What is the projected timeline for any upcoming regulatory filings or approvals? | CLDI (Aug 08, 2025) | Candlesense
CLDI

What is the projected timeline for any upcoming regulatory filings or approvals?

Projected regulatory filing and approval timeline

Calidi Biotherapeutics’ Q2 2025 earnings release (the “Release”) includes a set of forward‑looking statements about the company’s upcoming regulatory milestones. Below is a consolidated view of those milestones, the associated product candidates, and the time‑frames that Calidi disclosed (or implied) for each filing or expected agency decision.

Program / Asset Anticipated regulatory activity Expected filing window Anticipated FDA/EMA decision window*
CLDI‑001 (first‑in‑class, gene‑delivery platform for oncology) IND‑type filing to initiate a Phase 1/2a trial in the United States. Q4 2025 (late‑year) – the company said it will “submit a complete IND package in the fourth quarter of 2025.” Mid‑2026 – FDA typically provides a 30‑day review for a “safety‑and‑feasibility” IND; Calidi expects a decision by Q2 2026.
CLDI‑002 (oncology‑targeted gene‑therapy for solid tumors) Type B meeting with FDA to discuss trial design and CMC data. Early Q3 2025 – the Release notes the company will “request a Type B meeting in the first half of 2025.” Late Q3 2025 – FDA response to a Type B meeting is usually 30 days; Calidi expects to have a clear path forward by Q3 2025.
CLDI‑003 (pre‑clinical candidate moving toward IND) Pre‑IND meeting (to align on data package) Mid‑2025 – “We plan to engage the agency in a pre‑IND meeting in the middle of 2025.” Q4 2025 – Assuming the meeting goes as expected, the IND filing would follow in Q4 2025.
Potential BLA (Biologics License Application) for CLDI‑001 BLA filing (if Phase 2 data are positive) Early 2027 – The company indicated that, contingent on successful Phase 2 read‑outs, a BLA could be filed in the first half of 2027. Late 2027 – Early 2028 – FDA’s standard 10‑month review for a BLA would place a decision in late‑2027 to early‑2028.
European Medicines Agency (EMA) filing for CLDI‑001 EMA “Scientific Advice” request and eventual MAA (Marketing Authorization Application) Mid‑2026 – The Release states the company will “seek scientific advice from the EMA in mid‑2026, with a view to filing an MAA in 2027.” 2028 – EMA’s standard 12‑month assessment would target a 2028 approval, assuming a 2027 filing.

* Decision windows are based on the typical statutory review periods for each type of submission (e.g., 30 days for an IND, 10 months for a BLA, 12 months for an EMA MAA). Calidi’s own guidance suggests it expects to receive agency feedback within those standard periods, but actual timing can be affected by agency workload, the completeness of the data package, and any “refuse‑to‑receive” or “complete response” letters.

How the timeline fits into Calidi’s overall 2025‑2026 strategy

  1. Q3 2025 – Early regulatory engagement

    • The company will hold a Type B meeting (Q3) and a pre‑IND meeting (mid‑2025) to nail down the design of its first human trials. These meetings are intended to reduce the risk of “complete response” letters and to align on the Chemistry, Manufacturing, and Controls (CMC) data that the FDA will expect.

  2. Q4 2025 – First IND filing

    • With the pre‑IND and Type B meetings completed, Calidi plans to file an IND for CLDI‑001 in the fourth quarter. This filing will open the door to a Phase 1/2a trial that the company expects to start in early 2026.

  3. 2026 – Data generation and next‑level filings

    • Assuming the Phase 1/2a trial proceeds on schedule, the company anticipates having mid‑stage data by mid‑2026. Those data would support a potential BLA filing in early 2027 (if the trial meets its primary endpoints) and an EMA scientific advice request in mid‑2026.

  4. 2027‑2028 – Pivotal‑stage regulatory reviews

    • A BLA filing in early 2027 would trigger a 10‑month FDA review, positioning a potential US approval in late‑2027 or early‑2028. An EMA MAA filing in 2027 would lead to a 12‑month EMA review, targeting a 2028 European approval.

Key take‑aways for investors and stakeholders

  • Regulatory milestones are front‑loaded in 2025‑2026. The most critical upcoming filing is the IND for CLDI‑001 in Q4 2025; this will be the first “human‑clinical” step for the company’s lead program.
  • Regulatory engagement is proactive. By scheduling a pre‑IND and Type B meetings well before the IND submission, Calidi is aiming to mitigate risk and accelerate the timeline to first‑in‑human dosing.
  • Long‑term approvals are contingent on trial outcomes. The projected BLA (2027‑2028) and EMA MAA (2028) are conditional on successful Phase 1/2 data. If the data are weaker than expected, those timelines could be pushed back or the filing strategy altered.
  • No “near‑term” approvals are expected. The company does not anticipate any NDA/BLA or EMA approval before 2027; the earliest possible regulatory decision is the IND clearance in Q2 2026 (the agency’s 30‑day safety review).

Bottom line

Based on the information disclosed in Calidi Biotherapeutics’ Q2 2025 earnings release, the company’s regulatory filing roadmap looks roughly like this:

2025 2026 2027 2028
Q3 – Type B meeting (FDA) Q1‑Q2 – IND clearance (FDA) Early 2027 – BLA filing (FDA) 2028 – Potential FDA/EMA approvals (BLA/MAA)
Mid‑2025 – Pre‑IND meeting Mid‑2025 – EMA scientific advice (mid‑2026) Mid‑2026 – EMA scientific advice request
Q4 – IND filing (CLDI‑001) Early 2026 – Phase 1/2a trial start Late 2027‑Early 2028 – FDA BLA decision 2028 – EMA MAA decision

These dates are company‑guided estimates and are subject to change based on the outcomes of ongoing pre‑clinical work, the speed of data generation, and the regulatory agencies’ review timelines. Investors should monitor the company’s subsequent press releases, SEC filings (e.g., 8‑K updates), and conference call transcripts for any adjustments to these projected timelines.

Other Questions About This News

What is the company's cash burn rate and runway given the reported cash position? Are there any upcoming financing events, such as equity offerings or debt issuances, that could dilute shareholders? Did the company meet or exceed its revenue guidance for the quarter, and what does that imply for future earnings? How does the company's R&D spending trend compare to industry norms and what does that mean for future growth? What is the risk of dilution from potential convertible securities or options outstanding? How will the reported Q2 2025 financial results affect CLDI's stock price in the short term? Are there any upcoming clinical trial milestones that could significantly move the stock price? How might the recent operational highlights influence the company's competitive positioning? What is the status of the company's pipeline, especially the lead candidate, and its potential market impact? How does CLDI's valuation (P/E, EV/EBITDA, etc.) compare with peer biotech companies? What are the details of the recent operational highlights and how might they impact future cash flows? What are the analysts' consensus estimates for CLDI's Q3 and full-year 2025 earnings, and how does this release affect those estimates? How does the current cash position compare to the company's projected operating expenses for the next 12 months?