[Schekin]

The drug works. This is a scientific breakthrough! It’s early in the trials. NGEN’s got legs. Stock just got ahead of itself. Cooling off is essential. Not easy to watch but the climb was too much too fast based on misguided assumptions made by blind investors.

[tootalljones]

explain how the rats were performing trapeeze acts and doing jumping jacks after getting the drug, and the human patients had highly muted responses? Is it because the patients in this experiment were deemed chronic?

[Grey_Ghost]

Today's announcement was great. Meeting the primary endpoint along with a clear and demonstrable improvement in one of the secondary endpoints is a huge win. The stock's reaction is one of the 'challenges' of a mostly retail base. They (we) hold unrealistic expectations and panic when those expectations aren't met. I get it. Nonetheless, there's a reason they scheduled a presentation at ASIA: that community will get it and it will be viewed as a great achievement. After the conference call tomorrow afternoon there will likely be enhanced institutional interest. Remember, this was a proof of concept trial and, in this cohort, the concept was proven successfully. The chronic cohort consisted of people who have had little to no movement for years. To overcome the long-established scarring and atrophy is no small feat. They'll take what they've learned from this cohort and apply it to the P3 trial for enhanced success.

[Schekin]

Looks that way! Yes.

[Grey_Ghost]

The company wouldn't initiate an awareness campaign if they didn't have the goods. Next week's topline readout should be groundbreaking.

[Grey_Ghost]

If you're just discovering this company and have a half-hour over the holiday weekend do yourself a favor and watch this video. NGENF CEO Mike Kelly was interviewed for the Oppenheimer Healthcare Conference in February where he gives a great overview of the company and its prospects. You'll be glad you did!

[Grey_Ghost]

Yeah, I'm really wondering what market cap will be assigned to a very strong chronic topline. I guess we'll find out in 2 weeks.

[Schekin]

We’ve seen nothing yet! Nervgen has what will become a breakthrough for science!

[Grey_Ghost]

NervGen Pharma to Present Topline Data for NVG-291 Phase 1b/2a Chronic Cohort Study at the American Spinal Injury Association Annual Scientific Meeting

VANCOUVER, Canada, May 21, 2025 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuroreparative therapeutics, today announced that topline results from the chronic cohort of the ongoing Phase 1b/2a study of NVG-291 will be presented as an oral presentation at the 52nd American Spinal Injury Association Annual Scientific Meeting being held June 2-4, 2025 in Scottsdale, AZ.

“We are looking forward to completing the data analysis, unblinding the data, and presenting the first results from the chronic cohort in this initial proof-of-concept, double-blind, placebo-controlled clinical trial of NVG-291 in spinal cord injury (“SCI”),” stated Daniel Mikol, MD, Ph.D., NervGen’s Chief Medical Officer. “In this trial we have incorporated both clinical assessments as well as electrophysiological assessments of connectivity, as we feel this gives the highest probability of observing and characterizing an efficacy signal with NVG-291. We are hopeful that the results of the chronic cohort of our Phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable neural repair in individuals with SCI and will support further investigation of NVG-291 in SCI.”

https://nervgen.com/nervgen-pharma-to-present-topline-data-for-nvg-291-phase-1b-2a-chronic-cohort-study-at-the-american-spinal-injury-association-annual-scientific-meeting/

[Grey_Ghost]

Dang. Great movement over the last couple of weeks. Thank goodness my first tranche of shares will be long-term in a couple of weeks. I hope the company details their plans to uplist shortly after the acute cohort results are released in early June - assuming they're positive. Based on MK's investor presentations this year, it seems highly probable that they are.

[Schekin]

Looking good!
NGENF

[Grey_Ghost]

Clinicaltrials.gov was updated a couple of days ago. Primary completion now 3/26.

https://clinicaltrials.gov/study/NCT05965700

[Grey_Ghost]

How does the company tell us at the end of the third quarter that they are "nearing completion" of enrollment, yet here we are at the end of the 4th quarter and still no word on complete enrollment? It's only a 20-person trial; why the difficulties?

[timberwolf7]

Q3 was their 'goal' for enrollment in the PH 1/2A study..

IF they say they saw improvement in motor skills (ie, its working)??

Guessing the fda will require a PH 3 of some sort, even if this does help people
and shows no safety issue (another one ATNM has something that works, but the fda
is making them do a new PH 3 trial, that denys people that could benefit from their
development from helping save/make their lives better)

So guessing even if this shows it works, can help folks get better, the fda will
force them to do a PH 3 which means a few more years.. Damn..

[timberwolf7]

TIMELINE to being POTENTIALLY REWARDED??

for the current spinal recovery trials: at least 2 years??
got to finish the PH 2, and if the FDA makes them do at least a
partial PH 3? Looking at 2 years for those results (??)

on the others? Well over 2 years by the time the PH 1 is run and then...

Best they can hope for is that the safety profile and that there is no doubt
it works is to get 'conditionally approved' for usage with a parallel PH 3 to
observe to monitor whether or not the 'results' last, don't fade..

disclaimer: don't own any. Having a hard time understanding why IF
this LIN character is right, why the institutions
own so little of the shares. (reportedly 0% of the shares).. afterall, they
have a history of buying and holding to see what might happen in the next 5 years

[tootalljones]

Lin's comments in the Taylor interview just posted are big. He is saying, that he knows of a patients, via his mother, who son has gained significant, meaningful mobility. In fact, substantial mobility. He is also saying there is scuttlebutt and buzz around the patient group taking 291 -- their families and friends, which if you listen to it, means the drug is working. Working quite meaningfully. As he remarks, the patients themselves cannot say stuff, but they can share how they are doing with friends and family. And the F and F themselves are under no contract or agreement Not to communicate about the progress, if any. And the F and F's are themselves talking about real progress. SuBstantial progress, and this is why Lin is saying this is a trillion dollar opportunity.

[Schekin]

Mike Kelly interview recently.

https://m.soundcloud.com/biotechguru/how-nervgen-is-developing-novel-treatments-to-repair-damage-to-the-nervous-system

[tootalljones]

A TRILLION DOLLAR opportunity, with Ngenf, having today a 200 million dollar cap, suggest s an eventual price for the shares up above the heavens and into the stratosphere. Lin suggests it will be the new Eli Lilly. I will settle for 1/20th of that.

[tootalljones]

Jay Taylor and Super Investor Chen Lin start about Nervgen at the 13.40 minute mark. And Lin is following his old Sarpeta Model where he bought that stock in the low single digits. He himself related years ago, that he actually flew to the home of the first patient treated, who could not walk, and saw with his own two eyes, that after receiving the SRPT drug, the young patient could walk. Chen related in a Jay Taylotr podcast, "What could I say. I saw him, and he could walk!" Lin perhpas made 50X his original investment, and SRPT stock today is 150 bucks a share.
And if you listen to him carefully, you see that he is pretty much following the same formula with Nervgen, which he sounds far more excited about, calling it a 'TRILLION DOLLAR OPPORTUNITY"

[Schekin]

https://open.substack.com/pub/taylorjay/p/the-surrender-announcement-for-those?r=ym89d&utm_medium=ios
Listen @13:30

[tootalljones]

fyi ..https://neurosciencenews.com/glial-cells-neurogenesis-26408/

[tootalljones]

Today was a good day, the chart was simply too steep. I doubt Nergen will ever trade again below 2 bucks. The chart and story look very good going forward, My 2dc

[tootalljones]

new paper by Dr. Silver and the Nergen Scientific team:
https://www.biorxiv.org/content/10.1101/2024.05.07.592424v1.full.pdf

[tootalljones]

https://ceo.ca/@geodan/nervgen-regenerates-neurons-what-is-a-drug-that-reverses-paralysis-ms-stroke-and-alzheimers-worth
nice write up

[tootalljones]

Lilly AZ drug basically barely works if at all. The stock has gone from 290 to 900, LOLCNN.....imagine where Nervgen will be as the news spreads that it can rejuvenate nerve growth?..........in stroke, spinal cord, Parkinson's and AZ? As it stimulates and rejuvenates neuroplasticity.... to 5,000? 10,000?

[tootalljones]

"The annual stroke market is valued at over USD 37 billion1. The global stroke diagnostic and therapeutic market size is predicted to hit over USD 71.96 billion by 2032, growing at a CAGR of 8% during the forecast period 2023 to 20322."
Learn more:
https://nervgen.com/nervgen-pharmas-nvg-291-r-demonstrates-significant-functional-repair-from-a-stroke-7-days-after-onset-in-landmark-preclinical-study-by-university-of-cincinnati-and-case-western-reserve-univer/

"
The independent peer-reviewed study showed improved memory as well as motor and sensory functions in rodents when treatment with NVG-291-R began 7 days after stroke onset
There is currently no FDA-approved drug for the repair of damage from a stroke
NVG-291, currently in a Phase 1 clinical trial in healthy human subjects, could provide a completely new treatment paradigm for stroke patients"

https://nervgen.com/nervgen-pharmas-nvg-291-r-demonstrates-significant-functional-repair-from-a-stroke-7-days-after-onset-in-landmark-preclinical-study-by-university-of-cincinnati-and-case-western-reserve-univer/
"Vancouver, Canada July 28, 2022 – NervGen Pharma Corp., (TSX-V: NGEN) (OTCQX: NGENF), is pleased to announce......"

[tootalljones]

new article: https://stockhouse.com/opinion/independent-reports/2024/07/02/nervgen-are-amazing-human-trial-results-leaking-out

[tootalljones]

https://www.reddit.com/r/MultipleSclerosis/comments/tga280/remyelination_news_nervgen_cleared_to_enroll_2nd/
More info for investors from the Reddit bloggers

[tootalljones]

https://taylorjay.substack.com/p/is-nervgen-too-good-to-be-true
Jay Taylor has had his own investing blog for several decades (at least), which has been on Kitco Gold and elsewhere and his stuff is always good to read. He is a stand up guy, not easily fooled. Here he talks of Chen Lin, who he says is the world's greatest investor (or at least that he is aware of). Lin has had quite a few 5 and 10 and 20 baggers, per Lin. Here is one of Lin's many huge scores, Sarepta (SRPT), don't know where he bought it but surely single digits. That Jay has been relating of Lin's stock exploits for well over a decade says that Lin has stood the test of time. Just buy what Lin is buying, that is a sensible thing (in fact, Jay had a column called What is Chen Lin buying? at one time, don't know whether he still runs it but clearly, Chen Lin is in now, and committed, it would appear, to NervGen. A good sign indeed. I bet Lin's track record blows away Buffett's.

[Schekin]

Minor point…
Rats not mice

[tootalljones]

It all depends on the strength of the results and the number of patients, and of course, the FDA will have access to the OLE program. If the earthlings have anywhere close to the success of the mice, who were tested and measured in a half dozen preclinical studies (or mice trials), then this could move shockingly fast. And by that I mean 2 years from now. For instance, they have a category called "breakthrough" designation, which can move things up substantially. Personally, I would view the mice as candidates for breakthrough status by the FDA, but then again, they are just mice. If the humans in any way remotely approach the mice data, things could move very fast. There will be a deluge of patient volunteers in this regard as well, and the ramifications would be staggering. Even small improvements would be heralded. And I am betting we get significant or meaningful, functional improvements, a logical position to take based on the preclinicals. I am not expecting patients to regain the sort of lower limb function the mice did, but then again, I am a pessimist, but who knows. It was a wise choice to give the patients stronger doses than were given to the mice. And I just read an informed post on stocktwits, where the poster said, because of the size of the human spinal cord vs. a mouse's, that he thinks that while the drug might be effective very soon in the dozing process, the ultimate benefits (the learning curve), may not peak for 9 or more months....Remember the company says the mice had not reached their ultimate functionality when the preclinical studies were generally stopped. This suggests, if true, that while the current patients are getting almost 3 months of daily shots,.....their progress upward might top out until another 6 months of the drug, or who knows, even longer, ...but this is all just speculation. Plus the ramification of the drug for other central nervous system diseases is incalculable. Time will tell.

[tootalljones]

They will have to do a second trial, there is no question of this.....and depending on the strength of the results, the FDA has various means and ways of moving things relatively quickly. The best that can be hoped for is that they are granted some sort of expedited approval, over the next 1.5 years, and then an approval, with the condition they run another trial post approval, in order to learn more. The stock price will of course go crazy as this takes place, with also the company's other ideas and other indications taking root. Should be a tremendous next 3 years, depending on whether the signal in any remote way approximates the preclinical results, which btw, our CEO says was gained in at least half a dozen preclinical trials, fwiw....which I view as now reliable.
a somewhat or half hearted or semi marginal signal in pre clinicals is just so, so....but our signal in at least a half dozen preclincal mice trials, was overwhelming and ginormous.
Investor extraordinaire, Chen Ljn , the world's best, knows all of this far better..

[timberwolf7]

bigger question, IF they see 'results', will they be 'good enough' to directly submit an NDA or will they have to run at least 1/2 of a PH 3

I own shares in CRMD that had their PH 2 show very good results, but still had to do a PH 3 which was then halted at the half way point because the
results were so good.

I would like to think that IF this shows positive results, no safety issues that because of WHO needs it and WHY, that our FDA would say, start treating folks and let that count as the 'PH 3'..

But I fully expect them to say, at least a PH 3 with see how well it goes.

And if that happens, I suspect they will need to do some share selling to raise cash (dilution)..

disclaimer: Own none, but...

[tootalljones]

thanks, but with full enrollment in Q3, which we are now just starting, let's say by August 15th, the mid point, that would result in a very nice jolt to the stock price higher in late August, or early to mid Sept. Even getting the last patient enrolled in a trial such as this is big deal. Then the protocol requires 84 continuous daily shots to that last (new) patient, let's call it 3 months for that last one, so we are then at Dec. 15th of this year. I would expect actually 2 PR's, one of the preliminary data, which should be a blockbuster NR sometime in January 2025, with the full data release perhaps 2-3 months later. But the first PR will rock the world.

The stock will be ascending the rest of this year.....in anticipation. The market cap now is miniscule.

They will be analyzing all of the DATA which has already rolled in (I would think) as each patient or couple of patients graduate (actually while the daily dosing is taking place every once in a while), and we have already had quite a few already graduate from the trial regimen, for patients who have been in the trial since September 2023. through Q1 of this year. So I think it won't take long to finish up the data for the last few patients, as they will already have a near full data bank.. Which means we get a PR within 30 days or so of mid to late Dec of this year.

We will also get a PR at some point this year surely of the OLE "trial" being opened for the placebo patients, so they too will get the real drug certainly any time now soon (the first enrollees) and the already graduated patients who got the drug, so I would think this merits a very meaningful PR. They won't make these volunteers wait till the full trial is finished. We also should have something on the the new compound getting started this year (another PR), and remember, putting alzheimers's aside, the worldwide spinal cord market, both subgroups, is massive, a billion dollar annual market, and the MS market, (my quick google search, speaks of it being a 22 billion dollar annual market.....

but here is what has me genuinely excited. Check this clip from Dec 2023. Remember, the drug is supposed to show signs of working in a matter of weeks, per Dr. Silver (I would think within a month to 6 weeks +/....if not days?
But here is the clip that tells me they are getting a signal already from the patients already enrolled, it is her tone of voice which is soaring with enthusiasm, and the words she used. Preliminary for sure, but still....
check it out around the 42 minute mark. '
Also impressed by the people involved in this trial and the quality of management of the company....etc.
https://blinkofaneye.podbean.com/e/194-season-finale-nervegen-with-meghan-morrow/

[Grey_Ghost]

Good article overall, but there's one significant omission.

The author quotes the September 25, 2023 PR which states:

Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024.

He goes on to reiterate this timeline in his own narrative, stating, The news release said it expected to provide positive results “next summer.” So if you are looking for a driver for this company’s shares, we may be approaching a significant timeframe now.

However, NervGen's May 16, 2024 operational update offers the following guidance:

Recruitment in our Phase 1b/2a clinical study of NVG-291 for individuals with spinal cord injury (SCI) has gone well, however, it has been slower than originally anticipated during Q2 due to challenges in finding, screening, and onboarding individuals that meet our very specific and rigorous inclusion and exclusion study criteria,” said Mike Kelly, NervGen’s President & CEO. “Given the heterogeneous nature of spinal cord injuries and our efforts, through the novel design of our study, to recruit as homogeneous a SCI population as possible, the current study protocol and our single trial site location have limited the number of subjects that both qualify and can travel to Shirley Ryan AbilityLab in Chicago. While we have undertaken additional initiatives and operational directives that should help us in fully recruiting the study, we believe full enrollment of the chronic cohort is now more likely in Q3 of this year.

So, based on NervGen's own guidance, a readout from 1b/2a will not take place this summer as they have yet to achieve full enrollment. Instead, it seems more likely readout will take place mid-to-late Q4.

[tootalljones]

Here is another group, which actually does pretty quality stuff, and they too refer to Mr. Lin, who I presume has a following, and he should have. ....Lin has had so many (per Jay Taylor), 10 and 20 and 30 baggers...but this is the area where he finds them. at these prices or perhaps under 10 bucks. You don't get a massive score if you are buying a 20 dollar stock, By then, the brilliant investors have bought it so much lower. https://www.streetwisereports.com/article/2024/06/11/is-this-pharma-co-the-next-eli-lilly.html

[tootalljones]

Here is Jay Taylor's blog about Nervgen and Chen Lin, who he considers the world's greatest investor (the greatest he can find at least); One of Lin's many 20 baggers was Sarepta, which I followed. According to Taylor, he is seeing Nervgen as the next Sarepta. https://taylorjay.substack.com/p/is-nervgen-too-good-to-be-true

[tootalljones]

Having listened to the actual interview, which I posted, it is clear he is not referring to the clinical trial patient population, but he is projecting logically what will happen. How much he even knows about the status of the patients is completely unknown, but he was talking about pre clinicals.

[timberwolf7]

He shouldn't be talking about the TRIAL thats in progress.

That information is supposed to be inaccessible unless the trial
design allowed for a PUBLIC release of data, ie, a mid trial prelim read out for example.

When those happen, they are usually released again, via PR.

Yet this is one of my concerns. This kind of statement had been made back some time ago
and I was left wondering, how do they know unless someone who took a dosing. But I don't
recall them saying it in any of the PH1 trial releases.

So how do they know this unless someone took it during the 'development' phase, before the official
trials began.

[Schekin]

https://www.biotechtv.com/post/nervgen-june-26-2024

[tootalljones]

here it is I think: https://open.spotify.com/episode/5ytpuAI8fdTMLIXww7voj9?go=1&sp_cid=dbde4abb538527d46af24b10e852ad69&utm_source=embed_player_p&utm_medium=desktop&nd=1&dlsi=8b6d2d6913b34ee7

[tootalljones]

Schekin, I am guessing the first patient was dosed in mid Sept, ....and in your post, Dr. Silver appears to be talking in the present tense, and that he is referring to people (certainly not lab animals). He relates:

Dr. Jerry Silver, co-inventor of NVG-291. Image credit: NervGen
“Now when we give the peptide or the enzyme, those connections that are smothered wake up very rapidly. Do you remember when you asked me how long it would take for people to get better? And I said it would happen very quickly within weeks. That’s what we’ve seen,” Dr. Silver said.

To me he is referring to the up to that moment, trial population. When did he make this statement, and do you have a link to the interview? Thank you. It appears that he is making an observation that yes indeed, "What we've seen" ...is that there is a signal from the injections and it appears to take place in a "matter of weeks." (Presumably 3 to 6-8 weeks (?) He is referring to how the patients in the trial are responding.

[timberwolf7]

Its still a question of, how much 'trust' do we put in the 'chatter' to date..

[Schekin]

Too soon for a buyout. This one’s a long hold. Waiting for trials on stroke, MS, and Alzheimer’s.

[timberwolf7]

To TRUST or not that this works. Been tracking this one for a while now, but don't own any shares. My thoughts are:

-its a small Canadian company, tough to find 'love' on wall street, especially if its share price is 'cheap'
-given how much they have 'said' with respect to what they 'believe', I am leaning towards this 'can' help folks.
-I am tempted to buy shares for the PH 1/2 trial release that is 'anticipated' in Q3, but
-also wondering that IF this shows promise, and IF this doesn't show any side effects,
-will the FDA make them do a long drawn out PH 3 or
-will they allow for 'usage' as a PH 3 validation..

This has a lot of potential to help folks, again, they are chattering.. Yet no big pharma has bought them out. Is that an indication
that they have set a very high buyout price or big pharma isn't 'seeing' it yet..

Disclaimer: don't own any... But going to get some for the Q3 readout anticipated, just unsure as to how many shares, or what to expect on the news??

[Schekin]

https://www.newsfilecorp.com/release/198043/NervGen-Pharma-on-Track-to-Complete-Enrollment-Deliver-Data-Readout-in-Phase-1b2a-Clinical-Trial-for-NVG291-in-Spinal-Cord-Injury?k=
NervGen Pharma on Track to Complete Enrollment, Deliver Data Readout in Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord Injury
February 15, 2024 8:47 AM EST | Source: NervGen Pharma Corp.

On track to complete enrollment of the chronic cohort in Q2 2024
Data readout from chronic cohort expected in Q3 2024
Planning underway to make NVG-291 available to placebo-treated subjects following cohort completion
Vancouver, British Columbia--(Newsfile Corp. - February 15, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that it is on track to complete enrollment in Q2 2024 and deliver the data readout in Q3 2024 of the chronic cohort in the Company's Phase 1b/2a proof-of-concept, double blind, randomized placebo-controlled clinical trial for its proprietary investigational lead compound, NVG-291, in individuals with spinal cord injury (SCI). Preclinical studies of NVG-291 demonstrated functional improvement in both acute and chronic spinal cord injury models of SCI. The Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions and a pioneer in the use of objective, quantitative electrophysiological based motor connectivity assessments, is the single center for this clinical study.

Additionally, NervGen is developing plans to initiate a new study in which subjects completing the current trial who received placebo would have the option to receive open-label NVG-291 under a separate protocol. NervGen plans to initiate this open-label study, provided that an efficacy signal is observed in the chronic cohort, when the cohort is unblinded in the third quarter of 2024 and is contingent upon protocol approval by the U.S. Food and Drug Administration (FDA) as well as the study's Institutional Review Board.

"We are pleased with the pace of enrollment and smooth execution of this landmark clinical study in spinal cord injury," said NervGen's Chief Medical Officer, Dan Mikol, MD, PhD. "We believe the results of this study - once the study data are unblinded - will be a key enabling step that may bring us closer to the first approved therapy for spinal cord injury, and we look forward to the prospect of delivering positive results later this year. We are also very excited about our plans to offer open-label NVG-291 to those placebo-treated subjects who committed their time and energy in the current trial."

"Our dedicated team at Shirley Ryan AbilityLab is thrilled to be well underway with this important clinical research trial in individuals with spinal cord injury, and is encouraged by the many inquiries we've received from willing research subjects," stated Monica A. Perez, PT, PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; Professor of Physical Medicine & Rehabilitation at Northwestern University; Research Scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. "This trial employs a cutting-edge design that incorporates electrophysiology both as part of the inclusion criteria of participants and to monitor motor recovery. A wealth of information about connectivity and function is being collected from each subject throughout the study, and we look forward to analyzing these results in order to fully assess the efficacy of NVG-291."

Those interested in participation in this trial are invited to call 855-559-6902.

About the NVG-291 Phase 1b/2a Trial
The double blind, placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments that will offset a portion of the direct costs of this clinical trial.

About Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions - from traumatic brain and spinal cord injury to stroke, amputation and cancer-related impairment. The organization expands and accelerates leadership in the field that began at RIC in 1953. The quality of its care has led to the designation of "No. 1 Rehabilitation Hospital in America" by U.S. News & World Report every year since 1991. Upon opening in 2017, the $550 million, 1.2-million-square-foot Shirley Ryan AbilityLab became the first-ever "translational" research hospital in which clinicians, scientists, innovators and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or "translating") research real time. This unique model enables patients to have 24/7 access to the brightest minds, the latest research and the best opportunity for recovery. Shirley Ryan AbilityLab is a 501 (c)(3) non-profit organization. For more information, go to www.sralab.org.

About Wings for Life Accelerated Translational Program
Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research. The Wings for Life Accelerated Translational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation.

The ATP strives to assist applicants to find the best way forward in clinical translation of high caliber, promising therapies. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials. Select members of the ATP Support Network will be called upon, as required, to assist in ensuring that treatments with auspicious potential are translated in the most scientifically rigorous and efficient way possible.

About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. NVG-291 has received Fast Track Designation from the FDA.

About NervGen
NervGen (TSXV: NGEN) (OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial. The Company's initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.

Contacts

Huitt Tracey, Corporate Communications
[e-mail]
604.537.2094

Bill Adams, Chief Financial Officer
[e-mail]
778.731.1711

[Schekin]

Latest Feb 2024 Corporate presentation. NervGen Pharma
https://nervgen.com/wp-content/uploads/2024/02/1-NervGen-Presentation-20240201-web.pdf

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NVG-291 For stroke treatment
https://nervgen.com/wp-content/uploads/2023/07/NervGen-Stroke-Backgrounder_FINAL_July-10-2023_Web.pdf

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Is this stunning "evidence" that NervGen has the goods?
https://stockhouse.com/opinion/contributors/2024/02/01/is-this-stunning-evidence-that-nervgen-has-goods

This could be the signal that tiny NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) is destined to be one of the top performing biotech startup stocks this year.

It came in a seemingly innocuous podcast interview about the company’s ongoing Phase 1b/2a “proof of concept” human trials. In online investment chat groups, they’re saying that the podcast offered up a bombshell revelation – that extraordinary therapeutic improvements are apparently being achieved by paralyzed trial volunteers.

Simply stated, at least a couple of trial participants may apparently be regaining the use of their limbs – albeit incrementally.

This sneak peek inside this randomized double-blind, placebo-controlled trial has major implications.

Something quite remarkable appears to be happening at Chicago’s Shirley Ryan AbilityLab – a global leader in physical rehabilitation for patients with severe nerve damage. This is where at least one of the initial trial patients – mindful that there are only a handful of trial volunteers in total so far – is apparently regaining some function of his extremities, even though he suffers from chronic spinal paralysis.

This stunning revelation was shared by a globally-renowned podcaster called Louise Phipps Senft, who runs a non-profit advocacy/support organization for spinal cord injury victims called Blink of An Eye, which is based in Baltimore. She said in a December 20th podcast(minutes 42.10-42.41) that one of NervGen’s trial volunteers — who enrolled with the support of her organization – began to experience noticeable improvements after only a few once-a-day injections.

This volunteer has been administered NervGen’s experimental peptide called NVG-291 as part of a 12-week trial program that officially got underway late last year. It’s the first of its kind for humans. And that’s why the trial is being so closely watched by the medical community and investors alike.

Any suggestion that trial volunteers are getting remarkable results within weeks, rather than months, would not come a surprise to NervGen’s scientists. In the past, they have successfully used NVG-291 in numerous preclinical trials to achieve substantial and unprecedented recovery of functionality of laboratory rodents that had sustained severe spinal cord damage.

They also proved that NVG-291 is not toxic to these animals, even in high doses. This is one of the official reasons why this drug candidate has recently been fast-tracked by the FDA in human trials. Unofficially, it might be because FDA medical scientists have become aware that NVG-291 appears to be working already. Either way, this fast-tracking by the regulators represents another key signal to investors that the company’s share price may be getting primed for a sustained rally in 2024.

“Proof of Concept” Trial: Where there is smoke, is there fire?
Admittedly, it’s a big leap to hope for comparable results in humans to laboratory animals. But this seems to be what’s happening already with at least one of the trial’s first patients. This is mindful of the fact that he doesn’t know whether he’s being injected with the trial drug candidate or a placebo.

Importantly, these volunteers have a “chronic” injury that is between one and 5 years old. Apparently, there are no records of humans having significant recovery beyond 12-18 months post-injury. It would be almost miraculous if a patient getting the placebo experienced any noticeable improvement.

However, if a patient becomes able to move his digits during the trial, this represents a huge breakthrough for NervGen.

Consider the fact that the trial’s researchers set out with far more modest aspirations, which was to use electrical stimuli to detect subtle improvements in muscle functionality and limb mobility. Even the tiniest of improvements in that regard would be considered something of a success. But if patients can exhibit observable movement in response to the treatment, that’s by far a best-case scenario – one that appears to be playing out.

For anyone interested in the technical explanation of how trial results are measured, here it is: The primary endpoint is to show improvement of the body’s “electrophysiology”, or natural electrical impulses, according to NervGen’s trial scientists.

Functional improvements are secondary (even more desirable) endpoints. So if a volunteer is experiencing improved functionality, this means that the primary endpoint of increased electrical impulses has been successfully achieved, pointing to a successful trial.

Of course, no official comment can be expected from NervGen or from Shirley Ryan AbilityLab until much later this year after all the trial data readouts have been fully assessed. So the countdown has started to a pending trial outcome announcement that will surely have a major impact on NervGen’s share price. As of now, NervGen may then be just a few months away from a serious stock re-rating.

Here’s Why NVG-291 has “Blockbuster” Drug Potential
In terms of the Big Picture, NervGen believes that NVG-291 has the potential to be a revolutionary “blockbuster” treatment for all kinds of nerve and neuron damage, not just spinal cord injuries. This is mindful of the fact that no drugs have ever before been approved anywhere in the world for nerve regeneration and for improving plasticity in damaged nerves.

NervGen is also hoping to treat other conditions like MS and stroke, thanks to an extraordinarily strong collection of animal data. This means that NVG-291 might also be able to treat conditions as devastating to society as Alzheimer’s disease — an affliction involving 6 million Americans, which costs the US $350 billion a year to manage.

NervGen should complete the Phase 1b/2a trial later this year, which includes a post-trial evaluation. The trial will involve 20 people, who each receive a once-a-day injection for 12 weeks. Half receive the drug candidate and the other half receive a placebo.

It’s statistically significant that more than just the one trial volunteer is making what is being referred to as exciting progress by Meghan Morrow, who is the project manager for NervGen’s trial.

This was Morrow’s assessment when she was being interviewed last December on Louise Phipps Senft’s podcast about NervGen. And even though Morrow is professionally obliged to keep her cards close to her chest about the trial’s progress, she did offer the following tantalizing insight as to its possible outcome.

“It is a double-blind trial. So no one knows anything, except the pharmacist…But I will say that obviously there is speculation when we see individuals making gains. And then we get really excited…”

Key Investment Takeaways
A few savvy investors were quick to digest the implications of this podcast’s revelations, and the share price shot up accordingly on heavy volume soon after it aired. But now the stock is settling down again on normal volume, forming a new, higher price base ahead of its next anticipated up-leg. Whether that happens before or after the announcement of Phase 1b/2a trial results remains to be seen.

For now, NervGen continues to remain under the radar for most investors due to the company’s low-key public profile. The stock is accordingly still undervalued considering how far NervGen has come in validating the efficacy of NVG-291. And the prospect of continued success in human trials would surely send the company’s share price surging to new multiples.

It’s also worth remembering that the US federal government is encouraging NervGen’s progress too with its recent awarding of a Fast Track designation for trials. But this may not be such a surprise development to NVG-291’s co-inventor, Dr. Jerry Silver. He was quoted on a different podcast in late November, 2023 as saying that he expects human trial volunteers to respond as quickly to treatment as the animals did, which produced remarkable results within just a few weeks.

Click to enlarge
Dr. Jerry Silver, co-inventor of NVG-291. Image credit: NervGen
“Now when we give the peptide or the enzyme, those connections that are smothered wake up very rapidly. Do you remember when you asked me how long it would take for people to get better? And I said it would happen very quickly within weeks. That’s what we’ve seen,” Dr. Silver said.

The following few months promise to be last chance for investors to see NervGen remain undervalued and largely overlooked by most risk-tolerant investors. But if paralyzed trial volunteers keep improving, the announcement of such stunning results later this year would surely thrust NervGen in the investment limelight – setting the stage for a remarkable performance.

Disclosure:
The author of this article or members of his household or family, do not own shares in NervGen at this time. However, he may from time to time buy or sell shares in companies that are profiled in his various investment articles. Additionally, he is not compensated by the company directly or indirectly. His commentary is therefore based solely on his personal research and understanding of the life sciences sector. It is not intended as investment advice.

The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.

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HEALTHCARE

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https://nervgen.com/
Developing innovative treatments
that may enable the nervous system
to repair itself