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I hope the short interest keeps dropping and maybe price will keep rising!! Thanks for the update Lunatick!!!
Well thanks for the find!! I am surprised they have not PR any of this yet! They have been pretty absent from doing any events lately!!
No I did not hear about a failed trail and I do not think you do either because that did not happen!! If you are talking about the NBS10 trail that the street reported as failed and made many misleading remarks about that where not true>> I did hear that BUT if you did your DD you would have known about that!
I think we will have news before 2018 with out a doubt! Maybe a partnership with one of the trails we have going, possibly in Japan! We could have numerous updates that are very positive. To me if I was that negative about a stock I would probably walk away!
PCT, LLC, A Caladrius Company, to Manufacture EU-Compliant Cell Therapy Product for IRX Therapeutics, Inc. From Its New Jersey Facility
September 8, 2015 7:30 AM
ALLENDALE, N.J., Sept. 8, 2015 (GLOBE NEWSWIRE) -- PCT, LLC, A Caladrius Company (PCT), the manufacturing sciences and technical operations subsidiary of cell therapy leader Caladrius Biosciences (NASDAQ: CLBS) and leading external manufacturing partner to the cell therapy industry, announced today that it will expand its current manufacturing capacity at PCT's Allendale, New Jersey facility to support IRX Therapeutics, Inc. (IRX)'s anticipated clinical trial manufacturing needs for the INSPIRE Phase 2b study in head and neck cancer patients. PCT will provide IRX with personnel and dedicated clean room capacity within its current Good Manufacturing Practices (cGMP) infrastructure and, subsequently, pursuant to European Union (EU) cell therapy manufacturing standards.
PCT has been providing manufacturing services since 2008 to support IRX's development of IRX-2, a primary cell-derived biologic with multiple active cytokine components. IRX-2 is a cancer therapeutic designed by IRX to activate a patient's immune system by unlocking the power of immunotherapy to restore immunity and overcome cancer-induced immune suppression. IRX-2 is in late-stage development in a neo-adjuvant regimen for the treatment of head and neck squamous cell carcinoma.
The expanded arrangement includes IRX's use of PCT's ISO Class 6/Class 1,000 clean room system, enabling manufacture of cell-based products that can then be shipped to Europe and, when approved, commercially distributed on the EU market.
"We are pleased to expand our relationship with IRX to manufacture their cell therapy product to EU standards from one of our US locations. The versatility of our operations and our understanding of global regulatory processes provides cell therapy developers like IRX with a distinct advantage as they advance toward commercialization and render PCT the manufacturing partner of choice," said Robert A. Preti, PhD, President of PCT, and Senior Vice President, Development and Technical Operations and Chief Technology Officer of Caladrius Biosciences.
"We are excited to both continue and expand our manufacturing partnership with PCT. With the critical support of PCT's unique expertise and capabilities, we look forward to advancing the clinical and commercial development for our important and promising IRX-2 clinical development program," said Jeffrey Hwang, President and COO, IRX Therapeutics.
About IRX Therapeutics
IRX Therapeutics is a privately held company that develops immune therapies to treat cancer and related diseases. The company's therapies are designed to target and restore the immune system in order to improve a patient's response to next-generation cancer vaccines and novel targeted therapeutics. IRX Therapeutics was founded by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology. The company's product platform under development, which is based on over 30 years of research by Dr. Hadden, seeks to restore the immune system of cancer patients, which is suppressed by the onset of the disease. www.irxtherapeutics.com
About PCT, LLC, A Caladrius Company
PCT, LLC, A Caladrius Company, is an external cell therapy optimization, development, and manufacturing partner. With proven expertise and more than 16 years of experience, PCT supports the advancement of its clients' life-changing medical treatments by mitigating the risks of product development and providing efficient, cost-effective, custom manufacturing solutions to advance clinical development programs. PCT's diverse client base includes leading biotechnology and pharmaceutical companies, as well as academic research institutions. It is the only cGMP-compliant cell therapy manufacturing provider with facilities on both the East and the West Coasts of the United States, as well as the only one to see a client's cell therapy product receive approval from the US Food and Drug Administration for commercial sale. www.pctcaladrius.com
About Caladrius Biosciences
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius combines a leading cell therapy service provider with a development pipeline including late-stage clinical programs based on proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. www.caladrius.com
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Immuno-oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company's wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT, as well as its efforts to expand its capabilities into the cell therapy tools market. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 2, 2015, and in the Company's other periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.
CONTACT: Caladrius Biosciences, Inc.
Eric Powers
Manager of Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
http://www.streetinsider.com/dr/news.php?id=10872201
OMG I could not have said that as well as you did Lunatick!!!I think everybody thanks you for being so informative! At least I do!
The street has been pumping CLBS for the last couple weeks, they put almost the same report out a week ago! I am just a little leery how long this will last! The street seems to put a stock up then it is shorted and it drops. I hope not!!
Can Zacks not make up there mind! LOL follow the dates!!!
Zacks Investment Research, Inc. downgrades CALADRIUS BIOSCIENCES INC from HOLD to SELL.
Investars Analyst Actions - private – 1:09 PM ET 08/28/20
Zacks Investment Research, Inc. upgrades CALADRIUS BIOSCIENCES INC from SELL to HOLD.
Investars Analyst Actions - private – 7:13 AM ET 08/28/2015
Zacks Investment Research, Inc. downgrades CALADRIUS BIOSCIENCES INC from HOLD to SELL.
Investars Analyst Actions - private – 7:13 AM ET 08/27/2015
Zacks Investment Research, Inc. upgrades CALADRIUS BIOSCIENCES INC from SELL to HOLD.
Investars Analyst Actions - private – 7:08 AM ET 08/26/2015
OK somebody said that they are just redoing a warrant they had and do not anticipate using it?
This is what I heard!>>>
Apparently this is a non event. Simply a renewal of the old shelf that was set to expire this quarter. The amount was for the same I believe at $150 million. I think Mazzo said in the last CC that they would not need to take anything off the shelf until maybe next year but there's no guarantee there.
Need to read! I do not exactly what this means! http://www.sec.gov/Archives/edgar/data/320017/000032001715000066/s-32015shelf.htm#sb5ae21315f16417c83feebfc76a79143
It just dawned me!! Pecora has always taken part of his pay in stock, if you look down the sec filings you will see almost every 2 weeks his name listed! Then a couple weeks ago the others bought some, I wonder if they did that because Pecora was leaving to make themselves look good???
Wrote Eric Powers
Ok I wrote Eric Powers and here it is
ME>>Is there a reason they are not telling us why Andrew Pecora, MD resigned or was resigned?? This is ridiculous that a week later everybody is left hanging?? I know we are just investors but a little news will help!
Erics answer>>>>Andrew Pecora is not leaving as a Director. We have replaced him as medical director for PCT with a dedicated MD internally. Dr. Pecora’s full-time position is with Hackensack University Medical Center as it has been previously.
Eric Powers
I am hoping they make a announcement on Monday to let us know what is going on. I hope it is not for health reasons that he has left!
It pisses me off that they never announce anything! This happened 4 days ago, it must have been very unexpected! Who in his position gives two weeks notice??? He always seemed very enthusiastic on his position, they usually have a 3 to 6 month notice, this is 2 weeks! Something happened just my opinion. I also dislike the fact they get paid all there options for another 3 yrs??? Just has to stay on the board then they have to pay somebody else to fill his position, just like Robin! A lot of money going nowhere!
WOW nice find Lunatick! Thanks for the post found it really interesting!
I hope this is worth at least $10 LOL they all say $14 but we can not keep $2! Thanks for the post, It keeps me hoping!
YES and every time I see it I get pissed!! It is almost like CLBS has become a day traders dream! Sell in the morning and buy when it goes down at night! I know what the street does and I think they should get in trouble for manipulation! They short a stock then come out with a big BS story to make it go down and they do this constantly with a lot of stocks!
I posted that article from the Street a couple days ago, this is why I do not like them!! That stock went up fast then back down! I do not know for sure but I think they publish those articles, 1. BUY a lot of the stock 2. publish article about a break out(even if there is no reason for one) 3. wait till it goes up 4. SELL what they bought, just my opinion!
Vater just bought another 12,345 shares of stock??http://archive.fast-edgar.com/20150813/AOAJF62CZZ22JZZZ2H9P2ZZI6BQNZB22Z272/
I agree! I thought people would wait till after the earnings to get in! Earnings on CLBS always seem to lower the price! I know my sister took advantage of the price! I could not afford anymore for me!
Thanks for the post! I hope it does!!
That is a lot of shares!!!
I only have a minute got to scoot but yes they have decided to not continue with CLBS 10???? All I ever heard was how good the results where so I am totally out of it on why they decided to stop this trail!
SPEECHLESS!
Correction: Caladrius Biosciences Announces Second Quarter 2015 Financial Results Conference Call
New York, August 6, 2015 -- Caladrius Biosciences, Inc. ("Caladrius") (NASDAQ:CLBS), a cell therapy leader with a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and regenerative medicine, announced today that it will report its financial results for the second quarter ended June 30, 2015 today, August 6, 2015. Dr. David J. Mazzo, Chief Executive Officer, and Robert S. Vaters, President and Chief Financial Officer, will discuss results and provide a company update via a webcast and conference call on today, August 6, 2015 at 4:30 pm ET.
To access the webcast, visit the Investor Relations section of the company’s website at http://www.caladrius.com/investors/overview/. Alternatively, callers may participate in the conference cell by dialing 877-562-4460 or, for international callers, 513-438-4106, and providing conference ID 95197846. Please note that the earlier conference ID provided was incorrect.
An archive of the webcast will be available approximately two hours after the completion of the call. To access the archived webcast, visit http://www.caladrius.com/investors/news-events/events/.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. www.caladrius.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Immuno-oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company's wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT, as well as its efforts to expand its capabilities into the cell therapy tools market. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 2, 2015, and in the Company's other periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.
So what do you see in our future now?? I appreciate your post and advice even if it not the way I wanted it to go! LOL
I agree, it does have a lot going for it that is why I have been in it for 3 years now!
This is just more than frustrating! It is unbelievable! People are baling before the earnings and causing this stock to tank! I have to hold out at least till earnings incase they have a surprise! I hope I will not regret this!
Ok found trail IT IS NOT CLBS
>>>>https://clinicaltrials.gov/ct2/show/NCT01299324?term=retrograde%20coronary%20sinus%20infusion&rank=1
Really good article Lunatick, I just wish CLBS would publish some of these for everyone to see! It seems we have to dig deep for these articles that are at CLBS's fingertips! I honestly feel if they would get these articles out or post on there site the PPS would do better!
Lunatick, First I want to thank you for all the wonderful finds you have posted over the last couple days! I was gone for a couple days and just reading them today!
I do not know for sure BUT it looks like CLBS! I hope they have something more up there sleeve! I have gotten to the point I am afraid of good news, LOL Every time something good happens the PPS falls????
I honestly do not know! I wish I did! I know the earnings in the past have not been good! There is always that surprise element that could come into play! They could announce really good news, a partnership! I think I am just as scared as ever with the PPS this low!
Caladrius Biosciences Announces Second Quarter 2015 Financial Results Conference Call
NEW YORK, July 30, 2015 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. ("Caladrius") (NASDAQ:CLBS), a cell therapy leader with a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and regenerative medicine, announced today that it will report its financial results for the second quarter ended June 30, 2015 on Thursday, August 6, 2015. Dr. David J. Mazzo, Chief Executive Officer, and Robert S. Vaters, President and Chief Financial Officer, will discuss results and provide a company update via a webcast and conference call on Thursday, August 6, 2015 at 4:30 pm ET.
To access the webcast, visit the Investor Relations section of the company’s website at http://www.caladrius.com/investors/overview/. Alternatively, callers may participate in the conference call by dialing 877-562-4460 or, for international callers, 513-438-4106, and providing conference ID 95197846.
An archive of the webcast will be available approximately two hours after the completion of the call. To access the archived webcast, visit http://www.caladrius.com/investors/news-events/events/.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. www.caladrius.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Immuno-oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company's wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT, as well as its efforts to expand its capabilities into the cell therapy tools market. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 2, 2015, and in the Company's other periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.
I am hoping after the earnings which may bring it down there will be a up swing!
I hope it continues! We need people to keep interest in this stock! It is such a exciting company!
There was none! I asked the same question and they answered me they thought they where on another board!
Caladrius, PCT and TrakCel to Drive Cell Therapy Manufacturing Excellence
Companies will Collaborate on Cell Therapy Management Technology Implementation
July 28, 2015 05:00 AM Eastern Daylight Time
CARDIFF, Wales--(BUSINESS WIRE)--TrakCel Ltd. today announced a collaboration agreement with Caladrius Biosciences, Inc. (Nasdaq:CLBS) and its subsidiary PCT, a Caladrius Company (PCT) to implement its cell therapy process management and supply chain integration technology.
“We’re looking forward to collaborating with PCT as it strives to provide innovative solutions to its clients.”
TrakCel’s technology integrates and automates the entire cell therapy process end-to-end while providing real-time audit logs and chain-of-custody records to stakeholders. It further reduces the implementation risks associated with disparate, paper-based systems as TrakCel technology accelerates scale up and scale out of cell therapy processes through immediate access to data for validation and regulatory audits.
Dr. Robert A. Preti, President of PCT and Senior Vice President, Development and Technical Operations and Chief Technology Officer of Caladrius Biosciences said: “We’re committed to providing our clients with industry-leading cell therapy manufacturing founded on exceptional facilities, processes and people. TrakCel’s innovative technology holds significant potential and we are looking forward to realizing its benefits in the near future.”
PCT and TrakCel will undertake in Q4 2015 a design specification stage prior to implementing a customized cell therapy process management solution based on TrakCel’s technology.
“PCT has an unparalleled pedigree in contract manufacturing with over 16 years’ industry experience and over 30,000 products created,” said Kevin Smith, Director, TrakCel. “We’re looking forward to collaborating with PCT as it strives to provide innovative solutions to its clients.”
PCT has full-scale cGMP/GLP operations in New Jersey and California, thousands of square feet of Class 10,000 clean rooms, and full QA/QC support. The company has had over 100 clients whose products have treated over 6,000 patients.
The collaboration agreement supports UK-based TrakCel’s strategy to expand into the US market, and comes ahead of the company’s plan to establish US offices in 2015.
• ENDS -
http://www.businesswire.com/news/home/20150728005082/en/Caladrius-PCT-TrakCel-Drive-Cell-Therapy-Manufacturing#.VbdSPL7D-M9
I hope some other really good news comes out before earnings!