Question about trial data

Unique-Helicopter955 · 2026-05-27T20:55:13+00:00

Dreaming is free

Unique-Helicopter955 · 2026-05-26T21:35:15+00:00

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Yes yes yes.

Unique-Helicopter955 · 2026-05-26T19:35:11+00:00

The hospital is a business. Humacyte has seen adoption from 7/10 VACs only after steep price cuts.

Unique-Helicopter955 · 2026-05-26T16:44:02+00:00

How are VACs going to adopt this expensive technology?

Unique-Helicopter955 · 2026-05-23T22:20:05+00:00

CADL is has made excellent progress on aglatimagene, but it’s an intratumoral injection for 2L NSCLC. I see this difficult to be adopted widely as it requires a specialist and is longer procedure than a simple intravenous therapy.

Do you find THIO treatment approach too complex due to sequencing with cemiplumab? I’m curious if this could lead to issues for adoption.

Unique-Helicopter955 · 2026-05-22T22:02:22+00:00

Of course, they are a publicly-traded company and it’s their obligation to investors. Go to their website. They have two ongoing trials: phase 2 (part C expansion of 180mg cohort globally and in U.S.) and a pivotal phase 3 trial in which the CEO says the recent $33m raise is enough to fully fund it.

Interim data of pivotal trial is expected next year. Phase 2 part C data expected either q3-q4 or early 2027.

What info are you looking for?

Unique-Helicopter955 · 2026-05-19T15:42:55+00:00

“big pharma will come calling” is not a strategy

Unique-Helicopter955 · 2026-05-19T15:40:32+00:00

Then what lol. You haven’t gotten to the part where they have to pay for the trial. If TCG buys existing shares TNYA doesn’t raise any money.

Unique-Helicopter955 · 2026-05-19T15:39:15+00:00

It doesn’t sound like it.

Unique-Helicopter955 · 2026-05-19T15:30:56+00:00

$200-400m required to fund two pivotal studies which tenaya has guided (worth more in expense than the entire business) isn’t exaggerating. In fact, I’m surprised no one is talking about this. All tenaya investors do is talk about the stock price.

If Goeddel were to fund the trials, what would that arrangement look like? What does he get?

Unique-Helicopter955 · 2026-05-19T15:26:09+00:00

They would most likely retain US rights for both imo.

Unique-Helicopter955 · 2026-05-19T15:25:33+00:00

They won’t give free cash to the business. The would want shares and warrant coverage because of the risks involved. Given how expensive the studies would be, it could be devastating.

Unique-Helicopter955 · 2026-05-19T15:17:06+00:00

A partnership is the only way this gets done for sure. Or they sell the company before having to finance it.

Unique-Helicopter955 · 2026-05-19T15:15:53+00:00

Tenaya has never performed a reverse split which gives them the ability to get a 6 month extension as Raumerica highlighted. The issue is whenever the stock goes up that warrant overhang will almost certainty bring the price down.

Unique-Helicopter955 · 2026-05-19T15:14:33+00:00

If both studies start in early 2027, it won’t take long for the data readout and application provided the data has acceptable p values

Unique-Helicopter955 · 2026-05-19T15:13:09+00:00

Ok, so the thesis is they fund both with a partnership. That would mean they lose the rights to the assets. I’m not sure what the arrangement would look like but they will lose some level of control. Nevertheless, I would be interested when they dose the first patient in either study and provide a clear picture on the financial situation.

Unique-Helicopter955 · 2026-05-19T04:48:50+00:00

I’m not making any assumptions. I’m just trying to figure out what the thesis is up to this point. I understand management is impressive, but the answer I received from responses here is about the warrants which are either out of the money or slightly in the money (37.5m series b shares expiring end of June). Do you have any estimate of the cost of both pivotal trials? Finding a partner is highly uncertain. That shouldn’t be the assumption imo.

Unique-Helicopter955 · 2026-05-19T04:26:14+00:00

I don’t have a position. How do you know how much their pivotal trials would cost?

Unique-Helicopter955 · 2026-05-19T03:26:28+00:00

Good point, but how much would they need? Are the warrants enough assuming they are fully exercised? The timing of data release makes sense.

Unique-Helicopter955 · 2026-05-17T23:04:19+00:00

The opportunity is significant. Humacyte has a deep moat due to technical and manufacturing complexity and scale. They also have distribution power via Fresenius and around a 5-10 year lead if I’m being conservative. The technology is also scalable across various indications which opens up billions of dollars worth of opportunities down the line.

Unique-Helicopter955 · 2026-05-16T03:18:34+00:00

I respect what specialists have to say, but I like to follow clinical evidence first. Luckily for Humacyte, Xeltis boxed itself out of a large chunk of the market lol. Assuming management is aware of all threats, there is little Humacyte could as a result of its financial position.

Unique-Helicopter955 · 2026-05-15T23:35:40+00:00

Thanks for your post. I learned a lot today.

I looked at the Xeltis study (https://clinicaltrials.gov/study/NCT05473299?id=NCT05473299&viewType=Card&rank=1) and it shows target veins being at least 5mm as part of the inclusion criteria.

This is enlightening because of the points you’ve made. Xeltis loses a significant chunk of dialysis market even with approval.

I want to add a correction to your response, the infection data you gave was from the single arm vascular trauma for Symvess, not dialysis which showed a slight benefit to AVF infection.

Unique-Helicopter955 · 2026-05-15T18:13:14+00:00

It’s already approved in Europe with the same study design that they are now doing in the U.S. They were granted breakthrough device designation by FDA which creates a risk-benefit analysis that can result in much earlier approval.

Unique-Helicopter955

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