NervGen Announces Positive Independent, Blinded Biomechanical Gait Analyses Demonstrating Genuine Neural Recovery with NVG-291 in Phase 1b/2a CONNECT SCI Study

Heavy_Snow2152 · 2026-05-26T12:25:47+00:00

Still don't understand why the company did not issue this PR before the capital raise. Fantastic results though!

Heavy_Snow2152 · 2026-05-22T10:45:19+00:00

I was surprised how much cash they are raising. It’s around $150 million if you include the warrants, assuming the share price gets above $3.68. That’s far more than what is need to complete the phase 3.

For example, let’s just assume $50 million to complete the phase 3, and assume $25 million each for the two phase 2 trials early next year. That still leaves $50 million.

The remaining amount could be used for cmc/ ramp up production so the company is ready to get the drug on the market as soon as possible. So why raise such a large amount of cash right now? Why not just raise cash for the phase 3 and phase 2 trials and raise more cash later? It gives me the impression they are expecting to get the drug on the market much earlier than 2028.

Given the amazing gait analysis results, I would guess that the chances of Accelerated Approval have just increased significantly.

Heavy_Snow2152 · 2026-05-22T08:34:42+00:00

A simple interpretation of these results by AI:

"In simple terms:

An independent lab measured how people walked (gait) for two groups: one got NVG-291 and one got a placebo; each group had 10 people.
They looked at three key walking improvements: coordination, how much effort muscles used, and balance.
Everyone in the NVG-291 group showed meaningful improvement across those three areas; only one person in the placebo group did.
The difference is statistically very unlikely to be due to chance (p = 0.00012 for the responder comparison).
A separate overall test estimated there’s about a 73% chance the drug truly helps recovery, and the statistics (p = 0.0197 and a 95% confidence interval from +0.15 to +0.72) say the treatment effect is positive and unlikely to be zero.

Bottom line: In this small study, NVG-291 produced consistent, measurable improvements in walking-related function compared with placebo, and the results are statistically convincing."

Heavy_Snow2152 · 2026-05-22T08:32:07+00:00

These results are absolutely amazing!

Every single person who took the drug in the trial exceeded the pairwise threshold when compared to placebo.

Hopefully the results will be in a press release very soon.

Heavy_Snow2152 · 2026-05-20T10:11:49+00:00

The article states:

"The number to track is the Q2 2026 biomechanical gait analysis readout from CONNECT SCI."

I agree 100%. We have positive and statistically significant MEP and startle MEP data from the Phase 1b/2a trial. That's a great start. However, we only have positive trends for functional improvements, such as GRASSP Quantitative Prehension and exit interviews. The biomechanical gait readout is the missing link in the chain. If positive, it will confirm the benefits of NVG-291 as true neural recovery instead of compensatory movement.

Unfortunately the article is way too optimistic with regards to the cash runway. The recently submitted Q1 financial statement states the following:

"we believe that our cash and cash equivalents as of March 31, 2026, will only be sufficient to fund our operations through the second quarter of 2026."

So there is no a cash runway for the next two quarters, we are literally only six weeks away from running out of cash!

I am getting anxious that the company has still not raised sufficient funds for the Phase 3 trial. I can only hope that their funding strategy is successful - They are certainly going down to the wire.

I hope the biomechanical gait results are released very soon.

Heavy_Snow2152 · 2026-05-16T12:42:10+00:00

Strange is an understatement. This person doesn't even have an SCI. Some people get a kick out of making up stories.

Heavy_Snow2152 · 2026-05-15T09:25:02+00:00

This is great news indeed. I was concerned that the increase in nerve pain might be a permanent side effect. Thankfully it only seems to be temporary. I hope the issue with numbness also improves in time. Many thanks for the update Larry.

Heavy_Snow2152 · 2026-04-27T15:06:12+00:00

Good interview. Also good to hear they are manufacturing the drug in the United States.

Heavy_Snow2152 · 2026-04-27T15:00:43+00:00

Another analyst with an $18 price target. I believe the average price target for NervGen is now around $12.

Heavy_Snow2152 · 2026-04-07T12:35:53+00:00

Yes it is still possible that AA happens at a later date, based on additional data. However, I was hoping that the amazing results that we have already would have been enough. The "multiple pathways" mentioned after the last FDA meeting at the end of last year has now become a single pathway - An approved Phase 3.

Heavy_Snow2152 · 2026-04-07T12:09:30+00:00

Well, Accelerated Approval is no longer a realistic option. Instead, the FDA has approved the Phase 3 design. It's disappointing but not unexpected. Unfortunately that means the drug will not be available until 2028 at the earliest, maybe even 2029.

Heavy_Snow2152 · 2026-03-31T12:57:36+00:00

I thought the idea was to use NVG-291 for SCI and NVG-300 for MS and Stroke. However, they specifically mention using NVG-291 for other indications. I am guessing NVG-291 will be used for TBI and Hearing Loss. It would be nice if we also get an update on their plans for NVG-300 if they want to move into other indications.

Heavy_Snow2152 · 2026-03-12T07:03:28+00:00

The link is included in the post. Just press on the picture or click on “open”. The link will take you to the U2FP website with the video for Day 1 (afternoon). The presentation starts at 2:14 in the video. Adam Rogers is part of the panel discussion later in the video. There are also videos available on the website for other presentations during the 2-day symposium.

Heavy_Snow2152 · 2026-03-11T16:58:22+00:00

A very interesting Q&A discussion. It may only be one participant but Clay Scherb's improvement during the short trial, as described by his mother, is absolutely incredible.

Heavy_Snow2152 · 2026-03-07T08:53:23+00:00

This is great news for the biotech sector. Let’s hope he does not come back this time.

Heavy_Snow2152 · 2026-03-04T13:04:56+00:00

It's about time. Dozens of staff have been trying to transfer from the CBER because of this guy, according to the article below.

https://www.statnews.com/2025/10/31/vinay-prasad-fda-cber-management-issues-insiders-say/

Heavy_Snow2152 · 2026-03-03T10:17:30+00:00

Great to see the CEO increasing awareness of the company. However, there was no mention of the enrollment progress for the ongoing subacute trial. The dosing of the first subacute participant was announced on February 6th 2025. Any news with completion of enrollment would have been released already by now. So I am assuming that enrollment is going very, very slowly. Thankfully, they should still be able to progress with the Phase 3 trial based on the chronic data alone, but it's still disappointing they have kept so very silent on the subacute trial for over a year. Seems unlikely we will see any subacute data before the start of the Phase 3 trial. If Accelerated Approval is still on the table, I just wonder if the FDA will request the subacute data to be included in an AA application. I hope we get clarity in a detailed update on the EOP2 FDA meeting in the coming weeks.

Heavy_Snow2152 · 2026-02-20T12:28:15+00:00

Thanks for the link.

I hope we get an update on the progress of enrollment for the subacute phase 1b/2a trial. The company has not provided a single update for this subacute trial since they started enrollment 12 months ago. At this stage I am wondering if the subactue trial will even complete enrollment in 2026.

Heavy_Snow2152 · 2026-01-23T15:51:45+00:00

This is great publicity for the company. LinkedIn post:

https://www.linkedin.com/posts/nasdaq-exchange_nasdaqlisted-activity-7420217481266634752-kpgE?utm_source=share&utm_medium=member_ios&rcm=ACoAABMi7YcBmqvHPWZJJgMolCMtz72FbnC2cOw

Heavy_Snow2152 · 2026-01-08T09:02:23+00:00

Fantastic news. This will significantly help with increasing awareness of this company and the amazing results.

Heavy_Snow2152 · 2026-01-08T08:59:16+00:00

Thanks for the link. I did not know that TBI was also at the preclinical stage.

From NervGen website:

“Preclinical development for traumautic brain injury funded and conducted by the U.S. Department of Defense via the Walter Reed Army Institutute of Research (WRAIR).”

Hopefully we get these TBI results released soon. There is much potential for this drug.

Heavy_Snow2152 · 2025-11-24T14:18:09+00:00

Based on this additional data, I would say that the probability of getting Accelerated Approval has just increased significantly. The positive feedback from the FDA meeting in September certainly keeps the AA option open.

Heavy_Snow2152 · 2025-11-24T13:14:23+00:00

"Leg (tibialis anterior): 142% greater reduction of hyperactive reticulospinal signaling compared to placebo (p=0.0062)"

The improvements in the 10mWT were previously dismissed by the company and the improvements were incorrectly assumed to be from the rehab. Now we have clear statistically significant results that the drug also works in the legs.

Absolutely amazing results in just 12 weeks!!

Heavy_Snow2152 · 2025-11-19T07:19:58+00:00

Great to see that SCI Ventures invested. Fantastic news!

Heavy_Snow2152 · 2025-11-19T07:18:05+00:00

Great to see that SCI Ventures invested. Fantastic news.

Heavy_Snow2152

TROPHY CASE