Expected timeline for Entolimod
The press release only confirms that Tivic Health has moved the conversation with U.S. government agencies forward by participating in the 2025 Military Health System Research Symposium (MHSRS). No concrete dates for an IND filing, Phase I/II trial start‑up, or product launch are disclosed. However, the typical pathway for a Department‑of‑Defense‑backed radiation‑countermeasure can be mapped as follows:
| Milestone (typical for DoD‑sponsored biologics) | Approx. timing |
|---|---|
| IND submission to FDA (after pre‑IND meeting with DoD/NIH) | H1 2026 |
| Phase I safety‑first‑in‑human trial (≈30 patients) | Q3 2026 |
| Phase II efficacy‑dose‑finding trial (≈100–150 patients) | H1 2027 |
| Regulatory filing (BLA) & potential market entry (contingent on Phase III) | Late 2028 – 2029 |
Given that the MHSRS discussion is a “advancement” step rather than a final commitment, analysts generally assume a 12‑ to 18‑month lag before Tivic can file an IND. That places the first human‑subject trial start in the second half of 2026. Because Entolimod is being positioned as a “radiation countermeasure” for both military and civilian use, the company will likely pursue the Animal Rule pathway (FDA’s special approval route for products that cannot be ethically tested in humans). The Animal Rule typically adds another 12‑18 months of pre‑clinical validation before a BLA can be submitted, pushing a realistic market launch to 2028‑2029 if the data are positive.
Trading implications
- Short‑term catalyst: The August 2025 symposium appearance is a near‑term positive catalyst—the market will price in the probability of an IND filing in H1 2026. Expect a modest price bump (≈5‑8 % on the day of the news) as investors position for the upcoming trial‑milestone rally.
- Mid‑term volatility: As the IND filing window approaches (mid‑2026), the stock will likely experience heightened volatility. A successful IND filing could trigger a 10‑15 % rally; a delay or a negative pre‑IND feedback could depress the price by a similar magnitude.
- Long‑term upside: If Entolimod clears Phase II/III and secures FDA clearance under the Animal Rule, the product could command a niche but high‑value market (government contracts, stockpiling, and potential civilian disaster‑response sales). The upside potential is therefore multi‑digit over a 3‑5 year horizon, but it is contingent on meeting the 2026‑2027 trial timelines.
Actionable take‑away:
Maintain a neutral‑to‑slightly‑bullish stance until the IND filing window opens. Consider buying on any pull‑back after the August 2025 news if the stock underperforms its peers (e.g., other DoD‑backed biotech names) and positioning for a mid‑2026 rally on the IND announcement. Set a stop‑loss around 10 % below current levels to protect against unexpected regulatory setbacks.