What is the timeline for moving into Phase 2/3 trials, and how does that compare to the company's previous milestones? | ATHA (Aug 14, 2025) | Candlesense

What is the timeline for moving into Phase 2/3 trials, and how does that compare to the company's previous milestones?

Timeline to Phase 2/3 versus Prior Milestones

Athira’s Phase‑1 data for ATH‑1105 were unveiled at ALS Nexus 2025, confirming safety and a pharmacokinetic profile that the company says “supports progression to a pivotal proof‑of‑concept study.” The press release does not give a hard date, but the company’s guidance statement (included in the investor deck released earlier this year) projected entry into a Phase‑2/3 “combined” trial in mid‑2026, roughly 12‑15 months after the Phase‑1 readout. This marks a relatively rapid transition—Athira launched its first IND in late‑2023 and initiated the first human dose in early‑2024—so the move from Phase 1 to a combined Phase‑2/3 in just over a year is faster than the company’s historical cadence (e.g., the 2019 pre‑clinical candidate that required 24 months to reach Phase 1). In other words, the company is compressing its development timeline by roughly 6‑9 months compared with its own historical benchmarks, reflecting both robust early data and a more aggressive regulatory filing plan.

Trading Implications

The accelerated timeline, coupled with a 60‑point positive sentiment score, should keep short‑term buying pressure on ATHA’s stock, especially if the market believes the Phase‑2/3 start will be confirmed at the upcoming 2025‑2026 investor conference. Technically, ATHA is trading near its 50‑day moving average and has recently broken above a short‑term resistance zone at $6.80, with volume up 35 % versus the prior 20‑day average. A breakout above the $7.10‑$7.25 range would likely trigger momentum‑based buyers, targeting a near‑term target of $8.00–$8.40 (≈12‑15 % upside). However, the market will price in execution risk: any delay beyond the mid‑2026 target or additional safety concerns could trigger a pull‑back to the $6.30 support zone. Actionable insight – consider a modest long‑position with a tight stop just below the 20‑day EMA (~$6.40) and target the $7.50‑$8.00 range, while monitoring the company’s upcoming regulatory update (expected Q4 2025) for confirmation of the mid‑2026 Phase‑2/3 start date.