Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Very, very true and deserves a sticky above all the other BS stickys.
NP has fueled all the irrational speculations with his Naderspeak over the last year in all his BS press releases, proactive videos and CCs. NP virtually instigated all the bad animus towards the FDA by creating false sense of achievement when there was none and then dangling new carrots when caught in the middle of screwups, failures or lies.
NP gotsta go.
Yup, but the MMs been doing that as long as I've been here. So if they didn't feel somewhat good about our direction, IMO, then, yeah, I think it would've tanked more than just 7% after the big run up. I really think we're getting some traction with new investors heading into the next big news drop
definition of a "crash" is not up 28% one day and then down 6.99% the next day. It's all good.
Week 3 reached yet ZERO CEO communication, with the exception of the Philippine video call.
You know what this means:
Trial has Succeeded!, consistent with past « sure thing » promises from the company which ALL magically Steadily Succeeded
Income coming and P/S will reflect! and loser bashers paid by other BPs or nitwit Shorters will have to sell their cars and watch their 'girlfriends/wives/husbands/boyfriends/etc' dump them via Ihub chat board
Difference with last summer:
company now about to payoff all "toxic loans" and Samsung due bills
The rise will be sudden and violent
Well, we already know the safety profile is as good as water, and probably better than the stuff in flint, so, unless you've seen the actual EIND forms filled out with the FDA then how do you know they weren't allowed to give up to 4 shots. It is only afterwards for the ongoing trials that the FDA said to keep it at 2 shots. If you have seen the forms that state they cannot give 4 shots, then post it.....otherwise:
DEBUNKED!
oooh, I wanna play.
Hmmm, 2000's, new technology, beating back competitors wanting to steal tech.... thinking either Nextel? or a GSM new-comer like Powertel in the SE or a Voicestream in the NW?
Humanigen CEO Durrant on Fox talking about Lenz. States they should have final data from phase 3 to FDA by end of the year. Well...of course he didn't talk about all the side effects, but at least he's on a MM outlet talking about his product. He's coherent, didn't yell at Tucker to sell if he doesn't like what he's doing and didn't blame anyone for problems they've run into or milestone missed. So there's that.
I think you are over simplifying a bit... but yes, money in this world tends to get you a little farther down the tracks.
Can totally see your point, but isn't that what the trials are supposed to find out?
So in the case of LL vs Regn for example. Here's 2 mab trials, I don't think Rockleo was referring to this btw, I would wager they were "paying", or investing if it sounds better for you, in their trials versus what we were paying. Combine that with potentially better oversite by their sponsor as well. (I refer you back to our Mexico/mail fiasco)
While I would hope that we would get equal considerations from doctors and hospitals for our trial, I can totally see how Regn 1)being around longer 2)have other approved drugs on the market 3)and pays better.... would look like a better trial than LL. The continual mistakes in management only exacerbates this obvious bias at the trial level. Not being argumentative, just different, albeit very cynical view with CYDY lately.
Can totally see your point, but isn't that what the trials are supposed to find out?
So in the case of LL vs Regn for example. Here's 2 mab trials, I don't think Rockleo was referring to this btw, I would wager they were "paying", or investing if it sounds better for you, in their trials versus what we were paying. Combine that with potentially better oversite by their sponsor as well. (I refer you back to our Mexico/mail fiasco)
While I would hope that we would get equal considerations from doctors and hospitals for our trial, I can totally see how Regn 1)being around longer 2)have other approved drugs on the market 3)and pays better.... would look like a better trial than LL. The continual mistakes in management only exacerbates this obvious bias at the trial level. Not being argumentative, just different, albeit very cynical view with CYDY lately.
PSea, so... if all things are potentially equal as to the effectiveness of 3 different unknown treatments... wouldn't money even be any consideration in your view? I'm not a doctor, but in my mind if there's no clear "winner declared" at the beginning of 3 separate trials, I would think I too would go with the one that funds the best as it would then end the quickest. But again, I'm no doctor. But I do know that's how the world generally works....not just in the trials.
Exactly! SMH, just don't get leadership the last 4-5 months when it comes to finances especially.
Just curious Rockleo, I don't want to put you on the spot for specific costs of your trials, but based upon your experience and given what you know about the Incentive package that was just approved, is that the kind of money that would be needed to push these trials faster? Or are you talking far greater $$'s? Far less $$'s?
I'm in the camp that didn't vote for this package based upon our current situations. But can't help to think that money could've been used better elsewhere like "greasing the wheels" at these trial sites or better comm's or.... you know what I mean.
Likely so, since it's Lilly. Couple of points:
1) The "Proof of Concept" report for their Mild to Moderate Interim look stated that it could reduce the "potential" for hospitalizations. As many have mentioned before, this group of people isn't a huge concern but still significant.
So here's from their recently published "Proof of Concept"
The prespecified primary endpoint, change from baseline in viral load at day 11, was met at the 2800 mg dose level, but not the others. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Additional analyses of viral data demonstrated that LY-CoV555 improved viral clearance at an earlier time point (day 3) and reduced the proportion of patients with persistently high viral load at later time points. Sound familiar?
2) They are behind us by a bit in this same category(M-M), but have more in their study. My question, where is our "Proof of Concept"?
Yup and he didn't butcher the pronunciation either. He said,
"We also continue to accelerate life saving therapies. We're seeing promising results that are Monoclonal Antibodies treatments which help the immune system fight the virus and help, very significantly we're finding, can reduce hospitalizations now by more than 70%"
Sorry if I wasn’t clearer I think my CYDY translator is low on batteries. I meant total time to results is prob 4 weeks out. 2 weeks until end of final patient outcome and another 2 weeks to process.
And yes I agree it should be quicker considering the endpoints being looked at..... but I Also remember a lot of talk from CCs about getting the top line data for the M2M rather quickly also..... and, well I didn’t have my translator then.
Well... I think you need to translate what they actually said into what they actually meant, based purely upon past CCs this year. My understanding is:
1) Nasdaq is to respond next week with further questions, due to our current financial situation. May or may not have final announcement. I think no announcement yet at this stage of the game.
2) Cd-12 results approx 4 weeks. 2 weeks is the end of the final patient outcome. Then comes the "easy computations" of the data. 4 weeks minimum
3) Yes! FDA gave us a 30 day window to resubmit with corrections to the initial BLA filing. Then the 6mo window begins assuming they don't give us another RTF.
Just my translation though, please correct me if my CYDY translator is off. Seems to be a high degree of variations into these translations from what I'm learning this year.
Since Remdesivir got expansion into Mild population does that mean our request for MM EAU does not get approved since there's no "UN-MET NEED"? Or am I confusing this with some other FDA requirement?
I'll play. So what's the tea leaves say about this PR referring to next weeks CC that's going to be 3 trading days away?
1) Great News :) that have to be discussed by all thus not putting out a PR about it today? and if it happens to trap a few shorts thinking it's gonna be the same ole/same ole red week BS type of news....., oops.
2) Real BS News :( that they need time to discuss and come up with some answers for us in order to get thru another week?
3) Just plain, "middle of the road" or "almost there guys" or "no bad-news is still good-news"....etc.? Kinda like NP always said he'd do for us shareholders, be transparent as possible and keep us as updated as possible?
Talk amongst yourselves. PS. If your upset this week about the SP.... take the weekend off, GLTA!
money.... it's all about the money. Just follow and it will expose
You realize he has to pay taxes on the ~323k shares he was alloted....so.... let's all do the math together.... he can sell some of those shares to pay Uncle Sam for the realized gains. Comprende?
yes
just enough to pay taxes on his position. common tactic.
Brief mention by Dr. Nesheiwat on Fox while discussing Eli Lilly Mono-C trial in nursing homes. She just briefly mentions at min 1:25 Regeneron and Cytodyn also doing similar trials.
https://video.foxnews.com/v/6177778741001/
Non Dilutive Funding to help deliver Leronlimab to patients “regulatory pathway for Covid-19 (3 different pathways)
hmmmm.... 1) Mild-Moderate, 2) Severe/Crital ..... 3)"Long Haulers"?
wow! Connecting the dots for next week.....
https://mobile.twitter.com/YoDoctorYo/status/1284315105069539329
Replying to
@YoDoctorYo
Physicians needs to start running cytokine panels on their post-COVID19 patients in the clinic. The body is telegraphing a message and we need to pick it up. If this is true, then leronlimab can treat post-COVID19 symptoms.
#cydy #leronlimab
----------------
My clinical proposal if this is true: Patients get 700mg SQ dose on discharge, then weekly doses of leronlimab until cytokine especially RANTES normalizes.
#rantesnotpanties #cydy
I would be more inclined to agree. I come from the telecom world and anytime there's rumors of mergers, acquisitions, major expansions, etc.... from a business perspective, there's typically some odd silence surrounding "other business plans"/relationships that hasn't become public just yet, from either party. Combine that with the position that CYDY, as a company, is in I believe a little distancing is probably in order until some of these dominos like trials and up listing begin to fall. IMO.
Also, I believe DR BP has a patent pending on his testing mechanisms for Rantes.
https://www.oaoa.com/news/business/article_67ca5126-5944-507a-8372-d07b95109f5a.html
In addition to him possibly looking at the blood work, I'm guessing there may be some future "business relations" about to bud which would require a little distancing at this stage of the game with Cytodyne, FDA approvals, Testing....etc
Liking him more and more. A lot of good info to digest, must watch replay thats for sure. Thought i heard him allude to triple digit sp vs double digit....
Well, if it sounds like I'm confused....it's because I am. How could they go straight from EIND to Phase 3? With less Enrollment numbers than us. The more I investigate these Bio Stocks/FDA regs...etc, the more i just want to blow off some fireworks and some fingers. I'm done. Happy 4th Longs!!!!
------------------------------------------------------------------------
https://www.humanigen.com/press/FDA-Approves-Initiation-of-Humanigen%E2%80%99s-Phase-III-Study-of-Lenzilumab-in-COVID-19-Patients
------------------------------------------------------------------------
FDA Approves Initiation of Humanigen’s Phase III Study of Lenzilumab in COVID-19 Patients
April 15, 2020
Company to Begin Enrolling Patients as Soon as Possible at Several Leading Centers
Phase III study enrollment to focus on adult, hospitalized patients with COVID-19 pneumonia and at high risk of progression to respiratory failure
US multi-center, randomized, placebo-controlled, double-blinded Phase III study which, if successful, may lead to a lenzilumab product approval for COVID-19
Burlingame, CA, April 15, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human GM-CSF monoclonal antibody, announced that FDA has given permission to commence a Phase III study of lenzilumab in patients with COVID-19.
Humanigen plans to enroll patients in a multicenter, randomized, placebo-controlled, double-blinded clinical trial with lenzilumab for the prevention of respiratory failure and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection in COVID-19 patients.
“We are working with some of the top centers and clinicians in the US, alongside our contract research organization partner, CTI, to bring lenzilumab rapidly through this clinical study which, if successful, may reduce serious and potentially fatal outcomes in patients hospitalized with COVID-19 and at high risk of progression,” said Dr. Cameron Durrant, chief executive officer of Humanigen.
“We are pleased with the unprecedented speed with which this program has moved from concept to active trial,” remarked Tim Schroeder, founder and CEO of CTI. “It is a demonstration of both the commitment of the CTI and Humanigen teams and an exceptional level of collaboration between us and our counterparts at the FDA. Everyone is working extraordinarily hard to help bring treatments to patients, and we are proud to be a part of that effort.”
Dr. Durrant continued, “Lenzilumab has demonstrated an excellent safety and tolerability profile in other disease settings, including severe asthma. As the only company that has been working on prevention of cytokine storm through GM-CSF neutralization for nearly three years, we have published extensively in this field and filed extensive IP. We plan to bring this experience to the COVID-19 setting and recruit patients into this Phase III study as quickly as possible.”
More details on the company’s programs in COVID-19 can be found on the company’s website at www.humanigen.com under the COVID-19 tab.
About COVID-19
COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with almost 2 million confirmed cases and over 125,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS), respiratory failure and death.
In severe patients with COVID-19, published research suggests GM-CSF as the key link between pathogenic Th1 cells and inflammatory monocytes, which secrete additional GM-CSF1.
Lenzilumab is a late clinical-stage, monoclonal antibody targeting GM-CSF, a pro-inflammatory cytokine up-regulated in the serum of COVID-19 patients2. The percentages of certain GM-CSF-expressing cells are significantly higher in the blood of ICU-admitted COVID-19 patients compared with healthy controls and more pronounced in ICU-admitted COVID-19 patients versus non-ICU patients2.
1. Zhou Y, Fu B, Zheng X, et al. Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus. Pre-Print. 2020. https://doi.org/10.1101/2020.02.12.945576.
2. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. doi:10.1016/s0140-6736(20)30183-5.
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. The company’s immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, is underway to evaluate the sequential use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma, which is currently enrolling. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline. For more information, visit www.humanigen.com
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com.
Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase III study and the future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe COVID-19 infections or to be approved by FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Black Horse Capital and its affiliates owning more than 50% of our outstanding common stock, including their ability to control the company; our lack of profitability and need for additional capital to conduct the Phase III study and operate our business as a going concern; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.
CONTACT:
Investors and media:
ir@humanigen.com
Did HGEN go directly from eIND to phase 3 clinical starting late April? I thought i saw on CYDY FB page they also had lower enrollment #s for phase 3. Wouldn't that mean they are potentially ahead, at least as far as Phase 3 goes? They certainly have many more $$s from Gillead behind them if it's a close call between CYDY and HGEN.
Well Said!
Well, post your hopes on the Fox News website. Let's flood their site with CYDY and Leronlimab actual results....what we know so far
https://www.foxnews.com/politics/hydroxychloroquine-helped-save-coronavirus-study
That's true and a good power play to get to the table with the big boys if FDA drags their feet, IMO.
yup
well dang, this bioworld article doesn't even mention CYDY. Guess we didn't pay their add fee. Had enough research....
https://www.bioworld.com/articles/436226-snowballing-research-preps-avalanche-to-bury-covid-19
Maybe it's be Immuvance cuz it's easier to say in public?
(joke from another board)
:)
HCQ now with the Ford Study? It's been in the market for decades. Not sure what the results actually are though for that study.
Obviously Remdesevir with the major Fed buy up by Gil. Baricitinib appears to be an existing RA product already available.
Or just as likely the Henry Ford Study on HCQ...save a little face. But in either case, the conversation will shift from Vaccines to Therapeutics where we will eventually shine!