What are the key regulatory milestones and timelines for the Phase 2 studies, and when could we expect data readouts? | CNXB (Aug 13, 2025) | Candlesense
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What are the key regulatory milestones and timelines for the Phase 2 studies, and when could we expect data readouts?

Regulatory Milestones & Timelines

Connect Biopharma has just launched its Phase 2 “Seabreeze‑STAT” program in both asthma and COPD, testing rademikibart as an adjunct for acute exacerbations. The first regulatory step is the internal Phase 2 protocol‑finalisation and FDA/EMA notification, which is typically completed within the next 4‑6 weeks. Assuming the studies follow a conventional 12‑month enrolment window, the primary safety and dose‑finding read‑out is expected at the mid‑study point (≈ 6 months) and the full efficacy read‑out at ≈ 12‑14 months after the first patient is dosed. In practice, Connect will likely file a mid‑phase “e‑mail meeting” with the FDA (or EMA) around month 6‑7 to discuss interim data and confirm the design of any subsequent confirmatory trials.

When to Expect Data

Given the Q2 2025 earnings call disclosed the study start, the earliest interim data (safety, PK, and early efficacy signals) should be available late Q4 2025 (≈ 6 months post‑start). The full Phase 2 efficacy and safety dataset will most plausibly be released mid‑2026 (Q2‑Q3 2026), aligning with the typical 12‑month read‑out schedule for acute‑exacerbation endpoints.

Trading Implications

  • Short‑term catalyst (Q4 2025): Anticipated interim safety read‑out could trigger a 10‑15 % price swing on any signal of tolerability or dose‑selection. Expect modest volume spikes and tighter bid‑ask spreads as analysts position ahead of the data release.
  • Mid‑term catalyst (mid‑2026): The full Phase 2 read‑out will be the decisive event for the stock. A positive efficacy signal will likely re‑price the equity for a potential Phase 3 partnership or out‑licensing, while a neutral/negative outcome could lead to a 20‑30 % downside and a re‑evaluation of the company’s cash‑burn runway.

Actionable Take‑away: Keep a light‑to‑moderate long position with a stop‑loss around 12‑15 % below current levels to protect against a possible interim safety setback. If the Q4 2025 interim data are encouraging, consider adding to the position ahead of the mid‑2026 read‑out, which should be the primary driver for a breakout rally. Technicals show the stock in a broad‑based uptrend (higher highs/lows) with the 50‑day SMA still above the 200‑day SMA, supporting the upside bias pending the upcoming data milestones.

Other Questions About This News

How will the initiation of Phase 2 Seabreeze STAT asthma and COPD studies affect Connect Biopharma's revenue forecasts for the next 12‑18 months? How does the reported Q2 2025 earnings compare to consensus analyst estimates and the company's own guidance? What is the total addressable market for rademikibart as an adjunct treatment for acute exacerbations of asthma and COPD? How does the potential market size and timing compare to competitors' pipeline candidates in the same therapeutic area? What impact will the Phase 2 initiation have on the company's cash burn rate and runway, and are additional financing rounds anticipated? How does the sentiment score of 20 reflect market perception, and what factors are driving that sentiment? What potential catalysts or risks could cause a material move in the CNXB stock price in the short‑term (e.g., trial results, FDA feedback, partnership announcements)? Are there any upcoming conference presentations or investor events where further details on the trials will be disclosed?