • Metabolic dysfunction-associated steatohepatitis (MASH) and obesity
  • Coronavirus infections (SARS-CoV-2, SARS-CoV-1, MERS-CoV, and related viruses)
• Capabilities include small molecules and oligonucleotides with end-to-end drug discovery, preclinical and clinical development, in-house CMC (chemistry, manufacturing and controls) and partnerships with CDMOs.
• Current status: all assets are pre-commercial.

Pipeline at a glance

• pevifoscorvir sodium (formerly ALG-000184)
  • Mechanism: capsid assembly modulator (CAM-E) for chronic HBV infection.
  • Stage: Phase 2 (B-SUPREME; NCT06963710) comparing pevifoscorvir sodium monotherapy to tenofovir disoproxil fumarate (TDF) for 48 weeks in about 200 adults with chronic HBV.
  • Endpoints: HBV DNA suppression (<LLOQ) as primary endpoint (different definitions for HBeAg+ vs HBeAg- cohorts); multiple HBV biomarkers (HBV DNA, HBV antigens, HBV RNA).
  • Interim/topline timing: first interim analysis in 1H 2026 (≈60% of HBeAg- participants completed 12 weeks); topline data expected in 2027.
  • Background: Prior Phase 1 data showed substantial HBV DNA and RNA reductions and HBsAg reductions; the program is being developed as a potential replacement for standard-of-care NA therapy and as a component of combination cure regimens.
• ALG-055009
  • Mechanism: THR-β agonist for MASH and obesity; designed for liver-targeted, liver-selective activity.
  • Stage: Phase 2a (HERALD) in presumed MASH patients; additional dose-ranging and safety PK work in Phase 1.
  • Key Phase 2a result: met the primary endpoint with reductions in liver fat by MRI-PDFF at Week 12 that were supported by statistical analysis; dose groups 0.5–0.9 mg showed pronounced liver-fat reductions; up to 46.2% relative reductions vs placebo; up to 70% of subjects achieved ≥30% relative liver-fat reduction at Week 12.
  • Additional findings: dose-dependent improvements in atherogenic lipids (reductions in LDL-C, Lp(a), apoB) and increases in sex hormone binding globulin; preclinical data indicate potential synergy with GLP-1 incretin therapies in obesity models.
  • Status: Pre-commercial; evaluating options to fund continued development, including potential out-licensing.
• ALG-097558
  • Mechanism: small-molecule pan-coronavirus protease inhibitor (ritonavir-free).
  • Stage: Phase 1 completed (single doses up to 2000 mg; multiple dosing up to 800 mg Q12H for 7 days); Phase 2 underway in standard and high-risk COVID-19 patients (AGILE trial, NCT04746183; sponsored by University of Liverpool/MRC/Wellcome Trust).
  • Key findings: Phase 1 demonstrated acceptable PK without a ritonavir-boosting requirement; no clinically meaningful drug-drug interaction with midazolam.
  • Funding/support: NIH/NIAID AViDD program and contract funds; IND filed Q3 2024; anticipated NIH support of about $15.3 million across awards/contracts.
  • Status: pursuing Phase 2 COVID-19 studies and ongoing nonclinical activities; funded in part by NIH/AViDD programs.
• Additional programs
  • Antisense oligonucleotide (ASO) programs for chronic HBV and hepatitis delta under collaboration with KU Leuven and other IP.
  • Discovery efforts include small molecules, peptidomimetics (3C-like protease programs with KU Leuven/CD3 collaborations), and broader oligonucleotide platforms (GalNAc targeting, BNA chemistries).

Platform and capabilities

• Small molecule capabilities: CAM-Es and THR-β agonists with emphasis on potency, PK, and targeted tissue effects; in-house structure-guided design, computational chemistry, and crystallography.
• Prodrug strategy: pevifoscorvir sodium is the prodrug of ALG-001075 (active CAM-E parent).
• Oligonucleotide platform: siRNAs and ASOs with specialized chemistries (GalNAc, bridged nucleic acids) for liver targeting and improved PK.
• Collaboration-driven IP and discovery partnerships support antiviral protease and oligonucleotide programs.

Intellectual property and licenses

• Owned IP (as of 12/31/2025)
  • Drug candidates with U.S. and international patent coverage:
    • pevifoscorvir sodium (HBV CAM-E): 2 issued U.S. patents; 2 non-provisional U.S. applications; 38 total foreign applications; U.S. patents 11,191,747 and 11,771,680 expire April 2040; related families expire 2040–2045 (subject to extensions/adjustments).
    • ALG-055009 (THR-β agonist): 2 issued U.S. patents; 3 U.S. non-provisional applications; 4 U.S. provisional applications; 2 PCTs; 18 issued foreign applications and 21 foreign applications; U.S. patents 11,091,467 and 12,180,192 expire May 2040; related patents expire 2040–2045.
    • ALG-097558 (pan-coronavirus PI): 2 issued U.S. patents; 1 non-provisional U.S. application; 26 foreign applications; U.S. patents 11,851,422 and 12,252,481 expire 2042; related patents expire 2042 (subject to extensions/adjustments).
  • Discovery-stage patent families cover HBV, MASH/obesity, and coronavirus targets with expiration windows in the 2040–2045 range.
• Licensed IP
  • Emory University (CAM-E): exclusive rights in the HBV CAM-E field (Emory retains certain non-commercial rights); milestone and royalty structure; aggregate potential milestone payments up to $125.0 million plus ongoing patent costs; first milestone paid in 2025.
  • KU Leuven: collaboration for coronavirus protease inhibitors; exclusive worldwide license for antiviral products; potential milestones up to $30.0 million on commercial sales milestones and up to $32.0 million in development/regulatory milestones per licensed product; low-to-mid-single-digit royalties; possible sharing of upfront consideration if partnered.
• Term and economics: licenses expire with the last-to-expire patent term or related royalty terms; royalties are low-to-mid-single-digit and scaled by milestones; company intends to pursue patent term extensions where applicable.

Manufacturing and operations

• Modalities: small molecules and oligonucleotide therapeutics (siRNA/ASO).
• Internal capabilities: in-house CMC, process development, analytical development, quality, and supply chain management.
• External partners: CDMOs for larger-scale production beyond early clinical needs; CROs engaged for many nonclinical and clinical activities with the company maintaining regulatory responsibility and oversight.

Commercialization status

• All assets are pre-commercial.
• No established sales and marketing organization beyond senior management; plans include building a specialty sales/marketing and distribution capability or partnering for commercialization in select markets.
• Strategy: pursue independent development in select indications/markets while exploring out-licensing and collaborations to scale development and potential commercialization.

People and corporate footprint

• Employees: 82 full-time as of December 31, 2025 (64 in research and development).
• Headquarters: One Corporate Dr., 2nd Floor, South San Francisco, CA.
• Public market actions: November 2024 shelf registration statement (up to $400 million of securities); private placements raised $92.1 million (Oct 2023) and $105.0 million (Feb 2025).

Financial position (highlights)

• Revenue: No product sales revenue to date; company is pre-commercial.
• Net income (loss): 2025 net loss of $24.2 million; 2024 net loss of $131.2 million.
• Cash and liquidity: cash, cash equivalents and short-term investments of $77.8 million as of 12/31/2025.
• Funding runway and going concern: company expects existing resources to fund operations into the third quarter of 2026. The auditors’ 2025 report includes an explanatory paragraph expressing substantial doubt about the company’s ability to continue as a going concern.
• Cash burn drivers: nonclinical and clinical development, manufacturing scale-up, regulatory filings, potential milestone payments under Emory/KU Leuven licenses, and potential commercialization preparations.

Summary takeaway

• Aligos is a clinical-stage biotech focused on liver disease and viral infections with three lead programs: HBV CAM-E pevifoscorvir sodium; THR-β agonist ALG-055009 for MASH/obesity; and pan-coronavirus protease inhibitor ALG-097558, plus preclinical and ASO efforts.
• The company holds substantial owned and licensed IP, including obligations to Emory and KU Leuven.
• Aligos is pre-revenue and advancing multiple Phase 2 programs while relying on external funding; it reported net losses and a going-concern explanatory paragraph but has cash runway into 2026 supported by recent capital raises.
• Manufacturing and development combine in-house capabilities with CDMOs and CROs for execution and scale-up.