Tim DraperFounder and Managing Partne, Draper Associate · I back the ideas that look crazy first

Tolka AI Therapeutics is paving the way for a smarter approach to medicine. 🧪

3 Apr 2025 · 2 min

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2:01

In this multi‑speaker discussion, the team outlines Tolka AI Therapeutics' regulatory approach for its phage‑based therapy. They have secured FDA approval to treat a patient named Johan under an expanded‑access program and plan to treat an additional 5–10 patients similarly while gathering data to support future pivotal trials. Timeline expectations range from a minimum of four to five years for expedited pathways, up to ten years, which aligns with the average development time for new antibiotics. Funding needs are tied to these long horizons, and investors are cautioned about the extended risk period before potential payoff. The company relies heavily on Dr. Bob, an experienced MD from Adaptive Phage Therapeutics, for medical and regulatory expertise, supplemented by consultant Bolad. The founder shares a personal motivation—17 years of dealing with the underlying problem and a physician spouse—driving the urgency to commercialize the technology, lower costs, and achieve FDA approval quickly.

Chapters

How do you do the regulatory perspective with respect to clinical trials and approvals, you know?
I think that is completely fair. You know, regulatory pathway is such an important part of biotech. It would be strange if people were not concerned about it.
So we already got approval to treat Johan with the FDA, and these early conversations will help us pave the way to future clinical trial approvals in the next few years. But before that, we'll treat 5 to 10 more patients under the same expanded access program.
You said a few years. Walk me through the exact timeline that you're expecting, and how does this funding help you? It sounds like there might be risk in that timeline. It can be very long. You might need more capital. It is a long timeline. What are we talking about, 10 years, 20 years?
Many investors, they have a different time horizon. Biotech really is, you wait a very long time, and then if you succeed, you get a massive payday.
10 years is the average for an antibiotic.
We are going to target patients that basically don't have a lot of other options. So we are going to ask for expedited— essentially every way to expedite the process we can. But we're still looking at 4 or 5 years at the very least from now.
Do either of you have an MD?
So that would be Bob. Bob is the MD. Bob has a tremendous amount of experience because he was at Adaptive Phage Therapeutics in the past. They've really pioneered a lot of these phage technologies.
So there's a high reliance on Bob, and I'm sure he's phenomenal in terms of providing that medical expertise, but also the regulatory expertise. But that's one person.
Well, we also have Bolad on our side and consultants.
How did you hear about this?
Well, obviously I've had the problem myself for 17 years. My wife is a physician. 2.5, 3 years ago, we read all the papers that had recently come out. This was the most promising technology. People were not making progress on commercializing it quickly enough. So somebody really needs to bring down the cost, increase the speed, and actually get proper FDA approval.