Twin Vee Powercats, Inc. Q2 FY2026 earnings call

• Lanafibinor Mechanism and Differentiation: Lanafibinor is a novel PPAR pan-agonist (alpha, delta, gamma) designed to address both hepatic (fibrosis, inflammation, steatosis) and extra-hepatic (metabolic) drivers of MASH. It features partial PPAR gamma agonism, aiming to reduce side effects like weight gain and edema compared to full agonists like pioglitazone.
• Native Phase IIb Data: The Phase IIb study showed robust histological improvements after six months: 18% placebo-adjusted improvement in fibrosis, 26% MASH resolution, and 24% composite endpoint improvement. Efficacy was observed across early (F1) and later stage (F2/F3) disease, including in patients with type 2 diabetes.
• Safety Profile: Adverse events were generally mild-to-moderate. Weight gain was biphasic (early fluid retention, later adipose remodeling) and attenuated compared to full TZDs. Edema prevalence was lower than pioglitazone (~2% drug-related vs. ~20-25%). These effects are understood and manageable, potentially via SGLT2 inhibitors.
• Native Phase III Trial Progress: The pivotal Native 3 trial is fully recruited with ~1,400 patients (1,009 in the main F2/F3 cohort, 410 in an exploratory cohort). The last patient completed the 72-week visit earlier in the month. Top-line results are expected in Q4 2026.
• Regulatory and Commercial Strategy: If Native 3 data is positive, Inventiva aims for accelerated approval from the FDA in H1 2027 and conditional approval from the EMA. A commercial organization is being built for a potential US launch in 2028.
• Future Development: An outcomes trial is planned to evaluate lanafibinor in patients with compensated advanced chronic liver disease (CACLD) due to MASH, targeting those with clinically significant portal hypertension.

Inventiva is a clinical-stage biopharmaceutical company with a single product candidate, lanafibinor. Therefore, the entire financial performance relates to this single segment.

• R&D Expenses: €46.2 million in H1 2026, consistent with the prior year, reflecting continued clinical development of lanafibinor for MASH.
• Marketing and Business Development Expenses: €2.6 million in H1 2026, an increase from prior periods as the company prepares for potential commercial launch.
• G&A Expenses: €22.2 million in H1 2026, an increase due to organizational growth and capital structure optimization activities.
• Cash Position: As of June 30, 2026, the company held €233.9 million in combined cash, cash equivalents, and short-term deposits.

• Top-Line Data Readout: Management expects to report top-line results from the Native 3 Phase III trial in the fourth quarter of 2026.
• Regulatory Filing: Subject to positive Phase III results, the company targets submitting a New Drug Application (NDA) to the FDA in the first half of 2027.
• Cash Runway: Current resources provide cash runway until the end of Q2 2027. Assuming full exercise of tranche three warrants and successful completion of tranche C debt financing following positive data, the runway extends to the start of Q1 2028.
• No Specific Guidance on Efficacy/Safety Magnitudes: Management explicitly declined to guide on specific efficacy endpoints (e.g., fibrosis % improvement) or tolerability metrics (e.g., weight gain magnitude) from the upcoming top-line readout, stating it is too early to speculate.
• Launch Timeline: Potential commercial launch in the US is targeted for 2028.

• Clinical Trial Failure Risk: The success of lanafibinor depends on achieving statistical significance in the primary composite endpoint of the Native 3 trial. Failure could delay or prevent regulatory approval.
• Side Effects and Tolerability: Potential adverse events include weight gain, edema, and hemoglobin decline. While managed differently than full TZDs, these could impact patient adherence or physician prescribing if not adequately mitigated.
• Regulatory Uncertainty: Approval is contingent on positive Phase III data and subsequent regulatory interactions with the FDA and EMA. Accelerated approval pathways carry the requirement for confirmatory trials.
• Market Competition and Adoption: The MASH market is evolving with increasing diagnosis rates and competition. Physician acceptance may depend on demonstrating clear differentiation in efficacy and safety compared to existing or emerging therapies.
• Financial Dependency: The company’s cash runway is heavily dependent on achieving positive Phase III results to unlock additional financing tranches (warrants and debt). Negative results could severely limit financial resources.

Q: Analyst asked about the commercial strategy if both doses in Native 3 show benefit, and the correlation between biomarkers (like NITs/liver stiffness) and histology. / A: CEO stated that if both doses are statistically significant, both could be brought to market depending on efficacy/tolerability trade-offs (e.g., one for earlier stage, one for urgent cases). CMO explained that biomarkers like ProC3 tracked well with histology, but liver stiffness (TE) changes were modest (~10%) at 6 months due to early fluid retention from PPAR gamma engagement, which he expects to resolve by 18 months as fibrosis improvement dominates.

Q: Analyst asked about blinded Phase III data on weight gain/edema and whether these are impediments to treatment durability. / A: CMO shared that in Phase II, ~50% of patients had no weight gain (>±5%), and only ~10% of adverse event reports related to weight gain, indicating it is not a major tolerability concern. CEO added that edema is mechanistically understood, mild-to-moderate, and less prevalent than with pioglitazone; it can be managed with SGLT2 inhibitors or diuretics, and does not drive discontinuation.

Q: Analyst asked about the higher proportion of F3 patients in Native 3 vs. Native 2 and the impact of GLP-1 drop-ins (9%) on trial outcomes. / A: CEO noted that removing F1 patients from analysis improved response rates, giving confidence in the F2/F3 focus. CMO added that F3 biology is similar to F2, lanafibinor has direct anti-fibrotic action independent of metabolic changes, and the 18-month duration allows time for fibrosis resolution. Regarding GLP-1s, drop-ins were on non-MASH doses, so no histological impact is expected; pre-specified sensitivity analyses will rule out confounding effects.

Q: Analyst asked about the design of the confirmatory outcomes trial for CACLD and patient selection criteria. / A: CMO outlined that the trial will target patients with clinically significant portal hypertension, identified via non-invasive methods (liver stiffness, platelets). He highlighted that the Native 3 exploratory cohort includes 75-100 cirrhotic patients exposed to lanafibinor for up to 4 years, providing safety/pharmacology data. Phase I studies in hepatic impairment also support safety in Child-Pugh B/C patients, informing the trial design.

Q: Analyst asked about biopsy completion rates and why previous interim blinded weight gain data shouldn't be used as a reference for final Phase III results. / A: CEO confirmed dropout rates are comfortably below the 30% threshold used for powering. CMO explained that using blinded data from >1,000 patients is fraught with interpretation errors and is not guided upon. He clarified that the 'plateau' in weight gain is due to partial gamma agonism (reducing long-term sodium channel activation) and alpha/delta agonism improving glucose utilization, preventing further storage.