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From other board
President and CEO Myron Holubiak spoke about the company’s four pipeline programs – Milo-Lok, Halo-Lido, Mino-Wrap and iMSC – at the Benzinga Global Small Cap Business Conference on May 13, 2021.
Halo-Lido is a proprietary topical formulation of halobetasol and lidocaine using 505(b)(2) to provide anti-inflammatory and anesthetic relief to people suffering from hemorrhoids.
Mino-Wrap, a malleable, bio-absorbable film impregnated with minocycline and rifampin, is designed to reduce infections associated with the use of breast-tissue expanders (TE) used in breast reconstruction surgeries following mastectomies.
Citius Pharmaceuticals (NASDAQ: $CTXR) partnered with Novellus Therapeutics Ltd. to form the subsidiary NoveCite to develop induced Mesenchymal stem cells (iMSCs), for the treatment of acute respiratory distress.
Mino-Lok, the lead product for Citius, is an antibiotic lock therapy for salvaging catheters that cause bloodstream infections in vulnerable populations. Administered in two vials, one containing minocycline and the other a combination of ethylenediaminetetraacetic acid (EDTA) and ethanal, Mino-Lok is intended to salvage central venous catheters.
“The problem with central venous, particularly in cancer patients and hemodialysis patients, is they become infected, and when they do it’s life-threatening,” Holubiak said during his presentation.
There are about 7 million central lines implanted every year in the United States, Holubiak said, and up to 500,000 can lead to serious bacteremia, which is the presence of bacteria in the bloodstream. These infections are associated with 12% to 25% mortality and morbidity.
It costs a lot of money to deal with a CLABSI (central line-associated bloodstream infection) and the bundled payment system is somewhere in the $50,000 range, Holubiak said.
Of those funds, $10,000 is used for removing and replacing the catheter — two separate procedures.
“That’s where our product comes in,” he said.
Mino-Lok is the first and only therapy under investigation that can be used to sterilize and salvage infected catheters, avoiding all the complications, discomfort and the cost of removal and replacement.
As Holubiak spoke about complications, he displayed figures that showed reported infections occur in 5% to 26% of patients, 5% to 19% of patients experience mechanical complications, and thrombotic, blood clot, complications occur at a rate of 2% to 26%. Holobiak also presented new information that he said people are not yet aware of.
Well over one-half to two-thirds of patients report they have physical and psychological symptoms associated with catheter removal and reinsertion. That information was based on a study conducted by MD Anderson Cancer Center that Citius funded.
Holubiak said with Citius’s program, the catheter is left in and sterilized instead of being removed and replaced. With a detailed diagram displayed, the catheter is filled with Citius’s solution and sits for two hours. The solution dwells in the locked catheter, so it doesn’t drip into the human body. At the end of the two hours it is aspirated and discarded. The line is then flushed with saline and the venous line is reinstituted.
The procedure is repeated over five to seven days, and to date salvaging the catheter has been 100% successful, Holubiak said.
“This is our Phase 2b trial results,” he said. “We took them to the FDA. The FDA was impressed and authorized our Phase 3 study.”
Phase 3, called “Time to Catheter Failure,” looks at 21 versus 38 days in a 42-day period. Holubiak said Citius is well along with the trial and ready for its superiority efficacy analysis, which will happen this quarter.
The company’s drug-monitoring meeting will take place in Q2, 2021 according to the timeline Holubiak provided.
Holubiak closed his presentation with the financial summary of the company, touted its attractive, diversified portfolio to potential investors while highlighting the nearly $104 million banked —enough to fund all the programs Holubiak showcased.
View the entire Citius Pharmaceuticals presentation here, and for more company information visit citiuspharma.com.
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© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
In my opinion, trying to scare weak hands into selling. Have a good day.
I agree, just take a little time. imo.
Their getting cheap shares from weak hands. Soon cheap shares will be gone. imo.
We should be hearing some news soon, on one of the projects I would think.
Thank you for your comments, I do read them.
I agree with you, pure manipulation. When deep pockets get all the shares they want, then up we go up where it belongs. imo.
Good article, thanks.
I agree with you, need to be more transparent. I bought yesterday, and waiting to hear from the company before I purchase anymore. Have a great day.
So did I
That's good, ty for the info.
Powell dosen't see inflation and it looks like he's going to keep interest rates low. That's good for the economy and for the stock market. imo.
Yahoo Finance Morning Brief withh Myles Udland and Sam Ro
Thursday, Mar 18
Why Jay Powell isn't worried about inflation this year
The Federal Reserve on Wednesday upgraded its expectations for the U.S. economy.
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As my colleague Brian Cheung notes: "In its updated Summary of Economic Projections, the FOMC now expects the unemployment rate to tilt down to 4.5% by the end of this year with inflation reaching 2.2%. Three months ago, the Fed expected an unemployment rate of 5.0% by the end of 2021 with inflation missing 2% until 2023."
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GDP growth is also expected to hit 6.5% this year, up from projections of 4.2% just three months ago.
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But with this upgraded outlook for growth and inflation, the Fed's latest interest rate forecast still suggests there will be no rate hikes before the end of 2023. Economist Neil Dutta called this a continuation of the Fed's "passive easing" of monetary policy.
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And so simply put, the Fed does not believe any pricing pressures in the economy will warrant a change in its interest rate policy for the next three years.
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To help explain this thinking, Fed Chair Jay Powell cited dinner norms in his press conference on Wednesday afternoon.
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"There very likely will be a step-up in inflation as March and April of last year drop out of the 12-month window, because they were very low inflation numbers," Powell said. "Those will be a fairly significant pop in inflation, but those will wear off quickly because [of the way] the numbers are calculated."
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"Past that," Powell added, "as the economy re-opens, people will start spending more. You can only go out to dinner once per night, but a lot of people can go out to dinner. And they're not doing that now, they're not going to restaurants, they're not going to theaters...and travel, and hotels, that part of the economy is really not functioning at full capacity." (Emphasis ours.)
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And while the Twitter commentariat had fun with Powell's exact phrasing — apparently the kind of person who watches the entirety of a Fed press conference is also a multiple-dinner enthusiast — the point the Fed chair makes is economically sound.
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The anticipated increase in growth, inflation, and a recovery in the labor market is all part of a one-time recovery story in the U.S. economy. A demand surge against stressed supply chains or understaffed restaurants and bars that results in higher prices this year will not last.
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The dinner is a metaphor.
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No one thinks the economy will grow at 6% for years to come. No one thinks the 7 million or 8 million jobs added back to the economy this year will be repeated next year. And Powell does not think any inflation pressures that result from this unlocking of activity will re-set the current inflation regime.
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Later in the same answer, Powell added, "[Inflation regimes] tend to change over time, and they tend to change when the central bank doesn't understand that having inflation expectations anchored at 2% is the key to it all."
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If you look at 5-year/5-year inflation expectations — which measures inflation expectations over the next 5 years starting 5 years from now — we see they are at exactly 2%. Powell referred to current inflation expectations as "well-anchored" on Wednesday.
Trying to cover their shorts. Most of the market is down, it'll turn around. imo.
I bought more on the dip, the company has a lot in the works, imo
In my opinion it's a good time to add. I picked up 1000 shares at 15.50 and a 1000 shares at 15.13 Have a great day longs!
Could it be shorty might be hurting.
What a joke, watch it climb and learn. imo.
From other board...
CX-101959: Solid Oxide Electrolysis Cells (SOEC) Integrated with Direct Reduced Iron (DRI) Plants for Producing Green Steel
11/17/2020 U.S. DOE: Office of Energy Efficiency and Renewable Energy - Environmental Questionnaire
RECIPIENT: University of California Irvine
Funding Opportunity Announcement Number
DE-FOA-0002229
Procurement Instrument Number
DE-EE-0009249
NEPA Control Number
GFO-0009249-001
CID Number
Rationale for determination:
The U.S. Department of Energy (DOE) is proposing to provide funding to University of California Irvine (UCI) to develop and test a novel solid oxide fuel cell device for use in the production of direct reduced iron (DRI). A prototype system would be developed which would interface a Solid Oxide Electrolysis Cell (SOEC) system with a computer-based setup designed to simulate a traditional DRI furnace. The project would be completed over three Budget Periods (BPs) with a Go/No-Go Decision Point in between each BP.
Proposed project activities would include system design and development, computer modeling, data analysis, SOEC component fabrication, system assembly, performance testing, and techno-economic analysis. UCI would oversee and coordinate all project activities. All project work would be performed at existing, purpose-built laboratory and/or manufacturing facilities. Computer modeling and design work would be performed by UCI at its campus in Irvine, CA.
Prototype development, SOEC component fabrication, and physical testing would be performed by project partners FuelCell Energy and Versa Power Systems at a manufacturing facility operated by FuelCell Energy in Danbury, Connecticut. FuelCell Energy fabricates and tests SOEC components and associated equipment as part of its routine course of business at this location.
Additional computer analysis and design work would be performed by project partners Hatch Associates Consultants, Inc. (Pittsburgh, PA), Laboratorio Energia Ambiente Piacenza (Piacenza, Italy), and Politecnico di Milano (Milan, Italy). Project activities at these locations would be limited to computer-based analysis.
Hardware-in-the-loop (HIL) development would include the installation and testing of hardware at FuelCell Energy’s facility in Danbury, Connecticut. The hardware would consist of a SOEC system and sensor equipment housed within an enclosure measuring approximately 5m x 2m x 3m. This unit would be connected to a DRI simulator. The DRI simulator would consist of a computer system used for process simulations, gas controls/lines, and gas sampling units. The DRI simulator would be housed on a test stand measuring approximately 3m x 2m x 1m. Both the SOEC system and DRI simulator test stand would be assembled for testing within existing laboratory space. No ground breaking activities, facility modifications, or changes to the use, mission, or operation of existing facilities would be required as part of this project. No additional permits or authorizations would be required.
Project work would include the use and handling of reactive gases and laboratory equipment operating at elevated temperatures/pressures. All such handling would be performed at facilities that regularly perform laboratory-based research and/or manufacturing as part of their regular course of business. In order to mitigate potential risks, established health and safety policies and procedures would be adhered to. Protocols would include personnel training, the use of personal protective equipment, engineering controls, monitoring, and internal assessments.
Hazardous substances would be disposed of properly in accordance with established waste management policies. UCI and its project partners would observe all applicable Federal, state, and local health, safety, and environmental regulations.
NEPA PROVISION
DOE has made a final NEPA determination.
Notes:
Fuel Cell Technologies Office
This NEPA Determination does not require a tailored NEPA Provision.
NEPA review completed
https://www.energy.gov/nepa/downloads/cx-101959-solid-oxide-electrolysis-cells-soec-integr
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Ha ha Lol
Bad time to be a short, I wouldn't touch it with a ten foot pole. Long and strong.
I agree, I have enough shares, but couldn't pass it up at this price.
Don't get left behind, don't get greedy.
Added 2460 @ 2.04
How obvious, go Fuel Cell
Shaking weak hands, for cheap shares.
Should of said it adds to their relationship.
Shorts are trying to stop the inevitable. The Department of Energy gave FCEL a 3 million Award project, I'd say that's a big deal. That gives them a good relationship also.
Good for you, I'm all in.
Don't let the shorts cover with your shares. If the supply isn't there they will have to pay much more.
The company is the same company when it hit over $3 and they have good management and Groton should be coming along if not already complete. How about their backlog and more.
Their going to have to eventually buy those shares back, then see what happens.
It's so obvious there are shorts on this board trying their best to keep it down. Here's to us longs, thumbs up!
I like my fcel nice and steady, added today.
It' a nice steady move upward, that's what I like seeing.
Shorts, are you saying uncle yet?
ExxonMobil and Princeton renew partnership to advance carbon capture, fuel cell technologies
By Mary Page Bailey | July 2, 2020
Princeton University is advancing carbon capture technology with new research to better understand how stored CO2 flows within rocks and interacts with minerals, improving the understanding of underground storage capacity. Future CO2 storage projects can be more optimally planned and operated to achieve net emissions reductions.
Princeton University scientists are also working with ExxonMobil on the development of carbonate fuel cells. This is in addition to the company’s ongoing collaboration with FuelCell Energy to enhance technology for capturing CO2 from industrial facilities and electric power generation.
Over the past five years, through the company’s participation in E-ffiliates, ExxonMobil scientists have collaborated with Princeton faculty and researchers to support early-stage research projects that are focused on identifying lower-emission technologies that can accelerate the energy transition. Results have been published in peer-reviewed journals including Nature Geoscience, Science, Applied Energy, Journal of the American Chemical Society, and Energy and Environmental Science.
This will backfire on shorts. Company has to much going for it. imo.
Back in