LTListener
2 days ago
Reading a bit more about NIH HEAL program and I am thinking more and more that most likely there is a partner(s) already identified.
I read where NIH encourages that early in the process to help package all the various information needed for IND. It is one thing to advance into tier 3, IND enabling, but another to also facilitate the details, like manufacturing and clinical support/locations, etc....
Looking at pharma deals, obviously have mentioned a competitor gabakine SAN711 with a nice deal in phase 1, and with KRM-ll-81 likely having a better selectivity profile and addressing both pain and epilepsy could be magnitudes better deal. A lot of speculation on this support forum and from company about how they structure all the assets. Lilly acquired an asset from Scorpion for up to 2.5 billion in milestones and sale targets, etc but Scorpion was noted to also create a new company to spin out all the other non-acquired assets and people and Lilly took a minority position in that newco.
Seeing what they are hinting at with EndeavourRx, LLC I wonder if something similar is in the works here. Strike a deal with BP after KRM-ll-81 has an IND package and ready for phase 1 while then spinning out the rest of the neuromodulator platform to a newco that could be traded on a different exchange. I suppose to they could utilize RSPI entity and with a significant upfront payment and milestones incoming they could find a RM or M&A route to Nasdaq or such down the road.
meixatech
2 days ago
These are results for βWhat is the potential for RespireRX to become a multi billion dollar company?β
AI Overview
RespireRx Pharmaceuticals Inc. has the potential to become a multi-billion dollar company, particularly if it can successfully develop and market drugs for obstructive sleep apnea (OSA) and other sleep disorders. The company's focus on the relatively underserved OSA market, with a large patient population and limited approved treatment options, offers a significant opportunity for growth.
Here's a more detailed look:
Strengths and Potential:
β’ Untapped Market:
OSA is a prevalent condition affecting millions, with a significant unmet need for effective and convenient treatment options.
β’ Lack of Approved Drugs:
Unlike some other sleep disorders, there are limited FDA-approved medications specifically targeting OSA.
β’ R&D Pipeline:
RespireRx has a pipeline of potential drugs, including dronabinol, which has shown promise in preclinical and clinical trials for OSA.
β’ Strategic Partnerships:
Collaborations with organizations like the US Department of Defense can provide funding and expertise, accelerating research and development.
β’ Market Valuation:
RespireRx's market valuation has seen significant growth in recent months, reflecting investor confidence in its potential.
Challenges and Considerations:
β’ Competition:
While the market is underserved, other companies may also be developing treatments for OSA, creating competition.
β’ Drug Development Risks:
The drug development process is inherently risky, with the possibility of trials failing or regulatory hurdles.
β’ Market Acceptance:
Even if a drug is approved, it needs to gain acceptance among physicians and patients, which can be influenced by factors like cost and convenience.
β’ Financing:
Maintaining the company's growth requires ongoing investment and fundraising, which can be challenging in the current market.
Overall:
RespireRx's future trajectory is linked to the success of its drug development pipeline and its ability to navigate the challenges of the pharmaceutical industry. While the market potential is significant, the company needs to demonstrate consistent progress in its clinical trials, regulatory approvals, and market adoption to achieve its multi-billion dollar valuation goals.
BuccaneerGoblin51
4 days ago
RSPI has SO MANY ASSETS in the pipeline, a BP deal surely is in place, but the itemization of each assets treatment would have Tesla's, the scientist not the company, head spinning?
Dr. Lippe didn't carry these curative and remedying as long as he has to short change their efficacy, which might NEED LENGHTHY EVALUATING DISCUSSION with all concerned in inking a deal?
The creation of an international Pharma company, an offshoot from a BP seeking a deal with RSPI might be the easier way to go, hiring peers of Dr. Lippe to progress the assets forward rather than trying to slot each into existing cubbies holes within the existing BP?
LIPPA has transparently shared all he could about his collective meritocracy of assets. I would think staffing g a NEW OFFSHOOT would be creative and not put anyone else or their ego in jeopardy...or at least be the least threatening and most productive avenue going forward, not in any small measure bypassing this tarriff-fest idiocy plaguing much if not all of global trade?
The biggest and best in business today and going forward is HOW business models are innovating and inventing and experimentally forged for optimality AND sustainability?
LTListener
4 days ago
Do you think maybe they already have the deal/NDA all lined up with a BP pending the finalization of the IND enabling studies with HEAL and that is why they went EM... Curious all this after the CEO interview and discussing how remarkable KRM-ll-81 is and opening "purse strings"?
If that was the case, then maybe there is some logic of going the EM route. Which if that logic is true, then any of these shares/scraps floating around are like gold.
They are still required to disclose material events, so it is not like the EM provides them cover to not do so. So is an IND close, phase 1 close, etc?
LTListener
4 days ago
I am not sure how. There is no leverage when your market valuation is peanuts and you have no outlet to raise the smallest amount of capital.
And of course the presentation and look of it all gives a non serious appearance. I think what is more likely is as some others here have alluded to is that a NDA is and has been already in place with a BP. It would make some sense. The NIH wants to accelerate development of opioid mitigation therapies, so transitioning from tier 2 into tier 3 IND enabling smoothly would likely involve some BP input as who is going to take the baton going forward. RSPI has zero capacity and even less on the EM.
Assuming they are nearing exiting IND enabling, they will need partners to go forward. Maybe the NIH would help facilitate this, but I do not beleive the NIH pays for all costs in development in phase 1-2-3 clinicals as BP would be better situated to approach devleopment, deciding on indications, manufacturing, marketing strategies,etc, etc...
Could it be possible a deal has mostly been in place with the caveat of just finishing up all that was needed in tier 3 and IND enabling package, etc??
LTListener
4 days ago
I stand corrected. I guess it does help some who are able to accumulate what few shares are available on the EM.
I guess my point is more along the lines of building investor interest, developing that much needed professional touch to presentation and communication, attracting resources whether people or collaborative, positioning the company/assets to capitalize on success, etc, etc...
GLTU with those shares, that will be a nice ROI if/when they can strike a deal to get KRM-ll-81 into phase 1/2 with a BP similar to the Acadia/Saniona deal last year for their gabakine.
LTListener
4 days ago
Yeah, the CEO and CFO has been involved with venture capital their entire careers it appears. There is a strategy to everything.
I think the story here is rather simple, yet this EM path very unusual and chalking that one up to the dumb OTC playground.
The OSA and ampakine platforms have been hampered by lack of funding for years, well before the gabakine platform entered. The OTC provides little flexibility to move on those assets as liquidity and significant capital is hard to come by. They essentially have been stating this in their filings for a long long time.
The progress with the HEAL program is significant and I think the CEO interview tells the entire story. The NIH confirmed Respire's preclinical results with KRM-ll-81. It then progressed into tier 3 NIH trials, which is stated to be IND enabling studies, prepping for phase 1. CEO sounded geuinely excited about it as well as intent to open investment community "purse strings" and many probably accumulated more shares on this move into tier 3 NIH. The NIH HEAL is for opioid mitigation/pain management therapies. This is high profile. The progress also likely allowed Respire to also pursue IND enabling for epilepsy, the source of the grant application work with the consultants which they had high review scores on and hopefully have a status update soon on if funded...
So anyone who has read their filings, the publications and see all the insider equity linked positions and read about competitor compounds, especially the gabakine deal between Saniona and Acadia can see this might have a good chance of becoming something special and certainly worth leaps and bounds more than the valuation on this EM "market". On top of that they put out a very nice shareholder letter several months ago spelling out significant goals and activities they intend to get going for the entire pipeline. None of this happens until major investment. Which I think all of this is waiting on.
LTListener
5 days ago
Well, I think we are all watching closely and waiting for a flood of information, funding and clinical progress to unveil itself.
We can't forget they presented at I think at least 2 significant institutional investor conferences going on almost 3 months ago... So between possible institutional, BP and NIH dealings and who knows what else with in-licensing and more grant fundings, there could be quite the stew brewing...
In an odd way, this is kinda like that classic hot rod... The doors and hood could be off it and several mechanics working on it and people would probably pass by not paying much attention, but place a cover on the whole thing and have mechanics work on it, then curiosity and interest increases.. what ya got under there... what you doing under there... when can we see it...
LTListener
5 days ago
All things considered....
If the intention of the NIH HEAL program is to accelerate and support development of therapeutics that can address the opioid/pain management arena, then given the tier 3 status beginning well over a year ago and RSPI stated toxicology ongoing awhile ago now it is reasonable that a BP/support structure to take into clinical trials should be well on its way to being established.
And logically, they stated they needs funds to support the phase 2 SCI trial, funds to advance the OSA program, funds to pay the consultant fees for the epilepsy grant they are hopefully going to achieve, funds for admin/SEC filings. All this and still planning to file for MORE grant funding for ampakines which will need support capital. As well as entertaining in-licensing more compounds which is not free... un huh...
Not a poker player, but I think we can reason a good idea what they have in their back pocket to go forward with... Excited to see how they position everything in the coming weeks and months.. GLTA.
meixatech
5 days ago
As I noted previously CX929 can be orally administered in a recent study with spectacular results reflective of what is discussed here. I can only surmise that RSPI has an even better compound.
September 1, 2006
Ampakines May Reverse Age-Related Memory Loss
Author(s):
Myra Partridge
Ampakines, agents that have been shown to enhance memory, appear to trigger endogenous brain-derived neurotrophic factor (BDNF), a natural mechanism in the brain that could restore neuronal viability and synaptic plasticity through increased trophic support.
A new therapy may reverse age-related cognitive decline, even after the drug has left the body, according to researchers from the University of California, Irvine (UC Irvine). Ampakines, agents that have been shown to enhance memory, appear to trigger endogenous brain-derived neurotrophic factor (BDNF), a natural mechanism in the brain that could restore neuronal viability and synaptic plasticity through increased trophic support.
Because previous studies have demonstrated that hippocampal CA1 basal dendritic field deficits in the stabilization of long-term potentiation (LTP) occur in middle-aged adults, the UC Irvine team, lead by Christine Gall, PhD, professor of anatomy and neurobiology, and Gary Lynch, PhD, professor of neuroscience, focused their study on middle-aged rats. Two groups of rats were treated in vivo twice a day for 8 days; one group received an ampakine, the other received placebo. In the first 4 days, the ampakine-treated rats received injections of saline plus 15% to 20% 2-hydroxypropyl-beta-cyclodextrin. In the next 4 days, they received injections of 5 mg/kg of ampakine CX929, a proprietary compound from Cortex Pharmaceuticals (Irvine, California). When the rats' brains were examined using electrophysiology and protein measures, they showed increased BDNF protein levels in the cortical telencephalon and restored stabilization of basal dendritic LTP.
The results of the study suggest that even brief exposure to ampakines can elevate endogenous BDNF protein levels. Restoration of LTP was found in the rats more than 18 hours after the ampakine had cleared from the animals' bodies. This was significant, according to the authors, because the therapy has a half-life of only 15 minutes. Therefore, they concluded that daily ampakine treatments might have enduring effects.
According to the authors of the study, the results also suggest that neurotrophin levels in the adult brain can be regulated in a way that is minimally disruptive to physiology and behavior. The authors hope that therapies using ampakines may eventually be used to treat age-related memory impairment as well as CNS disorders such as Alzheimer disease and schizophrenia.
The citation for this study is Rex CS, Lauterborn JC, Lin CY, et al. Restoration of long-term potentiation in middle-aged hippocampus after induction of brain-derived neurotrophic factor. J Neurophysiol. 2006;96:677-685.