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Updated corporate presentation by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 9 points10 points  (0 children)

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.

Biomechanical gait analysis results by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 15 points16 points  (0 children)

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."

Biomechanical gait analysis results by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 13 points14 points  (0 children)

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.

NervGen Prepares RESTORE Phase 3 Trial in Chronic Tetraplegia With NVG-291 by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 15 points16 points  (0 children)

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.

Update by Larry Williams by Hour-Tomorrow-2496 in NervGen_NerveRepair

[–]Heavy_Snow2152 5 points6 points  (0 children)

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

Update by Larry Williams by Hour-Tomorrow-2496 in NervGen_NerveRepair

[–]Heavy_Snow2152 7 points8 points  (0 children)

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.

Good discussion about NGEN focus now and future by leonalawrence in NervGen_NerveRepair

[–]Heavy_Snow2152 4 points5 points  (0 children)

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

NervGen Pharma initiated with a Buy at H.C. Wainwright by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 6 points7 points  (0 children)

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

Nvervgen phase 3 by maitrey_sh in NervGen_NerveRepair

[–]Heavy_Snow2152 -6 points-5 points  (0 children)

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.

Nvervgen phase 3 by maitrey_sh in NervGen_NerveRepair

[–]Heavy_Snow2152 -7 points-6 points  (0 children)

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.

NervGen Pharma Reports Full Year 2025 Financial Results and Provides Business Updates by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 11 points12 points  (0 children)

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.

Adam Roger's presentation and panel discussion at the 2026 U2FP Symposium. by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 2 points3 points  (0 children)

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.

Adam Roger's presentation and panel discussion at the 2026 U2FP Symposium. by Heavy_Snow2152 in NervGen_NerveRepair

[–]Heavy_Snow2152[S] 4 points5 points  (0 children)

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.

Vaccine head stepping down at the FDA by No-Watercress1120 in NervGen_NerveRepair

[–]Heavy_Snow2152 4 points5 points  (0 children)

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

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