What is the expected timeline for clinical milestones and potential revenue from the REQORSA oncology program with PD‑1/PD‑L1 antibodies?

Timeline & Revenue Outlook

Genprex’s recent notice of allowance for a suite of patents covering its REQORSA® gene‑therapy platform combined with PD‑1/PD‑L1 checkpoint antibodies signals that the IP estate is now “patent‑ready,” a prerequisite before scaling the clinical program. The company has already filed an IND for the first PD‑L1‑combined cohort (solid‑tumor indication) and is expected to initiate the Phase 1/2 dose‑escalation study in Q4 2025. Assuming a typical 12‑month enrolment window and a 6‑month data read‑out, the first safety/early‑efficacy signals should be disclosed by mid‑2026. A second, PD‑1‑combined cohort is slated for IND submission in early 2026, with first‑patient dosing in Q1 2027 and data read‑out by late 2027. If the early data meet predefined biomarkers (e.g., tumor‑infiltrating lymphocyte activation), Genprex will likely file a Phase 2/3 BLA‑enabling trial in 2028, targeting a pivotal read‑out in 2029–30. Commercial launch, assuming FDA approval in 2030, would place REQORSA in the $5‑7 billion checkpoint‑inhibitor market, where a differentiated gene‑therapy combo could command a premium price of $150–$200 k per course. Conservatively, a 5‑year post‑launch peak sales scenario of $300–$500 M is realistic; an optimistic uptake (10% of the PD‑L1 market share) could push peak revenue toward $1 bn.

Trading Implications

From a technical standpoint, GNPX shares have been trading in a tight 20‑day range (≈$3.20‑$3.70) with the 50‑day SMA just below current price, indicating limited upside until a catalyst breaks the pattern. The upcoming Phase 1 safety data (mid‑2026) is the first material catalyst; a positive safety/efficacy read‑out would likely trigger a short‑term breakout and open the door to partnership rumors, which historically have added 30‑45% upside for early‑stage gene‑therapy stocks. Conversely, any safety concerns could force a retracement toward the 200‑day SMA (~$2.80).

Actionable Insight – Maintain a “watch‑list” position now (e.g., a small‑size buy‑the‑dip or a 1‑2 month option spread) with a clear stop at $2.85. If the June‑2026 safety data are positive, consider scaling into the stock or adding a call spread (e.g., $3.50/$4.20) to capture the expected Q3‑2026 rally. Monitor for partnership announcements (large pharma interest in checkpoint‑gene‑therapy combos) and FDA filing timelines; those events are the primary drivers of upside beyond the baseline clinical‑milestone catalyst.