Lisata Therapeutics Inc (LSTA)

[Ruffieruff]

Believe it’s a little higher than that. Still quite small. We need some news. Looks like profit takers now.

[MWM]

$CLBS With this kind of volume I bet we see a Big Gapper in the Morning!

[jaj-dan]

That’s just ridiculous. LOL!!

[jaj-dan]

$3 break!

[MWM]

Ibox is all pretty now...

[MWM]

$CLBS Outstanding as of May 6th,2020 12,840,403

[MWM]

$CLBS $5 coming back!

[MWM]

Going to grab the mod spot and clean her up...

[MWM]

Chart looks great

[MWM]

$CLBS really moving now! Such a tiny O/S of 12 million! Could explode in this environment...

[jaj-dan]

Hello!!!!! I’m just about out of messages for today!

[MWM]

On watch

[been there]

CLBS... Also has option trading available.

[F1ash]

BASKING RIDGE, N.J. (August 2, 2018) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces that the Company will release financial results for the three and six months ended June 30, 2018 after close of the U.S. financial markets on Thursday, August 9, 2018.

Caladrius’ management will host a conference call for the investment community beginning at 4:30 p.m. ET on Thursday, August 9, 2018 to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing [phone] (domestic), or [phone] (international), and providing conference ID: 8899285. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate on the live conference call, a replay will be available through August 15, 2018, and can be accessed by dialing [phone] or [phone]. All listeners should provide the following replay access code: 8899285.

The webcast replay will be archived on the Company’s website for 90 days at www.caladrius.com.

[TuiTui509]

Runs up again!! Go longs.

[TuiTui509]

Might be pulled back to sub 6 if support is gone.

[ClayTrader]

* * $CLBS Video Chart 06-20-18 * *

Link to Video - click here to watch the technical chart video

[crudeoil24]

On target! > Up 63% in PM.

[TuiTui509]

Up up big time. This will explode today.

[davidsson10]

And the easy money continues.....

[TheAnnointedOne]

Bought in at 5.16. 1500 shares. Still in, let’s see what tomorrow brings.

[TuiTui509]

This will gap up big. But from my experience this is where most companies will announce another round of offering at a discount to some PIPE investors if they need additional funding.

I would say there is a chance this will sell off tomorrow. I banked mine taking 100% profit from 8 month ago. Left a bit just to see if this will rock out the sky.

[ClayTrader]

* * $CLBS Video Chart 06-19-18 * *

Link to Video - click here to watch the technical chart video

[TheAnnointedOne]

What a monster. $10 tomorrow.

[TheAnnointedOne]

Right, I underestimated this.

[TuiTui509]

It runs to $7 today. Tomorrow $7 is the bottom.

[TheAnnointedOne]

I’m betting the bank, that his runs to $7 tomorrow.

[TuiTui509]

Thanks and sorry did not do any DD lately. What would be the impact of this deal on the share price?

Thanks

[F1ash]

Caladrius Receives FDA Regenerative Medicine Advanced Therapy Designation for CD34+ Cell Therapy for Treating Refractory Angina

BASKING RIDGE, N.J. (June 19, 2018) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces today that that the U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to the Company’s late-stage CD34+ cell therapy program for the treatment of refractory angina.

The FDA grants the RMAT designation to regenerative medicine therapies intended to treat a serious condition for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition. The RMAT designation affords regenerative therapies the advantages of expedited development and review of marketing applications as are available to drugs that receive breakthrough therapy designation, including increased meeting opportunities, early interactions to discuss potential surrogate or intermediate endpoints, shortened biologics license application (“BLA”) review times and the potential of accelerated approval.

“We are delighted and encouraged that the FDA has recognized our CD34+ cell therapy program with an RMAT designation. Refractory angina is a serious condition with high morbidity and no known effective treatments. We look forward to working with the FDA to define a path to registration for our therapy with the aim of providing expeditious treatment to patients suffering from this condition,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.

Caladrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire plc in March of this year. The acquisition included the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. This includes manufacturing procedures, preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.

[TuiTui509]

What happened today?

[senderos]

Market cap = share price x O/S shares.

[F1ash]

Here is something about this company that I just cannot understand.

How in the world can the market cap only be ~$36 million when they have more cash on hand than that figure.


“As of December 31, 2017, Caladrius had cash, cash equivalents, restricted cash and marketable securities of $60.1 million
compared with $7.1 million as of December 31, 2016. During 2017, the Company received gross proceeds of $79.4 million from the sale of PCT and $5.7 million in proceeds from stock issuance...”

It just makes no sense to me.

[Chess Master]

Seems like a robust trial design. Looking forward to the conference call to see if they talk about it more

[F1ash]

BASKING RIDGE, N.J. (March 13, 2018) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiovascular indications, announces today that the first patient has been dosed in the Company’s Phase 2 clinical trial in Japan with its proprietary CD34 cell therapy (CLBS12) for the treatment of no-option critical limb ischemia (“CLI”).

This trial is a 35-patient prospective, randomized, controlled, multicenter study. Patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34 cells (CLBS12) through intramuscular injection, in addition to receiving standard of care pharmacotherapy. Patients randomized to the control arm will receive standard of care pharmacotherapy alone. The primary endpoint is time to continuous CLI-free status, defined as two consecutive monthly visits in which the patient is determined by an independent adjudication committee to be “CLI-free”.

Based on discussions with the Japanese regulatory authorities and in accordance with the Japanese Pharmaceuticals and Medical Devices Law passed in November 2014, the Company believes that, with favorable results, the study will qualify for consideration of conditional approval for CLBS12 in Japan for the treatment of no-option CLI. The noted legislation expedites the development and commercialization of regenerative medicine therapies and grants conditional approval for regenerative medicines that demonstrate evidence for safety and the likelihood for efficacy.

“We are delighted to have dosed the first patient in this pivotal trial of CLBS12 in no-option CLI in Japan. As we previously reported, the study protocol and Chemistry, Manufacturing and Controls (“CMC”) strategy for the trial both were constructed in consultation with the Japanese Pharmaceutical and Medical Devices Agency. Based on those discussions, it was agreed that, should this trial be successful, it will qualify CLBS12 for consideration of early conditional approval in Japan for this indication,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “The study has a clinically relevant yet practical endpoint, time-to-CLI-free status, that encompasses a broader spectrum of improvement than do time-to-amputation or amputation-free survival, which are the historical endpoints in CLI studies.”

Commenting on the study, Douglas W. Losordo, M.D., FACC, FAHA, Senior Vice President of Clinical Medical and Regulatory Affairs and Chief Medical Officer of Caladrius, noted, “Our enthusiasm for this program is based on previous studies of autologous CD34 cell therapy for no-option CLI patients in both Japan and the U.S. suggesting that CD34 cell therapy was safe, led to improvement in CLI-free status and improved amputation-free survival.”1,2,3
____________________________
1 Losordo DW, et al; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30.
2 Kawamoto A, et al. Intramuscular transplantation of G-CSF-mobilized CD34(+) cells in patients with critical limb ischemia: a phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial. Stem Cells. 2009 Nov;27(11):2857-64.
3 Fujita Y, et al. Phase II clinical trial of CD34+ cell therapy to explore endpoint selection and timing in patients with critical limb ischemia. Circ J. 2014;78(2):490-501.

“With favorable data, we expect to pursue a commercial partnership for CLBS12 as a treatment for no-option CLI in Japan. We view CLI as the entry point to explore the broader applicability of CD34 therapy, which could potentially offer us significant opportunities across multiple underserved cardiovascular indications,” added Dr. Mazzo.

[akasidney86]

Anybody know why Shire wouldn't file it's own NDA with the FDA? What special sauce does CLBS have that they don't? I know that CLBS has a lot of knowledge with 34+, but ?. Either the data will support a filing or it won't as far as I know.

Also, any thoughts on the news out this morning? "Remains a statistical possibility"... not exactly a ringing endorsement, but not much I can do as I can't/won't sell until the fat lady sings in any event.

[F1ash]

BASKING RIDGE, N.J. (March 6, 2018) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces today that the Company acquired from Shire plc (LSE: SHP, NASDAQ: SHPG) an exclusive worldwide license to data from a late stage CD34+ cell therapy program for the treatment of chronic myocardial ischemia targeting refractory angina. Under the terms of the agreement, Caladrius acquired the exclusive worldwide rights to the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. In exchange, Shire will receive undisclosed up-front consideration, milestones and a royalty on product sales.

The comprehensive data set that Caladrius licensed includes preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.

The program is supported by data from 3 randomized placebo controlled trials. A recent publication in the European Heart Journal, entitled “Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials” combines the data from all three studies encompassing over 300 patients and reveals statistically significant improvements in mortality, exercise capacity and chest pain frequency. (See the publication at https://doi.org/10.1093/eurheartj/ehx764.)

“Prior to joining Caladrius, I designed and was principal investigator of the Phase 1 and Phase 2 studies of this CD34+ therapy that were conducted with the support of Baxter. I also designed and launched the Phase 3 study at Baxter prior to its spinoff of Baxalta and Baxalta’s subsequent merger with Shire. Given my intimate knowledge of this clinical program, I am very excited by our acquisition of this data license and remain positive about the prospects for this therapy as a treatment for patients suffering with refractory angina,” stated Douglas W. Losordo, MD, FACC, FAHA, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer of Caladrius. “Preclinical studies have established the mechanism of action of CD34+ cell therapy in restoring microcirculation and improving myocardial tissue perfusion and clinical trials have shown clinical benefit in a patient population that had exhausted all other available therapeutic options. We believe that the growing body of clinical data in support of CD34+ cell therapy as a treatment for refractory angina is very encouraging and we believe that Caladrius is uniquely positioned to advance this late-stage program through to potential regulatory approval.”

“This transaction offers an ideal opportunity for Caladrius to obtain a promising late-stage development asset complementary to our existing pipeline of CD34+ cell therapy development programs in ischemic repair,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “This program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the U.S. alone, with an incidence rate of 50,000 to 100,000 annually. We look forward to discussing with the FDA the most expeditious regulatory path aimed at registration for this CD34+ cell therapy program and to bringing this potentially restorative therapy to patients in need.”

About Refractory Angina

It is estimated that as many as one million people in the United States have chronic symptomatic coronary artery disease (often referred to as refractory angina) that is recalcitrant to medical therapy and unamenable to conventional revascularization procedures. Patients have reproducible lifestyle-limiting symptoms of chest pain, shortness of breath, and easy fatigability. These symptoms are often due to totally occluded coronary arteries or diffuse coronary atherosclerosis that makes revascularization problematic. As the population ages and the incidence of diabetes mellitus increases, this clinical condition will become more prevalent. Patients with this condition have significant morbidity and experience a lower quality of life.

[F1ash]

BASKING RIDGE, N.J. (January 18, 2018) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces the completion of enrollment in The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial of 110 patients to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (T1D).

CLBS03 is a personalized autologous cell therapy consisting of each patient's own regulatory T cells, or Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed through a collaboration with Jeffrey Bluestone, Ph.D. and renowned researchers at the University of California, San Francisco. Caladrius holds exclusive rights to an international portfolio of issued and pending patents related to this product.

CLBS03 as a treatment for T1D has U.S. Food and Drug Administration (FDA) Orphan Drug designation, European Medicine Agency Advanced Therapeutic Medicinal Product classification and FDA Fast Track designation, which represents the first T1D program to receive this distinction.

“Completion of enrollment in the landmark T-Rex study is a significant achievement for Caladrius. This program is supported by earlier work conducted by leaders in the field who demonstrated Treg cell therapy to be well tolerated, durable and preserving of beta cell function in children. These data were published in Clinical Immunology and supportive two-year follow-up data from this study were published in the Journal of Translational Medicine,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We look forward to reporting the topline data from the primary endpoint of the completed study in early 2019.”

The Phase 2 T-Rex study is being conducted with support from Sanford Research, a Sanford Health subsidiary, a grant from the National Institute of Health and a grant from the California Institute for Regenerative Medicine.

[F1ash]

BASKING RIDGE, N.J. (December 1, 2017) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces today that David J. Mazzo, PhD, President and Chief Executive Officer of the Company, will present at the 10th Annual LD Micro Main Event on Thursday, December 7, 2017 at 10:30 a.m. PST at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.

Dr. Mazzo’s presentation will be webcast live on the internet and can be accessed by visiting the Investor Relations section of the Company’s website at www.caladrius.com. Following the presentation, a replay of the webcast will be archived on Caladrius’ website for 90 days.

[hbhmb]

you have an interesting sense of humour

[andy e]

CLBS beats estimates by 0.04 and the stock drops below 3 bucks... LMAO

[hbhmb]

on second thought,maybe they should be decreasing his salary
to nothing , which is what investors have been getting here
the last few years

time to sue them - outrageous....

[hbhmb]

increase salary when stock is hitting lower and lower.


what a flipping joke, no accountability , just the rich getting rich
again.


disgusting, he should be fired not rewarded , two set of rules
for the rich and then the working class


who makes this crap up anyway?

[F1ash]

Caladrius Biosciences to Host 2017 Third Quarter Business Update Conference Call on November 9, 2017 at 4:30 p.m. Eastern Time

BASKING RIDGE, N.J. (November 2, 2017) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces that the Company will release financial results for the three and nine months ended September 30, 2017 on Thursday, November 9, 2017.

Caladrius’ management will host a conference call for the investment community beginning at 4:30 p.m. ET on Thursday, November 9, 2017, to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S. Toll-free Dial-in), or 513-438-4106 (International Dial-in), and providing the conference ID: 6198497. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events.

Following the conclusion of the conference call, the webcast will be archived on the Company’s website for 90 days.

[akasidney86]

So there's been steady daily selling now since mid-august, and moving into a pre-binary event. Anybody seen anything out there that would lead to the conclusion that the results in the Sanford trials aren't good? Someone seems pretty sure they're not.

[Westsoco]

Thanks for the article F1ash!

[F1ash]

BASKING RIDGE, N.J. (October 2, 2017) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces the award of a $1,941,000 Small Business Innovative Research (“SBIR”) grant from the National Heart, Lung and Blood Institute of the National Institutes of Health (“NIH”) to support a clinical study with CLBS14 in patients with Coronary Microvascular Dysfunction (“CMD”). CLBS14 is Caladrius’ propriety CD34+ cell therapy and CMD is a disease manifested by reduced blood flow to the heart muscle, resulting in pain and dysfunction. Under the terms of the grant, the Company expects to receive approximately $750,000 in 2017 with the balance to be received in 2018 and 2019 in conjunction with the advancement of the study.

“One of the body’s natural responses to ischemia is the recruitment of CD34 cells with these cells being pre-programmed to repair damage to the small blood vessels, or microcirculation,” said Douglas W. Losordo, M.D., FACC, FAHA, and Chief Medical Officer of Caladrius Biosciences. “We are excited to advance the clinical development of our CD34+ cells in CMD as there are currently no therapies to address defects in the small blood vessels that contribute to the impairment of patients with acute and chronic ischemia, such as in CMD.”

“Our enthusiasm for this program is underscored by a strong body of preclinical and human clinical data that support CD34 cell therapy as having a beneficial effect in many cardiovascular and peripheral vascular diseases. We look forward to initiating a 20-patient Phase 2 proof-of-concept study of CLBS14 in patients with CMD in early 2018 with the vast majority of the necessary funding being provided by this grant award,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We are particularly pleased to be awarded this SBIR grant as it highlights the NIH’s strong interest in the development of therapies to treat CMD, while also supporting our strategy to advance our clinical pipeline and generate more opportunities within our product portfolio through non-dilutive grants and collaborations"

[RickShah]

900k shares registration, what do you make of it?
new to this board, hi everyone.
The shares were initially part of a private placement, to Sanford and others. Now they are being registered so they can be traded, i.e. sold by those investors. Meaning initially at the placement they were not yet registered. If i got this right.
Anything unusual about this or common business practice?

Then on a different note, does anyone here believe a CLI Japan partner is going to surface this year?
Its just too quiet in Caladrius land.
Thanks

[noretreat]

Yes it is difficult to understand. Perhaps there is some liability in the notes to the filings that does not show up on the balance sheet. Any analysts we could ask?

[F1ash]

Looks like the company could liquidate at over $5 per share.

Perhaps the greatest service they could do for investors would be to close up shop and give everyone a ~30% premium on the current share price. Strange indeed.

[noretreat]

Cash net of liabilities is 46 million. Market cap is 35 million. Must be something else on the balance sheet that is a drag on value. Looks like the company could liquidate at over $5 per share.