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ow hard question! LOL I really don't know, I think it will hit $10 easy BUT with stem cells being the future and if there trails become reality it could go so fa past $10! I think it could hit $50 but not in the next year or 2
I have been with this stock 3 years now and it acts like no other!! LOL The news is good BUT it always seems to go down on good news! I think in the next 6 months we will see this stock start to go up fast and hopefully furious!!!
I agree totally they also have CLBS20 Phase3 trail and PCT is starting to make good money! Everything is really looking up lately!!
I would not worry this stock has a ways to go yet but the wait will be worth it when it is over $10 someday! (Not in the next 4 days)
At 8:14 CLBS is up 0.21 cents 17.5% pre-market!!!
Seeking Alpha has put out a article also! Can be found here!
http://seekingalpha.com/article/3721776-caladrius-bio-from-pawnshop-to-boutique?page=2
Thanks for the post F1ash
http://www.sciencedaily.com/releases/2015/11/151125143736.htm
Immunotherapy for type 1 diabetes deemed safe in first US trial
Novel therapy aims to use patients' own immune cells to protect cells that produce insulin
Date:November 25, 2015 Source:University of California - San Francisco Summary:Patients experienced no serious adverse reactions after receiving infusions of as many as 2.6 billion cells that had been specially selected to protect the body's ability to produce insulin, report scientists and physicians at the end of a trial focused on a new type 1 diabetes immunotherapy approach.
FULL STORY
In the first U.S. safety trial of a new form of immunotherapy for type 1 diabetes (T1D), led by UC San Francisco scientists and physicians, patients experienced no serious adverse reactions after receiving infusions of as many as 2.6 billion cells that had been specially selected to protect the body's ability to produce insulin.
T1D is an autoimmune disease in which the immune system, which normally defends against infections, somehow goes awry and targets insulin-secreting cells, called beta cells, in the pancreas. Many T1D therapies aim to tackle this problem by suppressing the immune response, but that approach can have serious consequences, including an increased susceptibility to infection or cancer.
As reported in the Nov. 25, 2015, online issue of Science Translational Medicine, however, the cells used in the completed Phase 1 trial, known as regulatory T cells (Tregs; pronounced "tee-regs"), are instead based on the concept of "immune tolerance" -- these cells have the potential to dampen the immune system's assault on beta cells while leaving its infection-fighting capabilities intact.
"This could be a game-changer," said first author Jeffrey A. Bluestone, PhD, the A.W. and Mary Margaret Clausen Distinguished Professor in Metabolism and Endocrinology at UCSF. "For type 1 diabetes, we've traditionally given immunosuppressive drugs, but this trial gives us a new way forward. By using Tregs to 're-educate' the immune system, we may be able to really change the course of this disease."
The encouraging safety results from the trial, conducted at UCSF by Stephen E. Gitelman, MD, professor of pediatrics, and at Yale School of Medicine by Kevan C. Herold, MD, "support the development of a Phase 2 trial to test efficacy of the Treg therapy," the research team writes.
The infused Tregs used in the trial were derived from the trial participants' own cells, using an ex vivo (outside the body) "isolation and expansion" technique first described by Bluestone and colleagues in 2009.
In this procedure, doctors remove less than two cups of blood, which in T1D patients usually contain between 2 and 4 million of the desired Tregs, commingled with millions of cells of other types. Using a method known as fluorescence-activated cell sorting (FACS), which precisely segregates cells based on molecules they display on their surface, the therapeutic Tregs are separated and then placed into a growth medium in which they can attain a 1,500-fold increase in number.
Bluestone and colleagues have shown in previous work that Tregs recovered after this expansion are more functionally active, can repair defects in the immune system of patients with T1D and are more likely to survive long-term in the body than Tregs produced by other means.
The trial marked the first U.S. study in which large populations of Tregs created using these techniques were infused back into patients' circulation. Fourteen patients from 18 to 43 years old, all with recent-onset T1D, were organized into four groups that successively received infusions containing greater numbers of Tregs: members of the first group received about 5 million cells, and the fourth group about 2.6 billion cells.
In addition to being well tolerated by all four groups, the treatments were durable, with up to 25 percent of the infused therapeutic cells still detectable in patients' circulation a year after they had received just a single infusion.
The positive safety results from the trial are particularly reassuring, because in some instances T cells that were therapeutically introduced in cancer treatment have caused patients' immune systems to spiral out of control. Based on the Phase 1 data from this trial, New Jersey-based Caladrius Pharmaceuticals is now in the early stages of planning a Phase 2 trial of Tregs for T1D.
Trial participant Mary Rooney, 39, who was diagnosed with T1D four years ago, said she has experienced no side effects from Treg treatment. "The work of Dr. Bluestone and his team offers new hope for people with type 1 diabetes and other autoimmune disorders," Rooney said. "The Treg intervention aims to prevent the development and progression of type 1 diabetes, freeing people like me from the daily grind of insulin therapy and lifelong fear of complications. It's truly groundbreaking research with enormous potential."
In addition to their potential value as a diabetes therapy, said Bluestone, a member of the UCSF Diabetes Center, Tregs hold great promise as treatments for other autoimmune diseases such as rheumatoid arthritis and lupus, and even as therapies for cardiovascular disease, neurological diseases and obesity.
UCSF research on Tregs and other novel approaches to autoimmune diseases recently received a significant boost from the Parker Foundation, established this year by Silicon Valley entrepreneur and philanthropist Sean Parker. In November, the foundation donated $10 million to establish the Sean N. Parker Autoimmunity Research Laboratory, with Bluestone as the laboratory's inaugural director.
"Using a patient's own cells -- identifying them, isolating them, expanding them, and infusing them back into the patient -- is an exciting new pillar for drug development," said Bluestone, "and we expect Tregs to be an important part of diabetes therapy in the future."
Story Source:
The above post is reprinted from materials provided by University of California - San Francisco. Note: Materials may be edited for content and length.
Thank You Lunatick for all the post! I am so sick I am down for the count! Got my flu shot and have been deathly sick ever since! Going on day 7 and getting worse! LOL
Thanks for the articles Lunatick
Caladrius Biosciences Presents Additional Data Supporting Lead Product Candidate for Metastatic Melanoma at SITC 2015
Presentations reiterate improved survival rate of treated subjects in the Company’s Phase 2 trial and provide preliminary correlation between treatment and expectation of efficacy
BASKING RIDGE, N.J. (November 9, 2015) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius”), a company combining a leading cell therapy service provider with a therapeutics pipeline including a Phase 3 clinical program in immuno-oncology, announces today that the Company presented two posters including new clinical and analytical data at the Society for Immunotherapy of Cancer (SITC) 2015 Annual Meeting, which took place from November 4-8 in Baltimore, Maryland.
The data, drawn from ongoing analysis and follow-up from a completed Phase 2 study, further support the technology being explored in a currently enrolling Phase 3 clinical trial to investigate Caladrius’ lead product candidate, CLBS20, for the treatment of metastatic melanoma.
Data highlights included:
•A new subset analysis of patient results from a 42-patient, open-label, randomized Phase 2 trial that compared the treatment effects of CLBS20 (n=18) versus a control group of irradiated tumor cells alone (n=24). The analysis concluded that CLBS20 immunotherapy was associated with improved survival in each of the four different subsets defined by the stratification variables (namely measurable or non-measurable disease as defined by RECIST and most advanced stage of disease being stage IV or recurrent stage III – see below for associated table).
•A series of studies undertaken by the company to elucidate mechanism of action and support expectation of efficacy for CLBS20 in which the data supported the tumor-initiating properties and the antigenic potential of the self-renewing cancer-initiating cells that Caladrius isolates in its manufacturing process. The data also indicate a statistically significant relationship between immune response triggered by CLBS20 and overall survival of melanoma patients. The analysis showed decreases in multiple tumor and inflammation markers at four weeks after baseline in responding patients treated with CLBS20.
The first poster presentation, titled “Superiority of Dendritic Cell Vaccine vs Tumor Cell Vaccine: Survival by stratification subsets in MACVAC randomized phase II trial of patient-specific vaccines utilizing antigens from autologous melanoma tumor cell lines,” described analyses of updated survival data that previously had not been presented. Statistical significance could not be reached due to the size of the subsets; however, the analyses demonstrated a clear trend towards improved survival in all subsets.
The second poster presentation, titled “Functional Properties of Patient-Derived Melanoma Cancer Stem Cells,” presented data demonstrating the tumor initiating nature of the purified cell lines used in CLBS20 manufacturing and a pathway analysis using serum markers suggestive for the mechanism of action of CLBS20 and immune response of treated patients. The data analysis identified potential predictive markers of survival, and identified markers that typified low responders. In short, the data support Caladrius’ expectation of efficacy for CLBS20 and suggest the potential to identify the patients for whom the experimental treatment might be most effective.
The posters are available on the Caladrius website at www.caladrius.com/sitc2015posters.
Treatment Effect per Subsets Defined by Stratifications in Phase 2
Here is all I have to say about the PPS from the 3rd quarter results PPPPFFFFTTTT!!!!
Good article! Thanks for the post!
I know it is pre-market BUT HOLY SH*T>>>>>>
Caladrius Biosciences, Inc. (CLBS) Pre-Market Trading
CLBS $2.05 * 0.74 56.49%
http://www.nasdaq.com/symbol/clbs/premarket
YES we did beat, and revenues blew me away!!
Caladrius Biosciences Announces Third Quarter 2015 Financial Results and Provides Corporate Update
Revenues Increase 43% Driven by Growth in Clinical Services at PCT Subsidiary
BASKING RIDGE, N.J. (November 5, 2015) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius”), a company combining a leading cell therapy service provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, announces financial results for the three months ended September 30, 2015.
Business Highlights
•Total revenues for the third quarter of 2015 increased 43% to $5.9 million when compared with $4.1 million in the year-ago third quarter, driven by increases in Clinical Service revenue at the Company’s PCT subsidiary, an external development and manufacturing partner for the growing cell therapy industry
•PCT entered into a long-term dedicated capacity agreement with IRX Therapeutics, Inc. to support their anticipated clinical trial manufacturing needs including the manufacture of EU-compliant cell therapy product, adding to a growing list of immuno-oncology clients with similar arrangements including Kite Pharma and ImmunoCellular Therapeutics
•Continued patient enrollment in a Phase 3 clinical study of lead product candidate CLBS20 for the treatment of recurrent Stage III or Stage IV metastatic melanoma
•Presented data elucidating the mechanism of action of CLBS20, suggesting correlations between a distinct immune response triggered by CLBS20 and overall survival of melanoma patients
•Received an initial award of $300,000 out of a potential award of up to $2.3 million from the National Cancer Institute to fund the first phase of a project for process optimization of CLBS20
•Entered into a collaboration agreement with Sanford Research to develop CLBS03, the Company’s T regulatory cell therapy product candidate, for the treatment of adolescents with recent-onset type 1 diabetes, which the Company expects to advance to a Phase 2 clinical study in early 2016
•Promoted Joseph Talamo to Chief Financial Officer and Todd Girolamo to General Counsel.
Management Commentary
“PCT continues to post strong revenue growth, which we expect to continue as the immuno-oncology sector is experiencing industry-wide advances and there are increasing numbers of such products on the market and in development. We expect PCT to continue to capitalize on its unmatched cell development and manufacturing expertise as industry demand for cell therapy services continues to grow,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “In addition, we continued to advance our own clinical development programs in immuno-oncology (CLBS20) and immune modulation (CLBS03), while maintaining financial discipline that allowed us to lower our cash burn.”
2015 Third Quarter Financial Highlights
Total revenue for the third quarter of 2015 increased 43% to $5.9 million compared with $4.1 million for third quarter of 2014, primarily due to higher reported Clinical Services revenues at PCT.
Research and development expenses in the third quarter of 2015 decreased 24% to $6.3 million compared with $8.5 million for the third quarter of 2014. The decrease was primarily related to lower costs associated with the Company’s ischemic repair and immune modulation programs. The lower costs were partially offset by increased expenses associated with the Intus Phase 3 clinical trial that initiated in 2015.
Selling, general and administrative expenses were approximately $5.1 million for the third quarter of 2015 compared with $7.9 million for same period in 2014. The decrease was primarily due to lower equity-based compensation expenses in the current quarter compared with a year ago and, to a lesser extent, lower expenses associated with other general and administrative activities.
The net loss for the third quarter of 2015 was approximately $11.4 million or $0.21 per share, compared with a net loss of $17.2 million or $0.48 per share for same period in 2014.
As of September 30, 2015, Caladrius had cash, cash equivalents and marketable securities of $29.4 million.
Conference Call
As previously announced, Dr. Mazzo and Mr. Talamo will host a conference call to discuss results and provide a company update today at 5:00 pm Eastern time. To participate in the conference call, dial 877-562-4460 (U.S.) or 513-438-4106 (international) and provide conference ID 95709215. To access the live webcast, visit the Investor Relations section of the Company’s website at http://www.caladrius.com/events.
Caladrius Biosciences, Inc. Selected Financial Data (unaudited)
(in thousands, except per share data)
Three Months Ended
September 30, Nine Months Ended
September 30,
2015 2014 2015 2014
Statement of Operations Data:
Revenues $5,888 $4,118 $14,928 $12,662
Costs and expenses:
Cost of revenues 4,809 4,012 13,976 11,515
Research and development 6,316 8,470 20,720 19,025
Impairment of intangible assets - - 9,400 -
Selling, general, and administrative 5,147 7,894 24,971 24,310
Total operating costs and expenses 16,271 20,376 69,068 54,850
Operating loss (10,383) (16,258) (54,140) (42,188)
Other income (expense), net (410) (687) 4,399 (1,063)
Interest expense (553) (183) (1,651) (384)
Loss before income taxes and noncontrolling interests (11,346) (17,129) (51,392) (43,634)
Provision (benefit) for income taxes 47 47 (3,610) 142
Net loss (11,393) (17,177) (47,782) (43,776)
Less - net income from continuing operations attributable to noncontrolling interests (17) (202) (93) (515)
Net loss attributable to Caladrius Biosciences, Inc. common stockholders $(11,376) $(16,974) $(47,689) $(43,261)
Basic and diluted loss per share attributable to Caladrius Biosciences, Inc. common shareholders $(0.21) $(0.48) $(1.04) $(1.37)
Weighted average common shares outstanding 55,239 35,053 45,868 31,663
September 30, 2015 December 31, 2014
Balance Sheet Data:
Cash, cash equivalents, and marketable securities $29,392 $26,254
Total assets 119,703 126,275
Total liabilities 64,706 68,202
Total equity 54,996 58,074
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 immune modulation and ischemic repair. 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, Immune Modulation Program, Ischemic Repair 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 totally agree with you Akasidney86 ((LETS DANCE))LOL
I really hope so Hbhmb, I have been in this stock to long and it has just gone down, I am hoping for the golden ring someday!
Caladrius Biosciences to Present at Multiple Upcoming November Conferences
Presentations to highlight Company's therapeutic development programs and expertise
BASKING RIDGE, N.J. (November 2, 2015) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius”), a company combining a leading cell therapy service provider with a therapeutics pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of earlier clinical phase projects in immune modulation and ischemic repair, announces today that the Company’s leadership, experts and related research investigators will present at three conferences in November.
SITC 2015 30th Anniversary Annual Meeting & Associated Programs •Website: http://www.sitcancer.org/2015/
•Venue: Gaylord National Hotel & Convention Center, National Harbor, Maryland
•Date and Time: Thursday, November 5, 2015, 4:00 PM ET
Session 1 •Presenter: Robert Dillman, MD, Vice President, Oncology
•Poster Topic: Superiority of Dendritic Cell Vaccine vs Tumor Cell Vaccine: Survival by stratification subsets in MACVAC randomized phase II trial of patient-specific vaccines utilizing antigens from autologous melanoma tumor cell lines
Session 2 •Presenter: Gabriel Nistor, MD, Vice President, Research
•Poster Topic: Functional Properties of Patient-Derived Melanoma Cancer Stem Cells
American Heart Association Scientific Sessions 2015 •Website: http://scientificsessions.org
•Venue: Orange County Convention Center, Orlando, Florida
Session 1 •Date and Time: Monday, November 9, 2015, 9:00 AM ET
•Session Moderator: Douglas Losordo, MD, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Biological Therapies in Peripheral Artery Disease: Current Standards and Concepts
Session 2 •Date and Time: Monday, November 9, 2015, 9:24 AM ET
•Presenter: Douglas Losordo, MD, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: CD34 Positive Cells in PAD: Current Evidence
Session 3 •Date and Time: Monday, November 9, 2015, 4:15 PM ET
•Presenter: Arshed A. Quyyumi, MD, Professor of Medicine at Emory University, Lead Principal Investigator of PreSERVE-AMI study
•Topic: Infused CD34 Cell Dose, Not Bone Marrow CD34+ Cell Content, Improves Clinical Outcomes and LVEF in Patients with Left Ventricular Dysfunction Post STEMI: Results of the PreSERVE-AMI trial
Society for Melanoma Research 2015 Congress •Website: http://www.melanomacongress.com/
•Venue: San Francisco Marriott Marquis, San Francisco, California
•Date and Time: Wednesday, November 18, 2015, 7:30 PM PT
Session 1 •Presenter: Robert Dillman, MD, Vice President, Oncology
•Poster Topic: Superiority in a Randomized Trial of Patient-Specific Dendritic Cell/Tumor Cell Vaccines vs Tumor Cell Vaccines in Subsets Defined by Disease Stage, Tumor Measurability, and Lactate Dehydrogenase (LDH) level
Session 2 •Presenter: Gabriel Nistor, MD, Vice President, Research
•Poster Topic: Mechanism of Action of CLBS20, A Patient-Specific Immunotherapy Targeting Metastatic Melanoma
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 a proprietary platform technology for immuno-oncology, as well as additional platform technologies for immunomodulation and ischemic repair. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. For more information, visit 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, Immune Modulation Program, Ischemic Repair 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 and very curious how many they have enrolled! Would be nice to see a high number or all of them enrolled since there are a lot of people in this category that need help!!
I hope so Hbhmb, that would be so nice! I like you noticed the increase and was surprised BUT it should be higher for phase 3 anyway. Then you get the day traders that put money in on the chance it goes up and they dump right away!
Caladrius Biosciences to Host Third Quarter 2015 Financial Results Conference Call on November 5 at 5:00 pm
October 29, 2015
Basking Ridge, N.J., Oct. 29, 2015 — Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius”), a company combining a leading cell therapy service provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, today announced that the Company will release financial results for the three and nine months ended September 30, 2015, after the market close on Thursday, November 5, 2015.
Caladrius’ management will host a conference call for the investment community beginning at 5:00 pm ET on Thursday, November 5, 2015, to discuss the financial results and to answer questions.
Shareholders and other interested parties may participate in the conference call by dialing (877) 562-4460 (US) or (513) 438-4106 (International) and entering passcode 95709215. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events.
The call will be archived on the Company’s website for 90 days at www.caladrius.com/events.
Meeting on the Mesa>>Published on Oct 22, 2015
David Mazzo, Ph.D., CEO
Basking Ridge, NJ
(NASDAQ: CLBS)
This is a YouTube Video (go get your popcorn ready then click here>>
Good article, I liked it, I also think it is a very true description!!
Press Release
Caladrius Biosciences Announces Management and Board Changes
Published: Oct 8, 2015 7:30 a.m. ET
http://www.marketwatch.com/story/caladrius-biosciences-announces-management-and-board-changes-2015-10-08
Promotes Joseph Talamo to Chief Financial Officer and Todd Girolamo to General Counsel
BASKING RIDGE, N.J., Oct 08, 2015 (GLOBE NEWSWIRE via COMTEX) --
Caladrius Biosciences, Inc. CLBS, +2.19% ("Caladrius"), a company combining a leading cell therapy service provider with a therapeutics pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of earlier clinical phase projects in immune modulation and ischemic repair, announces the promotions of Joseph Talamo from Vice President, Corporate Controller and Chief Accounting Officer to Chief Financial Officer and Todd Girolamo, Esq. from Vice President, Legal to General Counsel. In addition, the Company announces that Robert S. Vaters, is no longer serving as an employee of the Company and has resigned from the Company's board of directors.
"Bob Vaters joined Caladrius in January 2015 to help me accelerate the Company's near-term organizational and strategic evolution. He has been instrumental in identifying and affecting multiple changes that have contributed to the Company's new course. We greatly appreciate the contributions he made and wish him continued success in his future endeavors," said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius Biosciences.
"We are delighted to promote Joe and Todd, both experienced executives who have demonstrated their leadership, competence and diligence in the execution of their duties. I am confident each will continue to contribute meaningfully to the Company's success as we expand our leadership position as the premier cell therapy service provider and advance our pipeline of clinical development programs," added Dr. Mazzo.
Joseph Talamo
Mr. Talamo joined Caladrius in 2011. He is a versatile finance executive with leadership experience in publicly-traded development and commercial-stage companies, along with a strong background in SEC compliance. He has led companywide forecasting, planning and analysis activities, including for M&A, and has had extensive experience with integrating transactions and raising capital. At Caladrius, Mr. Talamo has been responsible for numerous financial functions including SEC reporting, forecasting, planning and analysis, cash management and accounting.
Prior to joining Caladrius, from 1996 to 2010 Mr. Talamo held various senior positions at OSI Pharmaceuticals, Inc., a publicly-traded biopharmaceutical company focused on cancer, diabetes and obesity, most recently as Vice President and Corporate Controller. At OSI, Mr. Talamo helped build the accounting and finance infrastructure to support the clinical development and commercial launch of Tarceva(R), OSI's targeted therapy approved by the FDA for the treatment of patients with non-small cell lung cancer and pancreatic cancer. Prior to OSI, Mr. Talamo worked at Bristol-Myers Squibb from 1995 to 1996 in the Financial Reporting and Consolidations Group, and at KPMG from 1993 to 1995 in the Health Care and Life Sciences Audit Group.
Mr. Talamo received a Bachelor of Business Administration in Accounting from Hofstra University and a Master of Business Administration in Finance from Hofstra University. Mr. Talamo is a certified public accountant in the State of New York.
Todd Girolamo
Todd Girolamo joined Caladrius in 2011. He is a seasoned attorney specializing in health-related products and businesses. As a member of the Caladrius senior management team, Mr. Girolamo has been responsible for managing all legal aspects of the Company's research and development pipeline, from preclinical research to multinational pivotal clinical trials, including academic and corporate collaborations. He has been responsible for the Company's licensing activities, the strategy, maintenance and prosecution of the Company's extensive global patent estate and the management of all litigation involving the Company and its subsidiaries.
Mr. Girolamo began his legal career as an associate at Cahill Gordon & Reindel, and concluded his tenure in private practice at Reid & Priest, where he gained expertise as a general commercial litigator, practicing in the areas of intellectual property, securities law, employment law and bankruptcy. In addition to over a decade of experience as both corporate counsel and private practitioner, Mr. Girolamo spent 12 years on Wall Street where he specialized in therapeutic healthcare equity securities at Oppenheimer & Co., CIBC World Markets, Leerink Swann & Company and Summer Street Research Partners.
Mr. Girolamo received a Bachelor of Arts from Harvard College, a Juris Doctor from the University of Pennsylvania Law School and a Master of Business Administration from Columbia Business School.
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.
Been looking BUT no new news
Have not heard anything yet! I know they enrolled there first patient BUT that is all they have said.
Caladrius Biosciences to Present at Multiple Upcoming October Conferences
October 1, 2015
Presentations to Highlight Company’s Cell Therapy Manufacturing and Therapeutic Development Programs
BASKING RIDGE, N.J. (October 1, 2015) – Caladrius Biosciences, Inc. (NASDAQ: CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, announces today that the Company’s management will present at multiple conferences in October.
Stem Cell Meeting on the Mesa
•Website: stemcellmeetingonthemesa.com
•Venue: Estancia La Jolla Hotel, La Jolla, California
Session 1
•Date and Time: Wednesday, October 7, 2015, 7:15 AM PT
•Session Chair: Robert Preti, Senior Vice President, Development and Technical Operations and Chief Technology Officer, Caladrius; President of PCT
•Topic: Manufacturing & Scale-Up Workshop: Application of Traditional Drug & Biologics Development Principles to Regenerative Medicine
Session 2
•Date and Time: Wednesday, October 7, 2015, 11:00 AM PT
•Presenter: David Mazzo, Chief Executive Officer
•Topic: Company Presentation
Session 3
•Date and Time: Friday, October 9, 2015, 10:15 AM PT
•Poster Presenter: Candice Junge, Associate Vice President, Clinical Strategy and Commercial Assessment
•Topic: Evaluation of Safety & Efficacy of Autologous Ex Vivo Expanded TRegs (CLBS03) for the Treatment of New Onset Type 1 Diabetes Mellitus in an Adolescent Population
Session 4
•Date and Time: Friday, October 9, 2015, 10:15 AM PT
•Presenter: Gabriel Nistor, Vice President, Research
•Topic: Functional Properties of Patient-derived Melanoma Cancer Stem Cells Utilized as Treatment for Metastatic Melanoma in a Phase III Clinical Trial
Transcatheter Cardiovascular Therapeutics (TCT) 2015
•Website: http://www.crf.org/tct
•Venue: The Moscone Center, San Francisco, California
Session 1
•Date and Time: Thursday, October 15, 2015, 2:23 PM PT
•Lecturer: Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Cell-Based Therapies Prevent and Cure Heart Failure: More Than an Adventure
Session 2
•Date and Time: Thursday, October 15, 2015, 2:50 PM PT
•Discussant: Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Stem Cell Advances: Targeting Heart Failure
Session 3
•Date and Time: Thursday, October 15, 2015, 5:02 PM PT
•Discussant: Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Stem Cell Therapy Clinical Trials: Yes, We Can!
Cardiac Research Safety Consortium Sponsored Workshop for Cardiovascular Safety for Cell Therapies in Development for Cardiovascular Indications
•Date and Time: Friday, October 23, 2015, 10:35 AM ET
•Website: http://clbs.bio/csrcOct2015
•Venue: Sheraton College Park North Hotel, Beltsville, Maryland
•Presenter: Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Is Demonstration of Dose Dependency Required for Establishing Safety and Bioactivity
Cavendish Global Health Impact Forum
•Dates: Sunday, October 25 – Wednesday, October 28, 2015
•Website: http://cavendishglobal.com/2015-cleveland-clinic/
•Venue: Cleveland Clinic, Cleveland, Ohio
•Presenter: David Mazzo, Chief Executive Officer
•Topic: Company Presentation
2015 Till and McCulloch Meetings
•Date and Time: Tuesday, October 27, 2015, 11:25 AM ET
•Website: http://clbs.bio/tillmc15
•Venue: Sheraton Centre Hotel Toronto, Toronto, Ontario
•Presenter: Hans Keirstead, Senior Vice President, Research and Chief Science Officer
•Topic: Tumor-Initiating Cell-Based Immunotherapy for Cancer
Sofinnova Japan Biopharma Partnering Conference
•Date and Time: Tuesday, October 27, 2015, 9:05 AM JST
•Website: http://www.sofinnovajapanpartnering.com/
•Venue: Conrad Hotel, Tokyo, Japan
•Presenter: Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Company Presentation
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 a 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. For more information, visit 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.
Thank You Lunatick! I love this part!>>>Furthermore, the data suggest correlations between a distinct immune response triggered by CLBS20 and overall survival of melanoma patients. OVERALL SURVIVAL !!!
Thanks F1ash!!! Hopefully with all the good that is starting to show up the PPS will show up!!
Somebody had posted on another board they had to go down and fill a gap at $1.85 well that is done so maybe upward and on ward!!! Thanks again for the new post Lunatick!
WOW you think they would have posted that on there site!! Nice find Lunatick!!!
Thank You!! I also would like to thank Lunatick for all the great posts!
Thank you for the post! ((You beat me to it, LOL)
I can not get the link you posted to load????
http://www.telegraphindia.com/pressrelease/prnw/en01983.html#.VfgsjlXtlBc
Yes that is where I found my article!!
Dillman, R.O., et al. (2015) Dendritic Versus Tumor Cell Presentation of Autologous Tumor Antigens for Active Specific Immunotherapy in Metastatic Melanoma: Impact on Long-Term Survival by Extent of Disease at the Time of Treatment. Cancer biotherapy and radiopharmaceuticals, doi: 10.1089/cbr.2015.1843.
http://online.liebertpub.com/doi/pdfplus/10.1089/cbr.2015.1843
WOW that was a good find and a good article Lunatick! I do not know why they do not post these on there site to get attention?? I actually think it would help the stock!!!