New Risk • May 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 3.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 3.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$106m net loss in 3 years). Market cap is less than US$100m (US$74.3m market cap). Announcement • May 03
Pliant Therapeutics Announces First Patient Dosed in Fortify Phase 1B Indication Expansion Trial Evaluating Pln-101095 in Patients with Ici-Refractory Solid Tumors Pliant Therapeutics announced the dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion clinical trial of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of the integrins avß8 and avß1. The primary objective of this trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of PLN-101095 when administered orally in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors. The expansion trial is enrolling three cohorts of patients with NSCLC, clear cell renal cell carcinoma, or one of a subset of tumors with high tumor mutational burden. Patients will be treated for 14 days with PLN-101095 as monotherapy dosed at 1,000 mg twice daily, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027. PLN-101095 is an oral, small molecule inhibitor of integrins avß8 and avß1. Activated transforming growth factor-ß (TGF-ß) has been shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer. Blocking integrins avß8 and avß1 has been shown to prevent the activation of TGF-ß and is expected to stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment. PLN-101095 is currently being evaluated in Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT 06270706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone. In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration. Announcement • Apr 24
Pliant Therapeutics, Inc., Annual General Meeting, Jun 11, 2026 Pliant Therapeutics, Inc., Annual General Meeting, Jun 11, 2026. 
