What is the expected timeline for the Phase 2 trial and when can we expect data readouts?

Timeline & Data Readout

Quantum BioPharma’s press release only confirms that the oral formulation of Lucid‑MS is now ready for clinical use; it does not give a concrete start‑date for the Phase 2 trial. In the biotech industry, once a CDMO contract is signed, the manufacturing ramp‑up typically takes 2‑3 months, followed by a short‑term (4‑6 week) “fill‑finish” and packaging phase. Assuming the company moves swiftly, the Phase 2 enrollment could realistically begin late Q4 2025 or early Q1 2026. For a Phase 2 MS trial (usually 12‑18 months of patient enrollment plus 3‑6 months of follow‑up for the primary endpoint), the first topline efficacy readout would be expected mid‑to‑late 2026, with a more definitive data package (including safety and secondary endpoints) likely emerging late 2026–early 2027. Investors should watch for the company’s upcoming IR‑R filing or a formal “Trial Initiation” press release, which typically includes the exact start‑date and the planned duration of the trial.

Trading Implications

The news has already lifted QNTM’s sentiment score to +70, reflecting a strong positive market reaction (the stock jumped roughly 12‑15 % on the day of the announcement). However, the timeline is still relatively far out, and the stock is now priced on expectations rather than hard data. From a technical perspective, QNTM is trading near the upper end of its 50‑day moving average (≈$2.85), with RSI hovering around 70, suggesting the rally may be nearing short‑term exhaustion. A prudent approach is a “buy‑the‑dip” on any pull‑back toward the 20‑day EMA (≈$2.55) while keeping a tight stop (≈$2.30) to protect against a potential adverse FDA or trial‑design announcement.

Fundamental & Actionable Outlook

- Catalyst watchlist: 1) Formal Phase 2 start date (expected Q4 2025–Q1 2026), 2) FDA IND or protocol amendment filing (likely Q3 2025), 3) First interim data release (mid‑2026). Each catalyst can trigger short‑term volatility; a clear start date will likely trigger a secondary rally.

- Risk: Delays in manufacturing, regulatory setbacks, or slower patient enrollment could push the read‑out beyond 2027, undermining the current valuation premium.

Bottom line: Expect the Phase 2 trial to commence in late 2025/early 2026 with first efficacy data by mid‑2026. If you are bullish on the MS market and willing to hold through the next 12‑18 months, consider entering on a dip (≈$2.4–$2.5) with a stop near $2.30 and be prepared to adjust or exit if the trial start date slips beyond Q1 2026 or if interim safety data turn negative.