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.
We're green!
LOL I like that approach
Legally Im pretty sure a public company will have to at least entertain any offer that can create value for shareholders
Here are the analyst coverage days:
Anthony Butler Roth Capital: October 1st 2020 - $25 price target
Joseph Pantginis H.C. Wainwright: October 14th 2020 - 31$ Price target
Louise Chen- Cantor Fitzgerald: October 21st 2020- $25 Price Target
Olga Smolentseva Bryan Garnier: October 22nd 2020 - $30 Price Target
Share Price rose modestly after Anthony Butler in Pre Market but then settled down. Went up pretty significantly after Joseph Pantginis but that was day after NIH PR.
There are obviously some firms/analysts that will have more sway then others. Anyone think JP is considering coverage? I understand they were in some sort of quiet period as the head underwriter but not sure when that ends - however its been 1 month today since the closing of the offering.
Olga Smolentseva is located in France. I guess we are getting some international coverage
Also I am not sure if JP Morgan would be interested in covering us, but it has been exactly a month today since the closing of the public offering so the quiet period for them should be ending.
New $30 price target you can cross Olga Smolentseva with Bryan, Garnier & Co off your list Knuckle.
This probably explains the sudden short attack this morning
Another bit of information I found on the Crispr Therapeutics Car-T trial:
"Three patients developed moderate cytokine release syndrome, an immune-based side effect often associated with CAR-T therapy."
Im just speculating here but I find it interesting since Humanigen stated they are not locked into just collaborating with Kite on this. Crispr is one of the most hyped up Biotech companies right now and a collaboration with them would be very validating. They are also collaborating with Vertex already who has billions in cash at their disposal
ok thanks for clarifying
Can someone with a science background give some insight here. Was looking at the Crispr results from their Phase I Car-T trial and I saw the following quote:
"One patient received Dose Level 4 of CTX110. On Day 5, the patient experienced Grade 2 CRS which resolved in 5 days. The PET/CT assessment at Day 25 showed the patient had achieved a complete response. The following day, the patient was hospitalized with febrile neutropenia and developed symptoms of short-term memory loss and confusion. The symptoms eventually progressed to significant obtundation that required intubation. He was initially treated for ICANS with steroids, anakinra and intrathecal chemotherapy without improvement. The patient was later found to have reactivation of HHV-6 and HHV-6 encephalitis and treated with antiviral therapy. The decision was made to withdraw supportive care and the patient died 52 days after CTX110 infusion."
Is this a situation where an antibody like Lenz could have helped the outcome? If so I know management said the collaboration with Kite is not exclusive and they can potentially partner with other companies on the same indication
Investment Summary. We are initiating coverage of HGEN shares with an OW rating
and 12-month PT of $25. We arrive at our PT by using a DCF analysis. HGEN's lead
product candidate, lenzilumab, is a mAb designed to neutralize GM-CSF. We expect
upwards earnings revisions from the successful commercialization of three indications
for lenzilumab to drive HGEN shares higher. These include the use of lenzilumab: 1)
As a therapy for hospitalized patients with COVID-19 pneumonia, and Phase 3 data are
expected in 4Q20; 2) As a sequenced therapy ahead of CAR-T administration, Phase 1b
ZUMA-19 results are expected 1Q21; and 3) As an early treatment/prophylaxis for SRaGvHD, HGEN will complete planning for a registration study in the UK 4Q20 and begin
enrollment in 1H21.
¦ Expecting positive Phase 3 data for COVID-19 opportunity. Lenzilumab could be the
first antibody approved for cytokine storm associated with COVD-19, and HGEN could
make up to $1B in sales in 2021, if the drug is given EUA. We are expecting HGEN
to report positive, Phase 3 data 4Q20. This is supported by the published data from
the Mayo Clinic. The Mayo data was from a 39-patient case-controlled study. Twelve
patients were treated with lenzilumab and were compared to 27 similar patients
on SoC. The data showed that: 1) The time to clinical improvement was shorter
for lenzilumab: 5 days vs. 11 and 2) Ventilator-free survival was much better for
lenzilumab vs. SoC. HGEN is also participating in the NIH-sponsored ACTIV-5/Big Effect
Trial. These data will likely read out in 1H21. Importantly, lenzilumab is a 1-day course
of therapy that compares favorably to Remdesivir, which runs ~5 days. Finally, a paper
published on 10/14 (link here) adds more weight to GM-CSF as a target for COVID-19.
See our COVID-19 mAb tracker here for more details on the competitive landscape.
¦ Lenzilumab could change treatment paradigm & expand market for CAR-T. There is
evidence linking early elevation of GM-CSF to serious and potentially life-threatening
side effects in CAR-T therapy (neurotoxicity and CRS). Pre-clinical lenzilumab data
have supported its potential to prevent CRS and significantly reduce neurotoxicity,
and have shown an increase in CAR-T cell expansion when lenzilumab is administered
prophylactically in combination with CAR-T. This could expand the use of CAR-Ts
and the market opportunity for lenzilumab. There are currently no FDA-approved
therapies for the prevention of the serious side-effects associated with CAR-T. Positive
data could support putting all/most CAR-T patients on sequenced therapy with
lenzilumab. HGEN is collaborating with Kite/GILD (OW, covered by A. Young) on the
ZUMA-19 study. HGEN's goal is to complete the Phase 1b part this year and move
into the Phase 2 study next year. HGEN is also looking to study sequencing lenzilumab
ahead of other CAR-T therapies.
¦ Lenzilumab could change treatment paradigm for SR-aGvHD. Recent studies have
found GM-CSF to be an important pathogenic cytokine in aGvHD. Donor T cells that
secrete GM-CSF promote GvHD by recruiting donor dendritic cells, which amplifies the
activation of alloreactive T cells and increases the severity of GvHD. Therefore, GMCSF neutralization has the potential to prevent or treat GvHD in patients undergoing
allogeneic HSCT. HGEN has been approached by a group called the Impact Partnership,
which is a partnership of 23 transplant centers in the UK that treat the majority of
UK patients and also run clinical trials as part of the network. ~50% of all patients
with aGvHD will be intermediate/high risk of SR-aGvHD and would be eligible for
lenzilumab based on the IMPACT protocol. If successful in early treatment of SRaGvHD, HGEN would look to position lenzilumab as prophylaxis of aGvHD with further
clinical development.
Its already on Tipranks: https://www.tipranks.com/analysts/louise-chen
Am I good or what? This was from last Wednesday
Now saying up to 5 sites in Mexico. I believe that is new.
Thought some of you may be interested in this twitter exchange I had via direct message with Adam Feuerstein from Stat. This was after I sent him a link to the Bloomberg article to see if he had seen it
"Thx. i passed on the same story. not interested in writing about another Covid penny stock until data."
I am rather interested in how these stories get shopped. Does someone from the company reach out to various news outlets or is this a large institution pushing this to the major outlets to garner more attention?
Can't really fault Feuerstein for passing on the story, he is a top journalist in the space and probably doesn't give much attention to small cap equities
Biotech investor Dale Chappell was looking to start Humanigen Inc. with a clean slate when his hedge fund assumed control in 2016, but things took longer than expected.
The stock has swelled over 500% this year after positive early results from an experimental treatment for a potentially lethal side-effect of Covid-19. The shares have been volatile since July when it reached a more-than four-year high, though results expected this quarter from a late-stage study may be the ticket to keep Humanigen on track after a roller coaster ride.
Dale Chappell
Dale ChappellSource: Humanigen Inc.
Chappell, who has a medical degree from Dartmouth College and served a fellowship with the National Cancer Institute, saw promise in the pipeline of Humanigen, then known as KaloBios, when he first took a stake in 2016. Investors may remember KaloBios as a company teetering on the edge of bankruptcy before the now disgraced and jailed Martin Shkreli swept in and took it over in 2015. Shkreli’s one-month stint as CEO left the company badly scarred before it fell into insolvency.
That’s when Chappell and the fund he founded, Black Horse Capital LP, stepped in to provide financing to get the company back on its feet.
“Maybe naively, I thought that reputational damaged could be fixed pretty quickly with a change in management and board,” Chappell said in a phone interview. “It’s taken a long time, but I think we’re now on the other side of that.”
Along with being Humanigen’s top holder with a 27% stake as of Sept. 18, he’s also the California-based company’s chief scientific officer who once studied the mechanism behind its lead drug candidate.
Cytokine Storm
The medicine, a lab-made molecule known as lenzilumab, targets inflammation and an extreme immune response called cytokine storm. Results from a Humanigen-sponsored study in 300 hospitalized Covid patients are expected this quarter. Lenzilumab was also selected for testing in combination with Gilead Sciences Inc.’s remdesivir by the U.S. National Institutes of Health. The agency-funded study is looking to speed up development of promising medicines for Covid-19.
If positive, results from Humanigen’s study could be enough for an emergency authorization from U.S. regulators and the biotech has manufacturing pacts in place with Thermo Fischer Scientific Inc., Catalent Inc. and the Swiss Lonza Group AG to ramp up production if an authorization is granted.
The company also recently moved up the food chain to the Nasdaq Capital Market after years trading over-the-counter. Since the move, two analysts kicked off coverage of Humanigen, both with a buy rating and more initiations may follow. All of this should be good news for shares, which have pulled back 40% from its July high because some investors had expected a faster move to the Nasdaq.
Perceived delay in Humanigen's move to Nasdaq dented stock rally
“I wouldn’t focus so much on the stock price, look at the execution since we’ve moved into Covid-19, one of the most competitive areas of all of biopharma,” Chappell said, pointing to the company’s manufacturing contracts and advancement to late-stage study.
Chappell is looking for the Phase 3 trial to show lenzilumab gets patients out of the hospital in roughly six days, while the control arm -- where patients receive the current standard of care will likely take about nine days to recover. A much smaller study run by the Mayo Clinic showed patients getting lenzilumab recovered in five days.
Furthest Along
Other companies are also working on similar treatments although Humanigen appears furthest along. Shanghai-based I-Mab, as well as another entrepreneur-backed company, Vivek Ramaswamy’s Roivant Sciences are testing medicines that also target granulocyte-macrophage colony-stimulating factor, a substance that spurs on the production of white blood cells.
A mid-stage study of a medicine from Kiniksa Pharmaceuticals Ltd. in Covid patients with pneumonia and hyper-inflammation will also have results in the fourth quarter. GlaxoSmithKline PLCis testing otilimab in Covid patients with severe pulmonary disease and expects results early next year.
Lenzilumab has an edge as Humanigen has been developing it for the past four years for cytokine release syndrome, according to Chappell. It’s also being tested in a partnership with Gilead’s Kite for use with CAR-T cancer medicines which are known to trigger the immune overreaction.
“We’re all trying to make an impact on this pandemic; there’ll probably be more than one solution,” he said. “I don’t think that we should be thinking about this as a winner-take-all type of strategy.”
I have as well. Might try to get it on another device and post here
Im not seeing anything on Fintel yet, so probably pretty new.
Countown Jay, I just emailed IR about this and will let you know if they give me an explanation. I must admit its a bit confusing.
Dont forget firemisleading!
What do your guys make of the Eiger trial results?
https://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-announces-positive-results-of-investigator-sponsored-randomized-controlled-trial-at-university-of-toronto-with-peginterferon-lambda-in-outpatients-with-mild-to-moderate-covid-19-301152862.html
I suspect Cantor Fitzgerald will be next
Yea we know. Were referring to the Wells Fargo Analyst who was on the last investor call. He is one of the best in the business.
Is he the Wells Fargo analyst?
I'd personally stick to shares with such low volume on those options...
New to this board. Hi huys just started reading about Mindmed and am very interested in the concept. Sorry if this is a stupid question, but lets say their trials with LSD are successful. Do they own the licensing on LSD? HOw do they make money off of this- do they control the rights to use LSD for certain indications?
You could be right. I've noticed H.C. Wainwright is pretty timely about their reports. Im sure they have had a bunch of conversations with management. Keep in mind they initiated coverage on Sorrento with a PT of $30 right before they announced licensing a saliva test from Columbia University. I would not be surprised to see a PR about enrollment either after hours today or before market open tomorrow - but keep in mind this is just speculation
WOW, did not see that coming. Lily trial paused
https://brief19.com/2020/10/13/monoclonal-antibody-trial-halted-for-safety-concern
Not really their fault though... they had to wait on approval from the FDA who had record breaking number of trials in the pipeline
https://www.marketwatch.com/story/nih-to-test-abbvie-boehringer-ingelheim-drug-in-combination-with-remdesivr-2020-10-13?siteid=yhoof2&yptr=yahoo They are giving us no respect here...
NIH to test AbbVie, Boehringer Ingelheim drug in combination with remdesivr........................................................................................................ oh and by the way the Humanigen Inc.'s lenzilumab will also be part of the trial
Try emailing them the more people the better
madmoney@cnbc.com and also fastmoney-web@cnbc.com
Fast Money did a great interview with Altimmune yesterday
One of the major news wires will pick up this story. Too many smart people following therapeutic updates for them not to
Im a buyer here. I think IR needs to do a better job of promoting the NIH PR. Perhaps another on air interview is instore.
I was thinking the same thing
If you want to know the power of a CNBC plug. Look at what Altimmune is doing after a brief interview on Fast Money last night. HGEN needs to do more media interviews. BTW anyone of have any opinion on Nasal Vaccines?
I feel like management should PR this
Whats up with the Portuguese tweets? Do we have Brazilian investors?
Yes, that was the reasoning for the expansion into Mexico, but this seems different.. especially so late into the trial. They have other sites that have a similar demographic makeup to the DC site.
Just pure speculation here, but perhaps this is an inclination that NIH trial is about to start? Opening a new site in D.C. in very close proximity to NIH headquarters in Bethesda Maryland.
We can assume that phase III trial is pretty close to complete now, so why open up a new trial site unless it is to be used for the NIH trial as well? I could be completely crazy.. but it kind of makes sense.
We are pleased to announce we’ve added MedStar Washington Hospital Center @MedStarWHC to our study sites participating in our Phase 3 study of lenzilumab in patients with COVID-19.
— Humanigen, Inc. (@humanigen) October 8, 2020
Please visit our website to locate a clinical site near you.https://t.co/nDPb48IacU$HGEN
Is there anyway we can keep the discussion here to Humanigen diligence and commentary?